Cure that hurts

That Johnson and Johnson could get away without paying compensation after implanting faulty hip replacement devices points to a regulatory deficit, and lack of medical ethics

Written by Shah Alam Khan | Updated: August 30, 2018 12:07:56 am

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It is critical to note that J&J in the US behaves much better than it does in India. (Illustration: CR Sasikumar)

An important expose (IE, August 25) has revealed that the Indian arm of Johnson and Johnson (J&J), a leading global pharma major, “suppressed” key facts on the harmful aftermath of surgeries conducted on hundreds of patients in the country using “faulty” hip replacement systems imported by the company. The report also revealed that J&J did not provide compensation to all the affected patients. An expert committee of the Union Ministry of Health and Family Welfare (MoHFW) had recommended that the pharma giant provide compensation to the patients who had undergone a surgery to implant the faulty device.

In fact, J&J did not even provide a list of all the 4,700 patients who had undergone the surgery to the concerned committee. This is a breach of medical ethics and moral principles and J&J stands exposed as a classical example of corporate high handedness, emboldened by administrative flaws and poor procedures of accountability.

It is important to unravel this violation of patients’ rights because that will help us be vigilant against future malpractices by international pharma firms. The J&J case makes for an interesting study of the factors that interact to “manufacture” a public health catastrophe.

First, there is a booming market for joint replacement in India. A recent survey projects that the joint replacement market will grow at an annual rate of around 25 per cent to 30 per cent over the next five to seven years. These are impressive figures and billions of dollars are at stake. It would be naive to believe that such a market would remain untouched by multinationals like J&J.

Joint replacement, like cardiac stenting, is a robust and useful technology. However, the need for a medical implant is governed not just by its utility and ease of use but also by the hype generated around it. A interesting study based, on the data of the Australian Orthopaedic Association National Joint Replacement Registry published in November 2017, revealed that a greater number of hip replacements happens in the more advantaged groups as compared to the disadvantaged population with a similar incidence of disease. This makes a physician’s offer of hip replacement to a patient more arbitrary than has been thought so far.

It is important to remember that two important events accelerated the country’s decent into a healthcare nightmare: The uncontrolled opening up of Indian markets in the 1990s and the country ratifying the World Trade Organisation (WTO), which led to it becoming fully compliant with Trade Related Intellectual Property Rights (TRIPS) in January 2005. The latter made it easy for pharma companies to carry out clinical trials in the country. There was an influx of international companies who claimed to provide the state-of-the-art drugs, implants and technologies to doctors and patients, mostly in the garb of clinical trials. The absence of rigorous regulations led to serious violations of patients’ rights, as was evident from the Human Papilloma Virus (HPV) Vaccine Clinical Trial Scam in 2009. It is believed that between 2005 and 2012, more than 2,000 patients have died across the country while participating in clinical trials conducted by pharma companies.

Second, it is critical to note that J&J in the US behaves much better than it does in India. The company has settled more than 9,000 lawsuits over the defective hip model in question for around $4.4 billion between 2013 and 2015. Since 2015, juries in the US have awarded $1.7 billion as compensation over the hip implants. So why does the pharma major behave as it does in India? Why has the company been high-handed and careless, as the MoHWF expert committee suggests? Much of this has to do with with the regulatory deficit in the medical devices market. The data suggests that technology assessment for medical devices and quality control methods in the country do not compare well with those in the Western world. Unfortunately, the National Medical Device Policy 2015 is still being debated in policy circles.

Finally, poor regulation of clinical practices is a reason for errant medical giants going unpunished. It is no secret that pharmaceutical companies and medical device manufacturers sponsor foreign trips, national and international conferences and even vacations of physicians. Doctors serve on the payrolls of medical device companies. They promote implants, including the faulty hip replacement device in question. It would thus be naïve to expect criticism of faulty implants or reporting of a serious side effect by surgeons or physicians obliged to the companies that manufacture them. Poor regulation of clinical practice not only emboldens pharma giants like J&J but also reduces the burden of their guilt. The poor medical ethics of the Indian physician serves their interests well.

The unethical behaviour of J&J is neither the first nor the last episode in ongoing tragedy that is the saga of the poor Indian patient. With a poor regulatory mechanism, a corrupt healthcare system and a greedy doctor at their doorstep, such companies and their businesses stand to thrive in the graveyard of India’s healthcare. The medical community must decide: Do we want to be part of the colossal injustice heaped on the patient, or call out suspected malpractices when we see them? After all, even the most comprehensive ethical system is of no use if the people it is meant for lack the will to do what’s right.

The writer is Professor, Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi and author of Man with the White Beard. Views are personal

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