New Studies Raise Questions About Quality of Drug & Medical Device Testing
In medical device and pharmaceutical lawsuits, plaintiffs often allege that the product manufacturer conducted inadequate testing on its product before releasing it on the market. Plaintiffs also claim that the manufacturer failed to conduct adequate post-approval studies to identify and prevent serious side effects. Now, a recent study published in a prominent medical journal lends supports to these assertions.
A May 2017 study, published in the British Medical Journal, reports that the FDA often approves new drugs based on limited evidence. The quality and quantity of post-approval studies also vary widely, raising questions of just how reliable the initial clinical evidence really is.
Researchers Look Into Quality of Post-Approval Clinical Trials
In this study, the researchers reviewed all new drugs approved by the FDA between 2005 and 2012 and identified whether the manufacturer performed any case-controlled clinical studies published after the drug was approved. The FDA approved 117 new drugs (for 123 disease indications for use) during this period. In each case, the FDA approved each drug based on a single pivotal trial.
While the FDA may require the drug manufacturer to conduct additional studies as a condition of the drugs’ approval, the studies are often targeted to address specific disease indications. For a drug that may cause problematic side effects for heart disease patients, for example, the FDA may require additional testing for patients with pre-existing cardiovascular disease.
Only 18.2 percent of the drugs reviewed in this study had at least one randomized, controlled, double-blind studies (with a primary endpoint of a clinical outcome) published after approval of the drug that showed superior efficacy for the approved indication. The manufacturers failed to conduct any additional trials for 43 (of the 123) disease indications. Where the manufacturer performed additional clinical studies, the number of participants varied widely, from only 38 to over 500.
Though doctors and patients have high expectations for the safety and efficacy of FDA-approved drugs, the authors noted that “less than one third of new drug indications approved by the FDA on the basis of a single pivotal trial had at least one post-approval trial showing superior efficacy; [and] even fewer used clinical outcomes.”
Other studies also appear to support the findings from the British Medical Journal study. For example, studies have shown that when “highly cited studies” are published, the results are often not validated by additional clinical studies that confirm the original findings. More than a third of the new drugs analyzed had “no published postapproval controlled studies investigating efficacy.”
Manufacturers Left Out Unfavorable Results
British Medical Journal published a similar study in June 2015, which reported that manufacturers of cardiovascular devices like pacemakers and defibrillators often submitted data to the FDA that did not always line up with the data obtained in their clinical trials. They found discrepancies in both the reported number of participants and in the results.
The manufacturers frequently left out unfavorable results from their FDA submissions and only provided the data that favored their drug. Even when these studies are published, the results can differ substantially from the manufacturers’ FDA summaries.
Finally, about half of the clinical trials for new high-risk cardiovascular devices remained unpublished over two years after FDA approval. The authors concluded that because much of the clinical trial evidence may be withheld from the medical community, doctors may be left unaware of the true clinical trial results.