Big Pharma on the Hill: Still Plenty of Clout

A recent Senate committee action gives us a chance to see how Big Pharma is doing these days in terms of political clout:
http://www.mynorthwest.com/?nid=21&sid=348660

This ought to be one of those no-brainers--should we continue to allow the brand name drug companies to employ a loophole in the generic drug laws, and pay off generic drug companies not to compete with them by bringing their alternative drugs onto the market as soon as the law allows? It's estimated that the big companies take us for $3.5B/year through this ploy, called "pay-to-delay."

Sen. Herb Kohl, D-WI, co-sponsor of the Sunshine Law to require disclosure of drug industry payments to physicians, authored the measure to close this loophole. It passed the Senate Appropriations Committee.

It's interesting to see how close it came to not passing. Sen. Arlen Specter, D-PA, who until recently was an R instead of a D (and who has lost his primary bid to stand for re-election), started the bidding for Pharma by introducing an amendment to strike this provision from the larger bill of which it is part. The AP reports that the drug lobbyists who filled the audience thought they had it made when they picked up four Democratic votes in Specter's favor, including Frank Lautenberg (D-NJ) and Barbara Mikulski (D-MD), both representing states with a lot of drug-related jobs. The drug lobby figured it had all the Republican votes on the committee in their back pocket.

They were thwarted, however, by Richard Shelby, R-AL, whose vote on Kohl's side deadlocked the panel at 15-15. As a majority vote was needed to kill the Kohl provision, the industry's move failed.

Bottom line: In the Senate, the drug lobby can commandeer virtually all the Republican votes and usually also enough Democratic votes to get whatever they want.

What's Playing in Peoria? Commercial Influence over CME Is Alive and Well

One problem I continually run into as an academic-type physician is to get a fix on what's happening out there in the "real world." We've seen on this blog recently how if one only looks from the vantage point of the ivory tower, it would seem as if pressure is mounting to free continuing medical education from commercial influence. Authoritative groups such as the Institute of Medicine have called for a complete rift betwen CME and industry funding:
http://brodyhooked.blogspot.com/2009/05/iom-report-on-coi-yes-we-really-mean-it.html


The real-world perspective was brought to my attention today by some colleagues who have been pioneers in creating CME venues that support themselves completely with registration fees and accept no industry cash. Names will be changed to protect the guilty, so let's just say we are going to talk about a certain state-level medical specialty society in an unnamed state.


My friends had entered into some discussion with that state society to see about offering their CME program in connection with a society meeting. There was some hemming and hawing--amidst profuse expressions of approval for the excellent way that the CME program had been organized and its superb content. When they asked folks to please fish or cut bait, they were able to get the following statement from a Deputy Executive Vice President of the organization: "I can't say 100% no, but I seriously doubt we can use this format for our annual meeting. We use our meeting to launch many of our national initiatives, and they all have commercial support. If we were to use this format/meeting, it would have to be at a different time of year, and I do not think that's an option for us right now. Will chat with X about this...but don't get [your] hopes up."


Reading just a bit between the lines, somebody else involved in the negotiations translated the above as: "They won't offer a good course with proven reviews because they risk offending their commercial support?"


So from one vantage point we seem to be making real progress. From another vantage point, not only can we not get rid of commercial report for CME and other medical organization "initiatives," but we cannot even offer a commercial-free CME program at the same time as the meeting where the commercial folks show up, lest the commercial people take offense.


All of this led one of the parties to this discussion to conclude: "I don't know how we ended up in such a sleazy business."


Deja Vu All Over Again Department: Did you think you heard this story somewhere before? Well, you did. A few years ago, as I described in HOOKED, Dr. Bob Goodman tried to purchase display space in the annual meeting exhibit halls of both the American Academy of Family Physicians and the American College of Physicians, to set up a table for his "No Free Lunch" campaign and distribute buttons. Both groups initially refused to allow him into their exhibit halls, obviously out of fear that he'd offend the really well-paying customers.

Still Awaiting an Academic Physician to Suffer Consequences for Ghostwriting...

