Just after Hurricanes Gustav and Ike wreaked havoc, I posted on price gouging going on in Florida and Georgia.
It's been about a month. What has happened?
Florida:
A Florida gas station accused of price gouging after Hurricane Ike has agreed to reimburse anyone with a receipt who was overcharged for gasoline, under a settlement with the state attorney general.
Kelly Junior #9, a gas station in Quincy, Fla., will also pay the American Red Cross $2,000 under terms of the agreement and pay the costs of the state's investigation into the price gouging.
The price of unleaded gasoline at Kelly Junior #9, individually owned by S and K of Quincy, Inc., increased twice on September 12, starting at $3.99 and ending at $4.29.
That's one of 4,000 being investigated.
Georgia:
Nearly 150 Georgia gas stations are having to defend why they charged inflated prices after Hurricanes Gustav and Ike made fuel scarce over the past month.
The state has subpoenaed sales records from businesses following complaints from 1,500 customers angry over what they were paying at the pump. State officials received reports of gas as high as $9.99 a gallon for regular unleaded, said Bill Cloud, spokesman for the Governor's Office of Consumer Affairs.
He said his office is still getting a few dozen calls a day about gas prices.
One station in Cobb County was charging $8.82 a gallon, and a Houston County gas station was asking customers to pay $7 per gallon, Cloud said.
Source here.
How many will ultimately be found to have gouged GA consumers? Does it really take a month to figure out that charging $9.99 is gouging?
Wednesday, October 08, 2008
Eli Lilly to pay $62 million in Zyprexa settlement
From Reuters:
Lilly, has settled Zyprexa claims for $62 million. Zyprexa is Lilly's biggest product, with global sales of $4.76 billion in 2007.
The settlement with 32 states and the District of Columbia ends an 18-month investigation of the Indianapolis-based company, which had been accused of promoting the drug for unapproved off-label uses and of playing down side effects such as weight gain, which can increase the risk for diabetes.
Source here.
Lilly, has settled Zyprexa claims for $62 million. Zyprexa is Lilly's biggest product, with global sales of $4.76 billion in 2007.
The settlement with 32 states and the District of Columbia ends an 18-month investigation of the Indianapolis-based company, which had been accused of promoting the drug for unapproved off-label uses and of playing down side effects such as weight gain, which can increase the risk for diabetes.
Source here.
Total Body Formula Lawsuit: State Court Hearing 10/13/08
On Monday October 13, 2008 at 9:00 a.m. in Decatur, GA Judge A. Wong will hold the first hearing on cases involving folks who claim they were injured by a supplement known as Total Body Formula and Total Body Mega Formula.
I and others will attend. Judge Wong will consider a proposed Case Management Order on the currently filed cases.
Stay tuned.
I and others will attend. Judge Wong will consider a proposed Case Management Order on the currently filed cases.
Stay tuned.
Friday, October 03, 2008
Raptiva Brain Link?
From Bloomberg:
A patient taking its drug for chronic psoriasis, Raptiva, has developed a rare brain infection.
The infection, progressive multifocal leukoencephalopathy, or PML, was linked to a 70-year-old who received Raptiva for more than four years.
For more go here.
A patient taking its drug for chronic psoriasis, Raptiva, has developed a rare brain infection.
The infection, progressive multifocal leukoencephalopathy, or PML, was linked to a 70-year-old who received Raptiva for more than four years.
For more go here.
Tuesday, September 30, 2008
More Misleading Pharma Ads (FDA sez)
The FDA sent letters to Lilly, J&J, Novartis, Shire, and Covidien' Mallinckrodt with complaints about certain promotions.
Shire drew objections for a webpage and video testimonial posted on YouTube featuring television celebrity designer Ty Pennington. Both overstated the efficacy of Adderall XR, and the video left out important risk information, the FDA said.
Go here for the source.
Shire drew objections for a webpage and video testimonial posted on YouTube featuring television celebrity designer Ty Pennington. Both overstated the efficacy of Adderall XR, and the video left out important risk information, the FDA said.
Go here for the source.
FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease"
From the FDA site:
A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.
"The FDA's review, which began in 2007, is an example of the agency working to analyze products - throughout their lifecycle - to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.
The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.
Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.
Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.
More here.
A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.
"The FDA's review, which began in 2007, is an example of the agency working to analyze products - throughout their lifecycle - to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.
The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.
Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.
Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.
More here.
Georgia Federal Court: Recent Daubert Ruling
You can see it by going to Slideshare.net. The nutshell version: Daubert should only apply to junk science.
Friday, September 26, 2008
Zimmer Hip Cup Recall
Zimmer Holdings, the largest producer of orthopedic devices in the United States, recently halted sales of a hip replacement implant which has been failing in unacceptably high numbers. The Durom Cup hip socket implant, introduced by Zimmer in 2006, has been implanted in over 13,000 patients across the nation. Of those, doctors say that hundreds will most likely need to undergo more expensive and painful surgery to replace the replacement.
Over 5% of patients implanted with the Zimmer Durom Cup hip replacement experience serious problems, according to research conducted by the company and orthopedic surgeons. In these patients, the metal hip implant fails to bond properly with the existing bone structure. Instead, the metal socket loosens and separates, grinding painfully against bone as it moves.
Although Zimmer Holdings was alerted to problems with its Durom Cup hip replacement as early as 2007, it did not launch an investigation until April 2008, and did not cease its sales of the defective device until July 2008. Because of the company’s delay, even more unsuspecting patients were implanted with the faulty Durom Cup hip replacement. Each may need hip replacement surgery, which is a lengthy and expensive procedure, costing anywhere from $30,000 to $40,000.
The Zimmer Durom Cup Hip Implant – A Timeline
2006 – The Zimmer Durom Cup hip implant is introduced. A metal hip socket replacement originally designed for a 15- to 20-year lifespan to accommodate young, active patients, the Durom Cup implant begins to show signs of trouble not long after its debut.
2007 – Prominent orthopedic surgeon Dr. Lawrence Dorr, alerts Zimmer Holdings, the implant’s manufacturer, after noticing that the Zimmer hip replacement implant has an abnormally high failure rate. Dorr states that many of his patients return to his office complaining of extreme pain only months after undergoing hip replacement surgery. Despite Dorr’s extensive experience, Zimmer Holdings blames the implant failures on Dorr’s surgical technique and brushes the warning aside.
2008 – In April, Dr. Dorr goes public with his concerns, warning other orthopedic surgeons against using the Durom Cup hip implant. Zimmer responds by launching an investigation, but refuses to take any further action for months. In July 2008, after its own investigation reveals an implant failure rate of over 5%, Zimmer suspends sales of the device but promises to resume business after doctors are trained to ‘properly’ install the implant.
Over 5% of patients implanted with the Zimmer Durom Cup hip replacement experience serious problems, according to research conducted by the company and orthopedic surgeons. In these patients, the metal hip implant fails to bond properly with the existing bone structure. Instead, the metal socket loosens and separates, grinding painfully against bone as it moves.
Although Zimmer Holdings was alerted to problems with its Durom Cup hip replacement as early as 2007, it did not launch an investigation until April 2008, and did not cease its sales of the defective device until July 2008. Because of the company’s delay, even more unsuspecting patients were implanted with the faulty Durom Cup hip replacement. Each may need hip replacement surgery, which is a lengthy and expensive procedure, costing anywhere from $30,000 to $40,000.
The Zimmer Durom Cup Hip Implant – A Timeline
2006 – The Zimmer Durom Cup hip implant is introduced. A metal hip socket replacement originally designed for a 15- to 20-year lifespan to accommodate young, active patients, the Durom Cup implant begins to show signs of trouble not long after its debut.
2007 – Prominent orthopedic surgeon Dr. Lawrence Dorr, alerts Zimmer Holdings, the implant’s manufacturer, after noticing that the Zimmer hip replacement implant has an abnormally high failure rate. Dorr states that many of his patients return to his office complaining of extreme pain only months after undergoing hip replacement surgery. Despite Dorr’s extensive experience, Zimmer Holdings blames the implant failures on Dorr’s surgical technique and brushes the warning aside.
2008 – In April, Dr. Dorr goes public with his concerns, warning other orthopedic surgeons against using the Durom Cup hip implant. Zimmer responds by launching an investigation, but refuses to take any further action for months. In July 2008, after its own investigation reveals an implant failure rate of over 5%, Zimmer suspends sales of the device but promises to resume business after doctors are trained to ‘properly’ install the implant.
Ex-Medtronic Lawyer: Company took Docs to Strip Club
From the Minneapolis paper:
'A whistleblower lawsuit against Medtronic Inc. that highlighted perks allegedly paid to doctors was filed by one of the company's lawyers, according to a report today in the Wall Street Journal. The legal action was ultimately settled in 2006 for $40 million.'
The suit, filed by former senior legal counsel Ami P. Kelley, claimed that the company lavished spine surgeons with a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in.
Link.
OK, so why does this matter? Senator Grassley has been investigating such activities to determine if the perks offered by Medtronic to doctors induce them to use the company's spine products in "off-label" ways not approved by the Food and Drug Administration (FDA). The FDA has warned that surgeons' off-label use of a Medtronic bone graft called Infuse has led to potentially life-threatening side effects in dozens of patients.
The Infuse Bone Graft has been claimed to cause complications when used in surgeries on the cervical spine, or the area around the neck. The bone protein is approved for use in a variety of spinal, oral and dental graft procedures, but the paper reported that Infuse has been linked to complications when used in "off-label" procedures, or operations for which is has not specifically been approved.
Earlier this summer, the FDA warned doctors that it could cause dangerous complications when used in neck surgeries. The complications included swelling that caused difficulty in swallowing, breathing and speaking, which in some cases lead to tracheotomies and further surgeries. Source here.
'A whistleblower lawsuit against Medtronic Inc. that highlighted perks allegedly paid to doctors was filed by one of the company's lawyers, according to a report today in the Wall Street Journal. The legal action was ultimately settled in 2006 for $40 million.'
The suit, filed by former senior legal counsel Ami P. Kelley, claimed that the company lavished spine surgeons with a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in.
Link.
OK, so why does this matter? Senator Grassley has been investigating such activities to determine if the perks offered by Medtronic to doctors induce them to use the company's spine products in "off-label" ways not approved by the Food and Drug Administration (FDA). The FDA has warned that surgeons' off-label use of a Medtronic bone graft called Infuse has led to potentially life-threatening side effects in dozens of patients.
The Infuse Bone Graft has been claimed to cause complications when used in surgeries on the cervical spine, or the area around the neck. The bone protein is approved for use in a variety of spinal, oral and dental graft procedures, but the paper reported that Infuse has been linked to complications when used in "off-label" procedures, or operations for which is has not specifically been approved.
Earlier this summer, the FDA warned doctors that it could cause dangerous complications when used in neck surgeries. The complications included swelling that caused difficulty in swallowing, breathing and speaking, which in some cases lead to tracheotomies and further surgeries. Source here.
Spirivia and Atrovent Slammed by JAMA
So says Medline Plus. You can access the JAMA abstract here.
The drugs Spirivia and Atrovent are prescribed for chronic obstructive pulmonary disease (COPD), and according to a recent report, each is associated with an increased risk of heart attack, stroke and other cardiovascular problems.
Spiriva and Atrovent are the most commonly prescribed once a day drug for treatment for COPD.
Chronic obstructive pulmonary disease (COPD) is a lung disease in which the lungs are damaged, making it hard to breathe. In COPD, the airways—the tubes that carry air in and out of your lungs—are partly obstructed, making it difficult to get air in and out.
Cigarette smoking is the most common cause of COPD. Most people with COPD are smokers or former smokers. Breathing in other kinds of lung irritants, like pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD.
The airways branch out like an upside-down tree, and at the end of each branch are many small, balloon-like air sacs called alveoli (al-VEE-uhl-EYE). In healthy people, each airway is clear and open. The air sacs are small and dainty, and both the airways and air sacs are elastic and springy. When you breathe in, each air sac fills up with air like a small balloon; when you breathe out, the balloon deflates and the air goes out. (See the How the Lungs Work section for details.) In COPD, the airways and air sacs lose their shape and become floppy. Less air gets in and less air goes out because:
* The airways and air sacs lose their elasticity (like an old rubber band).
* The walls between many of the air sacs are destroyed.
* The walls of the airways become thick and inflamed (swollen).
* Cells in the airways make more mucus (sputum) than usual, which tends to clog the airways.
Source.
There was a 58 percent increased risk of cardiac death, heart attack or stroke in people taking these drugs according to Dr. Sonal Singh, assistant professor of internal medicine at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. Singh was lead author of a paper published in the Sept. 24 issue of the Journal of the American Medical Association.
Medline Plus link is here.
The drugs Spirivia and Atrovent are prescribed for chronic obstructive pulmonary disease (COPD), and according to a recent report, each is associated with an increased risk of heart attack, stroke and other cardiovascular problems.
Spiriva and Atrovent are the most commonly prescribed once a day drug for treatment for COPD.
Chronic obstructive pulmonary disease (COPD) is a lung disease in which the lungs are damaged, making it hard to breathe. In COPD, the airways—the tubes that carry air in and out of your lungs—are partly obstructed, making it difficult to get air in and out.
Cigarette smoking is the most common cause of COPD. Most people with COPD are smokers or former smokers. Breathing in other kinds of lung irritants, like pollution, dust, or chemicals, over a long period of time may also cause or contribute to COPD.
The airways branch out like an upside-down tree, and at the end of each branch are many small, balloon-like air sacs called alveoli (al-VEE-uhl-EYE). In healthy people, each airway is clear and open. The air sacs are small and dainty, and both the airways and air sacs are elastic and springy. When you breathe in, each air sac fills up with air like a small balloon; when you breathe out, the balloon deflates and the air goes out. (See the How the Lungs Work section for details.) In COPD, the airways and air sacs lose their shape and become floppy. Less air gets in and less air goes out because:
* The airways and air sacs lose their elasticity (like an old rubber band).
* The walls between many of the air sacs are destroyed.
* The walls of the airways become thick and inflamed (swollen).
* Cells in the airways make more mucus (sputum) than usual, which tends to clog the airways.
Source.
There was a 58 percent increased risk of cardiac death, heart attack or stroke in people taking these drugs according to Dr. Sonal Singh, assistant professor of internal medicine at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. Singh was lead author of a paper published in the Sept. 24 issue of the Journal of the American Medical Association.
Medline Plus link is here.
Wednesday, September 24, 2008
Total Body Formula Update: MDL Hearing in Boston 9/25
Our office is investigating claims of people who were hurt by a recalled dietary supplement called Total Body Formula.
On September 25, 2008, one of my law partners will be attending a Federal Court hearing in Boston that will address a request to centralize the USDCT court cases in one court. The process is referred to as Multidistrict Litigation, or "MDL."
Multidistrict litigation is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. The decision whether cases should be transferred is made by a panel of seven federal judges appointed by the Chief Justice of the United States Supreme Court. The Judicial Panel on Multidistrict Litigation meets periodically to review requests that cases be consolidated for pretrial matters pursuant to 28 U.S.C. § 1407
Some folks I have spoken with have asked if the MDL Court is the same as a class action - it is not.
Although class actions may be transferred to an MDL consolidation in the same manner as single plaintiff cases. For cases to be treated as proper for an MDL, however, consolidation the Panel must find they one or more common questions of fact. Since commonality is also an required element for a class action, class actions are frequently litigated in MDL proceedings.
As to the Total Body Formula litigation, each Defendant would like the cases heard in Alabama. Others have asked for an MDL Court in FL or LA.
Stay tuned.
On September 25, 2008, one of my law partners will be attending a Federal Court hearing in Boston that will address a request to centralize the USDCT court cases in one court. The process is referred to as Multidistrict Litigation, or "MDL."
Multidistrict litigation is a procedure utilized in the federal court system to transfer to one federal judge all pending civil cases of a similar type filed throughout the United States. The decision whether cases should be transferred is made by a panel of seven federal judges appointed by the Chief Justice of the United States Supreme Court. The Judicial Panel on Multidistrict Litigation meets periodically to review requests that cases be consolidated for pretrial matters pursuant to 28 U.S.C. § 1407
Some folks I have spoken with have asked if the MDL Court is the same as a class action - it is not.
