Have #India’s poor become human guinea pigs? #clinicaltrials


By Sue Lloyd-RobertsBBC Newsnight

Narayan Survaiya and family
Narayan Survaiya’s mother Tizuja Bai died several weeks after being given new drugs

Drug companies are facing mounting pressure to investigate reports that new medicines are being tested on some of the poorest people in India without their knowledge.

“We were surprised,” Nitu Sodey recalls about taking her mother-in-law Chandrakala Bai to Maharaja Yeshwantrao Hospital in Indore in May 2009.

“We are low caste people and normally when we go to the hospital we are given a five rupee voucher, but the doctor said he would give us a foreign drug costing 125,000 rupees (£1,400).”

The pair had gone to the hospital, located in the biggest city in Madhya Pradesh, an impoverished province in central India, because Bai was experiencing chest pains.

Their status as Dalits – the bottom of the Hindu caste system, once known as Untouchables – meant that they were both accustomed to going to the back of the queue when they arrived and waiting many hours before seeing a doctor.


Nitu Sodey

This was really expensive treatment for the likes of us”

Nitu Sodey

But this time it was different and they were seen immediately.

“The doctor took the five rupee voucher given to BLPs [Below the Poverty Line] like us and said the rest would be paid for by a special government fund for poor people,” Sodey explains. “This was really expensive treatment for the likes of us.”

What Sodey says she did not know was that her mother-in-law was being enrolled in a drugs trial for the drug Tonapofylline, which was being tested by Biogen Idec. Neither could read and Sodey says she does not remember signing a consent form.

Bai suffered heart abnormalities after being given the trial drug. She was taken off it and discharged after a few days. Less than a month later, she suffered a cardiac arrest and died at the age of 45.

The trial, which was registered in the UK by Biogen Idec, was later halted due, say the company, to the number of seizures recorded. The company also says Bai’s death was not reported to them.

Her case is not an isolated incident.

In a different trial with a different company, Narayan Survaiya says neither he nor his late mother Tizuja Bai were asked if she wanted to participate, or even told that she was taking part in one, when she sought treatment for problems with her legs. And, like Sodey, he claims the family were told that a charity was footing the bill for the care.

A few weeks after taking the drug, Survaiya says his mother’s health deteriorated and she was left unable to walk.

“I told the doctor, but he said don’t stop the doses. It is a temporary paralysis and the drug will make it better.”


Please don’t do these trials on poor people – rich people can overcome these problems but if I can’t work the whole family suffers”

Ramadhar Shrivastav

His mother died a few weeks later.

In all, 53 people were test subjects in that trial, which was sponsored by British and German drug companies, and eight died. There is no hard evidence that the drug was the cause of death, but nor were there any autopsies to enable a full investigation.

Over the past seven years, some 73 clinical trials on 3,300 patients – 1,833 of whom were children – have taken place at Indore’s Maharaja Yeshwantrao Hospital. Dozens of patients have died during the trials, however no compensation has been paid to the families left behind.

Internal hospital documents seen by Newsnight reveal that since 2005, 80 cases of severe adverse events in trials have been recorded in Indore. One patient listed on the severe adverse events document is Naresh Jatev, who is now four.

His father, Ashish Jatav, says that his son was a healthy three-day-old baby when doctors said he needed a polio vaccine.

Naresh Jatev and familyNaresh Jatev – in the white shirt – with his family

The family says that they had no idea that the drug Naresh was given was a trial one, and that the hospital forms which they signed had been written in English “so we couldn’t understand anything”.

According to an investigation by the hospital, the healthy baby boy had a seizure shortly after receiving the drug and suffered an attack of bronchitis.

Drug trials in India

  • Almost 2,000 trials in past seven years
  • Tests include drugs made by well-known companies such as Biogen Idec, Astra Zeneca and Glaxo Smith Kline
  • 288 deaths in 2008
  • 637 deaths in 2009
  • 668 deaths in 2010
  • 438 deaths in 2011

He now has breathing and eating problems, although the family have been assured that this is nothing to do with the trial vaccine. They say they no longer know what to believe.

