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It Wasn't Always Like This
The Truth About the Drug Companies

TAGline - Volume 11 Issue 9 - September 2004

[excerpts from The Truth About the Drug Companies: How They Deceive Us and What to Do About It (Marcia Angell, 2004)]

"There used to be something faintly disreputable about really big fortunes. You could choose to do well or you could choose to do good, but most people who had a choice in the matter thought it difficult to do both. That belief was particularly strong among scientists and other intellectuals. They could choose to live a comfortable but not luxurious life in academia, or they could "sell out" to industry and do less important but more remunerative work. One of the results has been a growing pro-industry bias in medical research… and CME programs—exactly where such bias doesn't belong." (page 8)

"Many members of the FDA's eighteen advisory committees have financial connections to interested companies [see Who Evaluates and Licenses the Drugs You're Taking]. Although there are conflict-of-interest rules that prohibit participation in such cases, the agency regularly waives them on the unlikely grounds that someone's advice is indispensable." (page 210)

"Med ed writers and circuit speakers are often paid consultants for the drug companies. They are usually required to disclose financial ties [see Who provides you with up-to-date treatment information], and that disclosure is supposed to make it acceptable that they have them. But drug companies or their agents, the MECCs, often suggest the topic and speaker—and even put together the slides." (page 140)

"It's hard to believe that close and remunerative personal ties with drug companies do not add to the strong pro-industry bias in medical research and education. Big pharma not only controls the details of the way clinical trials are performed, but as backup, it also works to win the hearts and minds of researchers." (page 104)

"Drug companies are extremely generous to doctors in their 'education' activities… Doctors are invited to dinners in expensive restaurants or on junkets to luxurious settings to act as 'consultants' or 'advisors.' The doctors listen to speakers and provide some minimal response about how they like the company drugs or what they think of a new advertising campaign. That enables drug companies to pay doctors just for showing up [$1,000 a pop for the coveted high prescribers as of August 2004]. Participants may also receive training to serve on speakers' bureaus, so that they too can become company shills." p141

"Such gifts would trigger a red bribery alert in the mind of just about any public official or government contractor. But not, it seems, in the minds of many doctors." (page 128)

"Why do doctors pretend they believe drug companies are interested in education? (Some of them actually believe it.) The answer is: It pays. Doctors would lose the travel and entertainment and other emoluments too many of them have come to believe are entitlements to their profession. Many doctors become indignant when it is suggested that they might be swayed by all this industry largesse. But why else would drug companies put so much money into them?" (page 147)

"One of the more sobering indications of the extent to which big pharma has compromised the research community is its extensive inroads into the NIH itself. Senior NIH scientists routinely supplement their income by accepting large consulting fees and stock options from drug companies that have dealings with the institutes." (page 103)

"Congress also put the FDA on the pharmaceutical industry's payroll when, in 1992, it enacted the Prescription Drug Users Fee Act, which authorized drug companies to pay user fees to the FDA. These were to be employed to expedite the approval of drugs. They… soon accounted for half the budget of the agency's drug evaluation center. In the 2002 renewal, which was tacked on to a bioterrorism bill that swept through Congress without a murmur, the fees were increased to about $576,000 per NDA. User fees now account for about $260 million a year." (page 208)


Pharmaceutical Industry Revenue and Expense Breakdown, 2002 †
Research & Development $31 billion
Marketing $67 billion
Profits $36 billion
† Based on total worldwide sales of $217 billion.
Source: Public Citizen Congress Watch, "2002 Drug Industry Profits: Hefty Pharmaceutical Company Margins Dward Other Industries," June 2003 (cited in M Angell, 2004)
Pharmaceutical Industry
Marketing + Med Ed Outlays, 2001
Marketing $19.1 B
Free samples $10.5 B
Drug reps 5.5
DTC advertising 2.7
Medical journal ads .4
Medical Education and
Communications Companies ("MECC")		 $35.0 B
Total $54.1 B
Source: U.S. General Accounting Office, October 2002 (GAO-03-177); (cited in M Angell, 2004)

"How to Save the Pharmaceutical Industry—And Get Our Money's Worth"
Seven broad problems:
  1. Too many me-too drugs and too few innovative ones.
  2. The FDA is too much "in thrall" of the industry it is supposed to regulate.
  3. Drug companies have too much control over clinical research on their own products.
  4. Patents and other exclusive marketing rights are too long and too elastic.
  5. Drug companies control medical education about their own products.
  6. Key information about R&D, marketing and pricing is kept secret.
  7. Prices are too high and too variable.
Seven broad reforms:
  1. Shift the emphasis from me-too to innovation.
    • U.S. patent law should be enforced in its original form.
    • FDA regulations should require that new drugs be compared against existing drugs (and at equivalent doses) for the same conditions (and not just against placebos).
Angell: "If I could choose only one of the reforms I am suggesting, it would be this one. This change would have multiple beneficial ripple effects. And this is the one that could be accomplished easily by congressional legislation."
  1. Strengthen the FDA.
    • Repeal the Prescription Drug User Fee Act (or allow it to expire in 2006).
    • Increase public funding for the agency.
    • Exclude experts with financial ties to industry from the FDA's advisory committees.
  2. Create an institute to oversee clinical trials.
Angell: "I propose that an Institute for Prescription Drug Trials be established within the National Institutes of Health (NIH) to administer clinical trials of prescription drugs to ensure that clinical trials serve a genuine medical need and to see that they are properly designed, conducted, and reported."
  1. Curb monopoly marketing rights.
    • The clock on patents should not begin ticking until the drugs come to market. Then it might have a duration of, say, six years instead of twenty years from the time the patent was filed.
    • The law granting drug companies an extra six months of exclusive marketing rights for testing drugs in children should be repealed.
    • The loopholes in the Hatch-Waxman Act should be closed so that exclusivity cannot be stretched out for years.
  2. GET BIG PHARMA OUT OF MEDICAL EDUCATION.
    • Once and for all, we should clarify a simple fact: Drug companies are not providers of education—and they cannot be.
      No laws, regulations, or guidelines should be based on the idea that they are.
      The medical profession needs to take full responsibility for educating its members just as other professions do.
      There are a few simple steps to make this happen:
      1. Medical schools should teach students about drugs, not leave such education to industry-sponsored programs and teaching materials.
      2. Teaching hospitals should regard drug [.] reps just as they do other salespeople (who are not allowed to traipse around at will, promoting their wares and offering gifts and meals to medical students and doctors in training.]
      3. The profession needs to take responsibility for continuing medical education (CME). JUST AS THERE SHOULD BE NO PRIVATE CLINICAL RESEARCH INDUSTRY, THERE SHOULD BE NO PRIVATE MEDICAL EDUCATION INDUSTRY HIRED BY THE DRUG COMPANIES.
      4. Professional associations need to be self-supporting.
      5. Direct-to-consumer advertising should be prohibited in the United States—just as it is in other advanced countries.
  3. Open the "black box" of R&D and marketing costs.
    • The pharmaceutical industry should be regarded as a public utility: its books should be open.
  4. Establish reasonable and uniform pricing.
    • Drug prices should be not only transparent but reasonable and as uniform as possible for all purchasers.
    • President Bush's Medicare reform bill (2003) should be repealed and replaced by a simple measure that guarantees all Medicare beneficiaries appropriate coverage of their drug costs, with government-negotiated payments to industry and a medically based formulary.

Summarized from her book, The Truth About the Drug Companies: How They Deceive Us and What to Do About It (Marcia Angell, 2004)

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