Global corrupt medical (#implant) market & unholy nexus: tip of iceberg revealed


With aberrant  evolution of modern medicine and advancement  of  medical procedures, everything appears to be   controlled by medical industry. The  investors have gained  control of  the financial  game.  How large companies  create a web of  corrupt practices, and earn   huge profits, is a common prevalent sentiment.  Tip of the Iceberg has been revealed indicating inducements to  some doctors and dubious deals with hospitals. If these are the hallmarks of the big unregulated medical bazaar in India and some others, a rare case involving a global major has put a figure to it.

In a filing two months ago, the top financial regulator in the USA, the Securities and Exchange Commission (SEC), ordered the world’s leading manufacturer of orthopaedic implant devices, Stryker, to pay $7.8 million (over Rs 55 crore) in settlement for violating its corruption norms in India, China and Kuwait, documents accessed by The Indian Express reveal.

The settlement, recorded by the SEC on September 28, came after the Commission’s “accounting and audit enforcement” proceedings noted a number of “violations” by the company’s Indian subsidiary and its dealers. These “violations” include questionable payments to doctors for “consulting fees, travel, and other benefits” and “inflated invoices” issued to “mostly large, corporate hospitals”.

And that’s not all. In 2012, the anti-monopoly regulator, Competition Commission of India (CCI), fined an authorised distributor of Stryker India and two other firms Rs 3 crore for allegedly rigging bids, manipulating tenders and forming a cartel to sell equipment to the All India Institute of Medical Sciences (AIIMS) and Safdarjung Hospital, two of the largest government hospitals. In its scrutiny of Stryker’s India operations, including the findings of internal audits between 2010 and 2015, the US SEC concluded: “Payments intended to benefit HCPs (Health Care Providers) also lacked sufficient documentation, such as consulting fees paid to doctors without adequate explanation of the doctors’ consulting services or hours billed, and payments for HCP travel with documentation that appeared falsified…

“Additionally, the forensic review found missing or inaccurate documentation for numerous other transactions flagged as high-risk, including expenses related to consulting fees, travel, and other benefits to health-care professionals in India.”

The US regulator’s severe indictment of Stryker’s India operations is one of the most startling findings to emerge from the Implant Files investigation by The Indian Express and the International Consortium of Investigative Journalists (ICIJ) on the medical bazaar, where pharma majors hard sell their products without any regulation via a dubious nexus with hospitals and doctors.

Stryker India has four offices in the country — Delhi NCR, Mumbai, Chennai and Kolkata — and an annual turnover of Rs 300 crore in FY 2017-18, mainly from selling hip and knee implants, and medical devices for spine and neuro surgeries. The US-based parent company has a market cap of $58.87 billion with operations spread across 100 countries covering Asia, Europe, Africa and Latin America.

Dubious deals with hospitals:

Private hospitals that “requested inflated invoices from dealers  profited from their purchase of Stryker orthopaedic products by passing on the higher (invoiced) prices to their patients or their patients’ insurers, even as the hospitals paid the lower prices previously negotiated with Stryker India to Stryker India’s dealers”, the US SEC found.

In doing so, the SEC said, the dealers “allowed these private hospitals to gain a windfall from passing on the higher (invoiced) prices to their patients or their insurance companies”.

Linking Stryker to these deals, the regulator said: “Stryker India authorized these dealer transactions only after Stryker India’s management negotiated and approved the price that the hospitals would pay to the dealers. Thus, in determining the price charged to dealers, Stryker India’s management and the dealers specifically  negotiated the profit margin such dealers would stand to earn based on the difference between what hospitals paid the dealers and what the dealers paid Stryker India.”

SEC records do not identify the dealers involved. But documents maintained by CCI show that it had fined PES Installations, an authorised distributor, and two other firms, MDD Medical System and Medical Product Services (MPS), Rs 3 crore in April 2012 for a number of alleged irregularities in sale of equipment to AIIMS and Safdarjung Hospital, both in Delhi.

Responding to a questionnaire from The Indian Express on the SEC findings, Stryker said in a statement: “We are committed to working with our customers to make healthcare better while operating ethically and in compliance with all applicable laws and regulations.”