Time after time in Indore, I heard a depressingly familiar tale of poor, often uneducated people saying how flattered and privileged they were made to feel as they were suddenly offered the chance to receive medicines usually out of their reach. All of them claim that, contrary to Indian laws governing drugs trials, there was no informed consent.

I also repeatedly heard patients’ relatives say that the treatment they received at Maharaja Yeshwantrao Hospital was overseen by Dr Anil Bharani.

Bharani has since been charged by the state government for receiving illegal payments and foreign trips from drug companies, and for carrying out drugs trials without patients’ consent.

He refused to speak to Newsnight, even when I approached him in person in his office at the hospital. He called security and I was marched out of the hospital by an armed guard. But two days later, Bharani was himself transferred from the hospital after more than 30 years service.

Bharani is just one of a number of doctors at the hospital who have been already been fined for irregularities during drugs trials. None of the problems might have ever come to light if it had not been for another doctor, Dr Arnand Rai, who had an office on the same floor of the hospital.

Dr Arnand Rai with Sue Lloyd RobertsDr Rai says he was fired for raising concerns

Rai says he became concerned when he saw poor people being ushered in to the best consulting rooms. He says he was sacked from his job because of his questioning, but that he has been researching the hospital trials ever since.

“They choose only poor people,” he says, even though drug trial protocols demand that they should be carried out on all sections of society. “They chose poor, illiterate people who do not understand the meaning of clinical drug trials.”

Dr KD Bhargava, head of the ethics committee at Maharaja Yeshwantrao Hospital, admits that the hospital’s oversight of the trials has been flawed. “Suddenly lots of money got involved and there was too much going on. And, yes, maybe we may have lost control,” he says.

But the issue goes well beyond one hospital.

Since India relaxed its laws governing drugs trials in 2005, foreign drug companies have been keen to take advantage of the country’s pool of educated, English-speaking doctors and the huge population from which to choose trial subjects.

The Bhopal disaster

A rally in memory of the Bhopal victims
  • Considered the world’s worst industrial disaster
  • On night of 2 December 1984, Union Carbide’s pesticide plant leaked tonnes of lethal chemicals over Bhopal
  • At least 3,000 people died in first 24 hours
  • And thousands more from after-affects

In the past seven years, nearly 2,000 trials have taken place in the country and the number of deaths increased from 288 in 2008 to 637 in 2009 to 668 in 2010, before falling to 438 deaths in 2011, the latest figures available.

The provincial capital of Madhya Pradesh is Bhopal – a city whose name will for ever be linked with the world’s worst industrial accident. An explosion at the Union Carbide plant caused a gas leak that killed an estimated 25,000 people, campaigners say.

The only good thing to come out of the disaster was the Bhopal Memorial Hospital, built as part of a compensation agreement with Union Carbide to help care for some half a million locals affected by the disaster.

Little did they know that when they came for treatment, some would be used for clinical drug trials.

Ramadhar Shrivastav was one such person. As he makes his way uncertainly to the door of his house to greet me, he says he was lucky, having got off comparatively lightly in the 1984 disaster – only his sight was affected.

Five years ago, he suffered a heart attack and went to the Bhopal Memorial Hospital. He does not read English, and it was a journalist who last year noted that his discharge paper showed that he was part of a trial by the British company Astra Zeneca on a drug being tested for patients with ACS (acute coronary syndrome).

Shrivastav claims the drug has affected him badly and he now cannot work.

Ramadhar Shrivastav and family
Ramadhar Shrivastav had previously been caught up in the Bhopal leak

When he learned we were from Britain, he asked us to pass on a message to Astra Zeneca.

“Please don’t do these trials on poor people. Rich people can overcome these problems but if I can’t work the whole family suffers. Why did they choose us? They should have tested it on themselves.”

Professor NP Mishra

It’s not being tried out to harm them” Professor NP Mishra

Astra Zeneca admit there were problems with consent with a few patients on the trial identified through there routine monitoring during the trial and the issues were quickly rectified. They say that Shrivastav was not one of those affected.

