Weeks after the issue of Johnson and Johnson's faulty hip implants was made public through an expert committee report submitted to the Union health ministry, a section of doctors have pointed out the drug regulator's laxity, and the company's complicity, in endangering patient safety.
“It's a gross regulatory failure on part of the government,” Dr Raju Vaishya, senior joint replacement surgeon, Indraprastha Apollo Hospital told THE WEEK. Vaishya, president of Indian Cartilage Society (ICS), said that Johnson and Johnson was “shying” away from the issue of tracing the affected patients. “It is strange that about 4,700 patients received the faulty hip implants in India, but over 3,600 of them still remain untraceable. It is not difficult to identify these patients from the hospital data,” he said. Doctors, he insisted, were not at fault since it was the company's responsibility to inform and update the doctors about the faulty design. “No doctor would put his reputation at stake by concealing important information about patient safety,” he said.
Back in 2012, Vaishya said that he had highlighted the issue of the faulty hip implants through a letter published in the prestigious American journal, The Journal of Arthroplasty. This letter was written in response to a research paper “Hip Resurfacing Arthroplasty in Inflammatory Arthritis: A 3 to 5 Year Follow-up Study”, by a team of orthopaedic surgeons of AIIMS. In the article, the authors had reported good results for the implants, a fact that Vaishya says he had opposed in his response.
Vaishya said that even the government did not take the matter seriously. “There is no government body such as a National Joint Replacement Registry in our country. This is despite the fact that the formation of such a body was suggested many years ago. However, Central Drugs Standard Control Organization (CDSCO) did not take any timely action on this matter, despite knowing the problems related to these implants since at least 2010,” he said. A national registry, he said, would not just help in tracking the progress of the implants, but also help doctors use the data for research.
His concerns on the subject were echoed by other doctors as well. Dr Atul Srivastava, secretary, Indian Orthopaedic Association (IOA), said that setting up a national body—one that may be called National Joint Replacement Registry or National Healthcare Data Storage and Management Committee—would help in the cause of preventing such a crisis.
Dr Rahul Gupta, additional director, Brain and Spine Surgery, Fortis Escorts Heart Institute & Research Centre, New Delhi said that more catastrophic failures of medical implants and devices were "almost guaranteed" to occur because of a lack of regulation in the field of implants.
Senior cardiologist Dr R.N. Kalra, medical director of Kalra Hospital and Sri Ram Cardiothoracic & Neurosciences Centre, New Delhi said that India should follow the systems developed by other countries that allow doctors and patients to register their opinion and complain about adverse effects of an implant or a drug. “That way, the government authority can immediately know if there is any flaw in them. However, currently, there is no such system in India,” he said.
The Metal on Metal prostheses (ASR) was manufactured by a subsidiary of J&J and secured approval for sale and use in patients in India in 2006. In December 2009, the product was recalled in Australia, due to an unacceptable incidence of early complications related to these artificial hip joints.
While the company recalled the product globally in August 2010, doctors point out that India “waited till 2017” to set up a committee to investigate the issue.