The US SEC, meanwhile, found a number of similar violations in Stryker’s operations in China and Kuwait, too. According to the SEC, it took into consideration “Stryker’s cooperation and remedial acts undertaken” while deciding to accept the company’s settlement offer to be paid “within 14 days”.

Unlike in India, the US has robust anti-corruption checks in place with the Foreign Corrupt Practices Act (FCPA), enacted in 1977, prohibiting the payment of bribes to foreign officials to assist in obtaining or retaining business, and mandating companies “to maintain accurate books and records”. In Stryker’s case, the SEC decided on a settlement after issuing a “cease-and-desist” offer to the company.

WHAT THE US REGULATOR FOUND

Inadequate oversight of dealers

* In 2012, in response to allegations of misconduct concerning Stryker India’s dealers, Stryker exercised its audit rights over three dealers in India. Those audits revealed insufficiencies in the financial record-keeping and internal accounting controls of all three dealers. Additionally, Stryker identified suspicious expenses by one dealer and instances of another dealer over-billing a hospital upon the hospital’s request. While Stryker took some corrective actions in response to these audits, including terminating one of the three dealers, the actions were limited to the three dealers audited.

* (The)deficiencies violated Stryker India’s agreements with its dealers. Specifically, the deficiencies in dealers’ financial record-keeping violated dealers’ obligation to “maintain complete and accurate records relating to [their] promotion, marketing, use and distribution of [Stryker] Products,” and the over-billing violated Stryker’s business conduct policy prohibiting participation in any improper payments. Despite the red flags raised during the 2012 audits, and numerous complaints reported to Stryker of dealer misconduct, Stryker did not act to determine the scope of dealer-inflated invoices until 2015.

* In 2015, Stryker performed audits of other dealers in India. The audits revealed that the practice of Stryker India’s dealers inflating invoices for the sale of Stryker orthopaedic products to certain private hospitals — an improper practice identified three years earlier in connection with the 2012 audits — had become more widespread.

Lack of accurate books, records

* From 2010 through 2015, Stryker India failed to make and keep complete and accurate books and records that reflected its transactions and disposition of assets. In particular, Stryker India recorded potentially problematic payments to its dealers and to HCPs, some of which lacked any supporting documentation reflecting a clear  business purpose.

* A forensic review of Stryker India’s general ledger for the period 2010 through 2015 found a complete lack of documentation for 144 out of 533 transactions selected as a sample of Stryker India’s highest-risk and most compliance-sensitive accounts.

* During the period of 2010 through 2015, Stryker was unable to provide any documentation for 27% of sampled high-risk transactions on Stryker India’s general ledger.

The SEC ordered Stryker to appoint an independent consultant, review and evaluate the company’s internal controls, record-keeping and anti-corruption policies, and procedures relating to use of dealers, agents, distributors, sub- distributors, and other such third parties that sell on behalf of the company. The SEC noted in its official filing: “Stryker fortified its existing compliance program, which is designed to prevent, detect, and remediate potential misconduct. This program develops, maintains, and implements corporate policies and standard operating procedures setting forth specific due diligence and documentation requirements for relationships with foreign officials, health care professionals, consultants, and distributors.”

The company has also retained an independent consultant to “formulate a work plan: that will be evaluated by the agency and Stryker to address the SEC’s findings”.

WHAT INDIA’S REGULATOR FOUND

Dealers rigging bids, forming cartel

* In April 2012, the CCI fined PES Installations, MDD Medical System and Medical Product Services for “bid-rigging and forming a cartel” in tenders for procurement of a Modular Operation Theatre (MOT) and other medical equipment at AIIMS and Safdarjung Hospital.

* The CCI also examined a contentious question: did the dealership agreement between Stryker India and PES violate sections of the Competition Commission Act? According to the official website of the Ministry of Corporate Affairs, the Act, enacted in 2002, aims “to

prevent practices having adverse effect on competition, to promote and sustain competition in markets, to protect the interests of consumers and to ensure freedom of trade carried on by other participants…”

* In its final order issued on April 16, 2014, based on the documents placed before it, CCI ruled that “according to the agreement struck with the dealer (PES Installations), Stryker could appoint any other firm as its dealer”. “However, according to the agreement, in this case PES Installations, the dealer could not sell products of any other company without the permission of Stryker,” the order said.