From a medical point of view, doctors agree that the long-term effects of exposure to the Bhopal gas, methyl isocyanate, are still not known so why use the victims for drug trials? I put this question a doctor involved in setting up the Bhopal Memorial Hospital and who once served on the ethics committee there, Professor NP Mishra.

He says trials are carried out for the long-term benefit of patients. “It’s not being tried out to harm them.”

But haven’t these people suffered enough? Is it right to put them at further risk in a clinical drug trial? “The way you talk, medicines would never be developed.”

I ask again, why choose gas victims? “That I cannot comment on,” he says. “It was not my job to find out.”

Sue Lloyd-Roberts reports from the poverty-stricken state of Madhya Pradesh

The problem, I found while working on this subject, is finding anyone who is prepared to be held responsible.

I found Tarjun Prajapati supervising a construction site in a new suburb of Bhopal. He is joint owner of a building company. His father was a gas victim who, four years ago, suffered a heart attack. He was given drug called Fondaparinux at the Memorial Hospital. When he ran out of the medication, his son found it easier to nip out to the shops rather than cross town to pick up more from the hospital for his father.

“I went to the market to buy them but couldn’t,” he remembers. “I was told they were only available from the hospital and only then did I realise he was on a trial drug. I feel very bad that my Dad died because of those medicines.”

This claim is impossible to verify because, once again, there was no autopsy.

On the trial documents, it says that the British company Glaxo Smith Kline are the sponsors of the drug, are responsible for the trial and are the investigators of the drug.

But GSK says they bought the rights to the drug while the trial was being carried out by the French company Sanofi, which is named as a collaborator on the document. When we contacted Sanofi, they told us the trial was in fact “conducted through an Indian research organisation called Quintiles”.

Lawyer Satnam  Singh BainsSatnam Singh Bains, a British barrister in Indore, is looking into the complaints

There is no doubt that the drugs trial set-up can be complicated. A couple of drug companies might team up and then delegate the actual work of the trial to what in India are called Clinical Research Outsourcing Organisations. In the past, when there have charges of malpractice, drug companies have tended to blame these local companies.

Which leaves those who believe they have a just grievance against the drug companies somewhat bewildered.

Lawyers are now looking at whether there is a case to answer in the UK. Satnam Singh Bains, a British barrister in Indore, is looking into a couple of cases.

He shows me a recently published report by the Indian Parliamentary Committee on Health and Family Welfare that looks into what is happening around the country. The report is damning.

It confirms that the set-up for regulating trials in India is, in Singh Bains’ words, “not fit for purpose”. There are too few inspectors at the regulatory agency, coping with too many demands, including having to supply data on 700 parliamentary questions and 150 court cases in one year.

“Still worse,” the report says, “there is adequate documentary evidence to come to the conclusion that many opinions [during the drug trials] were actually written by the invisible hand of drug manufacturers and experts [the doctors] merely obliged by putting their signatures.”

Singh Bains says there are real concerns. “About, at the very least, collusion between experts and the drug manufacturers or, at worse, there is a suggestion that there is a fraud taking place – that these reports are being signed off without any independent, clinical scrutiny of their findings in the way that conclusions are expressed.”

He adds that this could have global implications about “whether the findings of these clinical trials can be safely relied upon”.

#India- #Abbott suspends giving gifts to doctors #goodnews #medicalethics


 

 

 

 

By Frederik Joelving

 

NEW YORK | Tue Oct 16, 2012 6:03pm EDT

 

(Reuters Health) – Abbott Laboratories Inc has instructed its sales representatives in India not to give gifts to doctors, who are prohibited by local law from accepting them, a practice that has been used as a bargaining chip by companies wanting a piece of the country’s burgeoning healthcare market.

 

According to an internal email dated October 11 from Sudarshan Jain, managing director of Abbott Healthcare Pvt. Ltd, the gift-giving has been temporarily suspended.

