When Doctors Go to Class, Industry Often Foots the Bill - WSJ
Fri, 6 Dec 2002
A front page article in The Wall Street Journal by Scott Hensley sheds further light on the corruption of medical ethics by focusing on a drug marketing ploy that is promoted as "continuing medical education"(CME).
CME courses have been transformed into pharmaceutical company sales pitches. Doctors who clamor for freebies shamelessly conspire with the drug companies by pretending that sales pitches for new and upcoming drugs-- some still in development--are "educational" sessions. They pretend as they wine and dine at lavish company paid-for dinners.
The vulgarity exhibited by the physicians--who are industry's accomplices in this charade--is especially disconcerting for those of us who assumed that (except for a few "rotten apples") doctors have personal integrity and follow professional ethics standards. In this latest expose, The Journal reports that FDA has been unable to hold in check doctors who hawk the wares of their commercial sponsors for unapproved uses. Doctors who engage in such activities deserve no more respect than snake oil salesmen.
The Journal reports that a psychiatrist who was about to make a pitch for a new antidepressant is reported to have begun his presentation with the following opener: "Ever hear of Prozac poop-out?" "Many chuckled at the reference to long-term patients on the famous antidepressant who relapse."
One might ask, what would these doctors and their sponsoring drug companies do, if a cure for depression were developed and patients didn't relapse?? Would medical cures spell financial ruin for this unholy alliance?
A lawsuit claims that Warner-Lambert used continuing education as one method for causing doctors to write inappropriate prescriptions for Neurontin. Because the suit charges that Medicaid was defrauded of hundreds of millions of dollars, the federal government has joined as a co-plaintiff.
PAGE ONE THE WALL STREET JOURNAL
When Doctors Go to Class, Industry Often Foots the Bill
Lectures Tend to Feature Pills But Drug Firms Deny Influence
By SCOTT HENSLEY
Dec 4, 2002
Nearly 400 doctors crowded the Astor Ballroom at the Marriott Marquis in Times Square last June for a free dinner of filet mignon and red snapper and a lecture on depression drugs.
The speaker, psychiatrist Jay Fawver, cued his computer slide show and loosened up the audience like a Borscht Belt pro: "Ever hear of Prozac poop-out?" Many chuckled at the reference to long-term patients on the famous antidepressant who relapse. Near the end of the talk, Dr. Fawver brought up an experimental medicine called duloxetine, which is designed to help doctors treat difficult depression patients. Duloxetine's maker, Eli Lilly & Co., paid for the dinner and lecture. It hopes to get approval next year to sell the drug under the name Cymbalta.
Best of all for the doctors: The dinner and talk counted as two hours of credit toward their annual requirements for continuing medical education, or CME.
Courses such as this one are supposed to help doctors keep pace with advances in medical knowledge. Once put on primarily by nonprofit medical societies and academic institutions, the courses increasingly are sponsored by drug companies and organized by for-profit medical-education firms. The risk: the courses tilt toward promoting the corporate sponsors' drugs.
Drug-company interest in CME has been building for years, but it has intensified since the industry adopted a voluntary code of sales conduct in July that emphasizes educating, rather than entertaining, physicians. The code bars currying doctors' favor with resort junkets, tickets to sports events or free tanks of gas -- all gambits used in the past. In response, manufacturers are stepping up their involvement in continuing education.
Growing Reliance The growing reliance on corporate sponsorship also means that drug companies rather than doctors often determine the overall agenda for CME. Doctors are hearing a lot more about medical conditions that can be treated with expensive brand-name drugs and less about subjects from which manufacturers can't profit, such as psychotherapy, autism and domestic violence, some medical educators say.
The educational firms that now run many CME courses depend on the goodwill of the drug companies for their livelihood, says Arnold Relman, a former editor of the New England Journal of Medicine. Education providers "are not going to be paid if they don't speak well of the companies' products," Dr. Relman adds -- an assertion the providers deny.
Thirty-six states require doctors to take continuing education to maintain their medicallicenses. In those states, the average requirement is about 27 hours of lectures or seminars a year. Drug companies now underwrite many courses offered by nonprofit universities and professional societies, as well as by for-profit companies. At the typical medical school, more than 40% of funding for CME comes from commercial sponsors, compared with 17% in 1994, according to the nonprofit Society for "Leslie Baer"; "Christine Stencel"; "Laura Rodriguez"; "Jessica Aungst"; "Jim Jensen"; "Andrew Pope"; "Jennifer Otten"; firstname.lastname@example.org; email@example.com; "Sandra McDermin"; "Jamie Casey"Academic Continuing Medical Education.
Government and industry guidelines forbid manufacturers from directly controlling the courses. But there isn't aggressive enforcement, and there are plenty of ways to influence them. Drug makers, for instance, may suggest speakers as long as the education provider has the final say.
