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.

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.

Thousands Healthy deaths vs one hospital death. Perception of moral burden of negligence (# SUPREME COURT on pothole deaths)


There is a  infernal  difference in  the kind of  media  projection, burden of negligence and accountability of preventable multiple healthy deaths by civic negligence   as compared to one hospital death occurring due to severe  disease. In fact the burden of   negligence here in healthy deaths is massive and  these deaths are unpardonable. But reality is opposite.  Strangely  “alleged and perceived negligence” ( with no proof and no investigation )  in death of someone already having disease  and death in hospital  during treatment attracts more scrutiny and   stringent  punishment   as compared to a naked “negligence  in deaths of healthy people” in such cases  of civic negligence.  

Massive civic negligence  leading to  entirely preventable loss of lives. These incidents bring fore the misplaced priorities of media and society which too have  contributed to  some extent to these unabated ongoing preventable   deaths  of  thousands of  healthy people.

 

Deaths due to potholes ‘unacceptable’,  Supreme court

The bench,  said the number of deaths from 2013 to 2017 in accidents due to potholes indicated that the authorities concerned were not maintaining the roads. The Supreme Court Thursday expressed concern over 14,926 people being killed in road accidents due to potholes in last five years and termed it “unacceptable”. A bench said the large number of deaths caused due to potholes across the country was “probably more than those killed on border or by the terrorists”. Terming the situation as frightening, the top court had asked the Supreme Court Committee on Road Safety to look into the matter. The bench had also said that people who have lost their lives as a result of accidents due to potholes should be entitled to compensation. 

 

Multiple  Deaths  in healthy people by civic negligence :

Large numbers of death and morbidity happen amongst absolutely healthy population due to preventable causes like open manholes, drains, live electric wires, water contamination, dengue, malaria, recurring floods  etc. These deaths  of people are in thousands, and are almost entirely of healthy people, who otherwise were not at risk of death. In fact the burden of   negligence here is massive and  these deaths are unpardonable

 

       Single  Death in Hospital due to disease:

The media has always, instead, focused on the stray  and occasional incidents of perceived alleged negligence  in hospital deaths which could have occurred due to critical medical condition of patient. However an impression is created as if the doctors have killed a healthy person. It is assumed without any investigation that it was doctor’s fault.  Media has been responsible for creating a misunderstanding about the whole process of treatment and creating  something sensational out of nothing.

 

Point to ponder-Misplaced priorities:

Who is to be  blamed for  the deaths of healthy people which occur because of civic negligence? Here relatives may be helpless and  the vital questions  may go unanswered or taken as a routine.  There are no punching bags like doctor  for revenge. But on the contrary, any stray incident of death of an already ill patient is blown out of proportion by media forgetting the fact that thousands of patients are saved everyday by  doctors. But media instead chose to defame medical profession by igniting the emotions of people by sensationalizing death of diseased and ill,  who probably were already at risk of death and did not give due importance to highlighting prevention of healthy  and absolutely 100% preventable deaths.

Right issues raised at right time will save thousands of healthy preventable deaths. Multiple  healthy deaths should carry more burden of negligence than  one death due to disease.

      

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.

 

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

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

Quack menace: Patient killed by quack (Delhi): qualified doctors regulated strictly but not unqualified?


 

In an era, when even licensed and qualified doctors are finding it  difficult to practice medicine, it is strange that unqualified and unlicensed are having a field day. Why a strict regulation does not apply to them, is beyond any reasoning and logic. If a medical facility or clinic is functional, it is difficult for the patient, specially in emergency, to check or even doubt its credentials. How such facilities are open, functional and thriving, which does not have a qualified medical person is beyond logic. Sadly our regulation is trying to regulate, who are already regulated. It is trying to punish those who are qualified and licensed, but turns a blind eye towards unlicensed and unqualified doctors.

Such fake doctors own medical set ups, may conduct surgeries,  sometimes run with little help from qualified doctors,  and do procedures. Another problem is that they   promote fake rumours about genuinely qualified doctors and create a mist of mistrust to propagate their fake medical business.

If this is state of medical affairs prevalent in heart of capital and such facilities are functional and thriving, what will be state of affairs in peripheral or remote areas. Again it does not need an Einstein brain to guess.

The Delhi Medical Council (DMC) on Wednesday ordered criminal action against a quack whose “treatment” resulted in the death of a patient in November last year.

The hospital in which the patient was treated was also not registered with the Directorate of Health Services, Delhi. The patient was treated by an unqualified person in an unregistered hospital and did not receive proper treatment, which led to his death. The man, who had pretended to be a doctor, had been practising medicine for almost 12 years in Delhi and was a member of the Indian Medical Association (IMA), a pan-india representative organisation of doctors, and the Indian Academy of Paediatrics (IAP), a renowned association of paediatricians.

The 45 years old patient  had an undiagnosed liver disease. He went to a private hospital in Munirka ( New Delhi) around 2 pm on noticing blood in his vomit and stool. Within nine hours, the condition of the patient deteriorated and he was taken to Safdarjung hospital New Delhi , where he was declared dead on arrival at 2 am.