 

“Only Abbott-approved clinical/scientific literature may be distributed to current and potential customers,” said the email, which was reviewed by Reuters on Tuesday. “No brand reminders or therapy reminders in your possession should be given to any current and potential customer and no further brand reminders or therapy reminders should be ordered.”

 

Accepting gifts or travel arrangements from drugmakers is against the law in India, but enforcement is inconsistent.

 

Public health experts say gift-giving leads to dangerous overprescribing and unnecessary use of expensive medications when cheaper versions are available. That can be a significant burden for the 400 million people in India who live on less than $1.25 a day.

 

A sales representative with Abbott Healthcare told Reuters that therapy reminders are low-value items such as pens, whereas brand reminders refer to electrical appliances and other pricier merchandise.

 

The representative, who spoke on condition of anonymity, said he was not worried about his job getting harder without the gifts, but, he quipped, it would certainly make his bag lighter.

 

As multinational drug companies ramp up investments in emerging markets to realize billions of dollars in annual sales, they have faced increased scrutiny from the United States and European governments. U.S. authorities are currently probing a number of leading global drugmakers for kickbacks and bribery overseas.

 

A Reuters investigation in September showed Abbott’s Indian subsidiaries plied doctors with scanners, vacuum cleaners, coffee makers and similar items in return for prescribing the company’s drugs to patients. Sales representatives were shown lists of gifts in strategy guides issued by the company.

 

In August, Pfizer Inc paid $60.2 million to settle a U.S. probe involving illegal payments to win business overseas, including kickbacks such as cellphones and tea sets given to doctors in China. Last year, Johnson & Johnson agreed to pay $70 million to settle U.S. charges under the Foreign Corrupt Practices Act (FCPA) that it had bribed healthcare providers in Greece, Poland and Romania.

 

Scott Davies, a spokesman for Chicago-based Abbott Labs, confirmed the decision but declined to say what had prompted the move. He said he was not aware of any inquiries from regulators about the company’s dealings in India.

 

“This is an internal action,” he told Reuters. “We are suspending that brand reminder program while we review it.”

 

Davies said the suspension encompasses Abbott Healthcare and Abbott True Care, but did not have information on whether other Indian subsidiaries would continue the practice. He declined to address travel payments.

 

(Editing by Ivan Oransky, Michele Gershberg, Maureen Bavdek and Claudia Parsons)

 

 

Anybody ill here and seen a doctor yet?


 

KRISHNA D. RAO,  The Hindu

 
GLOOMY PROGNOSIS: For the hardship that rural doctors have to endure, government service offers relatively little in terms of quality of life. Photo: Singam Venkataramana
The Hindu
GLOOMY PROGNOSIS: For the hardship that rural doctors have to endure, government service offers relatively little in terms of quality of life. Photo: Singam Venkataramana

Addressing the scarcity of medical practitioners in rural India is fundamental to achieving universal health care in the country

The Planning Commission’s draft 12th Plan for health has attracted much debate and controversy. Critics have been quick to direct their attention at two issues in it — the proposed increase in government health spending from one per cent to 1.58 per cent of GDP, and the “managed care model.” The spending increase was rightly felt to be grossly inadequate to move India towards achieving universal health care. The “managed care” model was expected to relegate the government’s role to a purchaser of services and undermine its role in the service provision. By focusing on these two issues, the debate on the 12th Plan for health, and indeed the Plan’s approach paper itself, ignores some of the more fundamental obstacles to achieving universal health care in India. For one, the scarcity of rural doctors currently prevents the delivery of even basic clinical services to needy citizens. Simply spending more or changing the way health services are purchased will not solve this problem.

Urban-rural divide

People deliver health services. Urban Indians can be forgiven for thinking that there are enough doctors in the country. Indeed, our cities are abundant with all manner of clinics, diagnostic centres and hospitals. But having a qualified doctor nearby is a rarity for the vast majority of Indians who inhabit the country’s rural spaces. According to the 2001 Census, there is a tenfold difference in the availability of qualified doctors between urban and rural areas i.e. one qualified doctor per 8,333 (885) people in rural (urban) areas of India. Addressing this rural scarcity is fundamental to efforts for achieving universal health care in India.

