From the Baxter site:
Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/ML 10 and 30mL Multi-Dose Vials
NDC NUMBERS 0641-2440-45, 0641-2440-41, 0641-2450-45 and 0641-2450-41; LOTS: 107054, 117085, 047056, 097081, 107024, 107064, 107066, 107074, 107111
DEERFIELD, Ill., January 25, 2008 – Baxter Healthcare Corporation has announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product. Baxter is conducting a thorough investigation of these reports to identify the cause of the increase in allergic-type reactions.
Adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, feeling your heart beat strong or fast, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth. Some of these reactions may be severe or life threatening.
Heparin is a prescription, injectable blood anticoagulant (also called a blood thinner). The 1,000 units/mL multi-dose vials are primarily used for hemodialysis and cardiac invasive procedures. To date, the company has not observed a significant increase in adverse event reports occurring with any other of its heparin presentations.
Customers have been instructed to discontinue use and segregate the recalled product from the rest of their inventory. Customers should then contact Baxter to arrange for return and replacement product. Customers with recalled product purchased indirectly should contact their wholesaler or distributor for return and replacement product. Customers with questions may contact Baxter at 1-800-667-0959. Representatives are available Monday through Friday from 7 a.m. to 6 p.m. CT.
Baxter International Inc. (NYSE:BAX), through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. For more information about Baxter, visit www.baxter.com.
News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation. Lawyers for consumers and injured people.(No advice on this blog, though) mark(at)markzamora.com
Tuesday, January 29, 2008
Google's New Search Results: Timeline View
I have the Google Blog on my RSS. Today there is something that may be a big help.
From their site:
"Introducing experimental views for search results. There have been a lot of recent improvements to web search, but the appearance of results themselves has been pretty constant -- 10 or so web pages in a vertical list. Frequently this is exactly the right format, but for some searches you need more options and more control. That's why we've created our experimental search page to let you try out some of our newest ideas.
Timeline view
Timeline view does the same thing as map view, but for dates found on the web. This includes dates of upcoming or historic events, or even biographical information -- all generated automatically from your search results.
The graph across the top of the page summarizes how dates in your results are spread through time, with higher bars representing a larger number of unique dates. Click anywhere on the graph to zoom in to that particular period of time, and use the text box to the right to specify any range of years, months, or days. Much as in map view, the results below the graph emphasize the dates contained on each page.
Go here for more.
OTC Eardrops: Possible Hearing Loss/Damage?
Researchers at The Montreal Children's Hospital have revealed that certain over-the-counter earwax softeners can cause severe inflammation and damage to the eardrum and inner ear. The results of the study, recently published in The Laryngoscope, suggest that use of these medications should be discouraged.
"Patients often complain that wax is blocking their ears and is causing discomfort and sometimes deafness," says Dr. Sam Daniel principal investigator of the study and director of McGill Auditory Sciences Laboratory at The Children's. "Over-the-counter earwax softeners are used to breakup and disperse this excess wax. However, the effects of these medications on the cells of the ear had not been thoroughly analyzed."
For more go here.
"Patients often complain that wax is blocking their ears and is causing discomfort and sometimes deafness," says Dr. Sam Daniel principal investigator of the study and director of McGill Auditory Sciences Laboratory at The Children's. "Over-the-counter earwax softeners are used to breakup and disperse this excess wax. However, the effects of these medications on the cells of the ear had not been thoroughly analyzed."
For more go here.
Monday, January 28, 2008
FDA To Require Suicide Studies in Drug Trials
From the New York Times:
The FDA is now requiring drug makers to study closely whether patients become suicidal during clinical trials. Rules
The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.
Link is here.
The FDA is now requiring drug makers to study closely whether patients become suicidal during clinical trials. Rules
The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.
Link is here.
Email? C U L8tr; Its a Txt wrld
In our practice I am slowly starting to use texting to reach certain clients. It's easier, not web-dependent, and I almost always get a faster reply. Texting is mostly limited to clients under 35. For the uninitiated, texting is also known as text messaging or SMS (Short Message Service). This allows short text messages to be sent and received on a mobile phone.
Messages can be sent from one phone to another by addressing the message to the recipient's phone number.
This weekend, from the ajc.com there is this:
"What once seemed like a dazzling new communication tool is not only taken for granted by the generation that grew up with it, it's outright scorned.
According to a new survey, "Teens and Social Media," conducted by the Pew Internet & American Life Project, e-mail ranks last in teenagers' preference among seven ways of communicating. Using a landline phone was first, with 39 percent of teens talking on the phone daily with friends. Talking in person was third, and e-mail was dead last, with a mere 14 percent, supplanted by text messaging, instant messaging and social network sites like Facebook and MySpace."
For the rest of the article, go here.
Friday, January 25, 2008
Why are Lawyers Suing Vytorin Makers So Soon?
I just shake my heads sometimes over the actions of lawyers. Just two weeks have passed since the hubbub over Vytorin.
Lawsuits have been filed in federal courts in states including California, Florida, Louisiana, Minnesota, Mississippi, New Jersey, New York and Ohio, according to court documents and interviews with attorneys. The consumer fraud suits, which all seek class-action status, were filed on behalf of patients and medical insurers who paid for the expensive cholesterol drugs.
Additional suits are pending in several other states and Puerto Rico and may eventually be filed in every state but Michigan, which bars such lawsuits against drug makers, said Louisiana attorney Daniel Becnel, who is coordinating filings with firms in other states. Link to Business Week here.
