No drug has come more in the lay press in recent times than Hydroxychloroquine (HCQ). It is in the news not because of its miraculous property, but because of the amount of controversy it has generated. The conflicting reports about this drug are an alternation between hope and despair in our fight against COVID-19.
HCQ is a cheap generic drug that has been around for ages with its primary use in arthritis as an anti-inflammatory agent, but without credible evidence for use against viruses. India accounts for 70 percent of the global output, producing 10 times its domestic requirement. Notwithstanding the divided expert opinion on effectiveness, proving it beneficial has high stakes in business.
Higher are the stakes for Remdesivir, a new-on-the-block prohibitively expensive, patent-protected antiviral agent. Although its credentials are yet to be proven beyond doubt, the medical community is desperately hoping the drug would work. It has the potential for a windfall profit for Gilead Life Sciences. Humble Hydroxychloroquine may be a stumbling block between the potential and the real windfall.
What is interesting in this war is the turf itself. COVID-19, with all the panic notwithstanding, is but a mild disease with 90 percent of those tested positive not developing even a minor illness and only a tiny fraction actually needing any treatment. In an infection of this type, anything and everything can be proven to be effective unless subjected to intense scrutiny.
Leave aside torturing the data (a la Ronald Coase), even a small statistical jugglery can make a huge difference in such a setting. Some years ago Kotak Mahindra Bank ran a campaign – “50 percent more interest on your savings account”. It was actually a 6 percent vs 4 percent campaign. Two percentage points more can be shown as 50 percent more.
Bring this analogy to medical research. There are two groups of 200 patients each – “A” on no drug (control) and “B” on drug (study). In the end, there are two adverse events in the control group and only one in the study group. It is actually a half percent real risk reduction that can also be called 50 percent relative risk reduction. This is just an example of a very honest research rephrased into smart marketing. And it is par for the course.
What is not, is deceit to discredit. This is precisely what happened to Hydroxychloroquine. On May 22, the World Health Organization (WHO) issued an advisory to stop all clinical trials of Hydroxychloroquine, citing concerns of adverse side effects. The concern for adverse effects emanated from a preprint report in The Lancet (a journal of formidable standing in the medical world with a high impact factor) based on data provided by
a dubious Illinois firm called Surgisphere that has neither the
expertise nor the experience in the field of medicine.
Exposure on the credentials of the firm left many, including WHO and The Lancet, red-faced. In less than a fortnight, on June 2, WHO had to hurriedly rescind its earlier order, to be followed by The Lancet retracting the article on June 04. You don’t need a rocket scientist to deduce the role of business forces working behind the scenes.
The issue before the medical fraternity is bigger than the effectiveness of a particular drug. It is more about our quest for truth. It relates to our raison d’être. The doctor, being a fiduciary, is bound ethically to act in the other’s (read patient’s) best interests. When truth is being manufactured in pursuance of a hidden agenda, the best interest of the patient is a natural casualty.
In 2005, Prof John Ionandis (presently professor of Epidemiology at Stanford) highlighted the problem in his paper “Why Most Published Research Findings Are False”. Besides data manipulation, he highlighted the motive – flagrant conflict of interest, financial and intellectual – in that order. Business interest is a prime mover, researchers can act in complicit and, at times active, collaboration out of both need and greed. It is now cancerous.
Richard Horton, editor of The Lancet has lamented his frustration, “The case against science is straightforward: Much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, science has taken a turn towards darkness.” He goes on to add, “The bad news is that nobody is ready to take the first step to clean up the system.”
The writer is (retired) professor of Oorthopaedics. His views are personal. ECONOMIC TIMES