Nobody Should Volunteer for Clinical Trials While Research Data Is Secret

12/18/2013 09:45

by Vera Sharav


In their compelling Op Ed article in The New York Times, "Drug Data Shouldn't Be Secret", Peter Doshi and Tom Jefferson, take their case advocating for clinical trial data disclosure to the wide public. They describe how pharmaceutical companies like Roche, manufacturer of the drug, Tamiflu, get away with generating false claims about the safety and effectiveness of their products when published in medical journals whose peer-review process is supposed to ensure scientific honesty. Pharmaceutical companies do so, by concealing the data from their trials, which they alone control--thereby undermining the integrity of the peer-review process and the credibility of the published reports.

Despite evidence exposing corrupted peer-review process, company-generated assertions in medical journals about safety and efficacy of drugs, vaccines, and medical devices, journal reports are presumed to be science-based. Indeed, those largely unsubstantiated assertions in journals form the basis for medical practice guidelines and public health policies which may--and often have--proven harmful to our health and also to our fiscal policies.

The authors sought Tamiflu data which Roche promised, but did not honor. They sought access to data from 10 clinical trials, 8 of which had not been published a decade after completion, representing more than 4,000 patients from every continent except Antarctica.

But, as the authors correctly note, by law, companies are required to disclose to the FDA all clinical trial data pertaining to drugs for which they seek a license to market. But the FDA has never required drug or medical device manufacturers to share their data with independent researchers or academics.  In fact, the FDA treats the company data as secret and proprietary. In effect, the FDA collaborates in the concealment of vital drug safety information.

FDA's assessment of the data submitted by Roche shows that Tamiflu is of minimal benefit--no more than aspirin. In adults, the label states, "there was a 1.3 day reduction in the median time to improvement in influenza-infected subjects receiving TAMIFLU compared to subjects receiving placebo."  In geriatric patients there was a  1 day reduction, and in children 1.5 days compared to placebo. The  label states that "Tamiflu has not been shown to prevent serious bacterial infections" (for instance, pneumonia). 

As a result of data secrecy, the public interest--both health and fiscal--is ill served when government agencies, lacking access to the scientific data, make public health policy decisions based on the false assertions in medical journal reports because they put their trust in the integrity of the peer- review process.

So why, did the US government stockpile this drug paying more than $1.5 billion at taxpayer expense?  Because officials of the US Centers for Disease Control, the Dept. of Health and Human Services, and the World Health Organization disregarded FDA's efficacy assessment. They issued pronouncements--without supporting data--declaring that the drug was effective in reducing the duration of hospitalizations, reducing serious complications (such as pneumonia), cutting transmission of the virus.  Roche didn't need sales reps to convince doctors to use their drug--authoritative public health agencies were Tamiflu's best emissaries.

Company controlled clinical trial data has been accessible during legal litigation in the US many years after the drugs have been marketed and have caused harm. Invariably, the data has contradicted safety and efficacy assertions in journal reports, which explains why manufacturers routinely conceal the data.

Although the authors focus on their experience in trying to obtain Tamiflu data from Roche, they make the case that public trust in public health policies can only be won if the scientific basis informing those policies--namely, the data documenting the risks and benefits--are made public and open to independent analysis.

Human beings who volunteer to serve as research subjects have been led to believe that their sacrifice--undertaking risk and discomfort--will serve a humanitarian purpose. If sponsors of research are not compelled by law to disclose the data from those trials--the integrity of the research is thrown into doubt. Absent the humanitarian raison d'etre for enrolling in a clinical trial, no human being should be put at any--even minimal risk--without adequate compensation as a laborer and the protection of Workmen's Compensation insurance.