Why Big Pharma should buy your doctor lunch ~~ WHAT???

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http://www.slate.com/id/2257785?nav=wp 

 

Appetite for InstructionWhy Big Pharma should buy your doctor lunch sometimes.

By WapnerPosted Wednesday, June 30, 2010, at 7:07 AM ET

The war against industry-sponsored medical education is in full tilt. In recent

anti-pharma news, industry employees have been barred from giving talks during

at least two important upcoming medical meetings, and oncologists from Vermont,

Minnesota, and Massachusetts were forbidden from partaking in the snacks

provided at corporate exhibit booths during a recent annual cancer society

meeting. These developments come on the heels of a movement already well under

way at medical centers around the country: ending the free lunch.

Every year, the pharmaceutical industry spends billions of dollars on

educational programs for doctors, many of them involving food and drinks.

Doctors who are experts on a new medication are paid handsomely by the drug's

maker to speak to other doctors—over a fancy dinner or a casual lunch—about

updates on treating a particular disease that (no surprise here) the new drug

just so happens to treat. This approach isn't the only way that doctors continue

their post-med-school education, but it is a mainstay, and not just because of

the free and tasty grub. These sessions help move the latest medical advances

out of the lab and into daily practice.

But with the mounting concern about ties between doctors and the pharmaceutical

industry, commercially supported medical education is being axed from hospitals

and university medical centers around the country. Not only is this change

unfortunate for anyone with a doctor, but it also doesn't make any sense.

When the FDA approves a new drug, the package label notes a very specific

indication, and pharmaceutical companies may only market the drug for that

purpose. But often the appropriate use, or standard of care, differs from the

use the FDA approved. For example, when Remicade was first marketed for the

treatment of Crohn's disease, the approved, or on-label, indication was a single

intravenous infusion. In reality, Remicade needs to be given on a continual,

long-term basis. Patients given a single infusion quickly develop antibodies

against the drug, resulting in an allergic reaction on subsequent exposure. But

a long-term trial would have delayed getting it to patients in need—Remicade

was a much better treatment than what was already available for Crohn's. So

although the well-respected doctors who served as trial investigators knew that

routine use of Remicade needed to be long-term, they decided to submit the

single-dose data for regulatory review.

The FDA regulates how a drug is marketed, not how it's used by doctors. While

Remicade's manufacturers couldn't advertise the drug for long-term use, trial

investigators could demonstrate the appropriate, off-label, use. For several

years, gastroenterologists from the world's top medical centers, who'd been part

of Remicade's development since its inception, traveled around the world,

instructing doctors on how to use the drug.

That practical knowledge could never have been gleaned from a journal article or

the package insert. Generally, the published reports of clinical trials present

complicated statistical analyses about a drug's likelihood to benefit patients.

They don't teach how to use the drug. Physicians needed in-person training. They

needed to hear an expert discuss the ins and outs of a new medication—what

side effects to expect, how to manage them, how long to wait between infusions,

when dose adjustments might be needed. That was the only way to ensure the

optimal treatment of patients with Crohn's disease. Most, if not all, of those

sessions were paid for by the drug's maker and often included food and drinks.

But sessions like this—meetings with key opinion leaders over lunch, dinner,

or a snack to discuss the latest advances in treating this or that

condition—are being banned left and right. Since at least June of 2009, the

University of Pittsburgh, Mount Sinai School of Medicine, Stanford University

School of Medicine, s Hopkins School of Medicine, and several other

prominent institutions have prohibited industry-funded meals. Politicians and

other federal overseers are concerned that commercially supported medical

education leads to misuse of drugs—in particular, that doctors who have

enjoyed a meal on the pharmaceutical company's tab will prescribe an expensive

drug even if it is not the best treatment option. Like that curl of smoke

carrying an irresistible scent in an old cartoon, pharma-provided victuals, the

thinking goes, woo doctors into mindless, expensive prescribing.

But cauterizing industry-sponsored education leaves a huge gap in care.

Hanauer, one of the clinical investigators who developed Remicade and who has

been paid to speak to doctors about it, explains that as Remicade teaching

sessions have been nixed, misuse of the drug has risen—and Hanauer thinks that

the two phenomena are connected. Hanauer now regularly sees Crohn's disease

patients who were treated inappropriately with Remicade. Uneducated about its

off-label use, the physicians gave the drug as a single infusion, which led to

resistance, leaving patients with very limited treatment options. The

investigators also discovered that breaks between doses need to be kept short,

but many gastroenterologists haven't had the chance to learn that, resulting in

unnecessary sickness.