Although class actions may be transferred to an MDL consolidation in the same manner as single plaintiff cases. For cases to be treated as proper for an MDL, however, consolidation the Panel must find they one or more common questions of fact. Since commonality is also an required element for a class action, class actions are frequently litigated in MDL proceedings.
As to the Total Body Formula litigation, each Defendant would like the cases heard in Alabama. Others have asked for an MDL Court in FL or LA.
Stay tuned.
Tarceva: Two Deaths from Hepatorenal Syndrome
The FDA has reported that the makers of the cancer drug erlotinib (Tarceva) have reported two deaths -- one from hepatorenal syndrome and one from rapidly progressing liver failure -- among patients taking the agent.
As a result of the deaths, OSI Pharmaceuticals and Genentech, the makers of the epidermal growth factor receptor inhibitor, are revising the label to include new warnings about both liver and kidney risks.
They added a warning about the need for extra caution when using the drug in patients with hepatic impairments (total bilirubin less than upper limit of normal or Child-Pugh A, B, and C).
The label will recommend stopping the drug if "changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range."
Additionally, the precaution about hepatoxicity has been updated and moved to the warnings section from the precaution section of the label. Now it will state that erlotinib dosing should be interrupted or discontinued is total bilirubin is greater than three times the upper limit of normal and/or transaminases are greater than five times the upper limit of normal in the setting of normal pretreatment values.
And a precaution about renal failure was also moved to the warnings section and has been updated to include a warning about hepatorenal syndrome.
Erlotinib is approved for monotherapy of locally advanced or metastatic non-small-cell lung cancer. It is also approved in combination with gemcitabine (Gemzar) for first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer.
Source here.
As a result of the deaths, OSI Pharmaceuticals and Genentech, the makers of the epidermal growth factor receptor inhibitor, are revising the label to include new warnings about both liver and kidney risks.
They added a warning about the need for extra caution when using the drug in patients with hepatic impairments (total bilirubin less than upper limit of normal or Child-Pugh A, B, and C).
The label will recommend stopping the drug if "changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range."
Additionally, the precaution about hepatoxicity has been updated and moved to the warnings section from the precaution section of the label. Now it will state that erlotinib dosing should be interrupted or discontinued is total bilirubin is greater than three times the upper limit of normal and/or transaminases are greater than five times the upper limit of normal in the setting of normal pretreatment values.
And a precaution about renal failure was also moved to the warnings section and has been updated to include a warning about hepatorenal syndrome.
Erlotinib is approved for monotherapy of locally advanced or metastatic non-small-cell lung cancer. It is also approved in combination with gemcitabine (Gemzar) for first-line treatment of locally advanced, unresectable, or metastatic pancreatic cancer.
Source here.
Tuesday, September 23, 2008
Tech: Using Rocket Dock
Rocket Dock is a free Mac dock "clone" that anyone is able to use on a Windows-based PC or notebook. Most desktops including mine are loaded up with junk. The Rocketdock I now use has just a few icons - Mozilla, a database icon, an icon for my WP system.
It's free and easy to use. Go here to get it.
You can also view the video how to here.
RocketDock 1.3.0 Final! - Watch more amazing videos here
Monday, September 22, 2008
FDA News: Rituxan
From the FDA:
Genentech has informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. PML is a brain infection and had already been noted on Rituxan's label as a possible risk.
The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan.
Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.
You can find the Dear Doctor letter here. (PDF)
Genentech has informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. PML is a brain infection and had already been noted on Rituxan's label as a possible risk.
The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan.
Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.
You can find the Dear Doctor letter here. (PDF)
Wednesday, September 17, 2008
Atrovent News: Increased Risk for Cardiovascular Death
In patients with COPD, an anticholinergic drug used to prevent bronchospasm, ipratropium bromide (Atrovent)increased the risk of cardiovascular death, researchers here reported.
A nested case control study found that ipratropium use was associated with a 34% increase in risk of cardiovascular death (OR 1.34, 95% CI 1.22 to 1.47), according to Todd A. Lee, Pharm.D., of Hines VA Hospital in Hines, Ill., and colleagues.
Additionally, theophylline exposure was associated "with a statistically significant increase in respiratory deaths compared with the unexposed group (OR 1.71, 95% CI 1.46 to 2.00)," they wrote in the Sept. 16 issue of Annals of Internal Medicine
For more, go to this Link
A nested case control study found that ipratropium use was associated with a 34% increase in risk of cardiovascular death (OR 1.34, 95% CI 1.22 to 1.47), according to Todd A. Lee, Pharm.D., of Hines VA Hospital in Hines, Ill., and colleagues.
Additionally, theophylline exposure was associated "with a statistically significant increase in respiratory deaths compared with the unexposed group (OR 1.71, 95% CI 1.46 to 2.00)," they wrote in the Sept. 16 issue of Annals of Internal Medicine
For more, go to this Link
Tuesday, September 16, 2008
Gas Prices: Gouging in Hurricane's Wake?
In Georgia as in many parts of the country people saw a run on prices for gasoline. In turn, many of us (including yours truly) were angered by what seemed to be gouging at the pumps. It's not just me; even a County Sheriff thinks so.
In Florida:
Florida’s agriculture and consumer services commissioner said Monday that he is issuing subpoenas for financial information from 16 major oil terminals in Florida. The subpoenas, which were being hand-delivered to the terminals on Tuesday, seek records to determine whether any of them illegally increased the wholesale prices that were passed on to retail gas stations and, ultimately, customers. Link.
In Georgia, will a GOP Governor take any action? From a TV station's website:
"The [Georgia] Governor's Office of Consumer Affairs reported they have had 140 official complaints about price gouging of gasoline, and 48 businesses have been put on notice that they will be investigated.
The GOCA is are faxing out these warnings of Georgia law to businesses.
In my neighborhood, 1 station went from $3.69 to $4.29 in five hours. In another Atlanta suburb station, the price jumped to nearly $6. No, that's not gouging is it.
Officials say their phones have been busy all day taking complaints, but they are urging Georgians who think they have been the victim of price gouging to report violators. Dougherty County's Sheriff thinks price gouging has happened, and his deputies are keeping records."
Note to the Georgia Governor: We're watching. Florida will punish those who clearly gouged --- will Georgia hold those who did accountable?
In Florida:
Florida’s agriculture and consumer services commissioner said Monday that he is issuing subpoenas for financial information from 16 major oil terminals in Florida. The subpoenas, which were being hand-delivered to the terminals on Tuesday, seek records to determine whether any of them illegally increased the wholesale prices that were passed on to retail gas stations and, ultimately, customers. Link.
In Georgia, will a GOP Governor take any action? From a TV station's website:
"The [Georgia] Governor's Office of Consumer Affairs reported they have had 140 official complaints about price gouging of gasoline, and 48 businesses have been put on notice that they will be investigated.
The GOCA is are faxing out these warnings of Georgia law to businesses.
In my neighborhood, 1 station went from $3.69 to $4.29 in five hours. In another Atlanta suburb station, the price jumped to nearly $6. No, that's not gouging is it.
Officials say their phones have been busy all day taking complaints, but they are urging Georgians who think they have been the victim of price gouging to report violators. Dougherty County's Sheriff thinks price gouging has happened, and his deputies are keeping records."
Note to the Georgia Governor: We're watching. Florida will punish those who clearly gouged --- will Georgia hold those who did accountable?
Tech: Secure Instant Messaging for a Law Office
In my office we rely on technology in many areas, including Instant Messaging ("IM"). What is it? IM is a text-based computer conference over the Internet between two or more people who must be online at the same time; Unlike email instant messaging software allows you to 'talk' to someone in real time by typing and receiving messages.
Why do we use it? I have two offices with multiple folks assisting on various projects and files. It's too cumbersome to read 100+ emails a day. Also, phone calls back up, and intercom use is too disruptive. Thus, IM.
For many, IM has been through AOL or Yahoo. I wanted to have control over IM, have it occur in a closed environment, and I wanted it to be either cheap or free. I may have found the solution.
24im.com is what we are trying. From their site, you will see the service provides:
Enterprise Instant Messaging
Presence Management
Project management
Department directories
Guest user access
Broadcast messaging
Group activity feed
Web-based or desktop access and
Role based administration
The messaging is encrypted. I like it a lot, and will test it fully for bugs and ease of use. Stay tuned.
Why do we use it? I have two offices with multiple folks assisting on various projects and files. It's too cumbersome to read 100+ emails a day. Also, phone calls back up, and intercom use is too disruptive. Thus, IM.
For many, IM has been through AOL or Yahoo. I wanted to have control over IM, have it occur in a closed environment, and I wanted it to be either cheap or free. I may have found the solution.
24im.com is what we are trying. From their site, you will see the service provides:
Enterprise Instant Messaging
Presence Management
Project management
Department directories
Guest user access
Broadcast messaging
Group activity feed
Web-based or desktop access and
Role based administration
The messaging is encrypted. I like it a lot, and will test it fully for bugs and ease of use. Stay tuned.
Wednesday, September 10, 2008
9/11/08: Voices To Bring 9/11 Museum Relics To Life
As I sit down to write this blog post, I noticed that coincidentally this is post 911 on my blog ....
From CBS.com:
The artifacts awaiting their place in the Sept. 11 museum sit in storage - crushed emergency vehicles, dust-covered purses, a giant steel column covered with victims' pictures. Now, voices will bring them to life.
There's the recorded voice of FDNY retiree Peter Bondy, who put Sept. 11 firefighter Jonathan Ielpi's picture on the 62-ton "last column" at the ruined World Trade Center site in 2002.
And John Abruzzo, a quadriplegic, telling how he was carried down 69 stories of the north tower by his colleagues in a special wheelchair.
And Michele and John Cartier, siblings talking about how they found each other in the chaos before the towers fell, and about their brother, James, who did not make it out.
These are among hundreds of Sept. 11 stories - taped remembrances, even podcasts playing on the Internet - being collected by museum planners who want to connect physical relics of the nation's worst terrorist attack to memory.
They hope the multimedia library - already containing more than 800 oral histories - will have special meaning in what has already become one of the most exhaustively documented events ever.
For more, go here.
I'll never forget ... will others?
From CBS.com:
The artifacts awaiting their place in the Sept. 11 museum sit in storage - crushed emergency vehicles, dust-covered purses, a giant steel column covered with victims' pictures. Now, voices will bring them to life.
There's the recorded voice of FDNY retiree Peter Bondy, who put Sept. 11 firefighter Jonathan Ielpi's picture on the 62-ton "last column" at the ruined World Trade Center site in 2002.
And John Abruzzo, a quadriplegic, telling how he was carried down 69 stories of the north tower by his colleagues in a special wheelchair.
And Michele and John Cartier, siblings talking about how they found each other in the chaos before the towers fell, and about their brother, James, who did not make it out.
These are among hundreds of Sept. 11 stories - taped remembrances, even podcasts playing on the Internet - being collected by museum planners who want to connect physical relics of the nation's worst terrorist attack to memory.
They hope the multimedia library - already containing more than 800 oral histories - will have special meaning in what has already become one of the most exhaustively documented events ever.
For more, go here.
I'll never forget ... will others?
Drug Ads Subject of FDA Web Site for Consumers
From a Yahoo Press Release:
"EthicAd, a nonprofit organization devoted to improving public health through consumer education, announces the launch of a new FDA Web site created to help the general public better understand direct-to-consumer (DTC) advertising of prescription medications. The site, "Be Smart About Prescription Drug Advertising," is hosted by the FDA's Center for Drug Evaluation and Research and was developed by the FDA in partnership with EthicAd."
The site is here.
"EthicAd, a nonprofit organization devoted to improving public health through consumer education, announces the launch of a new FDA Web site created to help the general public better understand direct-to-consumer (DTC) advertising of prescription medications. The site, "Be Smart About Prescription Drug Advertising," is hosted by the FDA's Center for Drug Evaluation and Research and was developed by the FDA in partnership with EthicAd."
The site is here.
FYI: Lemon Law Blog
Came across the Lemon Justice Blog: http://www.lemonjustice.com/blog/
Worth a read. Here is one post:
Car Complaints: The Dubious Honors Go To …
We’ve been discussing the 2008 cars that made their way to the top of the Center for Auto Safety’s Car Complaint Index. We’ve wound our way through Volkswagens, Jeeps, and even a Lexus.
Today, we’re covering the vehicles that had the highest ratio of complaints (to the National Highway Traffic Safety Administration) to the number of cars sold.
Coming in second on the list of most complaints… the Dodge Nitro.
One consumer who had leased a Nitro had a nightmarish tale to tell the NHSTA. He wrote, “My wife routinely started the Nitro, put her foot on the brake (and not the gas), and engaged the gear from Park to Reverse. Within a split second, the car made an unusually loud noise and the car burst backward, taking out the right side of our gate and a portion of the fence adjacent to the gate…. She applied the brake, but the brake was not able to engage as the transmission had torqued the engine so hard that it forced her into the side of the house and the rear bumper rammed into a brick pillar supporting the roof of the front porch.”
The 2008 Nitro had six Technical Service Bulletins issued that reported problems with, among other items, the power train, the air bags, and the engine electronics.
And topping the list… The vehicle with the dubious honor of ranking first on the Complaint Index is… The Toyota FJ Cruiser.
Link here.
Worth a read. Here is one post:
Car Complaints: The Dubious Honors Go To …
We’ve been discussing the 2008 cars that made their way to the top of the Center for Auto Safety’s Car Complaint Index. We’ve wound our way through Volkswagens, Jeeps, and even a Lexus.
Today, we’re covering the vehicles that had the highest ratio of complaints (to the National Highway Traffic Safety Administration) to the number of cars sold.
Coming in second on the list of most complaints… the Dodge Nitro.
One consumer who had leased a Nitro had a nightmarish tale to tell the NHSTA. He wrote, “My wife routinely started the Nitro, put her foot on the brake (and not the gas), and engaged the gear from Park to Reverse. Within a split second, the car made an unusually loud noise and the car burst backward, taking out the right side of our gate and a portion of the fence adjacent to the gate…. She applied the brake, but the brake was not able to engage as the transmission had torqued the engine so hard that it forced her into the side of the house and the rear bumper rammed into a brick pillar supporting the roof of the front porch.”
The 2008 Nitro had six Technical Service Bulletins issued that reported problems with, among other items, the power train, the air bags, and the engine electronics.
And topping the list… The vehicle with the dubious honor of ranking first on the Complaint Index is… The Toyota FJ Cruiser.
Link here.
FDA: 20 Drugs under a Safety Probe
A 2007 federal law requires the FDA to disclose all its investigations into reports of possibly drug-related adverse events. The first of this series of quarterly reports has been released. It includes adverse events reported between January 1 and March 31, 2008.
Last week, the first posting of certain drugs happened. According to various sites, the quarterly list of prescription drugs shows those under investigation for potential side-effects, with the aim of keeping doctors and patients better informed.
The drugs are under review based on complaints from the public. Inclusion on the list does not mean the U.S. Food and Drug Administration has concluded the drug is dangerous, officials stressed, but that safety reviewers think the reported problem needs to be looked at more closely.
"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research.
"If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently." Source
Here's the list of drugs and the adverse events that have been reported:
Arginine Hydrochloride Injection (R-Gene 10) -- Pediatric overdose due to labeling and packaging confusion
Desflurane (Suprane) -- Cardiac arrest
Duloxetine (Cymbalta) -- Urinary retention
Etravirine (Intelence) -- Hemarthrosis (blood in a joint)
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) -- Adverse events due to name confusion
Heparin -- Anaphylactic-type (life-threatening allergic) reactions
Icodextrin (Extraneal) -- Hypoglycemia (low blood sugar)
Insulin U-500 (Humulin R) -- Dosing confusion
Ivermectin (Stromectol) and Warfarin -- Drug interaction
Lapatinib (Tykerb) -- Hepatotoxicity (liver toxicity)
Lenalidomide (Revlimid) -- Stevens-Johnson syndrome (a deadly drug reaction)
Natalizumab (Tysabri) -- Skin melanomas (deadly skin cancer)
Nitroglycerin (Nitrostat) -- Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR) -- Ileus (bowels not moving)
Oxycodone Hydrochloride Controlled-Release (OxyContin) -- Drug misuse, abuse, and overdose
Perflutren Lipid Microsphere (Definity) -- Cardiopulmonary reactions (lung/heart problems)
Phenytoin Injection (Dilantin) -- Purple glove syndrome (discoloration, pain, and swelling of the hand that may lead to amputation)
Quetiapine (Seroquel) -- Overdose due to sample pack labeling confusion
Tebivudine (Tyzeka) -- Peripheral neuropathy (tingling or numbness in the extremities)
Tumor Necrosis Factor (TNF) Blockers -- Cancers in children and young adults
Last week, the first posting of certain drugs happened. According to various sites, the quarterly list of prescription drugs shows those under investigation for potential side-effects, with the aim of keeping doctors and patients better informed.
