Americans Spend Billions to Be ‘Big Pharma’s Guinea Pigs’
Major pharmaceuticals treat the public as guinea pigs to test their drugs, accuses investigative reporter Martha Rosenberg. Except, unlike lab animals, the public pays billions for the privilege.
Rosenberg takes on “Big Pharma” in a recent Raw Story article: “Big Pharma’s guinea pigs: 8 drugs used by millions before being pulled for dangerous side-effects.” Raw Story is an online news publication that claims 4 million unique visitors a month.
Rosenberg made similar points earlier this year in: “7 Drugs Whose Dangerous Risks Emerged Only After Big Pharma Made Its Money.” That article was on AlterNet, a nonprofit online news service that draws more than 1 million visitors a month.
Rosenberg’s articles mention many of the blockbuster drugs of the last three decades, including Lipitor, Nexium, Vioxx, Darvon, Darvocet and Paxil. Her complaints against the pharmaceutical industry include:
1. Companies bring drugs to the market — and the FDA grants its approval — before adequate testing. The drug industry operates on the tenet that it is impossible to know the consequences of a drug until it is has been used by millions. Thus, the public serves as the guinea pigs.
“The official answer from the FDA and Big Pharma is that problems with a drug are only seen after millions begin using it,” wrote Rosenberg.
2. Pharmaceutical companies conceal their knowledge of a drug’s risks. They consider the inevitable legal actions prompted by a dangerous drug to be part of the cost of doing business. The companies often make many billions of dollars more than they pay out in jury awards and settlements.
“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,” wrote Rosenberg.
3. The companies’ strategy is based on the patent timeline. While a drug is still under patent, it is a cash cow for the manufacturer. “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?” Rosenberg asked.
For these reasons, some doctors advise their patients to wait several years before trying a new drug, waiting to see if news of adverse effects belatedly surface.
Here are glimpses at six of the examples Rosenberg details in her articles:
1. Darvon, an opioid-linked pain reliever by Eli Lilly, approved in 1957, and Darvocet, a related product approved in1972. The drugs have been linked to addiction, overdoses and death. One group said in 2006 that Darvon had been linked to 10,000 U.S. deaths. Consumer groups called for a ban or restrictions on the drugs starting in 1978, but the FDA did not ban the drugs until 2010. By then, Eli Lilly had made billions on more than four decades of sales.
2. Vioxx, a pain reliever from Merck. As many as 20 million people used Vioxx, even though it was found that the drug doubled the risk of heart attack, and that Merck reportedly knew about the risk long before it became public knowledge. The New England Journal of Medicine accused Merck of concealing “critical data on an array of [Vioxx-related] adverse cardiovascular events.”
Vioxx was withdrawn from the market in 2004. In 2007, Merck agreed to pay 33,000 heart attack and stroke patients almost $5 billion (about $150,000 each). Meanwhile, Merck made more than $12 billion on the drug during its last five years on the market.
3. Baycol: a statin from Bayer, was approved in 1997. The drug was withdrawn from the market three years later, after more than 400 cases of rhabdomyolysis (break down of muscle tissue leading to kidney failure) were linked to the drug, including 52 that ended in death. Bayer made about $1 billion a year on the drug during the four years it was sold to the public.
4. Lipitor, a statin from Pfizer approved in 1997, is the best-selling (legal) drug in the history of drugs. Lipitor sales totaled $125 billion during a 14-year period, including as much as $11 billion in a single year. More than 29 million people in the U.S. have taken Lipitor.
In 2012, Lipitor’s patent expired. The same year, for the first time, the FDA required Lipitor and other high-potency statins to add a label warning about diabetes, liver injury, muscle damage and memory impairment.
Pfizer is currently facing about 1,500 federal Lipitor lawsuits and the number is growing quickly. But it has a $125 billion Lipitor nest egg to draw from.
5. Nexium, a proton-pump inhibitor to treat GERD (acid reflux), manufactured by AstraZeneca, was approved in 2001 and is still on the market. In 2012, the FDA issued a warning that Nexium and other proton-pump inhibitors have been linked to clostridium difficile, a potentially fatal intestinal infection that is resistant to treatment. Nexium’s patent ran out earlier this year. Nexium is the second best-selling drug after Lipitor and has made as much as $5 billion in a single year.
6. Paxil is the well-known antidepressant from GlaxoSmithKline. It was approved in 1992 and its patent ran out in 2002. Paxil sales totaled as much $2 billion a year. After the patent expired, GSK’s own study revealed that adolescents were six times more likely to become suicidal on the drug. That’s not the result you’re looking for with an antidepressant. In 2012, GSK settled pending lawsuits for $3 billion, but the company had already made several times that much on sales of the drug.
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