Many drugs are used off-label on a regular basis. Clinical trials are done in a

vacuum, and even when the standard-of-care use does not differ quite so starkly

from the on-label use, doctors still require hands-on learning. Right now, the

most effective way to do that is through commercially supported medical

education so that the speakers can be paid and the session can be done in a way

that works within doctors' busy schedules.

But surely there must be other options. Can't doctors meet with the experts in

the absence of fancy cheese? Not necessarily. Teaching sessions often take place

during the lunch hour. As Hanauer, who practices at the University of Chicago

School of Medicine, describes, the elimination of paid lunches sent hungry

doctors to the cafeteria instead of the lecture hall. " But the lines were so

long that they missed the conference, " he says. " So attendance at our grand

rounds conferences went to miniscule. " Now the doctor has a sandwich but isn't

up to date on how to treat a serious disease. That may sound silly, but it's

often the mundane reality. " There are sometimes times when residents have to

choose between lunch and a conference, " Goldberg, an oncologist at the

University of North Carolina, wrote in an e-mail.

The backlash against commercial support has also led many prominent medical

centers to ban faculty from receiving significant amounts of industry dollars

for teaching and consulting. But these professors are often the top experts in

their field, the ones at the research helm. Promotional talks given by drug

reps—who are company employees, not doctors—are monitored by the FDA, and

any discussion of off-label use is strictly prohibited. That's for good reason;

the only people telling doctors how to use a drug should be doctors who know how

to use the drug. But if these doctors are prohibited from giving talks, then how

is that going to happen?

Continuing medical education programs are another option. The pharmaceutical

industry spends more than $1 billion a year on educational programs that are

also CME-certified (see Table 6 here)—that is, doctors attending them can earn

the credit hours they need in order to keep their medical licenses. These

programs do permit off-label discussion of drugs. However, CME guidelines are

strict. Programs must present a balanced view of all treatment options for a

given disease, and pharmaceutical companies may not influence the program.

Fair enough. Companies shouldn't be able to determine the content of any

educational program, especially one that qualifies for CME credit. But as this

wall has thickened, pharma has pulled away from funding CME programs, which

means fewer free educational opportunities for doctors. Unsponsored, in-person

CME programs can cost hundreds to thousands of dollars, which starts to pinch

the wallet, even for doctors, who aren't all loaded. The reluctance stems not

only from the lack of opportunity to influence doctors but also fear of being

seen as promoting a drug. Many companies have decided it's just not worth the

risk or trouble. Besides, some universities are already pushing industry out of

CME programs, too.

Without programs being brought to their door, most doctors will get their

necessary credits in one fell swoop at their specialty's annual conference,

which offer CME sessions. But an hour-long talk in a giant lecture hall is

hardly the intimate atmosphere truly needed to learn about a new drug. More than

30,000 people attended the recent annual meeting of the American Society of

Clinical Oncology, the largest meeting for cancer health care professionals.

Presenting new drug data to an audience of thousands precludes the pertinent

dialogue that's possible in a smaller setting. And waiting until the annual

meeting rolls around doesn't seem like the best way to stay on top of the latest

developments. Furthermore, the balanced nature of CME programs often leads to a

very watered-down presentation of cutting-edge advances. A seminar may present

several speakers discussing multiple treatments for a disease without honing in

on the specifics of using one

essential new tool. The content, the size, and the impersonal nature of these

talks don't deliver the level of detail that doctors must know as they inject a

new foreign substance into a living, breathing human.

The same goes for the plethora of online videos and other materials produced

without commercial support. There is no substitute for a small group of people

listening to a doctor talk about how to treat a disease. And there is no

substitute for the commercial support required to run such programs.

In a recent study, academic researchers were paid a modest honorarium to travel

around the country teaching more than 14,000 doctors about new treatment

guidelines for high blood pressure. Each researcher met with small groups of

doctors to educate them about the latest advances. In counties where the most

sessions took place, adherence to the guidelines rose by more than 8 percent. In

counties with the fewest such sessions, adherence decreased by 2 percent. The

approach that the pharmaceutical industry has been taking for years is actually

an effective way to educate doctors.

The concern about industry's influence over medical care is obviously

well-founded. There are plenty of cases in which doctors have promoted unproven

off-label use or have become unduly biased toward prescribing a drug that they

learned about through a pharma-paid program. And it's doubtful that companies

would shell out so much money if their bottom lines didn't stand to benefit.

But the entanglement caused by for-profit drug development can't be undone by

eliminating the free lunch. As one physician suggested, perhaps pharmaceutical

companies should be required to pay for medical education. After all, if

companies are going to unleash new drugs into the world, shouldn't they be

responsible for teaching people how to use it? Ousting commercial support is

creating a huge chasm in medical education, leaving doctors not only hungry but

also starved for knowledge.

 

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