Reshaping medical industry & medical profession/Doctor: #Doctor assault


 

    Routine instances of verbal abuse,  threat  and physical assaults are common incidents. Usually media justifies assaults on doctors, administration and courts are of little help. Doctors suffer for  no fault of theirs. Many become punching bags for the inept medical system and invisible medical industry. The threat of physical assault is quite real these days.  Recently, even female doctors have not been spared by mobs. Silence of prominent social people, celebrities and society icons on this issue is a pointer towards increasingly uncivilized mindset of society. But these are not without having long term effects. There will be definite effects on how medical profession and industry reshapes  in coming times.

    1.  Poor advertisement for  Private medical college seat- Doctor assault is definitely a poor advertisement  for the medical students, who want to buy a private medical college seat by paying millions. Medical colleges are owned by rich and powerful.  There is possibility of loss of business. Why should one pay millions and bear  risk of being beaten or killed, while doing such a  stressful duty. People will be fearful to be doctors on a free seat, leave alone on the paid seatIt will be a naïve idea to pay millions and be a doctor.

       So  “loss in business” is something which can force administrators and  government to make laws against doctor assault and lawlessness against doctors.  That is the only silver lining  of doctor assaults. If private medical colleges are to survive and attract rich candidates  and earn money, a law to protect doctors is a must.

 

  1. Closure-Bundling out single practitioner and doctor run small practices: small nursing homes and single or doctor couple practices depend on a good doctor patient relationship. In  an era of deep mistrust  generated by media, it is difficult for individual doctor to have community practices, which were cheap and helpful locally. Doctors can not work with fear and in an unprotected environment. Automatically these smaller units will cease to exist and practically   It is a natural consequence of such incidents. There will be scanty friendly neighborhood doctors or their quality will  suffer.

 

  1. Lesser   doctors for emergency work: as working in life and death situations is attracting heavy risk to doctor’s life, there will be less enthusiasm to work in emergency situations. If the  situations continue, it will be more of a forced decision rather than  elective to work in emergencies.
  1. Corporate health care will be a way of life: when doctors owned small practices becoming extinct and  remain rudimentary or  cease to exist, the investor run big set ups  will be the only option. The big systems will be run on business model and doctors will be better protected workers in  the industry. That will become way of life as far as health care is concerned.
  2. Doctor & nurses turning into cheap labor: biggest threat of the oppressive system is the minimizing  independence of doctors as professionals.  Dependence on investor driven big health systems will increase. So abundance of skilled manpower will be available to investor led healthcare, and doctors and nurses  end up  being converted    into cheap labor for industry.
  3. Good for administrators and health managers: the dream of health industry to have cheap skilled manpower, is not that distant now. Security risk will close independent practices and they will be available for safer zones,  which for administrators and investor is a dream coming true. Less expensive abundant skilled manpower is an administrator’s delight.
  4. Demoralization of doctors and nurses: needless to say, it is one of darkest era for medical professionals. They are ebbed from all sides. Medical profession reeks of desperation and desolation, with not any one from power corridors to protect them, no courts, no human right commission for them to save the saviors from its decrepit state. Real medical profession has been devastated with little hope of regeneration.
  5. Survival of  commercially fittest doctors: doctors who survive in changing environment will be commercially fittest, able to entrench themselves in changing business environment, able to wriggle through legalities, well connected, glib talking, able to connect to industry. Doctors, who  do not possess above qualities, will not survive the health markets.
  6. Medical Community broken to single  suffering individuals: Every doctor knows that some thing is really wrong happening against the profession.  Not only every day minor irritants but there  are recurring episodes of blatant cruelty against doctors. The whole profession is being criticized openly in the garb of stray incidences or in cases of genuine poor prognosis. Each and every doctors  wants  to react.  But no one knows  really “ how to do it”. There is no unity  amid this chaotic problem. The community has been broken  and pushed to behave as single suffering   whatever way  they choose to react ,  the slightest reaction may  invite the ire of many unknown people, may be mighty and revengeful. More over, it is the individuals, not a community, that remains  non-united,  whose  career   and life is at stake.
  7. Effect on patients: at present,  leave it to wisdom of readers.