The drugs are under review based on complaints from the public. Inclusion on the list does not mean the U.S. Food and Drug Administration has concluded the drug is dangerous, officials stressed, but that safety reviewers think the reported problem needs to be looked at more closely.
"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research.
"If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently." Source
Here's the list of drugs and the adverse events that have been reported:
Arginine Hydrochloride Injection (R-Gene 10) -- Pediatric overdose due to labeling and packaging confusion
Desflurane (Suprane) -- Cardiac arrest
Duloxetine (Cymbalta) -- Urinary retention
Etravirine (Intelence) -- Hemarthrosis (blood in a joint)
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric) -- Adverse events due to name confusion
Heparin -- Anaphylactic-type (life-threatening allergic) reactions
Icodextrin (Extraneal) -- Hypoglycemia (low blood sugar)
Insulin U-500 (Humulin R) -- Dosing confusion
Ivermectin (Stromectol) and Warfarin -- Drug interaction
Lapatinib (Tykerb) -- Hepatotoxicity (liver toxicity)
Lenalidomide (Revlimid) -- Stevens-Johnson syndrome (a deadly drug reaction)
Natalizumab (Tysabri) -- Skin melanomas (deadly skin cancer)
Nitroglycerin (Nitrostat) -- Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR) -- Ileus (bowels not moving)
Oxycodone Hydrochloride Controlled-Release (OxyContin) -- Drug misuse, abuse, and overdose
Perflutren Lipid Microsphere (Definity) -- Cardiopulmonary reactions (lung/heart problems)
Phenytoin Injection (Dilantin) -- Purple glove syndrome (discoloration, pain, and swelling of the hand that may lead to amputation)
Quetiapine (Seroquel) -- Overdose due to sample pack labeling confusion
Tebivudine (Tyzeka) -- Peripheral neuropathy (tingling or numbness in the extremities)
Tumor Necrosis Factor (TNF) Blockers -- Cancers in children and young adults
Tuesday, September 02, 2008
Diabetes Drugs (Avandia and Actos): Significant Cardiovascular Risks
According to the Wake Forest University Baptist Medical Center's recent report. It refers to a generic form of Avandia and Actos.
From several reports:
A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members.
“We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market,” write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences. Rosiglitazone and pioglitazone are the two major thiazolidinediones.
In the editorial Singh and Furberg say, “At this time, justification for use of thiazolidinediones is very weak to non-existent.”
Source for the above is here.
From several reports:
A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members.
“We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market,” write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences. Rosiglitazone and pioglitazone are the two major thiazolidinediones.
In the editorial Singh and Furberg say, “At this time, justification for use of thiazolidinediones is very weak to non-existent.”
Source for the above is here.
Antipsychotic Drugs: Double the Stroke Risk?
People taking antipsychotic drugs -including Zyprexa and Seroquel -- are nearly twice as likely to have a stroke compared to those not on the treatment according to British researchers.
"The risk is even higher -- about 3.5 times -- for men and women with dementia, which means doctors should only prescribe such medicine to these patients as a last resort, the researchers said.
Previously, stroke risk associated with older antipsychotic drugs was unclear but the study published in the British Medical Journal showed both old and new treatments carry increased risk."
For more go here.
"The risk is even higher -- about 3.5 times -- for men and women with dementia, which means doctors should only prescribe such medicine to these patients as a last resort, the researchers said.
Previously, stroke risk associated with older antipsychotic drugs was unclear but the study published in the British Medical Journal showed both old and new treatments carry increased risk."
For more go here.
Friday, August 29, 2008
Weekend: College Football Has Begun
Officially, that is. It began last night here in the South and parts elsewhere. Down here, however, it's different. Equal parts Christmas, St. Patrick's Day, Lundi Gras, and your birthday, college football unites as well as divides in the South.
A business introducton in my South in the fall may often include - in addition to being asked your name - the question, "Who ya for?" And the questioner does not mean do you support McCain or Obama, but rather the Tide, the Bayou Bengals, or the Gators.
In honor of this vital way a life, in honor of a chromosome that is in the DNA of many where I live, a lighthearted, non-legal ode to college football, and how it is different 'down here' --
FOOTBALL SEASON - NORTH VS SOUTH
WOMEN'S ATTIRE
Up North: Chapstick in their back pocket and a
$20 bill in their front pocket.
Down South: Louis Vuitton duffel with two
lipsticks, powder, mascara waterproof), concealer,
and a fifth of bourbon. Wallet not necessary -that's
what dates are for.
STADIUM SIZE
Up north: College football stadiums hold 20,000.
Down south: High school football stadiums hold
20,000.
NAMES
Up North: Doug Flutie
Down South: Peyton Manning
WEATHER
Up North: Rain and overcoats.
Down South: Sunny, highs mid-60s, lows in the
thirties.
FATHERS
Up North: Expect their daughter to understand
Sylvia Plath.
Down South: Expect their daughters to
understand pass interference.
ATTIRE
Up North: Male and female alike: woolly
sweater or sweatshirt, jeans.
Down South Male: -pressed khakis, oxford
shirt, cap with frat logo, Justin Ropers.
Down South Female: -ankle-length skirt,
coordinated cardigan, flat riding boots,
oxford.
ALUMNI
Up North: Take prospects on sailing trips
before they join the law firm.
Down South: Take prospects on fishing trips so
they don't leave for the NFL their senior year.
CAMPUS DECOR
Up North: Statues of Founding Fathers.
Down South: Statues of Heisman Trophy winners.
HOMECOMING QUEEN
Up North: Also a physics major.
Down South: Also Miss USA.
HEROES
Up North: Mario Cuomo
Down South: "Bear" Bryant
GETTING TICKETS
Up North: 5 days before the game you can walk
into the ticket office on campus and still
purchase tickets.
Down South: 5 months before the game you can
walk into the ticket office on campus and
still be placed on the waiting list for tickets.
FRIDAY CLASSES AFTER A THURSDAY NIGHT GAME
Up North: Students and Teachers are not sure
if they are going because they have class on
Friday.
Down South: Teachers cancel class on Friday
because they don't want to see the few hungover
students that might actually make it to class
on Friday.
PARKING
Up North: An hour or two before game time the
university opens the campus for game parking.
Down South: RV's sporting their school flags
begin arriving on Wednesday for the weekend's
festivities. The real faithful begin arriving
on Tuesday.
GAME DAY
Up North: A few students party in the dorm and
watch ESPN on TV.
Down South: Every student wakes up, has a beer
for breakfast, and rushes over, 2 hours early, to where ESPN is
broadcasting Game Day "Live" to get on camera
and wave to the idiots from up North who wonder
why Game Day never broadcasts from their campus.
TAILGATING
Up North: Wieners on the grill, beer with a
lime in it, listening to local radio station with
truck tailgate down.
Down South: 30-foot custom pig-shaped smoker
fires up at dawn. Arguments about what type of sausages are
served with breakfast. RV neighbor walks around in bathrobe with school
logo on it, and coffee mug with a 'touch' of bourbon in it. Cooking accompanied by live performance by Hootie & the Blowfish, who come
over during breaks and ask for a hit off your
bottle of bourbon.
GETTING TO THE STADIUM
Up North: You have to ask, "Where's the stadium?"
When you find it you walk right in with no line.
Down South: When you're near it, you'll hear
it. On game day, it becomes the State's third
largest city.
CONCESSIONS
Up North: Drinks served in a paper cup filled
to the top with soda.
Down South: Drinks served in a plastic cup
with the home team's mascot-filled less than
halfway to ensure enough room for bourbon.
WHEN THE NATIONAL ANTHEM IS PLAYED
Up North: Stands are less than half full.
Down South: 80,000+ fans sing along in perfect
3-part harmony. Tears shed, after flyover from Blue Angels.
THE SMELL IN THE AIR AFTER THE FIRST SCORE
Up North: Nothing changes.
Down South: Fireworks with a twist of bourbon.
COMMENTARY (MALE)
Up North: "Nice play."
Down South: "Dammit you slow sumbitch-tackle
him and break his legs!!!
COMMENTARY (FEMALE)
Up North: "My, this is a violent sport."
Down South: "Dammit you slow sumbitch-tackle
him and break his legs!!!"
AFTER THE GAME
Up North: The stadium is empty before the game > >ends.
Down South: Another rack of ribs on the smoker, followed by
40 plus people watching two more games on satellite TV
attached to a flat screen. Somebody goes to the nearest package
store for more bourbon, planning begins for next
week's party.
Note: This isn't mine, it's been on emails for nearly a decade.
Happy Labor Day.
A business introducton in my South in the fall may often include - in addition to being asked your name - the question, "Who ya for?" And the questioner does not mean do you support McCain or Obama, but rather the Tide, the Bayou Bengals, or the Gators.
In honor of this vital way a life, in honor of a chromosome that is in the DNA of many where I live, a lighthearted, non-legal ode to college football, and how it is different 'down here' --
FOOTBALL SEASON - NORTH VS SOUTH
WOMEN'S ATTIRE
Up North: Chapstick in their back pocket and a
$20 bill in their front pocket.
Down South: Louis Vuitton duffel with two
lipsticks, powder, mascara waterproof), concealer,
and a fifth of bourbon. Wallet not necessary -that's
what dates are for.
STADIUM SIZE
Up north: College football stadiums hold 20,000.
Down south: High school football stadiums hold
20,000.
NAMES
Up North: Doug Flutie
Down South: Peyton Manning
WEATHER
Up North: Rain and overcoats.
Down South: Sunny, highs mid-60s, lows in the
thirties.
FATHERS
Up North: Expect their daughter to understand
Sylvia Plath.
Down South: Expect their daughters to
understand pass interference.
ATTIRE
Up North: Male and female alike: woolly
sweater or sweatshirt, jeans.
Down South Male: -pressed khakis, oxford
shirt, cap with frat logo, Justin Ropers.
Down South Female: -ankle-length skirt,
coordinated cardigan, flat riding boots,
oxford.
ALUMNI
Up North: Take prospects on sailing trips
before they join the law firm.
Down South: Take prospects on fishing trips so
they don't leave for the NFL their senior year.
CAMPUS DECOR
Up North: Statues of Founding Fathers.
Down South: Statues of Heisman Trophy winners.
HOMECOMING QUEEN
Up North: Also a physics major.
Down South: Also Miss USA.
HEROES
Up North: Mario Cuomo
Down South: "Bear" Bryant
GETTING TICKETS
Up North: 5 days before the game you can walk
into the ticket office on campus and still
purchase tickets.
Down South: 5 months before the game you can
walk into the ticket office on campus and
still be placed on the waiting list for tickets.
FRIDAY CLASSES AFTER A THURSDAY NIGHT GAME
Up North: Students and Teachers are not sure
if they are going because they have class on
Friday.
Down South: Teachers cancel class on Friday
because they don't want to see the few hungover
students that might actually make it to class
on Friday.
PARKING
Up North: An hour or two before game time the
university opens the campus for game parking.
Down South: RV's sporting their school flags
begin arriving on Wednesday for the weekend's
festivities. The real faithful begin arriving
on Tuesday.
GAME DAY
Up North: A few students party in the dorm and
watch ESPN on TV.
Down South: Every student wakes up, has a beer
for breakfast, and rushes over, 2 hours early, to where ESPN is
broadcasting Game Day "Live" to get on camera
and wave to the idiots from up North who wonder
why Game Day never broadcasts from their campus.
TAILGATING
Up North: Wieners on the grill, beer with a
lime in it, listening to local radio station with
truck tailgate down.
Down South: 30-foot custom pig-shaped smoker
fires up at dawn. Arguments about what type of sausages are
served with breakfast. RV neighbor walks around in bathrobe with school
logo on it, and coffee mug with a 'touch' of bourbon in it. Cooking accompanied by live performance by Hootie & the Blowfish, who come
over during breaks and ask for a hit off your
bottle of bourbon.
GETTING TO THE STADIUM
Up North: You have to ask, "Where's the stadium?"
When you find it you walk right in with no line.
Down South: When you're near it, you'll hear
it. On game day, it becomes the State's third
largest city.
CONCESSIONS
Up North: Drinks served in a paper cup filled
to the top with soda.
Down South: Drinks served in a plastic cup
with the home team's mascot-filled less than
halfway to ensure enough room for bourbon.
WHEN THE NATIONAL ANTHEM IS PLAYED
Up North: Stands are less than half full.
Down South: 80,000+ fans sing along in perfect
3-part harmony. Tears shed, after flyover from Blue Angels.
THE SMELL IN THE AIR AFTER THE FIRST SCORE
Up North: Nothing changes.
Down South: Fireworks with a twist of bourbon.
COMMENTARY (MALE)
Up North: "Nice play."
Down South: "Dammit you slow sumbitch-tackle
him and break his legs!!!
COMMENTARY (FEMALE)
Up North: "My, this is a violent sport."
Down South: "Dammit you slow sumbitch-tackle
him and break his legs!!!"
AFTER THE GAME
Up North: The stadium is empty before the game > >ends.
Down South: Another rack of ribs on the smoker, followed by
40 plus people watching two more games on satellite TV
attached to a flat screen. Somebody goes to the nearest package
store for more bourbon, planning begins for next
week's party.
Note: This isn't mine, it's been on emails for nearly a decade.
Happy Labor Day.
Thursday, August 28, 2008
Byetta (Diabetes drug): Four Deaths reported
Amylin Pharmaceuticals said there have been four deaths among patients with pancreatitis who took its diabetes drug, Byetta. This is in addition to the reports of two other deaths.
The company said the four cases had not been reported last week to the FDA. The FDA had received six reports of patients who developed hemorrhagic or necrotizing pancreatitis that required hospitalization. Two of those patients died.
For more, go here.
The company said the four cases had not been reported last week to the FDA. The FDA had received six reports of patients who developed hemorrhagic or necrotizing pancreatitis that required hospitalization. Two of those patients died.
For more, go here.
Tuesday, August 26, 2008
Hot Pockets Recall
Yes, you read that right. From various sources:
"Nestle Prepared Foods Company is recalling about 215,660 pounds of frozen stuffed pepperoni pizza sandwich products, known as Hot Pockets Pepperoni Pizza, because the product might contain small pieces of hard red plastic and other foreign material, which pose a risk of serious injury to consumers.
"The recall involves 54-ounce, 12-pack cartons of Hot Pockets Pepperoni Pizza brand stuffed sandwiches. Printed on the side of each carton is "8157544614D," "EST 7721A," and "BEST BEFORE JAN2010." They were produced on June 5 and distributed to retail establishments nationwide."
A laugh out loud riff on the product is here:
"Nestle Prepared Foods Company is recalling about 215,660 pounds of frozen stuffed pepperoni pizza sandwich products, known as Hot Pockets Pepperoni Pizza, because the product might contain small pieces of hard red plastic and other foreign material, which pose a risk of serious injury to consumers.
"The recall involves 54-ounce, 12-pack cartons of Hot Pockets Pepperoni Pizza brand stuffed sandwiches. Printed on the side of each carton is "8157544614D," "EST 7721A," and "BEST BEFORE JAN2010." They were produced on June 5 and distributed to retail establishments nationwide."
A laugh out loud riff on the product is here:
Daytrana Patch Recall
From various sites:
Noven Pharmaceuticals Inc. said its partner Shire Ltd. is voluntarily recalling two lots of the attention deficit hyperactivity disorder drug patch Daytrana because of a problem with the patch liner.
In the recalled lots, the liner that needs to be released before the patch can be applied does not meet specifications, meaning patients might have difficulty removing the liner in order to apply the drug.
