July 2010

Pay-to-delay deals help no one and nothing outside of the bottom lines of a few big pharmaceutical companies.  Here’s hoping they go away soon…

FOR TOO LONG, pay-for-delay settlements have been an accepted part of the health-care landscape. In these deals, a brand-name drug manufacturer pays a generic competitor to delay its entry into the market. Sound illegal? It isn’t — but a provision to be considered by the Senate Appropriations Committee on Thursday would finally make it so, banning such settlements unless drug manufacturers could prove they were not anticompetitive. It’s a good idea that could save consumers billions of dollars.

Source: Ending ‘pay for delay’ tactics on generic drugs could mean lower prices

I’ll be honest with you. I don’t trust pharmaceutical sales reps.  Few of them are medical doctors, but they tell doctors which drugs should be prescribed for which patients.  Traditionally, their compensation is based in part upon how many drugs the doctors they visit prescribe.  This leads to a gigantic incentive to engage in off-label marketing and other unethical practices.

Perhaps this is going to stop at GSK.

Starting next year, bonuses will be determined “in part, by customer feedback, and by a sales professional’s adherence to the company values of transparency, integrity, respect and patient-focus,” the company said earlier this week. (Here’s the Dow Jones Newswires story.)

Source: Bonuses For GSK Pharma Sales Reps Won’t Be Tied to Sales – Health Blog – WSJ

Time will tell.

The fact that the average plaintiff will receive $10,000 doesn’t surprise me.  These were very, very difficult cases to prove. There are many causes of diabetes, and it’s pretty tough to prove that Seroquel is what caused it.

AstraZeneca Plc agreed to pay $2 million to settle more than 200 cases over its antipsychotic drug Seroquel in the first resolution of lawsuits alleging the medicine causes diabetes, people familiar with the accords said.

The settlement, which provides an average payout of more than $10,000 per case, came as the result of a U.S. court- ordered mediation involving 26,000 cases filed against London- based AstraZeneca over Seroquel, the people said.

Source: Astrazeneca Said to Pay $2 Million in First Settlements of Seroquel Suits – Bloomberg

I’ve chatted with several Avandia lawyers about the fact that the FDA isn’t allowing anyone else to enroll in the TIDE study:

WEDNESDAY, July 21 (HealthDay News) — No new patients will be permitted to enroll in a safety study of the controversial diabetes drug Avandia until further notice, the U.S. Food and Drug Administration announced Wednesday.

Click here to find out more!

 

But under the partial clinical trial hold, those patients already enrolled in the TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) trial will be allowed to continue to participate, the agency said in a news release.

Source: FDA Puts Partial Hold on Avandia Safety Study – US News and World Report

The Avandia lawyers I’ve spoken to are confident that the FDA will eventually pressure GSK to withdraw Avandia from the market.  Some lawyers have gone so far as to dub Avandia to be the “Son of Vioxx.”

If you had a heart attack while taking Avandia, contact me and I’ll put you in touch with an Avandia lawyer.

There are still thousands of Avandia lawsuits pending, but apparently 10,000 of them will be settled:

On Tuesday, Glaxo agreed to pay $460 million to settle thousands of lawsuits over Avandia, Bloomberg reported, citing people familiar with the settlements.

Glaxo will settle about 10,000 suits for an average of $46,000 each, Bloomberg said. A source familiar with the litigation told Reuters that at least 2,500 claims out of as many as 14,000 have been settled

Source: U.S. advisers say keep Glaxo diabetes drug on market | Reuters

Personally, I think $46,000 is a little low for someone who suffered a heart attack as an Avandia side effect.  Of course, the reason the settlements are in that low dollar range is likely because plaintiffs are having a hard time proving what’s called specific causation.

In order to win any Avandia lawsuit, you need to prove general causation and specific causation.  General causation is proving that Avandia is capable of causing a heart attack.  Specific causation is proving that Avandia caused your heart attack.  Proving general causation is always easier than proving specific causation.  Especially if the person who suffered the heart attack also had other risk factors for a heart attack, such as being overweight, high cholesterol, etc.

Still, GSK must be worried that at least some plaintiffs can prove specific causation, otherwise it wouldn’t be spending half a billion dollars to settle these cases.

If it weren’t for the Avandia lawyers who are suing GSK, this deposition would have never been taken.  That’s because, surprisingly, the FDA can’t subpoena GSK employees and records while any Avandia lawyer can.

WASHINGTON—A former Food and Drug Administration official said the maker of diabetes drug Avandia withheld from regulators information suggesting the drug posed an increased risk for serious heart problems, according to people familiar with her statements.

* * * *

The statements by the ex-FDA official, made in a deposition for lawsuits filed against Glaxo, are included in a letter received Monday by the agency from Sen. Charles Grassley (R., Iowa), the top Republican on the Senate Finance Committee, which has been investigating Glaxo and Avandia. His letter, co-signed by committee chairman Sen. Max Baucus (D., Mont.), includes additional information detailing internal company records about Avandia, according to people familiar with the letter.

Source: Glaxo Withheld Avandia Risk Data, Says Sen. Grassley – WSJ.com

One of the things I like best about the work I do is the opportunity to read depositions like these.  I get to learn about the things major pharmaceutical companies try and hide from the FDA and the general public.  I wish I could write about all of them here, but in most pharmaceutical lawsuits, pharmaceutical companies obtain BS protective orders.  (And BS is NOT a legal term of art.)

You see, a pharmaceutical company will have a document in their possession that says something like, “This data is really bad.  We need to hide it from the FDA so they don’t make us put a new warning on our drug.”  A lawyer will get his hands on that document, but the pharmaceutical company asks a court to place the document under seal so the lawyer can’t disclose it.  The pharmaceutical company argues that the document is a trade secret and that it will hurt them if their competitors get a hold of it.  Sure.  The truth is that it will hurt the product’s sales and may subject the company to FDA scrutiny if the document gets released.

I haven’t yet had a chance to read any depositions from Avandia lawsuits, but I’m looking forward to it.  If you or someone you know had a heart attack while taking Avandia, contact me.

Something interesting I recently learned is that people who took Fen-Phen as long as 20 years ago may just now be starting to develop severe heart problems, such as Primary Pulmonary Hypertension, or PPH.  The PPH lawyers I’ve spoken to indicate that Fen-Phen lawsuits are far from over.

Wyeth, acquired by Pfizer Inc. in October, set aside more than $21 billion to resolve almost 200,000 lawsuits involving fen-phen.

Source: Fen-Phen Risks Won’t Color U.S. FDA Diet Pill Review – BusinessWeek

The above article gives an overview of some of the new weight loss drugs coming on the market.  Some are supposedly similar to Fen-Phen, but hopefully they won’t cause the same side effects.