[mobglob-discuss] Who benefits when doctors endorse drugs?

[Graeme Bacque]

http://www.thestar.com/NASApp/cs/ContentServer?GXHC_gx_session_id_=3c3cd4ac897e0b8b&pagename=thestar/Layout/Article_Type1&c=Article&cid=1026144065788&call_page=TS_News&call_pageid=968332188492&call_pagepath=News/News

Aug. 9, 2002. 07:49 AM  The Toronto Star
Who benefits when doctors endorse drugs?
By Judy Gerstel

Is your doctor for sale? Does your doctor work with marketing companies to 
promote drugs and products?

Very often, I get news releases from public relations companies promoting 
health products — usually drugs, but occasionally supplements or 
over-the-counter products — that include the name or names of physicians 
willing to speak to the media about the benefits of these products.

They tell us, the journalists. We tell you, the public. Commerce is effected.

Remember those television commercials in which "three out of four doctors" 
recommend an over-the-counter remedy? Sometimes, there'd even be an actor 
dressed up in a white lab coat to simulate a doctor. Inevitably, the actor 
was male, mature, paternal and appeared to be wise — often with the help of 
glasses.
Today we consumers are wiser. We're not about to fall for some character 
from central casting with advice about how to fix what ails us.

So now we're getting the real thing: clinicians and academics with 
impeccable credentials touting drugs and supplements to the public through 
the media. These aren't spokespeople acting like doctors. These are doctors 
acting like spokespeople, endorsing specific products.

"It's tremendous marketing," says Dr. John La Puma, formerly a physician at 
the University of Chicago Hospitals who has written books about medical 
ethics and was associate editor of The Journal of Clinical Ethics. "It's 
brilliant on the part of pharmaceutical companies to engage credible, 
authoritative spokespersons."
Often, these promotional activities occur around the time a drug is 
approved by Health Canada and available for sale.

For example, Zelnorm, a drug made by Novartis to treat irritable bowel 
syndrome, recently won approval from Health Canada. Sure enough, a media 
kit arrived in the mail with an endorsement from Dr. Gervais Tougas, 
associate professor of medicine and gastroenterology at McMaster University.

"Zelnorm represents the most promising prescription treatment in many years 
for those affected by constipation-predominant IBS," says Tougas. "Its 
approval is great news for sufferers."

Novartis and Edelman Public Relations advise that "physicians are available 
for interviews" in eight Canadian cities.

Last week, Bayer and Weber Shandwick Worldwide, the world's largest public 
relations company, announced that Health Canada approved the use of Aspirin 
for primary prevention to reduce the risk of heart attacks and strokes, 
although it's been used that way for some time.

Quoted in the news release, Dr. Anatoly Langer, a cardiologist at the 
Canadian Heart Research Centre, says, "The official, clinically proven 
indication is wonderful news as it will increase confidence among 
physicians in recommending the use of Aspirin to help prevent a first heart 
attack to the benefit of patients at risk."

Although any generic acetylsalicylic acid would do the same job, Langer's 
quoted reference to the drug in the news release refers specifically to the 
Bayer product in capital letters followed by the circled "R" to indicate a 
registered trademark.

Some other publicity campaigns in the last three months and the physicians 
involved in them:

Paxil was approved by Health Canada for treatment of post-traumatic stress 
disorder. "With Paxil's approval, we have a much greater chance of 
successfully treating PTSD," says Dr. Martin Katzman, assistant professor 
in the department of psychiatry at the University of Toronto, as quoted in 
the news release issued by GlaxoSmithKline and National Pharmacom, a public 
relations company. Katzman was also available for interviews, along with 
physicians in Vancouver, Calgary, Halifax, Ottawa and Montreal.

New Gatorade Kid's Packs were introduced. "Research shows that during 
exercise and play, active children stay better hydrated when they drink a 
sports beverage, like Gatorade, compared to water alone," says Dr. Oded 
Bar-Or, professor of pediatrics at McMaster University, as quoted in the 
news release. Bar-Or is also a member of the Sports Medicine Review Board 
at Gatorade Sports Science Institute in Barrington, Illinois.

New insulin and an insulin monitoring system were introduced by Novo 
Nordisk Canada Inc. and Lifescan Canada Ltd. A media release advised, "Top 
diabetes researcher Dr. Lawrence Leiter, endocrinologist and head of the 
division of endocrinology and metabolism, St. Michael's Hospital, will be 
available for telephone interviews throughout the day."

I placed calls to all these physicians to ask how and why they're promoting 
products in news releases.

Endocrinologist Leiter told me he'd been an investigator for a large study 
funded by the pharmaceutical company of the new insulin, Novorapid. When 
the company asked him to participate in the product launch and speak to the 
media, he agreed. He says no honorarium was involved. "I was doing it 
because I have knowledge and expertise in this area," he says, "and could 
share this with the general community."

