History & Evolution of Vaccination


Before the first vaccinations, in the sense of using cowpox to inoculate people against smallpox, people have been inoculated in China and elsewhere, before being copied in the west, by using smallpox, called Variolation.

Variolation was the method of inoculation first used to immunize individuals against smallpox (Variola) with material taken from a patient or a recently variolated individual, in the hope that a mild, but protective, infection would result.

   The procedure was most commonly carried out by inserting/rubbing powdered smallpox scabs or fluid from pustules into superficial scratches made in the skin. 

    The earliest hints of the practice of variolation for smallpox in China come during the 10th century. The Chinese also practiced the oldest documented use of variolation, which comes from Wan Quan’s (1499–1582) Douzhen Xinfa  of 1549. They implemented a method of “nasal insufflation” administered by blowing powdered smallpox material, usually scabs, up the nostrils.

   Various insufflation techniques have been recorded throughout the sixteenth and seventeenth centuries within China. Two reports on the Chinese practice of inoculation were received by the Royal Society in London in 1700; one by Martin Lister who received a report by an employee of the East India Company stationed in China and another by Clopton Havers. In France, Voltaire reports that the Chinese have practiced variolation “these hundred years”.

     In 1796, Edward Jenner, a doctor in Berkeley in Gloucestershire, England, tested a common theory that a person who had contracted cowpox would be immune from smallpox. To test the theory, he took cowpox vesicles from a milkmaid named Sarah Nelmes with which he infected an eight-year-old boy named James Phipps, and two months later he inoculated the boy with smallpox, and smallpox did not develop.

   In 1798, Jenner published An Inquiry into the Causes and Effects of the Variolae Vacciniae which created widespread interest. He distinguished ‘true’ and ‘spurious’ cowpox (which did not give the desired effect) and developed an “arm-to-arm” method of propagating the vaccine from the vaccinated individual’s pustule. Early attempts at confirmation were confounded by contamination with smallpox, but despite controversy within the medical profession and religious opposition to the use of animal material, by 1801 his report was translated into six languages and over 100,000 people were vaccinated. The term vaccination was coined in 1800 by the surgeon Richard Dunning in his text Some observations on vaccination.

   In 1802, the Scottish physician Helenus Scott vaccinated dozens of children in  Mumbai (previous Bombay) against smallpox using Jenner’s cowpox vaccine. In the same year Scott penned a letter to the editor in the Bombay Courier, declaring that “We have it now in our power to communicate the benefits of this important discovery to every part of India, perhaps to China and the whole eastern world”.  Subsequently, vaccination became firmly established in British India. A vaccination campaign was started in the new British colony of Ceylon in 1803.

    By 1807 the British had vaccinated more than a million Indians and Sri Lankans against smallpox. Also in 1803 the Spanish Balmis Expedition launched the first transcontinental effort to vaccinate people against smallpox. Following a smallpox epidemic in 1816 the Kingdom of Nepal ordered smallpox vaccine and requested the English veterinarian William Moorcroft to help in launching a vaccination campaign. In the same year a law was passed in Sweden to require the vaccination of children against smallpox by the age of two. Prussia briefly introduced compulsory vaccination in 1810 and again in the 1920s, but decided against a compulsory vaccination law in 1829.

    A law on compulsory smallpox vaccination was introduced in the Province of Hanover in the 1820s. In 1826, in Kragujevac,  future prince Mihailo of Serbia was the first person to be vaccinated against smallpox in the principality of Serbia. 

    Following a smallpox epidemic in 1837 that caused 40,000 deaths, the British government initiated a concentrated vaccination policy, starting with the Vaccination Act of 1840, which provided for universal vaccination and prohibited Variolation.

    The Vaccination Act 1853 introduced compulsory smallpox vaccination in England and Wales.

    The law followed a severe outbreak of smallpox in 1851 and 1852. It provided that the poor law authorities would continue to dispense vaccination to all free of charge, but that records were to be kept on vaccinated children by the network of births registrars. It was accepted at the time, that voluntary vaccination had not reduced smallpox mortality, but the Vaccination Act 1853 was so badly implemented that it had little impact on the number of children vaccinated in England and Wales.

In the United States of America compulsory vaccination laws were upheld in the 1905 landmark case Jacobson v. Massachusetts by the Supreme Court of the United States. The Supreme Court ruled that laws could require vaccination to protect the public from dangerous communicable diseases. However, in practice the United States had the lowest rate of vaccination among industrialized nations in the early 20th century.

