February 27, 2008

Big Pharma Lives to Cheat Again

Two stories in the news this week reflect increased scrutiny of Big Pharma malfeasance coupled with evidence that this scrutiny isn't going to change anything soon.

1. After many months of running the ad campaign where Robert "I am not a licensed doctor, but I play one on Television" Jarvik promoted Lipitor, Pfizer announced it was ending the campaign.

Pfizer to End Lipitor Campaign by Jarvik (NY Times)

This might look like a triumph for those who pointed out that "Dr. " Jarvik was never licensed to practice medicine, that he didn't actually invent the artificial heart, and that the footage of a man looking exactly like him indulging in energetic rowing was actually shot using a body double, since Jarvik doesn't row.

But it isn't that significant because this ad campaign has been running for so many months already that it was due to be replaced. Pfizer is hard at work on yet another campaign whose message is that the you shouldn't use a cheap generic statin. If you do, Pfizer's profits will tumble.

This deceptive ad campaign was very suited for Lipitor. This is, after all, the most misrepresented drug in history. Research studies have shown that statins do not prevent heart attacks in anyone except males under 56 years old who have already had heart attacks.

Statins do cause significant cognitive symptoms--including what can be permanent memory loss. They can compromise your liver. They can even weaken your heart muscle. But such is the power of the saturation advertising pursued by Pfizer and other statin manufacturers that few doctors are informed about the actual data supporting the claims that statins prevent heart attack.

2. Our second story is about the second most oversold family of drugs, SSRI antidepressants. Scientists invoked the Freedom of Information Act to get access to the many studies submitted to the FDA as part of the drug approval process for a long list SSRI antidepressants. In many cases, the publication of these studies had been suppressed by the drug manufacturers. In others they had been published with critical information left out so that misleading conclusions could be drawn.

The latter is a common practice. If, say, a placebo cures 30% of those who take it and the drug under study cures 30% of those who take it--which shows it is no more effective than a sugar pill--a misleading way of publishing the study would be to leave out any mention of placebo and headline the study, "New Drug cures 30% of those who take it." This, it turns out is exactly the way that the SSRI manufacturers spun a bunch of studies.

The meta-analysis of this suppressed and misrepresented data showed conclusively that SSRI antidepressants don't work any better than sugar pills except in the case of people with severe depression where they are only slightly more effective. Severe depression is the kind of depression that renders a person completely unable to function. Untreated people who have it end up institutionalized. It is not the mild depression that characterizes 98% of those prescribed Prozac, Zoloft, Paxil, etc.

You can read the published research paper about the actual effectiveness of SSRIs here in the metastudy published in Public Library of Science (PLoS) Medicine :
Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration

You would think this would have been front page news, given how these drugs have been prescribed to over 40 million people. But since drug company advertising heavily funds most media outlets in the U.S. the story went almost unreported. Fortunately, the British press which is not allowed to advertise drugs picked it up and that brought it to my attention.

What many people don't know about depression is this: studies conducted decades ago found that if you give psychotherapy to a group of people with mild depression one third will get better. But if you give no treatment at all to another group of people with mild depression one third will also get better. So with that in mind, you can reinterpret the way that drug companies promote these drugs with statistics showing, you guessed it, that one third of those given the drugs get better.

Unfortunately, getting better using an SSRI also means getting fatter, increasing your insulin resistance, decreasing your sexual function, and developing a dependency on the drug that will cause you to suffer serious neurological symptoms if you try to stop taking it.

And as I reported a few blog postings ago, taking an SSRI also seems to remodel the neuron distribution in your hippocampus, an effect whose long-term impact is unknown but should be troubling. Changes to the hippocampus as we age cause dementia.

What is even more troubling is that it took more than 20 years for the suppressed studies to see the light of day. This is long enough for many of the drugs involved in those studies to go off patent, after earning billions for the companies that suppressed the evidence that they were selling expensive, addictive placebos that have frightening side effects and most definitely increase insulin resistance.

If you care about your health, demand that your elected representatives change the laws that allow drug companies to sell their drugs to the public via television advertising. These ads are alway full of misrepresentations, but the drug companies know that by the time they get nailed for them, the ad will have already been seen hundreds of times by hundreds of millions of medically naive consumers.

And if you care about health, you should also demand that your elected representatives demand that the FDA make public all studies submitted as part of the drug approval process. Before the drug is approved.

Our ability to trust the safety of FDA-approved medications is lower now than it has been at any time since the FDA was first chartered to protect the public from drugs that were maiming and killing people. If the system isn't cleaned up, it is only a matter of time until we have a drug-induced disaster that will make the effects Thalidomide look trivial.

For that matter, we may already have had it. It may just take another decade for people to realize it.