According to one report (source below), "We just have hundreds and hundreds of (potential) clients contacting us every day," asking to be represented in the matter, he said Thursday. Becnel said he has already filed a motion for the suits to be consolidated in a single location under one federal judge.
Why? What is the injury to the consumer at this early stage in the reporting? It's a race to the cash, IMHO. I've spent several hours reviewing the reports, and unlike recent cases, this one is apparently NOT about a physical injury. I'm skeptical to say the least. At a minimum, if insurers have issues relating to the drug's marketing and pricing, why jump to suit so quickly?
I'll keep looking; stay tuned.
Lawsuits have been filed in federal courts in states including California, Florida, Louisiana, Minnesota, Mississippi, New Jersey, New York and Ohio, according to court documents and interviews with attorneys. The consumer fraud suits, which all seek class-action status, were filed on behalf of patients and medical insurers who paid for the expensive cholesterol drugs.
Additional suits are pending in several other states and Puerto Rico and may eventually be filed in every state but Michigan, which bars such lawsuits against drug makers, said Louisiana attorney Daniel Becnel, who is coordinating filings with firms in other states. Link to Business Week here.
According to one report (source below), "We just have hundreds and hundreds of (potential) clients contacting us every day," asking to be represented in the matter, he said Thursday. Becnel said he has already filed a motion for the suits to be consolidated in a single location under one federal judge.
Why? What is the injury to the consumer at this early stage in the reporting? It's a race to the cash, IMHO. I've spent several hours reviewing the reports, and unlike recent cases, this one is apparently NOT about a physical injury. I'm skeptical to say the least. At a minimum, if insurers have issues relating to the drug's marketing and pricing, why jump to suit so quickly?
I'll keep looking; stay tuned.
Thursday, January 24, 2008
Law Tech: Blackberry v. T-Mobile Sidekick
Most lawyers use the Blackberry, but I'm sold on a recent addition, the Sidekick 3.
From various reviews:
In my experience with a BB ... it has an awkward interface that mocks rules of good design. Clicking on a link on a Web page should take you to a new page, but here it invokes a menu many items long. Opening a memo requires choosing between reading it and editing it; when you close a document, the default action is to discard your edits.
T-Mobile's Sidekick 3 does not have that problem. It has an LCD screen that slides open to reveal a QWERTY keyboard that falls right under your thumbs, with the important controls (on either side.
The Sidekick Web browser and e-mail program are far more approachable than the BlackBerry's. Mine also has instant-messaging software for AOL's, Microsoft's and Yahoo's networks. We use IM at home and to a certain extent at work.
The Sidekick it has a higher-resolution camera, Bluetooth wireless, and MP3-only music playback.
I'm sold on it more than anything else because the size of the keyboard and the screen size help this greying litigator see each without squinting.
From various reviews:
In my experience with a BB ... it has an awkward interface that mocks rules of good design. Clicking on a link on a Web page should take you to a new page, but here it invokes a menu many items long. Opening a memo requires choosing between reading it and editing it; when you close a document, the default action is to discard your edits.
T-Mobile's Sidekick 3 does not have that problem. It has an LCD screen that slides open to reveal a QWERTY keyboard that falls right under your thumbs, with the important controls (on either side.
The Sidekick Web browser and e-mail program are far more approachable than the BlackBerry's. Mine also has instant-messaging software for AOL's, Microsoft's and Yahoo's networks. We use IM at home and to a certain extent at work.
The Sidekick it has a higher-resolution camera, Bluetooth wireless, and MP3-only music playback.
I'm sold on it more than anything else because the size of the keyboard and the screen size help this greying litigator see each without squinting.
FDA Blasted By Congress Over Warning Label Proposals
A group of Congressional Democratic leaders complained about a FDA proposal that would limit when drug and device companies can add warnings to product labels.
In a letter to Commissioner Andrew von Eschenbach, several lawmakers said current FDA rules give companies latitude to make needed changes. They said the new policy is restrictive and comes "at the expense of consumers and violates the mission of the FDA."
For more, go NJ.com here.
In a letter to Commissioner Andrew von Eschenbach, several lawmakers said current FDA rules give companies latitude to make needed changes. They said the new policy is restrictive and comes "at the expense of consumers and violates the mission of the FDA."
For more, go NJ.com here.
"Don't Get Worked Over"
Says this Denver,CO lawyer on a youtube.com video. What do you think about this video?
Wednesday, January 23, 2008
Tech: Going Paperless
One of my resolutions was to go paperless as much as possible, and to go that route inexpensively, efficiently, and in a way that is consistent with office operations.
We started with the Fujitsu Scan S510 model:The ScanSnap S510 can convert up to 18 pages per minute into a PDF file at the click of a button.It's 18 ppm/36 ipm
After the first week, we are hooked here in this small office. It is ridiculously easy to setup and run, it saves in searchable PDF, and for the most part, after nearly 5,000 scans per unit, we are moving right along. Cost? $395 per scanner.
NOT TWAIN or ISIS Driver COMPATIBLE....this means you need to use the software that comes with it and only that software. From their site:
One button scanning to searchable PDF
Scan directly to Microsoft® applications
20% faster scanning speed
Business card scanning
Color Duplex 18 pages per minute/36 images per minute
We started with the Fujitsu Scan S510 model:The ScanSnap S510 can convert up to 18 pages per minute into a PDF file at the click of a button.It's 18 ppm/36 ipm
After the first week, we are hooked here in this small office. It is ridiculously easy to setup and run, it saves in searchable PDF, and for the most part, after nearly 5,000 scans per unit, we are moving right along. Cost? $395 per scanner.