There are several notable reasons why doctors are reluctant to serve in rural areas. Fundamentally, the professional and personal expectation of medical graduates is not compatible with the life of a rural doctor. Their ambition lies in becoming medical specialists. Once they specialise, the professional, income, lifestyle, and family life opportunities in cities make rural jobs unattractive. Moreover, with private medical schools and their high fees dominating medical education, it makes little sense for medical graduates to take up jobs that don’t offer them the opportunity to recover their investment.

The scarcity of rural doctors places an important responsibility on the government. However, its efforts to place government doctors in rural posts have been largely unsuccessful. For the hardship that rural doctors have to endure, government service offers relatively little in terms of remuneration, quality schooling for their children and a chance at a decent family life. Human resources in the State health services are also poorly managed.

For instance, there is little transparency about transfers and postings because they are a source of both corruption and political patronage in the health system. Absenteeism is another issue. Indeed, most of the court cases facing State health departments have to do with human resource issues. However, given the professional and personal expectations of doctors, it appears unlikely that large increases in salaries and management changes will attract adequate numbers to government jobs and rural posts.

Situation abroad

Interestingly, many high, middle, and low-income countries also face a scarcity of rural doctors. Many of them have ameliorated this problem by using non-physician clinicians to deliver basic health services. In the United States, the United Kingdom, many countries in Africa, and even in South Asia, individuals such as nurse-practitioners or medical assistants, who have some years of basic clinical training, perform many of the clinical functions normally expected of fully qualified doctors. In sub-Saharan Africa and many parts of Asia, clinical services in rural areas are possible only because of these non-physician clinicians. They provide a range of clinical functions, including basic clinical services, manage deliveries, caesarean sections and abortions. Importantly, assessments from a variety of settings have shown that they perform as well as doctors.

Clinician cadre

India, however, has had an uneasy relationship with mid-level clinical cadres. At the time of India’s independence, licentiate medical practitioner (LMP)s, who underwent three years training, comprised nearly two-thirds of the qualified medical practitioners (the other one-third being doctors) and they mostly served in rural areas. LMPs were abolished after Independence but doctors never really occupied the space that LMPs vacated. Now, the shortage of rural doctors has forced some States to look towards non-physician clinicians for relief. Clinicians with around three years of clinical training currently serve at government rural health clinics in Chhattisgarh and Assam. Importantly, assessments of their performance in Chhattisgarh have shown them to be as competent as doctors for delivering basic clinical care. And because their training focuses on serving as rural clinicians and their career ambition is to have a government job, these clinicians, as the Chhattisgarh experience shows, have a greater likelihood of staying and serving in rural areas. The Central Health Ministry has proposed to expand this clinician cadre nationally through the Bachelors of Rural Health Care (BRHC) course. Unfortunately, expanding this cadre has met with considerable opposition and a former health minister even labelled them as “qualified quacks.”

The road to universal health care in India necessarily requires a serious assessment of basic problems that afflict the health system like the lack of human resources in rural areas. While this piece has focused on doctors, the rural scarcity of other health worker cadres such as nurses, lab technicians and pharmacists is equally acute and equally deserving of serious attention.

Higher government spending on health or how health services are purchased will do little to ensure that all Indians have health care if there are inadequate numbers of trained health workers with the right skill mix. The experience of other countries and two States in India show that non-physician clinicians, whether they are three-year trained clinicians or nurse-practitioners, can be part of the solution.

(Krishna D. Rao is senior health specialist, Public Health Foundation of India, and visiting faculty, Department of International Health, Johns Hopkins University, U.S. The views expressed are solely his and not of his affiliated institutions.)