"Shire has advised that, because the voluntary recall is not due to product safety issues, all Daytrana patches, including those in the lots subject to the recall, can continue to be used unless the release liner cannot be removed, or the patches are damaged while being opened," Noven said, in a statement.
Link here.
Noven Pharmaceuticals Inc. said its partner Shire Ltd. is voluntarily recalling two lots of the attention deficit hyperactivity disorder drug patch Daytrana because of a problem with the patch liner.
In the recalled lots, the liner that needs to be released before the patch can be applied does not meet specifications, meaning patients might have difficulty removing the liner in order to apply the drug.
"Shire has advised that, because the voluntary recall is not due to product safety issues, all Daytrana patches, including those in the lots subject to the recall, can continue to be used unless the release liner cannot be removed, or the patches are damaged while being opened," Noven said, in a statement.
Link here.
Saturday, August 23, 2008
Tech Weekend: PC Mag's Top 100 "Undiscovered Sites
Sites on the web you may not have heard about as you work. Link here.
Some of the sites include:
Tech Daily Dose
Run by the National Journal, this is a site for those interested in the role technology plays in government would be hard-pressed to find a better news outlet than this National Journal-run blog. From piracy to Net neutrality to online campaigning, this site is a fantastic resource for exploring tech policy inside the Beltway.
Jooce.com
This desktop-away-from-desktop lets you access your personal stuff from any computer. Load up your browser-based Jooce desktop with files, music, videos, and anything else you might need and you can get to it just by logging in.
Mux.am
Mux is an excellent video conversion/sharing site that lets you enter in the URL of a video clip (or its location on your hard drive) and specify what format you'd like to receive the video in (iPod, PSP, DivX, MPEG-4, and lots more).
If you have any sites you think need to be 'discovered' email me.
Some of the sites include:
Tech Daily Dose
Run by the National Journal, this is a site for those interested in the role technology plays in government would be hard-pressed to find a better news outlet than this National Journal-run blog. From piracy to Net neutrality to online campaigning, this site is a fantastic resource for exploring tech policy inside the Beltway.
Jooce.com
This desktop-away-from-desktop lets you access your personal stuff from any computer. Load up your browser-based Jooce desktop with files, music, videos, and anything else you might need and you can get to it just by logging in.
Mux.am
Mux is an excellent video conversion/sharing site that lets you enter in the URL of a video clip (or its location on your hard drive) and specify what format you'd like to receive the video in (iPod, PSP, DivX, MPEG-4, and lots more).
If you have any sites you think need to be 'discovered' email me.
Tuesday, August 19, 2008
What Happens After a Recall?
As the news spreads about the voluntary recall of Total Body Formula, what is particularly striking to me is how the news of the recall makes it to consumers. From the many folks I talk with every month on a variety of matters, it seems that most consumers don't know of recalls, and as of yet there is no uniform method as to recalls.
From today's Wall Street Journal:
"The recall itself is touted as a powerful tool of regulators for keeping consumers safe, and the Consumer Product Safety Commission points to the growing number of recalls as an indication that the system is working to protect consumers. But sometimes, not enough is done beyond the announcement to ensure that consumers and all retailers know about the recall.
The CPSC is charged with ensuring that roughly 15,000 products in the U.S. marketplace today are safe to use. Yet, when a product is cited as a hazard, it is mainly up to the consumer to learn about the recall and take action. Unlike Ms. Bykowski, few consumers do.
On average, just 15% to 30% of consumers who have purchased a defective product respond when the item is recalled, says the CPSC. Responses can rise to about 60% for higher-profile recalls that include some children's products or home appliances. But often more than two-thirds of recalled products go unaccounted for, leaving children and adults vulnerable to injuries ranging from lead poisoning caused by mouthing certain toys to burns from overheated fax machines.
That is because the notification, which relies in part on press releases that may or may not be picked up by the media, is often lax or low-tech. And many consumers simply don't want to deal with the paperwork or the hassle of mailing something back, especially large items, like a crib, which has to be disassembled. Of course many consumers may never learn of the recall."
The article goes on to note: "The recall system just doesn't work," said Nancy Cowles, executive director of Kids in Danger, a Chicago child-safety advocacy group. "The very concept is backwards." She cited the need to improve the safety of products before they reach store shelves."
Link here.
From today's Wall Street Journal:
"The recall itself is touted as a powerful tool of regulators for keeping consumers safe, and the Consumer Product Safety Commission points to the growing number of recalls as an indication that the system is working to protect consumers. But sometimes, not enough is done beyond the announcement to ensure that consumers and all retailers know about the recall.
The CPSC is charged with ensuring that roughly 15,000 products in the U.S. marketplace today are safe to use. Yet, when a product is cited as a hazard, it is mainly up to the consumer to learn about the recall and take action. Unlike Ms. Bykowski, few consumers do.
On average, just 15% to 30% of consumers who have purchased a defective product respond when the item is recalled, says the CPSC. Responses can rise to about 60% for higher-profile recalls that include some children's products or home appliances. But often more than two-thirds of recalled products go unaccounted for, leaving children and adults vulnerable to injuries ranging from lead poisoning caused by mouthing certain toys to burns from overheated fax machines.
That is because the notification, which relies in part on press releases that may or may not be picked up by the media, is often lax or low-tech. And many consumers simply don't want to deal with the paperwork or the hassle of mailing something back, especially large items, like a crib, which has to be disassembled. Of course many consumers may never learn of the recall."
The article goes on to note: "The recall system just doesn't work," said Nancy Cowles, executive director of Kids in Danger, a Chicago child-safety advocacy group. "The very concept is backwards." She cited the need to improve the safety of products before they reach store shelves."
Link here.
Vioxx: Another Article (Annals of Internal Med.) Critical of Merck
Did Merck "endanger" patients in 1999 when it disguised a marketing program as a scientific trial of its now-withdrawn painkiller Vioxx? That is what is claimed in an an article and editorial to be published in the Annals of Internal Medicine.
From the Philadelphia Enquirer:
"The editors of the Annals of Internal Medicine, which is based in Center City, said the journal's findings may point to a broader problem in the pharmaceutical industry. Drug companies have long been suspected of enlisting doctors in trials solely to get doctors in the "habit of prescribing a new drug," the editors said in what they described as an unusual, if not unprecedented, editorial. These are known as "seeding" trials."
What is particularly noteworthy in the editorial is this comment: "The documents do tell us that deception is the key to a successful seeding trial." Link.
The editorial says "seeding trials" pay doctors involved in them to consult with the drug company plus a fee for each patient they enroll.
For more go here.
From the Philadelphia Enquirer:
"The editors of the Annals of Internal Medicine, which is based in Center City, said the journal's findings may point to a broader problem in the pharmaceutical industry. Drug companies have long been suspected of enlisting doctors in trials solely to get doctors in the "habit of prescribing a new drug," the editors said in what they described as an unusual, if not unprecedented, editorial. These are known as "seeding" trials."
What is particularly noteworthy in the editorial is this comment: "The documents do tell us that deception is the key to a successful seeding trial." Link.
The editorial says "seeding trials" pay doctors involved in them to consult with the drug company plus a fee for each patient they enroll.
For more go here.
Monday, August 18, 2008
Total Body Formula Article in Atlanta Journal Constitution (daily paper)
This weekend the Atlanta Journal Constitution had a lengthy and well written article on Total Body Formula's recall and the recalled product had on several people. One person named in the article is a current client of mine. We've file several lawsuits, and are not part of any class action regarding Total Body Formula.
Here is an excerpt:
At least 197 people in a dozen states —- 53 of them in Georgia —- were sickened earlier this year after taking the liquid supplement Total Body Formula. Their hair fell out in clumps, their fingernails fell off. They suffered nausea, vomiting and fatigue. Some had disabling joint pain, according to the Centers for Disease Control and Prevention and state health officials.
Doctors treating 21-year-old Felicia Blasingame of Acworth this spring first thought she had the flu, then tested her for everything from parasites to lupus to rheumatoid arthritis, trying to figure out what was causing her nausea, seizures, knee pain and hair loss, she said.
Edgar Gurley, 78, of Marietta said he went from being active and healthy to suddenly in January battling a cascading array of symptoms, including diarrhea, fatigue and confusion. Gurley said doctors struggled to explain why his blood chemistry and thyroid levels were out of whack, his kidneys were failing and his hair was falling out.
As their symptoms worsened, Blasingame and Gurley said they continued to take their daily 1-ounce dose of Total Body Formula, thinking it was critical to their health.
Yet several batches of Total Body Formula and Total Body Mega Formula contained hazardous amounts of the mineral selenium —- up to 40,800 micrograms per serving, 200 times the amount listed on the product’s label, according to the U.S. Food and Drug Administration.
The FDA is still investigating how this happened, and state health officials are still tallying the human toll.
Because of several pending lawsuits, lawyers for three companies involved in the manufacture and sale of Total Body products declined to discuss what happened.
Go here for the complete article.
Here is an excerpt:
At least 197 people in a dozen states —- 53 of them in Georgia —- were sickened earlier this year after taking the liquid supplement Total Body Formula. Their hair fell out in clumps, their fingernails fell off. They suffered nausea, vomiting and fatigue. Some had disabling joint pain, according to the Centers for Disease Control and Prevention and state health officials.
Doctors treating 21-year-old Felicia Blasingame of Acworth this spring first thought she had the flu, then tested her for everything from parasites to lupus to rheumatoid arthritis, trying to figure out what was causing her nausea, seizures, knee pain and hair loss, she said.
Edgar Gurley, 78, of Marietta said he went from being active and healthy to suddenly in January battling a cascading array of symptoms, including diarrhea, fatigue and confusion. Gurley said doctors struggled to explain why his blood chemistry and thyroid levels were out of whack, his kidneys were failing and his hair was falling out.
As their symptoms worsened, Blasingame and Gurley said they continued to take their daily 1-ounce dose of Total Body Formula, thinking it was critical to their health.
Yet several batches of Total Body Formula and Total Body Mega Formula contained hazardous amounts of the mineral selenium —- up to 40,800 micrograms per serving, 200 times the amount listed on the product’s label, according to the U.S. Food and Drug Administration.
The FDA is still investigating how this happened, and state health officials are still tallying the human toll.
Because of several pending lawsuits, lawyers for three companies involved in the manufacture and sale of Total Body products declined to discuss what happened.
Go here for the complete article.
Wednesday, August 13, 2008
Powerful Antacid Drugs Raise Fracture Risk
Aciphex, Nexium, Prevacid, Prilosec and Protonix are the drugs in question.
From Health Day:
"New Canadian research shows that long-term use of proton pump inhibitors for acid reflux, peptic ulcers and related disorders elevates the risk of osteoporosis-related fractures.
This is now the third large study finding an increased risk of such fractures in people who use these medications. This latest study, reported in the current issue of the Canadian Medical Association Journal, found the longest period of time from starting the drugs to seeing problems emerge.
Physicians and patients may need to curb their enthusiasm for prescribing proton pump inhibitors, which have surged in popularity, experts said."
For more,go here.
From Health Day:
"New Canadian research shows that long-term use of proton pump inhibitors for acid reflux, peptic ulcers and related disorders elevates the risk of osteoporosis-related fractures.
This is now the third large study finding an increased risk of such fractures in people who use these medications. This latest study, reported in the current issue of the Canadian Medical Association Journal, found the longest period of time from starting the drugs to seeing problems emerge.
Physicians and patients may need to curb their enthusiasm for prescribing proton pump inhibitors, which have surged in popularity, experts said."
For more,go here.
Drug Companies Don't Want to Disclose Lawsuit Defense Costs
Several drug firms sent a letter last week accounting-rule lawmakers, arguing that mandatory disclosure of estimated costs of ongoing litigation is expensive, not helpful and won't provide worthwhile information for investors.
Costs estimating of ongoing litigation is "highly subjective, subject to huge swings as underlying assumptions change, and unlikely to provide financial statement users with meaningful or reliable information," the companies said in a letter to the Financial Accounting Standards Board. Link here.
Currenly, drug companies only have to disclose the estimated costs when they believe it is probable a case will be lost.
Costs estimating of ongoing litigation is "highly subjective, subject to huge swings as underlying assumptions change, and unlikely to provide financial statement users with meaningful or reliable information," the companies said in a letter to the Financial Accounting Standards Board. Link here.
Currenly, drug companies only have to disclose the estimated costs when they believe it is probable a case will be lost.
Tuesday, August 05, 2008
CLE: GTLA Torts Seminar 8/7-9/08
Time for a seminar at the beach ... this weekend, the GTLA is holding its Summer Seminar in Sandestin. Here's the agenda, and note my time slot .. Saturday morning at 9 AM:
Thursday, August 7
800am Registration, Breakfast & Exhibits
8:30am Welcome & Registration
8:40am The Sun Was in My Eyes and Other Insurer Favorites – Mike Neff, Law Office of Michael,Lawson Neff P.C., Atlanta
9:20am A Good Beginning is a Fine Start: Mastering the Art of Opening Statements – Michael Warshauer, Warshauer Poe & Thornton, P.C., Atlanta
10:10am The Most Neglected Parts of Trial Gino
Brogdon, Brogdon, Davis & Adams. LLC. Decatur
10:50am Handling Wrongful Death in Auto Cases Pete
Law, Peter A. Law, P.C.
12:00pm Adjourn (lunch on your own)
1:00pm Golf Tournament (Choctawhatchee Bay Golf – Call GTLA to reserve a spot)
6:30pm Civil Justice PAC Welcome Reception
Friday, August 8
8:00am Registration, Breakfast & Exhibits
8:30am Welcome & Registration
8:40am Finding the Coverage in Catastrophic Injury Cases
Linley Jones, Linley Jones, P.C.
9:20am Drugs, Alcohol and Accidents: Handling Personal Injury Cases When the Defendant Driver is Under the Influence
Michael Goldberg, Fried, Rogers, & Goldberg, Atlanta
9:50am Break
10:10am Website Marketing Essentials
Sam Chontos, FindLaw
10:30am Truck Accidents, What Makes Them Different Than a Typical Car Wreck Case
Joe Fried, Fried, Rogers, & Goldberg, Atlanta
11:00am How Juries Assign Blame: An Heuristic Approach
RobinFrazer Clark, Robin Frazer Clark, P.C., Atlanta
Saturday, August 9
8:00am Registration, Breakfast & Exhibits
8:30am Welcome & Registration
8:40am The Top 10 Reasons Lawyers Get Sued
David Lefkowitz, The Lefkowitz Firm, Atlanta
9:20am Using Free or Inexpensive Technology to Enhance your Auto Practice Mark
Zamora, Atlanta
9:50am Break
10:10am Probate Issues in Auto Cases
Lloyd Bell, Bell Law Firm, Atlanta
10:50am How to Get the Most out of Mediation
Victor Faenza
11:20am Handling UM Cases with Special Attention to Thurman, Toomer, and Thompson Steve Ozcomert, Stephen M. Ozcomert, P.C., McDonough
Plaintiffs' Lawyers Only.
I've never spoken while wearing flip flops - this will be a first.
At the Trial Lawyer Blog: Matt Garretson on Fee Agreements
Good stuff at the TLRC blog:
One of the attorneys at Matt Garretson's Firm has prepared a “practice tip” sheet for updating a client fee agreement. Among other topics, the article incorporates the points addressed in NY Professional Ethics Committee Opinion (#739, July 7, 2008), which contains logic that is instructive no matter what state(s) you practice in.
From the blog: "No matter how big the case, your retainer agreement is the most important document in the file. If it hasn’t been revised in a while, its time to dust it off and make sure it reflects the changing nature of settlement. Doing so will make your settlements run more smoothly and provide you with the tools and time needed to satisfy your obligations and ensure that the settlement ultimately does exactly what it needs to do for your client.”
Go here for the complete article.
One of the attorneys at Matt Garretson's Firm has prepared a “practice tip” sheet for updating a client fee agreement. Among other topics, the article incorporates the points addressed in NY Professional Ethics Committee Opinion (#739, July 7, 2008), which contains logic that is instructive no matter what state(s) you practice in.
From the blog: "No matter how big the case, your retainer agreement is the most important document in the file. If it hasn’t been revised in a while, its time to dust it off and make sure it reflects the changing nature of settlement. Doing so will make your settlements run more smoothly and provide you with the tools and time needed to satisfy your obligations and ensure that the settlement ultimately does exactly what it needs to do for your client.”
