Wednesday, June 01, 2005

Medical Whistleblowers' Roundtable

PLoS Medicine just published a summary of a round-table discussion by notable whistleblowers about pharmaceutical companies' research and marketing practices, with an accompanying editorial. (The on-line journal stepped in as a sponsor 10 days before the conference, after the unnamed journal that originally was going to sponsor the meeting pulled out on its lawyers' advice.)
The conference underlined some of the issues that have appeared on Health Care Renewal. Some notable quotes:
  • Betrayal of Mission: According to David Graham (who raised concerns about the safety of Vioxx), The US Food and Drug Administration (FDA) is in a "collaborative relationship" with pharmaceutical companies. A senior FDA official told Graham, "industry is our client." The public may be excused for thinking that they are supposed to be the FDA's clients.
  • Tactics to Increase Likelihood of Favorable Results: Several participants talked about specific tactics used by some pharmaceutical companies to increase the likelihood that research results will be favorable to their products. An anonymous industry scientist noted that it takes only two positive studies to get FDA approval. But if a study has bad results, "typically a company is not going to publish the study at all." Furthermore, he said "drug companies assiduously avoid acquiring information about side effects." Patients who have increased risks of side-effects "are excluded from studies deliberately, even though, when the drug is approved, these patients will be targeted for sales." He also charged that studies are deliberately designed to be too small, or be over too quickly to detect serious adverse effects.
  • Conflicts of Interest: Several participants suggested how drug companies convey money to public officials to influnce state level decisions about drugs. One charged that officials who were responsible for writing state guidelines about psychiatric treatments could access a secret account financed by drug companies. He was told, "Look, drug companies write checks to politicians, they write checks to politicians on both sides of the aisle - back off." He was then advised, "quit being a salmon, swimming against a stream."
  • Ghost-Writing: The anonymous industry scientist described the process of ghost-writing, "When studies are published, they are frequently written not by the trained research scientist, who might have designed and analyzed the study, but by a designated medical writer with little if any backgroun in research, but who is trained instead to craft the findings of the study in the best possible way for the company."
This is important additional evidence about how deep these problems run. Solving them will take a lot of salmon.

2 comments:

InformaticsMD said...

On "Tactics to Increase Likelihood of Favorable Results", where several participants talked about specific tactics used by some pharmaceutical companies to "assiduously avoid acquiring information about side effects," my recent job-seeking experience (including in in adverse events data management) suggests another tactic:

Ignoring the field of Medical Informatics.

-- SS

00slick said...

The fact is that the medical industry has an unjust advantage over the American consumer and uses that to make money in a manner that kills hundreds of thousands of people, every year. That's fraud, which is a felony, which makes the deaths of the victims, homicide.