Healthy Skepticism Library item: 19742

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Publication type: news

Kassirer J
Outlook: On the Take
The Washington Post 2004 Oct 12
http://www.washingtonpost.com/ac2/wp-dyn/A17496-2004Oct8?language=printer

Full text:

It seems that the country’s roughly 87,000 drug reps, those appealing salespeople who pop in on doctors in their offices and in hospital conference rooms to promote new drugs, just aren’t selling enough. So the pharmaceutical industry, ever inventive, is recruiting and funding a potent new potent marketing force: our nation’s doctors.

In an article in Sunday’s Outlook section, Jerome Kassirer, the former editor-in-chief of the New England Journal of Medicine and professor at Tufts University medical school, bemoans the role many doctors play in plugging pharmaceuticals. Kassirer says the physicians are particularly useful in promoting the so-called “off-label” use of certain drugs. These drugs have been approved by the Food and Drug Administration (FDA), but only for specific conditions. The pharmaceutical industry and its reps are prohibited by law from advertising other uses of those drugs, but doctors can legally prescribe the medications as they see fit.

Kassirer says that this new marketing force of doctors is being mobilized under the guise of educational or quality improvement ventures. The organizations have names that lend them an air of academic respectability or of promoting government standards. They include the Council for Leadership on Thrombosis, the National Lipid Education Council, the Council on Hormone Education and the National Initiative on Sepsis Education. They sponsor Web sites, provide free patient education or continuing education for physicians, collect patient data and publish free books for doctors. In the end, however, Kassirer says, the point is promotion —- and that’s not what doctors should be doing.

Kassirer, author of “On the Take; How Big Business is Corrupting American Medicine,” was online Tuesday, Oct. 12, at 11 a.m. ET to discuss his article, These Two Make Quite A Team.

Editor’s Note: Washingtonpost.com moderators retain editorial control over Live Online discussions and choose the most relevant questions for guests and hosts; guests and hosts can decline to answer questions.

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Arlington, Va.: The old-line medical establishment has consistently resisted reforms that have had the effect of empowering patients to participate in decisions as to their own care, by providing them with information about available drugs and other treatments. If these forces had their way, we would be returned to a world of total dependency, where one’s doctor was the exclusive gatekeeper for medical information. Is this your preference? And if not, please explain why you think it is possible to dis-empower the pharmaceutical reps without simultaneously dis-empowering patients?

Jerome Kassirer: I’m not sure why you think that the medical establishment resists empowering patients. In fact, there has been a movement, at least among enlightened physicians to engage patients increasingly in decisions that affect their own care. There are even interactive computer programs to help patients understand very complex decisions, such as those involved with prostate disease.
You are right that some physicians resist patient autonomy and bristle when patients bring in mounds of downloaded material from unreliable Internet sites.
More than 20 years ago in an editorial in the New England Journal of Medicine I argued that patients should take a greater hand in their own illnesses, and I still believe that.
I would disempower the pharmaceutical representatives in favor of having physicians get their information from less biased sources. The drug salesmen usually push the latest, most expensive drugs, and of course, these are the very drugs for which little is known about their toxicity because they have typically been used for only a short time. There are plenty of such sources.
There are 87,000 drug reps in the country. Imagine what good could come if the money spent for them was used in drug development.
J.P. Kassirer, M.D.

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Silver Spring, Md.: You mentioned in your article that the American Medical Association lobbied to protect industry-sponsored “speakers’ bureaus” from regulation. I understand why the AMA would want to protect doctors’ rights to say what they think about a drug, including what they think about an off-label use. But why would the AMA take the official position that doctors’ rights to get paid by drug companies should be protected?

Jerome Kassirer: Good question. The AMA is in a tough position. Many of its physicians want to keep receiving gifts, free continuing medical education, and free meals from industry, and if the AMA comes down hard on physicians’ receiving such gifts, it may lose membership. In fact, the rank and file members have consistently voted against limiting gift acceptance. And the AMA has lost membership over the years: it doesn’t want to lose more.

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Rockville, Md.: This is a comment not a question. I found your Outlook article very informative. Interestingly, in last week’s Outlook, a psychiatrist wrote an article suggesting there is underuse of medicication for children and adolescents with depression. One reason she cited for this was the placebo effect many children experience in placebo-controlled trials. She concludes her article by saying that many of her young patients have benefitted from medication. But how does she know that many of these patients would not have benefitted equally from a placebo? Oh, by the way, she admits she has accepted “small” honoraria from drug companies. At best, this doctor’s credibility is suspect; at worst, she’s hurting patients who could have benefitted equally from a placebo. This is one example why doctors need to stop accepting money and gifts from the drug and device industries.

washingtonpost.com: Mysteries of the Mind, (Post, Oct. 3)

Jerome Kassirer: I agree with your conclusion that physicians should stop receiving gifts, honoraria, meals, etc. from drug companies, but in an individual instance, it is extremely difficult to know whether a given recommendation is tainted by money. Just because someone has a financial conflict of interest, such as the psychiatrist you cite, doesn’t mean that they necessarily act in a biased way because of the financial arrangement. The problem is that it’s difficult (probably impossible) to read someone’s mind and determine whether money motivated their action.
When deciding whether or not some action is biased, it takes an expert who knows the field well, and even then, experts sometimes disagree about what constitutes the most appropriate action.
Finally, in any individual case, it is impossible to know whether a patient might have been benefitted from a placebo or simply watchful waiting. That’s what controlled trials are for.
J.P. Kassirer, M.D.

