A flood of sub-standard implants and stents, largely from China, are making the eyes of many doctors and hospitals sparkle
In February 2017, ProPublica, in association with The Atlantic, published a horrifying expose of how doctors in the US are recommending stents for patients despite them not needing the procedure.
The expose speaks volumes of the commercialisation, greed and indifference to ethics that have overtaken many healthcare givers in that country.
In India, such an expose is yet to be done, although the situation is indeed ripe for it. What was once hushed whispers within the medical fraternity is now being spoken about openly, that a set of doctors and hospitals, in an effort to maximise profits, are recommending and using stents and medical implants, which are sub-standard.
The result is felt by the patient – in the form of unbearable pain and very high necessity for revision surgery – meaning surgery to correct the problem.
Across the world, as access to healthcare improves and affordability increases, the demand for medical implants has only accelerated.
According to Dr Bharat Chanana, HOD, Interventional Cardiology, Maharaja Agrasen Hospital, New Delhi, “The 2016 Global Burden of Disease Report revealed 1.7 million Indians battling heart diseases and projected a significant growth in the future. The government, in its scheme, announced a price-capping mechanism to contain out-of-pocket-expenditures. In 2017, the National Pharmaceutical Pricing Authority (NPPA) fixed the prices of bare metal stents at Rs 7,260, whereas drug-eluting stents (DES) and biodegradable stents were fixed at Rs 29,600.”
But the Chinese manufacturers of sub-standard medical implants, especially stents, have managed to circumvent the cap, undercutting the larger and more expensive American and European makes, helping doctors and hospitals make a quick buck at the expense of the patient.
According to Abhay Raj of the Delhi-based NGO Prahar, at least half of the 60,000 patients undergoing angioplasty every year in India receive unapproved stents.
“There might be a linkage to the price cap issue,” said Dr Anant Bhan, Researcher, Bioethics and Health Policy in Bhopal. “This is a reflection of regulatory failure. Some hospitals are still profiting significantly due to this, because the cost has a commission factor to it. We need to ensure quality and very seriously worry about the health consequences of such sub-standard implants.”
Regulation of stents has a turbulent history. Reports show that in June 2005, Mumbai’s state-run JJ Hospital was using unapproved drug-eluting stents on at least 60 high-risk cardiac patients.
These stents were called Axxion, manufactured by Occam, a Netherlands-based company. The stents were not approved in India, nor in the Netherlands.
This case was reported at length in the Indian Journal of Medical Ethics - “In the course of an official investigation, it was learnt that the department had been using unapproved stents since February 2004. While the hospital dean indicated that the stents were bought directly from the market by patients, the payments were recorded in the hospital’s accounts. In other words, the government hospital could not evade responsibility for this practice. Further, the investigating committee found that government departments gave conflicting opinions on the legal status of the stents. The Drugs Controller General of India said drug-eluting stents were not drugs and therefore were not covered under the Drugs and Cosmetics Act. The Indian Food and Drug Administration described as “illegal” the use of imported stents that don’t have approval from either their own country or the regulatory authority of the United States. It also held that the very description “drug-eluting stent” implies that it is a drug. As a result of the investigation, government ministries have started discussions on standardising medical devices in the country. Devices used in treatment are now defined as drugs and regulated under the Drugs and Cosmetics Act. This will include pacemakers, valves, stents, catheters – both medicated and non-medicated – as well as implants for hip and knee replacements. These high value implants will be brought under government regulation like any other new drug being introduced in the country. It may be pertinent to mention that in the USA, devices used there must be approved by the country’s regulatory body.”
Medical implants like stents and orthopaedic implants, say doctors, are overpriced and now that prices of some are capped, can make way for sub-standard makes that pose a danger to patients.
Dr Madan Mohan Reddy, senior consultant orthopaedic surgeon at Apollo Hospitals explains how the pricing works. “The bulk manufacturing cost of these hip or knee implants will not be more than Rs 7000 or Rs 8000 apiece,” he said. “Even after the cap, it costs Rs 54,000. So those are the margins we are talking about here,” he added.
He also pointed to the “accessories” like screws used in orthopaedic implants. “One kilogram of titanium costs Rs 10,000 in the market. We can make 10,000 screws out of that,” he said.
While Dr Reddy himself avoids using Chinese implants as a practice, he says that there are many doctors who do use them – and their patients suffer as a result.
“The biggest problem with using implants which have either faulty design or which are sub-standard is of infection,” said Dr Reddy. “Loosening of the implant means the patient has to go in for revision surgery. A knee replacement should last for 30 years. If you compromise, it will wear off and ultimately your patients will be in terrible pain,” he added.
AdvaMed, a global organisation that acts as an advocacy for medical implant makers, in an email questionnaire, agreed that the problem of usage of sub-standard medical implants post the price cap was widespread.
“Along with affordability and accessibility, ensuring quality healthcare is also imperative,” wrote AdvaMed. “After price cap was imposed, there was a general trend by some of the hospitals to use a more economically viable and base-level implant and equipment. Such a scenario might come into play even for patients who might need differential and value-added equipment. No one wants a product on the market that is not tested and safe for patients.
For AdvaMed and its members, patient safety has always been a priority. We are the innovators of the new treatments and cures of tomorrow that lead to longer, healthier and better lives. For any medical technology to qualify as a preferred choice, the benchmarks of safety, efficacy and quality checks must be met with. This further reinforces our commitment to quality and overcoming gaps in regulatory standards as well as poor impact of price control on innovation,” they wrote.
Dwight W Clark, Medical Director of US-Sino HeartCare, wrote in the China Daily that both the US and China are facing the same problem that India is battling.
“Approximately 700,000 stent procedures are performed each year at the cost of more than USD 110 billion,” writes Dr Clark.
“China has a similar or worse problem, with many patients receiving two to six stents without a convincing documentation of need. Every year, about 500,000 stents are being implanted in China. Almost 100% of these procedures use drug-eluting stents to treat patients with angina. Unfortunately, many stents are overused for asymptomatic patients identified as having a “blockage” through CTA (coronary computed tomography arteriography) screening.
This practice, which not only overutilizes scarce medical resources, exacts a large physical and psychological toll on the unsuspecting patients and their families. This problem has come to the attention of the National Committee of the Chinese People’s Political Consultative Conference (CPPCC).
According to Dong Xieliang, a member of the CPPCC, hospitals buy a made-in-China heart stent for 3,000 yuan (USD 456) and sell it to the patient for 27,000 yuan,” he writes.
The global medical community, it appears, is battling to survive this onslaught of greed by a few, which is making the life savers take the flak. How and where they will even begin, especially in a country that is as diverse and complex as India, is a question for those superior minds.