Medical device harms, hidden by regulator: policies akin to protection @USFDA


        

                   Modern medicine has been captivated by the  industry. In the name of people’s health, business and industry  receives a kind of  protection  by none other than regulator itself.  The report about USFDA,  hiding the adverse events or device failure and harm is just one example how  powerful  industry has become.  It is not always possible to identify  complications arising out of device failure and there can be possibility of  these  not  being reported. The numbers that are hidden may also represent a fraction of  actual number of harms related to device.  A sad truth of present era, where doctors are punished  and blamed for human errors or even  natural poor prognosis,  Medical industry remains not only  hidden behind the scenes, but  receives  policies akin to protection  by regulator.

USFDA ‘hid’ reports of medical device snags The US Food and Drug Administration (FDA), which claims to have stringent processes in place to ensure safety of medical devices, has been found to maintain a “hidden database” of reports of serious injuries and malfunction of devices. Since 2016, over a million incidents that were reported went to the hidden database rather than to the publicly available database of suspected device-associated deaths, serious injuries and malfunctions. This was revealed in an investigation carried out by Kaiser Health News, a US-based non-profit news service covering health news. The revelation has serious implications for India, which approves a lot of devices based on USFDA approval. KHN found that “about 100” devices including mechanical breathing machines and balloon pumps were granted “reporting exemptions” over the years. The investigation revealed that many doctors and engineers dedicated to improving device safety not only did not know the issues raised in these reports, they didn’t even know about the existence of the “hidden database” or the exemptions. While the agency hid such crucial information about device risks, lawsuits and FDA records show that patients have been injured, hundreds of times in some cases, noted KHN. According to KHN, FDA confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” an FDA spokesperson told KHN. The USFDA’s public database that tracks medical device failures, Manufacturer and User Facility Device Experience (MAUDE), receives thousands of medical device reports that are used to detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. These reports are submitted by mandatory reporters — manufacturers, importers and device user facilities — and by voluntary reporters — healthcare professionals, patients and consumers. MAUDE is used by doctors to identify problems or to check the safety record of a particular device. But they could reach the wrong conclusion as they would be unaware of and have no access to the reports on the “registry exempted” products, pointed out a former FDA official to KHN. For instance, KHN found that in 2016, while reports of only 84 stapler injuries or malfunctions were submitted to the public database, nearly 10,000 malfunction reports were included in the hidden database. Medtronic, which owns Covidien, considered to be the market leader in surgical staplers, had used reporting exemption. Surgical staplers are used to cut and seal tissues or vessels quickly, especially during minimally invasive surgeries and if the device fails the patient could bleed to death unless the doctors moved quickly to resuscitate the patient and seal the tissue/vessel. After the KHN report was published, the FDA has written to doctors expressing concern about the safety of surgical staples and staplers. The agency said it has received reports of 366 deaths, over 9,000 serious injuries and over 32,000 malfunctions. The letter also acknowledged that the FDA was aware that “many more device malfunction reports during this time frame” were submitted as “summary reports”. The agency said it was analyzing the reports and that the results would be made public. According to the KHN report, the FDA has deemed manufacturers of over 5,600 types of devices including cardiac stents, leadless pacemakers and mechanical heart valves, eligible to file “voluntary malfunction summary reports”, one of the many exemption programmes. Ironically, in India, doctors and regulators have argued that FDA has the most stringent regulation for devices compared to regulators in Europe, Canada, Australia or Japan and have even sought to make it mandatory for devices to have USFDA approval to be eligible for government procurement tenders. This was especially evident during the efforts to cap the price of stents when top cardiologists argued for higher prices or even price cap exemption for USFDA-approved stents.

Black coat vs white coat. What if money part is taken out of medico legal cases?


What if  financial part  is taken out of medico-legal issues, like compensation and lawyers fee?  The cases will drop down drastically?  If money part is zero, only errors will be identified and punished. Few  will remain only for idea of revenge.  In an era where people cheat their brothers, sisters and spouses for money, it will be naïve to think that idea of money extracting from doctors does not exist.