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Washington, D.C.: I have a friend in med school and she tells me about the frequent dinners sponsored by pharmaceutical reps that she attends. She goes for the free grub — but it seems as if what the pharmas are doing is trying to court legions of future prescription writers.

Jerome Kassirer: Your friend is right, of course. Tell her to buy her own food.

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Rockville, Md.: Mr. Kassirer:

The fear of losing membership is often cited as the number one concern of associations such as the AMA. Since “membership” really refers to “dues-paying members”; it seems that both the AMA and the drug manufacturers are motivated by money and not by ethics. Perhaps if the AMA sided with the public more often and not with drug companies, their membership base and the money that comes with it, may increase.

Jerome Kassirer: I think that the leaders of the AMA are truly interested in the welfare of our nation’s patients, but they are in a bind when the rank and file disagree with policies that restrict gift acceptance.

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Clifton, Va.: How are pharmaceutical companies pressuring doctors to make off-label prescriptions?

Jerome Kassirer: As I stated in last Sunday’s Outlook section, they are doing so by engaging physicians to make off-label recommendations. Though pharmaceutical companies and their sales representatives are forbidden by law from recommending off-label uses, physicians have no such restrictions, and the companies are sponsoring many “Front Organizations” such as the National Anemia Education Council and the Council for Hormone Education. These organizations have an official sound to them, but they are not under the same restrictions as industry. Take a look at the article, or look at the discussion in my book, “On The Take: How Medicine’s Complicity with Big Business Can Endanger your Health,” published yesterday.
J.P. Kassirer, M.D.

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Annandale, Va.: Dear Sir,
Your article is just one of the many doctor-bashing articles that seem to be so popular lately. Just your title quickly smears the integrity of our profession.

We doctors have gone to school for many years and we are not as naive or stupid as you would make us out to be. We know that a study of 22 patients is not a very reliable study. We don’t need you to tell us that. We know that the pharmaceutical reps and the doctors hired as their speakers are biased toward their products. We understand that!

Your statements about off-label prescribing are totally off. Even for the medication you mention, Neurontin. Why don’t you tell the millions of diabetics who have found relief of their neuropathy that we doctors are wasting healthcare dollars on off-label prescribing? If we were to wait for the FDA to approve all indications, there would be a lot of unnecessary suffering in the U.S.

We are educated scientists who have gone through a lot of schooling and it is our job to decide what is helpful for our patients and in the majority of the cases we DO help our patients.

As far as getting paid for our services as speakers for the pharmaceutical companies, I do not think this is as wrong as you make it sound. We provide our time and our services for their benefit and it should be compensated. Why have we come to the point where we believe that all doctors have no ethics or integrity and that we are willing to sell our mothers for a few dollars? Why is it that every other profession gets paid for their time and services and we are supposed to help everyone else make millions for free? I scoured all our oaths and found nothing regarding this.

Jerome Kassirer: I never said that off-label uses are always inappropriate, and your Neurontin example for diabetics is a good one, but Neurontin was pushed hard for many uses for which there was no evidence whatsoever, and the company that sold it lost a multimillion dollar suit for having physicians push its off-label uses.

The brochure in which 22 patients was cited was directed at patients, who are less sophisticated than trained physicians, and the companies spend enormous sums to get the patients to go to their doctors and ask if drug X is “right for them.”

I dispute the notion that gifts and meals and fees can be taken without some measure of reciprocity. Many studies show that gifts motivate behavior, and doctors are no exception. Nobody wants doctors to work for nothing. Doctors should be paid appropriately for their services; many, especially primary care physicians are unable to make a decent living, as I point out in my book, given the current reimbursement system.
J.P. Kassirer, M.D.

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Anonymous: Mr. Kassirer, do you really believe that a meal is enough to sway a doctors’ prescribing habits?

Jerome Kassirer: Whay would the pharmaceutical industry spend 20 billion dollars a year on meals and events if meals didn’t have an effect?
Many doctors admit that the friendliness of a pharmaceutical representative is enough to sway them to prescribe their drugs.

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Annandale, Va.: Mr. Kassirer,

It should be a doctors’ prerogative to prescribe off label and since the pharmaceutical companies cannot inform us of these off-label uses, how are we to get informed? The doctors speaking for the companies are an important tool for information and if these doctors provide their time they should get paid. There are many positve off-label uses and there is laots of suffering being relieved bu off label use of medications.

