As a medical blogger with a skeptical bent and a rather aggressive proclivity towards defending science-based medicine, I generally like STAT News. Sure, it’s occasionally screwed up royally (e.g., its credulous false balance reporting on a patient of cancer quack Stanislaw Burzynski named Neil Fachon), but in general it’s usually a good source of medical news and analysis. No publication is perfect, of course, but STATNews is generally better than average, and I appreciate that.
That’s why I was disappointed to see how thoroughly a pharma-backed astroturf group whose mission is to loosen restrictions on physicians interacting with drug companies played STATNews last week and how long it took STATNews to do something about it. The screwup began last Friday, when STATNews published an op-ed by a physician named Dr. Robert Yapundich entitled How pharma sales reps help me be a more up-to-date doctor. No, that’s not a joke. That’s actually what the title of the op-ed was. If you click on the link now, you’ll find a note from the editor of STATNews explaining that the article has been retracted and providing reasons (although not a particularly in-depth explanation) for why the op-ed had been retracted. However, the almighty Wayback Machine will show us why, when I saw the article over the weekend, my first reaction, was “WTF?” but why the whole op-ed stunk to high heaven and set my skeptical antennae twitching furiously. (I note that I was not alone.) However, I didn’t write about it until things blew up yesterday with revelations that were very embarrassing to STATNews, particularly about the undisclosed conflicts of interest on Dr. Yapundich’s part and—surprise! surprise!—ghostwriting.
First, let’s take a look at the offending article, with the help of the Wayback Machine. Dr. Yapundich notes:
As a neurologist in practice for more than 20 years, I have experienced many changes that regulate and limit the drug industry’s interaction with physicians and other health care providers. These changes are aimed at preventing companies from having undue influence on physicians.
Correct. Dr. Yapundich even seems to concede that it’s a good idea to prevent pharma reps from having undue influence over doctors. But in the op-ed he soon expressed “worry” that “lawmakers could eventually implement further restrictions on these interactions that could de facto ban communications between pharmaceutical companies and doctors.” Personally, I’m not sure that that would be such a bad thing, but clearly Dr. Yapundich thinks that it would be, were such a ban ever to occur. Personally, I also highly doubt that such a complete ban would ever be instated, much less enforced. Be that as it may, Dr. Yapundich seems to fear such an eventuality. Why? He seems to think that drug reps are necessary for doctors to keep pace with the fast-changing world of health care and new drug treatment recommendations:
Many doctors find it difficult to keep pace with the breakneck speed of research and development. With more than 7,000 new medicines in the pipeline, treatment options are constantly expanding. In 2016, U.S. authorities approved 46 new medicines for sale.
Unaware of the latest treatments, many doctors stick to their old prescription patterns. That can lead to people not getting the best medications for their illnesses. By one calculation, the average American patient fails to receive the recommended drug in nearly one 1 of every 3 doctor visits.
Drug company representatives can provide doctors with vital nuggets of information on the latest treatments while preserving their freedom to treat patients as they see fit.
He even used an anecdote about how a drug rep told him about a new drug to treat Parkinson’s disease psychosis. (More on that later.)
I can’t speak for my fellow physicians, but my response to this sort of twaddle is that if you can’t find other ways to keep up with the medical literature other than meeting with drug company reps whose job it is to persuade you to prescribe more of their product and to choose their products over those of competing drug companies, you really should reassess your continuing medical education strategy, particularly in the age of the Internet. I’m not one of those who argue that doctors should never have contact with pharma reps, but, come on! These are not physicians. They might not even have a science background. There are better sources for information.
Also, doctors seem to have a rather arrogant belief that their judgment is not affected by gifts that drug companies love to lavish on physicians. It is a truly arrogant view that ignores huge amounts of social science and psychology research that shows that even relatively small gifts can influence behavior subconsciously. Yes, we are social apes, and we feel a powerful urge to reciprocate. It’s the reason why charities, for instance, will frequently include little gifts in their mailings soliciting donations. People feel very guilty accepting even tiny gifts without some form of reciprocation. It’s our nature. I get really tired of hearing my colleagues opine about how they are not at all influenced by drug company gifts. I really have to bite my tongue sometimes, rather than doing what I really want to do and responding, “Bullshit!” They really believe that, but I know they’re basically deluding themselves, which is why it irritates me so much to hear them self-righteously proclaim that they could never, ever be influenced by such trinkets.
Of course, the real point Dr. Yapundich is getting at is something that his pharma paymasters (oops, did I spill the beans?) want so, so badly:
Doctors benefit from hearing about such off-label uses, as they inform doctors about alternative uses of medications. However, existing law essentially bans industry reps from discussing off-label uses — even those that are widely popular in the medical community and proven to be effective and safe. Preventing sales reps from mentioning these uses can be detrimental to patients, especially considering that some conditions have no FDA-approved treatments. In these situations, off-label uses can be doctors’ only option for prescribing. Patients would benefit from having physicians be as informed as possible about effective off-label uses.