    Compulsory vaccination laws began to be enforced in the United States after World War II. In 1959 the World Health Organization (WHO) called for the eradication of smallpox worldwide, as smallpox was still endemic in 33 countries.

     In the 1960s six to eight children died each year in the United States from vaccination-related complications. According to the WHO there were in 1966 about 100 million cases of smallpox worldwide, causing an estimated two million deaths.

     In the 1970s there was such a small risk of contracting smallpox that the United States Public Health Service recommended for routine smallpox vaccination to be ended.

   By 1974 the WHO smallpox vaccination program had confined smallpox to parts of Pakistan, India, Bangladesh, Ethiopia and Somalia.

     In 1977 the WHO recorded the last case of smallpox infection acquired outside a laboratory in Somalia. In 1980 the WHO officially declared the world free of smallpox.

   In 1974 the WHO adopted the goal of universal vaccination by 1990 to protect children against six preventable infectious diseases: measles, poliomyelitis, diphtheria, whooping cough, tetanus, and tuberculosis.

    In the 1980s only 20 to 40% of children in developing countries were vaccinated against these six diseases. In wealthy nations the number of measles cases had dropped dramatically after the introduction of the measles vaccine in 1963. WHO figures demonstrate that in many countries a decline in measles vaccination leads to a resurgence in measles cases. Measles are so contagious that public health experts believe a vaccination rate of 100% is needed to control the disease.  Despite decades of mass vaccination polio remains a threat in India, Nigeria, Somalia, Niger, Afghanistan, Bangladesh and Indonesia.

   By 2006 global health experts concluded that the eradication of polio was only possible if the supply of drinking water and sanitation facilities were improved in slums. The deployment of a combined DPT vaccine against diphtheria, pertussis (whooping cough), and tetanus in the 1950s was considered a major advancement for public health. But in the course of vaccination campaigns that spanned decades, DPT vaccines became associated with high incidences of side effects. Despite improved DPT vaccines coming onto the market in the 1990s, DPT vaccines became the focus of anti-vaccination campaigns in wealthy nations. As immunization rates decreased, outbreaks of pertussis increased in many countries.

      In 2000, the Global Alliance for Vaccines and Immunization was established to strengthen routine vaccinations and introduce new and under-used vaccines in countries with a per capita GDP of under US$1000.

     Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

     REEL Heroes Vs Real Heroes

     21 occupational risks to doctors and nurses

     Covid paradox: salary cut for doctors other paid at home

 COVID-19 Vaccination  during Pregnancy; CDC data


Safety and Effectiveness of COVID-19 Vaccination during Pregnancy-

CDC released the first U.S. data on the safety of receiving an mRNA COVID-19 vaccine during pregnancy.

Evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy, although limited, has been growing. These data suggest that the benefits of receiving a COVID-19 vaccine outweigh any known or potential risks of vaccination during pregnancy.

  • No safety concerns were found in animal studies: Studies in animals receiving a ModernaPfizer-BioNTech, or Johnson & Johnson (J&J)/Janssen COVID-19 vaccine before or during pregnancy found no safety concerns in pregnant animals or their babies.
  • No adverse pregnancy-related outcomes occurred in previous clinical trials that used the same vaccine platform as the J&J/Janssen COVID-19 vaccine: Vaccines that use the same viral vector have been given to pregnant people in all trimesters of pregnancy, including in a large-scale Ebola vaccination trial. No adverse pregnancy-related outcomes, including adverse outcomes affecting the baby, were associated with vaccination in these trials. Learn more about how viral vector vaccines work.

