Government standards are supposed to protect us from bad science. But it often doesn’t work that way.
There are many areas in which we are told to do things or not do things in the name of science. How we eat, what we are allowed (or required) to inject into our bodies, and what we may use for energy are all at stake. In that last sentence I was thinking first of Michelle Obama’s lunch program, as well as many government nutrition statements, then of the arguments about measles vaccines, and finally about global warming claims. There are many other areas that are also affected.
When you think consider the claims of science and government-sanctioned standards for science, you owe it to yourself to get acquainted with this paper by Chris Cresser: “Behind the Veil: Conflicts of Interest and Fraud in Medical Research.”
A couple of weeks ago I wrote an article called Why Are Scientists and the Public So Often at Odds? I described the frequent disconnect between scientists and the general public on controversial issues like nutrition, vaccination, climate change, and genetically-modified foods.
In that article, argued that both the general public and scientists were to blame for the disconnect. In some cases the public does act out of ignorance, whether intentionally or unintentionally; in other cases, scientists have ignored the very real limitations and problems with the research they rely on to reach consensus.
But now he wants to move to another topic as indicated by the title: fraud and conflicts of interest.
He starts by talking about the role of the Food and Drug Administration in overseeing the approval of drugs for market. The FDA is supposed to make sure the labs running the studies are compliant with regulations that are supposed to guarantee honesty. When labs violate these standards, they might do so unintentionally. In that case, the FDA inspector is supposed to record VAI, “voluntary action indicated.” But in cases of outright fraud, the recommendation is OAI, “official action indicated.” This means the government is supposed to sanction the rule-breakers.
Cresser then reports on researchers who used Freedom of Information Acts and other sources to find cases where the FDA had recommended an OAI.
They found 57 clinical trials that were directly linked to an OAI inspection.
The misconduct identified by the FDA in these cases included:
- Falsification or submission of false information
- Underreporting of adverse events
- Failure to follow the investigational plan or other violations of protocol
- Inadequate record keeping
- Failure to protect the rights, safety, and welfare of patients
- Use of experimental compounds in patients not enrolled in trials
- Failure to supervise clinical investigations properly
The 57 trials Seife identified were in turn linked to 78 research articles published in the peer-reviewed scientific literature. 96 percent of these articles failed to mention the violations identified by the FDA inspection—despite the fact that in the majority of cases the inspection was completed at least 6 months before the article was published.
Doctors, researchers, and other health professionals rely on scientific studies to establish treatment protocols and public health policies. If the data in some of these studies are fraudulent, but the doctors and researchers have no way of knowing that, the decisions they make may be unsound and even put people at unnecessary risk.
So, the FDA’s protection of science or of the public may well be practically non-existent. Scientific “findings” were reported despite false information and also despite unethical experiment on human subjects.
I don’t see any reason to expect the FDA’s area of science is practiced differently than any other area of official science.
The Cresser paper is much longer and details a great deal more problems. Anyone who assumes “science” is being done honestly and ethically is being naïve.
Such a person is vulnerable to political and marketing agendas. The FDA simply gives us a false sense of security and protects commercial interests.