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                 Just Say No?
     When Drug Companies Make Offers Doctors Can't Refuse
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          by Carla Atkinson and John Geiger
         _Public Citizen_ magazine, March/April 1991
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     Transcribed by Joe Woodard <[e-mail]>
          Reformatted and arranged by Harel Barzilai

Doctors didn't have to be frequent flyers to get free airline mileage in
the mid-1980s. They just had to prescribe a lot of one of the latest drugs
on the market.

The "Travel for Knowledge" program, sponsored by the Wyeth-Ayerst
pharmaceutical company, gave doctors 1,000 points every time they
prescribed the company's new heart drug and sent in information on their
patients.

When doctors worked their way up to 50,000 points -- put 50 patients on the
drug -- they hit the jackpot: free American Airlines tickets.

Glitzy promotions like these have prompted a congressional investigation
and sent medical and pharmaceutical groups hustling to address the ethical
questions involved. The pharmaceutical industry spends more than $8 billion
a year on new research and development, and spends almost as much marketing
its new drugs -- more than $5 billion last year in the United States alone.
Some say this expense is passed on to the consumer.

"I don't think physicians should be educated about drugs by drug
representatives who have an obvious vested interest in selling
pharmaceutical products," says one doctor. This situation leads to overuse
of drugs, drugs prescribed for the wrong reason and inflated drug prices."
Critics say drug marketing practices have evolved into slick, thinly-veiled
forms of bribery - fancy gifts, money or other compensation in return for
pushing new drugs.

Questions about the ethics of drug promotions are not new. The same Senate
Labor and Human Resources Committee that called for hearings in December on
the industry's promotional practices held similar hearings back in 1974.
Since then, the market has gone wild and so have the promotions.

The pharmaceutical industry's staunch defense is that doctors need to have
detailed, reliable information about the drugs they prescribe, and drug
companies are best equipped to give them that information.

Patients suffer if their doctors aren't up-to-date on new drug therapies,
Gerald J. Mossinghoff, president of the Pharmaceutical Manufacturers
Association, told the Senate committee in December. "Physicians today must
be far better educated and informed as to new drugs," he said. "Since the
1970s, whole new categories of drugs have been introduced."

He warned that if the industry is to continue as a world leader in new
drug research and development, its products have to find prompt,
widespread acceptance [sic; not "understanding" but "acceptance"
--Harel Barzilai] among doctors. "Responsible marketing and promotion are
essential to such acceptance," Mossinghoff said.

But more than a few witnesses appeared at the Senate hearing to say that
companies aren't sticking to responsible marketing methods.


    **************************************************************
    The network, funded by pharmaceutical companies, began offering
    doctors a $35,000 office computer system, free of charge .. to
    receive the free system, doctors just [sic] had to listen to
    several promotional messages each month, then punch responses into
    the computer - providing more marketing information for drug
    companies.
    **************************************************************
    "Doctors frequently don't know the intent of the drug companies,"
    Jones told Public Citizen. They think they are doing honest
    research, but often they are just gathering marketing
    information."
    **************************************************************

"Many patients are harmed by the pharmaceutical companies' practices," says
David Jones, a former pharmaceutical executive who testified at the
hearings. "The companies entice doctors into prescribing drugs that are of
no use to the patient."

According to Jones and others, companies often ask doctors to keep records
for them on patients taking new drugs. They then compensate physicians for
this "research," much as Wyeth-Ayerst did with its "Travel for Knowledge"
promotion.

"Doctors frequently don't know the intent of the drug companies," Jones
told Public Citizen. They think they are doing honest research, but often
they are just gathering marketing information."

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, came
to the hearings armed with examples of doctor bribery - most of them taken
from a "Doctor Bribery Hotline" he set up in 1990.

Wolfe told the committee he set up the hotline to encourage doctors, their
office staff, drug industry employees and others to give documented
examples of what he considers unethical activity.

The Physicians' Computer Network, Inc., is just one of those examples. The
network, funded by pharmaceutical companies, began offering doctors a
$35,000 office computer system, free of charge, in 1988, Wolfe told the
committee. To receive the free system, doctors just had to listen to
several promotional messages each month, then punch responses into the
computer - providing more marketing information for drug companies.

Wolfe also testified about the Wyeth-Ayerst/American Airlines promotion,
which was called to a halt after the Massachusetts Attorney General's
office investigated the program for possible violations of the Medicaid
False Claims Act.

If any doctor compensated by this kind of promotion prescribes drugs for
Medicaid or Medicare patients, the company involved may be violating a
federal anti-kickback statute.

Wolfe says there are too many identical drugs on the market to treat the
same disease. In order to survive the competition, a company is often
driven to outlandish lengths to present its product as superior to the
other drugs in that market when price may be the only difference, Wolfe
says.

