A congressional crack-down on the education of physicians by pharmaceutical sales representativesthe estimated 100,000 so-called detailmen who hand out what a former top editor of the New England Journal of Medicine has called thinly disguised bribeshas become a live possibility, thanks in part to the probability that in November the voters will elect many more Democrats to the House and Senate and end eight years of Republican rule in the White House.
The drug industry, a Capitol Hill source said, fears that increased Democratic control of the next Congress could lead to enactment of the strong corrective legislation co-sponsored by Senate Democrats Herb Kohl (Wis.), chairman of the Special Committee on Aging, and Dick Durbin (Ill.), the Assistant Senate Majority Leader. As a result, the source said, industry lobbyists, much as they would like to kill Kohl-Durbin altogether, may support passage this yearif they are able to eviserate or at least greatly weaken it.
Its doubtful that the industry will get its way despite the gobs of money those lobbyists can throw around. The industrys total outlay for lobbying in just one 18-month periodJanuary 2005 through June 2006was $155 million, a Center for Public Integrity investigation found. Its also worth bearing in mind how highly the industry values detailing. To induce or seduce physicians to prescribe its highly-priced, highly-profitable purported blockbusters, it spends an estimated $5 billion a year, some of it for such assorted gifts as meals, tickets to ball games, travel, clocks, pens, pads, toys and free samples of those brand-name medicines. And, finally, its worth noting how entrenched detailing is.
In 191098 years agoan appalled Dr. David L. Edsall wrote in The Journal of the American Medical Association: The spectacle astonishes one now that it can be viewed from the perspective of growing distance: a learned scientific profession doing about one half of what is its chief worktreating the sickon the strength solely of information received from advertisements and detail men. In the same year, Abraham Flexner, who played a major role in introducing modern medical and science education to colleges and universities, said, The laity has in this matter more to fear from credulous doctors than from advertisements themselves: for a nostrum containing dangerous drugs is doubly dangerous if introduced into the household by the prescription of a physician who knows nothing of its composition and is misled as to its effect.
Under Kohl-Durbin, the Agency for Health Care Research and Quality within the Department of Health and Human Services would fund grants to assure quality health care. Specifically, the agency would fund grants to produce educational materials that would provide physicians and consumers with unbiased, reliable, print and electronic information comparing, in easy-to-understand formats, the safety and efficacy of medicines, whether prescription, non-prescription, brand-name, or generic.
The grantees would include schools of medicine and pharmacy and other entities with demonstrated skills in clinical pharmaceutical research. To distribute the educational materials to physicians, DHHS would set up a separate grant program intended to send to their offices nurses, pharmacists and other trained medical professionals. Also eligible would be nonprofit entities qualified to train staff and oversee results.
Kohl-Durbin is being considered in a favorable atmosphere. Recently, for example, the Association of American Medical Colleges, representing all 129 of the nations medical schools, proposed banning gifts from pharmaceutical and medical device manufacturers to their physicians, staff members and students. While schools can ignore the associations advice, most follow its recommendations, Gardiner Harris wrote in the New York Times on April 28. His story continued:
Rob Restuccia, executive director of the Prescription Project, a nonprofit group dedicated to eliminating conflicts of interest in medicine, said the report would transform medical education.
Most medical schools do not have strong conflict-of-interest policies, and this report will change that, Mr. Restuccia said.
The rules would apply only to medical schools, but they could have enormous influence across medicine, said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University.
Were hoping the example set by academic medical colleges will be contagious, Dr. Rothman said....
With Dr. Roy Vagelos, a former Merck chief executive, serving as the task forces chairman and the chief executives of Pfizer, Eli Lilly, Amgen and Medtronic on the roster, some who advocate for greater restrictions on industry influence in medicine predicted that the report would be weak.
They were wrong. ...
Dr. Robert J. Alpern, dean of the Yale School of Medicine, said that the university presently had no limits on participation in company speakers bureaus, but that because of the medical college associations report he was thinking of taking them on.