#Expensive-modern-health-care: Reminiscent of an ancient realm of medical regulation #Medical-lawsuits


With the evolution of medical science and medical care intertwined with  medical business, braided changes in  medical  regulation is not an far off expectation. But reticulation of evolution to modern medicine  and health care has not happened  in  isolation. Simultaneously there has been  progressively complex emerging trends in medical business and changing patterns of health investments along with an era of corporate investments in health care  has also ushered.  Every one now wishes  to live longer  and  dreams of better quality of life with support of progressive medical care.  Opportunities projected by advancements in health care, have shown that these dreams can be a real possibility, in many cases. That kind of perception has given patients a hope in lieu of some money. With rich people willing to spend more, the insurance sector and corporate invested money into health care, which was unthinkable few decades back in the  past.  This reticulation of business and  health care really took away the profession from control  of doctors. As it is no more simply treating a disease and involves many more issues.  New model of business in  health care is  still  not a mature process. It has emerged and progressed in  just  for few decades, as compared to  medical treatments and systems that existed since ancient times. It is still in infancy and still has to go a  long way to do real justice to every one.   No one really knows how to regulate this difficult area,  which encompasses life and death, deals with extremes of poverty and riches, mortality and morbidity, pain and  relief , sadness and happiness, smiles and sorrows and uncountable emotions, intertwines with financial aspects. Most difficult part is  amalgamation of  intricacies of science with minds of  patient and doctor’s skill in  newly evolved milieu of financial complexities.  Results are not encouraging for the profession.

 An effort to govern or  regulate the medical profession  is not new. Hammurabi  had initiated to  write the rules of the game. This single professional species was managed with cruel regulation 5000 years ago, that initiated a change in the global perception and regulatory system in radical and unprecedented ways.

Hammurabi,  5000 years ago,  was  not even at the   doorstep of medical science, but he  promulgated some rules. It is difficult to say whether he was naïve or  brilliant  enough to make it more mathematical. He fixed  heavy prize for saving lives and used to  cut the hands of physicians for death or untoward incident. But he was still wise enough to pay heavily if life was saved.   After thousands of years, with some scientific advancements, our regulation has remained more or less similar in basics. It is still based on principles of revenge and punishments. Now clearly  knowing well the limitation of medical science and the uncertainties and complexities of human body in better way, it still  remains  somewhat  unfair to doctors.  In other words, it has not attained enough  evolution and maturity.

  Hammurabi at the start of civilization believed that doctors needed to be punished in case there was poor prognosis. He failed to understand the complexity of human body and the limitations of medical  science, most of which was unknown at that time. By an application of average wisdom, doctor can be easily blamed for poor outcome, because he is always a common link between treatment and poor prognosis. Stricter punishments were imposed to  regulate medical profession, even  when the medical science was not even developed enough to deal with most of diseases.  Children are always taught in school that medical profession is a noble one. But they are never told, about the cruelty this profession has faced since ancient times.  Almost universally, the earlier work or contribution of  a doctor  to society is  not taken into account.  Even for complexities of medical science and uncertainties of the outcome, blame can  conveniently be  passed on doctors by application of average wisdom.

    Hammurabi’s Codex specified the harshest form of deselection of health providers possible. If the physician erred through omission or commission, his fingers or hands were cut off, immediately stopping his practice. Therefore, a single mistake can undo all the good work of past or the future good work that could have been accomplished. Problem here is that who can differentiate with certainty the real cause of sufferings of patient, a poor prognosis or a mistake.  Such  regulatory systems will dissuade  other good people joining the profession, again  resulting in  further inhibition and flourishing of profession for the good.  Obviously,  harsher  penalties will discourage a physician surplus.

Today the global  system of medical regulation, is becoming somewhat  similar, to those ancient regulations in  terms of punishment and revenge. Differential payment system for health care also resembles the Code of Hammurabi in some respects. And this is despite the fact that now we are very well conversant with the known uncertainty and complexity of the human body and despite cognizance of the poor prognosis in many disease states.

