Visita médica, el futuro...? (XV): La influencia de la promoción por la Industria farmacéutica...

Alarms sounded around the globe in 2004 when Vioxx was withdrawn from the market due to its association with cardiovascular toxicity. Following the provision of over 80 million prescriptions worldwide, this withdrawal carried enormous consequences. The story rightfully attracted widespread attention regarding public health implications of drug promotion. The VIGOR study,1 published in 2000, had found Vioxx to increase the risk of myocardial infarction as compared to naproxen, yet Vioxx was promoted as a safer alternative. Worse yet, evidence later revealed in the Vioxx litigations suggested that the authors of the study knowingly understated the rates of myocardial infarction in the Vioxx group that led to misleading conclusions.2 The New England Journal of Medicine later called the authors to submit a correction. Studies also suggested that Vioxx manufacturer, Merck and Co., manipulated data and used academic researchers to enhance the credibility of articles written largely by Merck.3 The editor and deputy editor of the Journal of the American Medical Association responded by saying “the profession of medicine in every aspect — clinical, education and research — has been inundated with profound influence from the pharmaceutical and medical device industries.”4 An investigation showed that Merck and Co. sales representatives systematically avoided presenting evidence of Vioxx's cardiac toxicity to health professionals,5 and the US death toll was estimated at between 35,000 and 45,000.6

The attention being paid to the relationships between the pharmaceutical industry and health care providers is steadily increasing, along with a growing awareness of the link between industry promotion and drug use decisions.7 The purpose of this paper is to identify techniques used by the pharmaceutical industry to promote their products, while highlighting the impact on our patients and profession. By familiarizing themselves with such techniques, pharmacists, pharmacy students and pharmacy schools will be ready to employ strategies needed to appropriately respond to industry advertising and ensure we are meeting high ethical professional standards.

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While meeting with a sales representative, it is advantageous to be mindful of a study by Ziegler et al.23 The study indicated that 11% of statements made by sales reps were inaccurate. Equally worrisome is that all inaccurate statements were favourable towards the promoted drug, and none of the statements about competitors were favourable. In September 2009, Pfizer was fined 2.3 billion dollars for illegal promotion of several of their drugs.24 Marketing fines have also been dished out to GlaxoSmithKline, Takeda Pharmaceuticals, Merck, Eli Lilly and Abbott.25 Industry's influence is growing so deep that it may be difficult to recognize. Prominent medical researchers involved in determining treatment guidelines have been paid up to $50,000 in 3 months from drug companies.26,27 Industry documents indicate that clinical trials for Vioxx were authored by employees of the manufacturer, but often attributed first authorship to academically affiliated researchers who did not always disclose payment from the manufacturer.28

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Ver tambien

The Accuracy of Drug Information From Pharmaceutical Sales Representatives

Michael G. Ziegler, MD; Pauline Lew, PharmD; Brian C. Singer, PharmD

JAMA. 1995;273(16):1296-1298

Visita médica, el futuro...? (XIV): Qué opinan los médicos...

VIOXX: Victimario.../Just How Many Americans Did Vioxx Kill?

Whistleblower Dr. David Graham, in testimony before the US Senate, estimated 88,000 to 139,000 Americans experienced heart attacks as a side effect from the drug, and 30 to 40 percent of these died. That would be an estimated 27,000 to 55,000 preventable deaths attributed to Vioxx.

Vioxx at its peak was being taken by 20 million Americans. In 2003 sales of Vioxx totaled about $2.5 billion. Vioxx prescriptions were 19,959,000 in 2003 and 13,994,000 in 2004, a decline of about 6 million prescriptions (about a 30% drop). (Source: IMS Health)

Nobody is saying it, but it looks like Vioxx did kill many thousands of Americans. (Ver)

April 21, 2006

Bill Sardi [send him mail] is a consumer advocate and health journalist, writing from San Dimas, California.

VIOXX: La "cocina"... Naked capitalism: The case of Vioxx and Heart Disease

Yesterday I caught a lecture at Columbia given by statistics professor David Madigan, who explained to us the story of Vioxx and Merck. It’s fascinating and I was lucky to get permission to retell it here.

Disclosure

Madigan has been a paid consultant to work on litigation against Merck. He doesn’t consider Merck to be an evil company by any means, and says it does lots of good by producing medicines for people. According to him, the following Vioxx story is “a line of work where they went astray”.

Yet Madigan’s own data strongly suggests that Merck was well aware of the fatalities resulting from Vioxx, a blockbuster drug that earned them $2.4b in 2003, the year before it “voluntarily” pulled it from the market in September 2004. What you will read below shows that the company set up standard data protection and analysis plans which they later either revoked or didn’t follow through with, they gave the FDA misleading statistics to trick them into thinking the drug was safe, and set up a biased filter on an Alzheimer’s patient study to make the results look better. They hoodwinked the FDA and the New England Journal of Medicine and took advantage of the public trust which ultimately caused the deaths of thousands of people.

.../...

Just as the financial system has to be changed to serve the needs of the people before the needs of the bankers, the drug trial system has to be changed to lower the incentives for cheating (and massive death tolls) just for a quick buck. As I mentioned before, it’s still not clear that they would have made less money, even including the penalties, if they had come clean in 2000. They made a bet that the fines they’d need to eventually pay would be smaller than the profits they’d make in the meantime. That sounds familiar to anyone who has been following the fallout from the credit crisis.

One thing that should be changed immediately: the clinical trials for drugs should not be run or reported on by the drug companies themselves. There has to be a third party which is in charge of testing the drugs and has the power to take the drugs off the market immediately if adverse effects (like CVT events) are found. Hopefully they will be given more power than risk firms are currently given in finance (which is none)- in other words, it needs to be more than reporting, it needs to be an active regulatory power, with smart people who understand statistics and do their own state-of-the-art analyses – although as we’ve seen above even just Stats 101 would sometimes do the trick. (Ver)

Ver anterior:

VIOXX: Victimario...