I dont have a problem with doctors making $3,000 or $5,000 a year on the side, he said, but its a totally different thing when its $80,000. Even more distasteful, Dr. Alpern said, is that the slides used in many of these presentations are created by drug makers, not the speakers.
Thats like ghost-talking, Dr. Alpern said.
Dr. Arthur S. Levine, dean of the University of Pittsburgh School of Medicine, said that when he graduated from medical school in 1964, Eli Lilly gave him his first doctors bag, and Roche gave him an Omega watch for being valedictorian. He still has the watch.
But this years graduating class of doctors at Pittsburgh will not be allowed to accept any of these gifts, and the daily pizza lunches brought by drug companies are gone, he said.
Julie Gottlieb, assistant dean of policy coordination for Johns Hopkins University School of Medicine, said Hopkins had adopted some of the associations recommendations and was considering others.
This report is bound to influence our deliberations, she said.
Dr. Vagelos, formerly of Merck, said that the reports recommendations were certain to face resistance among faculty who liked the present system.
The outcome of this for the industry is that those companies that are strong in science will always be welcome at medical colleges and others wont, Dr. Vagelos said.
Sen. Kohls Special Committee on Aging held one hearing on Kohl-Durbin in June 2007 and another in March 2008. One witness was Shahram Ahari, who was hired by Eli Lilly as detailman while still fresh from college, spent 20 months increasing the market share of my companys drugs, and quit in 2001 to begin working for the publics health in academé.
It became clearly apparent that a drug sale had much more to do with establishing personal relationships than it did with understanding the latest science, Ahari testified. The ranks of reps are replete with sexual icons: former cheerleaders, ex-military, models, athletes. ... Noticeably lacking among most new reps is any significant scientific understanding.
He told the Committee, he had become more convinced than ever that the goals of the pharmaceutical industry often stand in direct conflict with the practice of ethical and responsible medicine. He provided a stunning example, a sell, Sell, SELL! talk for Neurontin, a Parke-Davis drug for a tiny market. A tiny legal market.
The Food and Drug Administration had approved Neurontin, in 1993, for adjunctive or supplemental anti-seizure use by epilepsy patients, and for nothing else. Parke-Davis, a division of Warner-Lambert before it was acquired by Pfizer in 2000, was determined to broaden that market, one way or another. A senior marketing executive was blunt about this. I dont want to hear that safety crap, John Ford told Parke-Davis detailmen:
I want you out there every day selling Neurontin. Neurontin is more profitable than Accupril so we need to focus on Neurontin. Pain management, now thats money. We dont want to share these patients with everybody, we want them on Neurontin only. We want their whole drug budgetnot a quarter, not halfthe whole thing. We cant wait for them to ask, we need to get out there and tell them up front. Holding their hand and whispering in their ear: Neurontin for pain, Neurontin for everything. I dont want to see a single patient coming off Neurontin before theyve been up to at least 4,800 milligrams a day. I dont want to hear that safety crap, either. Have you tried Neurontin? Every one of you should take one just to see theres nothing. Its a great drug!
Dr. David P. Franklin was a research fellow at Harvard Medical School. In 1996 he left to become a medical liaison for Parke-Davis, only to quit later that year and then to file a whistleblower lawsuit. To increase sales of Neurontin, he said in court papers unsealed in 2002, Parke-Davis had aggressively pitched it for more than a dozen medical conditions for which it did not have FDA approval. The lawsuit led to civil and criminal investigations by the Department of Justice. The outcome was extraordinary.