* The Director General appointed by CCI, under section 26 of the CCI Act, to conduct the investigation noted that the agreement that restricts PES to Stryker alone “impeded and restricts competition” and “constitutes violation of the law”.

* However, the CCI ruled in its final order that the agreement was “not violative of the law” on the grounds that “there are other competing products in the market” that are available to other “similarly placed” distributors.

The point to ponder here is that, with such unholy scenario and  milieu developing, where business deals and investors decide the treatment with  aberrant medical evolution taking place. Doctors involved with such big  companies will be promoted,  projected and survive. Will the honest doctors, who are not part of the game, be able to survive, sustain themselves or ultimately alienated  to  extinction?

source

 

Made in India coronary stents non inferior to international stents


In a major advancement, a study shows that made in India coronary stents are as good as those manufactured in other countries by multinational companies, according to a recent scientific trial.

The study’s findings were presented at the prestigious international conference on Non Surgical Cardiac interventions—TCT (Trans Catheter Interventions)—on September 22 in San Diego, USA.

The study, which involved around 1,500 patients, was conducted in various countries of Europe and monitored by an international reputed clinical research organisation (CRO), Cardialysis.

The scientific study had the acronym TALENT.

The study dispels the perception among many doctors and patients that stents made in India may not be as safe and efficacious as those manufactured in foreign countries.

The TALENT trial was conceived by Prof Upendra Kaul, a well known interventional cardiologist who is currently the chairman of Batra Heart Centre, New Delhi, and Prof Patrick Serruys, an internationally acclaimed researcher in this field from the Netherlands.

 

Coronary stents are devices made of metal, usually chromium cobalt and coated with polymers and drug to treat blocked coronary arteries and also with a good and safe long-term performance.

In the recently conducted randomised trial to compare an India-made stent Supraflex with the world leader Xience stent from Abbott Vascular, the Supraflex sirolimus-eluting coronary stent manufactured by SMT in Surat emerged to be as good as the Xience stent made in Europe and the USA.

The study was sufficiently powered to give the final answer regarding non-inferiority of the Supraflex sirolimus-eluting stent versus the best-in class Xience stent from Abbott. The study was done in all comers with no exclusions, Prof Kaul said.

“The aim of the study was to test the hypothesis that both stents are equal in performance and safety. To dispel the belief that imported coronary devices are better, it needed a scientific study without any bias,” he explained.

In February, last year, when the Indian government decided to cap the prices of coronary stents, there was a dramatic reduction in prices from an average of USD 1,800 for the drug-eluting stent (DES) to USD 480 irrespective of the country they were manufactured in.

This resulted in increase in the usage of domestic stents because they offered it at lower prices, Dr Kaul said.

“However, the users still had the belief that India made stents may not be as good (as the imported ones). This required an acceptable scientific trial to draw a comparison between the two stents,” he claimed.

“The study was done in Europe to remove any bias and it was monitored by an international clinical research organisation (CRO), Cardialysis, which is world reputed,” Dr Kaul added.

The study showed that the composite end points consisting of cardiac death, target-vessel MI and clinically indicated repeat procedures at 12 months were similar for both.

Thus proving that the India made stent Supraflex was as good as the market leader Xinence, Dr Kaul claimed.

The study has important economic implications in countries where cost of the stent is an important issue. The full paper of this trial will soon be published in the Lancet, he said.

Dr Kaul further called upon other Indian manufacturers to do similar clinical trials to prove that their devices are worthy competitors to those made abroad.

source

Food supplement or Concealed harmful drugs? Dangling false promise of miracle


One of the paradox of the era is about dangling a false promise of miracle about health  may be bought easily and used with great confidence rather than a scientifically proved truth and fact.  Same is particularly truth about the health supplements and many so called “natural products” that are sold with just publicity or mere endorsement. There are no safe guards and users are completely oblivious of  the harm caused by uncounted number of  such health supplements or  substances.