Go here for the complete article.
Attorneys: Yellow Pages Ads Gather Dust
From The Journal Record an article on what may seem obvious to some:
"It’s pretty much required these days for a law firm to have a Web site," according to Jim Calloway, a member of the Oklahoma Bar Association.
Read more here.
"It’s pretty much required these days for a law firm to have a Web site," according to Jim Calloway, a member of the Oklahoma Bar Association.
Read more here.
Monday, August 04, 2008
Anemia Drugs Label Change
The FDA has ordered label changes on cancer patients' use of drugs with erythropoiesis- stimulating agents (ESA) made by the companies. The changes would be added to a "Black Box" warning. The drugs are Epogen and Aranesp.
The FDA states that the new label must stated that the drugs are not to be used in cancer patients receiving chemotherapy when a cure of the cancer is anticipated.
As part of the label change, there will be a statement added that the drugs should not be administered when hemoglobin levels are greater to or equal to 10 grams per deciliter and that usage should stop if the hemoglobin exceeds a level needed to avoid transfusion.
Link here.
The FDA states that the new label must stated that the drugs are not to be used in cancer patients receiving chemotherapy when a cure of the cancer is anticipated.
As part of the label change, there will be a statement added that the drugs should not be administered when hemoglobin levels are greater to or equal to 10 grams per deciliter and that usage should stop if the hemoglobin exceeds a level needed to avoid transfusion.
Link here.
Friday, August 01, 2008
Priest Sues Over Care At Manatee Memorial Hospital
Attorney Richard Shapiro from Bradenton, FL is to me, a lawyer's lawyer. He takes causes, not cases, he says.
Recently he filed suit in a case involving a priest's care at a Florida hospital. A client of Shapiro's claims a hospital erroneously believed he was trying to get powerful pain medication while overlooking multiple bone fractures that ultimately left him permanently incontinent and barely able to walk. Shapiro called the episode "a crime against humanity."
You can read more at this link, or watch the video.
Recently he filed suit in a case involving a priest's care at a Florida hospital. A client of Shapiro's claims a hospital erroneously believed he was trying to get powerful pain medication while overlooking multiple bone fractures that ultimately left him permanently incontinent and barely able to walk. Shapiro called the episode "a crime against humanity."
You can read more at this link, or watch the video.
Tuesday, July 29, 2008
Georgia: 3rd Best State for Business
From the AJC:
The business climate in Georgia is surpassed only by Texas and North Carolina, according to a study by marketing company Development Counsellors International.
Georgia was followed by Tennessee and Florida, which tied for fourth place. Some 20.4 percent said Georgia was the state with the most favorable climate. Executives usually cited three factors for their choices: a strong labor market, low operating costs and a pro-business climate.
“With the battle for business more intense than ever, states and their economic development organizations need to pay close attention to the results of this survey,” DCI President Andrew T. Levine said in a statement. “Whether accurate or misguided, perceptions about a location’s business climate often play a crucial role in site selection decisions and where companies invest money and create jobs.”
DCI said its survey was sent to a random selection of 3,591 U.S. companies with annual revenue of at least $25 million.
My comment: This is so even though each year state partisan politics trots out the need for reform in the justice system.
The business climate in Georgia is surpassed only by Texas and North Carolina, according to a study by marketing company Development Counsellors International.
Georgia was followed by Tennessee and Florida, which tied for fourth place. Some 20.4 percent said Georgia was the state with the most favorable climate. Executives usually cited three factors for their choices: a strong labor market, low operating costs and a pro-business climate.
“With the battle for business more intense than ever, states and their economic development organizations need to pay close attention to the results of this survey,” DCI President Andrew T. Levine said in a statement. “Whether accurate or misguided, perceptions about a location’s business climate often play a crucial role in site selection decisions and where companies invest money and create jobs.”
DCI said its survey was sent to a random selection of 3,591 U.S. companies with annual revenue of at least $25 million.
My comment: This is so even though each year state partisan politics trots out the need for reform in the justice system.
FDA Execs Received "Lavish" Bonuses
As if the FDA's weekly bludgeoning at the hands of Congress is not enough, there is this news:
Congressman Bart Stupak informs that 28 senior FDA executives took in a combined $1 million in bonuses last year. To me, this news is obscene. Clearly the FDA is a weak guardian when it comes to the safety of drugs and food. Yet, with this news, you would think that perhaps the entire system has gone mad.
Bonuses for FDA bureaucrats? Yep. Look at these examples:
$48,000 in a cash award and retention bonus went to an associate commissioner whose plan to overhaul FDA field labs was rejected by Congress as poorly thought-out.
$41,000 went to the director of the office of criminal investigations, pushing his total income to enforce one statute to $208,000 - more than the director of the FBI makes.
What's most galling? CBS News notes that "The person who was hired to reform the bonus system received the biggest bonus, $58,000."
Nearly 25% of the $35 million in bonuses the FDA handed out last year went to bureaucrats, not technical experts.
For more go here.
Congressman Bart Stupak informs that 28 senior FDA executives took in a combined $1 million in bonuses last year. To me, this news is obscene. Clearly the FDA is a weak guardian when it comes to the safety of drugs and food. Yet, with this news, you would think that perhaps the entire system has gone mad.
Bonuses for FDA bureaucrats? Yep. Look at these examples:
$48,000 in a cash award and retention bonus went to an associate commissioner whose plan to overhaul FDA field labs was rejected by Congress as poorly thought-out.
$41,000 went to the director of the office of criminal investigations, pushing his total income to enforce one statute to $208,000 - more than the director of the FBI makes.
What's most galling? CBS News notes that "The person who was hired to reform the bonus system received the biggest bonus, $58,000."
Nearly 25% of the $35 million in bonuses the FDA handed out last year went to bureaucrats, not technical experts.
For more go here.
Monday, July 28, 2008
Selenium: Link to Diabetes?
From various sites:
A new analysis of data from a large national study found that people who took a 200 microgram selenium supplement each day for almost eight years had an increased risk of developing type 2 diabetes than those who took a placebo or dummy pill.
The data came from the Nutritional Prevention of Cancer Trial (NPC), a large randomized, multi-center, clinical trial. It was designed to evaluate whether selenium supplements prevent skin cancer. In the study being published, researchers selected 1,202 participants who did not have diabetes when they were enrolled in the NPC Trial. Half received a 200 microgram selenium supplement and half received a placebo pill for an average of 7.7 years.
Link to at least one site here.
A new analysis of data from a large national study found that people who took a 200 microgram selenium supplement each day for almost eight years had an increased risk of developing type 2 diabetes than those who took a placebo or dummy pill.
The data came from the Nutritional Prevention of Cancer Trial (NPC), a large randomized, multi-center, clinical trial. It was designed to evaluate whether selenium supplements prevent skin cancer. In the study being published, researchers selected 1,202 participants who did not have diabetes when they were enrolled in the NPC Trial. Half received a 200 microgram selenium supplement and half received a placebo pill for an average of 7.7 years.
Link to at least one site here.
Digitek Recall
My good friend Angel Reyes and his firm are based in Dallas, Texas and his firm has a national reputation. From their site:
"Heygood, Orr, Reyes, Pearson & Bartolomei is a business litigation and personal injury law firm, based in Dallas, Texas. We have worked with executives, business owners, and individuals to try over 300 cases to a jury verdict."
The firm is a drug known as Digitek.
Eric Pearson's report - it's copyrighted:
Digitek is the trade name for digoxin tablets manufactured in the United States by Actavis Totowa, LLC, the U.S. manufacturing division of international generic pharmaceutical company Actavis Group. The tablets are distributed in the U.S. by Mylan Pharmaceuticals, based in Morgantown, West Virginia and by UDL Laboratories, based in Rockford, Illinois. Both Mylan Pharmaceuticals and UDL are owned by parent company Mylan, a drug company based in Pittsburgh, Pennsylvania with a market cap of $4 billion. The tablets are distributed by Mylan under a “Bertek” label and by UDL under a “UDL” label. It appears that the tablets distributed under the UDL label are distributed to hospitals and other health care facilities in unit dose form in a foil blister pack. The tablets distributed by Mylan under the Bertek label are believed to have been distributed in standard pill bottles.
The Digitek tablets are manufactured by Actavis Totowa in their Elizabeth, New Jersey plant. Their website describes the plant as a “solid-oral-does facility for tablets and capsules supporting a broad therapeutic range” with a “core competency on modified-release products.” The FDA has a different take on the competency of this facility. As set forth in the Warning Letter attached hereto as Exhibit A, the FDA conducted a plant inspection from January 10 through February 6, 2006 and found numerous issues of concern, including:
● Failure to submit required FDA Adverse Drug Experience (“ADE”) Reports;
● Failure to promptly investigate serious and unexpected ADE reports;
● Failure to ever file a required Periodic Safety Report;
● Manufacturing numerous prescription drug products without approved applications.
Digitek was approved by the FDA through a process known as an Abbreviated New Drug Application (“ANDA”). An ANDA applies to a generic equivalent of a prescription drug that has already received FDA approval. The already-approved drug on which Actavis based its ANDA was Lanoxin, a digoxin tablet manufactured by GlaxoSmithKline. In order to secure FDA approval, Actavis was required to demonstrate that its Digitek tablets were “bioequivalent” in comparison to Lanoxin. Bioequivalence factors scrutinized by the relevant authorities concern active ingredient(s), quality, safety, dosage forms and strengths, performance characteristics and intended use. Actavis’ ANDA No. 40-282 was approved by the FDA by letter dated December 23, 1999.
III. The Digitek recall.
On April 25, 2008, Actavis announced a recall of all lots of Bertek and UDL Laboratories Digitek tablets. According to its Press Release, attached hereto as Exhibit B, Actavis initiated the voluntary all-lot recall because “due to the possibility that tablets with double the appropriate thickness may have been commercially released.” Actavis further stated that “[t]hese tablets may contain twice the approved level of active ingredient than is appropriate.” Further, according to the Actavis Press Release:
The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.
IV. Dosing issues.
Digitek tablets are sold in two doses, .125 mg and .25 mg. A study of patients given a single .25 mg daily dose of digoxin showed a median digoxin concentration level of .9 ng/mL for women and .8 ng/mL for men. Rathore, Sex-Based differences in the Effect of Digoxin for the Treatment of Heart Failure. Long-term results from the same study showed a mean digoxin concentration of .97 to 1.01 ng/mL between all sexes. Id. Similar data was obtained from a large scale study completed in 1997. Among 1485 patients, the mean digoxin level for patients taking a .25 mg tablet was .89 ng/mL.”). The Digitalis Investigation Group, The Effect of Digoxin on Mortality and Morbidity in Patients With Heart Failure. That same study showed a mean digoxin level for patients taking a .125 mg tablet of .76 ng/mL. Id.
According to data provided to the FDA in Actavis’ NDA, a patient given two of the .25 mg tablets will typically have an immediate mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL. The concentration level is expected to rapidly decline to a level of less than .6 ng/mL within six to eight hours.
According to information provided to the FDA by the makers of Lanoxin, about two-thirds of adult patients considered adequately dosed with digoxin (and without evidence of toxicity) have serum digoxin concentrations ranging from .8 to 2.0 ng/mL. About two-thirds of patients suffering from digitalis toxicity have serum digoxin concentrations above 2.0 ng/mL while one-third have levels below 2.0 ng/mL.
According to Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, peak serum concentrations of digoxin measured in a variety of clinical tests ranged from 1.13 ng/mL to 2.4ng/mL depending on dosage. Baselt also states that one study of 48 patients exhibiting signs of digoxin toxicity found average serum concentrations of digoxin of 3.7 ng/mL with a range from 1.6 ng/mL to 13.7 ng/mL. another study of some 1000 patients found a mean serum digoxin level in nontoxic patients of 1.4 ng/mL. Bhatia, Digitalis Toxicity—Turning Over a New Leaf. Although the serum digoxin level in patients with toxicity was two to three times higher, “there was considerable overlap between the two groups of patients.” Id.
The foregoing data demonstrates that digoxin has a very narrow therapeutic range. As one medical publication has explained:
Digoxin has a narrow therapeutic window: that is to say, there is only a small range of plasma concentration between the drug being ineffective through underdosing, and toxic through overdosing.
This conclusion has been borne out by a variety of studies found in the medical literature. See, e.g., THCP Education Consortium, Digoxin Toxicity (“There is a narrow therapeutic range for digoxin – which means that the patient can easily have too much or too little of the drug on board.”). Based on the available literature, it appears clear that a double dose of digoxin could lead to digoxin toxicity.
V. Possible side effects of digoxin use.
According to the Lanoxin Product Insert (which is identical to the Digitek product insert), attached hereto as Exhibit C, various side effects may arise from the use of digoxin. Adverse reactions are generally dose-dependent. Exhibit C at p. 7. In the past, approximately one-half of all adverse reactions were cardiac in nature. Id. One-fourth of all adverse reactions were gastrointestinal and the final one-fourth were related to the central nervous system (“CNS”).
A.Cardiac events.
As stated above, about one-half of previously reported adverse events were cardiac in nature. According to the product insert, among the cardiac problems that may be caused from a high dose of digoxin are the following:
first-degree, second-degree (Wenckebach) or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation.
Exhibit C at p. 7. Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, lists possible cardiac side effects as “cardiac disturbances such as tachycardia, premature contractions, atrial fibrillation and atrioventricular block.” Manifestations of these cardiac events include palpitations, loss of consciousness and difficulty breathing.
B.Gastrointestinal events.
Gastrointestinal events caused by digoxin may include anorexia, nausea, vomiting and diarrhea. Other, less frequent, events include abdominal pain, intestinal ischemia and hemorrhagic necrosis of the intestines.
C.Central nervous system and other adverse events.
Events related to the central nervous system include visual disturbances such as blurred or yellow vision, headaches, weakness, dizziness, apathy and confusion. Other possible side effects include mental disturbances such as anxiety, depression, delirium and hallucinations. Gynecomastia, or breast enlargement in males, has also been reported.
VI. Digoxin toxicity.
A.General principles.
Digitek tablets are sold in two doses, .125 mg and .25 mg. A patient given two of the .25 mg tablets will typically have an immediate mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL. According to information provided to the FDA by the makers of Lanoxin, about two-thirds of adult patients considered adequately dosed with digoxin (and without evidence of toxicity) have serum digoxin concentrations ranging from .8 to 2.0 ng/mL. According to Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, peak serum concentrations of digoxin measured in a variety of clinical tests ranged from 1.13 ng/mL to 2.4ng/mL depending on dosage.
While the highest strength Digitek tablet is .25 mg, Lanoxin used to be prescribed in doses up to .5 mg. In fact, when Actavis did testing of their .25 mg pill, they gave the subjects two of the pills (or .5 mg) because they were attempting to replicate studies that GlaxoSmithKline had done on their .5 mg pills. Thus, a patient taking one .25 mg Digitek tablet that contained a double dose of digoxin would arguably be expected to achieve the same digoxin serum level as did those patients in the clinical trials conducted by Actavis: a mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL.
Unfortunately, there are many problems with drawing a bright-line rule from the available data and studies. First, the effects of digoxin are highly variable among patients. Second, the narrow therapeutic range of digoxin makes it difficult to determine whether a particular digoxin level is therapeutic or toxic in a particular patient:
Considering there is some overlap between therapeutic and toxic serum digoxin levels, symptoms of toxicity may be reported in patients whose levels are within the therapeutic range, while others may have no symptoms hen their serum digoxin levels are above the therapeutic threshold.
Hixson-Wallace, Digoxin Toxicity: A Review. Finally, digoxin levels taken less than 6 hours after the administration of digoxin may overstate the true digoxin level. See Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. As stated in the Lanoxin Product Insert:
Following drug administration, a 6- to 8-hour distribution phase is observed. . . . clinical evidence indicates that the early high serum concentrations do not reflect the concentration of digoxin at its site of action . . . . To allow adequate time for equilibration of digoxin between serum and tissue, sampling of serum concentrations should be done just before the next scheduled dose of the drug. If this is not possible, sampling should be done at least 6 to 8 hours after the last dose, regardless of the route of administration or the formula used.