A plaint that regular readers of this blog have now heard several times: when is an academic physician going to suffer any bad consequences as a result of being exposed as having been the putative author of a ghostwritten article? When is one of our great academic medical centers, that huff and puff about how unethical ghostwriting is, going to prove it actually means business?

Just maybe we are a step closer.

A story was unfolding right in my own Texas back yard, which i was unaware of till tipped off by the redoubtable duo of Jonathan Leo and Jeffrey Lacasse, who have continued their anti-ghostwriting crusade in the Chronicle of Higher Education:
http://chronicle.com/article/GhostwritingAcademic/123613

Not much new ground was covered in that article, that we have not already looked at previously:
http://brodyhooked.blogspot.com/2010/02/ghostwriting-academic-medical-centers.html

However, they mentioned in passing that on July 12, Dr. Steven M. Haffner was accused in a letter from the U.S. Senate Finance Committee (read: Sen. Charles Grassley, R-IA) of having allowed his name to be placed on a ghostwritten article at the behest of GlaxoSmithKline, in that instance about Paxil. According to Sen. Grassley's folks, Haffner was a part of the CASPPER program revealed in internal GSK documents released by litigation, the program that won the award for "cute name" after it was edged out in the "professional ethics" category:
http://brodyhooked.blogspot.com/2009/08/friendly-ghosts-why-should-academic.html

Hmm. Steven Haffner--where have we heard that name before? Sonofagun--that was the same guy who leaked the Nissen-Avandia research manuscript to GSK, in violation of the New England Journal's editorial policies (and all professional ethics):
http://brodyhooked.blogspot.com/2010/02/avandia-story-failures-of-regulation.html

Putting all that together led in turn to a recent article in The Daily Texan:
http://www.dailytexanonline.com/content/former-professor-faces-allegations-avandia-case

--and Ed Silverman at the Pharmalot blog:
http://www.pharmalot.com/2010/07/baylor-college-probes-avandia-and-ghostwriting/

--and finally an article by Paul Basken in Chronicle of Higher Education, July 16 (subscription required). Interestingly, neither the Chronicle nor the Daily Texan connected the dots; each reported the ghostwriting claim but not the NEJM leak.

What can we learn from all of this? The following seems to be the overall chronology based on what's been made public:

• 2007: Dr. Haffner is on the faculty at University of Texas-San Antonio medical center. If you Google him you'll see right off the list of drug companies for whom he's a paid speaker and consultant. Being a GSK paid consultant, one day after being sent the manuscript of Nissen's paper on Avandia by the NEJM, he faxed a copy of the "confidential" manuscript to his pals at GSK.
• 2008: Brian Vastag writes about the Haffner case for Nature (see: http://brodyhooked.blogspot.com/2010/04/should-drug-companies-censor-medical.html). Haffner tells Vastag he's really sorry for the slip-up; he was not feeling well that day and he made a bad decision.
• 2008-2010: There is some muffled noise about both NEJM and UT-San Antonio investigating Dr. Haffner for this breach of editorial ethics. If there is any outcome, nobody says anything.
• 2009: Dr. Haffner "retires" from UT-San Antonio. Possibly this has something to do with the above investigation? If so nothing is said.
• 2009: Baylor College of Medicine in Houston hires Dr. Haffner as a part-time assistant professor. A Baylor spokesperson, in the context of the more recent flap, says that Baylor knew about the NEJM leak matter when they hired him and accordingly, hired him only part-time and only for limited activities related to his special expertise in clinical epidemiology of cardiac risks. Here we have some evidence of real consequences, even if people are not saying why. At San Antonio, Haffner had apparently held the rank of (full) professor, having been on their faculty since 1981. To be hired on by Baylor at the rank of assistant professor would seem like a pretty severe slap in the face.
• July 2010: The Grassley subcommittee accuses Haffner of ghostwriting, and Baylor says it will investigate. (GSK, as you'd expect, claims that Haffner "contributed substantially" to the article he was said to have ghostwritten and so no ghostwriting occurred.)