NOT TWAIN or ISIS Driver COMPATIBLE....this means you need to use the software that comes with it and only that software. From their site:
One button scanning to searchable PDF
Scan directly to Microsoft® applications
20% faster scanning speed
Business card scanning
Color Duplex 18 pages per minute/36 images per minute
FDA Will Not Preview Direct To Consumer Ads
In the post below, "Trouble Sleeping" there is a concise commentary from C.R. dissecting a Sleep Aid ad. Here's the statement, thanks to the Pharma Mkting Blog:
The FDA statement:
User Fee Program for Advisory Review of Direct-to-Consumer
Television Advertisements for Prescription Drug and Biological
Products; Program Will Not Be Implemented
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not ``provided in advance in appropriations Acts'' as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the previously issued notice establishing user fee rates for the program for fiscal year (FY) 2008 is being withdrawn.
....
SUPPLEMENTARY INFORMATION: On September 27, 2007, the President signed into law FDAAA (Public Law 110-85). Title I of FDAAA reauthorized the Prescription Drug User Fee Act for FYs 2008 to 2012. In addition, Title I created new section 736A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h-1), which authorized a new and separate user fee program for the advisory review of DTC prescription drug television advertisements. The DTC user fee program would have been available to companies interested in voluntarily submitting to FDA for advisory review a DTC television advertisement, as defined in section 736A(h)(4) of the act. FDAAA provided, however, that if FDA fails to receive at least $11,250,000 in advisory review fees and operating reserve fees combined by 120 days after the legislation is enacted (i.e., by January 25, 2008), the program shall not commence (section 736A(f)(1) of the act). FDAAA also provided that the fees authorized for the DTC program ``shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts.'' (section 736A(g)(1) of the act).
On December 26, 2007, the President signed the Consolidated Appropriations Act, 2008 (Public Law 110-161). The law does not appropriate user fee funds for the voluntary review of DTC television advertisements. As a result, under section 736A(g)(1) of the act, FDA does not have the authority to collect and spend user fees for this purpose. Furthermore, as noted previously, section 736A(f)(1) of the act provides that if FDA has not collected at least $11,250,000 in advisory review fees and operating reserve fees combined by 120 days after the legislation is enacted (i.e., by January 25, 2008), the program shall not commence. Therefore, no invoices will be sent. Advertisements voluntarily submitted for FDA review will be reviewed in as timely a manner as resources permit. In addition, FDA is withdrawing the previously issued Federal Register notice establishing the user fee rates for this program for FY 2008 (72 FR 70334, December 11, 2007).
Dated: January 10, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-740 Filed 1-15-08; 8:45 am
The FDA statement:
User Fee Program for Advisory Review of Direct-to-Consumer
Television Advertisements for Prescription Drug and Biological
Products; Program Will Not Be Implemented
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not ``provided in advance in appropriations Acts'' as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the previously issued notice establishing user fee rates for the program for fiscal year (FY) 2008 is being withdrawn.
....
SUPPLEMENTARY INFORMATION: On September 27, 2007, the President signed into law FDAAA (Public Law 110-85). Title I of FDAAA reauthorized the Prescription Drug User Fee Act for FYs 2008 to 2012. In addition, Title I created new section 736A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h-1), which authorized a new and separate user fee program for the advisory review of DTC prescription drug television advertisements. The DTC user fee program would have been available to companies interested in voluntarily submitting to FDA for advisory review a DTC television advertisement, as defined in section 736A(h)(4) of the act. FDAAA provided, however, that if FDA fails to receive at least $11,250,000 in advisory review fees and operating reserve fees combined by 120 days after the legislation is enacted (i.e., by January 25, 2008), the program shall not commence (section 736A(f)(1) of the act). FDAAA also provided that the fees authorized for the DTC program ``shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts.'' (section 736A(g)(1) of the act).
On December 26, 2007, the President signed the Consolidated Appropriations Act, 2008 (Public Law 110-161). The law does not appropriate user fee funds for the voluntary review of DTC television advertisements. As a result, under section 736A(g)(1) of the act, FDA does not have the authority to collect and spend user fees for this purpose. Furthermore, as noted previously, section 736A(f)(1) of the act provides that if FDA has not collected at least $11,250,000 in advisory review fees and operating reserve fees combined by 120 days after the legislation is enacted (i.e., by January 25, 2008), the program shall not commence. Therefore, no invoices will be sent. Advertisements voluntarily submitted for FDA review will be reviewed in as timely a manner as resources permit. In addition, FDA is withdrawing the previously issued Federal Register notice establishing the user fee rates for this program for FY 2008 (72 FR 70334, December 11, 2007).
Dated: January 10, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-740 Filed 1-15-08; 8:45 am
Trouble Sleeping?
Consumer Reports has posted the second in our series of AdWatch videos that add commentary and context to widely seen pharmaceutical advertisements. The video mentions the ad with Abe Lincoln and a talking beaver It’s the one that has Abe Lincoln and a talking beaver offering consolation to an unfortunate insomniac.
They've taken on the RLS ads as well.
Go here for the video.
Why should anyone care? IMHO, your first move after a sleepless night or two should not necessarily be to beg for a prescription.
They've taken on the RLS ads as well.
Go here for the video.
Why should anyone care? IMHO, your first move after a sleepless night or two should not necessarily be to beg for a prescription.
FDA Warns Against Cold Drugs for Kids Under 2
Children under 2 years old should not be given over-the-counter cough and cold medicines because they are too dangerous for that age group.
Deaths, convulsions and rapid heart rates have been reported in rare cases in children younger than 2, the FDA has informed.