In a so-called whistle-blower lawsuit pending in federal court in Boston, a former employee of Warner-Lambert Co. has accused the ompany of hand-picking speakers and signing off on their presentations about unapproved uses of Neurontin, an epilepsy drug. The courses, given around the country, were supposed to have been prepared by ndependent education providers.
The suit claims that by means of its role in continuing education, among other actions, Warner-Lambert caused doctors to write inappropriate prescriptions for Neurontin through at least 1998. That, in turn, cost the Medicaid insurance program for the poor hundreds of millions of dollars, the suit claims. The federal government has joined the suit as a co-plaintiff, seeking unspecified compensation for the alleged overpayments.
Pfizer Inc. acquired Warner-Lambert in 2000. Spokeswoman Mariann Caprino says Pfizer won't comment on activities at Warner-Lambert "many years before we were involved. However, all of Pfizer's CME programs are conducted within the appropriate guidelines and are based on solid, scientific research."
Drug companies are prohibited from promoting their medicines for uses other than those approved by the Food and Drug Administration. CME courses, by contrast, may discuss unapproved uses of commercially available drugs, which doctors are free to prescribe as they see fit, or experimental drugs. The courses thus potentially become a backdoor way for companies to get the word out more broadly about their products.
For drug giant Lilly, that was one benefit of the CME course last year at the Times Square Marriott. Through this and similar courses, the Indianapolis-based company helped generate buzz about Cymbalta, the depression drug, long before its expected approval next year.
Lilly's goal in such courses "is to disseminate scientific information in an objective and nonpromotional way," says spokesman Robert Smith. Lilly didn't control the content of the depression course, and attendees heard about multiple products, as well as the science underlying depression treatments, Mr. Smith says. All of these attributes are required by the Accreditation Council for Continuing Medical Education, a nonprofit group whose board is drawn from medical associations and hospital groups.
Optima Educational Solutions, a closely held company outside Chicago, was paid more than $2 million to organize the depression lecture series. Angelo Grossi, the company's president, says he has had "an explosion of orders" from drug makers since July, when the new marketing code went into effect.
Optima put together the depression curriculum, including the standardized set of slides used by lecturers. The small company also obtained accreditation, found speakers and rounded up attendees. Optima says its depression course ran for five months, ending in September, with a dozen doctors delivering talks toa total of about 5,400 people in cities from coast to coast.
The medical-education company says all of its courses are prepared by leading medical experts but aren't reviewed or approved beforehand by Lilly or other sponsoring companies. Mr. Grossi says Lilly's drug deserved on the merits to be included in the depression course. He also says he thinks he would get future business from Lilly even if he didn't include its drug because Lilly had funded previous Optima programs that didn't include a drug Lilly was selling.
Dr. Fawver, the Fort Wayne, Ind., psychiatrist who gave the Times Square talk, says that while Lilly's new drug was featured in the set of slides Optima provided, he would have discussed the medicine anyway when surveying the latest treatments. He says his talk wasn't scripted by either Optima or Lilly. Optima says that only 3% of the attendees questioned the course's objectivity in a survey the company administered afterward.
Optima declines to say what it paid Dr. Fawver. He says the gig was a financial "break-even situation" for him, given the patient fees he had to forgo back home. Lectures generally pay from $1,000 to $5,000 or more each. The pleasure of teaching and the chance to help colleagues stay current draw him to CME, Dr. Fawver says.
Blurring the Lines
Psychiatry is a particularly hot area for industry-sponsored courses because companies are coming out with many new drugs in the field and new uses of existing ones. The lines between education and promotion can blur in other specialties, too. AstraZeneca PLC paid bonuses to sales representatives based on how many doctors they recruited for a class on gastrointestinal disease it sponsored in recent months, a former AstraZeneca employee says.
AstraZeneca spokeswoman Rachel Bloom-Baglin says, "To the extent that such a field-initiated contest may have occurred, it was not within the company's policy," which forbids financial incentives to sales reps to boost attendance. "We are not aware of any such contests at the present time," she adds.
The free half-day course on gastro-esophageal reflux disease, the kind of serious heartburn that can cause permanent damage, was held at 32 hotels across the country through last month. AstraZeneca, maker of heartburn drugs Prilosec and Nexium, paid the Cleveland Clinic, a top teaching hospital, to organize the course, as well as related self-study programs. The cover of a brochure describing the course that was mailed to doctors across the country is purple, the same color as the company's heartburn capsules and its corporate logo.
Only 1% of doctors participating in the Cleveland Clinic class on gastrointestinal disease supported by AstraZeneca reported detecting any commercial bias, William Carey, the clinic's continuing-education director, says.
Institutions such as the Cleveland Clinic need industry financial support because "expenses for most CME activities exceed the amount that can reasonably be met by registration fees," Dr. Carey says. As recently as the mid-1990s, most of the courses ran primarily on fees, which doctors can deduct from their income for tax purposes.