 

German doctors free to take cash from drug firms #Badnews


 
A recent ruling by Germany‘s Supreme Court has caused a public storm over the ethical conduct of doctors and drug companies in the country. Rob Hyde reports from Hamburg.
Self-employed physicians in Germany accepting up to €10 000 from drug companies in cash, or gifts such as computers, equipment, or holidays, will not face corruption charges.
The Federal Court of Justice, in Karlsruhe, Germany‘s Supreme Court, ruled that drug companies cannot be penalised under current legislation, even when paying German freelance physicians to prescribe their drugs. Similarly these doctors can now officially accept this money without either party facing criminal charges of bribery. The ruling could apply to around 124 000 of 342 000 doctors working in the country, which includes around 121 700 independent physicians working under freelance contracts in Germany’s national health system.
The most recent case in question involved a sales representative of a major German drug firm who, via its benefits programmme, paid cash to a group of national health service doctors. Here each doctor received a 5% commission on each product they prescribed. Though the firm officially said the money was remuneration for delivering academic presentations, these seminars never took place. The sales agent was then charged with commercial bribery by a lower court, and fined.
When the sales representative appealed, the case was referred to the Federal Court of Justice. Here the Grand Criminal Panel reversed the lower court’s ruling and acquitted the accused. It then also ruled that the physicians were neither civil servants, nor representatives of a state institution, and so could not be charged with “bribery of public officials”, as defined in paragraph 332 of the German Penal Code, or under criminal law. The court further decided that the physicians were also neither employees nor representatives of a business operation, and so could not be charged with commercial bribery under paragraph 299.
The court’s decision has been welcomed by a wide range of leading German health organisations. Though declining to comment directly, in a written press statement Birgit Fischer, managing director of the Association of Research-based Pharmaceutical Companies, said the decision meant doctors “…can now continue to see themselves as members of a free profession and are not just categorised as the extended arm of the statutory health insurance funds”.
Speaking to The Lancet, head of the German Medical Association, Frank Ulrich Montgomery, shared the view, saying the court ruling protects the rights of doctors to operate in an independent professional capacity. “Such physicians are not public servants or employed by anyone, so they should be free to perform freelance work for clients in the same way that an architect or lawyer can.”
“Self-employed entrepreneurs are not an organ of health insurance funds and this is a good thing. If they were either civil servants or had been commissioned by the health fund then they would be working for the health fund and so would be subordinate to it. This means they would have to consider the economic interest of this insurance fund before the needs of the patient. A freelancer is free of this economic agenda.”
Much of the German press, however, has reported the recent court verdict in terms of it now officially giving drug companies and doctors the legal right to bribe and be bribed, respectively. Coverage has included headlines such as “Bribery of doctors is completely legal” from the television news channel n-tv. According to Montgomery, the media coverage of the case is part of wider behind-the-scenes agenda to tarnish the reputation of doctors. “We now have a campaign orchestrated by the health insurance funds to make doctors out to be completely corrupt…The Supreme Court did indeed rule that the doctor had not broken criminal law, but that definitely does not give doctors now the right to be bribed by the pharmaceutical industry. Doing this breaches the professional code of the German Medical Association.”
For Ann Marini, spokesperson for the Central Association of Health Insurance Funds, it is not enough for a professional code of conduct to be left to apply the penalties which the legal system is not able to. She said that the Supreme Court has not taken a clear stance on the real issue. “It cannot be that behaviour for one type of doctor is considered by the German Penal Code, to be a crime of bribery, and yet the very same behaviour from a freelance physician is perfectly legal. We would have wished that the court had openly and clearly said that all doctors, of all sorts, can be prosecuted for corruption.”

Doctors’ freebies to be Taxed :-) #Goodnews


 

C Unnikrishnan, TNN Aug 7, 2012, 03.56AM IST

MUMBAI: The income-tax (I-T) department will tax the amount pharmaceutical and allied health sector industries spend on freebies for medical practitioners and their professional associations. Those who accept the freebies will also be taxed.

The decision follows an amendment to Medical Council of India regulations banning doctors and their associations from accepting freebies. The freebies include money, travel facilities and hospitality extended by pharma firms and makers of medical devices and ‘nutraceuticals’.