Warner-Lambert faced criminal charges in connection with illegal and fraudulent promotion of unapproved uses of Neurontin. To resolve them, the company agreed to plead guilty and pay a fine of $240 millionthe second largest criminal fine ever imposed in a health care fraud prosecution, the Department announced in May 2004. The company also faced civil liabilities. To get out from under these, it agreed to pay additional fines of $190 million. Why Warner-Lambert decided that the wiser course would be to admit guilt and pay combined fines approaching a half-billion dollars was made obvious by the acts it committed to boost sales at any cost. From the Departments press release:
Warner-Lamberts strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved. The company promoted Neurontin for the treatment of bipolar mental disorder, various pain disorders, Amyotrophic Lateral Sclerosis (ALS, a degenerative nerve disease commonly referred to as Lou Gehrigs Disease), attention deficit disorder, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and as a first-line monotherapy treatment for epilepsy. ...
Warner-Lambert promoted Neurontin even when scientific studies had shown it was not effective. ...
This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision making, thereby putting patients at risk, stated US Attorney Michael Sullivan. This scheme deprived federally-funded Medicaid programs across the country of the informed, impartial judgment of medical professionalsjudgment on which the program relies to allocate scarce financial resources to provide necessary and appropriate care to the poor. ...
Warner-Lambert used a number of tactics to achieve its marketing goals, including encouraging sales representatives to provide one-on-one sales pitches to physicians about off-label uses of Neurontin without prior inquiry by doctors. ...
Warner-Lambert paid doctors to attend so-called consultants meetings in which physicians received a fee for attending expensive dinners or conferences during which presentations about off-label uses of Neurontin were made. These events included lavish weekends and trips to Florida, the 1996 Atlanta Olympics and Hawaii. There was little or no significant consulting provided by the physicians.
The pharmaceutical company implemented numerous teleconferences in which physicians were recruited by sales representatives to call into a pre-arranged number where they would listen to a doctor or a Warner-Lambert employee speak about an off-label use of Neurontin. ...
Warner-Lambert paid physicians to allow a sales representative to accompany the physician while he or she saw patients, with the representative offering advice regarding the patients treatment which was biased towards the use of Neurontin. ...
The company also sponsored purportedly independent medical education events on off-label Neurontin uses with extensive input from Warner-Lambert regarding topics, speakers, content, and participants. ...
In at least one instance, when unfavorable remarks were proposed by a speaker, Warner-Lambert offset the negative impact by planting people in the audience to ask questions highlighting the benefits of the drug.
Bruce Sackman, Special Agent in Charge of the Northeast Field Office of the Office of Inspector General for Department of Veterans Affairs [said]: Parke-Davis directly promoted off-label drug uses to Veterans Affairs physicians and pharmacists on a nationwide basis, in direct violation of FDA laws. From 1994 to 2002, sales of Neurontin to the Department of Veterans Affairs jumped from $287,000 to $43.2 million.
Successful detailmen must be, in Shahram Aharris words, eloquent and convincing; if ineloquent and unconvincing they would be useless, or worse. This helps to explain why pharmaceutical manufacturers keep sales reps in the dark about the same scary realities that they frequently also conceal from the FDA.
It really wouldnt do for Mercks Vioxx detailmen, say, to know that the painkiller was causing many tens of thousands of heart attacks and strokes. Or for Lillys Zyprexa detailmenAharai was oneto know that patients on the schizophrenia drug were developing diabetes. Or for Johnson & Johnsons Ortho Evra detailmen to know that women using the patch for birth control were, for no good reason, facing sharply increased risks of blood clots and strokes. Or, going back a few decades, for thalidomide detailmen to know that women on the William S. Merrell sedative/tranquilizer in the first trimester of pregnancy were giving birth to armless, legless, and limbless babies.
Harvard Medical School professor Jerry Avorn cited Vioxx as an example of drugs that are at once needlessly life-threatening and far more expensive than safer and effective generics. Every time a doctor prescribes an expensive new blood pressure or diabetes pill that costs the patient over $1,000 a year, every year, instead of a generic drug that costs under $50 a year, thats like an annuity for the companyeven if the generic drug has a better track record of safety or effectiveness than the new, more expensive drug, he told Kohls committee.