Jerome Kassirer: I would have no intention of eliminating a doctor’s prerogative to prescribe off-label drugs, but do you really think that getting information about off-label uses from financially conflicted “experts” is the best source? I don’t.
Where to get the information? I’d prefer to get it from the best medical journals, from unbiased sources such as the Medical Letter or the computer program Up-to-Date, or from reliable web sites set up by academic medical centers and the government.

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Fargo, N.D.: What is your position on the profit motive of pharmaceutical companies? Are you for limiting sales activities? Are you for price controls? In a capitalist economy, the corporation exists to maximize the value to its shareholders — including fellow readers whose mutual funds and retirement accounts invest in many industries, including pharma companies.

Are you for creating a regulated pharmaceutical industry — similar to utilities?

Jerome Kassirer: In recent weeks several books have been published about the pharmaceutical industry, and many do take the position that they should be run as a utility. A new book by Barlett and Steele, two reporters from Time Magazine also addresses the issue.

My book is about doctors; I take extensive stands about what doctors should do, not how the industry should be regulated.

Given the meager output of the industry in recent years (in therms of important new drugs), its attempt to extend patents on existing drugs, and its unwillingness to spend money on drugs we really need (for malaria, for example), some kind of regulation may be necessary.

Having said that, it seems highly unlikely that the climate in Washington will favor regulation. If anything, it favors less regulation.

J.P. Kassirer, M.D.

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Washington, D.C.: My undergraduate degree is in journalism. One of our required courses, to be taken in the final semester, was on ethics. In it, we were told to NEVER accept any sort of gift, even a cup of coffee, from someone you once wrote about or used a source, or who you might cover in the future. Anything else gave the whiff of possible bias. It’s a rule I abided by in 10 years as a writer.

Do physicians similarly have required ethics training? And why not if that’s the case?

Jerome Kassirer: Good question. Most medical schools do have courses in ethics, but frequently little attention is paid to financial conflict of interest. In addition, students and residents see their teachers taking free meals and gifts, and assume that it’s OK to do so. I think it’s particularly sad that journalists have far more stringent conflict of interest guidelines than physicians.

J.P. Kassirer, M.D.

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Centreville, Va.: Dear sir:

I’m surprised to see the MD behind your name. Your article is such an anti-doctor smear that it makes it difficult to believe you are one of us. Are you so easily swayed? Does a free meal impair your judgment as to what is best for your patients? There are many people out there that believe that we doctors have no integrity but to hear it from one of us really depresses me! We do have the intelligence to know what is biased information and what is not. We are being squeezed on all sides and yet the pharmaceutical industry and the health insurance industry continue to make millions thanks to our services. Yet we are expected to just be content with their thank yous and provide our time and services for free.

Jerome Kassirer: It’s astonishing to me that anyone thinks that doctors should give their services free. I believe that they should be paid appropriately for their work

Sorry to depress you, but there are an enormous number of examples in which physicians are influenced by gifts, meals, and honoraria.

J.P. Kassirer, M.D.

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Annandale, Va.: You make the example of the anemia brochure directed at patients. How about all the direct to consumer advertisement directed at patients? I believe doctors have a better chance of recognizing biased opinions. Your efforts should be directed at stopping these other practices which are trying to take advantage of the lay person.

Jerome Kassirer: Good question. Direct to consumer advertising certainly does sway patients to ask their doctors for the newest and most expensive drugs, and these drugs may nt always be in their best interests.
Many others have suggested eliminating such advertising, and I agree that it probably does more harm than good. Patients would be better off getting their medical information elsewhere.
J.P. Kassirer, M.D.

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Anonymous: This is maybe more of a medical question than a policy one, but do you ever wonder if people are just generally taking way more medicines than they should? People with chronic, serious diseases (diabetes, depression) need medication, obviously. But sometimes it seems that everyone over 45 has a list of pills they take long-term. I wonder sometimes….

Jerome Kassirer: Many people certainly are taking more medications than appropriate. This often happens because of our fragmented medical care system, in which patients see several different doctors, each doctor prescribes their own drugs, and no one physician is taking charge of the whole patient.

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Annandale, Va.: Do you believe that the “academic centers” and the “government” are actually non biased? Do you believe that the government has no interest in promoting the pharmaceutical industry agenda? Furthermore, in the closing paragraph of your article, your intent is clearly against off-label prescribing. You blame it “raising the cost of medical care and impairing the public’s trust toward the profession.” Yes, you call it “inappropriate use of drugs” but throughout the article you basically equate the two.

Jerome Kassirer: No, academic medical centers are not always unbiased; they too push their own agendas, which may not be in a community’s best interests.
Off-label use is certainly not always inappropriate use. Using the newest and most expensive drug, just because a drug representative has given out some free samples, may be just as inappropriate.

J.P. Kassirer, M.D.