So there is at least a chance that up to this point, Dr. Haffner has actually suffered some significant consequences; and there's a fair chance he stands to suffer more. In which case he'd be first case I know of that we can report thusly.

A personal disclaimer: some might imagine that I get my jollies from berating and outing my fellow academic physicians, not to mention those who are fellow members of the U-Texas System faculty. The fact is that any such naming of names is extremely distasteful and I wish I could see my way clear to avoiding this aspect of the whole mess. Why can I not see my way clear? Because if the root problem is that people engage in these unethical actions but nevertheless advance in their climb up the academic ladder; and in academe, one's good reputation is the main coin of the realm; then if you are not willing to name names, you are unfortunately perpetuating the very problem you seek to ameliorate. I heartily wish it were otherwise.

AAFP and Coca-Cola, Continued: How I Just Spent $100

Let me recommend to you that you consider spending a bit of your own money in the way that I just spent $100.

I received an e-mail from Richard Bruno, med student, Class of 2013, Oregon Health & Science University. He responded to my recent published commentary on the AAFP-Coca-Cola controversy and added that he was a member of a group of students, representing a number of medical schools, that are planning an action at this weekend's meeting of students and residents interested in Family Medicine at the AAFP headquarters in Kansas City. He asked me to donate $100: "Specifically we want to set up a table, pass around a petition, have buttons and stickers, and have people sign postcards that we will send to the AAFP board of directors. We are very passionate about ending this conflict of interest and exploring healthier partnerships for the sake of our members and our future patients....$100 could provide us with 300 postcards, 100 buttons, and 100 stickers to pass out at events and at a table."

When I replied to indicate my interest, he informed me of two ways to get him the money: 1) send a check to Richard Bruno, 2164 NW Aspen Ave, Portland, OR 97210; or 2) send the money via PayPal to rabruno@gmail.com.

Now, I am an old-fashioned skinflint, and generally parting with a hundred bucks would not leave me in a good mood. So why am I so upbeat about this particular expenditure? First, I am quite impressed (as readers of this blog know) at the immense power that med students have exerted in the conflict-of-interest debate generally, as evidenced most impressively by the AMSA Pharm-Free campaign and their brilliant PR ploy of "report cards" giving med schools failing grades if they allowed too much coziness with the drug industry. I can testify as to how much stock AAFP puts in the student/resident contingent, as that is the entire future of our specialty, so these folks can get the attention of the AAFP leadership in a way that old fogeys like me never could. Finally there is the donation multiplier effect of the fact that med students work incredibly cheap. A dollar donated to a student group goes a long way farther than a dollar donated to a group of, well, people like me.

So go get 'em, Richard and friends, and let this blog hear from you how the meeting goes in Kansas City!

What's New In Pittsburgh? Current Status of Physicians and Drug Industry Cash

So--for the past few years some of us have been hammering away at why it is ethically bad news for docs to take cash from drug companies for activities such as speakers' bureaus. How are we doing? A longish report by Kris Mamula in the Pittsburgh Business Times:
http://pittsburgh.bizjournals.com/pittsburgh/stories/2010/07/26/story1.html?b=1280116800%5E3693951

--provides us with some clues.

First, Mamula is able to report payments to docs in the Pittsburgh area made by four large drug companies that either voluntarily released data or are doing so under legal pressure from litigation. It's noted that 8 other large drug firms currently have no such disclosure. The article as a whole in my view is reasonably balanced but with a slight tilt against the practice of commercially-paid speakers.

What seems to give us a clue as to the current situation is some of the comments from docs, handing out the same tired rationalizations we have been hearing for decades. Dr. Anthony Gentile, an ob-gyn and top pocketer of company funds ($89K) in the Pittsburgh area, said: ...the notion that drug companies could influence doctors’ prescribing practices [is] “total, unequivocal hogwash.” “People think we get up there to push this drug or that drug,” Gentile said. “That’s not what we do. We just say this is something you should consider. We educate, and that’s what I have a big passion for.”