But the American Medical Association assured the committee that
doctors are unlikely to compromise their objectivity. Doctors don't
"knowingly or intentionally compromise their patients' care as a
result of gifts from industry," [anymore than, say, a judge in a court
house, and others who are above mere Human trivialities like wealth --HB]
AMA representative Daniel H. Johnson, Jr., told the committee.

Gifts may make doctors more likely to listen to sales presentations and use
a new drug on a trial basis, but most won't continue to prescribe a drug
that doesn't work, added Johnson, a radiologist [Again, imagine anyone
saying such nonsense about a court judge. --HB]

But some doctors clearly see big dollar signs beneath drug company
education and research programs.

"There's definitely a conflict in the pharmaceutical companies between the
scientists and the marketers," says Dr. Charles van der Horst, a professor
in the Department of Medicine at the University of North Carolina at Chapel
Hill. "The scientists are out to better humanity and the marketers want to
make money."

    **************************************************************
    Their survey of medical faculty .. from 1977 to 1988 found strong
    statistical associations between conversations with drug reps,
    honoraria, travel and research grants "and whether a drug was
    recommended for formulary addition,"
    **************************************************************
    Some studies are "purely devices the companies use to get patients
    on their drugs," says Jones, formerly a vice-president at Abbott
    Laboratories
    **************************************************************

Drug companies are particularly interested, for example, in hospitals'
formularies, or the lists of drugs authorized to be used there, says van
der Horst. The physician committees that help select the drugs for these
lists are prime targets for companies' influence, he says.

Medical residents are also regularly bombarded by sales reps, Dr. Nicole
Lurie, who instructs residents and medical students in a teaching hospital,
told the Senate committee. She described "donut rounds," twice-a-week
sessions in which drug companies provide coffee and donuts while their
sales reps talk to residents.

[Next: direct-marketing to grade-school teachers about which brands of
notebooks are the best for the children they teach, including "bonus
systems" --HB]

Lurie and two colleagues investigated the industry-physician relationship.
Their survey of medical faculty at a number of university-affiliated
institutions from 1977 to 1988 found strong statistical associations
between conversations with drug reps, honoraria, travel and research grants
"and whether a drug was recommended for formulary addition," Lurie told the
committee.

The study led her to believe that marketing efforts are so effective "that
most physicians are unaware of the fact that they are being compromised."
David Jones, the industry defector who gave an insider's view of
pharmaceutical marketing at the hearings, says companies are more than
aware of the means they are using and the end they want to achieve.

Some studies are "purely devices the companies use to get patients on their
drugs," says Jones, formerly a vice-president at Abbott Laboratories and
executive director of public affairs at Ciba Geigy. This is particularly
true, he says, of maintenance drugs - those that chronically-ill patients
depend on to stay alive.

A cardiologist in New Jersey said in a recent interview that he shunned an
offer from a pharmaceutical company to do a drug study. "A new blood
pressure drug came out and they offered me money to do some research on
it," says the doctor, who preferred anonymity. "I had to get five people to
do the project."

Less than five patients, and the deal was off, the cardiologist says. "It
seemed fishy to me, so I didn't do the study." When a doctor is told to
send back only some information, Jones says, "like age, sex, test results,
it's not research, it's pure marketing. Real research involves reams of
information.

"I was proposing programs of this nature when I worked for the industry,"
says Jones, who is now a volunteer lobbyist in the North Carolina state
legislature for grassroots AIDS groups. "This stuff is routine with
pharmaceutical companies."

"Human beings and diseases become abstract concepts. This system
contributes to that and it has to be rectified."

That point has been driven home to several professional organizations in
the past year.

The AMA, the Board of Regents of the American College of Physicians and the
Pharmaceutical Manufacturers Association have all adopted ethical
guidelines for relationships between physicians and drug companies.

The PMA's "Code of Pharmaceutical Marketing Practices" says the industry
must use "complete candor" in dealings with health professionals, provide
scientific information with "objectivity and good taste... and with
scrupulous regard for truth," and comply with federal policies and
procedures.

"The pharmaceutical companies are marketing in a very responsible way,"
says Mark Grayson, PMA assistant vice-president. "In any industry you can
find isolated abuses, but damning a whole industry just isn't justified."

[How about damning a profit-based instead of human-needs-based system?]

The PMA code also endorses the AMA and American College of Physicians'
guidelines.

For its part, the AMA says textbooks, modest meals and other gifts are
appropriate if they serve "a genuine function.. and are not of
substantial value." [no doubt meals and other "gifts" *do* serve a
"function" as far as the Pharmaceutical industry making them is
concerned. --HB] Payments to defray the cost of attending conferences,
cash or "gifts with strings attached" shouldn't be accepted.

It does allow for "reasonable honoraria" and reimbursement for
"reasonable travel lodging and meal expenses" while attending symposia
or conferences.

