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Drugs and Devices

June 2012, Volume 48, No. 6

Money & medicine 

Interview with Jerome Kassirer

 

 

SIDEBAR
'Take 1,600 of these and call me in the morning'
by Matthew Malamud

Big pharma representatives often sell more than the newest drug or latest medical device—they also peddle influence by offering physicians financial enticements to prescribe their drugs, participate with a speakers’ bureau, or sign a ghostwritten article. Dr. Jerome Kassirer, distinguished professor and senior assistant to the dean at Tufts University School of Medicine in Boston, witnessed these abuses firsthand.

A strong advocate of professionalism in medicine, Kassirer served from 1991 to 1999 as editor-in-chief of the New England Journal of Medicine. He has written extensively on ethical scientific conduct and the dangers of physicians’ financial conflicts of interest. His acclaimed book, On the Take: How Medicine’s Complicity With Big Business Can Endanger Your Health (Oxford Univ. Press, 2004), provides an eye-opening exposé of big pharma’s influence on physicians. He talked with Trial Associate Editor Steven M. Sellers about this worrisome mix of money and medicine.

Q: You have long criticized the influence of pharmaceutical industry money on physicians. What has changed since you wrote your book?

A: I first began to be interested in financial conflicts of interest in 1993 when I was at the New England Journal of Medicine. By the time I wrote the book in 2004, I thought things had gotten worse. They had gotten to the point where a large fraction of doctors—and even a large fraction of academics—were engaged in some way with the industry. I thought this was an important factor in what was beginning to be a feeling by the public that they couldn’t trust the profession and, in some instances, where they couldn’t trust their doctors.

By the time I wrote my book, I was deeply concerned about the profession and worried that trust in medicine had eroded quite substantially. Since then, we’ve learned more about the extent of physicians’ involvement. There were two surveys done in 2007: A population survey of doctors of the American Medical Association showed that a large fraction of those doctors had taken things from industry.1 Sixteen percent of a random sample were receiving personal money for service on speakers’ bureaus and 18 percent were receiving personal money for consulting with industry.

There also was a survey of academics, and it turned out that almost two-thirds of department chairs had some form of personal relationship with industry and almost all of them believed that it didn’t influence what they did.2

Now there’s a lot more research by psychologists and sociologists about conflicts of interest, and the general conclusion of that research is that even though people believe they are not influenced by money, the overwhelming data show that they are. And they are influenced in ways they don’t even appreciate. That is, a lot of this is not a conscious thing; it’s not that people are greedy. The evidence is really quite clear that money has a major influence on decisions doctors make.

Q: What was your first experience with pharmaceutical company influence?

A: When I was an assistant professor, I was asked by the company that makes Lasix to give lectures. They left me alone and they paid me well.

They let me talk whenever I wanted to and when they realized I was a pretty good talker, they invited me to come to Madison Avenue to learn how to give talks and make ­videos. So I went and learned how to emote in front of a camera, and they said, “Now you’re ready to go out and give more talks for us. All you have to do when you give these talks is mention this product, Lasix, once.” That was news to me! So I said, “I don’t do that,” and my talks pretty much evaporated after that.

Q: What about when you were a practicing physician?

A: When I was practicing nephrology, I refused to see drug reps. I just wouldn’t see them because I didn’t need them. I got my information about new drugs from the medical literature.

Q: Don’t physicians need information about new drugs that may help their patients?

A: There are enormous numbers of websites where you can get information about drugs. You don’t need a drug rep to do that. You can go to the FDA website, and there are some terrific websites at the National Institutes of Health that cover all kinds of illnesses and all kinds of drugs. I go to them myself. And there are other aids, such as the online medical dictionary, that have all kinds of information on drugs. And there’s a publication called Medical Letter that has a lot of very useful information about drugs and side effects. You don’t need to see a drug rep to learn about new meds.

Q: A health care industry survey released in 2010 reportedly found that at least 20 percent of physicians refused to meet with drug company sales representatives at their offices.3 Are physicians rejecting hard-sell tactics?

A: There are a couple of things physicians are really aggravated about. One is the intrusion of drug reps who make their bonuses based on the number of times they actually encounter the doctor, not just the doctor’s staff. The second thing is that drug companies know exactly what they’re prescribing. The pharmacists are selling that information to the drug companies, and the drug companies know whether the doctor is prescribing the drug that they’re pushing. They know they can influence the doctor through these meetings or gifts or whatever. I think there is a backlash against the industry, but I don’t think it’s strong enough.

The other thing that’s happening is that many academic physicians are now much more reluctant to be engaged with the industry than they were before, especially with respect to consultations, meetings, and speakers’ bureaus, because they have to disclose these relationships, and that’s a good thing.