Financial  zeroing  can be done  in larger public interest to  keep down the cost of medical expenses.  It is  because of career building of few professions, that medico-legal cases are being fueled. Medical errors and complications are integral part of the treatment . Even simplest of diseases carry some amount of risk.  These  will still remain, even if doctors are hanged to death. Natural complications, poor prognosis can be attributed to errors by clever lawyering and because of benefit derived by other professions.

     Many careers  are  shining in name of preventable deaths  and medical errors at the cost of medical profession.  The managers, right activists, media   and lawyers  have made their career and wealth out of it. Ask any doctor really, are these issues really preventable after a point.  The  line separating errors or natural complications is really blurred and arbitrary. People who work in life and death situation know it well that  even natural poor prognosis can be labelled and proved as error by retrospective analysis and wisdom of hindsight and more certainly with luxury of time at disposal for lawyers and courts.

     Lawyers  and courts  should also be given those fraction of moments to decide same as is available to doctors. Otherwise it becomes a unbalanced match specially when the amount of money which was paid to doctor to save a life was peanuts as compared to now being paid to punish him.

Cure for AIDS may be possible in near future


“London patient” becomes second person to be cured of AIDS after stem cell therapy. It has helped them put their infection under remission without medication. The breakthrough offers hope for a potential cure using gene manipulation for an infection. Concept that scientists will one day be able to end AIDS, the doctors said, but does not mean a cure for HIV has been found.

An HIV-positive man in Britain has become the second known adult worldwide to be cleared of the AIDS virus after he received a bone marrow transplant from an HIV resistant donor, his doctors said.

Almost three years after receiving bone marrow stem cells from a donor with a rare genetic mutation that resists HIV infection – and more than 18 months after coming off antiretroviral drugs – highly sensitive tests still show no trace of the man’s previous  HIV infection.

“There is no virus there that we can measure. We can’t detect anything,” said Ravindra Gupta, a professor and HIV biologist who co-led a team of doctors treating the man.

The case is a proof of the concept that scientists will one day be able to end AIDS, the doctors said, but does not mean a cure for HIV has been found.

Gupta described his patient as “functionally cured” and “in remission”, but cautioned: “It’s too early to say he’s cured.”

The man is being called “the London patient”, in part because his case is similar to the first known case of a functional cure of HIV – in an American man, Timothy Brown, who became known as the “ Berlin patient” when he underwent similar treatment in Germany in 2007 which also cleared his HIV.

 

Brown, who had been living in Berlin, has since moved to the United States and, according to HIV experts, is still HIV-free.

Some 37 million people worldwide are currently infected with  HIV  has killed around 35 million people worldwide since it began in the 1980s. Scientific research into the complex virus has in recent years led to the development of drug combinations that can keep it at bay in most patients.

Gupta, now at Cambridge University, treated the London patient when he was working at University College London. The man had contracted HIV in 2003, Gupta said, and in 2012 was also diagnosed with a type of blood cancer called Hodgkin’s Lymphoma.

In 2016, when he was very sick with cancer, doctors decided to seek a transplant match for him. “This was really his last chance of survival,” Gupta told Reuters in an interview.

The donor – who was unrelated – had a genetic mutation known as ‘CCR5 delta 32’, which confers resistance to HIV.

The transplant went relatively smoothly, but there were some side effects, including the patient suffering a period of “graft-versus-host” disease.

Most experts say it is inconceivable such treatments could be a way of curing all patients. The procedure is expensive, complex and risky. To do this in others, exact match donors would have to be found in the tiny proportion of people — most of them of northern European descent — who have the CCR5 mutation that makes them resistant to the virus.

