FDA Panel To Review Trasylol Safety

The folks at the FDA have scheduled a meeting to review the safety of Trasylol, which has been under government scrutiny for more than a year.

Trasylol was approved for U.S. marketing in 1993 to reduce the need for blood transfusions in bypass surgeries.

On September 12, 2007 the FDA will review documents that may show Trasylol can cause kidney damage, heart failure and even death.

More information here.

NYT Article Regarding Vioxx

From the article:

"None of the 45,000 people who have sued Merck, contending that they or their loved ones suffered heart attacks or strokes after taking Vioxx, have received payments from the company. "

The article goes on to note:

"Promising to contest every case, Merck has spent more than $1 billion over the last three years in legal fees. It has refused, at least publicly, to consider even the possibility of an overall settlement to resolve all the lawsuits at once."

Link here.

Avandia and Actos Get Blackbox

Avandia and Actos will carry U.S. regulators' strictest warning on the risk of heart failure.

The drugmakers agreed to a black box warning on prescribing information.

An analysis of existing research published last month in the journal Diabetes Care found that Avandia and Actos doubled the risk of heart failure in diabetics. Use of Avandia and Actos may increase the likelihood by causing fluid retention or swelling, which can make the heart work harder. The study found that a quarter of heart-failure cases occur in people younger than 60.

``Despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure,'' said Steven Galson, director of the FDA's Center for Drug Evaluation and Research. Source here.

Canada Yanks Permax as of August 30, 2007

Health Canada is ordering a drug used for treatment of Parkinson's disease off the market. HC claims that it has told distributor Eli Lilly that sales of the drug Permax (pergolide mesylate) must cease as of Aug. 30.

Source here.

Blawgworld 2007?

At legalunderground there is a link to the free PDF of a document known as BlawgWorld 2007 , which reduced to a plain description features essays from the legal blog world. The TechchnoLawyer touts it as a new way for law firms to find answers to management and technology questions.

Me? I love Eric Goldman's description of this endeavor:

"77 blogger chose their favorite posts, which were compiled into an e-book. The compilation turns out to be a great way to get noisy [bloggers] to promote their brilliant contributions to the e-book, which generates traffic and link love for the publisher, which in turn creates a nice delivery vehicle for sponsored content/advertising."

At the Trial Lawyer Blog: Trucking Request for Production

Just added to the Trial Lawyer Resource Blog, a one hundred plus subject production request:

Go here for more. You will see among others, these:

FMCSR

61. Any “out of service” stickers ever issued to the defendant from any governmental or regulatory agency of the United States or any state.
62. A copy of the periodic inspection report as required by 49 C.F.R. & 396.21
63. Any documents containing information as to any investigative inquires concerning the defendant driver as required by 49 C.R.F. & 391.23.
64. All safety management controls (as defined by 49 C.R.F. & 385.3) which the Defendant had in effect during 2004.
65. All Safety ratings (as defined by 49 C.R.F. Section 385.11) issued to the Defendant by any state or federal government agency for the last 5 years.

From Forbes: Unsafe at the FDA

From Forbes.com, this scathing assessment over the Avandia hearings last week:

"The biggest damage from the proceedings [as to Avandia] may be to the FDA itself." During the process of the meetings, "the agency displayed its weaknesses on drug safety and the wounds that have been caused by years of controversy, giving the agency's critics more ammunition."

First there was the conflict: David Graham, a drug safety reviewer who played a key role in the mounting criticisms of Vioxx, told the advisory panel that Avandia should be pulled off the market. His boss, Gerald Dal Pan, head of the FDA's Office of Surveillance and Epidemiology, backed him up. But Robert Meyer, a top official in the office that approves drugs, took a more tempered stance, admitting there were fundamental disagreements at the FDA about what to do with Avandia."

Good work by David Graham. Once again, shame on the FDA.

For more, go here.

Friday Diversion: Credit Card Sized Survival Tool

Can opener, saw blade, wrench. And? $5 bucks. Find it here.

Crazy Pants Lawyer Loses His Job ?

From the WaPo blog, looks like the ALJ who lost his crazy pants lawsuit is about to be given the heave ho from his Administrative Law Judge position.

Go here to read more.

From that blog:

Meanwhile, at a fundraiser for the Chungs (dry cleaning defendants) last week, donors contributed more than $62,000 toward the legal fees the family incurred in their defense against the Pearson suit. Another $30,000-plus came in from Post readers and others who made contributions to a defense fund around the time of the trial in June.

Accutane Users Getting Pregnant

From the AP: More than 100 women became pregnant in the past year while taking an acne medicine that causes birth defects, even though each was enrolled in a program designed to prevent those pregnancies from happening.

If a woman becomes pregnant while taking Accutane her baby may be at risk to suffer brain and heart defects, mental retardation and other abnormalities, regardless of the dosage or duration. There may be a risk for 30 days after stopping the drug as well.

Of the 122 pregnancies, 78 were taking the drug when they became pregnant. Another 10 were already pregnant when they started the drug including two who had a prescriber falsify pregnancy test results. The report didn't give a reason. Another eight became pregnant in the month after stopping the drug. The program couldn't provide details on the remaining pregnancies.

For more, go here the Wash. Post article.