"We strongly recommend that over-the-counter cough and cold products should not be used in infants and young children under 2 years of age because serious and potentially life-threatening side effects can occur," Dr. Charles Ganley, head of the FDA office that reviews nonprescription drugs, told reporters.
Source go here.
Deaths, convulsions and rapid heart rates have been reported in rare cases in children younger than 2, the FDA has informed.
"We strongly recommend that over-the-counter cough and cold products should not be used in infants and young children under 2 years of age because serious and potentially life-threatening side effects can occur," Dr. Charles Ganley, head of the FDA office that reviews nonprescription drugs, told reporters.
Source go here.
Tuesday, January 22, 2008
Legal Broadcast Network Video: Attorney Rick Kuykendall
Mark Wahlstrom will bring his LBN team to the STLA Convention in New Orleans next week. You can view a video by LBN with attorneys Jan Schlictman and Rick Kuykendall by going here.
From the LBN site: "The Legal Broadcast Network is the first online podcasting network specifically for trial lawyers, paralegals and others dedicated to the fight for civil justice and access to the courts for ordinary citizens."
From the LBN site: "The Legal Broadcast Network is the first online podcasting network specifically for trial lawyers, paralegals and others dedicated to the fight for civil justice and access to the courts for ordinary citizens."
Trucks in Canada: "They Suck"
Or so says Sgt. Ray Boldt in British Columbia. From canada.com:
Among 28,700 injuries and 460 fatalities from vehicle crashes in 2005, heavy-commercial-vehicle crashes (including those involving buses) injured more than 1,550 people and killed 82, according to the Insurance Corporation of B.C.
A Transport Canada study in 2004 showed that truck crashes are responsible for a much higher rate of death and injury than accidents caused by passenger vehicles: eight fatalities per 10,000 vehicles compared with 1.5 per 10,000 for all vehicles combined.
The death toll from big-rig crashes makes up 18 per cent of all fatal collisions in the province.
It's not just an epidemic of safety here in the U.S. Go here for more.
Among 28,700 injuries and 460 fatalities from vehicle crashes in 2005, heavy-commercial-vehicle crashes (including those involving buses) injured more than 1,550 people and killed 82, according to the Insurance Corporation of B.C.
A Transport Canada study in 2004 showed that truck crashes are responsible for a much higher rate of death and injury than accidents caused by passenger vehicles: eight fatalities per 10,000 vehicles compared with 1.5 per 10,000 for all vehicles combined.
The death toll from big-rig crashes makes up 18 per cent of all fatal collisions in the province.
It's not just an epidemic of safety here in the U.S. Go here for more.
Timeline: How Vytorin Fell Short
The fallout from Vytorin is national news. A recent study prompted The American College of Cardiology to weigh in after a study by Merck & Co. Inc. and Schering-Plough Corp. The study showed that Vytorin worked no better than the generic cholesterol drug simvastatin.
A well written article on the Street.com lays out a timeline and goes into more detail. Excerpts:
In 2000, Schering-Plough teamed up with Merck in an effort to develop a next-generation cholesterol drug that could lower the risk of heart attacks.
In 2002, Merck and Schering-Plough had won approval for Zetia and introduced the first new cholesterol drug to hit the market in more than a decades. The more common course of through statins, slow the liver's production of cholesterol to cut the risk of heart attacks. Zetia works differently, slowing the body's absorption of cholesterol.
In 2004, Schering-Plough and Merck combined Zetia with Zocor (which was about to go off patent) and created Vytorin.
Two trials followed - ENHANCE and IMPROVE-IT.
Read the rest here.
A well written article on the Street.com lays out a timeline and goes into more detail. Excerpts:
In 2000, Schering-Plough teamed up with Merck in an effort to develop a next-generation cholesterol drug that could lower the risk of heart attacks.
In 2002, Merck and Schering-Plough had won approval for Zetia and introduced the first new cholesterol drug to hit the market in more than a decades. The more common course of through statins, slow the liver's production of cholesterol to cut the risk of heart attacks. Zetia works differently, slowing the body's absorption of cholesterol.
In 2004, Schering-Plough and Merck combined Zetia with Zocor (which was about to go off patent) and created Vytorin.
Two trials followed - ENHANCE and IMPROVE-IT.
Read the rest here.
Monday, January 21, 2008
FDA Approves Update to Label on Birth Control Patch Ortho Evra
From the FDA site:
The U.S. Food and Drug Administration (FDA) approved on 1/18/08 additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.
The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE.
"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.
"This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products."
For more, go here.
Chantix (Stop Smoking Med) Gets a Suicide Warning
Chantix is classed as a selective nicotinic acetylcholine receptor partial agonist, and is the first smoking cessation drug that is not based on nicotine to come out in the last 10 years.
Pfizer Inc. strengthened the warning for iChantix recently, and warned medical professionals to be on the lookout for for abnormal behavior after the shooting death of a rock musician using the drug led to added reports of side effects.
A possible link between the drug and reports of agitation, depressed mood and suicidal thoughts among some patients taking it can't be ruled out, according to Pfizer.
A change in the ``warnings'' section of the drug's prescribing information follows accounts of bizarre behavior by singer Carter Albrecht of the band New Bohemians, who was taking Chantix to quit smoking, before his shooting death in September.
For more, go here.
MLK Day: Parting the Waters
In 1989 I was a recent law school graduate when I first heard of "Parting the Waters: America during the King Years," by Taylor Branch. I had a chance to hear him speak just after his book was published, and purchased the book right away. It's worth reading. Nearly twenty years after it was first published, the book still holds a special place in my heart. The book is part of a three volume social history of that age.