In an effort to institute  a  well controlled  healthcare, our society is in a way re-entering the realm of an ancient medical regulatory  system. Certain aggrieved health care consumers may welcome a move toward harsh penalties in the name of justice and simply for revenge but we need to keep in mind the  poor outcomes in complex diseases, limitation of science and of course the idiosyncrasies of the human body. Evolution of medical legal system and medical regulation has to evolve and mature, to enjoy  benefits of medical advancement to the fullest. Fear factors and  Impact  of present legal complexities,  on doctors  is  already on a par with that of  Hammurabi  era.

Re-blogged

Price fixing by broad generic drug makers in collusion : allege 45 US states


The states said the drug makers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market.

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  a collusion among  generic drug makers, to jack up prices.  If these allegations are proved correct, it may expose   one  reason of exorbitant prices of pharmaceutical industry.  Whereas doctors are blamed for healthcare being expensive, the real  health industry remains hidden and  earning huge profits by dubious means.

Soaring drug prices from both branded and generic drug manufacturers have sparked outrage and investigations in the United States. President Donald Trump this year accused pharmaceutical companies of “getting away with murder” with their drug pricing.

It might be the biggest price-fixing scheme in U.S. history. On Friday, Connecticut and a coalition of more than 40 states filed a 500-page lawsuit accusing the biggest generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars. It’s a more sweeping version of a similar lawsuit the states filed in 2016 that’s still being litigated. The generic industry vehemently denies the allegations.

Congress established the current generic industry in 1984 to push prices down. The idea was that once patents on brand name drugs expired, generic makers would compete to make drugs more affordable. But 1,215 generics, many of them the most prescribed drugs, jumped on average more than 400 percent in a single year.

A large group of US states accused key players in the generic drug industry of a broad price-fixing conspiracy, moving on Tuesday to widen an earlier lawsuit to add many more drug makers and medicines in an action that sent some company shares tumbling.

The lawsuit, brought by the attorneys general of 45 states and the District of Columbia, accused 18 companies and subsidiaries and named 15 medicines. It also targeted two individual executives: Rajiv Malik, president and executive director of Mylan NV, and Satish Mehta, CEO and managing director of India’s Emcure Pharmaceuticals.

Shares of Pennsylvania-based Mylan, also named as a defendant, closed down 6.6%.

The states said the drug makers and executives divided customers for their drugs among themselves, agreeing that each company would have a certain percentage of the market. The companies sometimes agreed on price increases companies sometimes agreed on price increases in advance, the states added.

The states said Malik and Mehta spoke directly to one another to agree on their companies’ shares of the market for a delayed-release version of a common antibiotic, doxycycline hyclate.

“It is our belief that price-fixing is systematic, it is pervasive, and that a culture of collusion exists in the industry,” Connecticut Attorney General George Jepsen, who is leading the case, told a news conference in Hartford.

Mylan said in a statement it had found no evidence of price-fixing by the company or any of its employees, and vowed to defend itself vigorously. Malik, the company’s second-ranking official, has received more than $50 million in compensation over the past three years, last year making more than CEO Heather Bresch.

Emcure, also a defendant in the case, did not immediately respond to a request for comment.

Two former executives of Emcure’s subsidiary Heritage Pharmaceuticals pleaded guilty in January to federal charges of conspiring to fix prices and divide up the market for doxycycline and the diabetes drug glyburide.

The two men, former Heritage president Jason Malek and former chairman and chief executive Jeffrey Glazer, reached a deal with 41 states and territories in which they each agreed to pay $25,000 and cooperate with the state probe.

Executives like Mylan’s Bresch and former Turing Pharmaceuticals CEO Martin Shkreli

have been called in front of Congress to defend the cost of their products.

MORE COMPANIES TARGETED

The original complaint, filed in December, targeted Mylan, Heritage, Aurobindo Pharma USA Inc, Citron Pharma LLC, Mayne Pharma USA Inc and Teva Pharmaceuticals USA Inc.

