That misconduct happens isn’t shocking. What is: 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.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

From the Slate article: Are Your Medications Safe?

In the past week or so, I’ve come across several important articles that will leave any rational observer increasingly skeptical of the entire medial industry in the U.S. This isn’t something I say lightly, and I think it’s an absolutely horrific development for our society.

Just last week, Liberty Blitzkrieg published an article titled, Introducing “Physician Dispensing” – The Latest Troubling Medical Industry Scam, which expounded on why an erosion of trust in doctors is so troubling. If you missed that piece, I suggest going back and reading it. Here’s an excerpt:

Once the corruption reaches a certain level of societal saturation, you create a culture in which people simply stop trusting everyone and everything. For obvious reasons, this is a very dangerous development. There are people whom you need to trust for any civilization to function reasonably well. Police are one, but doctors are another. I can speak for myself when I say that I am not convinced that any medical professional I see has only my best interests at heart. I seriously wonder how he or she is balancing my health with the ability to earn more money. From conversations with friends and family, I have found that this is much more widespread than we would like to admit. This is incredibly bad and incredibly sad.

While that article was bad enough, it is nothing compared to what I just read by Charles Seife, a journalism professor at New York University. He and his students set out to research the FDA and how it deals with evidence of fraud and misconduct in pharmaceutical drug trials. What he found will shock and disturb even the most hardened cynic. If you are one of the 70% of Americans that take at least one prescription drug, brace yourself…

From Slate:

Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wildvideo. It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing. Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching. That misconduct happens isn’t shocking. What is: 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. We didn’t have to search very hard to find FDA burying evidence of research misconduct. Just look at any document related to an FDA inspection. As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted. My students and I looked at FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only roughly 100 cases were we able to figure out which study, which drug, and which pharmaceutical company were involved. (We cracked a bunch of the redactions by cross-referencing the documents with clinical trials data, checking various other databases, and using carefully crafted Google searches.) For the other 500, the FDA was successfully able to shield the drugmaker (and the study sponsor) from public exposure.

Think about that. Despite all that digging, they were able to link questionable data to specific drugs in only 20% of the cases examined.

As usual, it’s all about protecting corporate profits. America’s new religion.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

For related articles, see:

First is a MUST WATCH hilarious video by John Oliver: Video of the Day – John Oliver on Pharma Company “Marketing to Doctors”

Fraud Alert: FDA Allowed Drugs with Fraudulent Testing to Remain on the Market

The FDA is Caught Spying on its Employees and Creating an “Enemies List”

Introducing “Physician Dispensing” – The Latest Troubling Medical Industry Scam

In Liberty,

Michael Krieger



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