The main facts are well known. Branch supplies nine hundred pages of details, never shocking but cumulatively surprising in their behind-the-scenes portrait of the civil-rights movement. Branch lets the facts speak for themselves and comments sparingly. The volume of his research is staggering.
You can buy it used on Amazon.com and everywhere else. It will take you some time to finish, but IMHO it will be worth it.
Bono and the boys paid homage to Dr. King in their song, Pride (In the Name of Love):
Friday, January 18, 2008
Resolutions 2008: Too Cold to Exercise? Try Another Excuse
One of my resolutions this year is to complete a half marathon before June 1, 2008. That means running in the cold (cold for the South, at least).
From the New York Times, you can read why it never really is too cold to exercise. Some folks you know may already cutting out on a New Year's resolution to exercise because of "the weather." Well, now you know this:
"Extreme cold can be safe for exercisers ... . John W. Castellani, an exercise physiologist at the Army Research Institute of Environmental Medicine" informs that it turns out that even though cold can be frightening, more people are injured exercising in the heat than exercising in the cold.
Dr. Castellani was lead author of a 2006 position paper from the American College of Sports Medicine on exercising in the cold.
“The big question was, ‘Is it ever too cold?’” Dr. Castellani said. “The answer is no. People go to the poles, people are out there when it’s minus-50 degrees, people do incredible things, and safely. There really isn’t a point where you can tell people it is not safe anymore.”
A few gems from the NYT article:
"Some worry that cold air will injure their lungs or elicit asthma symptoms. Or they are convinced that they are more susceptible to injury when it is cold and that they have to move more slowly — forget about sprinting or running at a fast clip.
But lungs are not damaged by cold, said Kenneth W. Rundell, the director of respiratory research and the human physiology laboratory at Marywood University in Scranton, Pa. No matter how cold the air is, by the time it reaches your lungs, it is body temperature, he explained.
Some people complain that they get exercise-induced asthma from the cold. But that sort of irritation of the respiratory tract is caused by dryness, not cold."
Get the rest of the article here. As for me, I'll be running this weekend in Atlanta, which by the way is expecting three inches of snow on Saturday.
From the New York Times, you can read why it never really is too cold to exercise. Some folks you know may already cutting out on a New Year's resolution to exercise because of "the weather." Well, now you know this:
"Extreme cold can be safe for exercisers ... . John W. Castellani, an exercise physiologist at the Army Research Institute of Environmental Medicine" informs that it turns out that even though cold can be frightening, more people are injured exercising in the heat than exercising in the cold.
Dr. Castellani was lead author of a 2006 position paper from the American College of Sports Medicine on exercising in the cold.
“The big question was, ‘Is it ever too cold?’” Dr. Castellani said. “The answer is no. People go to the poles, people are out there when it’s minus-50 degrees, people do incredible things, and safely. There really isn’t a point where you can tell people it is not safe anymore.”
A few gems from the NYT article:
"Some worry that cold air will injure their lungs or elicit asthma symptoms. Or they are convinced that they are more susceptible to injury when it is cold and that they have to move more slowly — forget about sprinting or running at a fast clip.
But lungs are not damaged by cold, said Kenneth W. Rundell, the director of respiratory research and the human physiology laboratory at Marywood University in Scranton, Pa. No matter how cold the air is, by the time it reaches your lungs, it is body temperature, he explained.
Some people complain that they get exercise-induced asthma from the cold. But that sort of irritation of the respiratory tract is caused by dryness, not cold."
Get the rest of the article here. As for me, I'll be running this weekend in Atlanta, which by the way is expecting three inches of snow on Saturday.
Extract Text From PDF, .Doc, and other Files
Thanks to the folks at lifehacker and elsewhere for this tip, which I started using. It works, at least on early use here in the office. It's a program called Text Mining Tool:
From the text mining site:
Text Mining Tool is a freeware program for extraction of text from files of the next types:
pdf, doc, rtf, chm, html without need to have installed any other programs like Word, Arcrobat, etc.
The beauty of the program is that it works, extremely simply, on almost all common forms of documents. That includes HTML web pages, both DOC and RTF document formats from Microsoft Word and others like Open Office, Windows Help files ending in CHM, and portable documents using PDF format.
Text Mining Tool antivirus report
Its comfortable and easy usage is defined by the following key features:
* No payment or license restrictions. Tool is absolutely free.
* Works as converter of PDF, DOC, RTF, CHM, HTML files to text.
* User-friendly interface with hotkeys available.
* Console tool minetext for automation of text converting is included.
* .NET 2.0 framework based.
* No installation is needed. Just unpack the program and use.
If you don't have lifehacker.com on your RSS feed, you should.
From the text mining site:
Text Mining Tool is a freeware program for extraction of text from files of the next types:
pdf, doc, rtf, chm, html without need to have installed any other programs like Word, Arcrobat, etc.
The beauty of the program is that it works, extremely simply, on almost all common forms of documents. That includes HTML web pages, both DOC and RTF document formats from Microsoft Word and others like Open Office, Windows Help files ending in CHM, and portable documents using PDF format.
Text Mining Tool antivirus report
Its comfortable and easy usage is defined by the following key features:
* No payment or license restrictions. Tool is absolutely free.
* Works as converter of PDF, DOC, RTF, CHM, HTML files to text.
* User-friendly interface with hotkeys available.
* Console tool minetext for automation of text converting is included.
* .NET 2.0 framework based.
* No installation is needed. Just unpack the program and use.