The states are pressing a new complaint that would add Novartis AG’s unit Sandoz, India-based Sun Pharmaceutical Industries Ltd, Endo International PLC’s unit Par Pharmaceutical, Dr

Reddy’s Laboratories, Apotex Corp, Glenmark Generics Ltd, Lannett Company Inc, Alkem Laboratories Ltd’s unit Ascend Laboratories and Cadila Healthcare Ltd’s unit Zydus Pharmaceuticals Inc.

Jepsen said the investigation is continuing, and that claims would likely be brought against more companies, and possibly executives, in the future.

The news hurt shares of companies named in the expanded suit that are traded in the United States. In addition to Mylan’s drop, Lannett lost 13.7 percent. Shares of Endo were up 7 percent, but down from their 12 percent peak before the news of the amended lawsuit.

Teva spokeswoman Denise Bradley said the company denied the allegations. Endo spokeswoman Heather Lubeski said the company would vigorously defend itself against the claims. Other companies did not immediately respond to requests for comment

The expansion of the suit requires the court’s permission.

The original lawsuit centred on just two medicines, delayed-release doxycycline and glyburide.

The price of doxycycline rose from $20 for 500 tablets to $1,849 between October 2013 and May 2014, according to US Senator Amy Klobuchar, a Minnesota Democrat who had been pressing for action on high drug prices.

The amended complaint would expand the number of drugs to include glipizide-metformin and glyburide-metformin, which are among the most commonly used diabetes treatments.

Others include: acetazolamide, which is used to treat glaucoma and epilepsy; the antibiotic doxycycline monohydrate; the blood pressure medicine fosinopril; the anti-anxiety medicine meprobamate; and the calcium channel blocking agent nimodipine.

The US Justice Department is conducting a parallel criminal investigation. On Friday, the department asked the Pennsylvania court presiding over the lawsuit to put the lawsuit’s discovery process on hold, saying it could interfere with the criminal probe.

Connecticut Assistant Attorney General Joseph Nielsen said on Tuesday the states would likely oppose that request, which could slow the lawsuit.

source

 

Bedaquiline: New anti TB drug: Govt may allow usage by private health sector


 

Bedaquiline is  a TB drug which is also known by the trade name  Sirturo. Bedaquiline works by blocking an enzyme inside the Mycobacterium tuberculosis bacteria called ATP synthase. This enzyme is used by the bacteria to generate energy. Without the ability to generate energy, the TB bacteria  are killed.

Bedaquiline is used in combination with other TB drugs to treat pulmonary TB in adults when they have multi drug resistant TB (MDR-TB

It should only be used when effective  Tb treatment cannot otherwise be provided.

It should be always be used in combination with at least 3 other TB drugs which drug susceptibility testing has shown that the patient is susceptible to. If drug susceptibility testing is not available then bedaquiline should be used with at least 4 other drugs to which the patient is likely to be susceptible.

The safety and efficacy of the drug in the treatment of HIV positive patients with MDR-TB has also not yet been established.

side effects of bedaquiline                          

The most common side effects are headache, dizziness, feeling sick, being sick, joint pain and increases in liver enzymes. Side effects can be experienced by more than one in ten people.

Another  side effect is that QTc prolongation.

The US Food and Drug Administration (FDA) on 28th December 2012 granted approval for bedaquiline to be used to treat drug resistant TB.  FDA News Release, 31st December 2012 . In October 2013 the CDC issued new federal guidelines on the use of the drug, for the treatment of multi drug resistant TB.

Government may allow private sector to use key drug used for treating tuberculosis

Around 2.1 million people have TB in India, of which an estimated 30,000 people have MDR-TB. Only 6,500 patients are on the bedaquiline-based treatment regimen, which may cause severe side effects such as heart problems and hearing impairment.

The Union health ministry (India) is considering a proposal to allow bedaquiline, a controlled-access drug used in the treatment of multi-drug resistant tuberculosis (MDR-TB), to be open for prescription in the private sector.

