Editor’s note: The following article is a follow up to a previous AlterNet piece about drugs whose dangerous side-effects emerged only after the pharmaceutical industry’s patents ran out. Read part 1 here.
When a prescription drug causes risky side effects, the word often doesn’t get out for years, allowing Big Pharma to make money anyway.
The FDA and Big Pharma contend that dangerous side-effects in a prescription drug only emerge when it is used by millions instead of the relatively small group of people in clinical trials. But there is another reason the public ends up guinea pigs. Prescription drugs are rushed to market in as little as six months so industry can start making money while safety is still being determined. Both Merck’s risk-laden bone drug Fosamax and painkiller Vioxx were on the market after a six-month review. In the case of Vioxx, it was because “the drug potentially provided a significant therapeutic advantage over existing approved drugs,” the FDA said.
Thanks for that. And five drugs (Trovan, Rezulin, Posicor, Duract and Meridia) rushed through in 1997 because of Pharma and congressional pressure on the FDA, says Public Citizen, were subsequently withdrawn.
Here are some drugs whose risks did not did not keep them from getting their “patent’s worth.”
You’d think Merck would have learned from Vioxx and Fosamax that aggressive marketing can only hide emerging risks for so long. It didn’t. To sell its asthma and allergy drug Singulair to children, the drug giant partnered with Olympic gold-medalist swimmer Peter Vanderkaay and Scholastic and the American Academy of Pediatrics even as the FDA warned about “neuropsychiatric events” including agitation, aggression, nightmares, depression, insomnia and suicidal thinking.
While Merck marketed Singulair, which comes in a cherry-flavored chewable formulation, to parents with slogans like “Singulair is made with kids in mind,” Fox TV and over 200 parents on the website askapatient reported that children on Singulair exhibited altered moods, depression and ADHD, hyperkinesis and suicidal symptoms. Fifteen-year-old Cody Miller of Queensbury, NY reportedly took his own life days after taking the drug in 2008. Still, Singulair made $5 billion for the company in 2010. After its patent expired in 2012, Australia’s Therapeutic Goods Administration, the FDA’s counterpart, reported 58 cases of adverse psychiatric events in children and teenagers, primarily suicidal thinking. Who knew?
How do you sell a drug that causes 30 percent of users to gain 22 pounds and some to gain as much as 100 pounds? By burying the risks. The antipsychotic Zyprexa was supposed to be Eli Lilly’s followup to its blockbuster antidepressant Prozac even though Lilly knew as early as 1995, according to the New York Times, that Zyprexa was linked to unmanageable weight gain or diabetes. Zyprexa’s side effects of “weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” wrote Lilly’s Alan Breier, who later became chief medical officer, in documents obtained by the Times.
Even as Lilly settled charges that it withheld the drug’s link to high blood sugar levels and diabetes and illegally marketed the drug for dementia, Zyprexa made $5 billion in 2010 and out-earned Prozac. Who says crime doesn’t pay? Zyprexa was especially marketed to the poor and became one of the nation’s top Medicaid drugs extracting at least $1.3 billion of our tax dollars in 2005 alone. In 2008, Lilly settled an Alaskan suit to cover the cost of Medicaid patients who developed diabetes on Zyprexa. Unbelievably, Lilly offered a “free service” to “help” states buy mental illness drugs like Zyprexa as a fox guards the henhouse and 20 states took the bait. Zyprexa’s patent ran out in 2012.