7 Drugs Whose Dangerous Risks Emerged Only After Big Pharma Made Its Money
Stay up to date with the latest headlines via email.
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.
It is the business model for new drugs that provokes Big Pharma to bury risks and exaggerate benefits. A new drug under patent has a high price and no competition, and will make millions or even billions every year it is under patent. A settlement for death or injuries down the road is a nuisance and just the cost of doing business. Needless to say, the "forgiveness is cheaper than permission" business plan breeds shameless repeat offenders since the company makes money and no officers go to jail.
Hidden and unforeseen risks in new drugs are such a danger that some medical professionals advise patients to wait up to seven years before they try a new drug. Of course, the drug is no less risky when made by a generic drugmaker except that it has been in use longer and is not accompanied by slick advertising to push demand and even "sell" the condition it treats. But generics have their downside, too. Unlike branded drug companies, a 2013 Supreme Court ruling says generic drug makers can't be sued.
Here are some drugs whose risks did not did not keep them from getting their "patent's worth."
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 risk of cardiac events , causing 27,785 heart attacks and sudden cardiac deaths according to news sources.
While Merck pleaded ignorance, the New England Journal of Medicine in 2006 accused Merck of concealing "critical data on an array of adverse cardiovascular events" caused by Vioxx. It was withdrawn in 2004. In 2007, Merck agreed to pay $4.85 billion to patients or survivors' families which represented less than one year of Merck's profits, computed the New York Times. Vioxx made Merck an estimated $2.5 billion a year from its 1999 launch to its 2004 withdrawal. Who says crime doesn't pay?
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.