Rolling Stone Article On Zyprexa, Antipsychotics Contains Error, Odd Omissions

After putting up the original post, I went back and slightly changed the portion where I discuss RS's handling of patient accounts in the article. I had overstated something and wanted to correct it. PD

Two weeks ago, I noted that a just-published Rolling Stone article had detailed the scandal around the atypical antipsychotic Zyprexa and delved into how its maker, Eli Lilly, had engaged in deceptive marketing of the drug off-label for some psychiatric conditions. Regular readers of this site know that I gave a lengthy interview to Ben Wallace-Wells, a contributing editor for RS, but that he failed to credit me or this site in any way. At the time, I hadn't read his article yet, as it was unavailable on newsstands or online. I've now read the article (now online) several times. I've held off on writing about the article until now because I wanted to separate my own frustrations with how the help I gave Wallace-Wells was uncredited from the article itself.

Overall, it's a good article, but there are some odd slip-ups, including a factual error, and globally it's odd how its author and RS chose to ignore people who acted heroically in warning the public about the dangers of this drug and who provided evidence of how the company had behaved.

There is no mention in the article of either David Egilman or Jim Gottstein, both of whom worked to leak to the public and the media court documents from a federal court case against Lilly. Egilman was later fined $100,000 for violating a court seal on the documents. Gottstein was also found in violation of the seal, although he wasn't a party to the case, and faces unspecified sanctions. Gottstein is currently appealing the court's finding against himself and Lilly has continued to go after Gottstein in court over his role with the documents. I know that Wallace-Wells interviewed both men, as Wallace-Wells told me he spoke with Egilman and Gottstein told me he'd been interviewed by the RS author. Given their central roles in getting the documents into the public realm, it's astonishing that Wallace-Wells didn't mention their service and courage. (Wallace-Wells also didn't mention the reporting done by the New York Times' Alex Berenson, to whom the documents were given in late-2006 and whose reporting truly pissed off a federal court judge in the case.) Even stranger, there is nary a mention of a single patient who took Zyprexa and the ones who are present are there as brushstrokes in a long article. A story about a drug and a company that victimized people that doesn't have some of the actual victims in it doesn't exactly make for compelling journalism, in my journalistic opinion.

What's even more striking and journalistically perplexing is that throughout his article, Wallace-Wells quotes doctors who say they knew early on that Zyprexa caused serious weight gain in patients and that they were astonished by Lilly's attempts to market the drug off-label. But there is no evidence I can find that any of these doctors did a thing to warn the public about the dangers of Zyprexa, that they contacted the FDA with their concerns or that they contacted anyone in the media. That's such an odd choice for a journalist to make with a story like this where real heroes took real risks that it makes me shake my head.

Throughout the article, Wallace-Wells mentions that Zyprexa is but one of a number of atypical antipsychotics. However, he never mentions these other drugs (Seroquel, Risperdal, Abilify, Geodon, Invega), never mentions that at least two of these drugs (Seroquel and Risperdal) have been documented as causing many of the same problems as caused by Zyprexa and that their respective makers are facing numerous legal claims similar to those faced by Lilly (for causing diabetes and hiding that fact, as well as for off-label marketing). Risperdal and Seroquel each generate about as much in sales as does Zyprexa and are used about as widely, so it's odd that the author didn't note this, even in brief in a 10,000-word article.

An uninformed reader could read the RS article and walk away with the impression that Zyprexa is the only bad atypical antipsychotic when clearly there are huge issues surrounding the other drugs. Neither is there any mention of Bristol-Myers Squibb's $515 million settlement with the feds over charges of off-label marketing of Abilify. In the issue the week before Wallace-Wells' article appeared (the one with former President George W. Bush on the cover), there is a prominent ad for Abilify toward the front of the magazine (obviously, I cannot reproduce it here). I'm not inferring a connection, but it sure is an odd coincidence.

The bottom line is that the entire class of atypicals is flawed and dangerous. When Wallace-Wells tries to briefly get at the idea, he commits an error of fact:

"But some medical researchers who have studied the atypical antipsychotics say that, in the final tally, the drugs, which have already been linked to some deaths, may eventually be responsible for tens of thousands of cases of diabetes and other potentially fatal diseases."

Some deaths? My jaw just about hit the floor when I read this. "Some" means just a few, but there is clear evidence that this class of drugs can be tied to the deaths of between 5,000 to about 7,000 people. Zyprexa alone is believed to be responsible for the deaths of 3,455 people, according to an FDA document. Taken together, the number of deaths caused by the atypicals exceeds those caused by Vioxx, generally considered one of the worst drugs in recent history for causing deaths of patients.

To describe the deaths caused by the atypicals as "some" is a flat-out error of fact or a wild distortion of reality, one the magazine should address in an appropriate fashion.

What's more, there is a curious omission in how the author characterizes Lilly's various legal settlements, including last month's $1.4 billion settlement with the feds and more than two dozen states:

"Lilly has already agreed to pay $2.6 billion to settle charges that it built the market for Zyprexa first by concealing its side effects, and then by marketing it 'off-label,' for diseases for which it had not been approved."

There is no mention of the fact that last month Lilly, as part of its settlement with the feds, agreed to plead guilty to a criminal misdemeanor charge. Pharmaceutical companies--like corporations in general--almost never plead guilty to anything and it's odd that RS would fail to mention this fact, given the rarity of such a plea and given the right of RS's readers to know the full scope of sanctions Lilly has faced to date over its handling of the drug.

Wallace-Wells makes much hay throughout the article that rules changes at the FDA over the last two decades and particularly under the recent Bush Administration worked to help make the Zyprexa scandal possible. While the FDA's laxity didn't help matters, it's an easy out to hang this on the agency when thousands of psychiatrists knew about problems with Zyprexa and how Lilly was marketing the drug and did very little to warn the public or alert the media to these problems.

While I have some thoughts on places in the article where Wallace-Wells' writing reflects information I gave him in an interview last August and where it's fairly obvious to me he's using documents and evidence obtained from this site, I'll leave my critique at the above.