The patient was just put on a saline and given some antibiotics and pain medication. No diagnostic test was done to find the source of the bleeding, neither was any blood given to the patient. Any doctor can tell you the treatment was wrong. First he gave a DMC number, but the number corresponded to someone else. So, he provided  a registration number of the Goa Medical Council, again it belonged to someone else.

 

This is an  example of  how modern medicine is detrimental in unsafe hands, that are functional without proper training. How these fake doctors openly call themselves doctors, use prefix of Dr and register themselves somehow.   It is no less than fraud with lives of innocent public.

Neglect towards this sad reality  is akin to playing with health of innocent people. Medical organizations and media  has either  not taken it seriously or not able to take any constructive step  in curbing this menace by quacks.

Although genuine doctors face many problems from system of quackery. Misuse of antibiotics, local goonism and nuisance, all kinds of malpractice, misguiding the patient are few examples. But ultimately it is the society who is  the sufferer. Therefore resistance to such practices and  a wish to have good health system is  actually need of society. Unless people themselves make a true effort towards a robust health system, this menace of quackery is likely to persist, due  to prevalence  of  vested interests.

Pharma- Malaise may get treatment: unique IDs of drugs soon to check fakes


Usually every problem related to health is called medical malaise, but that is a misnomer.  In fact health care comprises tens of different industries. Collective malaise of all these is conveniently projected as medical malaise, related to doctors. Rest remain invisible, earn money and  doctors are blamed. As doctor is a common universal link that is visible with patient. By an average application of wisdom, it is easy to blame doctors for everything,    that goes wrong with patient.

One such problem is presence of fake medicines.  If patient gets fake or low quality medicines and does not get well or gets side effects, doctor will face harassment. Whereas people involved and industry will be sitting pretty and  make money.

Therefore any such step  to correct Pharma –malaise should be a welcome step for  doctors. Although it will be a complex issue, because of complexity involved in implementation and execution of policies. But recognition and beginning to think of the problem is also an important step.

May be a time to treat Pharma- malaise.

India’s highest advisory body on drugs will discuss a mechanism to end the menace of counterfeit medicines at a meeting on 16 May.

According to the proposal to be discussed at the Drug Technical Advisory Board meeting, consumers will be able to check whether the medicines that they have purchased are genuine by texting a unique code to be printed on the medicine’s package to a number, said two people aware of the matter, both of whom requested anonymity.

The government plans to initially build a data bank of 300 medicine brands and their consumption pattern in various parts of the country.

Drug companies will then be asked to print a unique 14-digit alphanumeric code on the package of the drug. Consumers buying the medicine can then inquire via a text message whether the code—and therefore the medicine—is genuine or not.

Pharma firms may be asked to print a unique 14-digit code on drugs’ packaging; consumers can send a text message to find out if the code is genuine or not

A government survey conducted between 2014 and 2016 had found 3.16% of drug samples it tested to be sub-standard, while 0.02% were spurious

A WHO report in 2017 revealed approximately 10.5% of medicines in low- and middle-income countries including India are sub-standard or fake

 

The unique identification code will help consumers avoid buying fake products. The idea is that within seconds, the person should receive a reply indicating whether the drug is legitimate.

 

Fake medicines lead to drug resistance in humans and cause a significant number of deaths, according to public health experts. A government survey

conducted between 2014 and 2016 to check the proportion of substandard drugs in India had found 3.16% of the samples it tested to be substandard, while 0.02% were spurious.

Significantly, even samples from big drug makers were found to be not of standard quality during the survey carried out through the National Institute of Biologicals, according to regulator Central Drugs Standard Control Organization.

Glenmark Pharmaceuticals under regulatory scrutiny for alleged misconduct


Glenmark Pharmaceuticals Ltd is under regulatory scrutiny for alleged misconduct in carrying out clinical trials recently in Jaipur.

The Central Drugs Standard Control Organisation (CDSCO) has allegedly found that fake identities were used in clinical trials, as well as evidence of substantial departures from good clinical practice (GCP), in what could be the latest blow for India’s drug-testing industry, which has run into a series of problems with international regulators in recent years.

The alleged misconduct on the part of the company has triggered a tough response from India’s apex drug regulatory authority, which has sent a show cause notice to the company for failing to ensure that clinical trial was conducted in accordance with the Drug and Cosmetics Act, 1940 and Rules 1945, GCP guidelines. The regulatory body has sought an explanation about the alleged irregularities within 10 days. Glenmark has, however, denied any wrongdoing.

The company came under the scanner following reports that several people were deceived into participating in an ongoing trial for pain medication to treat osteoarthritis at a  Multispeciality Hospital in Jaipur. A total of 38 kits were supplied by the company, of which only three were issued to the enrolled patients on April 6. Glenmark has suspended the trials.

CDSCO, which had initiated the inquiry and sent a team from its head office on 22 April to the site, found inadequate and inconsistent patient identification. According to the investigations, the enrolment of subjects was “falsified” and “cannot be relied upon”.

The team also found that out of three patients mentioned in the informed consent form (ICF), two were related to each other and did not visit the hospital in the last six months.

 

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