If you don't have lifehacker.com on your RSS feed, you should.
Thursday, January 17, 2008
Vioxx Registration Deadline Passes: Merck Hopes 85% Take the Deal
With the first milestone passing this week (1/15/08) Merck's confident it will reach the goals necessary to set a $4.85 billion Vioxx settlement into play.
There are report that law firms representing more than 55,000 plaintiffs had registered their claims by the deadline. Only those who registered by the deadline will then have the option to take part in the settlement. As is now known, Merck conditioned settlement on 85 percent approval by registered plaintiffs to sign on to the settlement in each category or the deal falls apart. It could be several months before it is known if that goal has been achieved.
From this source: "We expect to meet and exceed the 85 percent in both categories. We just don't know when that will occur," said Kent Jarrell, a spokesman for Merck's legal team.
There are report that law firms representing more than 55,000 plaintiffs had registered their claims by the deadline. Only those who registered by the deadline will then have the option to take part in the settlement. As is now known, Merck conditioned settlement on 85 percent approval by registered plaintiffs to sign on to the settlement in each category or the deal falls apart. It could be several months before it is known if that goal has been achieved.
From this source: "We expect to meet and exceed the 85 percent in both categories. We just don't know when that will occur," said Kent Jarrell, a spokesman for Merck's legal team.
Vytorin Video
Reporting on the drug's troubles.
It's two minutes long, but it's not on YouTube.com Go here to see it.
Wednesday, January 16, 2008
Bad News for Vytorin: "It just doesn't work"
Vytorin is a combination of Zetia and Zocor. It is prescribed nearly 100,000 times a day, and sales topped $5 billion last year. Drug companies Merck and Schering split the profits from the medicines in equal parts.
This week Merck and Schering-Plough revealed that the active ingredient in their cholesterol drugs Zetia and Vytorin had flunked a clinical trial measuring its effect on artery plaque. The news was - as you can imagine - not taken very well.
"This drug doesn't work. Period. It just doesn't work." That is what Steven Nissen, the head of cardiology at the Cleveland Clinic said. Congressman Bart Stupak said, "It is easy to conclude that Merck and Schering-Plough iintentionally sought to delay the release of this data.
Source here.
This week Merck and Schering-Plough revealed that the active ingredient in their cholesterol drugs Zetia and Vytorin had flunked a clinical trial measuring its effect on artery plaque. The news was - as you can imagine - not taken very well.
"This drug doesn't work. Period. It just doesn't work." That is what Steven Nissen, the head of cardiology at the Cleveland Clinic said. Congressman Bart Stupak said, "It is easy to conclude that Merck and Schering-Plough iintentionally sought to delay the release of this data.
Source here.
Monday, January 14, 2008
National Clean Out Your Desk Day Today
It's National Clean-Off-Your-Desk Day. Today is the day to fill your recycling bin to overflowing.
You can use Jott to help you clean up that desk.
Also high on my list is http://www.vitalist.com./ It handles to do recurrent tracking, ticklers, in a basic way. Contextual organization is the focus of the site.
Vitalis will sms or email you reminders. It's mobile web accessible. Oh, and it's free.
You can use Jott to help you clean up that desk.
Also high on my list is http://www.vitalist.com./ It handles to do recurrent tracking, ticklers, in a basic way. Contextual organization is the focus of the site.
Vitalis will sms or email you reminders. It's mobile web accessible. Oh, and it's free.
Sunday, January 13, 2008
Did Avandia Contribute to Thousands of Heart Attacks?
According to a November 2007 report by the Senate Finance Committee, an analysis by FDA scientists presented at a July 30, 2007, safety panel meeting estimates that Avandia has caused approximately 83,000 excess heart attacks since coming on the market.
The report summarizes the Committee’s findings regarding GlaxoSmithKline’s intimidation of Dr Buse, an independent scientist who first voiced concerns about Avandia back in 1999, in a report found here.
In November 2007, the FDA added a black box warning to GlaxoSmithKline’s diabetes drugs Avandia, Avandamet, and Avandaryl about an increased risk of heart attacks, and a boxed warning about an increased risk of heart failure was added in August 2007.
On October 26, 2007, Senator Chuck Grassley (R-Iowa), ranking member of the Finance Committee, sent a letter to FDA Commissioner Andrew von Eschenbach asking him to respond to reports that on October 2, 2007, the agency convened a drug safety oversight board that voted to keep Avandia on the market by a one-vote margin while considering whether to add a second warning.
According to the Senate Committee report, if the drug maker had considered Avandia’s increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr Buse, instead of trying to limit an independent medical opinion, some of the 83,000 heart attacks may have been avoided.
Buse was said to have written to the maker of Avandia: "Please call off the dogs. I cannot remain civilized much longer under this kind of heat." Source.
Source here.
The report summarizes the Committee’s findings regarding GlaxoSmithKline’s intimidation of Dr Buse, an independent scientist who first voiced concerns about Avandia back in 1999, in a report found here.
In November 2007, the FDA added a black box warning to GlaxoSmithKline’s diabetes drugs Avandia, Avandamet, and Avandaryl about an increased risk of heart attacks, and a boxed warning about an increased risk of heart failure was added in August 2007.
On October 26, 2007, Senator Chuck Grassley (R-Iowa), ranking member of the Finance Committee, sent a letter to FDA Commissioner Andrew von Eschenbach asking him to respond to reports that on October 2, 2007, the agency convened a drug safety oversight board that voted to keep Avandia on the market by a one-vote margin while considering whether to add a second warning.