  • COVID-19 vaccines do not cause infection, including in pregnant people or their babies: None of the COVID-19 vaccines contain the live virus that causes COVID-19 so a COVID-19 vaccine cannot make anyone sick with COVID-19, including pregnant people or their babies.
  • Early data on the safety of receiving an mRNA COVID-19 vaccine (Moderna or Pfizer-BioNTech) during pregnancy are reassuring:
    • CDC released the first U.S. data on the safety of receiving an mRNA COVID-19 vaccine during pregnancy. The report analyzed data from three safety monitoring systems in place to gather information about COVID-19 vaccination during pregnancy. These early data did not find any safety concerns for pregnant people who were vaccinated or their babies.1
    • Another report looked at pregnant people enrolled in the v-safe pregnancy registry who were vaccinated before 20 weeks of pregnancy. Scientists did not find an increased risk for miscarriage among people who received an mRNA COVID-19 vaccine during pregnancy.2
    • Many pregnancies reported in these safety monitoring systems are ongoing. CDC will continue to follow people vaccinated during all trimesters of pregnancy to better understand effects on pregnancy and babies.
  • Early data suggest receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for infection: A recent study from Israel compared pregnant people who received an mRNA COVID-19 vaccine with those who did not. Scientists found that vaccination lowered the risk of infection from the virus that causes COVID-19.3
  • Vaccination of pregnant people builds antibodies that might protect their baby: When pregnant people receive an mRNA COVID-19 vaccine during pregnancy, their bodies build antibodies against COVID-19, similar to non-pregnant people. Antibodies made after a pregnant person received an mRNA COVID-19 vaccine were found in umbilical cord blood. This means COVID-19 vaccination during pregnancy might help protect babies against COVID-19. More data are needed to determine how these antibodies, similar to those produced with other vaccines, may provide protection to the baby.4

Additional clinical trials that study the safety of COVID-19 vaccines and how well they work in pregnant people are underway or planned. Vaccine manufacturers are also collecting and reviewing data from people in the completed clinical trials who received a vaccine and became pregnant.

Vaccine Side Effects

Side effects can occur after receiving any of the available COVID-19 vaccines, especially after the second dose for vaccines that require two doses. Pregnant people have not reported different side effects from non-pregnant people after vaccination with mRNA COVID-19 vaccines (Moderna and Pfizer-BioNTech vaccines). If you experience fever following vaccination you should take acetaminophen (Tylenol®) because fever—for any reason—has been associated with adverse pregnancy outcomes. Learn more at What to Expect after Getting a COVID-19 Vaccine.

Although rare, some people have had allergic reactions after receiving a COVID-19 vaccine. Talk with your healthcare provider if you have a history of allergic reaction to any other vaccine or injectable therapy (intramuscular, intravenous, or subcutaneous).

Key considerations you can discuss with your healthcare provider include:

  • The unknown risks of developing a severe allergic reaction
  • The benefits of vaccination

If you have an allergic reaction after receiving a COVID-19 vaccine during pregnancy, you can receive treatment for it.

     Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

     REEL Heroes Vs Real Heroes

     21 occupational risks to doctors and nurses

     Covid paradox: salary cut for doctors other paid at home

Medical Education- a business: Supreme Court


The medical profession and education have become a business and now the regulation of medical education has also gone that way which is the nation’s tragedy, an anguished Supreme Court said on Tuesday, giving one chance to the Centre to put its “house in order” and take a call on reversing the changes made to the NEET Super Speciality Examination 2021 syllabus.

The apex court was not satisfied with the justification given by the Centre, National Board of Examination (NBE) and National Medical Commission (NMC) on making the last minute changes after the notification for examination was issued in July.

“This is how botched up our education system has become,” it said.

A bench of Justices D Y Chandrachud, Vikram Nath and B V Nagarathna in an over two hour hearing gave time to the Centre, NBE and NMC to come up with a solution by Wednesday morning and said it will continue hearing the matter to avoid any prejudice to the young doctors.

“This matter is part heard and you can still put your house in order, we will give you time until tomorrow. We will not adjourn the part heard matter now as this will only cause prejudice to the students but we hope better sense prevails. If there is a sense of obduracy, then we are armed with law and they are long enough to reach out to the obduracy. We are giving you one opportunity to reform,” the bench said.

The top court was hearing a batch of pleas of 41 Post Graduate doctors and others who have challenged the last minute changes made to the syllabus after the notification for examination was issued on July 23 for the test to be held on November 13 and 14.

Additional Solicitor General (ASG) Aishwarya Bhati, appearing for the Centre, said the court should not get the impression that the last minute change in syllabus was done to fill vacant seats in private colleges and they will try to persuade the court to dispel this notion.

“We are getting a strong impression that the medical profession has become a business, medical education has become a business and the regulation of medical education has also become a business. That’s the tragedy of the nation,” the bench said.

The authorities should show some concern for the students, as these are the students who do not start preparation for these course two or three months in advance but right from the time they join a Postgraduate course, they aspire for a super speciality, which requires years of commitment, it said.

The government has to balance out the investment made by the private sector in these medical colleges but it should equally think in the interest of the medical profession and the interest of students, the top court said.

“The interest of students must weigh far higher because they are the people who are going to be a torch bearer of providing medical care and it seems perhaps we have forgotten them in the whole process,” it said.

