What gifts are you giving doctors? US asks Drug Companies

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What gifts are you giving doctors? US asks Drug Companies

23 Feb 2004

Drug company marketing gets more scrutiny as states seek ways to lower the

cost of prescription drugs.

At the latest medical meeting sponsored by a drug company that Sidney Gold,

MD, attended, spouses were not invited.

'I think there's been a big change,' the Woodland Hills, Calif.,

psychiatrist said. 'The focus was much more on education and less on the

trinkets and freebies that they had in the past.'

The nature of pharmaceutical marketing to doctors may have changed, but old

stories of lavish meals and gifts linger. So much so that state legislators

across the country are putting the doctor-detailer relationship under the

microscope in hopes that this scrutiny will eventually lower prescription

drug costs.

The first step state lawmakers are taking is requiring companies to report

how much sales representatives are spending and what they're spending it on.

Sponsors of these bills acknowledge that they may not immediately lower

costs, but new laws could cause a budget shift with less spent on marketing

and more spent on samples, medical education support and research and

development.

In 2002, Vermont enacted the nation's first legislation of this type. It

requires drug company representatives to report to the state pharmacy board

any gifts that they give to doctors that are valued at more than $25 (free

samples are excluded). The pharmacy board then forwards the information to

the state attorney general.

Nevada, New Mexico and Maine followed suit, and 10 states have similar bills

active in their legislatures.

'We don't have any leadership at all in the federal government when it comes

to reducing prescription drug prices,' said Illinois Rep. Jack s, who

has introduced a bill into that state's Legislature.

'It's obvious Washington has sold out, so it's up to the states to protect

our citizens from being gouged.'

s said his bill is based on model legislation crafted by the

Washington, D.C.-based Center for Policy Alternatives, where Policy Director

Bernie Horn maintains that industry reforms have not significantly altered

industry practices.

'Detailing has a tremendous impact on what prescriptions are written,' Horn

said. 'There's plenty of scholarly research on this. We're not making it

up.'

Guidelines in place

The drug industry and medical profession have responded to these concerns by

establishing codes of conduct that help clarify what gifts are appropriate

and which ones are unethical.

Fleming, MD, president of the American Academy of Family Physicians,

said most gifts to doctors today are insignificant items such as pencils and

notepads. So if legislators want to know about that, he said, that's fine

with him. But he predicted reporting wouldn't lead to a noticeable change in

behavior or cost.

'I don't think most physicians would have any problem with it all, but I

think there are a group who would find it more disturbing because they take

more substantial gifts,' the Shreveport, La.-based family physician said.

'The vast majority of companies are living by the code very well, but some

reps ignore it and, if anybody in the management of their companies knew

what was going on, they'd turn green.'

Dr. Fleming suggests that physicians 'need to fix our own house' and behave

more professionally and to not accept any gifts that they would be ashamed

to have publicly reported.

Goldrich, MD, chair of the AMA Council on Ethical and Judicial

Affairs, essentially agreed. He said 'Physicians have the ethical obligation

to do the right thing' and so educating physicians on the ethical boundaries

is the key issue here.

The AMA guidelines on industry gifts were approved in 1990 and state that

physicians should accept only gifts that have some benefit to patients, are

of modest value and come with no strings attached. In 2001, an educational

campaign was launched to remind doctors of these guidelines.

The Pharmaceutical Research and Manufacturers of America, which represents

about 80 drug and biotechnology companies, also believes the issue has been

effectively addressed.

PhRMA spokeswoman Wanda Mobius said the bills, which the organization

opposes, are unnecessary because of PhRMA's Code on Interactions with

Healthcare Professionals, a set of voluntary standards put in place in July

2002.

Under this code, meals that are 'modest by local standards' are allowed as

long as they are accompanied by an educational presentation or discussion.

Meals in which sales representatives provide food but are not present are no

longer considered acceptable.

'Anytime an industry self-regulates ... it's better than government

regulations that can vary from state to state and can cost more in the long

run, and that's money that could go into research and development,' she

said.

One lawmaker said his bill is meant to ensure that everyone abides by the

rules PhRMA established.

land state Delegate Chuck Boutin, an attorney and former mayor of the

city of Aberdeen, said the purpose of his bill is to ensure that

pharmaceutical detailers who behave ethically won't be put at a

disadvantage.

'All we're doing is codifying the ethics rules that already exist,' Boutin

said. 'What's the matter with codifying it in order to catch a few bad

apples?'

Money at the root

Other supporters of reporting bills say ethical behavior is challenged by

the money involved in drug marketing.

Drug companies spent $21 billion on marketing in 2003, Mobius said, compared

with $32 billion on research and development. Of the marketing portion, $2.6

billion was spent on advertising, leaving '18 point something' billion

dollars, of which 80% to 90% was spent on free samples.

Horn, meanwhile, cited a U.S. General Accounting Office study that showed

$16 billion was spent on direct marketing to physicians in 2001.

'That's outrageous by any measure,' he said, adding that the study also

revealed that direct marketing expenses rose 74% between 1997 and 2001 and

that the number of drug company detailers rose from 42,000 to 88,000 (110%)

during that same period.

Horn said this indicates that the industry's self-regulation efforts in 1990

failed, and he doesn't expect reforms instituted in 2002 to do better.

Art Kuebel, a former detailer from Washington state, agrees. He is

supporting the effort to get a gift-reporting law passed there.

'How many attempts are we going to be making in self-regulation?' said

Kuebel, who said he worked in the industry almost 16 years. 'There is a

do-what-it-takes-and-beg-for-forgiveness-afterward attitude which shows

there is little interest [in self-regulation].'

Kuebel said the impact of the PhRMA code is fading. 'There was a brief

period when there was a decrease in activity, but physicians I talk to say

there is a shifting back to the status quo.'

Fogarty, MD, said there has been no backward trend in Vermont, though

he is not sure if it's because of the state's reporting law or because of a

general shift among the parties involved. 'The days of the free trips with

no medical education associated with them are pretty much gone, I haven't

seen those in years,' said Dr. Fogarty, chair of the department of family

medicine at the University of Vermont in Burlington.

He said there have been changes as a result of doctors consciously choosing

to avoid gifts or activities that may increase costs or affect prescribing.

This included a decision by the Vermont Academy of Family Physicians to not

have a drug company sponsor its last annual meeting. Also, Dr. Fogarty said

the university has a 'counter-detailing' program where a pharmacist joins in

on drug company visits with residents.

Dr. Gold said he thinks legislators should focus more on regulating

direct-to-consumer advertising, which he said causes him to spend

substantial time giving patients the scientific explanation for why he's not

prescribing the drug they saw on TV.

Horn, however, said reporting bills are needed because of the unique way

prescription drugs are purchased -- a consumer takes the drug that another

person has chosen and another entity usually pays for.

'It's an artificial system that inflates the price of drugs, and it's been

pretty well accepted that this is a driver of high prices,' Horn said. 'It's

not really about consumers finding the information, it's about disclosure

discouraging improper gifts, which tend to result in prescriptions written

for the wrong reasons.'

American Medical Association

http://www.ama-assn.org/amednews/2004/03/01/prl10301.htm