Exhibit C at pp. 3, 9. When reviewing any digoxin serum concentration level, it is important to know when it was drawn relative to the ingestion of digoxin.
B.Digoxin levels as a predictor of digoxin toxicity.
Despite the foregoing issues, properly obtained digoxin levels remain the best indicator of digoxin toxicity. A digoxin level of 3.0 ng/mL or greater is a strong predictor of digoxin toxicity:
Baselt states that one study of 48 patients exhibiting signs of digoxin toxicity found average serum concentrations of digoxin of 3.7 ng/mL.
Another study of some 1000 patients found a mean serum digoxin level in patients suffering from digoxin toxicity of 2.8 ng/mL to 4.2 ng/mL. Bhatia, Digitalis Toxicity—Turning Over a New Leaf.
A study of nearly 800 patients in Japan found that all patients with a digoxin level over 3.0 ng/mL exhibited clinical evidence of digoxin toxicity.” Miura, Effect of Aging on the Incidence of Digoxin Toxicity.
One study showed that “the risk of toxicity at a digoxin concentration of higher than 3.0 ng/mL was 12-fold the risk of at a serum concentration of 0 to .99 ng/mL.” Bhatia, Digitalis Toxicity—Turning Over a New Leaf.
A study of more than 2000 patients found that the mean digoxin serum concentration level for patients with definite digoxin toxicity was 3.6 ng/mL and the mean level for patients with possible digoxin toxicity was 3.4 ng/mL. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice.
One author has concluded that “although no serum digoxin level proves or disproves toxicity, a level higher than 3.0 ng/mL in the appropriate setting lend strong support to diagnosis of digitalis excess.” Bhatia, Digitalis Toxicity—Turning Over a New Leaf.
A digoxin level greater than 2.0 ng/mL is also a fair predictor of digoxin intoxication. A study from North Carolina showed that 60% of patients with a digoxin level over 2.0 ng/mL that was measured more than 6 hours after administration of digoxin had clinical evidence of digoxin toxicity. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice.
A digoxin level below 2.0 ng/mL is a possible indicator of digoxin toxicity. Anywhere from 10% to 33% of patients with such a level may experience adverse side effects as a result of digoxin toxicity:
One study of some 1000 patients showed that 10% of patents with digoxin toxicity had serum concentrations of less than 2.0 ng/mL. Smith, Digitalis Glycosides: Mechanism and Manifestation of Toxicity.
As stated in the Lanoxin Product Insert: “since one-third of patients with clinical toxicity have serum digoxin concentrations less than 2.0 ng/mL, values below 2.0 ng/mL do not rule out the possibility that a certain sign or symptom is related to digoxin therapy.”
A study in Japan “showed that there was an overlapping (toxic and nontoxic) range of serum digoxin concentrations in which the incidence of digoxin toxicity was patient dependent (1.4 – 2/9 ng/mL).” Miura, Effect of Aging on the Incidence of Digoxin Toxicity.
Baselt states that one study of 48 patients exhibiting signs of digoxin toxicity found average digoxin serum concentrations ranging from 1.6 to 13.7 ng/mL.
Another study of some 1000 patients found “considerable overlap” in the digoxin serum concentration levels of nontoxic and toxic patients. Bhatia, Digitalis Toxicity—Turning Over a New Leaf.
Clearly, there will be many patients --- perhaps between 10 and 33% -- with a digoxin level below 2.0 ng/mL who will suffer the effects of digoxin toxicity.
C.At-risk patients.
Of course, certain patients are more susceptible to digoxin toxicity, and the above conclusions do not apply to those patients. This includes elderly patients. See Schreiber, Digitalis Toxicity (“Advanced age (>80) is an independent risk factor and is associated with increased morbidity and mortality.”); Miura, Effect of Aging on the Incidence of Digoxin Toxicity (“clinical evidence of digoxin toxicity in patients > 71 years old was 26.5%, despite their SDCs falling between 1.4 and 2.0 ng/mL . . . . “[t]his raises the possibility that patients > 71 years show clinical evidence of digoxin toxicity despite having SDCs within the recommended therapeutic range.”).
Patients who have previously suffered from renal failure are also particularly susceptible to digoxin toxicity. Exhibit C at p. 5 (“[i]f appropriate care is not taken to reduce the dose of digoxin, such patients are at high risk for toxicity, and toxic effects will last longer in such patients than in patients with normal renal function.”). Other at-risk patients are those with electrolyte disorders such as hypokalemia (low blood potassium), hypomagnesemia (magnesium deficiency) or hypocalcemia (low blood calcium levels). Exhibit C at p. 5. Patients with thyroid disorders are also especially at risk. Exhibit C at p. 5.
D.Symptoms of digoxin toxicity.
Although increased digoxin levels may be a good predictor of digoxin toxicity, the ultimate issue from a damage perspective is whether a patient suffered any injury because of digoxin toxicity. As one author has noted, “clinically stable patients receiving digoxin who have elevated SDCs but are without signs or symptoms of digoxin toxicity are at low risk of developing serious digoxin toxicity and do not generally require treatment beyond the discontinuation of digoxin therapy.” Park, Digoxin Toxicity in Patients with High Serum Digoxin Concentrations. Thus, it is important to be aware of the most prevalent symptoms of digoxin toxicity.
1.Cardiac events.
Increased congestive heart failure may be the initial manifestation of digitalis toxicity in as many as 7.5% of patients. Dysrhythmia, or an abnormal heart rate, occurs in 80% to 90% of patients with digitalis toxicity. Bhatia, Digitalis Toxicity—Turning Over a New Leaf. Perhaps the earliest cardiac manifestation of digoxin toxicity in many patients is premature ventricular contraction (”PVC”). The Digitalis Investigation Group, The Effect of Digoxin on Mortality and Morbidity in Patients With Heart Failure. Ventricular fibrillation and tachycardia are also common symptoms.
The type of arrhythmia will often indicate whether a cardiac event has been caused by digitalis toxicity. Among the types of arrhythmias most suggestive of digitalis toxicity are the following:
● Bidirectional ventricular tachycardia
● Bigeminal ventricular Rhythm
● Multiform premature ventricular complexes
● Atrial tachycardia with block
● Nonparoxysmal AV junctional tachycardia
● Supraventricular rhythm (atrial fibrillation) with ventricular ectopy
● Nonconducted premature atrial complexes
● Ventricular tachycardia with exit block
Bhatia, Digitalis Toxicity—Turning Over a New Leaf. HJJ Wellens has developed four criteria for the electrocardiographic diagnosis of digitalis toxicity. They are:
1.Appearance of a slow heart rate in a patent with a fast or normal heart rate;
2.Appearance of a fast heart rate in a patient with a normal heart rate;
3.Appearance of a regular heart rhythm in a patient with an irregular rhythm; and
4.Appearance of a regularly irregular rhythm.
Wellens, HHJ, The Electrocardiogram in Digitalis Intoxication. Other authors suggest that the most common EKG changes in digoxin toxicity are PR-segment prolongation and cupping of the ST segment. Another author has stated that the typical “digitalis effect” found in electrocardiogram readings are manifested by a shortened QT interval and a characteristic down-sloping ST depression with the T wave opposite in polarity to the QRS complex. TCHP Education Consortium, Digoxin Toxicity.
2.Other events.
The first symptoms of digitalis are often gastrointestinal – anorexia, nausea, vomiting, and diarrhea. THCP Edcuation Consortium, Digoxin Toxicity. The most common symptom associated with digoxin toxicity is nausea. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. Other, non-cardiac events associated with digoxin toxicity include:
● fatigue
● dizziness
● confusion
● delirium
● blurred vision
● disturbed color perception
● hallucinations
● abdominal pain
● headaches
The most common vital sign abnormality is bradycardia.
3.Death.
According to the Lanoxin Product Insert, “manifestations of life-threatening toxicity include ventricular tachycardia or ventricular fibrillation, or progressive bradyarrhymthias, or heart block.” Exhibit C at p. 8. The Product Insert also states that “the administration of more than 10 mg of dioxin in a previously healthy adult . . . often results in cardiac arrest.” Id. Of course, this information is of limited utility because most patients taking dioxin tablets already suffer from some type of heart problem and cannot be considered “healthy adults.” As a result, they are more susceptible to cardiac arrest. This fact also complicates the diagnosis of cardiac events attributable to digitalis toxicity.
A 2005 study by K.F. Adams and others “demonstrated a significant linear relationship between serum digoxin concentration and mortality.” Adams, Relationship of Serum Digoxin Concentration to Mortality. According to a 1997 study by the American Association of Poison Control Centers, of the patients who reported digitalis toxicity, approximately 1% died. Another study showed that 3 of 20 (15%) of patients diagnosed with digoxin toxicity died despite appropriate intervention. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. The Emergency Response Card for Digoxin published by the National Institute for Occupational Safety and Health states that severe exposures to digoxin may result in death, Perhaps most importantly, in its Recall Notice submitted to the FDA, Actavis stated that “[d]eath can result from excessive digitalis intake.” Exhibit B. Clearly, digitalis toxicity can lead to death.
Some of the predictors of whether digoxin toxicity can cause death are the serum digoxin concentration and the age of the patient. My compilation and analysis of data from the last five years of the Annual Report of the American Association of Poison Control Centers’ National Poison Data System yielded valuable insight into these predictors. According to the data, the mean serum digoxin level of patients who died from digoxin toxicity was 4.27 ng/mL. Further, 75% of fatalities from digoxin toxicity occurred with digoxin levels of 3.0 ng/mL or greater. With respect to age, the mean age of a patient judged to have died from digoxin toxicity was 78.5 years. Nearly 80% of all digoxin toxicity fatalities occurred in patients aged 70 years or older. None occurred in patients under the age of 60.
Finally, it is stating the obvious to note that the more pills a patient is taking, the greater the likelihood that a double-dose pill would cause death due to digoxin toxicity. Digitek is manufactured in .125 and .25 mg tablets. A typical daily therapeutic dose is .25 mg. However, patients are sometimes instructed to take several tablets per day in order to reach the desired digoxin level. As set forth in the Lanoxin Product Insert, “if rapid digitialization is considered medically appropriate, it may be achieved by administering a loading dose based upon projected peak digoxin body stores.” Exhibit C at p. 10 (“digitalization” simply refers to the use of digitalis glycosides such as dioxin to treat heart failure). Although the Lanoxin Product Insert provides information regarding an appropriate “loading dose,” it does so only with respect to digoxin injections. Medical literature, however, suggests that an appropriate loading does for digoxin tablets would an initial dose of .5 mg followed by additional doses of .25 mg to .5 mg every 6 hours until digitalization is achieved. Arnsdorf, Method of Digitalization. The total oral dose needed for digitalization is typically 1 to 2 mg using oral digoxin tablets.
Thus, in patients where rapid digitalization has been ordered, the patient may take up to 2 mg of digoxin tablets in one 24-hour period. Patients taking multiple doses of Digitek during a 24-hour period are much more likely to suffer a fatal digoxin overdose from a double-strength pill than those taking one .125 or .25 mg pill per day. We should therefore be on the lookout for injuries and deaths suffered by patients undergoing an initial “loading dose” of Digitek.
VII. What to look for in a case.
Given all of the above, what questions should an attorney ask when assessing potential cases against Actavis as a result of a double-dose of Digitek?
● Does the patient have the pills?
● What strength pills were prescribed?
● How frequently were they taking the pills?
● Was the patient in the middle of an initial loading dose?
● What was the patient’s digoxin serum concentration level?
● When was the digoxin level measured?
● How soon after taking the double dose pill did symptoms of digoxin intoxication develop?
● Was there a diagnosis of digoxin intoxication?
● What non-cardiac symptoms, if any, did the patient have?
● Did the patient suffer from renal failure or deficiency?
● What other drugs was the patient taking?
● Is there any evidence the patient was given treatment for digoxin toxicity such as administration of activated charcoal or digoxin-specific antibody fragments (Digibind or DigiFab).
● If the patient died, what was the listed cause of death?
● How old was the patient?
"Heygood, Orr, Reyes, Pearson & Bartolomei is a business litigation and personal injury law firm, based in Dallas, Texas. We have worked with executives, business owners, and individuals to try over 300 cases to a jury verdict."
The firm is a drug known as Digitek.
Eric Pearson's report - it's copyrighted:
Digitek is the trade name for digoxin tablets manufactured in the United States by Actavis Totowa, LLC, the U.S. manufacturing division of international generic pharmaceutical company Actavis Group. The tablets are distributed in the U.S. by Mylan Pharmaceuticals, based in Morgantown, West Virginia and by UDL Laboratories, based in Rockford, Illinois. Both Mylan Pharmaceuticals and UDL are owned by parent company Mylan, a drug company based in Pittsburgh, Pennsylvania with a market cap of $4 billion. The tablets are distributed by Mylan under a “Bertek” label and by UDL under a “UDL” label. It appears that the tablets distributed under the UDL label are distributed to hospitals and other health care facilities in unit dose form in a foil blister pack. The tablets distributed by Mylan under the Bertek label are believed to have been distributed in standard pill bottles.
The Digitek tablets are manufactured by Actavis Totowa in their Elizabeth, New Jersey plant. Their website describes the plant as a “solid-oral-does facility for tablets and capsules supporting a broad therapeutic range” with a “core competency on modified-release products.” The FDA has a different take on the competency of this facility. As set forth in the Warning Letter attached hereto as Exhibit A, the FDA conducted a plant inspection from January 10 through February 6, 2006 and found numerous issues of concern, including:
● Failure to submit required FDA Adverse Drug Experience (“ADE”) Reports;
● Failure to promptly investigate serious and unexpected ADE reports;
● Failure to ever file a required Periodic Safety Report;
● Manufacturing numerous prescription drug products without approved applications.
Digitek was approved by the FDA through a process known as an Abbreviated New Drug Application (“ANDA”). An ANDA applies to a generic equivalent of a prescription drug that has already received FDA approval. The already-approved drug on which Actavis based its ANDA was Lanoxin, a digoxin tablet manufactured by GlaxoSmithKline. In order to secure FDA approval, Actavis was required to demonstrate that its Digitek tablets were “bioequivalent” in comparison to Lanoxin. Bioequivalence factors scrutinized by the relevant authorities concern active ingredient(s), quality, safety, dosage forms and strengths, performance characteristics and intended use. Actavis’ ANDA No. 40-282 was approved by the FDA by letter dated December 23, 1999.
III. The Digitek recall.
On April 25, 2008, Actavis announced a recall of all lots of Bertek and UDL Laboratories Digitek tablets. According to its Press Release, attached hereto as Exhibit B, Actavis initiated the voluntary all-lot recall because “due to the possibility that tablets with double the appropriate thickness may have been commercially released.” Actavis further stated that “[t]hese tablets may contain twice the approved level of active ingredient than is appropriate.” Further, according to the Actavis Press Release:
The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.
IV. Dosing issues.
Digitek tablets are sold in two doses, .125 mg and .25 mg. A study of patients given a single .25 mg daily dose of digoxin showed a median digoxin concentration level of .9 ng/mL for women and .8 ng/mL for men. Rathore, Sex-Based differences in the Effect of Digoxin for the Treatment of Heart Failure. Long-term results from the same study showed a mean digoxin concentration of .97 to 1.01 ng/mL between all sexes. Id. Similar data was obtained from a large scale study completed in 1997. Among 1485 patients, the mean digoxin level for patients taking a .25 mg tablet was .89 ng/mL.”). The Digitalis Investigation Group, The Effect of Digoxin on Mortality and Morbidity in Patients With Heart Failure. That same study showed a mean digoxin level for patients taking a .125 mg tablet of .76 ng/mL. Id.
According to data provided to the FDA in Actavis’ NDA, a patient given two of the .25 mg tablets will typically have an immediate mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL. The concentration level is expected to rapidly decline to a level of less than .6 ng/mL within six to eight hours.
According to information provided to the FDA by the makers of Lanoxin, about two-thirds of adult patients considered adequately dosed with digoxin (and without evidence of toxicity) have serum digoxin concentrations ranging from .8 to 2.0 ng/mL. About two-thirds of patients suffering from digitalis toxicity have serum digoxin concentrations above 2.0 ng/mL while one-third have levels below 2.0 ng/mL.