According to the Senate Committee report, if the drug maker had considered Avandia’s increased cardiovascular risk more seriously when the issue was first raised in 1999 by Dr Buse, instead of trying to limit an independent medical opinion, some of the 83,000 heart attacks may have been avoided.
Buse was said to have written to the maker of Avandia: "Please call off the dogs. I cannot remain civilized much longer under this kind of heat." Source.
Source here.
Friday, January 11, 2008
STLA in New Orleans, 1/31-2/2
Once again, the Southern Trial Lawyers will meet in New Orleans. You can read more about the STLA by going here.
It's a lot of fun and worth your time.
Transfer Huge Files with PipeBytes
After having just downloaded a huge legal file in three parts, I've gone back to find a better solution ... and found one.
If you a need to transfer a large file but learn that the party sending the file is having trouble, try PipeBytes. It's free. From their site:
No software to install.
* All you need is web browser.
* Send files of any size!
* Your buddy could start downloading file as you upload it.
(That makes the file exchange process up to two times
faster than other web-based file exhange services!)
* It's private unlike BitTorrent or other P2P techologies.
The file is not shared on Internet - it is sent directly
to your recipient.
The sender heads to PipeBytes and gets a code to upload a file, and once the recipient enters the code, the site serves as the connector.
In the past I had issues with YouSendIt.com retaining my file, and this may be a better alternative.
If you a need to transfer a large file but learn that the party sending the file is having trouble, try PipeBytes. It's free. From their site:
No software to install.
* All you need is web browser.
* Send files of any size!
* Your buddy could start downloading file as you upload it.
(That makes the file exchange process up to two times
faster than other web-based file exhange services!)
* It's private unlike BitTorrent or other P2P techologies.
The file is not shared on Internet - it is sent directly
to your recipient.
The sender heads to PipeBytes and gets a code to upload a file, and once the recipient enters the code, the site serves as the connector.
In the past I had issues with YouSendIt.com retaining my file, and this may be a better alternative.
NY State Court To Dismiss Celebrex Cases
Plaintiffs suing Pfizer Inc. over its Celebrex do not have reliable scientific evidence to prove the drug can cause heart attacks and strokes at the 200-milligram dose. The 200 milligram dose is the most commonly prescribe dose of the medication.
The ruling is similar to one in U.S. District Court in San Francisco, where Judge Breyer ruled in November that lawyers for the more than 3,000 plaintiffs failed to produce scientifically reliable evidence that Celebrex causes heart attacks or strokes when ingested at the 200 milligram a day dose. A Daubert challenge worked.
The ruling is similar to one in U.S. District Court in San Francisco, where Judge Breyer ruled in November that lawyers for the more than 3,000 plaintiffs failed to produce scientifically reliable evidence that Celebrex causes heart attacks or strokes when ingested at the 200 milligram a day dose. A Daubert challenge worked.
Sunday, January 06, 2008
Top 5 P.I. Attorney Web Site Mistakes
From the abajournal.com
Of the "best" sites reviewed, here is a list of the most common mistakes:
-- Firms spend more time talking about themselves instead of their clients.
-- The sites lack compassion.
-- Photos are canned, stock art, rather than of real people.
-- The free consultation is ubiquitous.
-- Formal poses of lawyers are more reminiscent of high school yearbook photos than portraying lawyers on the job, investigating accident sites or making hospital visits.
From a link within the one below, there is this:
"4. Name us a personal injury attorney who doesn’t offer a free consultation? Yet, each site plays up this feature of their firm as if they invented it. Why not just invite accident victims to call you to discuss their experience and their legal options?"
Here is the source.
Of the "best" sites reviewed, here is a list of the most common mistakes:
-- Firms spend more time talking about themselves instead of their clients.
-- The sites lack compassion.
-- Photos are canned, stock art, rather than of real people.
-- The free consultation is ubiquitous.
-- Formal poses of lawyers are more reminiscent of high school yearbook photos than portraying lawyers on the job, investigating accident sites or making hospital visits.
From a link within the one below, there is this:
"4. Name us a personal injury attorney who doesn’t offer a free consultation? Yet, each site plays up this feature of their firm as if they invented it. Why not just invite accident victims to call you to discuss their experience and their legal options?"
Here is the source.
Top 10 PDF Tricks
Thanks to lifehacker, they include:
Managing PDF files in iTunes: One of the lesser-known features of iTunes is that it can manage PDF files as well as music. Here.
Another Top 10 is: Design your own DIY notepaper. "Check off your note-taking template options - with your name, project name, and optional hole-punch - and download a printable PDF of the result." Here.
Add the site to your feed.
Managing PDF files in iTunes: One of the lesser-known features of iTunes is that it can manage PDF files as well as music. Here.
Another Top 10 is: Design your own DIY notepaper. "Check off your note-taking template options - with your name, project name, and optional hole-punch - and download a printable PDF of the result." Here.
Add the site to your feed.
Friday, January 04, 2008
A Litigating MIST Cases Blog
You can find it here:litigatingmistcases.com/
What is MIST? Minimum Impact, Soft Tissue case.
It's a site worth checking out. A recent blog post included this:
"The ABA recently published my newest article on MIST cases. This article provides some basic tips on MIST cases. It is not a supplement for reading the book, but it does give you some basic tips. The outline appears below:
10. Read the literature.
9. Talk to the potential client.
8. Learn to use the internet.
7. Take a look at the cars.
6. Get to know the treating doctor.
5. Set reasonable expectations.
4. Get your discovery done timely.
3. Don't waste money.
2. Be aggressive but fair.
1. Try the cases."
The link to that article can be found here.
