Burying the Data on Drug Effectiveness

Two stories, released within 24 hours through different news outlets, but each telling the same tale.  Two drugs, designed to help people with mental illness, but with clinical trials that showed they not only didn’t work, but had side effects that would aggravate the depression.  Two companies that reacted to this by burying the data, allowing them to sell the drug freely and at great profit.  Two drugs that not only didn’t make the patients better compared to other drugs, but made them worse.  And the only way we learned about this was because of lawsuits.  Remember this the next time the pharmaceutical industry tells us they can regulate themselves.

The first company is AstraZenaca, whose drug Seroquel was designed to treat schizophrenia.  As reported by Bloomberg and as revealed in unsealed emails, they specifically suppressed the data from three specific clinical trials in 1999 that showed the drug to have serious side effects.  In one of these trials – trial 15 – the company used the positive results to show it was better than a placebo, but left out the data that it was outperformed by rival drug Risperdal and generic drug Haloperidol.  The trials also showed a weight gain as a serious side effect.  We’re not talking weight gain as in “the patients self esteem was worse” – we’re talking weight gain as in “increased the likelihood of diabetes.”  An unsealed report from the global safety officer in 2000 said there was “reasonable evidence to suggest that Seroquel therapy can cause impaired glucose regulation including diabetes mellitus in certain individuals.”  Yet the company told the FDA in August 2000, “preclinical data has provided no evidence that Seroquel treatment in man may be associated with diabetes.”

As a result, the full wheels of AstraZeneca marketing went into motion.  Once you’ve played fast and loose with the data with the FDA, making your case to doctors and patients is a snap.  Drug sales boomed, making Seroquel the number two seller for the company, netting $4.8 billion in 2008 and behind only Nexium.  I don’t know how many people are still taking the drug, but it’s enough for 15,000 patients to currently be suing the company for burying the data about its effectiveness and side-effects.  That’s the only reason we know it happened at all.

WSJ’s Health Blog tells us the Justice Department is investigating Forest Laboratories for doing much the same thing with its antidepressants Celexa and Lexapro (Lexapro is a derivative of Celexa – practically the same drug, but altered slightly to keep the patent alive -- R&D dollars at work!)  The negative study in this case suggested that the drug was not effective for children and had a nasty effect – it might increase suicidal tendencies.  For an antidepressant, that’s a pretty huge side effect!  The FDA looked at the positive trial and the negative trial, and rejected pediatric use of the drug on the evidence.  But when it came time to market the drug, the company kept the negative trial on ice – even from its own sales reps.  And, wouldn’t you know it, the drug was marketed as effective for everybody, teenagers and children as well.  P.S., Forest is also under investigation for obvious kickbacks to doctors who prescribe their drugs.

This is why medical waste is so unconscionable, particularly for prescription drugs.  It’s not just the waste of money – it’s the harm to patients.  All they wanted to get better, and they were willing to pay the money for the latest, most expensive treatment.  One set of patients got an inferior drug that increased their chances of diabetes.  The other got a drug that made their condition worse. 

Dr. Roy Poses on Health Care Renewal makes a point that few of us would even think of.  What of the people who put their health at risk to participated in the clinical trials in the first place?  To him, it “amounts to post-hoc abuse of research subjects who volunteered their participation believing that it would advance science and health care.”
Big Pharma has already declared their intention to mount a massive lobbying and advertising blitz against health care reform, saying the industry doesn’t need regulation and can self-police.  It would be a convincing argument if they didn’t get caught with their hands in the cookie jar so often -- and if thousands of patients didn't have to be hurt in order for them to be caught.

(Photo credit:  lst1984 on Flickr.)