Being a controlled-access drug, bedaquiline is dispensed only by the government to people with MDR-TB. At least four courses of treatment are needed. The drug costs Rs 28,000 per course, which means the cost per patient is Rs 1.12 lakh on medicine alone.

Around 2.1 million people have TB in India, of which an estimated 30,000 people have MDR-TB. Only 6,500 patients are on the bedaquiline-based treatment regimen, which may cause severe side effects such as heart problems and hearing impairment. “Technical opinion is being sought as there is no consensus among experts on opening access to the private sector,” said a senior health ministry official familiar with developments.

The health ministry, in collaboration with the departments of health research, biotechnology etc, is working out an institutional mechanism to give bedaquiline to patients in the private sector. “There is a huge pharma lobby that is building an argument for putting everyone on bedaquiline, but it doesn’t work like that. Even though it is being hailed as a wonder drug, it has side effects that include hearing loss. It’s a new drug, so we don’t really have adequate data on its long-term treatment outcome,” the official quoted above said.

“People generally assume bedaquiline is safer than other drugs but they forget that compared to a 6-8 months course for other medicines, a bedaquiline-based regimen could go up to 18-24 months. The longer duration could have its effects that our experts are looking at,” he added.

The ministry has begun compiling data on treatment outcome for all oral treatment regimens among Indians, which also includes the bedaquiline-related course. “About 20 patients in the private sector in Mumbai have been given conditional bedaquiline access by the government. But the entire private sector can be given access only if they strictly adhere to the drug-compliance regimen for complete cure and to stop the patient developing extremely drug-resistant TB,” the official said.

There will be strict vigilance. “Since it is a long-term regimen, it’s verifiable. A call will be taken soon,” said a second ministry official, requesting anonymity.

The United States Agency for International Development (USAID) has provided 22,000 doses to the government. “We don’t want to deny patients newer drugs if it benefits them, so we are considering the idea,” said the first health ministry official.

The United States Agency for International Development (USAID) has provided 22,000 doses to the government. “We don’t want to deny patients newer drugs if it benefits them, so we are considering the idea,” said the first health ministry official

 

 

 

Medical Consumer Protection Act: Root of “Us and Them Syndrome”. Effect on medical profession


In present scenario, when patient is no more “patient” and  defined as consumer, doctors is not more than a service provider. With  Medical Consumer Protection Act acquired roots,  the whole system of medical delivery  and healthcare has changed. Most striking is this  entire fiasco is the “Us and Them” syndrome that seems to afflicted  every one. Doctors are pitted against every one, for example,  Doctors vs administrators, doctors vs patients, doctor vs managers. From regulation, insurance and legal system, every change has affected doctors adversely. They have been reduced to just only one component  of the industry, who deliver care and remain at receiving end. Other important stake holder are patients. How this change has been beneficial for patients? Suppressed professionals  can be used to work more, get less paid and can be dragged to court. So fear of all kinds will make them more  careful. It should be a win-win situation for all, except doctors. Therefore everyone makes merry, while doctors sulk, except those who can mingle with the present scenario and act smart in  changed business and legal milieu.

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Negatives effect on medical profession: cons or disadvantages of  medical consumer Protection Act