Be careful while popping a pill for weight loss, muscle building or sexual enhancement. Several dietary supplements, most of which are widely available in India, have been found adulterated with unapproved and even banned pharmaceutical ingredients in the US with potential to cause serious health risks, a latest study published in ‘JAMA Open’ revealed.

At least 776 dietary supplements sold over the counter in the US over a period of 10 years from 2007 to 2016 were found containing unapproved pharmaceutical ingredients such as sildenafil, sibutramine and synthetic steroids — which have potential to cause side-effects ranging from stroke to kidney failure and even death, say researchers, who extracted and analyzed data from the US Food and Drug Administration’s (US FDA) Center for Drug Evaluation and Research.

These products were commonly marketed for sexual enhancement, weight loss, or muscle building.

In India  the problem may be bigger here as most of the dietary supplements are easily available and widely used in India without any regulation and guidelines. Even the US regulator said it has been able to test only a portion of products available on the market.

Dietary supplements in India are not tested or sampled by any authority and are easily available.

The dietary supplement segment which include nutraceuticals, foods for special dietary use and foods for special medical purpose poised to become a $10 billion industry by 2025. While rising income levels coupled with changing lifestyle have kindled demand for such products.

But  lack of regulation and usage guidelines have made these products easily available over the counter and through online sales.

In the absence of wherewithal to do product sampling and testing, quality, efficacy and safety of such dietary supplements continue to be under question.

Another major grey area in this issue is the overlapping between food and drugs. While drugs or medicines are regulated by the Drugs Controller General of India (DCGI), food supplements come under the purview of FSSAI. Often to circumvent drug price regulation or stringent pharmaceutical norms, companies tweak their pharma formulations and launch their products as food supplements, bypassing regulatory approvals from the DCGI. The US FDA data shows, more than 20% of adulterated dietary supplements contained more than one unapproved pharmaceutical ingredients.

Effectiveness and safety of many ingredients in dietary supplements remains questionable.

Good nutrition and a balanced diet are extremely important for good health. However, there are many people who turn to dietary supplements for a boost to their routines.

Many don’t seem to work, and some might even be harmful.

Dietary Supplements for Weight Loss guides readers through the confusing set of options in the marketplace.

People may not know that many manufacturers of weight-loss supplements don’t conduct studies in humans to find out whether their product works and is safe.

 

Loss of cabin pressure caused hypoxia, bleeds in Mumbai: Major tragedy in Greece@ air travel


More than 13 years ago, a Boeing aircraft crashed in a hilly terrain in Greece snuffing out 121 lives. A year later, investigators concluded that omissions in controlling cabin pressure was a key reason for the crash. Extreme case in 2005, a Helios Airline flight crashed into a mountain after the pilots lost consciousness from hypoxia.

One of the pilots said that generally, an aircraft is pressurized to 8,000 feet so that the pressure is adequate for the human body. Normally, a plane flies at an altitude of around 35,000 feet.

De-pressurization could even result in hypoxia for the people on board. Hypoxia or lack of adequate oxygen supply for the human tissues, can cause various problems, including deterioration in a cognitive abilities.

Loss of cabin pressure could result in hypoxia or the deprivation of oxygen. Oxygen deprivation is also the cause of headaches, nausea, and nosebleeds. A sudden drop in air pressure can be fatal for people with pre-existing conditions such as hypertension and cardiac anomalies .  There is a cavity in our oral and nasal passages and sudden change in air pressure of the surroundings negatively impairs the internal air pressure maintained in these cavities, thus causing bleeding through nose, ears or mouth. At the same time, the sudden drop in the pressure and lack of oxygen supply to the brain can also cause strokes, paralysis or convulsions in some people.

Drop in air-pressure in the surrounding affects people differently. While it usually causes heaviness in the head, dizziness and drowsiness in some, it can also be fatal for people with high blood pressure and a history of heart attacks. The five passengers suffered “barotrauma” of ear, which is caused due to a change in air pressure.