According to Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, peak serum concentrations of digoxin measured in a variety of clinical tests ranged from 1.13 ng/mL to 2.4ng/mL depending on dosage. Baselt also states that one study of 48 patients exhibiting signs of digoxin toxicity found average serum concentrations of digoxin of 3.7 ng/mL with a range from 1.6 ng/mL to 13.7 ng/mL. another study of some 1000 patients found a mean serum digoxin level in nontoxic patients of 1.4 ng/mL. Bhatia, Digitalis Toxicity—Turning Over a New Leaf. Although the serum digoxin level in patients with toxicity was two to three times higher, “there was considerable overlap between the two groups of patients.” Id.
The foregoing data demonstrates that digoxin has a very narrow therapeutic range. As one medical publication has explained:
Digoxin has a narrow therapeutic window: that is to say, there is only a small range of plasma concentration between the drug being ineffective through underdosing, and toxic through overdosing.
This conclusion has been borne out by a variety of studies found in the medical literature. See, e.g., THCP Education Consortium, Digoxin Toxicity (“There is a narrow therapeutic range for digoxin – which means that the patient can easily have too much or too little of the drug on board.”). Based on the available literature, it appears clear that a double dose of digoxin could lead to digoxin toxicity.
V. Possible side effects of digoxin use.
According to the Lanoxin Product Insert (which is identical to the Digitek product insert), attached hereto as Exhibit C, various side effects may arise from the use of digoxin. Adverse reactions are generally dose-dependent. Exhibit C at p. 7. In the past, approximately one-half of all adverse reactions were cardiac in nature. Id. One-fourth of all adverse reactions were gastrointestinal and the final one-fourth were related to the central nervous system (“CNS”).
A.Cardiac events.
As stated above, about one-half of previously reported adverse events were cardiac in nature. According to the product insert, among the cardiac problems that may be caused from a high dose of digoxin are the following:
first-degree, second-degree (Wenckebach) or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation.
Exhibit C at p. 7. Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, lists possible cardiac side effects as “cardiac disturbances such as tachycardia, premature contractions, atrial fibrillation and atrioventricular block.” Manifestations of these cardiac events include palpitations, loss of consciousness and difficulty breathing.
B.Gastrointestinal events.
Gastrointestinal events caused by digoxin may include anorexia, nausea, vomiting and diarrhea. Other, less frequent, events include abdominal pain, intestinal ischemia and hemorrhagic necrosis of the intestines.
C.Central nervous system and other adverse events.
Events related to the central nervous system include visual disturbances such as blurred or yellow vision, headaches, weakness, dizziness, apathy and confusion. Other possible side effects include mental disturbances such as anxiety, depression, delirium and hallucinations. Gynecomastia, or breast enlargement in males, has also been reported.
VI. Digoxin toxicity.
A.General principles.
Digitek tablets are sold in two doses, .125 mg and .25 mg. A patient given two of the .25 mg tablets will typically have an immediate mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL. According to information provided to the FDA by the makers of Lanoxin, about two-thirds of adult patients considered adequately dosed with digoxin (and without evidence of toxicity) have serum digoxin concentrations ranging from .8 to 2.0 ng/mL. According to Baselt, Disposition of Toxic Drugs and Chemicals in Man, Seventh Edition, peak serum concentrations of digoxin measured in a variety of clinical tests ranged from 1.13 ng/mL to 2.4ng/mL depending on dosage.
While the highest strength Digitek tablet is .25 mg, Lanoxin used to be prescribed in doses up to .5 mg. In fact, when Actavis did testing of their .25 mg pill, they gave the subjects two of the pills (or .5 mg) because they were attempting to replicate studies that GlaxoSmithKline had done on their .5 mg pills. Thus, a patient taking one .25 mg Digitek tablet that contained a double dose of digoxin would arguably be expected to achieve the same digoxin serum level as did those patients in the clinical trials conducted by Actavis: a mean serum concentration level of between 1.8 ng/mL and 2.0 ng/mL.
Unfortunately, there are many problems with drawing a bright-line rule from the available data and studies. First, the effects of digoxin are highly variable among patients. Second, the narrow therapeutic range of digoxin makes it difficult to determine whether a particular digoxin level is therapeutic or toxic in a particular patient:
Considering there is some overlap between therapeutic and toxic serum digoxin levels, symptoms of toxicity may be reported in patients whose levels are within the therapeutic range, while others may have no symptoms hen their serum digoxin levels are above the therapeutic threshold.
Hixson-Wallace, Digoxin Toxicity: A Review. Finally, digoxin levels taken less than 6 hours after the administration of digoxin may overstate the true digoxin level. See Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. As stated in the Lanoxin Product Insert:
Following drug administration, a 6- to 8-hour distribution phase is observed. . . . clinical evidence indicates that the early high serum concentrations do not reflect the concentration of digoxin at its site of action . . . . To allow adequate time for equilibration of digoxin between serum and tissue, sampling of serum concentrations should be done just before the next scheduled dose of the drug. If this is not possible, sampling should be done at least 6 to 8 hours after the last dose, regardless of the route of administration or the formula used.
Exhibit C at pp. 3, 9. When reviewing any digoxin serum concentration level, it is important to know when it was drawn relative to the ingestion of digoxin.
B.Digoxin levels as a predictor of digoxin toxicity.
Despite the foregoing issues, properly obtained digoxin levels remain the best indicator of digoxin toxicity. A digoxin level of 3.0 ng/mL or greater is a strong predictor of digoxin toxicity:
Baselt states that one study of 48 patients exhibiting signs of digoxin toxicity found average serum concentrations of digoxin of 3.7 ng/mL.
Another study of some 1000 patients found a mean serum digoxin level in patients suffering from digoxin toxicity of 2.8 ng/mL to 4.2 ng/mL. Bhatia, Digitalis Toxicity—Turning Over a New Leaf.
A study of nearly 800 patients in Japan found that all patients with a digoxin level over 3.0 ng/mL exhibited clinical evidence of digoxin toxicity.” Miura, Effect of Aging on the Incidence of Digoxin Toxicity.
One study showed that “the risk of toxicity at a digoxin concentration of higher than 3.0 ng/mL was 12-fold the risk of at a serum concentration of 0 to .99 ng/mL.” Bhatia, Digitalis Toxicity—Turning Over a New Leaf.
A study of more than 2000 patients found that the mean digoxin serum concentration level for patients with definite digoxin toxicity was 3.6 ng/mL and the mean level for patients with possible digoxin toxicity was 3.4 ng/mL. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice.
One author has concluded that “although no serum digoxin level proves or disproves toxicity, a level higher than 3.0 ng/mL in the appropriate setting lend strong support to diagnosis of digitalis excess.” Bhatia, Digitalis Toxicity—Turning Over a New Leaf.
A digoxin level greater than 2.0 ng/mL is also a fair predictor of digoxin intoxication. A study from North Carolina showed that 60% of patients with a digoxin level over 2.0 ng/mL that was measured more than 6 hours after administration of digoxin had clinical evidence of digoxin toxicity. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice.
A digoxin level below 2.0 ng/mL is a possible indicator of digoxin toxicity. Anywhere from 10% to 33% of patients with such a level may experience adverse side effects as a result of digoxin toxicity:
One study of some 1000 patients showed that 10% of patents with digoxin toxicity had serum concentrations of less than 2.0 ng/mL. Smith, Digitalis Glycosides: Mechanism and Manifestation of Toxicity.
As stated in the Lanoxin Product Insert: “since one-third of patients with clinical toxicity have serum digoxin concentrations less than 2.0 ng/mL, values below 2.0 ng/mL do not rule out the possibility that a certain sign or symptom is related to digoxin therapy.”
A study in Japan “showed that there was an overlapping (toxic and nontoxic) range of serum digoxin concentrations in which the incidence of digoxin toxicity was patient dependent (1.4 – 2/9 ng/mL).” Miura, Effect of Aging on the Incidence of Digoxin Toxicity.
Baselt states that one study of 48 patients exhibiting signs of digoxin toxicity found average digoxin serum concentrations ranging from 1.6 to 13.7 ng/mL.
Another study of some 1000 patients found “considerable overlap” in the digoxin serum concentration levels of nontoxic and toxic patients. Bhatia, Digitalis Toxicity—Turning Over a New Leaf.
Clearly, there will be many patients --- perhaps between 10 and 33% -- with a digoxin level below 2.0 ng/mL who will suffer the effects of digoxin toxicity.
C.At-risk patients.
Of course, certain patients are more susceptible to digoxin toxicity, and the above conclusions do not apply to those patients. This includes elderly patients. See Schreiber, Digitalis Toxicity (“Advanced age (>80) is an independent risk factor and is associated with increased morbidity and mortality.”); Miura, Effect of Aging on the Incidence of Digoxin Toxicity (“clinical evidence of digoxin toxicity in patients > 71 years old was 26.5%, despite their SDCs falling between 1.4 and 2.0 ng/mL . . . . “[t]his raises the possibility that patients > 71 years show clinical evidence of digoxin toxicity despite having SDCs within the recommended therapeutic range.”).
Patients who have previously suffered from renal failure are also particularly susceptible to digoxin toxicity. Exhibit C at p. 5 (“[i]f appropriate care is not taken to reduce the dose of digoxin, such patients are at high risk for toxicity, and toxic effects will last longer in such patients than in patients with normal renal function.”). Other at-risk patients are those with electrolyte disorders such as hypokalemia (low blood potassium), hypomagnesemia (magnesium deficiency) or hypocalcemia (low blood calcium levels). Exhibit C at p. 5. Patients with thyroid disorders are also especially at risk. Exhibit C at p. 5.
D.Symptoms of digoxin toxicity.
Although increased digoxin levels may be a good predictor of digoxin toxicity, the ultimate issue from a damage perspective is whether a patient suffered any injury because of digoxin toxicity. As one author has noted, “clinically stable patients receiving digoxin who have elevated SDCs but are without signs or symptoms of digoxin toxicity are at low risk of developing serious digoxin toxicity and do not generally require treatment beyond the discontinuation of digoxin therapy.” Park, Digoxin Toxicity in Patients with High Serum Digoxin Concentrations. Thus, it is important to be aware of the most prevalent symptoms of digoxin toxicity.
1.Cardiac events.
Increased congestive heart failure may be the initial manifestation of digitalis toxicity in as many as 7.5% of patients. Dysrhythmia, or an abnormal heart rate, occurs in 80% to 90% of patients with digitalis toxicity. Bhatia, Digitalis Toxicity—Turning Over a New Leaf. Perhaps the earliest cardiac manifestation of digoxin toxicity in many patients is premature ventricular contraction (”PVC”). The Digitalis Investigation Group, The Effect of Digoxin on Mortality and Morbidity in Patients With Heart Failure. Ventricular fibrillation and tachycardia are also common symptoms.
The type of arrhythmia will often indicate whether a cardiac event has been caused by digitalis toxicity. Among the types of arrhythmias most suggestive of digitalis toxicity are the following:
● Bidirectional ventricular tachycardia
● Bigeminal ventricular Rhythm
● Multiform premature ventricular complexes
● Atrial tachycardia with block
● Nonparoxysmal AV junctional tachycardia
● Supraventricular rhythm (atrial fibrillation) with ventricular ectopy
● Nonconducted premature atrial complexes
● Ventricular tachycardia with exit block
Bhatia, Digitalis Toxicity—Turning Over a New Leaf. HJJ Wellens has developed four criteria for the electrocardiographic diagnosis of digitalis toxicity. They are:
1.Appearance of a slow heart rate in a patent with a fast or normal heart rate;
2.Appearance of a fast heart rate in a patient with a normal heart rate;
3.Appearance of a regular heart rhythm in a patient with an irregular rhythm; and
4.Appearance of a regularly irregular rhythm.
Wellens, HHJ, The Electrocardiogram in Digitalis Intoxication. Other authors suggest that the most common EKG changes in digoxin toxicity are PR-segment prolongation and cupping of the ST segment. Another author has stated that the typical “digitalis effect” found in electrocardiogram readings are manifested by a shortened QT interval and a characteristic down-sloping ST depression with the T wave opposite in polarity to the QRS complex. TCHP Education Consortium, Digoxin Toxicity.
2.Other events.
The first symptoms of digitalis are often gastrointestinal – anorexia, nausea, vomiting, and diarrhea. THCP Edcuation Consortium, Digoxin Toxicity. The most common symptom associated with digoxin toxicity is nausea. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. Other, non-cardiac events associated with digoxin toxicity include:
● fatigue
● dizziness
● confusion
● delirium
● blurred vision
● disturbed color perception
● hallucinations
● abdominal pain
● headaches
The most common vital sign abnormality is bradycardia.
3.Death.
According to the Lanoxin Product Insert, “manifestations of life-threatening toxicity include ventricular tachycardia or ventricular fibrillation, or progressive bradyarrhymthias, or heart block.” Exhibit C at p. 8. The Product Insert also states that “the administration of more than 10 mg of dioxin in a previously healthy adult . . . often results in cardiac arrest.” Id. Of course, this information is of limited utility because most patients taking dioxin tablets already suffer from some type of heart problem and cannot be considered “healthy adults.” As a result, they are more susceptible to cardiac arrest. This fact also complicates the diagnosis of cardiac events attributable to digitalis toxicity.
A 2005 study by K.F. Adams and others “demonstrated a significant linear relationship between serum digoxin concentration and mortality.” Adams, Relationship of Serum Digoxin Concentration to Mortality. According to a 1997 study by the American Association of Poison Control Centers, of the patients who reported digitalis toxicity, approximately 1% died. Another study showed that 3 of 20 (15%) of patients diagnosed with digoxin toxicity died despite appropriate intervention. Williamson, Digoxin Toxicity: An Evaluation in Current Clinical Practice. The Emergency Response Card for Digoxin published by the National Institute for Occupational Safety and Health states that severe exposures to digoxin may result in death, Perhaps most importantly, in its Recall Notice submitted to the FDA, Actavis stated that “[d]eath can result from excessive digitalis intake.” Exhibit B. Clearly, digitalis toxicity can lead to death.
Some of the predictors of whether digoxin toxicity can cause death are the serum digoxin concentration and the age of the patient. My compilation and analysis of data from the last five years of the Annual Report of the American Association of Poison Control Centers’ National Poison Data System yielded valuable insight into these predictors. According to the data, the mean serum digoxin level of patients who died from digoxin toxicity was 4.27 ng/mL. Further, 75% of fatalities from digoxin toxicity occurred with digoxin levels of 3.0 ng/mL or greater. With respect to age, the mean age of a patient judged to have died from digoxin toxicity was 78.5 years. Nearly 80% of all digoxin toxicity fatalities occurred in patients aged 70 years or older. None occurred in patients under the age of 60.
Finally, it is stating the obvious to note that the more pills a patient is taking, the greater the likelihood that a double-dose pill would cause death due to digoxin toxicity. Digitek is manufactured in .125 and .25 mg tablets. A typical daily therapeutic dose is .25 mg. However, patients are sometimes instructed to take several tablets per day in order to reach the desired digoxin level. As set forth in the Lanoxin Product Insert, “if rapid digitialization is considered medically appropriate, it may be achieved by administering a loading dose based upon projected peak digoxin body stores.” Exhibit C at p. 10 (“digitalization” simply refers to the use of digitalis glycosides such as dioxin to treat heart failure). Although the Lanoxin Product Insert provides information regarding an appropriate “loading dose,” it does so only with respect to digoxin injections. Medical literature, however, suggests that an appropriate loading does for digoxin tablets would an initial dose of .5 mg followed by additional doses of .25 mg to .5 mg every 6 hours until digitalization is achieved. Arnsdorf, Method of Digitalization. The total oral dose needed for digitalization is typically 1 to 2 mg using oral digoxin tablets.
Thus, in patients where rapid digitalization has been ordered, the patient may take up to 2 mg of digoxin tablets in one 24-hour period. Patients taking multiple doses of Digitek during a 24-hour period are much more likely to suffer a fatal digoxin overdose from a double-strength pill than those taking one .125 or .25 mg pill per day. We should therefore be on the lookout for injuries and deaths suffered by patients undergoing an initial “loading dose” of Digitek.
VII. What to look for in a case.
Given all of the above, what questions should an attorney ask when assessing potential cases against Actavis as a result of a double-dose of Digitek?
