The public depends on the FDA to ensure that medicines are safe and effective, but through many months and almost 30,000 words of reporting, our “Drug Problems” investigation has revealed dangerously lax FDA oversight of prescription drugs. POGO’s ongoing, multi-part investigation shows that the FDA has:
-
set low standards
-
approved drugs based on flawed clinical trials
-
taken a toothless approach toward doctors who violate standards of clinical trials
-
allowed misleading marketing
-
provided inadequate warnings about drug hazards
-
slighted reports of drug-related deaths and injuries
-
made other dubious judgments that advanced the interests of pharmaceutical companies while putting patients at potentially deadly risk.
Our coverage is based in part on thousands of pages of FDA documents, many obtained through the Freedom of Information Act, and analyses we conducted based on data sets that we merged. The reporting has taken us deep into the science of experimental drugs and the technical details of clinical research. Our work was inspired by patients such as Sidney Denham, whose hospital records say he bled to death as a result of taking an FDA-approved drug.
We wanted to find out how well the FDA has done the difficult job of vetting drugs and balancing risks. We found that, in some manufacturer-sponsored clinical trials, experimental drugs looked good largely because the experiments were skewed in their favor. One such trial was led by President Obama’s nominee to head the FDA. We found that the FDA rarely imposes sanctions on doctors who mismanage clinical trials, even when FDA inspections uncover violations of the most serious kind. A clinical trial we examined in depth employed dozens of doctors who had been faulted by the FDA in inspections of prior clinical trials, including repeat and even three-time offenders. We found a blurring of lines between the regulators and the regulated.
Members of FDA advisory committees had financial ties to pharmaceutical companies; some advised the agency to approve a particular company’s drug and went on to receive substantial compensation from that same company. We found that the FDA has set a low bar for new drugs. To win FDA approval, drug makers are supposed to show that the new drug is “non-inferior” to one already on the market. However, we found that the FDA uses that term loosely. In the case of one widely advertised drug, the FDA set the bar so low that the product could be approved if it was proven only 50 percent as good as a drug that has been in use since the 1950s.
The first installment in our series told the story of one drug’s journey from clinical trial to FDA approval and beyond. Our 20,600-word, 17-segment report on Pradaxa, a blood thinner with blockbuster sales, explained the system and illustrated many of the problems. We presented the reporting online in a format we devised to enable readers to absorb our findings in brief or explore them in depth. The package we published on Oct. 15 was backed up with more than 400 notes on sources and other extra information. A second installment in the series told the story of another drug, Xarelto, which the FDA approved in 2011 over the objections of the main FDA scientists assigned to evaluate its safety and effectiveness. A third article in our series exposed a potentially crippling flaw in the Xarelto trial that the FDA evaluators seem to have overlooked. Our reporting continues.