Several passengers on a Jet Airways Mumbai-Jaipur flight suffered nose and ear bleeding on Thursday morning as the pilots forgot to switch on the system to maintain cabin pressure, the DGCA said. “The 9W 697 Mumbai-Jaipur flight was turned back to Mumbai after take off as, during the climb, crew forgot to select switch to maintain cabin pressure. This resulted in the oxygen masks dropping. Thirty out of 166 passengers experienced nose and ear bleeding, some also complained of headache,”   deputy director general, Directorate General of Civil Aviation (DGCA), said. The crew has been taken off duty and Aircraft Accident Investigation Bureau (AAIB) has started an investigation, DGCA added. Ministry of Civil Aviation has requested DGCA to file its report immediately on the issue. The passengers are being treated at Mumbai airport. In a statement, Jet Airways said the B737 aircraft landed normally in Mumbai. “All guests were deplaned safely and taken to the terminal. First aid was administered to few guests who complained of ear pain, bleeding nose etc. The flight’s cockpit crew has been taken off scheduled duties pending investigation. The airline is making alternative flight arrangements for guests on this flight. Jet Airways regrets the inconvenience caused to its guests.” Several passengers posted images from inside the plane,  that showed that oxygen masks had been deployed due to the low cabin pressure

Invisible medical harms of carpet-bomb treatments with FDC (fixed dose combination): @ Government prohibits 328 fixed dose combinations


Drug Technical Advisory Board said there is no therapeutic justification for the ingredients contained in the 328 fixed-dose combination or FDC drugs.

A fixed-dose combination or FDC drug contains two or more active ingredients in a fixed dosage ratio. It means it’s not the single drug but a combination of the two or more,  which may be   unnecessary for consumption.

  1. Antibiotic  resistance: Most harmful impact can be because of antibiotics in FDC.

– Logic is simple. If  some one  is  not able to recognize, whether it is a rat, cat, dog or tiger causing trouble, carpet bomb with combination of three or four   bombs.  Is it overuse of  weapons? Yes, it is. Similarly, abuse of multiple antibiotics has potential to cause massive antibiotic resistance, can have global harmful effect.

Quacks or by self medication,  antibiotics may be overused  and abused . Quacks  or alternative medicine doctors often prescribe FDCs as they are unable to pinpoint the exact cause of an illness and carpet-bomb patients with combination doses, in the hope that one of the drugs would work.

  1. Overuse of drugs: where one drug for example a paracetamol is required, patient will take three medicines.
  2. Increase in side effects: instead of one medication, patient will have side effects of all other medicines also.
  3. inadequate doses: If many drugs are combined in one, doses may be inadequate or less. So patient takes more drugs , but in adequate doses.
  4. Increase in cost: instead of one , the patient pays for three drugs, thereby increase in cost.

Government prohibits 328 fixed dose combinations 

     Painkiller Saridon and skin cream Panderm are among 328 fixed-dose combination or FDC drugs banned by the government to stop their “irrational use”. The health ministry says the ingredients in these medicines do not markedly add to the benefits that people can get from taking them. The order immediately bans the manufacture, marketing and sale of several common cough syrups, painkillers, and cold and flu drugs. The country’s drug advisory body, the Drug Technical Advisory Board or DTAB, has said there is no therapeutic justification for the ingredients in these drugs and they must be banned in public interest.

-The government has added restrictions to dosage and use of six more FDCs,  not among the 328 banned ones,  over their ingredients having no therapeutic value and posing a risk to consumers.

-The health ministry took the decision after the country’s top drug advisory body, the Drug Technical Advisory Board or DTAB, in a report said taking the 328 FDCs would be a health risk. India has some 2,000 FDCs as against a little over 500 in USA.

-It is a good move for public health. Individual drugs are approved by the centre, but some manufacturers make combinations of two drugs and get state licences.

-Mixing two drugs create a new medicine. For new medicine , pharma companies should approach the Drugs Controller General of India and apply for a fresh licence, conduct trials and  prove safety.

-In March 2010, the government restricted sales of 344 FDCs, a move that was challenged by pharma firms in court. The Supreme Court last December told the DTAB to ascertain whether FDCs should be banned from the market.

Every one is  calculative about  the loss of millions.  The invisible losses to human kind are still to be calculated.