Weve seen that happen with Vioxx, Avandia [a diabetes drug], Vytorin [a cholesterol drug], and many other widely used drugs, with substantial negative economic and clinical consequences, Avorn testified. Americans spent billions of dollars a year on those drugs, even though less overpriced alternatives would have worked as well or better. Ironically, much of that was taxpayer moneyenough to pay for more balanced drug education programs dozens of times over.
In 1990, the FDA banned gifts to physicians of substantial value but continued to allow nominally minor gifts such as meals, ball-game tickets, cruises and travel. That the reform did little to stop corruption of physician education cannot be doubted. Seventeen years later, the Special Committee heard testimony that in its fundamentals could have been heard in 1910 from David Edsall or Abraham Flexner. It came from Dr. Jerome P. Kassirer, Distinguished Professor at Tufts University School of Medicine in Boston, a former editor-in-chief of The New England Journal of Medicine, and author of On The Take: How Medicines Complicity With Big Business Can Endanger Your Health.
I will assert that the medical profession has become excessively dependent on the largesse of industry, that these financial connections have a negative influence on the quality and cost of patient care and the trust of the public, and that the professions response to these threats has been inadequate, Kassirer testified. His overview of these connections included much about drug detailing:
One-hundred-thousand drug reps visit doctors, residents, nurses, and medical students every day and ply them with free gifts, meals, and gadgets; medical meetings are mini-circuses, replete with enormous glittering displays and hovering attractive personnel. Although couched as education, these marketing efforts are thinly disguised bribes.
Just as surprising is the magnitude of physician involvement with industry. Among a random sample of doctors reported just weeks ago, more than 3/4 had taken free samples, free food, and free tickets to sporting events from industry, more than 1/3 accepted free continuing medical education, and another 1/3 had received payments for speaking or consulting for the companies or enrolling patients in clinical trials. Some estimate the industrys total advertising bill at 70 billion dollars.
There is nothing fundamentally wrong with advertising products, but when financial incentives yield inappropriate or dangerous care, when they inordinately raise the cost of care, when they risk patients lives in clinical trials, and when they damage the profession, they have gone too far. ...
Free drug samples encourage doctors to use the newest and most expensive drugs, and the samples themselves often get into the wrong hands. Drugs such as Natrecor, approved for acute heart failure only in the hospital, found widespread use in doctors offices, costing taxpayers hundreds of millions of dollars.
And what have leaders of the profession done to counter a trend in which the profession has become increasingly beholden to industry, at times to the detriment of the public? Not much. The American Medical Association and many other physician organizations permit their members to receive gifts and meals and to serve on pharmaceutical companies speakers bureaus. ... In fact, most medical society rules are no more stringent than those of PhRMA!
Another indicator of a changed environment is the enactment by Vermont and Minnesota of payment-disclosure laws. According to the summary reports released by the Vermont Attorney Generals office, 58 pharmaceutical companies disclosed to the state $5.58 million in payments between July 1, 2002, and June 30, 2004, Peter Lurie, Deputy Director of Public Citizens Health Research Group, told the Committee. Of these, 12,227 payments totaling $2.18 million were publicly disclosed. Thus, in dollar terms, 61% of all payments reported to the state were withheld on trade-secret grounds. Of the publicly disclosed payments, he said, 2,416 were to physicians for $100 or more; the median payment was $177; 68% were in the form of food, clearly providing no patient benefit and therefore potentially violating the AMA and PhRMA guidelines, and 26% were for detailing.
In Minnesota between Jan. 1, 2002, and Dec. 31, 2004, pharmaceutical houses disclosed 7,290 payments, Lurie testified in 2007. Of the total, he said, 86% were to physicians for $100 or more; 46% were for unspecified purposes; 27% for educational activities, and 13% for speaker activities. We identified 2,388 distinct physician recipients, approximately 14% of the 17,445 physicians holding an active license and who had a home address within the state. For these individual physicians, ... the median total amount received was $1000 (range: $100-$1,178,203).
