Medwatch Reporting of Statin Damage

The UCSD statin study has reported on a survey of some 600 patients concerning physician attitudes when hearing reports of statin problems.

There are no surprises here but if it is numbers you want this report gave numbers. In 98% of the time it was the patient not the physician who raised the subject of side effects when cognitive side effects were the issue. 96% of the time when discussing neuropathy and 86% of the time when discussing myopathy. The immediate response of the physician almost always was denial. They rejected possible statin causation even when literature support for the complaint was substantial. Physicians rejected possible statin causation even when given an 86-page Medscape printout of medical journal references for statin drug damage. This last sentence is mine, not from the UCSD statin study.

This in itself may explain the huge discrepancy between what the FDA is saying to the public by allowing direct to the patient advertising and what they are reporting about side effects to the prescribing physicians. Consider cognitive side effects, a subject dear to my heart because of personal involvement. "Statin's don't do this," doctors and pharmacists said when I explained my personal reaction to Lipitor.

My first TGA occurred 6 weeks after starting this drug in 1999. On the basis of my experience as a family doctor for 23 years I stopped my Lipitor immediately, regardless of physician counsel. The next year NASA doctors asked me to restart Lipitor and having had no confirmation from other doctors, I allowed it to be restarted at half the previous dose, five mg daily. Two months. later my second, far worse, TGA occurred. Physicians still said, "Statins don't do that." Naturally I reported my two Lipitor reactions to the FDA's Medwatch and have since referred hundreds of other people reporting statin TGAs to do the same.

Now, In September 2007 I have just completed a survey of Medwatch data for statin TGA and have found 408 reports just for Lipitor, from 1997 to the present. Yet, you can go into almost any physician's office today and hear, "Statins don't do that!" Incredible as this may seem physicians have yet to be informed.

Obviously the FDA is not reporting their data back to the medical community. They have the data, anyone can ask for it, but are not reporting. I ask you, does this sound like a reasonable protective program for our society?

The Medwatch form 3500 for drug adverse reporting is entirely adequate and takes only a few minutes to complete. The form is not the problem. The problem is that the FDA provides no effective screening and reporting on their observations. Clearly, a major overhaul of this post-marketing reporting system is in order. I say keep the form but have it sent to a far more responsive organization.

Duane Graveline MD MPH
Former USAF Flight Surgeon
Former NASA Astronaut
Retired Family Doctor


Books From Amazon

The Dark Side of Statins
The Statin Damage Crisis
Cholesterol is Not the Culprit
Statin Drugs Side Effects
Lipitor, Thief of Memory

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