 

How viruses, germ cross international borders? Toilets cleaner than Airport trays


Airport security trays carry more diseases than toilets.  The plastic trays that passengers put their hand luggage in at airport security checkpoints harbour the highest levels of viruses, even more than toilets, a study warns. Researchers from the University of Nottingham in the UK swabbed a variety of surfaces at Helsinki-Vantaa airport in Finland during the winter of 2016. They set out to identify and quantify the respiratory viruses on frequently touched surfaces in airports. The team found evidence of viruses on 10 per cent of the surfaces tested and most commonly on the plastic trays that are circulated along the passenger queue at the hand luggage X-ray checkpoint. The study, published in the journal BMC Infectious Diseases, concludes that hand washing and careful coughing hygiene are crucial to the control of contagious infections in public areas with high volumes of people passing through. The findings add weight to previous studies showing that microbes are commonly found on surfaces in public transport vehicles and will strengthen public health advice in preparation for future flu pandemics, researchers said. Airport security trays carry more diseases than toilets. The highest concentration of viruses was detected on the security check plastic trays with further viruses detected on shop payment terminals, staircase rails, passport checking counters, children’s play areas and in the air. The most common virus found in the survey was rhinovirus, which causes the common cold but the swabs also picked up the influenza A virus, researchers said. Interestingly, no respiratory viruses were found on toilet surfaces, they said.

Story of Unlabeled drugs and Fraud In name of Ayurvedic treatment


         A myth, that any plant extracted drug is useful, free of side effects, is a belief ingrained deep in the minds of people. Such unscrupulous advice is followed blindly without even verifying the authenticity of the source. A hope of miracle is flashed to patients who have been given a “no hope” by scientific medicine, are an easy prey for such fraudsters.

   Another major problem is that medicines and syrups distributed in such manner are without name of drug, contents and doses. It is not uncommon to get lethal substances like steroids, hormones and heavy metals in dangerous doses.  

     Ayurvedic medicines and practitioners  belong to a  stream, also based on a  science. The medicines and treatment has to be  controlled and regulated in the same way, as for allopathic  stream.  So that criminals, who are not trained in ayurvedic stream can not play with lives of gullible people, giving them false hope.  Such acts  are  real crime to society, done with an intention to cheat rather than treating them.

   Any one distributing medicines or medical advice of any kind, has to be registered with a council, for those particular medicines. advertisement of such drugs or products should be on some scientific basis.

Regulating Ayurvedic medicines and practice will help  not only the genuine  Ayurvedic  doctors but also go a long way  in benefiting the ancient system of medicine and promote research.  

  Following may be just one of the cases, millions may remain unnoticed.

False ayurveda hopes to the hopeless

Tarun Mandal has spent almost all of his savings trying to get his son, suffering from acute jaundice since his birth, treated for the past one and a half years. A desperate Mandal recently paid a youth Rs 65,000 for an ayurvedic cure. However, his wife’s suspicion about the ‘gold ash’ tasting like churan led cops to an inter-state racket cheating terminally ill patients with a promise of cure. Mandal, who sells food items on a cart at the Sarojini Nagar market, was not the only one to fall in the trap. Cops have found at least 40 people who had been duped by the gang. Most of the victims are family members of children from different states getting treated in the capital’s top government hospitals.
“I gave away all my savings to them. They even guaranteed that all my money would be returned if the medicines failed. But when I went back to the same shop, they refused to recognise me,” said Mandal, who has already spent Rs 2 lakh and needs more money for a surgery.
The gang has also duped the grandfather of a seven-year-old thalessemia patient from Uttarakhand.

other incident dangerous chemicals in alternate medicines

The Story of Faulty Johnson & Johnson (J&J) Hip Implant


Govt to track patients with faulty J&J hip implant to ensure compensation

Close to 4,700 people with damaged hip joints in India received the implant before 2010, when it was recalled, of which only 1,080 were tracked and compensated.

   The Union health ministry will establish committees at the Central and state levels to track and compensate patients who received a faulty artificial hip implant that was recalled worldwide by the manufacturer Johnson & Johnson (J&J), in 2010.

Close to 4,700 people with damaged hip joints in India received the implant before 2010, when it was recalled, of which only 1,080 were tracked and compensated. Of them, 275 underwent revision surgeries.

