California County Sues Glaxo Over Avandia Risks
11 CommentsBy Ed Silverman // March 1st, 2010 // 7:16 am
Santa Clara County in California late last week filed what appears to be the first governmental lawsuit against GlaxoSmithKline over links between its Avandia diabetes bill and cardiovascular risks, namely heart attacks, The San Jose Mercury News writes. The suit charges Glaxo falsely advertised the pill and concealed risks, and seeks compensation on behalf of patients and providers.
The county alleges Glaxo earned billions of dollars on Avandia and cited an estimate that the drug caused 60,000 to 200,000 heart attacks, strokes and cardiovascular deaths nationwide from 1999 to 2006. Tamara Lange, Santa Clara County’s lead deputy counsel, didn’t have an estimate for the number of deaths caused locally or the number of patients in Santa Clara County who took the drug.
But Lange did say local costs are higher than in many other areas because the county runs its own hospital and treats indigent patients. The county spent $2 million on Avandia from 1999 to mid-2007 for indigent patients and also absorbed the cost of treating heart patients whose problems could have been avoided had Glaxo warned of the risks, the county alleges. Last September, the county removed Avandia from its formulary, the paper notes.
The county was already considering a lawsuit, but was spurred on by the recently released FDA report. “We concluded it would really be in the interest of the people of California for a government entity to be out front challenging this sort of corporate behavior,” Lange tells the paper. The lawsuit seeks to recover costs incurred by anyone who purchased Avandia, including hospitals, clinics and counties.
V. Taylor
How can you move forward with a lawsuit when you don’t know how many people took the drugs and how many died as a direct result (if any). This sounds like a total opportunistic shakedown by a very liberal county looking for a little extra money. If they win such a suit, who gets this money? Shouldn’t it be the patients that were affected (IF they were affected)? There is no mention of this eihter. Again… shakedown….
Stephany
Fantastic, tip of the “Vioxx iceberg”! There is plenty of data recorded via patient records, insurance company records and drug sales records for statistics. Nice try attempting to turn this story around to “liberal county looking for for money”. LOL
harpy
yep, it certainly is. proving once again that if you’re gonna skirt the law, you have to do a really good job of keeping it under your hat
MsPiggy
This is just another glaring example of caused patient damage and death, corporate cover ups, and pesky little legal settlements being just part of the cost of doing business as usual with Glaxo and others.
Justice in MI
As I understand the suit, which seems to follow the FCA model, it doesn’t matter what the injury or death numbers might be.
What matters is whether Glaxo misrepresented the benefits/risks of Avandia in its promotion of the drug to a public entity–in this case, the county hospital. That’ the charge.
Doc
Go Santa Clara! By the way, why is this drug still on the market? Actos has the same efficacy without these issues. What better way to teach pharma companies to do the right thing, than take their drug off the market, if there is a reasonable alternative?
Sean
Doc…maybe the FDA should do the same with physicians. Take physicians off the market when there are plenty of other competent alternatives on the market. Isn’t that a reasonable alternative since not all physicians are created equal? Do physicians provide different levels of care and therefore efficacy?
harpy
I believe state medical boards take care of removing inadequate physicians. and malpractice lawsuits. or are you saying that once a drug has made it to market it should remain in aeternum due to the fact it is simply there?
patrons99
Harpy - I disagree. State medical boards are quite often feckless in removing “inadequate” physicians. I know of a particular case in which a certain state BOMEX, after “investigating” certain allegations of physician misconduct, simply punted the matter to federal regulators, alleging that clinical research fraud was under federal, not state, jurisdiction.
http://www.scribd.com/doc/17300794/Feb-19-2002-Arizona-State-Board-of-Medical-Examiners-Letter
Sean - it is certainly true that “not all physicians are created equal”. That applies to ALL professions, not just medicine. There are sociopaths in all walks of life. It is particularly troubling when BOTH state and federal regulators effectively refuse to reign them in. This explains, in part, why so few would-be whistleblowers are willing to step up and do the right thing. Whistleblower protections need to be strengthened. The current system quite often makes a pariah and outcase out of the whistleblower, someone to be shunned by his or her peers.
pharmavet
I agree with Patrons. In the 1970’s, my dad, who is a surgeon was appointed to head up a large PSRO (Peer Standards Review Organization) on the east coast. The purpose of the PSRO’S was to review physician performance and institute corrective measures where necessary in order to improve quality of care. They held a big stick, as they they had the authority to deny underperforming doctors admitting privileges at their hospitals. The program was highly effective, but unfortunately was discontinued with the advent of managed care. State medical board members are essentially political appointees, and do not care as much about enforcing standards as they do perpetuating their own interests.
Sean
I agree with each of the above posters regarding the lack of teeth with Medical Boards and their reluctance to enforce penalties on many members of the medical community. I also agree that the whistleblower act is weak and research shows most whistleblowers do not ever recover professionally or personally from their decision to step forward. External corporate ombudsman corporate support is needed in the pharma industry.