Express Pharma

The media on clinical trials: Watchdog or hound?

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‘The Fourth Estate: A Watchdog or A Hound?’ That was the topic of the 17th Lalit Doshi Memorial Lecture, given by Shekhar Gupta, Editor-in-Chief of The Indian Express in August 2011. His view was that the problem is not with the normative question of whether the Fourth Estate should be a watchdog or a hound, but in the way in which it assumes the role of a watchdog or a hound. (See report at http://bit.ly/VbqREI)

Of late, I found myself re-visiting the same query when some industry contacts commented that most media reports were “inaccurate” and “one-sided” when reporting on clinical trials. Pharmaceutical companies and CROs in India seemed to be feeling boxed in, not just by regulators (my editorial in the last issue referred to some of these issues: ‘Clinical trials: Edicts and effects’, http://bit.ly/XuU11Q) but also by the Fourth Estate.

Regulatory oversight is welcome, say industry insiders, but it should come with greater clarity and transparency. But are reporters given the same courtesy? Journalists who do want to feature both sides of the story are almost always stonewalled when they approach industry representatives for more information or clarifications.

Industry observers say that they understand that media has every right to be a watchdog, highlighting unethical practices and informing the public. The trouble starts, they say, when selective information is put out in the public domain, or when its given a slant that they feel is not logical. For instance, though India’s share of the global clinical trial pie is minuscule (less than two per cent), media reports refer to the country as a ‘clinical trials hub’ which paints the industry as a profiteering Goliath.

Reports that clinical trials are cheaper to conduct in India often mask the fact that certain trials, especially those calling for regular diagnostic tests like MRIs and CT scans, are more expensive to conduct in India because in other geographies, these are covered by insurance or the government. Industry sources claim that these costs get billed to the industry in India.

Industry claims that reportage on deaths of subjects during clinical trials will result in patients refusing to sign up for clinical trials. A pharma company insider narrated how an oncologist’s attempts to convince a relative of a cancer patient that a new investigational treatment had a good chance of working on his relative, only to hear him refuse permission, quoting some of these headlines. The doctor faced a moral and ethical dilemma. Who would take responsibility for the death of that cancer patient? The relative, for withholding a potential treatment, that could have given the patient a few more months with his family? Or the doctor, for failing to convince the relative of the merits of the best possible treatment available at the time?

Clearly, the pharma and CRO industry’s negative image has also rubbed off on the medical fraternity, thanks to shows like Aamir Khan’s reality show where the doctor-pharma company nexus was once again raked up. (Express Healthcare, June 2012, ‘Whose truth is it anyway?’: http://bit.ly/UYteMU)

But of late, there is a thaw, however slight, with some industry representatives coming forward to share information and clarifications. The dialogue has just started and it might take some time for both sides to develop a degree of mutual trust, but it is a step forward.

Maybe the thaw stems from the fact that it is completely in the industry’s interest to turn the tide of public opinion and go back to business as usual. But a common foe (dreaded diseases like cancer, diabetes, etc) needs some commonality of purpose. If we want the benefits of the latest medications, we need them tested as well. Of course, as per the highest possible ethical standards. Therefore, we will need to be both watchdog and hound, striking a pragmatic balance.

Viveka Roychowdhury
Editor

[email protected]

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