Off-label prescribing, of course, is a major part of medicine. Drugs are frequently used for indications for which they are not FDA-approved, because once a drug is FDA-approved for one indication it can be used for any indication. Not infrequently, there is evidence for the use of a given drug for an indication other than the indications for which it was approved by the FDA. Physicians thus have the freedom to prescribe drugs off-label when they see fit, based on their evaluation of their patients and interpretation of clinical trials. It’s part of our professional judgment and obligation. However, drug companies have a vested interest in promoting off-label use because it improves their bottom line. Also, why bother going through the tedious and difficult process of applying to the FDA for approval for a new clinical indication when the same thing could be accomplished by persuading a critical mass of doctors in the relevant specialty to use their drug for a non-FDA-approved indication? There’s a reason why it’s illegal for drug companies to advertise off-label uses for their drug. If they could do that, then all they would have to do is to get their drug approved for one indication and, instead of relying on physicians interpreting the evidence to start using their product off-label, they could promote such uses themselves, even if the drug hasn’t yet been approved for that indication or if the evidence for the off-label use is not that strong.
Even in the original iteration of this article, there was a major red flag in the bio of Dr. Yapundich:
Robert Yapundich, M.D., is a neurologist practicing in Hickory, N.C., and a member of the Alliance for Patient Access. The alliance supports regulations that expand manufacturers’ ability to discuss off-label uses, particularly those that are accepted in compendia and practice guidelines or reimbursed by the government and insurers.
So Dr. Yapundich is a member of a group that supports expanding manufacturers’ abilities to discuss off-label uses. That’s bad enough. However, not long after STATNews published his op-ed, Twitter erupted:
might want to disclose that author has been paid $200k+ in last 2 years https://t.co/QnmU27SPZ7 https://t.co/DMJgJ69yrl
— Zach Brennan (@ZacharyBrennan) September 1, 2017
And:
This pro drug rep article fails to mention the author received 134K in pharma payments in 2015. Disgusting!https://t.co/lFHjBaFNu7
— Stephen Popovich (@sjpopo) September 2, 2017
It’s actually worse than that. It turns out that Dr. Yapundich received $332,294 between 2013-2016 from pharmaceutical companies, which was not disclosed in the original article. That’s a pretty impressive lapse, don’t you think? Funny how he somehow forgot to disclose that or didn’t think it important:
As a matter of policy, we ask all our contributors to disclose payments from industry and other possible conflicts of interest. In this case, the author disclosed no conflicts other than his affiliation with an organization that supports expanding manufacturers’ ability to discuss off-label uses of drugs. In response to reader questions, we contacted Yapundich and he told us he had received more than $300,000 in recent years from pharmaceutical companies, including one he mentioned in the article. He also acknowledged that his organization was funded in part by pharmaceutical companies. We disclosed that information at the bottom of the article on Tuesday.
I’m not the sort who argues that physicians should never meet with pharmaceutical company representatives and salespeople, although personally I do try to keep my contact with them to a minimum. Occasionally, I’ve even gotten useful information from them, but I can’t recall a time when it was anything I wouldn’t have soon learned for myself another way. STATNews’ misstep was on another plane entirely. Here we have a physician who belongs to a what looks all the world to me like an astroturf group funded by pharma whose purpose is to lobby and do PR for loosening restrictions on pharmaceutical companies discussing off-label uses of their products.
That new addendum/disclaimer was the only change made; that is, until sometime yesterday afternoon, after the other shoe dropped in the form of an article by Kevin Lomangino at HealthNewsReview, ‘A blow to [STAT’s] credibility’: MD listed as author of op-ed praising drug reps didn’t write it. Ghostwriting/PR influence. Lomangino interviewed Dr. Yapundich and discovered that he didn’t write it. He contributed to it after a draft had been presented to him, but:
Here is Yapundich’s account of how the events surrounding the op-ed unfolded:
- The concept for the STAT article, as far as Yapundich knows (although this hasn’t been verified), came from the Alliance for Patient Access (AfPA), a physician group whose stated mission is “ensuring patient access to approved therapies and appropriate clinical care.” The group is supported financially by nearly 30 pharmaceutical companies.
- Yapundich is on the board of AfPA, and his membership is disclosed in the STAT piece. He says a staff member from the organization initially approached him about getting involved with the op-ed. The premise — “How pharma sales reps help me be a more up-to-date doctor” — is something Yapundich says he agrees with passionately. It didn’t take much convincing for him to decide to participate.
- Yapundich stated clearly that he did not write the initial draft of the article and doesn’t know who did. He said he “agrees with the spirit of the article” and “wouldn’t have put his name to it” otherwise. “AfPA sent me an initial draft that they composed, I made some changes and edits to it, and the process went back and forth for about a month until it was published,” he said.
That’s when the problems began in earnest.
As we reported earlier this week, Yapundich received more than $300,000 from the drug industry between 2013 and 2016, according to the federal Open Payments database. And yet disclosure of that conflict of interest was initially missing from Yapundich’s op-ed; it was added only after an outcry in the comments section of the STAT piece and on Twitter.