"We believe there are two parts to enforcement of the guidelines --
education and grievance," says an AMA spokesman. "The first is to
inform the physicians of the guidelines. There were never any rules
[what does this say about the *system*? which is now still in place
despite cosmetic reforms?--HB] concerning the doctors and
pharmaceutical companies. We believe once the doctors realize there
are rules they will comply. [Just like once the corporations "realize"
that human beings are human beings they will stop exploiting them in
the interest of profits -- despite the fact that the profit-based
system (and profit-based economy as a whole) rewards precisely that --HB]

"The second, grievance, involves state and county medical societies in
every state. When a violator is reported to the societies, (they) will take
action. They can reprimand or expel the physicians, which would show up on
the National Practitioners Data Bank." The data bank, mandated by a 1986
law and overseen by the Department of Health and Human Services, stores
information on the conduct and competence of physicians nationwide.
Consumer advocates have criticized the effectiveness of the data bank
because CONSUMERS ARE NOT ALLOWED DIRECT ACCESS to its information.
[emphasis added. --HB]


    **************************************************************
    "The drug companies say drug prices are so high because of
    research and development costs. But they include most of the
    subtle bribes and marketing research in the R&D costs they submit
    to Congress in the hearings."
    **************************************************************
    "For the FDA not to have criminally prosecuted a drug company for
    advertising and promotional violations for 20 years, in the face
    of a massive amount of violative activities, is an invitation to
    continued lawbreaking," [ -- and speaks loudly about who owns our
    "represetatives" --HB]
    **************************************************************

Increasing attention to the ethical and health implications of "doctor
bribing" may lead to changes in a system that has had few checks and
balances. Rep. Pete Stark, D Calif., plans to introduce legislation through
the House Ways and Means Committee that would curb pharmaceutical
companies' influence over doctors' prescribing practices.

The legislation would disallow drug promotions as a business tax deduction,
says a committee aide. CURRENTLY, COMPANIES CAN DEDUCT ALL PROMOTIONS --
from pens and journals to conferences in the Caribbean -- as business
expenses. [Emphasis added --HB]

Stark's legislation "would be a step in the process of stopping this
practice of influence," the aide says.

Dr. van der Horst says Congress has been ignoring the problem for too long.

"Congress is putting on the blinders when it comes to this problem of
promotions," he says. "The drug companies say drug prices are so high
because of research and development costs. But they include most of the
subtle bribes and marketing research in the R&D costs they submit to
Congress in the hearings."

Consistent demand will always support higher drug prices, van der Horst
says, and taxpayers ultimately pay through inflated Medicare and Medicaid
costs.

Congress should demand a detailed breakdown of the drug companies' expenses
to discern legitimate research and development from marketing bribes, he
says. And pharmaceutical sales reps should be eliminated, says van der
Horst.

Public Citizen's Wolfe says HHS and the FDA need to enforce existing laws
to curb the industry's growing influence.

"For the FDA not to have criminally prosecuted a drug company for
advertising and promotional violations for 20 years, in the face of a
massive amount of violative activities, is an invitation to continued
lawbreaking," he says [Again, *that* the FDA acted in this way speaks
loudly about the system, still in place, our system of government and
the corporate control over it. --HB]

Wolfe also urged Congress to pass new laws to give HHS and the FDA more
jurisdiction and prosecuting power.

"Even if the FDA was to do a perfect job in deciding which drugs are safe
and effective enough for which diseases to merit approval for marketing,
Wolfe says, "the current criminal, unethical and immoral marketing
practices of many drug companies seriously undermine this aspect of FDA
regulation."

Some say the new guidelines will gradually make doctors more aware of the
ethical questions involved when drug companies come courting. And the
recent round of hearings may inspire Congress to change the way the
industry does business by making regulatory changes.

Regardless of how it happens, critics say the rules of the promotion game
have to be overhauled [How about eliminating any "promotion game"? --HB]

"Unless these practices are forcefully and promptly stopped, they will play
a major role in destroying American medicine," says Sidney Wolfe.

"There's a point that you really see what your decisions are doing to
people," David Jones says of the industry he left. "You don't see it from
the corporate suite or the corporate jet flying from city to city. "The
price of prescription drugs is determined by what the market will bear.
Pain and suffering and desperation will support a high price indeed."

----
John Geiger is a regular contributor to Public Citizen

******************************************************************

Public Citizen
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Washington, D.C. 20036
Founded by Ralph Nader in 1971

(Possible) email:

[e-mail]
  Lori Wallach
  Washington DC USA 20003
  (Public Citizen /Citizen Trade Watch)
  Keys: trade, harmonization

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Subject: F<O>CUS/HEALTH: Just Say No? Private Greed, Bribed Doctors (I)
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Date: Sat, 21 Aug 1993 21:00:17 GMT

Subject: F<O>CUS/HEALTH: Just Say No? Private Greed, Bribed Doctors (II)
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Subject: F<O>CUS/HEALTH: Just Say No? Private Greed, Bribed Doctors (III)
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Subject: F<O>CUS/HEALTH: Just Say No? (Conclusion)
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