Specialists said it is also not yet clear whether the CCR5 resistance is the only key – or whether the graft versus host disease may have been just as important. Both the Berlin and London patients had this complication, which may have played a role in the loss of HIV-infected cells.

Sharon Lewin, an expert at Australia’s Doherty Institute and co-chair of the International AIDS Society’s cure research advisory board, told Reuters the London case points to new avenues for study. “We haven’t cured HIV, but (this) gives us hope that it’s going to be feasible one day to eliminate the virus,” she said.

Gene manipulation, like any experimental technology, comes with several caveats, including concerns about the “off target effects” that can cause adverse mutations, including cancer.

 

Illegal Organ (Kidney)transplant trade : Defined as crime, but saves life


A paradox, where a defined crime saves a life and following law and regulation correctly will result in end of life. If some one is asked to choose between a certain death or follow regulations, the choice will be very predictable. A patient , who has an irreversible organ failure, will try to defy death at all cost. People who can afford, can not see their children or loved ones to die, just for the sake of following law and regulations. Genuine concern here will be that If a patient can be cured of disease, why he should be left to die for just regulations. The wish to live is the basic reason, why the procedures, which are termed illegal, will flourish. They will thrive underground or in countries, where laws are lax. Touts, agents and liaison managers are people, who will be beneficiary and mint money by organization of the procedure. The people who can afford, get gift of life, in the bargain.

Organ transplant may be termed illegal, in certain circumstances as defined by Law. But legal or illegal, it gives life . It gives another chance to people to live or have their kith and kin, children , spouses and parent to live another life. Because of gap in demand and supply, when legal means do not help, adoption of illegal means becomes a compulsion. If following law and rules means death, they are unlikely to be complied with.

The gap in demand and supply of organs is the reason behind these activities. Nearly four lakh people suffering from end stage kidney failure need transplant and only 8000 get it. (Times of India). The recipient has two choices for Kidneys. It can be living donor and deceased donor or cadaveric in cases of brain death. 90% come from relatives, rest are cadaveric. The rest has to undergo repeated dialysis to survive.

After the enactment of The Human Organ Transplantation Act of 1994, transplants became less in India. But it was followed by booming market of donors In other countries like Pakistan, Philippines .

But given the circumstances of life and death, the underground market may still be existent.

The ACT also allows unrelated donors to give one of the kidneys if there is sufficient evidence to show that they know the recipient for a long time and are donating organs out of affection. The loophole has potential to be exploited. The affection or the papers for affection can be easily generated in today’s era in lieu of money or other favors in case of high profile cases. Therefore, the mediator’s work becomes easier to generate the papers projecting affection and tutoring and training of donors and recipient.

Alternatively, the procedure can be done in nearby countries. Therefore the role of doctor or surgeon doing a transplant (although the key point) is much smaller than the agent organizing the whole process. Thereby the agents , who can manage and organize the show, are thriving. The wish to defy a certain death is stronger than following the regulation. That will remain so till demand supply gap reduced , better awareness for brain death, medical infrastructure, organ retrieval and transport and supporting facilities are uplifted. Till it happens, even if it is defined as crime, the fruits will outweigh the risks, because of shear margin of money temptations and wish to live.

Administrative and infrastructure deficiencies in health care: fail and blame for doctors


Adverse outcome in patients  can be  because of  many factors. Most of the time it is  serious illness, natural poor prognosis of disease, genuine complications or infections. Sometimes, It can be deficiency of equipment, malfunction, lack of infrastructure or facilities. There can be poor training or lack of  proper human resource and many others. There may be unintentional or human errors  by doctors or staff.  Root cause for most of the problems  can be traced to  administrative and system deficiencies rather than mistake of doctor. But since doctor is universal final link, when a patient dies, who  is visible on the bedside. So by application of an average wisdom, it is the doctor who will be held responsible for any problem or adverse outcome. Administration and people who are responsible for building infrastructure, procurement of  equipment and allocating finances or manpower  are not visible in forefront. It is very common for the doctors  to find themselves in a helpless situation, specially  in presence of  deluge of patients, difficult circumstances, scarce resources  and other  administrative issues.  In cases of adverse outcomes,  administration can   pretend to hide behind the common escape route by punishing doctors and hold them  guilty for the adverse events, as no other cause or person   is visible. By retrospective analysis  and  wisdom of hindsight along with luxury of time , it is a cake walk to give  verdict of one’s choice later, by fault finding analysis.

