The Generic Drug Witch Hunt

CNS News has already achieved a certain degree of infamy in this blog for its subsidiary, CME Zone, an industry-funded CME factory. In a prior posting, I reviewed one article that masterfully tweaked information on anxiety disorders in order to promote Shwarz Pharma's Niravan, a orally-disintegrating version of Alprazolam (Xanax).

Now, unfortunately, CNS News is back on our radar screen for having commissioned an article bad-mouthing generic medications. You can find it as an insert in the November 2007 issue. The title is "Generic Antiepileptic Drugs: An Update," and the author is Andrew Wilner, M.D., a prominent neurologist with his own website.

Dr. Wilner's article is a biased article against using generic epilepsy drugs. He points out that the FDA allows generics to vary from 80% to 125% of the original drug's bioequivalence. But he ommits the crucial clarification that in actuality, generics vary from brand name by an average of only 3.5%, according to the most recent FDA analysis. He cites surveys of neurologists showing that most of them have seen breakthrough seizures when patients have been switched from brand name to generic formulations. But he fails to discuss how unreliable survey data like this can be. Response rates are low, and the physicians who have seen problems with generics are precisely those who are most likely to respond to a survey about possible generic drug dangers.

Dr. Wilner ends the article with an admission that proof of the dangers of generics is lacking, saying that no definitive study randomizing patients to brand name vs. generic has been done. But in fact, at least two randomized studies have been done. In one, patients randomized to generic carbamazepine had no more breakthrough seizures than patients randomized to a brand-name version. In another, patients on generic Dilantin actually had somewhat higher serum levels than brand name.

But these are all scientific quibbles, and they can reasonably argued in various ways. The most glaring problem is that there is no information about Dr. Wilner's numerous conflicts of interest. Instead, the article is said to be "independently developed by Mcmahon Publishing."

Discovering Dr. Wilner's industry ties is as easy as entering the terms "Wilner and disclosures" in Google. As it turns out, Dr. Wilner has received grants from several makers of anti-epileptic medications, including Shire (maker of Carbatrol), UCB (Keppra), and Novartis (maker of Trileptal). In fact, the first anti-generic survey study reviewed in the article was funded by Shire, and was conducted by none other than....Dr. Wilner!

I was astonished when I discovered this undisclosed conflict, and I wrote Dr. Wilner and the publisher this letter seeking a response. The first response was from the publisher, Donald Pizzi, who said that he had paid Dr. Wilner directly to write the article and that no industry money was involved. Pizzi said that historically, no disclosures are made in his journal, but "eventually" he will add them.

A bit later, Dr. Wilner sent me this letter. He parses the data a bit, engages in what I would consider some artful tweaking, but you can judge it for yourself if you choose to read it. I found it especially interesting that he defends his lack of disclosure by saying: "Regarding disclosures, while I have received grants and honoraria from the pharmaceutical industry in the past, I currently have nothing to disclose." I guess it depends, in the words of a former president, on what "is" is. In December of 2005, Dr. Wilner was funded by UCB pharmaceuticals, and in April of 2006 he helped write this article for a group of industry-funded neurologists, though it's unclear exactly who paid him. Other instances of his pharma funding can be found here and here and here.

Timing aside, the key issue is that Dr. Wilner's article appears to be biased in favor of brand medications, and he has been recently paid by precisely those companies whose profits are threatened by generics. He and the publisher should have disclosed this. If they had, readers would have given little credence to the article. But that would not have made the CNS News drug company advertisers very happy.

By the way, for a more balanced view of generics, visit this post on the Prescription Project's blog, Postscript.