Kohl-Durbin builds on academic detailing, an idea Harvards Avorn had proposed to the federal government in 1979, as he explained in these excerpts from testimony:
My colleagues and I trained pharmacists in four states to go visit physicians as un-sales reps, so they could provide doctors with educational outreach about several common prescribing topics. I named the approach academic detailing because it used the detailer approach of sending someone to meet with a doctor ... from a non-commercial, academic perspective.
We showed that the concept worked in a large four-state randomized trial involving over 400 doctors. As we reported in The New England Journal of Medicine, 92% of the doctors who were offered this service accepted it, and those who were randomized to the academic detailing group significantly improved their prescribing. In a formal benefit-cost analysis, we found that such a program could save $2 for every $1 it cost to run. ...
Since then, many additional studies have shown that academic detailing programs can improve the use of a wide variety of drugs, from antibiotics to sedatives, in settings from primary care offices to teaching hospitals to nursing homes. Some of these programs have also tracked clinical outcomes, and have found that patient outcomes also improveas expectedwith more evidence-based prescribing. Today, academic detailing services have been set up in England, the Netherlands, several Canadian provinces, and the entire nation of Australia. In the US, some integrated health care systems, particularly Kaiser, have mounted their own academic detailing services, and programs of varying size have been established or legislated in Pennsylvania, South Carolina, the District of Columbia, Vermont, New Hampshire, Maine, and other states.
The Pennsylvania program, which that states Department of Aging asked us to establish in 2005, is the largest publicly funded service. Supported by that states PACE program, we train pharmacists and nurses to meet with doctors in their offices to provide commercial-free educational outreach about the best treatments for several common conditions in the elderly. The program is conducted on a completely non-profit basis. My colleagues and I at Harvard Medical School develop the materials based solely on the best evidence in the medical literature, with no interference from the stateas is the case in nearly all such programs. Sometimes we encourage greater use of expensive drugs, if thats what the clinical trials show is the best thing to do. Physicians can get continuing medical education credit from Harvard, and have received the program with enthusiasm. ... We put everything we produce on the Internet for free, non-commercial use by anyone, at www.RxFacts.org .
In an ongoing evaluation, we examined the prescribing of doctors who were offered the program compared to similar physicians in counties where it is not in effect. That analysis found that the module on gastrointestinal drugs alonewhich addressed overuse of purple pills such as Nexiumis estimated to have saved over $500,000 per year through the PACE program alone, not counting the savings to other payors such as Medicaid and private insurers. ...
If war is too important to be left to the generals, then drug information is too important to be left primarily to the pharmaceutical industry. Proactively getting current, non-commercial, evidence-based drug information to doctors is an important public good, like good roads, primary-school education, and clean air. ... Now that Medicare has become the nations single biggest payor of drug bills, it would be fiscally irresponsible not to equip doctors with the information we need to make the best choices for our patients. The marketplace has not done this adequately, and will not. ...
From representatives and senators whose campaigns receive large injections of drug-industry money, and from pretend-conservative lawmakers, Kohl-Durbin will elicit cries of government meddling in the practice of medicine and the like. Their professed idol Adam Smith could be cited in response. He defined an ideal transaction as one resulting from an arms-length negotiation between a fully informed buyer and a fully informed seller. To that ideal the physician-patient prescription transaction has a tenuous connection at best. This was explained memorably by the late Senator Estes Kefauver, who was primarily responsible for the far-reaching reforms of the drug law in 1962: He who orders does not buy, and he who buys does not order.
Kohl-Durbin would revise Kefauvers pithy insight, albeit inelegantly: He who orders in response to academic detailing does not buy, and he who buys and does not order will not be harmed needlessly by an unsafe, ineffective, and costly medicine.
Morton Mintz, a senior advisor to niemanwatchdog.org, is a former longtime Washington Post reporter who covered the pharmaceutical and medical-device industries over a quarter-century and is the author of four books about their products and practices. He is also a former chair of the Fund for Investigative Journalism.
From The Progressive Populist, June 15, 2008
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