Non availability of ventilators or  malfunctioning  is not an issue, for which doctors are responsible. Procurement and allocation of funds is an  administrator’s domain.  But it is common that  doctors can be accused for not saving a life. They can be punished, dragged to court and even assaulted physically by crowds.  Dismal percentage of availability  of ventilators in Delhi Hospitals is a tip of the iceberg. This can be even  worse in other parts of the country. Ironically crowds visiting the hospitals only see and blame  the doctor, who is present on bedside and trying to save the patient. Patients hold them responsible for  malaise of the system  and fail to see the presence of  large  administration and industry,   that is behind  the scene. An unfortunate era,  when  the  doctors are blamed on  individual basis for system failure. In present circumstances, Lack of medical wisdom among masses is a cause of  huge discouragement for doctors.

With  High court being proactive in asking about the number of ventilators, the administration can not pretend to hide behind any more, but masses need to know the real truth.

Only 3.4% beds on Delhi Govt Hospitals have ventilator facility against the minimum requirement of 10% in every state run medical center. For  over 10,000 beds,  only 348 ventilators are there. That is an extremely low number.

52 of 400 ventilators in Delhi hospitals non-functional, state tells HC.

After 3-year-old Farhan died in the national Capital for an alleged want of proper ventilator care earlier this month, the state government of Delhi has told the High Court that a substantial number of ventilators in its government hospitals are not working. The state also told the HC on Tuesday that they were aiming to have a web portal up and running within two months, which would provide an online daily update on ventilator and bed availability across Delhi’s government hospitals.

After directions were issued by the HC, the state asked all its hospitals to provide a status update on ventilators and according to the information received from the government hospitals, up to 52 ventilators (13 per cent) of the total of 400 ventilator beds (including 300 ICU and 100 non-ICU) available in the hospitals are non-functional. “Fifty-two ventilators are non-functional and efforts are being made to get them repaired. The procurement of 18 ventilators is under process,” said the reply filed by the state government in the High Court on February 12.

The state government also stated in its reply that as far as maintaining real-time information on the availability of vacant beds in Delhi government hospitals goes, it may not be feasible to implement real-time availability information in the initial phase and the Delhi State Health Mission should be advised to start uploading information on bed availability in all the hospitals once a day in the morning.

The state government also said the State Programme Officer (MIS) of the Delhi State Health Mission has been requested, in

a letter dated January 31, to prepare a web portal for online bed/ ventilator availability and that such a Web portal should be made functional within two months.

The state government through an email sent on February 7 has also requested all the hospitals to complete repair, condemnation and procurement of ventilators at the earliest, according to Nutan Mundeja, Director General of Health Services.

After the matter of alleged unavailability of healthcare to Farhan came to light, the High Court moved a motion against the Union of India and sought a reply.

The number of ventilators as compared to bed strength in government hospitals is meager. “In private hospitals, there is one ventilator bed for every four normal beds. In government set-ups though, even as we have over 10,000 beds, we have only 348 ventilators. That is an extremely low number. Also, these ventilators may not be evenly distributed across the city,” pointed out  stated U Jhamb, Director, Professor and Head, Department of Paediatrics at the hospital.

 

Leopard tortoise designed pill to administer insulin in diabetes


The discovery  has a potential to  transform  lives of millions of patients with diabetics.  It can  counter the availability and cost of insulin in future.  If successful , the new technology can even change the  delivery of other  drugs as well.