  1. Promotes Defensive medicine: Every patient with any illness has potential to complications. Progression of any disease state can cause death.  If doctors start looking at every patient as a potential litigant, especially those who are dealing with very sick ones,  practice of defensive practice is a natural consequence. This may manifest as excessive investigations, more use of drugs and antibiotics  and even  sometimes even refusal to treat very sick patients. Worst scenario of excessive fear will be  refusal of very sick patients in emergency situations or non availability of doctors.
  2. Erosion of doctor-patient relationship: stray and occasional Incidents about negligence and the cases in courts or  their outcome are given wide publicity in media. People are unable to understand the correct  application of such stray incidents to themselves. But they always try to imagine themselves in the scenario applied. Because of prejudiced notions, a sense of mistrust gradually creeps in,  which then extends to and involves their own treating doctor .This sense of mistrust multiplies manifold whenever there is  some adverse or even small unpleasant  Ultimately doctor and patients move forward together with a strained relationship and the treatment goes on with a surmounting sense of mistrust.
  3.  Increased cost of care:   With the creeping in of practice of defensive medicine, there is a need to document everything and to offer everything possible in the world, leading to inflated  medical costs.  Insurance  companies and lawyers have positioned themselves in between. They charge everyone heavily for allaying the fears , both  patients(medical insurance, lawyer fee) and doctors(indemnity insurance, lawyer’s fee) alike. The vicious cycle of rising costs , need for insurance, medicolegal suits, high lawyer fee (for patients and doctors) goes on unabated. All these contribute significantly to overall increased cost of health care.
  4. Enhanced insecurity in medical profession : Needless to say,  consumer protection act has increased the anxiety  and insecurity in  the medical profession. One keeps wondering which patient will prove to be his bane and finish his total career or will result in professional hanging or a media trial, with these having real probability in today’s day to day practice.
  5. Unnecessary litigation: Legal cases can be put on doctors for various trivial reasons e.g  for sense of revenge or to extract money or simply for not having to pay for services.  In an era where family members , brothers and sisters fight for money, it will be naïve to think that idea of making money from doctor does not exist. These are further stoked by the incidents of previous high compensations granted  by courts .
  6. Increased paper work: excessive documentation and time consumption: crucial and large chunk of time of doctors and nurses, goes in completing documentation. Needless to say, this time previously was dedicated solely to patient service. Management is now-a days more worried about completing paper work as well. Initially it was a symbolic documentation , but now there is requirement of mammoth paper work. It leads to consumption of time  that was meant for real discussions for the benefit of patients.
  7. Doctors used as scapegoats for revenge : Any unsatisfied patient can vent his anger by putting complaint or case  against the doctor .  This is done to some extent for revenge or  trying to find some   human factor which can be punished. Not uncommonly doctors are used as  scapegoat to have  a concession on the patient treatment by health organizations. Everything can be easily put on doctors as they are universal final link to a patient’s treatment and adverse effects.
  8. Distraction of doctors from the primary point of intention:  Nothing else ever has  distracted doctors  more than these medico-legal cases and punishments. In many cases, saving themselves becomes more important than saving a patient. Uncertainty of prognosis, grave emergencies and split second life saving and risky  decisions which may later be proved wrong by retrospective analysis, complex  medico-legal situations are endless distractions that have creep in and are enough to distract doctors from primary point of intention.
  9. Early retirement or burn out:  Becoming a doctor and practicing has become a tough job. After people have reached a point of financial security or when near point of burn out, doctors tend to leave practice. No wise man will like to face medico-legal complexities in older age. Taken to court for a genuine decision by self  is enough to spoil and tarnish  health, wealth and fame earned by  grilling the whole life.
  10. Reluctance to do emergency, risky work: If the decision to decide or act or help someone in an emergency situation, puts ones own life and career to risk, why should one put oneself in that deciding position?  Therefore increasingly, financially secure doctors are staying away from the riskier jobs.
  11. Only Doctors are sufferers of the act: Patient can have poor outcome because of any reason. It can be severe disease, poor prognosis, rare or genuine complications or even unintentional mistake or human errors, system errors or deficiency. But retrospectively doctors can easily be blamed because of wisdom of hindsight.  All patients with unrealistic or unexpected outcome can go to courts. Whatever court decides, harassment of doctors is full and permanent. There is no compensation possible for the sufferings and agony spanned over years, even if court decides in favour of doctor.
  12. Spoils teamwork among doctors; Whenever there is adverse outcome in any patient, all the doctors involved may start looking  for whom to blame  among themselves. All of them will try to pinpoint other’s mistake.  Such situation produces a bitter and worst kind of disagreements among various teams or specialties. Mutual understandings take a back seat and the teamwork is spoiled permanently. Administrators in a bid to be safe, encourage putting doctor’s concerns against each other, creating a strange sense of enmity. Ultimately  a mutual understanding and team work takes a hit.
  13. Hugely benefited are medical industry, law industry and administrators; Rampant misuse of consumer protection act has instilled a sense of deep fear in mind of medical professionals. The act has been used as a whip for doctors by all these three stakeholders. Fear of medico-legal cases has reduced doctors to cheap labour. Industry has used the protective systems to gain out of doctors hard work.  Benefits to law industry are obvious and don’t need to be elaborated. Besides this, even insurance industry has collected money both from doctors and patients by creating the fear.
  14. Right decisions or wisdom of hindsight?; A certain element of doubt always remains in minds of doctor whether he will get justice in the long run, or will end up being victim of sympathy towards patient or clever lawyering.  What was medically right and judicious decision at that real time situation may look wrong later  retrospectively, especially when retrospective analysis  is done over years with fault finding approach.
  15. Delayed treatment in emergency situations: Due to prejudiced minds, it is not uncommon for patient’s relatives to keep seeking second opinion, thereby delaying consent for procedures, surgeries and treatment. Though doctors know this problem but they obviously cannot proceed without necessary documentation. With increasing mistrust, even emergency treatments are delayed only to repent later.  
  16. Instigation by law industry; Windfall profits for lawyers and law industry at the cost of doctors is a disadvantage for medical profession: One can see zero fee and fixed commission advertisements on television by lawyers in health systems even in  developed countries. They lure and instigate patients to file law suits and promise them hefty reimbursements. There is no dearth of such relatives, lawyers who are ready to try their luck sometimes in vengeance and sometimes for lure of money received in compensations.  This encouragement and instigation of lawsuit against doctors is a major disadvantage for medical profession.