Following complaints from patients, the health ministry set up an 11-member committee on February 7, 2017, to investigate patient complaints of adverse events against J&J’s metal-on-metal Articular Surface Replacement (ASR) hip implant devices — XL Acetabular Hip System and Hip Resurfacing System.

The committee  submitted its report on February 19, 2018. It said specialists must assess cases individually for treatment and compensation of at least Rs 20 lakh.

In November last year, the federal jury in Dallas had ordered J&J and its DePuy Orthopaedics unit to pay $247 million to six patients for not warning patients about the potential risks of the defective design of the metal-on-metal hip implants .

The committee at the state level will be tracking the affected patients. These cases are old and hospitals don’t have data available on them; close to 100 hospitals were approached but there was no data. State governments will be widely advertising the move to see that affected people approach them,” said a senior official, requesting anonymity.

Each case will be physically and clinically assessed by the state government committee to determine the degree of disability and refer to the central government committee to decide on the compensation amount.

In it response J&J said: “DePuy has fully cooperated with the expert committee in their investigation of the ASR matter. However, the Expert Committee Report has not been provided to the company for review to date, so it would be inappropriate for us to comment on it. We would like to reiterate that we have furnished full facts and data available with us to the expert committee.”

Metal on metal implants are rarely used now, say orthopaedic surgeons. “Metal-on-metal hip implants have been largely discontinued because of the associated complications. With other implants, the revision surgery rate would be around 3-5%, but with this particular brand, it was a higher 10-12 percent.

People complain of pain, which is largely due to loosening of the implant and wear and tear of the metal that would cause collection of metal in the body that it would react to. Another  available implant is ceramic cross-linked with plastic polyethylene socket, where head ball is of ceramic and socket of polyethylene.

After years of testing, ASR was imported and marketed in India and in various countries around the world, with all regulatory approval and permissions as were then applicable. After it was on the market, DePuy continued studying and closely watching how the device was performing and in August 2010.  DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry.

It immediately informed the Drugs Controller General of India (DCGI) about the voluntary recall. Since then, we have kept the DCGI informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements.”

Health policies to cover mental illness: Insurance regulator IRDAI issued a circular directing insurers


Insurance regulator IRDAI on Thursday issued a circular directing insurers to cover mental illness, which has reached serious proportions in the country. The Mental Healthcare Act, 2017 — which came into force from May 29 — has made it mandatory to provide “for medical insurance for treatment of mental illness on the same basis as is available for treatment of physical illness”. But to date, none of India’s 33 insurers has introduced a product that covers ailments such as depression, schizophrenia, and bipolar disorder, even though such covers are commonplace in many countries. The IRDAI order says, “All insurance companies are hereby directed to comply with the…provisions of the Mental Healthcare Act, 2017 with immediate effect.”

“This will ensure a life of dignity to those who have mental health issues. We believe it will create awareness, acceptance, and inclusion of mental illness as any other physical ailment. It will ‘normalise’ diagnoses, by reducing associated myths and stigma. Today, no one can say we won’t cover cancer, tuberculosis or heart attack. So why do we have this block towards covering mental health issues? They are just as debilitating and corrosive to a person’s well-being as physical ailments.”

Mental health conditions have always been in the list of exclusions of health insurance policies. The only exceptions to this have been the coverage of development conditions such as autism and Down’s syndrome by the National Health Insurance Scheme, and a few private schemes like Star Health Insurance’s cover for autistic children. Companies wishing to include mental health coverage will have to file a fresh product with the IRDAI, or add this to an existing product and file again. “They have to revise the rates, look at the actuarial risk, increase premium if need be. So far, no insurance company has filed for such a change with the regulator,” said a government official .

“At the lower end you have anxiety and depression. At the upper end there’s obsessive compulsive disorder, bipolar, borderline narcissistic personality disorder. We should first cover the lower end. It does seem harsh to tell a person we can’t cover you, when they are already depressed,”

It is uncharted territory. There are two coverages needed: First, OPD cover for therapy, consultation and drugs. Second, hospitalisation or rehab, which would be long-term and expensive. In western countries, both are covered. But in India, it is untested ground.

Source. Times of India

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