Q: As a former editor-in-chief of the New England Journal of Medicine, you’ve repeatedly criticized ghostwriting (articles written by industry representatives but bylined by physicians) in medical journals. Would you be a medical editor today?

A: I guess the answer is yes. I really enjoyed being a medical editor. It was a terrific job. I do worry a lot about ghostwriting, much more than I did when I was the editor there. When I was editor, I published one of the first exposés of ghostwriting that was submitted by Troy Brennan, who was then a health policy researcher at Harvard, and, quite frankly, we had no idea how extensive it was at the time. I’m sure people still don’t have any idea how extensive it is. My guess is that physicians will be a little more reluctant to sign their names to papers they had nothing to do with now, but some of them would be influenced by the money, I’m sure.

So I’m still worried about ghostwriting; I’m concerned that there’s more of it than we know about. We just don’t have a handle on how often it’s occurring. And it’s not just ghostwriting of review articles; it’s even ghostwriting of clinical trials. If you have a clinical trial by a drug company and they turn it over to a distinguished physician and ask the physician to put his or her name on it, that is a disaster because you just don’t know about the accuracy of the data that are being reported.

Q: If a physician signs a ghostwritten medical article about a drug that harms patients, should that physician be held legally responsible?

A: I like the idea. It would be hard to discover, but if it were discovered and somebody were to be sued for it, that would be a wake-up call for a lot of people who are involved in ghostwriting.

Q: A study released by the Archives of Internal Medicine last year showed that while 88 percent of doctors and nurses believed that industry funding of continuing medical education (CME) introduces bias, only 42 percent said they would be willing to pay more for education out of their own pockets.4

A: That’s a perfect example of cognitive dissonance. They believe that they can be influenced, but they wouldn’t pay more not to be influenced.

Q: The lead researcher suggested that, without any industry funding, CME would collapse. Do you agree?

A: The industry supplies an enormous amount of funding for these professional organizations’ meetings, such as the American Heart Association, the American Gastroenterological Association, and the American Society of Nephrology. What would those meetings look like if those funds disappeared? They wouldn’t be as glitzy as they are now, they wouldn’t be like circuses, and maybe there would be better exchange of information instead of all of that glitz. I’d be strongly in favor of the industry getting out of the business of CME.

Q: You’ve said that medical schools should train doctors on how to avoid financial conflicts of interest and yet, in these economic times, it’s not uncommon for medical students to have $150,000 in student loans. How have medical schools addressed this dilemma?

A: There are more courses on ethics and conflicts of interest. But unfortunately, when students get more advanced in medical school, they see their professors giving lectures for drug companies. Everything they learned or were taught in medical school may not apply in the practical world.

Q: In the last few years alone, drug and device manufacturers have paid billions of dollars in fines and settlements for claims of fraud, off-label marketing, and regulatory violations. Do such penalties have any effect in deterring misconduct?

A: These settlements have no influence. They’re meaningless. It’s only a few weeks of income for the pharmaceutical companies at most. What happens is, they violate the law, and during the time they violate the law they sell a huge amount of their product, make a huge profit, and then give some of it back to the government, that’s all. Until somebody actually goes to jail, this will continue.

Q: There has been controversy over members of FDA advisory panels who have pharmaceutical industry ties. For example, one panel considering the safety of the birth control drug Yasmin had as many as four members with ties to the company that produces the drug. How big is this problem?

A: The FDA unfortunately still allows conflicted physicians to sit on its major panels. There was a recent article in The New York Times that showed the composition of three different panels. It showed that even some panel cochairs had financial conflicts of interest. I believe it’s a bad idea to have them there, so I’m all in favor of trying to clean up those panels and to find people who don’t have financial conflicts of interest.

The issue with experts on these ­panels is very similar to the issue of finding­ experts to write articles in journals. When you look around at the top experts, almost all of them have financial deals with drug companies that make the drug that’s being discussed. The problem in putting a panel together is to dig deeper and find people who are just as expert but don’t have financial conflicts. It’s harder to do that, but it’s something these organizations have to do. And that’s not only the FDA panels, but also the panels that create clinical practice guidelines for some of the professional organizations, like the National Kidney Foundation.

Q: What role should the government play when physicians have financial conflicts of interest?

A: I was leery about the government getting involved because I felt the first line of defense should be the profession. The medical profession should be responsible for addressing this problem and turning it around. I wrote in my book that government would not be the best organization to make recommendations or changes because it generally does so with a pretty heavy hand. But that didn’t hold because the profession never stepped up—at least not enough. But the profession did a few things that I think are very interesting.

First of all, the Institute of Medicine published one report5 on financial conflicts of interest, and the Association of American Medical Colleges published two.6 All three came up with more or less the same recommendations that I made in 2004. And then a group of us got together and published a paper in 2006 in the Journal of the American Medical Association that received an inordinately large amount of publicity.7 It basically called attention to financial conflicts of interest. So the profession did speak out on this issue in some sense, but there was not a whole lot of take-up of the recommendations.