What is MIST? Minimum Impact, Soft Tissue case.
It's a site worth checking out. A recent blog post included this:
"The ABA recently published my newest article on MIST cases. This article provides some basic tips on MIST cases. It is not a supplement for reading the book, but it does give you some basic tips. The outline appears below:
10. Read the literature.
9. Talk to the potential client.
8. Learn to use the internet.
7. Take a look at the cars.
6. Get to know the treating doctor.
5. Set reasonable expectations.
4. Get your discovery done timely.
3. Don't waste money.
2. Be aggressive but fair.
1. Try the cases."
The link to that article can be found here.
Thursday, January 03, 2008
Top 10 Obscure Google Search Tricks
From lifehacker.com
Good stuff, including:
10. Get the local time anywhere.
9. Track flight status.
Good stuff, and you can find more here.
Good stuff, including:
10. Get the local time anywhere.
9. Track flight status.
Good stuff, and you can find more here.
Organizing Your "To Do" List
It's that time of year when folks resolve to get more organized. I'm one of them. I found a helpful post on Getting Things Done, and the excerpt is below. The post emphasizes a next action list, as opposed to a plain ol' "to do."
"There is nothing more demotivating and numbing than a large, unwieldy and obscure to-do list. It leads to more procrastination and certainly doesn’t invite you to be more effective and productive.
How to transform your deteriorated to-do list back to a lean and mean next action list? It’s time for some serious pruning!
Of course, a perfect GTD system would not allow your next action list to deteriorate into an amorphous list of undoable items. However, in my experience perfect GTD systems are few and far between!
I would therefore recommend applying the 10 tips below for pruning your next action list at least once a week, preferably as part of your weekly review. Remember, a true, lean and mean next action list is much more likely to get you to crank widgets!
1. Be specific
Does each item on your next action list represent the very next, physical and concrete step you must take to make progress on a certain project? Resist the temptation to add more than one next action for each project. Keep the other actions in your project support material.
2. Granularity
Don’t break down each and every thing in your life into tiny actions. Tying your shoe laces doesn’t have to be on your list. At the other end of the spectrum, make sure an item on your list isn’t actually a multi-step action (i.e. project).
3. Doability
Is the item on your next action list something you can and should do? Don’t add impossible items or actions somebody else should do (or could do better than you). Also make sure you really want to do the action (and the associated project).
4. 20 minute rule
In your estimation, will you be able to finish each next action in no more than 20 minutes or so? If not, that might be an indication that you should break down certain items (or perhaps they really are projects after all). Your mind will subconsciously resist complex and long actions.
5. Form
Make sure each item on your next action list actually starts with an action verb. E.g. “call Jim re: proposal project X” instead of “project X: Jim’s thoughts?”. You want each item to evoke action.
Also, limit your next action to a few words instead of complete sentences. You should be able to scan your next action list quickly. If applicable, add extra information to a notes field or even another list.
6. As soon as possible?
Does each item represent an action that needs to be done as soon as possible? Or does your list also contain items that should be done on a certain day (put these in your calendar), or items that you might do in the future (put these in your tickler or on your someday/maybe list), or even items that represent interesting information (put these in your reference system)?"
For more, go to here.
"There is nothing more demotivating and numbing than a large, unwieldy and obscure to-do list. It leads to more procrastination and certainly doesn’t invite you to be more effective and productive.
How to transform your deteriorated to-do list back to a lean and mean next action list? It’s time for some serious pruning!
Of course, a perfect GTD system would not allow your next action list to deteriorate into an amorphous list of undoable items. However, in my experience perfect GTD systems are few and far between!
I would therefore recommend applying the 10 tips below for pruning your next action list at least once a week, preferably as part of your weekly review. Remember, a true, lean and mean next action list is much more likely to get you to crank widgets!
1. Be specific
Does each item on your next action list represent the very next, physical and concrete step you must take to make progress on a certain project? Resist the temptation to add more than one next action for each project. Keep the other actions in your project support material.
2. Granularity
Don’t break down each and every thing in your life into tiny actions. Tying your shoe laces doesn’t have to be on your list. At the other end of the spectrum, make sure an item on your list isn’t actually a multi-step action (i.e. project).
3. Doability
Is the item on your next action list something you can and should do? Don’t add impossible items or actions somebody else should do (or could do better than you). Also make sure you really want to do the action (and the associated project).
4. 20 minute rule
In your estimation, will you be able to finish each next action in no more than 20 minutes or so? If not, that might be an indication that you should break down certain items (or perhaps they really are projects after all). Your mind will subconsciously resist complex and long actions.
5. Form
Make sure each item on your next action list actually starts with an action verb. E.g. “call Jim re: proposal project X” instead of “project X: Jim’s thoughts?”. You want each item to evoke action.
Also, limit your next action to a few words instead of complete sentences. You should be able to scan your next action list quickly. If applicable, add extra information to a notes field or even another list.
6. As soon as possible?
Does each item represent an action that needs to be done as soon as possible? Or does your list also contain items that should be done on a certain day (put these in your calendar), or items that you might do in the future (put these in your tickler or on your someday/maybe list), or even items that represent interesting information (put these in your reference system)?"
For more, go to here.
Wednesday, January 02, 2008
Avandia Warnings: Did They Scare People From Therapy?
"We believe that scrutiny of Avandia may have harmed the U.S. diabetic population by scaring some patients off of therapy. This is unfortunate, given lack of glucose control among diabetics and the growing diabetes epidemic in the country."
So says David Risinger, go here for more.
So says David Risinger, go here for more.
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