From the health-care point of view, the year 2018 will be noted for the Centre-commissioned report pulling up U.S. pharmaceutical giant Johnson and Johnson (J&J) for being evasive and guilty of suppressing vital information about a type of artificial hip implant. This device was globally recalled in 2010 for a high ‘revision rate’, i.e. about 12-13% of implants needed to be removed due to the blood poisoning caused by the leaching of some of the implant’s components, such as cobalt and chromium.
An obstacle course
Following this, hundreds of patients, who have doggedly pursued J&J to acknowledge its indifference to Indian patients on the one hand and the Indian bureaucracy to act on the other hand, have been filled with hope. A few months down the line, a compensation formula was devised where it was decided that affected patients would be paid ₹30 lakh-₹1.2crore, depending on the disability, age and risk factor. It was soon followed by the formation of Central and State-level committees to help patients get compensation.
This is easier said than done. As many as 4,700 Indian patients are believed to have received the implant that was marketed with much gusto as the perfect device for people in their 40s. Eight years later nobody — the government, the manufacturer, the hospitals where the surgeries were performed or the doctors who implanted the device — has a clue about who and where these patients are. The J&J incident also highlighted the complete lack of patient or ‘outcome registries’, which record patient histories, in India. A helpline created by the company claims to have registered 1,080 patients, of whom around 275 have undergone revision surgeries funded by the company. Why the company cannot hand over the details of these 1,080 patients to the government as the first step of doing right, or why the latter has not demanded so, remains a mystery.
With hope, scepticism prevails too. With J&J questioning the compensation formula in court, patients believe the battle will ultimately be fought there and the wait for an outcome could be interminable. Says Vijay Vojhala, a patient, “It looks like the government is doing a lot of things to get compensation for the patients. But it’s all an eyewash.” Mr. Vojhala, who has spearheaded the fight not only against J&J but also against the Indian bureaucracy, points out: “The Central committee that devised the compensation formula never involved patients in discussions. How can we call it democratic or patient-centric then? What is the guarantee that these multiple committees will get J&J to compensate us?”
Mahesh Zagade, a former commissioner with the Maharashtra Food and Drug Administration (FDA), also seems to echo Mr. Vojhala’s fears. Says Mr. Zagade, who was the first to file a First Information Report (FIR) against J&J: “The government is simply delaying the process of justice by putting patients through these scrutiny committees. The simplest way was to trace as many patients as possible, club their complaints into one FIR and get the police to file a charge sheet. Once the case is in court, life imprisonment can be sought for J&J authorities and compensation for patients.”
The Maharashtra FDA had also demanded a Central Bureau of Investigation inquiry but got no support from the Union Health Ministry or the Mumbai police. The first FIR lodged against the company, in 2011, has been gathering dust at the Mahim police station, in Mumbai, where at least six Deputy Commissioners of Police have come and gone since. It is equally baffling why the police has not filed a charge sheet so far when it has the testimonies of nearly 30 patients.
Not on the political radar
Says activist Abhijit More: “Health care has never been a political priority. When it comes to regulations and patients’ rights, the government is never in the forefront. These wars have always been fought by patients or civil society members. The Centre’s snail-paced approach and lack of initiative in handling the J&J issue only speak of its indifference.”
In 2012, health activist Amulya Nidhi was the first to expose, in Madhya Pradesh, the widespread abuse of clinical trial-recruits by international drug makers. In 2014, a Delhi-based lawyer filed a petition seeking price regulation on cardiac stents, which are life-saving medical devices but were exorbitantly priced, in turn triggering a debate on price control. Even today, it is organisations such as the All India Drug Action Network that fight for price regulation of life-saving drugs and devices.
Shouldn’t the government be taking the lead in all such issues?
Says Mr. Zagade, “Why would the government do so? It’s all a money game.” He adds that if one observes closely, there is a pattern in all the actions and enforcement by the government. “Every day, hundreds of products are recalled. But the effective enforcement is carried out very selectively. It all depends on who is at the receiving end. Is it a small-time drug or device maker or is it a $100 billion company?”
Only time will tell whether Indian lives will be considered on a par with those in developed nations and a similar scandal prevented from reoccurring.