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November 27, 2018

ICIJ’s global probe: Defective medical devices causing death, disability

Top Story

November 27, 2018

ISLAMABAD: An international investigation into medical devices reveals how faulty implants in human body have caused patients to suffer, many of whom have died worldwide.

However, in Pakistan data on such adverse events is not available due to a weak regulatory mechanism and doctor-distributor nexus, as such events go unreported. The year-long investigation [into medical devices] was conducted by the International Consortium of Investigative Journalists (ICIJ) together with a team of 250 reporters from 36 countries. The project was named Implant Files. The News was partner in this global investigation from Pakistan.

For patients, the devices are for improving health and many have but the ICIJ’s investigations have found that medical devices like pacemaker, coronary stents, artificial hips, knees, breast and contraceptives planted in human body have in many cases sickened, maimed and even killed patients in different countries. In India alone, as many as 903 adverse events were reported in four years by the Indian Pharmacopeia Commission. Of them, 325 are linked to cardiac stents, 145 to orthopedic implants, 83 to contraceptive devices, 58 to intravenous cannulas, 21 to catheters and 271 to adverse events of various other medical devices, reported The Indian Express which collaborated in this project.

The situation is in contrast in Pakistan. The Drug Regulatory Authority of Pakistan (DRAP) though has set up pharmacovigilance section allowing patients, companies importing medical devices and doctors to lodge complaints, it is a non-starter. While patients can be excused for ignorance is a non-starter. While patients can be excused for ignorance about such a facility coupled with their lack of awareness about faulty devices, neither any hospital nor any doctor implanting such devices has ever reported adverse events, discussions with the DRAP officials revealed.

Such incidents have not been reported in India alone, as more than 62,000 incidents were reported by hospitals in the UK to the regulator in three years (2015-18); 1004 resulted in death.

The US regulator Food and Drug Administration (FDA) received 5.4 million such reports in the past decade, some were from manufacturers of devices reporting problems in other countries. Why no adverse incident has been reported to DRAP in Pakistan? Has such incident not occurred there? Do we have the best doctors in the world? The reality is altogether different. No hospital in Pakistan has adopted clinical governance system except the Aha Khan Hospital in Karachi and Shaukat Khanum Memorial Cancer Hospital in Lahore, according to background interviews with doctors.

Even these hospitals don’t report the occurrence of adverse events to pharmacoviligance section. DRAP, on the other hand, isn’t strong enough to enforce regulation. The clinical governance system was set up in the UK in 1995 following a heart scandal during which an anesthetist, Dr. Stephen Bolsin, exposed the high mortality rate of pediatric cardiac surgery at the Bristol Royal Infirmary.

Clinical audit, risk managements and information management are three important components of this 7-point governance model. Remaining four are education and training, clinical effectiveness, research and development and openness. The system exists in the developed countries with different names.

The ICIJ investigations have also revealed that the patients affected by faulty devices are not only in third world countries, but also in developed nations like the US, the UK, Australia and other western countries.

Laxity of rules is largely to be blamed, as lobbyists push legislators to soften rules resulting in the entry of devices into the market without clinical trial. It has also emerged that American manufacturers have made “for export only” products which are implanted in patients in different countries except in the US and this resulted in creating complications for patients instead of alleviating their ordeal.

In Pakistan, there is no conformity assessment body to check the efficacy of these devices, which are largely imported from the western world. DRAP has allowed import of devices from as many as 17 countries: USA, UK, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland. Their import is subject to the approval from the regulatory body of the relevant country.

However, the ICIJ investigation, which is the first-ever probe into medical devices, has determined how the European Union’s softening of safety rules has contributed to mushrooming growth of device industry with the giants using the regulatory loopholes to introduce their products first in Europe to grab the business.

An American company, Zimmer Biomet, for example, introduced artificial hip in Europe well before it was approved by the US regulator. It was certified under European regulation as safe for use in 2003 without Zimmer having to provide clinical evidence for its safety. It nevertheless caused pain to patients, many went for replacement but the manufacturer went unaccounted due to lax regulations.

“Like Zimmer’s metal hip, many more products were developed by the US manufacturers before receiving their first safety approval in Europe. They include PleuraSeal, a lung sealant that leaked; RoboDoc, a robotic surgical device that caused tendon rupture and nerve damage; and Brio, a deep brain stimulation implant to treat Parkinson’s disease which had to be removed from some patients after body fluids seeped into the device and it stopped working,” reported ICIJ’s Simon Bowers.

Medtronic, another American company, was facing allegations in US of bribing doctors across Europe to use its products and paid a fine of $75 million to settle the charges.

The company’s “Healthy Heart for All” project turned out a sham in India, as an investigation by The Indian Express revealed “a range of alleged irregularities: from corruption of doctors via promos and freebies to ensnaring unsuspecting patients who didn’t need these products; from spending crores on conferences and seminars to push products, to screening patients and prescribing devices under the same roof.”

Johnson & Johnson’s hip implants adversely affected 4,000 patients in India and is now facing a case in the Supreme Court there.

The problem is not only with the European regulator, its American counterpart, FDA, has also acknowledged failure in keeping a close eye on all the products approved.

“Unfortunately, the FDA can’t always know the full extent of benefits and risks of every device at time of market entry. Sometimes, new signals emerge after a product is used by clinicians and a broad patient population,” said FDA commissioner, Scott Gottlieb in his #SundayTweetorial after ICIJ sought his version.

In this sorry situation, DRAP has left its due diligence to be done by regulators of countries manufacturing life-saving devices instead of devising its own conformity assessment system. There was even no system in place to register the imported devices with DRAP until January this year after the Supreme Court of Pakistan took notice of unregistered stents being used at cardiac facilities.

DRAP Act 2012 which was enforced to set up DRAP required regulation of devices. Rules were framed in this regard in 2015. Conformity assessment bodies were to be set up for examining the quality of devices imported and manufactured in Pakistan through a medical board, according to the rules. The plan didn’t materialize in absence of any existing facility.

The government woke up again when the SC intervened after the stent scandal. New rules were introduced on January 15 this year requiring the licensing of importers of devices and their subsequent registration with DRAP which is being done in case the devices are approved by regulators in the country of origin. However, there is no effective system in place to regulate hospitals to report adverse incidents in the event of implanting such devices. That job has been left at the discretion of device distributors which report occasionally and only when the manufacturing company orders recall.

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