Around the same time, Congress got involved. There was an investigator in the Senate who began to agitate about financial conflicts of interest and I went down to talk to him at one point. He managed to convince his bosses that legislation should be introduced. When the new health care act was passed under President Obama, it was inserted into the legislation, and it required some of the things I recommended in my book.

Q: You’re referring to the Physician Payments Sunshine Act?

A: Yes. The Sunshine Act is supposed to be implemented in 2013, and it requires pharmaceutical companies to report any physician who is making more than a small amount of money and to publish this information on a website that is searchable. What that does is force disclosure.

One of the problems with these disclosures is that sometimes they’re not up front, they’re hidden. For example, some journals will publish them on their websites but not in their print versions, so you have to go searching for the information. And sometimes the disclosures will tell you the name of a company but not much about the drug that’s being discussed, so those disclosures aren’t all that helpful.

The regulations were finally written for the Sunshine Act fairly recently and I must say I’m disappointed with them. The penalties are quite modest. Com­panies that made a little mistake would be penalized a little bit and companies that intentionally didn’t report are penalized up to about $100,000. We know already from the penalties companies have paid under the requirement that they not advertise drugs that are not FDA approved—those penalties are much higher, and still the companies continue to do it. I see these regulations as being watered down and not sufficient to really have an effect on company disclosures of these conflicts.

Q: The act includes a provision that requires senior executives of a drug company to attest to the accuracy of each report. If they can be held liable, wouldn’t this be a deterrent?

A: Maybe and maybe not. It’s possible that could happen, but I haven’t seen anybody sued for violating the rule about off-label drug marketing, which is in principle something that someone could go to jail for. I do think that lawsuits would catch the attention of some of the people who violate these regulations.

We have to appreciate that disclosure is necessary; it is an important aspect of potentially alerting people about possible influence. The problem is that it doesn’t solve the problem. The problem is the conflict that can then produce the bias. It’s not the lack of disclosure that is the problem. Yes, we should have disclosure, but having disclosure doesn’t make it clean.

For example, if you’re sitting in the audience and I’m giving a lecture on a Pfizer drug and I tell you that I’m paid $50,000 a year by Pfizer for lecturing for them, you won’t have any idea how to interpret what I’m saying. I might be biased, I might not be biased—you just won’t know. On the other hand, if I’m up there lecturing about a Pfizer drug and I tell you that I have no such relationship with Pfizer, you’re more likely to trust what I say. So disclosure is not a solution to the problem. It may actually exacerbate the problem to the extent that once you disclose it, you can say whatever you want.

Q: If you were to name three things that need to be done to prevent the drug and medical device industry from influencing physicians, what would they be?

A: Number one, a move by major professional organizations to progressively reduce the amount of money they take from industry.

Second, there should be widespread agreement by major professional organizations such as the American College of Physicians, the American College of ­Surgeons, and the American Medical Association that physicians should do fewer of these arrangements that cause conflicts of interest, such as consultations with industry and speakers’ bureaus.

Third, I don’t think that the drug and medical device industry has understood the fact that, by engaging physicians the way they do, they tend to denigrate the profession, and that’s bad for them.

Notes

  1. Eric G. Campbell et al., Institutional Academic-Industry Relationships, 298 JAMA 1779 (2007).
  2. G. Campbell  et al., A National Survey of Physician-Industry Relationships, 356 New Eng. J. Med. 1742 (2007).
  3. The survey results were reported by SK&A, a firm that provides strategic marketing data for the health care industry. See Press Release, SK&A, SK&A Announces Results of Physician Access Preferences (Oct. 12, 2010), www.skainfo.com/press_releases.php?article=96; Press Release, SK&A, SK&A Releases Updated Physician Access Study (Mar. 15, 2010), www.skainfo.com/press_releases.php?article=90.
  4. Jeffrey A. Tabas et al., Clinician Attitudes About Commercial Support of Continuing Medical Education, 171 Arch. Intern. Med. 840 (May 9, 2011).
  5. Inst. of Med., Conflict of Interest in Medical Research, Education, and Practice (Natl. Academies Press 2009).
  6. Assn. of Am. Med. Colleges, Protecting Subjects, Preserving Trust, Promoting Progress I: Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research, 78 Acad.Med. 225 (2003); Assn. of Am. Med. Colleges, Protecting Subjects, Preserving Trust, Promoting Progress II: Principles and Recommendations for Oversight of an Institution’s Financial Interests in Human Subjects Research, 78 Acad. Med. 237 (2003).
  7. Troyen A. Brennan et al., Health Industry Practices that Create Conflicts of Interest, 295 JAMA 429 (2006).


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