How Government Protects The Drug Companies: FDA Keeps Malfeasance Secret
Hah -- did you think government is there to protect you?
The latest bit of evidence that this isn't the case comes from The Verge. Elizabeth Lopatto reports that the FDA doesn't tell you when there's been scientific fraud. ("Out of sight, out of mind, out of the peer-reviewed literature"):
In at least 57 clinical trials conducted from 1998 to 2013, the US Food and Drug Administration found evidence of falsification, problems with reporting side-effects, inadequate record-keeping, and more. But only three of the resulting 78 publications monitored in today's report mentioned the misconduct uncovered during inspections. And no corrections, retractions, or other comments were added after publication. The author of today's report blames "regulatory capture" for the lapse, or a type of corruption where a public agency protects the interests of the groups it's meant to regulate rather than the interests of the public at large....The misconduct itself isn't so surprising, writes study author Charles Seife, who is also a journalism professor at New York University. Here's what he says is surprising, though:
When the FDA finds scientific fraud or misconduct, the agency doesn't notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.In at least one case, falsified data led to a patient's death, in a trial that compared chemotherapy regimens. In another trial, describing a stem cell treatment in 26 patients, all patients were described as having improved, even though one later had to have a foot amputated two weeks after being treated. And in yet another case, the FDA considered the entire clinical trial unreliable -- which wasn't noted in the publication.
What that means is that patients and doctors are left uninformed by the agency that's meant to protect them.
via @TimCushing
Wow. If this is corroborated, it's huge.
Cousin Dave at February 10, 2015 8:09 AM
The FDA is like the *layers of editors and fact checkers* at the New York Times.
You need a strong background, probably a doctorate level, in statistics, and the scientific method and pharmacology in order to understand, and peer review a drug study.
Most the people able to do this aren't working for the gubmint.
Isab at February 10, 2015 9:46 AM
Corporations and government, working together to build a better America.
Gog_Magog_Carpet_Reclaimers at February 10, 2015 11:47 AM
"You need a strong background, probably a doctorate level, in statistics, and the scientific method and pharmacology in order to understand, and peer review a drug study."
I suggest that this is the case for this report, also. The article is not enough to do more than start asking for changes in how business is done.
Radwaste at February 10, 2015 1:46 PM
that this is the case for this report, also. The article is not enough to do more than start asking for changes in how business is done.
Posted by: Radwaste at February 10, 2015 1:46 PM
Recognizing that a study is bogus is actually pretty easy, if you can recognize cherry picking, faulty assumptions, bad math, and sample sizing issues.
Constructing a valid study and accounting for all the unknown unknowns, is about four orders of science above that.
The Lancet has a particularly bad track record, but it wouldn't surprise me if most of the drug studies in the US are just as bogus.
Isab at February 10, 2015 3:10 PM
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