 

  1. Hostile environment for young impressionable doctors: The young and bright doctors complete their long arduous  training and then suddenly find themselves working in a hostile environment, at the receiving end of public wrath, law and  media for reasons they can’t fathom. They face continuous negative publicity, poor infrastructure and preoccupied negative beliefs of society.
  2. Subject of continuous blackmail: Even with routine complications amongst very sick patients, a threat looms over doctor’s head. People do not accept even the genuine complication, what to talk of unintentional mistakes.  Mistakes are always easy to  pinpoint with retrospective analysis and with lawyers pondering over it for years. In such situations , doctors are sitting ducks for  any kind of

 

 

 Positives, Pros or advantages of medical consumer protection act:

Although there are doubts, whether it will have any positive effect in long term, except monitory benefit to patient’s relatives and lawyers.

  1.     Quick  redressal of grievances:  patient will get satisfaction, if there is a genuine negligence case
  2.  Better quality of care will increase;  medical systems will improve as they will need to lessens the errors and  court cases. Better systems from abroad are also copied to improve the efficiency.
  3. Better introspection by medical profession: although doctors from the beginning are sensitive about their work and always look at how better results can be achieved. But act will make this process more formal and official.
  4. Training of medical professionals: it will be difficult  to put  errors under carpet.  Doctor will like to get trained better as no one want to be in soup.
  5. Future  learning from court cases:  each and every court decisions  is viewed carefully by medical fraternity. Improvement in protocol and policy making is a natural consequence.
  6. 6. Eye openers for medical profession: court cases and decisions have acted as eye opener for medical profession. It gives an idea, how law looks at medical treatment. It has made clear that medical science and medical law are a bit different. In real time, things are easier to be said than done.
  7. 7. Better documentation and communication: Doctors to save themselves, documentation is the key. Previously doctors were doing everything, but not documenting. But now there is lot of stress on documentation.

   Stress itself is not a bad thing. It can often help us perform at our best, expand beyond our limits and  achieve  better results.   The real problem lies in the fact that In this age of  anxiety prevailing more for care givers,  do not get enough relief  from stress.

        But sad thing about this kind of learning is that it is at the cost of few, unfortunate doctors, who were in difficult situation, actually suffered, did not know the legal implications  of  their acts or  situation. Most of the time, it is a system failure, but blame can be pinpointed to doctor.

May be The Act has good intention, but its practical application in its present form may cause more harm than good.    If the core of the health care  (medical hands) are harmed, no one can benefit in the long run.

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.

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