The top court said that prior to 2018, 100 per cent questions came from the feeder courses; from 2018 to 2020 there was major modification under which 60 per cent marks were from super specialisation and 40 per cent from the feeder super specialisation courses.

“Now what is sought to be done is one hundred per cent questions will be from primary feeder speciality which is general medicines. It is completely overlooking the facts that you are fundamentally changing the examination pattern and you are doing it for an examination announced to be held in November, 2021,” it said.

The bench added that NBE and NMC are not doing any favour in asking the court to push back the examination by another two months.

It told Bhati, “It does not matter as these doctors will join the Super Speciality courses two months later, so long the seats are filled up it does not matter. This shows us the length to which your clients are willing to go to ensure that seats are filled up. Nothing should go vacant”.

Bhati said that seats going vacant is not the only consideration that has weighed on experts but it is the comparative opportunity and comparative ease which will be in larger public interest of the students that has weighed with the experts.

The bench said, “So what really happened is this for all specialisation of super speciality, starting from critical care medicines, cardiology, clinical haematology and other courses the specialisation is only going to be and the examination will be on general medicines.”

“The idea is that general medicine has the largest pool, the largest group in PG, so tap and fill up the vacant seats. That seems to be the logic behind this, nothing more and nothing less”.

The top court said, “You may have a rationale; we are not saying you may not have a rationale. The question is that all changes, which you have brought has caused serious prejudice to the students. Problem is that you didn’t plan for the future. You did not have a vision and all that you do is that just because you have a certain degree of authority you will exercise it in whatever time you want”.

Don’t treat young doctors as football in power game, says Supreme Court on changes in syllabus

The bench asked Bhati and senior advocate Maninder Singh, appearing for NBE, what was the great hurry to do it for this year as heavens would not have fallen except for the fact that some 500 seats would have remained vacant in some private medical colleges.

On September 27, the top court said, “Don’t treat young doctors as football in the game of power,” and warned the Centre that it may pass strictures if it is not satisfied with justification for last minute changes to the syllabus.

Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

     REEL Heroes Vs Real Heroes

     21 occupational risks to doctors and nurses

     Covid paradox: salary cut for doctors other paid at home

Financial complexity of MIDDLE-MAN in Medical Industry # Insurance pays 45 -80 % of Covid bills


     

 Medical care  intertwined with health business, further braided with changes in medical law presents a more complex problem rather than   just treating a patient well. In present era, many kinds of organizations have positioned themselves between doctor and the patient.

      This era  belongs to a transitional phase, when  gradual  conversion of doctor-patient interaction to a business transaction  is being controlled by industry’s middlemen .  One such middle industry is Insurance industry. The medical industry, insurance, law industry and administrative machinery remain hidden in the background and enormously benefitted at the cost of doctors and nurses, who suffered at the front, as face of the veiled colossal medical business and remain the only visible components.  Insurance industry is in a position to extract business from doctor as well as patients.  One such example is published in Times of India, where insurance company  has paid bills between 45-80%.  Each one of the medical industrial component trying to have their pound of flesh, will not only push  the cost of health care upwards, but would leave  both the main stakeholders, doctors and patients feel dissatisfied.

Policy holders get only  45 -80 % of Covid bills TIMES OF INDIA

As the number of people hospitalised due to Covid rise, many find that they have to settle a big chunk of the bill out of their own pockets despite having health insurance. Policyholders are again caught in the crossfire between hospitals and insurers over the treatment of consumables like personal protection equipment (PPE) kits resulting in only 45% to 80% of hospital bills being recoverable by customers. For 81-year-old diabetic and hip fracture patient K Saraswathi, who was treated for Covid-19 for eight days got only Rs 56,500 reimbursed of the total Rs 1.18 lakh bill from third-party administrator Raksha. Among other things that were disallowed included Rs 17,600 for PPE claims. While insurers cite General Insurance Council (GIC) norms their argument may not hold water as IRDA has not approved any norms. “How can a hospital treat a patient without PPEs?” asked an official at the Insurance Ombudsman office which is snowed under with complaints for short-settlement. “We used to get a few cases last year, now we have 88 pending cases, 70% to 80% of which are short settlements,” the official said.