From Dr. Lawrence Glad, a Uniontown-area gynecologist who came in at third-highest-paid at $74,916: “Yes, it’s promotional, but it’s educational...I think we have some critical skills for our patients beyond who bought my last bagel.”
Glad made presentations in small towns, including Parkersburg, W.Va., where doctors have few opportunities to learn about the latest developments in medicine. These aren’t people “who can walk down the hall and hear nationally known doctors,” he said. “These are people who are lucky if they can get to one conference a year.” At least Dr. Glad was willing to admit that it's both promotional and educational--that's a step ahead of the old bromide, "it's not marketing, it's education."

Said Dr. Michelle Roberts, an endocrinologist and faculty member at the University of Pittsburgh School of Medicine: she takes her teaching role seriously at drug company sponsored sessions and always receives approval from her supervisors. Last year, Roberts received $8,525 to discuss the Lilly drug Forteo, used to treat people with severe osteoporosis.
Her purpose during the session was teaching, not selling, she said.
“I’m an educator, and my role is to better educate physicians about how to care for women with osteoporosis,” she said. “I would not compromise my job or integrity to sell drugs for Eli Lilly. I’m not a puppet for the drug companies.”

Psychiatrist and Allegheny County Medical Society President Dr. John Delaney, who received $69,350 from Lilly last year, said the money he receives from Lilly doesn’t affect his prescribing practices.
“The transparency has made it look like a bad thing, but I’m not embarrassed about it. I’m a big speaker for them....You end up prescribing the best drug at the time, regardless of the affiliations you have. I think all of us feel that way.”

Unfortunately, if these local docs seem to be in denial about the likelihood that their taking company money might influence their own prescribing or the message that they "educate" about, the official policies adopted by the local medical centers seem to compound the problem. For example, the University of Pittsburgh Medical Center's conflict of interest policy says: faculty members “may participate as speakers, provided that they prepare their own content without any control or approval of the content by industry.” What the policy ignores is that any faculty who actually follow this advice are likely to be in serious hot water with the Feds. If you take money from the company, you're considered a company employee, and are bound by the same rules for what you can and cannot say in marketing a drug--especially about off label uses--as is the company as a whole. Get off message and you're likely to find yourself facing Federal criminal charges. So the idea you have have your cake and eat it too--take the money but also maintain your independence as an academic physician--is sadly mythical.

The better advice comes at the very end of the article: For many years, Dr. John Walsh, distinguished service professor of urology at Johns Hopkins Medical Institutions and a critic of some drug company funding to physicians, said he has long told students, “You can have your money or you can have your reputation, but you can’t have both.” If the remainder of the article is any indication, many docs in Pittsburgh have not yet gotten the message; and their likelihood of having gotten the message seems inversely proportional to the amount of money accepted from drug firms.

Docs for Sale: The FDA Advisory Panel on Avandia

Thanks in part to Postscript, I was guided to two articles by Alicia Mundy in the on-line Wall Street Journal:
http://online.wsj.com/article/SB10001424052748704720004575377552600421936.html
http://online.wsj.com/article/SB10001424052748704723604575379292803755042.html

It appears this story has kept investigative reporter Mundy quite busy in the wake of last week's FDA advisory committee hearings on Avandia. Most of you know from the popular press that the committee voted 20-12 to keep Avandia on the market, though 17 of the 20 favored stronger warning labels or other measures to restrict use of the drug.

First Mundy found out that Philadelphia endocrinologist David Capuzzi, who was one of the three lonely members of the committee to give Avandia a free ride (keep it on the market without any extra warnings), had received $14,750 as a paid speaker from Avandia's manufacturer, GlaxoSmithKline. He argued that he had no conflicts of interest because he never gave any talks specifically about Avandia; instead he spoke about a different GSK drug.

Hardly was the ink dry (metaphorically; I know nobody writes with ink anymore) on that report than Mundy was out there again telling us about Abraham Thomas, head of endocrinology and diabetes at Henry Ford Hospital, Detroit. Thomas had been one of the 12 votes for taking Avandia off the market. He'd given two talks for Takeda, the manufacturer of the diabetes drug Actos, on behalf of that drug and made $2000-3000, between 2007 and 2008. Actos is the rival to Avandia that is the drug most patients are likely to be switched to if their physicians take them off Avandia and look for a similar drug to replace it. Dr. Thomas said he told the FDA all about his Takeda money and noted that the conflict-of-interest screening he'd been put through before this committee met was "extensive."

By way of exploring the dynamics of drug company funding of medical KOLs ("key opinion leaders"), consider what Dr. Capuzzi had to say to Mundy in his own defense. First, he said that even though he had voted in the most pro-Avandia way possible on the panel, he really did not think very much of that drug. He told Mundy "he isn't a fan of Avandia and uses metformin, an older diabetes drug, in his practice." [Hooray! An endocrino9logist, finally, who actually believes that you should treat diabetes patients with a drug that has been well-documented, in controlled studies, to reduce the risks of the serious complications of diabetes; and that's available generically to boot.] So why then did he vote to be so careful not to upset Avandia's role in the marketplace? Well, he said he was worried about Actos. He's worried that the rival drug may also have safety problems, and that switching patients from one to the other would do them no good.

Now, we can note two things about this line of reasoning. First, his opinion about Actos-related dangers is definitely a minority opinion; the panel overwhelmingly voted that Actos was safer than Avandia. Second, a standard industry ploy, when your drug is accused of causing bad side effects and your previous efforts to ward off attention to those effects have all failed, is that as a last-ditch effort you try to claim that so what, all the rival drugs cause the same risks. (That's why we now have a totally ridiculous warning label on Naprosyn claiming that it increases the risks of heart disease, because that was supposed to divert attention from whether Celebrex caused almost as much heart risk as Vioxx.)

Bottom line: Can we prove that Dr. Capuzzi voted the way he did because he was paid by GSK? Of course not. Can we claim a certain association between a doctor taking money from a drug company speaker's bureau, and the doc demonstrating patterns of thought that happen to resemble how industry marketers think about drugs? You be the judge.

Bottom bottom line: What is it going to take to get my fellow physicians, when a drug company waves dollar bills at them and invites them to join the speakers' bureau, to say, "No thanks, who needs that grief"? So that when Alicia Mundy goes to write her next story about unseemly behavior among highly-regarded professionals, she has to go write about lawyers, or politicians, or somebody other than doctors?

More on the AAFP-Coca-Cola Controversy

Since last fall I have been conducting my debate with the leaders of my own medical professional society, the American Academy of Family Physicians, within full sight of the readers of this blog. I submitted a long article (just out this week) to the AAFP academic journal, the Annals of Family Medicine, explaining at some length my disagreement with the leaders' decision to accept funding from Coca-Cola for patient education materials on obesity prevention:
http://www.annfammed.org/cgi/content/full/8/4/354

Not unreasonably, the Annals elected to offer the AAFP leadership, namely President Lori Heim, a chance to respond, which she did:
http://www.annfammed.org/cgi/content/full/8/4/359

I was not able to review the contents of Dr. Heim's rebuttal until the publication date earlier in the week. I then prepared my response which I have submitted to the journal's on-line TRACK discussion feature (meaning that if there is further give and take you can follow it on the Annals website, which has free open access). As the journal has to make up its mind before they decide whether to publish my response, I append it below.

A Reply to Dr. Heim

Dr. Heim (1) takes issue with my criticism of the AAFP and its leadership for accepting Cola-Cola funding for patient education materials (2) on the following grounds: It cannot be the case that appearance of a conflict of interest (COI)—“a person’s perception of another’s behavior—even absent relevant information related to the behavior or its outcome” (1, p. 359), is ethically the same as an actual COI. It must be the case that an appearance creates nothing more than a rebuttable presumption of possible ethical misdeeds. In the AAFP’s case, the careful and responsible way that the organization went about dealing with the funds—full disclosure, demanding editorial independence, etc.—successfully rebuts any presumption of unethical action. So, in accusing the AAFP of an ethical lapse, my criticism is not suitably evidence-based (“Dr. Brody has failed to bring forth evidence that the TCCC contract interfered with the AAFP’s ability to meet its mission”; (1, p. 360)).

On its surface this rejoinder appears quite reasonable, so it will require a bit of stepwise analysis to show why I believe that it ultimately fails to prove the point that Dr. Heim wishes to argue.

In my essay (2) I offered a definition of COI: that it arises “when individuals or organizations enter into a set of arrangements which under usual circumstances would lead to the reasonable presumption that they will be tempted to put aside their primary interests…” (2, p. 355, emphasis added). If this happens, according to the definition, we have not an apparent COI but an actual COI. Notice that part of what makes it a COI is that a reasonable onlooker would reasonably judge that the arrangements entered into by the organization would normally and naturally tempt it to forgo its primary commitments (in this case, to promoting the public health). It is not enough that the onlooker has a mere uninformed “perception” as Dr. Heim puts it (1, p. 359).

The majority of the people I am aware of outside of the AAFP leadership who have heard about the Coca-Cola deal concluded immediately that the arrangement could not pass what would vulgarly be called the sniff test. That is, they decided that receiving a “strong six figure” sum from Coca-Cola would reasonably be expected to cause an organization like AAFP to deviate from its mission of strong advocacy for the public’s health. Put another way, they wondered why Coca-Cola would spend that much money to support a patient-education program that AAFP supervised. Coca-Cola is not, after all, a non-profit or a charitable foundation. One could argue that the company is obligated to its shareholders not to spend that sort of money unless they could be quite sure that something of benefit to company sales was going to result. In effect, Coca-Cola was saying through their corporate behavior that they expected commercial benefit from this deal, whereas AAFP was insisting that no such benefit would accrue and that the result would be strictly a contribution to the public’s health. The onlooker might well decide that of these two accounts, Coca-Cola’s was the more plausible.

I assert that the fact that the AAFP entered into this arrangement with Coca-Cola, when reasonable onlookers would reasonably have this reaction, constitutes an actual COI. The reason is because of the link that I described between COI and one’s ability to maintain public trust (2). By entering into this deal, AAFP knew or should have known that it was placing itself in a position where the public’s trust could easily be compromised.

To risk public trust in this fashion is to take a serious gamble. We next need to ask what prompted AAFP to take such a gamble. If the only way to secure support for patient education materials was to get the funding from Coca-Cola, then we might have a reasonable rebuttal to the charge of COI. But the AAFP has come nowhere close to showing that it had no other choices of where to raise the funds.

Dr. Heim goes on in her commentary to list things that AAFP has since said about the dangers of drinking beverages that contain too much sugar. Presumably those statements count as actual “evidence” on the basis of which AAFP should be judged, while the criticisms lodged against AAFP last fall, when the deal was first announced, count only as “early, uninformed reaction” (1, p. 360). She adds that I “[offer] no evidence of long-term harm resulting from” those “uninformed” reactions (1, p. 360).

As a long-time member of AAFP, I am frankly delighted that I can offer no hard evidence of long-term harm to the trust that the public presumably feels toward AAFP. In the past year or so we have had two examples of organizations that have discovered “evidence of long-term harm” in terms of widespread public distrust created by their actions—Toyota and BP. I presume that Toyota and BP have each discovered what most of us already know, that it takes much less time and effort to lose public trust than to regain it once it is lost.

Last fall AAFP took a gamble with its reserve of public trust by signing the “six-figure” deal with a soft drink company. So far, the gamble appears to have worked out all right. Could one have been so sure, back in the fall, that this would have been the outcome? What sort of pressing need could have justified AAFP taking this sort of gamble with its most precious resource? Since it has been lucky so far, what sorts of even riskier gambles will it decide that it can take in the future? My argument is that AAFP is ethically accountable for such decisions, and that its ethical reasons are wanting thus far.

1. Heim L. Identifying and addressing potential conflict of interest: a professional medical organization’s code of ethics. Ann Fam Med. 2010; 8:359-361.

2. Brody H. Professional medical organizations and commercial conflicts of interest: ethical issues. Ann Fam Med. 2010;8:354-358.