CAMPAIGNING FOR FULL DISCLOSURE

In a time that personalized medicine is gaining popularity, the effects and efficacy of traditional pharmaceutical drugs is coming under question. In particular, access to information about these traditional drugs is becoming a bigger and bigger issue amongst health care providers and practitioners.

Pharmaceutical drugs typically go through three phases of clinical testing, (called Phase 1, 2 and 3 clinical trials) to determine the efficacy and side effects of the drug being developed. For each phase of the trail, a study occurs in which there are results, both positive and negative, that are recorded. Of all of these reports, less than half are published.

While this has been a known fact in the industry for quite some time, just recently an organization in the U.K. spear-headed by Ben Goldacre, a British physician, academic and the author of “Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients,” has taken up a cause to have all drug companies legally obligated to publish in total transparency all clinical trial results.

The campaign, called All Trials, has gained traction with almost 50,000 signatures on record, including drug giant GlaxoSmithKline. The majority of signatures are from physicians and research organizations that prescribe the pharmaceutical drugs to patients. Its goal is to have greater transparency and accountability within the drug development process.

Due to the lack of data regarding the clinical results of many drugs on the market, health care practitioners feel that their decisions when buying drugs and prescribing drugs are inhibited by a lack of information. Studies have shown that trials with significant positive results are more likely to be published than those with non-significant or negative results. This publication bias also carries over into the sale of the drug resulting in the prescription of drugs that may be more expensive and not ideal or effective for the patient taking them.

“It would mean that all of the data is available rather than just the data that companies want to make public. That would mean that meta-analyses and clinical guidelines would be based on all of the available knowledge and in my opinion would mean that doctors’ prescribing would be improved and patients’ would be more likely to be helped by the medications that they get and less likely to be harmed,” says Lexchin about the positive consequences of having the industry publish all results from their trials.

Though it has received more publicity in the U.K., the issues raised by the All Trials campaign have special significance to the Canadian industry. According to Dr. Joel Lexchin, practicing physician and professor at York University, unlike the FDA and the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., Canada has no registration or regulatory system for the publication of clinical trials. This means that any Phase 1, 2 or 3 trial conducted by a Canadian pharmaceutical company does not need to be registered with HealthCanada. Therefore, companies can publish, or not publish, whichever trial results they wish.

Recent attention in the media regarding the ‘muzzling’ of Canadian scientists and incomplete sales pitches to physicians by pharmaceutical salesmen and women that disregard negative side effects of drugs raise even more questions about the All Trials debate. According to a recent Maclean’s article (Nov. 2012), American pharmaceutical companies are subject to a fine of $10,000 per day for trials failing to register or report the results of clinical trials. In Canada, only federal funded research is subject to such requirements, with industry, this is not the case. There are portals that exist to facilitate registration or reporting of clinical trial results, such as clinicaltrials.gov and the International Federation of Pharmaceutical Manufacturers and Associations’ Clinical Trials Portal, however, publication is not mandatory for Canadian firms.

According to Lexchin, HealthCanada has considered setting up its own online registration system as far back as 2005, but nothing has come to fruition. Regarding the All Trials campaign itself Lexchin notes that the agency has remained silent.

While there are a number of reasons Canadian pharmaceutical and biotech companies may not wish to publish their trial results, whether for time, expense or issues regarding publication bias, the lack of transparency raises important questions about our regulatory environment that echo the goals and aspirations of the All Trials campaign in the U.K.

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