But is it Safe?

BY MIKAYLA PLISHKA

Deadly, dangerous, ineffective, unproven:  four terms that no one wants to read on the back of their bottle of medication. Pharmaceutical manufacturing is the most profitable industry in the United States1. Since most Americans depend on pharmaceutical products for their well-being, they are willing to accept certain costs for the peace of mind that comes with the belief that their medication is safe and reliable. This belief, however, is often misplaced, since drug trial results can be hidden or manipulated.  In other words, “no news” does not necessarily mean “good news” when it comes to drug safety.

Due to the sheer size of the pharmaceutical industry, regulation has been difficult, with self regulation being the dominant regime1. When a drug is successful, the pharmaceutical company funding the research receives an exciting return on its investment. When a drug proves to be harmful or ineffective, the investment can turn out to be a mistake worth millions of dollars. For this reason, there are enormous pressures  for researchers working in pharmaceutical companies to produce positive results. Even researchers working independently in universities may face these pressures if receiving funding from pharmaceutical companies.  At the same time, a researchers curriculum vitae is judged based on the number of publications and amount of money the researcher has attracted. Often, producing usable research for a pharmaceutical company leads to financial and professional rewards for academics and their institutions1. These pressures can often lead to biases in analyses, or worse, outright fabrication.

The pharmaceutical industry showed its dark side in a 1996 dispute between Apotex and a University of Toronto researcher, Dr. Nancy Olivieri. Olivieri, head of the Hemoglobinopathy Research Program, became aware of some concerning side effects of a drug she was monitoring during a clinical trial. She decided that it was crucial that she inform the patients receiving the drug of the discovery, despite the confidentiality agreement she had signed with Apotex.  At the same time, the University was in the midst of negotiating a 20 million dollar deal with Apotex. As a result, they did not support Olivieri’s decision to inform the patients and she was dismissed from her role as the head of the Hemoglobinopathy Research Program. Fortunately, she was cleared of any misconduct five years later1. The events involving Olivieri demonstrated the pressure put on researchers to produce positive results during drug trials.

Furthermore, pharmaceutical companies have the power to determine what results are published. It is common practice for them to engage in “selective reporting” in which they publish favourable results. A look at 2008s 74 FDA-registered studies of antidepressants published in the Journal of the American Medical Association revealed that 37 out of 38 positive studies were published whereas only 3 out of 38 negative ones were published1. As a consequence of this publication bias, those that read the journal will develop a skewed perception of what works. As far as the public can see, the drug is safe and effective.

Recently, a highly trusted antiviral medication faced scrutiny regarding its true effectiveness. Each year, the influenza virus makes its rounds, causing severe illness in three to five million people globally2. In 2009, panic about H1N1 swept the globe and billions of dollars were spent on stockpiling Tamiflu, a commonly prescribed drug to prevent serious side effects of the virus3. The fact that Tamiflu does not actually reduce the severity of complications (e.g pneumonia) from the flu was only known by Roche, the pharmaceutical company responsible for the misrepresentation of Tamiflu. Cochrane Collaboration, a worldwide non-for-profit organization that conducts reviews of clinical trials and healthcare interventions, engaged in a 5 year battle with Roche in an effort to expose the truth behind Tamiflu. Due to the threat of a pandemic, Cochrane was responsible for updating their reviews on Tamiflu by researching and summarizing all literature on the antiviral. In order to provide an accurate review, Cochrane demanded further data from Roche. Unfortunately, the data that Roche eventually shared with Cochrane was lacking much detail3.

Roche shared the Clinical Study Reports (CSR) in 2009 which provided some evidence to suggest that we all held misjudgements about Tamiflu. Millions of people rely on, and trust, something for their well-being that may not, as it turns out, help them at all. The CSRs showed 10 proven side effects, none of which were published3. This revelation suggested that more crucial information regarding Tamiflu was being withheld. Roche handed Cochrane all necessary information regarding the Tamiflu drug trials. As suspected, evidence was found that suggested that Tamiflu may not noticeably reduce the number of influenza-related hospitalizations3. The long battle over the true results from the Tamiflu drug trials is representative of the unconformity between public believe and pharmaceutical truth.

We should not let the pharmaceutical industry’s agenda overshadow their value in today’s society. They provide us with the essential products to maintain our health – we do need pharmaceutical companies. Fortunately, many corporations, such as GlaxoSmithKline, Roche, and Johnson & Johnson, are beginning to see that there is a need for greater transparency in the pharmaceutical industry. The AllTrials campaign, co-founded by doctor and author, Ben Goldacre, is a petition aimed at making clinical trial results more available in order to improve this transparency. It is currently signed by thousands of physicians, patient groups, and corporations (including GSK) worldwide3. It is a relief to see these multinational corporations realizing the implications of their misconduct and taking steps to change their behaviour. A combination of public scrutiny and continued efforts from drug corporations and developers to improve transparency may ensure the products that hit our shelves are safe.  

References:

  1. Fierlbeck, K. Health Care in Canada. 151 – 195 (University of Toronto Press, 2012).
  2. World Health Organization. Influenza Fact Sheet. (2014). at http://www.who.int/mediacentre/ factsheets/fs211/en/
  3. Goldacre, B. What the Tamiflu saga tells us about drug trials and big pharma. (2014). at http://www.theguardian.com/business/2014/apr/10/tamiflu-saga-drug-trials-big-pharma

Image: “Tamiflu” by idua_japan. CC 2.0.

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