But many physicians have grown accustomed to industry-subsidized education and now resist paying even modest amounts to attend classes. That makes it tough for universities and hospitals to charge doctors the full freight for course costs. As a result, these institutions now routinely take money from the drug industry.
Last year, direct commercial support for continuing medical education was $569 million, up 22% from 2000, according to the accreditation council. When spending on related exhibits and advertising is included, the industry share of support stood at $729 million last year, or 62%, of the $1.18 billion total spent for continuing medical education, according to the accreditation council. Admission fees and expenditures by universities and other nonprofits provide the balance.
Drug-company support for the courses began growing in the 1980s. In the early 1990s, an explosion of boondoggles offering credit became the subject of Senate hearings. That led to some reform, including stricter accreditation requirements and in some cases higher-quality courses.
The FDA, concerned about the promotion of drugs for unapproved uses, laid out guidelines in the early 1990s to prevent companies from using the educational system as a marketing tool. The main criteria: that courses be accredited and that drug companies not control course preparation, delivery or content. The agency sent warning letters to some companies that had supported the research of doctors who later gave continuing medical education speeches about off-label uses of drugs.
But First Amendment free-speech litigation in the 1990s spearheaded by the Washington Legal Foundation, a free-market advocacy group funded by drug makers and other manufacturers, successfully curtailed certain FDA efforts to restrict drug-company communication with doctors. The upshot is that the agency hasn't aggressively enforced its own guidelines.
Many physicians view industry-sponsored courses -- even those that follow all the rules -- as verging on infomercials. Diana Koziupa, a psychiatrist at the Pennsylvania Foundation, a group practice in Sellersville, Pa., recalls some of her audiences laughing during a lecture series she presented in late 1999 and 2000. Glaxo Wellcome PLC sponsored the course, and some attendees were audibly amused when the treatment of choice in a series of hypothetical depression cases turned out every time to be Wellbutrin, which is made by Glaxo.
"We were trying to make it less of an advertisement for Wellbutrin, and we didn't succeed," Dr. Koziupa says. That was because the obligatory slide presentation -- which was prepared by Projects in Knowledge, a Secaucus, N.J., medical-education company hired by Glaxo -- put a heavy emphasis on the drug.
Still, she says her talk wasn't scripted by either Projects in Knowledge or the drug company. "I talk around the slides, as most speakers do. It's not just Vanna White turning the letters," Dr. Koziupa says. She continues to deliver industry-sponsored presentations to supplement her income and because she enjoys lecturing. She says she can't recall what she was paid for the depression talks.
Glaxo merged with SmithKlineBeecham PLC in late 2000. GlaxoSmithKline PLC spokeswoman Mary Anne Rhyne says the manufacturer wasn't involved in decisions about the Wellbutrin presentation. "The contract with the vendor requires that it be independent medical education, and we believe this program was conducted accordingly," she says.
GlaxoSmithKline declines to say what it paid Projects In Knowledge. The education company says in a written statement that physicians who attended the lectures unanimously praised them for being informative and "free from commercial bias."
David Stout, president of GlaxoSmithKline's U.S. pharmaceuticals group, says CME offers a valuable way to communicate with doctors. "I've always held CME in very high regard," he says.
Having independent educational companies prepare the courses makes the classes credible, he says. And doctors, he adds, "need the CME credit." Some academic doctors say industry dollars are essential. "For academic medicine to not avail itself of the resources of the pharmaceutical industry and private sector would be foolish," says Jeffrey Lieberman, professor of psychiatry at the University of North Carolina in Chapel Hill and a paid speaker for a number of industry-sponsored CME courses. "It would be like major sports saying they won't take advertising from Nike. "The problem is where CME meets marketing," Dr. Lieberman says. That's a growing concern, he says, but the "bedrock of professional propriety" among physicians, combined with existing guidelines for commercial sponsorship, will protect against distortion of CME.
In some quarters, a just-say-no stance toward industry-funded education is coalescing. "We docs make very respectable incomes, and we should be able to budget" for CME, without industry support, says Frederick Sierles, a psychiatrist at Finch University of Health Sciences, in North Chicago, Ill.
Five years ago, before he took over responsibility for CME in his department, Dr. Sierles says industry-sponsored speakers were allowed. As a result, continuing education focused on drugs sold by the corporate sponsors, rather than other important areas, such as psychotherapy, medical ethics and economics. Now, Dr. Sierles says his department doesn't do any industry-sponsored CME. Instead, it budgets about $8,000 a year to pay modest fees and expenses for monthly guest lectures.
Write to Scott Hensley at firstname.lastname@example.org.
Updated December 4, 2002
FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior general interest in receiving similar information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use copyrighted material for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner.