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CAUT Bulletin Archives

November 2015

The long arm of Big Pharma

Navindra Persaud won’t prescribe morning sickness drug, but Health Canada won’t let him say why

Navindra Persaud has never shied away from standing up for what he believes in and medical ethics is at the top of that list.

In 2004, as a second year medical student at the University of Toronto, he blew the whistle on questionable content in a mandatory course in pain management given by the university.

The required lecture series was sponsored by a drug company that manufactured opioids — pain killers that are known through prescription names like Oxycontin or Vicodin. Persaud noticed the course’s reference book was funded by the drug company and discovered the lecturer leading the course had worked as a consultant for the drug company.

Worried that the risks associated with the pain killers were downplayed, Persaud complained to the upper ranks of the medical school.

“The lecture series was eventually cancelled (in 2010),” says Persaud, now a family doctor at St. Michael’s Hospital and assistant professor at the U of T.

Even though the alleged conflicts of interest with that particular course were resolved, Persaud believes that undue corporate influence persists in Canada’s medical schools.

He says he has been contacted by colleagues at other universities grappling with how best to manage drug industry involvement in medical education.

“We should ask ourselves: why do we have publicly funded universities? And we should ground our policies, culture and actions on the answer to that question,” he adds.

Persaud later wrote about his medical student experience in the Journal of Medical Ethics, arguing that better processes are needed for preventing, identifying and dealing with apparent conflicts of interest between the pharmaceutical industry and undergraduate medical education.

Back in his student days, he was whistleblowing on a pharmaceutical company’s influence on course content. Today, as a practicing physician, his attention has turned to Big Pharma’s influence on federal regulators.

He says it’s taken him four years to get access to clinical trial data about the use of Diclectin as a morning-sickness drug being held by Health Canada.

“I wanted to know if the drug was both safe for pregnant women and effective at treating the nausea and vomiting of pregnancy,” Persaud said.

He first obtained hundreds of pages of heavily censored documents in response to a 2011 freedom of information request, but notably absent were any of the adverse events data, withheld by Health Canada.

Earlier this year, he made his request again, this time under the new Protecting Canadians from Unsafe Drugs Act.

In September, Health Canada finally released the documents to Persaud but has required him to sign a confidentiality agreement, preventing him from speaking about the data or referencing it publicly, with the threat of legal action if he did.

After reviewing the data, he says he now believes Diclectin is not effective. But because he’s muzzled he can’t discuss why.

“I had to sign a strict confidentiality agreement that prevents me from sharing the information,” Persaud said. “This makes it difficult for me to do my research.”

He is trying to amend the agreement so he can publish his findings in a medical journal. The findings can’t be published in a peer-reviewed journal, because he can’t submit underlying research analyzing the data.

Persaud co-authored an article published last month in the Canadian Medical Association Journal calling for public regulatory agencies, like Health Canada and the U.S. Food and Drug Administration, to make clinical trial data publicly available.

Even though disclosure does not violate Canadian law, or even any international treaties, Persaud says Health Canada repeatedly refuses to disclose information.

The refusal, he notes, is often made on behalf of the drug industry in order to protect “confidential business information.”

According to Persaud, withholding the results of clinical trials from public scrutiny supports unethical research conduct. Without open access to clinical data, he argues research that is reported can be skewed to benefit a drug’s efficacy and play down side effects.

“Suppressing clinical trial data is wasteful and may expose patients to unnecessary or to ineffective treatments,” Persaud writes.

Other countries are already calling for more transparency on drug trials. Europe’s drug regulator, the European Medicines Agency, recently revised its data disclosure provisions to allow third parties to examine and verify data and even challenge the findings.

Persaud is pushing for this shift to make its way to Canadian regulators. “I am going to try to ensure that people have access to accurate, complete and balanced information about medications,” he said.

Will he continue to prescribe Diclectin to his patients?

Persaud’s short answer is “no.”

Why? For reasons he’s not at liberty to disclose.