This week in point counter point articles in the British Journal of Medicine (BMJ) debated whether is the conflict of interest unacceptable when pharmaceutical companies conduct trials on their own drugs?
On the side of industry conducting their own trials is Vincent Lawton, healthcare consultant and non-executive director of Medicines and Healthcare products Regulatory Agency, London, argues that there is no conflict.
Ben Goldacre, a doctor and writer from Nuffield College, Oxford, argues that there is a conflict. According to his website Bad Science, Dr. Goldacre is a award-winning writer, broadcaster, and medical doctor who specializes in unpicking dodgy scientific claims made by scaremongering journalist, dodgy government reports, evil pharmaceutical corporations, PR companies and quacks (this covers just about everyone but himself).
Dr. Goldacre believes that the financial interests of drug companies lead to distorted evidence, whereas Vincent Lawton believes that adequate safeguards exist to keep bias in check.
Vincent Lawton (No)
As Mr. Lawton asserts, “clinical trials are properly managed by a rigorous system of regulatory scrutiny throughout.” These trials are also carried about “by some of the best scientists in the world, often in collaboration with academic researchers.” Without such trials, the drug industry would not be able to develop medicines, which they have spent years doing research on and investing significantly in.
Mr. Lawton also noted the importance of clinical trials because they “are an essential part of developing safe and effective drugs, and after the drug is introduced to clinical use more is discovered about its effects.” Additionally, these trials “are done to provide further information and study whether new indications can be added to the drug’s use.”
Consequently, he defends the legitimacy of industry involvement in these trails because they “are assessed and endorsed by regulators who assiduously guard against inadequate trial design, insist on good clinical practice standards, and ensure high quality analyses.” Moreover, he explains how “ethics committees, who are fully independent, do not countenance a substandard study design, and frequently intervene before a study is allowed to proceed.” As a result, he cited specific evidence that “suggests that industry sponsored studies have higher methodological quality than those funded by other bodies.”
Regardless of these safeguards, Mr. Lawton does not discount the need to eliminate bias, and he notes that “industry has developed various transparency measures” by working with regulatory agencies for the design of studies. These transparency measures include publicly accessible databases that contain information regarding industry involvement.
Still, Mr. Lawton poses an important question: are these companies, who invest an average $1.2 billion and 10 years to bring a medicine to the market, supposed to surrender their intellectual property to a third party’s lack of infrastructure, expertise, and resources? Such a requirement he asserts “would inevitably lead to delays, cutting into patient access and the patent life of the medicine, which would be a sure way to drive away the incentive to innovate.”
Dr. Ben Goldacre (Yes)
Dr. Goldacre’s premise is that drug companies have a conflict of interest because “they want to sell their products, and so naturally they want a positive result from the trials they sponsor.” Supporting this claim, he asserts that “there is now good evidence … that this conflict of interest results in bad evidence, which distorts medical decision making and so harms patients.”
For example, he talks about how every single trial on non-steroidal anti-inflammatory drugs (NSAIDs) that compared one drug to another, the sponsoring company’s drug was either equivalent to, or better than, the drug it was compared to.
Another example he uses showed that 30 studies investigating the influence of industry funding found that studies sponsored by drug companies were more than four times as likely to have outcomes favoring the funder, compared with studies with other sponsors. Our question to Dr. Goldacre, is since more than 75% of funding for clinical trials comes from industry, where does he suggest the money come from?
He believes that funding creates a “questionable trial design” and that “industry can choose which data to publish, and which to leave unavailable.” He also asserts that publication bias can result from industry funding, which makes negative results disappear.
Consequently, he recommends that drug companies must demand “full mandatory publication of all trial data from themselves and their competitors.”
Dr. Goldacre however ignores the sources that Mr. Lawton sites by stating that regulators are failing to address these problems. As Mr. Lawton’s article notes, both industry and regulators are managing these potential conflicts through numerous safeguards such as independent ethics committees. The few examples that Dr. Goldacre use does not warrant the total transformation of the way clinical trials collaborate between academia and researchers that he calls for.
As a result, Mr. Lawton’s recommendation that companies must continue “to work closely with academia and regulators to identify weaknesses or shortcomings and find ways to address them” is more appropriate. In doing so, health care will “continuously improve,” and the competition and investment it creates will “drive innovation.”
British Medical Journal: Is the Conflict of Interest Unacceptable When Drug Companies Conduct Their Own Trials?