Drug Companies Cherry-Pick Data to Get Approval for Useless Drugs

By Sophie Bushwick | September 28, 2012 9:00 am

pills

It goes without saying that the drugs you take for a headache, or high blood pressure, or even depression should work better than a Tic-Tac. That’s what drug trials are for: researchers give a group of subjects either the drug under investigation or a placebo to check that the medicine is significantly more effective than a sugar pill. Plus, the trials can reveal any potentially harmful side effects. In theory, this is a great way to weed out useless or actively harmful drugs. But it fails when drug manufacturers cherry-pick their data, publishing papers on the positive trials and sweeping the unsuccessful ones under the rug. And this behavior is completely legal.

Science writer and medical doctor Ben Goldacre wrote a book, with a long excerpt published at the Guardian, about how this process leads to approval for drugs that don’t actually work. And as he explains, when widely used drugs—such as the diabetes medication rosiglitazone—have harmful side effects, they sometimes remain in common use.

In 2003 the Uppsala drug monitoring group of the World Health Organisation contacted [pharmaceutical company GlaxoSmithKline] about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.

During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.

In both published papers and results presented at conferences, trials sponsored by the drug industry are far, far more likely to yield positive results. Goldacre lists more examples where selectively chosen data and inadequate regulations let doctors treat their patients with useless or harmful drugs. Read about them in the longer excerpt at the Guardian.

Image courtesy of Candy / Wikimedia Commons

CATEGORIZED UNDER: Health & Medicine
  • Chris

    So much easier to eat a healthy well balanced diet and exercise regularly than to live an unhealthy lifestyle and take drugs to keep your system going.

  • NonnyMus

    So easy to assume all people’s health problems come from unhealthy lifestyles. Inaccurate, but ever so easy.

  • Jason

    How about breaking the FDA’s monopoly on drug certification? Monopolies create inefficiency and corruption. There are many industries wherein multiple independent testing and certification companies exist and compete. They guard their reputations carefully, strive to make testing efficient and accurate, and if they turn corrupt they will lose customers. For example, these potentially lethal products are tested and safety-certified by independent companies: electrical appliances, cellphone chargers, auto wheels, scuba gear, and garage lifts. One example of a well-regarded certification company is United Laboratories (UL). Look at your cellphone charger’s logos.

  • Craig

    There is very little left in our world that is made for purposes other than making people money. Why should medicine be any different? I’m sure lots of money was made and nobody got anything worse than a slap on the wrist, except the people who had the misfortune to take the medication of course.

  • http://duenez.evolicious.net Edgar Duenez-Guzman

    @Chris, the problem is that people don’t necessarily get sick because they are idiots, slobs, lazy or evil. Health problems are NOT a personal responsibility all the time (and I would go as far as to say that even not most of the time, either).

    The problem here is that the incentives are all screwed up. Scientists have very little power relative to pharmaceutical companies. And cherry-picking data should plain and simply be illegal and have VERY severe consequences for the offenders. I would send the bastards to bankrupt, make them spend every little cent they have (and the money of everyone who was responsible for this decision) to compensate the people affected. Whatever money is left, I would use to sponsor education programs and to foster a much more strongly arbitrated system.

    That would send the right message: “If you play with lives to fatten your pockets, you will be destroyed. Profiting from the health of people is NEVER appropriate behavior.”

  • Mike

    I like the suggestion above about ending the FDA’s monopoly. Other countries, especially Canada and the European Union get new medications and medical devices long before we do in the USA. The FDA appears to be a large, slow bureaucratic organization that is subject to outside influence and is not impartial. From what I have heard, they need a kick in the rear end and more oversight.

  • Kevin

    When Drug Companies, who now have representatives and lobbyists ruling the FDA, get caught, they rarely pay fines any where close to the amounts they earned. In most cases the law is applied without contacting the police, they are allowed to make deals to avoid prosecution. Even if they are convicted in a real court of law, the fines don’t approach punishment and exist almost as a divvying up of the loot. No Drug company executives or sales staff go to jail and they are free to repeat their murderous ways without fear, because getting caught means little more than; there are drinks owed to old friends.

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