So, not only was the op-ed published without a complete accounting of Dr. Yapundich’s conflicts of interest, but it was ghostwritten, and the anecdote he told about finding out about a new treatment for Parkinson’s disease psychosis was, to put it kindly, embellished:
“It didn’t come out the way I intended it to,” he said, speaking of the op-ed that carried his name. “The article made it seem like I’d never seen the drug before and that was not what I intended.”
He told me he was well aware of the drug at the time of the encounter with the sales rep, and that the rep had said something interesting about the drug — “new medication data,” Yapundich called it — that “set off a light bulb” in his mind and subsequently led to the positive patient encounter.
“I hope there aren’t other parts of the article that escaped my editorial oversight or review,” Yapundich said. “The next time I do one of these op-eds, I should be the one doing the drafting and they should be the ones doing the editing and reviewing.”
Ya think? That is so obvious that it’s amazing that Dr. Yapundich needed to be publicly embarrassed by being called out for his failure to disclose how much he benefits from pharma payments. Indeed, his contortions on the issue are epic:
Yapundich says he understands the importance of such financial disclosures and that the omission was unintentional. It resulted from miscommunication with AfPA and uncertainty regarding the disclosure requirements.
“In regards to COI, I’m not sure what is needed,” he recalled writing to his AfPA liaison. “Do you need the company names? Which years? What type of COI?”
His contact reportedly wrote back: “Hold on financial info. Hopefully only needed for AfPA and not for you individually.”
That’s the last Yapundich heard about the disclosure issue until STAT called him to clarify, he says.
Bloody hell, this is disingenuous. If you receive over $300,000 from pharmaceutical companies over the last 3 or 4 years, you should disclose it. You don’t have to name the companies. It’s clear that AfPA thought it could hide just how beholden to pharmaceutical companies Dr. Yapundich is by rolling it all into itself and having him disclose only that he belongs to the AfPA. Of course, most people are not going to look into the AfPA more, and the vague explanation that it promotes more discussion by pharma reps of off-label uses doesn’t tell the whole story in a way that communicates the magnitude of the COI.
Then, of course, there is the involvement of Keybridge Communications, who’s just as vague about its explanation for the lapse in full disclosure of COIs:
His explanation of the financial disclosure confusion appears to cast blame on STAT for not being thorough enough. But it may also reflect failure to respect accepted standards for acknowledging conflict of interest.
“As you know,” Snyder wrote, “Dr. Yapundich has many relationships with the pharmaceutical industry. This is no secret; the relationships are publicly detailed here. We didn’t send this along as we were under the impression that the editor was asking about the Alliance for Patient Access, and Dr. Yapundich wrote the piece in his capacity as a member of AfPA.”
Yes, there is blame to be placed on STAT, but Mr. Snyder is being quite disingenuous here. Keybridge Communications is a PR firm that touts its goal as “to get your message in front of your target audience, whether it’s influencers and consumers or lawmakers and voters, noting that opinion media “drives the public debate – and enables our clients to expand their footprint, sway attitudes, and achieve their strategic goals.” In other words, it tries to get op-eds published in high profile outlets like STAT in order to promote its clients’ message. I don’t believe for a minute that Keybridge doesn’t know what was being asked when STAT asked for relevant COIs or that it didn’t know damned well that its response would hopefully placate STAT without revealing the hundreds of thousands of dollars that Dr. Yapundich had received to be a pharma shill. (Yes, he is a real pharma shill, unlike the pharma shill accusations quacks and antivaxers frequently level at skeptics.)
Unfortunately, STAT fell for it. Even more unfortunately, STAT appears to be circling the wagons more than it should. Lomangino notes that when he raised his detailed concerns with the editors of STAT they declined to offer a detailed response or even to “make an attempt to investigate further and get back to me.” According to Lomangio, STAT told him, basically, he was “welcome to do that” himself.
I agree with Lomangino that op-ed contributions are not news pieces and therefore that op-ed writers should have more latitude. They are, after all, writing opinion pieces. Unfortunately, at the time this op-ed was published, STAT’s vetting procedures were so lax that they allowed a ghostwritten puff piece (as Lomangino put it) by a pharma-funded astroturf group and distributed through its PR company. Yes, I know that a lot of legitimate op-ed writers have PR companies getting their offerings published in newspapers, magazines, and online outlets, but it should be possible to make it more difficult for companies to get ghostwritten articles published. In this case, a few simple searches on Google and a couple of relevant websites (e.g., the Open Payments database) would have revealed that Dr. Yapundich wasn’t disclosing everything.
As I said, I generally like STAT (although one of its reporters doesn’t much like me any more—I won’t say who). It was a welcome addition to health reporting. It’s not perfect, and I don’t expect perfection. I do, however, expect better than this when it comes to a very basic function of journalism, disclosing relevant conflicts of interest.
