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.

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.

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.

Daubert Order GA Law
View SlideShare document or Upload your own. (tags: georgia law)

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.

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.


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.


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.

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.

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)

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

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?

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.

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?

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.

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.

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

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.

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.