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AMSA-LIST  December 2002

AMSA-LIST December 2002

Subject:

[AMSA] Pharm related article--continue if interested!

From:

garn0051 [log in to unmask]

Reply-To:

[log in to unmask]

Date:

Wed, 04 Dec 2002 10:03:15 CST

Content-Type:

text/plain

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text/plain (404 lines)

Here is the link and the text of an article from the Wall street journal
(not the most lefty newspaper ever that's for sure!).  It is talking about
the bias the drug industry adds to the CME classes.  Read on if interested.

Celia

On 4 Dec 2002, Alexander Tsai wrote:
> 
> http://online.wsj.com/article/0,,SB1038953904187251993.djm,00.html
> 
> December 4, 2002
>  PAGE ONE
> 
> When Doctors Go to Class, Industry Often Foots the Bill
> Lectures Tend to Feature Pills But Drug Firms Deny Influence
> By SCOTT HENSLEY
> Staff Reporter of THE WALL STREET JOURNAL
> 
> 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 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 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 company 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 independent 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 to a 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 [log in to unmask]
> 
>  URL for this article:
> http://online.wsj.com/article/0,,SB1038953904187251993.djm,00.html
> 
> 
>  Hyperlinks in this Article:
> (1) http://www.ama-assn.org/ama/pub/category/8876.html
> (2) http://www.cbinet.com/events/HB299/brochure.pdf
> (3) http://www.accme.org/index.asp
> (4) http://www.optimaed.com/
> (5) http://www.projectsinknowledge.com/
> (6) http://www.clevelandclinicmeded.com/general/welcome.htm
> (7) http://www.sacme.org/Biennial_Survey/default.htm
> (8) http://wsj.com/health
> (9) http://online.wsj.com/user-cgi-bin/searchUser.pl?action=emailalert
> (10) mailto:[log in to unmask]
> (11) http://online.wsj.com/article/0,,SB1024865135470218880,00.html
> 
> Updated December 4, 2002
> 
> 
> 
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