● Does the patient have the pills?
● What strength pills were prescribed?
● How frequently were they taking the pills?
● Was the patient in the middle of an initial loading dose?
● What was the patient’s digoxin serum concentration level?
● When was the digoxin level measured?
● How soon after taking the double dose pill did symptoms of digoxin intoxication develop?
● Was there a diagnosis of digoxin intoxication?
● What non-cardiac symptoms, if any, did the patient have?
● Did the patient suffer from renal failure or deficiency?
● What other drugs was the patient taking?
● Is there any evidence the patient was given treatment for digoxin toxicity such as administration of activated charcoal or digoxin-specific antibody fragments (Digibind or DigiFab).
● If the patient died, what was the listed cause of death?
● How old was the patient?
Total Body Formula Recall Makes News In Georgia Paper
My office has filed several lawsuits - NOT a class action - involving the Total Body Formula and Total Body Mega Formula recall.
In March, the FDA had warned consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
From an Athens, Georgia paper there was an article regarding the recalled products. The article refers to Total Body Formula as a "diet aid," although I would not have used those two words to describe the product.
More here.
In March, the FDA had warned consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
From an Athens, Georgia paper there was an article regarding the recalled products. The article refers to Total Body Formula as a "diet aid," although I would not have used those two words to describe the product.
More here.
Gardisil: Problems Looming?
From a news website:
Gardisil is a vaccine given to protect women against certain types of cervical cancer.
There have been complaints of paralysis, blood clots and death. The Centers for Disease Control and Prevention has recently stated that despite the complaint, none of the side effects can be linked to Gardasil.
From another site:
"Lisa Ericzon tells the New York Post that her daughter Jessica received her third dose of the vaccine on February 20th of last year. Ericzon says in the article that two days late, her daughter collapsed and died and she says her daughter had complained of pain in the back of her head following both the second and third vaccine shots. An autopsy could not determine the cause of death.
Merck, the company that makes Gardasil, says the New York Post never contacted them for comment on the story. The FDA, CDC and State Health Department continue to recommend Gardasil." Source.
For more go here.
Gardisil is a vaccine given to protect women against certain types of cervical cancer.
There have been complaints of paralysis, blood clots and death. The Centers for Disease Control and Prevention has recently stated that despite the complaint, none of the side effects can be linked to Gardasil.
From another site:
"Lisa Ericzon tells the New York Post that her daughter Jessica received her third dose of the vaccine on February 20th of last year. Ericzon says in the article that two days late, her daughter collapsed and died and she says her daughter had complained of pain in the back of her head following both the second and third vaccine shots. An autopsy could not determine the cause of death.
Merck, the company that makes Gardasil, says the New York Post never contacted them for comment on the story. The FDA, CDC and State Health Department continue to recommend Gardasil." Source.
For more go here.
Friday, July 25, 2008
Epilepsy Drug May Increase Risk of Birth Defects
So says the American Academy of Neurology (find more here):
Taking the epilepsy drug topiramate alone or along with other epilepsy drugs during pregnancy may increase the risk of birth defects, according to a study published in the July 22, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology.
Research has shown that many epilepsy drugs increase the risk of birth defects, but little research has been done on topiramate. Studies have shown that topiramate increases the risk of birth defects in animals. Maintaining effective epilepsy treatment during pregnancy is crucial because seizures may cause harm to the fetus.
For the study, researchers examined women who became pregnant while taking topiramate either on its own or along with other epilepsy drugs. Of 178 babies born, 16 had major birth defects. Three of these were in infants whose mothers were taking only topiramate, and 13 were in those whose mothers were taking topiramate and other epilepsy drugs.
Taking the epilepsy drug topiramate alone or along with other epilepsy drugs during pregnancy may increase the risk of birth defects, according to a study published in the July 22, 2008, issue of Neurology®, the medical journal of the American Academy of Neurology.
Research has shown that many epilepsy drugs increase the risk of birth defects, but little research has been done on topiramate. Studies have shown that topiramate increases the risk of birth defects in animals. Maintaining effective epilepsy treatment during pregnancy is crucial because seizures may cause harm to the fetus.
For the study, researchers examined women who became pregnant while taking topiramate either on its own or along with other epilepsy drugs. Of 178 babies born, 16 had major birth defects. Three of these were in infants whose mothers were taking only topiramate, and 13 were in those whose mothers were taking topiramate and other epilepsy drugs.
Friday Tech: Searching All Craigslist Sites
Craigslist.org is a website that at least in Atlanta is to me the best free version of classified ads around. I've been able to find a vehicle, temporary office workers, concert tickets, and a desk on it. In other cities I have found affordable by owner short term rentals, and even auto parts.
As useful as the site is, however, to me it was almost impossible to search all cities on Craigslist. From Lifehacker comes a solution (via wired.com):
Google's Advanced Search yields a way to limit results to domains, such as Craigslist.org. Advanced Search is the link located right next to the main search field on Google’s home page. Click on "Advanced Search" and follow the directions on the link posted above.
There is a shorthand method
* Type in the search field:
site:craigslist.org “antique coastal surveys ”
With or without quotes to broaden or narrow down the search.
* You can also use booleans to modify the range of your search:
site:craigslist.org antique|vintage coastal surveys
As useful as the site is, however, to me it was almost impossible to search all cities on Craigslist. From Lifehacker comes a solution (via wired.com):
Google's Advanced Search yields a way to limit results to domains, such as Craigslist.org. Advanced Search is the link located right next to the main search field on Google’s home page. Click on "Advanced Search" and follow the directions on the link posted above.
There is a shorthand method
* Type in the search field:
site:craigslist.org “antique coastal surveys ”
With or without quotes to broaden or narrow down the search.
* You can also use booleans to modify the range of your search:
site:craigslist.org antique|vintage coastal surveys
Thursday, July 24, 2008
Vytorin: Dear Doctor Letter Readied
Vytorin is a drug made by a partnership of Merck & Schering-Plough. There's news that a letter has been readied to be sent to doctor who may be asking about recently released study results that showed patients taking the cholesterol drug were at higher risk of dying from cancer.
Video (less than 90 seconds)here: http://www.cnbc.com/id/15840232?video=801729653
From various sites:
The companies will take the stance that the increase in cancer deaths and higher incidence of cancer in a recent study involving 1,873 people should be considered an anomaly. The SEAS study were released this week, and it is in that study that the cancer connection is alleged. Source.
What is SEAS? It is the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. It is a randomized, multicenter, placebo-controlled study evaluating the effects of combination ezetimibe/simvastatin (Vytorin) on clinical outcomes in roughly 1800 patients with aortic stenosis, and the results showed that the controversial cholesterol-lowering medication was no better than placebo in reducing the primary composite end point of aortic-valve and cardiovascular events. (Link)
Other sites note this:
What Do the SEAS Results Mean?
There was speculation that the trial could help rehabilitate Vytorin after the Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial was published in March, but the placebo-controlled trial design, as well as the patient population, were likely to limit the clinical impact.
The SEAS results are the first clinical results for Vytorin since ENHANCE was published. In that study, investigators tested the effectiveness of combined ezetimibe/simvastatin therapy in patients with familial hypercholesterolemia and found that the combination did no better than simvastatin monotherapy on several surrogate end points. The combination did not result in a significant difference in changes in intima-media thickness compared with simvastatin alone, despite significantly greater reductions in LDL cholesterol and C-reactive protein.(Link).
Video (less than 90 seconds)here: http://www.cnbc.com/id/15840232?video=801729653
From various sites:
The companies will take the stance that the increase in cancer deaths and higher incidence of cancer in a recent study involving 1,873 people should be considered an anomaly. The SEAS study were released this week, and it is in that study that the cancer connection is alleged. Source.
What is SEAS? It is the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study. It is a randomized, multicenter, placebo-controlled study evaluating the effects of combination ezetimibe/simvastatin (Vytorin) on clinical outcomes in roughly 1800 patients with aortic stenosis, and the results showed that the controversial cholesterol-lowering medication was no better than placebo in reducing the primary composite end point of aortic-valve and cardiovascular events. (Link)
Other sites note this:
What Do the SEAS Results Mean?
There was speculation that the trial could help rehabilitate Vytorin after the Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial was published in March, but the placebo-controlled trial design, as well as the patient population, were likely to limit the clinical impact.
The SEAS results are the first clinical results for Vytorin since ENHANCE was published. In that study, investigators tested the effectiveness of combined ezetimibe/simvastatin therapy in patients with familial hypercholesterolemia and found that the combination did no better than simvastatin monotherapy on several surrogate end points. The combination did not result in a significant difference in changes in intima-media thickness compared with simvastatin alone, despite significantly greater reductions in LDL cholesterol and C-reactive protein.(Link).
Wednesday, July 23, 2008
Truck driving while disabled: 'Major public safety problem'
From the Atlanta Journal Constitution comes news that thousands of drivers hold commercial licenses even though they also qualify for full federal disability payments.
From the article:
"The problems threatening highway travelers persist despite years of government warnings and hundreds of deaths and injuries blamed on commercial truck and bus drivers who blacked out, collapsed or suffered major health problems behind the wheels of vehicles that can weigh 40 tons or more. Georgia is among 12 states where drivers are sanctioned most often for violating medical rules."
The eye opener quote: "We have a major public safety problem, and we haven't corrected it," - says Gerald Donaldson. Donaldso is a director at the Washington-based Advocates for Highway and Auto Safety.
For more, go here.
From the article:
"The problems threatening highway travelers persist despite years of government warnings and hundreds of deaths and injuries blamed on commercial truck and bus drivers who blacked out, collapsed or suffered major health problems behind the wheels of vehicles that can weigh 40 tons or more. Georgia is among 12 states where drivers are sanctioned most often for violating medical rules."
The eye opener quote: "We have a major public safety problem, and we haven't corrected it," - says Gerald Donaldson. Donaldso is a director at the Washington-based Advocates for Highway and Auto Safety.
For more, go here.
Thursday, July 17, 2008
Avastin Tied to Anemia
From various sources, including CNN:
The FDA has, this week, issued an alert regarding cancer drug Avastin. There has been an alleged link to the development of anemia in several patients.
According to the FDA, patients have reported that when Avastin was taken in combination with Sutent, another cancer drug, reported microangiopathic hemolytic anemia (a loss of red blood cells).
What is particularly important is that Avastin is not approved to be taken in combination with Sutent, a cancer drug manufactured by Pfizer.
Here's the link.
The FDA has, this week, issued an alert regarding cancer drug Avastin. There has been an alleged link to the development of anemia in several patients.
According to the FDA, patients have reported that when Avastin was taken in combination with Sutent, another cancer drug, reported microangiopathic hemolytic anemia (a loss of red blood cells).
What is particularly important is that Avastin is not approved to be taken in combination with Sutent, a cancer drug manufactured by Pfizer.
Here's the link.
Sunday, July 13, 2008
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
From the FDA site for these listed drugs:Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.
The Release:
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.
The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.
Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.
"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."
The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.
Link here.
The Release:
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.
The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.
Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.
"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."
The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.
Link here.
Botox News: Lawsuits Filed
A number of Botox users and relatives of those who had the drug administered filed suit in California, claiming that the drug injured or killed. The maker of the drug, Allergan Inc. is the company, and the company is based in Califoria.
Cases include one where an over 60 nurse allegedly died after receiving injections for neck and shoulder pain. Another involves a child with cerebral palsy, also from Texas, who died in 2004, allegedly after receiving injections to control limb spasticity.
Source here.
Perhaps the most famous claimed user of Botox to address spasticity is Robert F. Kennedy Jr. Kennedy is is said has a condition called spasmodic dysphonia, a specific form of an involuntary movement disorder called dystonia that affects only the voice box.
Cases include one where an over 60 nurse allegedly died after receiving injections for neck and shoulder pain. Another involves a child with cerebral palsy, also from Texas, who died in 2004, allegedly after receiving injections to control limb spasticity.
Source here.
Perhaps the most famous claimed user of Botox to address spasticity is Robert F. Kennedy Jr. Kennedy is is said has a condition called spasmodic dysphonia, a specific form of an involuntary movement disorder called dystonia that affects only the voice box.
No Blackbox Warnings for Epilepsy Drugs
From various sources comes the news that anti-seizure drugs may allegedly cause increased suicidal tendencies in patients. Even so, it's not enough to result in the FDA imposition of the strongest warning label on them, according to the FDA law week.
A 20 member FDA panel vote unanimously to back findings on a number of antiepileptic drugs studied. Back at the start of 2008, FDA informed there could be a black box warning added after a study of 199 studies comparing the drugs, which are used by millions, to placebos.
For more, go here.
A 20 member FDA panel vote unanimously to back findings on a number of antiepileptic drugs studied. Back at the start of 2008, FDA informed there could be a black box warning added after a study of 199 studies comparing the drugs, which are used by millions, to placebos.
For more, go here.
Tuesday, July 01, 2008
Verdict in AWP Case in Alabama: $100 Million +
Tom Methvin's law firm in Montgomery rendered a verdict for the State of Alabama yesterday.
Pharmaceutical companies charged for drugs based on the Average Wholesale Price (AWP). Average Wholesale Price” or AWP has long been used as a pricing benchmark for almost all prescription drug sales in the United States. Health plans, Medicaid and other government programs, and employers determine how much to pay pharmacies and doctors to reimburse them for drugs that are dispensed to patients by using formulas based on the AWP for individual drugs. Source.
A jury in Montgomery County Circuit Court returned a verdict in favor of the State of Alabama in a case involving AWP and allegations of fraud, finding defendants GlaxoSmithKline and Novartis Pharmaceuticals Corp. liable for a total of $114,247,233, of which $80,989,539 is from GlaxoSmithKline and $33,257,694 is from Novartis.
For more on Tom's Firm's victory for the State of Alabama, go here.
Pharmaceutical companies charged for drugs based on the Average Wholesale Price (AWP). Average Wholesale Price” or AWP has long been used as a pricing benchmark for almost all prescription drug sales in the United States. Health plans, Medicaid and other government programs, and employers determine how much to pay pharmacies and doctors to reimburse them for drugs that are dispensed to patients by using formulas based on the AWP for individual drugs. Source.
A jury in Montgomery County Circuit Court returned a verdict in favor of the State of Alabama in a case involving AWP and allegations of fraud, finding defendants GlaxoSmithKline and Novartis Pharmaceuticals Corp. liable for a total of $114,247,233, of which $80,989,539 is from GlaxoSmithKline and $33,257,694 is from Novartis.
For more on Tom's Firm's victory for the State of Alabama, go here.
FDA: Avastin Useless against Breast Cancer
News from this week ...
Avastin: A metastatic colorectal cancer treatment and advanced non-small cell lung cancer treatment.
In a past clinical trial sponsored by the National Cancer Institute, researchers gave breast cancer patients either Avastin and the breast cancer drug paclitaxel (also marketed as Taxol) or just paclitaxel alone.
The results showed that the drug combination of Avastin and Taxol almost doubled the time before breast tumors worsened, from just less than six months with paclitaxel alone to 11.3 months with the combination. Preliminary results of the study were released in April 2005, before the end of the study. Source: Here.
In combination with another drug, Avastin posed problems as well. Researchers in February 2006 abruptly halted recruitment of patients for a study combining the anti-cancer drugs Avastin and Xelox after several patients involved in the clinical testing died. Xeloda, a medication used alone since 1998 as a first-line defense in the treatment of colon cancer.
Avastin: A metastatic colorectal cancer treatment and advanced non-small cell lung cancer treatment.
In a past clinical trial sponsored by the National Cancer Institute, researchers gave breast cancer patients either Avastin and the breast cancer drug paclitaxel (also marketed as Taxol) or just paclitaxel alone.
The results showed that the drug combination of Avastin and Taxol almost doubled the time before breast tumors worsened, from just less than six months with paclitaxel alone to 11.3 months with the combination. Preliminary results of the study were released in April 2005, before the end of the study. Source: Here.
In combination with another drug, Avastin posed problems as well. Researchers in February 2006 abruptly halted recruitment of patients for a study combining the anti-cancer drugs Avastin and Xelox after several patients involved in the clinical testing died. Xeloda, a medication used alone since 1998 as a first-line defense in the treatment of colon cancer.
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