The Senate committee started their investigation after the New England Journal of Medicine published a study in May 2007 warning of the possible cardiovascular risk of Avandia. Avandia entered the market in 1999 and reached annual revenue of $3 billion by 2006, including sales of a combination drug that includes Avandia. Sales plummeted to $1.2 billion in 2009, two years after that study was published which linked Avandia to a 43 percent increased risk of heart attack. Before that the drug was the company’s second best selling drug, and they did everything to protect sales, rather than users of the drug.
The Senate report provides incredible details on how the drug company pursued countless awful tactics to thwart many efforts to reveal to the public and the medical community just how unsafe Avandia is. The report notes: “The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.… Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.”
The company continues to fight to keep its drug in the market. You can imagine the army of lobbyists being used to safeguard the interests of drug companies.
Put aside the anti-government rhetoric of the Tea Party movement. The critical need is not for less government but for government that really works in the public interest, especially protecting consumers from dastardly corporate powers. Until that happens it is not surprising that the recent Washington Post-ABC News poll found that two-thirds of Americans are dissatisfied or angry about the federal government. Nearly 75 percent of independents felt this way. If you think that voting in either Democrats or Republicans will fix broken government, think again. Both major parties are corrupted by corporate interests.
Article comments
1 - Dave Nalle
Nice to see an article with no mention of an Articlve V convention, Joel.
But I have to say that given the large fines and many prosecutions you mention in the article it would seem like the system of holding pharmaceutical companies accountable for their actions is working.
Dave
2 - Joel S. Hirschhorn
Well Dave: if the system was working, then hundreds of thousands of Americans would not still be taking Avandia and facing avoidable heart risks. The Senate report is so significant because it blows the whistle on the ineffective FDA system.
3 - roger nowosielski
I think criminal prosecution is in order.
Fines is peanut change considering the big Pharma resources. But locking up the rascals, from CEO to CFO, just might do the trick.
Ken Lay of Enron was just a fraudster compared to these guys. They're more like Joseph Mengele in disguise.
4 - Christine
What is sad is that something (medicine) that started off as a noble cause; ends up in greedy hands who only care about the bottom line (cash).
The other side of the coin is ignorance and lack of discipline when it comes to health and wellness. Meds (pills) are only sometimes the answer and many health issues can either be prevented and/or cured by lifestyle choices. Key example are diseases that come from obesity like diabetes, high cholesterol, high blood pressure and depression, etc. And before anyone starts beating me up...some diseases warrant meds; not all!
5 - Glenn Contrarian
Joel -
AMEN!
6 - jeannie danna
Joel,
You spoke to my heart, tonight!
Put aside the anti-government rhetoric of the Tea Party movement. The critical need is not for less government but for government that really works in the public interest, especially protecting consumers from dastardly corporate powers.
Thank you, and, bless you...
:]I'm not even going to bitch.
7 - Dave Nalle
Joel, seems to me that even in the case of Avandia it's working, it's just working too slowly. But there has to be some sort of balance between actually making needed drugs available and protecting consumers.
Dave
8 - FCEtier
#4: Christine -- I agree. Lifestyle choices have a huge impact. Several of my patients (I'm a pharmacist) no longer need diabetic, cholesterol, or blood pressure meds since they lost literally tons of weight. (Several had bariatric surgery.)
Joel and Dave: You both make some good points. Remember though, back in the 80's congress called upon the FDA to streamline the new drug application process to get drugs onto the market faster, particularly in the case of AIDS meds. Perhaps it's time to revisit that legislation.