Proposed Rules Give Drug Companies Less Cover to Hide Harms During Trials

Clinical trials are the scientifically rigorous process by which drugs and medical devices are tested for how well they work and the risks they pose before the products are allowed to be marketed. Recently, the data from a lot of clinical trials sponsored by industry (that is, companies with a stake in the outcome) have come under fire, and now the feds are proposing rules to address that dangerous situation.

Readers of this blog might recall that one drug maker, Boehringer Ingelheim, hid the uncontrolled bleeding it knew was happening during its trials of Pradaxa, a blood thinner. Other industry trials have resulted in reports that were ghostwritten, that deliberately minimized harms and journal stories containing material planted by drug manufacturers.

As reported by, the rules proposed by health experts are intended to expand significantly how much information resulting from drug trials researchers and drug companies must provide to the public.

The U.S. Department of Health and Human Services (HHS) has issued a Notice of Proposed Rulemaking that defines the proposed changes. You can see it here, and the public is welcome to comment until Feb. 19.

As explained by AboutLawsuits, the pertinent law “requires [that] certain clinical drug trials in the U.S. be registered with and that summary results be submitted for public access. The site is administered by the National Institutes of Health, part of DHHS. Publication of the information and summary results is seen as a guard against publication bias and other biases that could affect the studies’ conclusions.”

The most significant change is the expansion of how much information must be provided on adverse events detected during the clinical trial. Previously, researchers were obliged to provide only two tables on adverse events that occurred during the trials – one depicting all serious adverse events, and one depicting all adverse events that exceeded more than 5 in 100 subjects within the study group.

The proposal requires much more data on adverse events including:

  • the time frame during which adverse event data were collected;
  • how adverse event data was collected;
  • a table listing participant deaths from any causes;
  • a determination on whether the adverse event was caused by drug being investigated.

Also, summary results must be submitted to whether or not a drug has been approved by the FDA. Currently, clinical drug trial results are required only if the drug has been approved, licensed or cleared for marketing by the agency.

The reasons for this provision are, according to the New England Journal of Medicine, “to reduce bias in publicly available information about investigational products stemming from selective disclosure of results, to assist those attempting to assess the benefits and harms of entire classes of drugs or devices, to avoid unnecessary duplication of trials of products shown to be unsafe or ineffective, and to inform the description of potential risks and benefits provided in consent forms for future studies.”

One hopes this would eliminate scenarios like that of Pradaxa. After it hit the market, the FDA was flooded with reports about patients bleeding to death. Data later turned up suggesting that the drug accumulates in patients with decreased kidney function, and that they might need monitoring in order to use the drug safely.

An investigation last year by the British Medical Journal unearthed internal documents from Boehringer Ingelheim noting that the risk of bleeding events could be reduced as much as 40% with more blood monitoring, but in its commercials, the company promoted the drug as requiring less monitoring than competing products.

Boehringer Ingelheim paid about $650 million to settle more than 4,000 Pradaxa lawsuits filed by patients charging that warnings and information about the bleeding risks were inadequate. The company was sanctioned by a federal judge for withholding evidence of bleeding risks.

Although pharmaceutical companies see these adverse legal outcomes as the cost of doing business (they make a lot more in drug sales than they pay out in penalties), there’s no question more rigorous trial requirements must be imposed if for no other reason than to reinforce that such behavior is not only immoral, but illegal.

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