cow hunting

If your doctor trusts the drug company data you can’t trust your doctor. That is the reality of “evidence-based medicine.”

An interview I heard on the radio a week ago finally resurfaced from what rattles around below the surface of my memory. The warnings about drugs apply also to medical devices. “The overwhelming majority of medical devices that are on the market, that are implanted in patients, undergo no clinical trials,” journalist and author Jeanne Lenzer says.

>Did you know…

  • Medical interventions have become the third leading cause of death in America, killing more Americans each year than diabetes, murders, car accidents and AIDS combined.
  • You might think medical devices—like pacemakers, artificial hips, cardiac stents, etc.—don’t have side effects like drugs do. Nothing could be further from the truth.
  • The FDA does not require clinical testing for most high-risk implanted devices, and only 5% of the highest risk cardiac devices undergo the equivalent of the standard requirement for drug testing: two randomized, blinded clinical trials. Patients serve as unwitting test subjects to determine whether devices are safe.
  • Tens of millions of Americans have an implanted medical device, and yet the death rate caused by these devices is unknown, because no one is keeping track. Not the FDA. Not the manufacturers. Not hospitals. Not doctors.
  • The FDA habitually defends the interests of industry over the public interest, in part due to the “revolving door” between the businesses being regulated and the FDA. (https://www.jeannelenzer.com/the-danger-within)


Back to the clickbait subject, drugs.

Examples of Methods used Pharmaceutical Companies to Get the Results They Want from Clinical Trials:

Conduct a trial of your drug against a treatment known to be inferior.

Trial your drugs against too low a dose of a competitor drug.
Conduct a trial of your drug against too high a dose of a competitor drug (making your drug seem less toxic).
Conduct trials that are too small to show differences from competitor drugs.
Use multiple endpoints in the trial and select for publication those that give favourable results.
Do multicentre trials and select for publication results from centres that are favourable.
Conduct subgroup analyses and select for publication those that are favourable.
Present results that are most likely to impress—for example, reduction in relative rather than absolute risk.

(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1140949/)

The much bigger problem lies with the original studies, particularly the clinical trials, published by journals. Far from discounting these, readers see randomised controlled trials as one of the highest forms of evidence. A large trial published in a major journal has the journal’s stamp of approval (unlike the advertising), will be distributed around the world, and may well receive global media coverage, particularly if promoted simultaneously by press releases from both the journal and the expensive public-relations firm hired by the pharmaceutical company that sponsored the trial. For a drug company, a favourable trial is worth thousands of pages of advertising, which is why a company will sometimes spend upwards of a million dollars on reprints of the trial for worldwide distribution.

Overall, studies funded by a company were four times more likely to have results favourable to the company than studies funded from other sources. In the case of the five studies that looked at economic evaluations, the results were favourable to the sponsoring company in every case.

 

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