VIOXX / Merck paga...

Merck & Co. paid claims to the families of 3,468 users of its Vioxx painkiller who died of heart attacks or strokes, a court-appointed administrator told a judge today.

A $4.85 billion settlement fund made payments to the families of 2,878 Vioxx users who died of heart attacks and 590 who died of strokes, according to Lynn Greer of BrownGreer LLP, a law firm in Richmond, Virginia, that analyzed 59,365 claims.

Merck pulled Vioxx from the market in 2004 after a study showed it doubled the risk of heart attacks and strokes. Merck set up the fund, which covers claims of death and lesser injuries, in 2007 after reserving $1.9 billion to fight 26,600 Vioxx suits. U.S. District Judge Eldon Fallon in New Orleans has overseen Vioxx lawsuits since February 2005 through a process known as multidistrict litigation.

“It’s a remarkable achievement,” Fallon said at a hearing, describing the MDL as the biggest in U.S. history. “We have really finished the large portion of this litigation.”

Más...

Emerger después de "morir" o..."After Big Pharma Made Its Money".

Have you ever noticed how warnings about dangerous prescription drugs always seem to surface after the drug is no longer marketed and its patent has run out? Whether it's an FDA advisory or a trial lawyer solicitation about harm that may have been done to you, the warnings are always belated and useless. If a drug you took four years ago may have given you liver damage, why didn't the FDA tell you then? Why didn't the FDA recall the drug or better yet, not approve it in the first place? 

The official answer from the FDA and Big Pharma is that problems with a drug are only seen after millions begin using it, which is why post-marketing surveillance is conducted. In other words—who knew? But in a startling number of cases revealed in court documents Pharma did"know" and clearly misled medical journals, the FDA, doctors and patients, hoping to get its patent's worth before the true risks of a drug surfaced. In other cases, Pharma and the FDA should have known before rushing a dangerous drug to market and making money at the expense of patients. (Más)

1. Vioxx
Remember the "super aspirin" Vioxx, that was heavily marketed by Merck and athletes Dorothy Hamill and Bruce Jenner 15 years ago? Vioxx was a wonder drug that treated everything from arthritis pain to menstrual cramps, its ads claimed, sparing users the gastrointestinal problems caused by older drugs like aspirin. It turned out that Vioxx was super at something else, too: it doubled the riskof cardiac events,causing 27,785 heart attacks and sudden cardiac deaths according to news sources. (...)

2. Fosamax 
Vioxx was not the only Merck drug demonstrating that forgiveness is easier and cheaper when it comes to marketing new drugs. Merck's Fosamax, the first of an anti-osteoporosis drug class called biphosphonates that included Boniva and Actonel, was linked to heart problems, intractable pain, jawbone death, bone fractures and esophageal cancer—only after its patent ran out in 2008. Court-released documents reveal that Merck scientists knew about Fosamax' link to jawbone death as early as the 1970s in animal studies.(...)  

3. Lipitor 
What is the best-selling drug in the history of pharmaceuticals? What made $125 billion in 14 and a half years and as much as $11 billion in a single year? Lipitor, Pfizer's blockbuster statin drug, owed its success to two factors. It was launched in 1997 when direct-to-consumer drug advertising was just beginning and it harnessed the growing national fear of cholesterol-linked heart attacks. Thanks to Lipitor's "Know Your Numbers" TV ads and Pfizer reps who saturated medical offices with free samples of the white pills and sometimes lunch, more than 29 million people were prescribed Lipitor. (...)

4. Nexium 
What is the second bestselling drug, after Lipitor? The Purple Pill. Like statins, Nexium and the other Proton-Pump Inhibitors (PPI) to treat gastroesophageal reflux disease (GERD), became household medications thanks to direct-to-consumer advertising. Before Proton-Pump Inhibitors, people took over-the-counter treatments like Tums or Tagamet when they had heartburn or indigestion. As the afflictions were upgraded into the "disease" of GERD, Nexium made almost $5 billion in the US in one year and the class of PPIs made $13.6 billion in one year, translating into 119 million prescriptions. (...)

5. Adderall 
It is no secret that doctors, parents and teachers are calling millions of children ADHD. Thanks to Pharma marketing, ADHD is now the second most common long-term diagnosis in children after asthma, says the New York Times, often conferred for "childhood forgetfulness and poor grades." While some critics of the massive dosing say kids are being penalized for being kids and that "treatment" used to be recess, Big Pharma's spin campaigns maintain that daily stimulants do not hurt children. (...)

6. Paxil 
Few SSRI antidepressants have the checkered safety profile of GlaxoSmithKline's (GSK) Paxil. In 2007 the BBC revealed that Paxil's Study 329 showed adolescents six times more likely to become suicidal on the drug but the results were buried. (GSK settled related charges in 2012 for $3 billion.) Rumors had circulated for years about suicide and toxic withdrawal symptoms with Paxil and they were evidently true in some cases. (...)

7. Ambien 
One of Big Pharma's cash cows has been insomnia pills, because everyone watches TV when they can't sleep—and they see sleeping pill ads. Leading the sleeping pill category was Sanofi-Aventis' Ambien, which netted $2 billion a yearbefore it went off patent in 2006. But even as the patent expired, stories began to circulate about deranged behavior committed in an Ambien blackout. People drove and made phone calls on the drug with no memory of it; dieters woke up amid mountains of pizza and Häagen-Dazs cartons, and one woman drank a bottle of black shoe polish in an Ambien blackout. (Sanofi-Aventis was forced to publish ads telling people if they were going to take Ambien, to get in bed and stay there.) (...)