Another Big Pharma scandal erupts

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Barely has the dust settled on the Celebrex research fabrication fiasco before another Big Pharma scandal has erupted. This time it centres on the diabetes drug Avandia, manufactured by GlaxoSmithKline.

US Senators have published a damning report linking Avandia (rosiglitazone) to heart attacks and deaths while two drug safety reviewers have recommended that it be pulled from the market. “At a July 30, 2007, safety panel on Avandia, Food and Drug Administration (FDA) scientists presented an analysis estimating that Avandia use was associated with approximately 83,000 excess heart attacks since the drug came on the market.”

Even more shocking (actually not so shocking-lah), the Senate Finance Committee report suggested that GSK was aware of the cardiac risks associated with Avandia years before the evidence became public.

Check out the conclusion of the report. The findings amount to a severe indictment of Big Pharma firms, which in recent years have had to pay staggering amounts in criminal fines:

In preparing this report, Committee investigators reviewed over 250,000 pages of documents provided by GSK, the FDA, the University of North Carolina, and others. Anonymous whistleblowers who contacted Senator Grassley’s investigators provided hundreds of other pages. For well over a year, Committee investigators also conducted numerous interviews and phone calls with GSK, the FDA and anonymous whistleblowers.

The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public. Several years prior to Nissen’s study, it can be argued that GSK was on notice that Avandia may have problems. 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.

In recent years, pharmaceutical companies have committed acts that forced them to pay the largest criminal fines in American history. In cases involving Pfizer, Eli Lilly, Bristol Myers Squibb and four other drug companies, these fines and penalties have totaled over $7 billion since May 2004.

In particular, Pfizer has been fined multiple times in the past 6 years for illegal off-label promotion of their drugs. In its latest plea agreement, which took place last September, Pfizer paid $2.3 billion in fines and penalties for off-label promotion of Bextra. This settlement was the largest criminal fine in U.S. history.

Such an environment requires diligent oversight by the FDA to protect the citizens of this country and to ensure the safety of American medicine.

Ho hum, just business as usual. Pity the poor patients.

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Anil Netto

New blog post: Another Big Pharma scandal http://anilnetto.com/health-care/another-big-pharma-scandal/

Eloi

Tsk Tsk! Dav…Axx on fire! I’m only going to talk facts…. 1) Dav must have been or is a medical rep, are you not? Feeling the heat i guess then ranting and raving here when we should talk about regulatory monitoring so these kinds of issues don’t happen anymore? I speak for medical reps as well, this is a job that has to be regulated? I know of some who are genuine too but what compares….Medical Reps or Doctors? We should be lining up at Pharmaceutical offices instead of Hospitals if what you say is right. 2) I’m talking from… Read more »

scientist

dav, Eloi is just asking med reps to share the reality of their work. The “insider story”. I’m sure there will be lots of interesting things to learn, and the public will benefit from the info. Both Eloi and My2cen hint at the truth. A med rep’s job is to please doctors and sell meds. Not to protect patient/public interests or to be medical specialists/experts. They are trained to sell their product, thats it. I think it is not clear if humans would suffer “without this so call giants pharmaceutical companies”. In fact, humans will benefit. Without the monopoly and… Read more »

dav

Eloi, Do not belittle the Med Reps.

dav

Eloi I think you are being very st…p to ask Med Reps to answer your question. Who are you to decide which medication should be in the market.Medicine are produce to help the people.Without this so call giants pharmaceutical companies do you think people could have survive so long. Every medication has its side effect.Dont be a smart A..

Mist

It is a myth that modern medicine had increased our lifespan(http://www.plimoth.org/discover/myth/dead-at-40.php).

In fact the number killer in countries that use modern medicine as the predominant healing modality is modern medicine itself. Modern medicine killed more people than cancer or heart attack(http://www.garynull.com/pix/DeathbyMedicine_march09bf2Faloon.pdf)

My2cen

Unfortunately, since the mega-mergers and race to be the top pharma companies, the big pharma boys have put bottom line against everything else, including real education and selling medicine for it’s real worth. To counter their off-patent drugs, many created short cuts in the development phases, pushed their new drugs for sale and thus downplayed the side-effects. Actually for Avandia, Some of these side effects can be mitigated, but no, they decided to promote the drug for all patients irregardless of the contra-indications. It was contra-indicated for heart failure, cause increase in liver function enzymes and bone depletion. But yet… Read more »

Motorist

Why do I get the feeling that these drug companies are not here to “Heal The World – Micheal Jackson” but are to make “Money Money Money – ABBA”

soohuey

bit of trivia..

in an interview of Barry Wain (who wrote Maverick Mahathir, which is still being considered by our home ministry whether sale be allowed in Malaysia), he said Mahathir studied medicine because he felt that he would have more credibility in the community if he was a doctor!

rather funny when considering some of the posts n comments here. lol.

Eloi

This has been going on for the longest time. The truth is only coming out now because the effects(side-effects rather) are too many to hide anymore. A few years back, I heard about the CELEBREX issue but when i questions the doctors (both private and government) they claim ignorance. These doctors should have stopped using these products but they continued using it with no sense of responsibility. Even now, some doctors are still prescribing it to the public. (All it took was a search on Google) I wonder if these doctors were bribed/coerced into using it by these billion-dollar pharmaceutical… Read more »

Shai-Hulud

Ben Goldacre of Bad Science has got some good essays about Big Pharma/research (amongst others).

“A quick fix would stop drug firms bending the truth”
http://www.badscience.net/2008/02/619/

“Blame the drug companies… and yourself…”
http://www.badscience.net/2007/04/blame-the-drug-companies-and-yourself/

“Regulating Research”
http://www.badscience.net/2006/08/regulating-research/

scientist

To bring discussions to the Malaysian scenario, notice in ABC News report, most doctors interviewed say they had stopped using the drug for a long time now and were privately clued in on the fact that the drug was bad. Unfortunately, I’m not sure if most of our Malaysian doctors would be or care to be clued in on whether their drugs work. I suspect what drugs they prescribe depends on how much benefit the drug companies give the doctors/hospitals. (Albeit, I have also had the fortune of being taken care of by 2 really good doctors in Penang, so… Read more »