Scientists have developed a “needle pill” that could allow diabetics to take insulin without the need for daily injections.

The pea-sized capsule contains a small needle made of solid, compressed insulin, which is injected into the stomach wall after the capsule has been swallowed.

When tested in pigs, the device worked consistently and was able to deliver equivalent doses of insulin to those required by someone with diabetes.

Giovanni Traverso, an assistant professor at Harvard Medical School affiliated Brigham and Women’s hospital and a co-author of the study, said: “Our motivation is to make it easier for patients to take medication, particularly medications that require an injection. The classic one is insulin, but there are many others.”

Injections can be painful, cause injuries and be a barrier to people taking medication, he added.

The shape of the capsule is inspired by the leopard tortoise, found in Africa, which has a steep, domed shell that allows it to right itself if it rolls onto its back. In the case of the capsule, the domed shape ensures that the needle is continually reoriented towards the stomach wall. The needle is attached to a compressed spring that is restrained by a disk made from sugar. When the capsule is swallowed, water in the stomach dissolves the disk, releasing the spring and injecting the needle into the stomach wall.

The stomach wall does not have pain receptors, so it is unlikely that this would cause any discomfort. The insulin needle takes about an hour to dissolve into the bloodstream. In tests in pigs, the researchers said they were able to deliver five milligrams of insulin – comparable to the amount that a patient with type 2 diabetes would need to inject.

The metal spring and rest of the capsule passed through the digestive system, without seeming to cause any problems.

The team are now carrying out further tests in pigs and dogs and hope to start the first human trials within three years.

Pharma industry sale growth rate doubles: reason to rejoice or matter of concern?


While for pharma  industry, news is  a matter  to rejoice, but for common man and doctors, there may be something  to worry or concern. The  advancements in medical science & knowledge should lead to  prevention of diseases ,  the use of medicines need to decline. With more mechanisms for diseases are discovered,  should lead to lesser occurrence of  diseases (preventive). There can be good reasons for pharmaceutical growth like more people using the medical systems and thereby  consumption of medicine has increased, that can be a simple argument to support the growth. There can be scientific and pharmaceutical  advancements, leading to healthy growth.

But there can be complex and thought provoking counter arguments, like more number of  people suffering from  diseases. There can be system failures  and inability  to prevent diseases resulting in  more people falling sick and forced to take more medicines. If  diseases like cardiac  , respiratory and cancer are on the rise ,  a common man should be worried about life style, stress  and our environment. What if infections are on the rise leading to more consumption of antibiotics?  There can be chances that antibiotics are overused and misused. There can be other uncomfortable thoughts in few minds, which worry all the patients and many among medical fraternity. These are like overuse of medicines by  doctors or even unauthorized physicians.  There  can be possibility of people indulging in   crosspathy or aggressive marketing by pharma companies.

The domestic pharma retail market registered a robust growth rate of around 10% in 2018, nearly doubling year-on-year, buoyed by higher volumes and launch of new drugs. In 2017, the market was impacted by the introduction of GST, resulting in a meagre growth rate of 5.5% – the lowest in recent years. Anti-diabetics, cardio-vascular, respiratory and derma medicines ended the year with strong double-digit growth, while overall drivers of the Rs 1.29-lakh-crore market include higher volumes (4.8%), price increase (2.2%) and new launches (2.4%), data from market research firm AIOCD-Awacs said. For December alone, the market showed 9.8% growth, higher than in November.  In fact, growth has been consistently above 9% over the last four quarters.Expansion was driven by top domestic companies mainly by  Anti-diabetic therapy, Ayurvedic hepatic protector Liv 52,  Anti-infectives ,  cardiac, gastro-intestinal.

Be it any reason for pharmaceutical growth, people need to know about reasons for rocket trajectory growth of pharma companies . It indirectly  depicts the health of the people and unfortunately inversely proportional to it. So there may be  more matter to worry than rejoice.

 

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.

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