For some insurers, the exclusions amount to a third of hospital bills. Liberty General officials said around 35% of the bill does not fall under the ambit of insurance coverage. Its VP and national claims manager for accident & health, Amol Sawai said, “On the industry level, the average Covid claim severity is Rs 1,40,000, the settlement severity is about Rs 95,000 of the claimed amount. We have seen almost 20% of the total bill is attributed to PPE costs.” India’s largest health insurer Star Health settles nearly 80% to 90% of claims under cashless settlement within two hours of receiving claims. S Prakash, MD of Star Health said, “One doctor who takes a round in the same PPE kit, cannot charge for each of ten patients he visits. The controversy is not in the reimbursement for PPEs, but in the number of PPEs covered. One cannot claim for ten PPEs per day. For ICUs, we allow a higher number of PPE kits compared to the ward,” he said.


According to the GIC officials, the referral rate for PPE kits is Rs 1,200 per day for moderate sickness and Rs 2,000 per day for severe sickness.


“We also see a spike in claims made for CT scans per person. We allow maximum two CT scans per patient,” he added. Officials at the GI Council blamed the hospitals for this situation. “Why are no directions given to hospitals on billing?” asks a council official. He points out an instance where a Tamil Nadu hospital charged Rs 14,000 for medicines, Rs 55,000 for diagnostics and Rs 50,000 for PPE besides room rent. When the insurer raised a red flag, the bill was halved to Rs 1.5 lakh.


“Is it okay for hospitals to loot with such high bills, whose money are we paying? It is the public’s money. If the premium doubles next year, will anyone even think of medical insurance. If we raise our hands and give up covering medical insurance, can anyone force us to provide a cover,” the official asked. The short settlement by insurance companies is resulting in a rise in complaints at the office of Insurance Ombudsman in Chennai.


“Insurers are citing some GI Council norms for claims settlement. Whatever they are saying does not hold water as IRDA has not approved any norms. How can a hospital treat a patient without PPEs?,” an official at the Insurance Ombudsman office said. Hospitals on their part blame the westernization of healthcare where insurance companies call the shots. “How can an insurance company decide on medication? A Dolo works for some while a Combiflam works for another, both these have a price differential. Now to say I will pay Dolo charges for a Combiflam or vice versa is plain stupidity. We need someone who looks at the bill and the patient and not one size fits all,” a MD and head of infectious diseases in a private hospital said. “The need is a regulator who understands medicine,” he said.

     Advantages-Disadvantage of being a doctor

     25 factors- why health care is expensive

     REEL Heroes Vs Real Heroes

     21 occupational risks to doctors and nurses

     Covid paradox: salary cut for doctors other paid at home

Johnson & Johnson held guilty for profiteering by GST body


 

Just one example how  intentions of industry  have been of profiteering rather than making  reasonable  profits.

NAA directs J&J to reduce prices of its products and asked the company to deposit Rs230 crore in consumer welfare funds of the central and state governments

J&J is liable for imposition of penalty under section 171(3A) of the CGST Act

The National Anti-Profiteering Authority (NAA) said Johnson & Johnson Pvt Ltd (J&J) profiteeredfrom reduction in rates under the goods and services tax (GST), denying the benefit of lower rates to consumers. The profiteered amount stood at Rs230 crore, according to an order dated 23 December 2019.

The Director General of Anti-Profiteering had filed an application against J&J in the matter.

“It is evident from the facts that the respondent (J&J) has denied the benefit of tax reduction to the customers in contravention of the provisions of section 171(1) of the CGST (Central GST) Act, 2017, and has thus, profiteered as per the explanation attached to section 171 of the above Act,” the order said.

“Therefore, he (J&J) is liable for imposition of penalty under section 171(3A) of the CGST Act,” it added.

The authority, in its order, directed J&J to reduce prices of its products and asked the company to deposit Rs230 crore in consumer welfare funds (CWFs) of the central and state governments.

“…18% interest payable from the dates from which the above amount was realised by the respondent (J&J) from his recipients till the date of its deposits,” the authority said in its order.

J&J will have to deposit Rs230 crore to CWFs of the centre and state governments within three months from the date of passage of the order. In case the company fails to do so, commissioners under the central GST and state GST will recover the amount, said NAA, the quasi-judicial authority of the GST structure.

Himachal Pradesh, Punjab, Uttarakhand, Haryana, Delhi, Rajasthan, Uttar Pradesh, Assam, Bihar, West Bengal, Jharkhand, Odisha will receive deposits above Rs1 crore in their state CWFs.

In 2017, the government had introduced an anti-profiteering clause to ensure businesses transfer the benefit of the tax credit to consumers by making products cheaper.

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.

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.

 

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.

source

Blog at WordPress.com.

Up ↑

%d bloggers like this: