University News

Industry leaders debate pros, cons of Rx drug regulation

By
Contributing Writer
Friday, October 9, 2009

The government’s role in the pharmaceutical industry — either highly regulative or uninvolved, leaving the industry to police itself through competition — was the subject of a Janus Forum-sponsored debate Thursday night before a half-full Salomon 001.

The event, “Doing Good or Doing Well: Responsibility in the Pharmaceutical Industry,” featured two medical professionals with opposing views on regulation. Marcia Angell, a senior lecturer in the department of social medicine at Harvard and the first female editor-in-chief of the New England Journal of Medicine, argued that drug companies primarily serve their own interests of profit-making with little regard to fulfilling “social responsibility.”

The other panelist, Mary Ruwart, who served as a research scientist for 19 years with Upjohn Pharmaceuticals, suggested government regulations force companies to raise drug prices in order to sustain the costs of research and development.

Angell spoke first, basing the majority of her argument on the claim that the industry’s “aim is almost always to make sales,” so it is not responsive to community health needs.
In response to the industry’s argument that high prices result from the heavy cost of research and development, Angell cited statistics showing that the major pharmaceutical companies spend much more on marketing than on they do on research.

She also refuted the argument that high prices are necessary for innovation. She referred to a study between 2000 and 2007 showing that drugs that were both innovative and reflected improvement over a placebo in trials constituted only 11 percent of total Food and Drug Administration approvals.

Because the FDA approves drugs by comparing their effect to a placebo, she said, a new drug simply “has to be better than nothing” to be released. As a result, “me-too drugs,” which are “trivial variations” on existing marketable drugs, arise. Many of these variations are created for “vague, chronic” conditions — like erectile dysfunction, acid reflux or shyness.

For those drugs that are innovative, she said the majority of breakthroughs come from labs funded by the National Institutes of Health. Drug companies then develop the drugs and “expect to be rewarded as if they were the source of the innovation.”

Ruwart countered Angell’s depiction of drug companies as solely profit-driven, saying that both the “stockholders and society” must be accommodated. She said FDA regulations drive up prices of development and force rapid increases in drug expenses. 

“There is a direct correlation between what we pay in the pharmacy and what the pharmacy pays in research and development,” she said. Without FDA regulations, projections show, pharmacy prices would be 85 percent lower.

“When we look at social responsibility,” Ruwart said, “we also need to look at the environment in which it works.” Owing to government regulation and long development periods, she said, “some people literally die waiting” for FDA approval of drugs.  

By suggesting Congress legislate regulations “requiring companies to compare” new drugs with existing drugs, Angell said more resources would then be diverted to new drug research for approval. 

Ruwart disagreed, saying that government regulation must be limited before prices can be lowered.

“Competition is a better regulator than Congress or the FDA,” she said.

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