While the money for the Novorapid research went directly to St. Michael's 
Hospital research fund, Leiter did serve on the advisory board for Novo 
Nordisk and has delivered educational lectures at company-sponsored meetings.

"I've done this for many other companies as well, all the companies 
involved with diabetes," he explains. "I've done clinical research, been on 
advisory boards and provided educational symposia to physicians at meetings 
sponsored by them." He's been reimbursed for his time by all these 
companies, he says.

The same circumstance applies to McMaster gastroenterologist Tougas. He 
conducted a clinical trial for Novartis and agreed to be quoted in the news 
release and to speak to journalists about Zelnorm, which sells for $2 per 
pill.

"They asked me to comment on the drug," he says. "There were no fees or 
honoraria. I don't mind as long as it's factual and doesn't overstate what 
the drug will do. This drug was better than placebo although it's not a 
panacea, not for everybody. If we target the right patients, I'm happy for 
them to know this.

"It's not a bad thing to tell people that there is something that will help."

Public service is also the reason psychiatrist Katzman puts forth for 
promoting Paxil as a treatment for post-traumatic stress disorder.

He says 7.8 per cent of Canadians suffer from PTSD. "One of the ways for me 
to get people to get treatment is to speak to the press. One of the reasons 
that I've agreed to do this interview is that I really want patients to be 
treated. I see patients every day who have waited 10 or 12 years to get help."

Katzman says he was not given an honorarium or fee for promoting Paxil in 
the news release or for doing interviews about the drug. But, yes, the 
funding for his research on the drug was paid for by GlaxoSmithKline, the 
makers of Paxil.

"They pay for the study," he explains. "It doesn't go directly into salary 
for me. It costs money to collect data, hire research personnel, do 
bloodwork, store data. There is a certain amount that I might draw for 
administrative costs."

Katzman says he is on the advisory boards of drug companies and delivers 
lectures for them.

"If I'm invited to educate, then, yes, my time is covered. I'm paid 
whenever I talk by whomever has asked me to do it. I've got to feed my 
family. I would say I've had my time covered by a variety of drug companies 
to speak on a variety of topics generally related to the diagnosis and 
treatment of anxiety disorders."

He is also paid by drug companies to participate in meetings as a member of 
advisory boards. "If a drug company comes and says, `Dr. Katzman, can we 
have `x' number of hours of your time,' you are funded for coverage of the 
time that you lose, because we all have to pay our bills."

However, the psychiatrist explains that he always makes time to talk to 
journalists. "I spend a lot of time working with the press to get 
information out to the community."

`It's conceivable that the professional organizations could take a much 
stronger stand around the conflict of interest issue. Disclosure is not a 
sufficient response to the problem. Whose interests are being promoted by 
the activity? The doctor's own financial interests or the patients' 
interests? How much trading is there on one's authority as physician?' 
Françoise Baylis Professor of medicine and philosophy in bioethics and 
philosophy Departments at Dalhousie University

Physician and author La Puma feels that bringing beneficial drugs, 
worthwhile products and health information to the attention of consumers 
may indeed be a valuable service.

"If doctors can speak up about products that patients can use and should 
use for their health, I think it can only help," he says. " People learn 
through the media, through watching television."

As is the case with most academic researchers in Canada, gastroenterologist 
Tougas does not receive money directly from pharmaceutical companies to 
conduct research. Rather, he's paid directly by McMaster, which receives 
money from the drug company. Tougas says his salary from the university is 
not related to the research money he brings in.

But he does receive money directly from pharmaceutical companies for 
"giving talks and giving lectures for drug companies." He adds, "Most 
people do.

"If it's something I'm comfortable with and they let me say what I want, I 
get a stand to give my own research and my own views. Sometimes companies 
get pushy. They're not going to invite me twice if I don't say what they 
want to hear, but that's fine."

Tougas says, "I have received fees, honoraria and research grants from all 
major pharmaceutical companies.

"I'm on advisory boards," he says. "You get paid for your day as a 
consultant. If I have to spend a day at a meeting to present data and 
discuss things, they'll reimburse us and I think it's appropriate. I don't 
do it as charity."

When Zelnorm was launched in June, Tougas presented the data to about 40 
doctors at a meeting in Toronto and received an honorarium from Novartis.

He met with marketing people in preparation for the media release. "They 
came and spent about 45 minutes asking questions," he explains. "Clearly, 
they had some spin they wanted to put to this.

"I was a bit grumpy the day they came," he recalls. "I thought, `Why am I 
not doing a clinic to talk to these people?' But I think it's better to get 
it straight from me than crooked from someone else."

Cardiologist Langer also says he's received fees, honoraria and research 
grants from all major pharmaceutical companies. He has participated in a 
number of studies of Aspirin, but the recent Health Canada announcement 
which led to the media release in which he was quoted was not based on any 
particular study. Langer is head of the Canadian Heart Research Centre, 
which co-ordinates enrolment of patients in studies and administers 
funding, overwhelmingly from pharmaceutical companies, to Canadian 
hospitals for specific studies.

