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[Fred A. Baughman Jr., MD:
---- Original Message ----- From: "veracare" [Fred A. Baughman Jr., MD:
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. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ http://online.wsj.com/article/0,,SB1038953904187251993.djm,00.html 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 [Fred A. Baughman Jr., MD:
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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.
[Fred A. Baughman Jr., MD:
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.
[Fred A. Baughman Jr., MD:
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 medical licenses. 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"; bob.cd@duke.edu; che3@georgetown.edu; "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.
Audience Laughing
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 scott.hensley@wsj.com10.
Updated December 4, 2002
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