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 If you click on the link now, you'll find a note from the editor of STATNews explaining that the article has been retracted and providing reasons (although not a particularly in-depth explanation) for why the op-ed had been retracted.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.
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The google ad for some car company is preventing me from reading the article as it yanks me back to the top of the page every time it loops. See if you can have the scienceblogs gurus fix that, or at least shut it down.
Orac writes,
I generally like STAT (although one of its reporters doesn’t much like me any more—I won’t say who).
MJD says,
Why mention it if you won't disclose the reporter's name?
FULL disclosure is what makes the ScienceBlogs Respectful Insolence an outstanding read.
Q. Is your subconscious affecting your respectful insolence?
There is a reason why most other fields have restrictions on giving gifts to people in whose decisions you have a financial interest. The line between gift giving and bribery is quite thin, and often gets erased when there is no written rule specifying where the line is. I don't always agree with where the line is drawn (e.g., the lack of limits to donating to political campaigns), but there is always a line somewhere.
Doctors are people, too, and the ones who aren't willing to acknowledge that probably shouldn't have gone into medicine.
To reinforce your point about gifts: there's a Jewish folk tale about a Rabbi who had his garden either come in one day bringing his personal crop of figs in early.
The worker mentioned he's appearing before the Rabbi, who also served as arbitrator in local disputes, later that day and wanted to get the work in early. The Rabbi immediately assigned the dispute to another Rabbi. Ashe was listening to it, he found himself seeking all the points in favor of his worker.
His moral, as he says it, was: "see what an impact. The figs were mine. I was going to get them. He just brought them in a little early. And that small act of giving made it hard for me to distance myself from his case.
Imagine a real gift."
We are human.
Indeed. It's why charities frequently send little gifts in their solicitations, like personalized address labels or pens. Research clearly shows that the extra money used to send such little gifts more than pays for itself in increased donations. When it comes to tchotchkes from drug reps, docs frequently say things like, "It's just a pen" or "It was just lunch," but those little gifts work, even if there is only the gentlest of selling going on, because docs will remember the product and be more likely to prescribe it. We remember who was nice to us and gave us things, even years later, which is why drug reps work on medical students and residents, too.
Oh, the irony. TIME TO POST!
"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."
I can't speak for the medical field, however this is common practice in business. I have myself been the author of a number of articles (technology trade press) that were entirely ghost written. Companies really don't like their valuable people taking the time to do this when it can be done better and cheaper by others. It's a bit of a surreal experience. The hired writer interviews you (usually by conference call with the PR/marketing person) and then scurries off to do their thing. We review and edit the draft, and where necessary I have to agree with the invented quotations (yes, I would or did say this). Eventually it gets published in some trade mag that is also in on the game. Somehow no matter how educational/neutral the subject our company's products and services always seem to get mentioned.
"I do, however, expect better than this when it comes to a very basic function of journalism, disclosing relevant conflicts of interest."
Exactly. At least in my articles my title, company affiliation and area of responsibility were prominently featured. Whether any of this is unethical or at least icky was not too concerning since all our competitors did the same ("hey, I saw your article in xxx -- nudge, nudge, wink, wink"). We might even include a quote from a customer (with their agreement) that would say something along the lines of: "he's right, do you know that?"
Andrew Wakefield's argument is that you don't have to disclose financial support from vested interests unless you spend it on the article in question.
Yup. And all his slimy enablers parrot that claim.
"...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.”
I hope he means the _journal_ should do the editing and reviewing, not the industry-funded influence group. But it's hard to tell.
Orac: "...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."
Really.
There was a semi-excuse for getting briefed by drug reps in the past, when the alternative was going to a conference or spending time in class. But there's a ton of good medical CME online now (much of it free), so the excuse no longer exists.
Isn't Orac endangering his own pharma-shill money and that of regular posters, by this post?
According to some the people here are just writing what they write, because of Big Pharma money.;)
Nah. Our pharma paymasters hate people who can't hide the fact that they are shills.
justawriter: "The google ad for some car company is preventing me from reading the article as it yanks me back to the top of the page every time it loops."
Yeah, that is annoying. I just turn on "airplane mode" while attempting to read the page. Those type of idiotic ads have also shown up in ScienceBasedMedicine, but unlike here they have a "report" button.
It’s why charities frequently send little gifts in their solicitations, like personalized address labels or pens.
What's more, it's free advertising space on you, your personal letter, or workspace.
The nearer to the person or physically bigger the pharma's name, the more professionally demeaning it looks to me. Think coffee cups and scrip/note pads.
When faced with large numbers like this, dollar amounts which are so beyond my quotidian experience, I try to put them into some sort of context.
$332,294 is half as large again as my pension pot, after 30 years of work and careful saving. And I consider myself reasonably well off.
What must he have done in just four years to be worth that much to Big Pharma? How many articles has he written (or had written for him)? How many talks has he given? How many people must he have influenced?
I have no context for that.
Conference swag works on more or less the same principle: that little gift makes conference goers more likely to buy that company's product rather than a competitor's. The key difference between conference swag and similar gifts from pharma sales reps is that, if I choose to buy, I am buying stuff for either my personal use or use in my research. I am not prescribing the product to third parties who have no particular reason to know that I received a gift from the company that makes the product. The prescribing physician is supposed to take the patient's best interests into account, and those interests do not always include prescribing the pharma rep's product; sometimes a competing product is better for the patient in question.
Maybe Dr Yapundich' next article should be about the dangers that ponies present to society.
A brief online search finds numerous professional sources for information and CME credit relating to Parkinson's disease (diagnosis and treatment).
For example, there's an independent subscription service (Prescriber's Letter) that provides information on new Parkinson's drugs.
Saying you need a drug rep to brief you on new Parkinson's meds is incredibly lame.
In some ways, the whole issue of whether Yapundich was on a pharma-shill payroll is a deflection. The copy itself, per Orac's intuitive reaction, is WTF twaddle PR-flack puffery. The question is where/how STAT gets off publishing it regardless of from whence and whom it came.
My first thought is that Orac may be too forgiving in saying STAT got played. Publishers typically aren't that stupid. They usually know where this kind of thing comes from, and there's often mutual back-scratching, maybe payments even, involved in these pieces receiving a place of privilege.
My second thought though is that STAT may have inadvertently performed a positive journalistic service by publishing something this transparently puffish. All they achieved is generating a lot of publicity for the underhanded shenanagins of pharma shills. One set of shills (AIPA) pimping for another set of shill (office visit sales reps). Barf. I believe quite strongly it's a legitimate publication activity to publish material from certain legitimated quarters so readers can see for themselves how much the BS being spread stinks. A sort of milder 'quote without comment' version of what Orac routinely does here. STAT's a magazine, yes?, not a refereed science journal where publication carries a warrant of editorial vetting and endorsement.
The problem is that few if any publications that now and then intentionally publish stuff because it's bad are clear and open about that, and typical readers assume that anything that appears in a publication does carry a seal of institutional approval. An exception is that savvy readers typically understandt that well-known opinion columnists speak only for themselves: a newspaper may carry both Paul Krugman and Ann Coulter, and since it's obvious the editorial staff can't agree with both of them, most readers get that the editors may not agree with either of them. From the editors' point of view, the same probably ought to be true of one-off op-ed pieces. But, truth to be told, these typically are weighted at least in favor of stuff the editors find some points of agreement with, and the vast majority of readers don't distinguish between these pieces and the official editorials that appear under the masthead.
STAT surely seems to think they donated a chunk of their own legitimation to blatant AIPA propaganda by virtue of the fact they're now trying to pretend the whole thing never happened. This, to me, is their great sin here. One difference between opinion and propaganda is that the first is an exchange of dialogue and the second is in unanswered monologue. There was nothing inherently wrong with STAT running "How pharma sales reps help me be a more up-to-date doctor." But to make that OK, to retain journalistic credibility, STAT needed to place it a context where the possibility that it is just crap could be entertained. By "circling the wagons" they're doing just the opposite.
Oh, dearie, dearie, me. I hope that "new medication data" has been run through the pharma company's science, legal, and compliance divisions before the rep started talking about it.
I've gone through pharmaceutical company compliance training, and reps are not supposed to just spout off about the latest studies until every word has been vetted by the company (and the FDA).
Also, you can't even give stress balls or pens away anymore.
Oh, c'mon--it's just a few hundred thousand COI dollars that wasn't disclosed by Yapundich. It wasn't like it was a much as the $500k+ that Andrew Wakefield failed to disclose to Lancet in COI money.
Heheh.
A few years ago Nature accepted sponsorship for a Special Issue from Saisei-Mirai, a Japanese chain of cancer-exploitation scammers. "Its research activities have contributed significantly to the clinical application of new cancer therapies."
http://web.archive.org/web/20150218052643/http://www.nature.com/nature/…
The package deal included the publication of a 5-page advertorial about their scammocopoeia of fraudulent 'treatments' (hyperthermia, Coley Vaccine, GcMAF, stem cells -- for some reason the advertorial didn't mention Laetrile).
http://web.archive.org/web/20150217214905/http://www.nature.com/nature/…
With Nature pimping themselves out to out-and-out cancer fraudsters, astroturfing seems almost benign.
@ HDB
I am wondering whether paying for an advertorial in Nature helps for having a scientific paper considered by the editors.
Pot, meet Kettle.
Ooh, that's going to leave a mark.
Not exactly a thesis statement, is it? ;-)
Ouch.
[youtube https://www.youtube.com/watch?v=Tf5YGlGOWZs?rel=0&w=420&h=236]
Reminds me of a joke:
What is the difference between a drug rep and a lawyer?
Well don't leave us hanging, captian_a. Tell us the punchline.
The lawyer knows when they are lying to you.