He takes the time to speak to the media, he says, because "apart from the 
pleasure of talking to individuals such as yourself, I think the message 
about how to reduce the morbidity and mortality of heart disease is a key 
message. I think it's important for patients at risk of cardiovascular 
disease to know they can reduce the risk."

La Puma thinks the publicity campaign about Aspirin's new indication, 
including comments by the cardiologist and promotion by Bayer, benefits the 
public.

"Aspirin is such an important drug in this primary prevention way that I'm 
all for getting people to know about it," he says. "I think medical 
endorsement is a terrific thing."

La Puma, a professor of nutrition at Kendall College in Chicago, a 
professionally trained chef and author of the best-selling diet book, 
RealAgeDiet, is often approached to serve as a spokesperson for foods being 
promoted as healthy. He turned down Pringles potato chips with olestra but 
does endorse Light 'n' Lively cottage cheese "because it fits well with 
established nutritional principles and good scientific evidence."

But as a physician and nutrition professor, he's not enthusiastic about a 
pediatrician promoting Gatorade. "If there's one thing kids don't need, 
it's more sugar," he says. "The best rehydrator is water, period."

Pediatrics professor Bar-Or, who sees patients at a childhood obesity 
clinic in Hamilton, says he received no direct payment for participating in 
the Gatorade Kid's Packs launch in Canada. He does receive "a few thousand 
dollars" a year, he says, for being on the Sports Medicine board of the 
Gatorade Sports Science Institute which "does research and promotes 
research in areas related to physical activity, health and nutrition and 
has a conference in different parts of the U.S. Canada, Italy and so on."

Bar-Or is also on the institute's speakers' bureau, travelling to meetings 
and conferences. Recently, he received a fee for participating in a U.S. 
"Beat the Heat" campaign in conjunction with a U.S. non-profit group called 
Safe Kids.

He says the salt in Gatorade is beneficial and that the carbohydrates — 
less than in fruit juice or Coke or Pepsi — will almost, but not 
completely, replenish the energy burned during intensive exercise.

Bioethics watchdog Sheldon Krimsky, a professor at Tufts University, finds 
all physician endorsements distasteful.

"Physicians should not be endorsing specific drugs or products, whether 
they're paid to do it or not," he says. "But if they're paid, it's 
certainly a very questionable ethical standard for physicians. It's a 
conflict of professional responsibilities. It seems to me that it lessens 
their authority, objectivity, ability to decide on what the best and most 
cost-effective treatment might be. If a generic comes out, they're bound to 
a particular corporation. It compromises their disinterested role as a 
caregiver."

He believes that even study findings and news about drug approvals should 
not be launched with public relations campaigns featuring medical 
researchers but instead should only be published in scientific journals 
where other physicians can examine the evidence and then decide on how to 
advise their patients.
But it may be naïve, with patients hungry for information and drug 
companies desperate to make money, to think there ought to be a 
"state-church" separation between the practice of medicine and the profit 
of bottom-line corporations.

Geoff Hudson, who directs the Hannah Institute, which provides grants for 
research on the history of medicine, thinks so. "Medicine has always been, 
in part, a commercial enterprise," Hudson says flatly.

Françoise Baylis, professor of medicine and philosophy in the departments 
of bioethics and philosophy at Dalhousie University, agrees. "It's 
certainly the case that the two issues can't be divorced."

She suggests that physicians, cherishing their independence as 
self-employed people, feel they are "free to negotiate with whomever wishes 
to pay for their services."

But she adds, "It's conceivable that the professional organizations could 
take a much stronger stand around the conflict of interest issue. 
Disclosure is not a sufficient response to the problem. Whose interests are 
being promoted by the activity? The doctor's own financial interests or the 
patients' interests? How much trading is there on one's authority as 
physician?"

Neither the Canadian Medical Association nor the College of Physicians and 
Surgeons of Ontario directly addresses the issue of physicians 
participating in publicity campaigns for products, whether or not they've 
been involved in researching them. However, in the code of ethics, 
currently under review, the college's regulations concerning advertising 
include the following:

"No member shall, (a) cause or permit his or her name to appear in any 
communication offering a product or service to the public; or (b) otherwise 
cause or permit himself or herself to be associated with the advertising or 
promotion of any product or service, other than the member's medical 
services ...."

While the ethics may be more or less fuzzy in some cases, it seems unlikely 
that any physician would jeopardize his or her integrity, credibility and 
professional status to help some of the most profitable companies in the 
world make a few more bucks.

And personally, I'm delighted that medical specialists do make themselves 
available to journalists. During one day last week, I had the full 
attention of an endocrinologist, a gastroenterologist, a pediatrician, and 
a cardiologist. It sure beats waiting months for an appointment.

Judy Gerstel's column appears Fridays in the Life section and alternate 
Sundays on the Body & Soul pages of the At Home section. Reach her at 
jgerstel at thestar.ca



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