The Central Board of Direct Taxes August 1 circular says the department has come across such instances and a senior pharma company official admitted companies do it to advance sales. He said a company was planning to take around 80 doctors from across the country on a full-expenses paid foreign trip for a ‘seminar’.

The I-T department grants an exemption to money spent on business promotion. It accepts firms’ claims and allows deduction. An official said, “Pharma firms cannot claim the benefit as regulations prohibit it. If we can prove the company extended freebies to doctors, they have to pay taxes. Those who receive freebies will also have to pay a tax on the gift’s value or money spent on it. If a doctor gets a fridge, its market value will be treated as income.”

Chandra Mohan Gulati, a drug regulatory expert, said it was a great first step but “let it not be the last”. He felt doctors should be told to mention details of their ‘gifts’. In 2009, MCI had set guidelines for doctors vis-a-vis pharmaceutical companies.

Ranga Iyer, who used to head Wyeth and the OPPI (Organization of Pharmaceutical Producers of India), said, “We must look at the IT Act changes in isolation. The need is for ethical marketing practices for pharmaceutical firms and we support any such move.”

Dr Arun Bal of the Association for Consumers’ Action on Safety & Health an NGO that works for patients’ rights, said, “This follows attempts by MCI and the government to bring about self-regulation among doctors and the industry.”

(With inputs from Malathy Iyer)

 

Follow professional ethics, doctors urged #SJ #Aamir Khan


Aarti Dhar, The Hindu, June 13

Aamir Khan’s “Satyamev Jayate” has drawn sharp criticism from Indian Medical Association

Taking forward the debate on commercialisation of health, initiated by actor Aamir Khan in his television show “Satyamev Jayate” that drew sharp criticism from the Indian Medical Association (IMA), health activists have said distortions in medical practices, induced by unregulated commercialisation, have become systemic problems.

In an open letter to the IMA, which has sought an apology from Mr. Khan for “maligning” the entire profession because of a few errant doctors, the Medico Friend Circle (MFC) and the Forum for Medical Ethics Society (FMES) have sought self-regulation by medical professionals and active involvement of citizens in the process, than bureaucratic regulation, to ensure rational care and patients’ rights.

‘Uphold dignity of medical profession’

They said: “We very much appreciate that you want to uphold the dignity of the medical profession. However, we feel that denying or minimising the importance of the issues raised by the show and demanding an apology fromAamir Khan is definitely not the most appropriate way of upholding the dignity of doctors. Instead, the IMA should seriously try to reverse the process of health system reforms for eliminating the distortions in medical practice. This would be immensely beneficial to patients and would also raise the dignity of the medical profession manifold. Instead of ‘silencing the messenger,’ we need to listen to the main message of the show and take steps to address problems which are very real.”

The letter raised questions on cut practice and commissions, irrationality in investigations and surgical practices, influence of the pharmaceutical industry on doctors, and inflation of patient bills as a consequence to all these practices.

“This has resulted in massive problems related to both cost and quality of medicare for people. Besides the evidence from various studies on Caesarean section rates, injection practices, prevalence of hysterectomies and sex selective abortions are admitted to by most practicing doctors, and are not limited to a few isolated individuals,” the letter said.

“As good physicians, if we go beyond addressing the ‘symptoms’ and make a ‘comprehensive diagnosis,’ it will be obvious that all these disturbing features are due to a system of unregulated commercialisation of medical care, which has emerged over the last few decades.

Large number of discontented individuals, doctors as well as ordinary citizens, need to come together and start changing this system through a large scale social process,” the MFC and FMES said.

*An open letter to office bearers of IMA*

To,

The National office bearers,

Indian Medical Association

Dear IMA office bearers,

We are writing this letter in context of the apology recently demanded by
IMA from Aamir Khan, regarding the episode on 27 May 2012 of his show
‘Satyamev Jayate’ (SJ) dealing with certain practices of the medical
profession. We write to you as members of Medico Friend Circle (MFC,
http://www.mfcindia.org) and Forum for Medical Ethics Society (FMES). MFC is a
nation-wide 39 year old platform of pro–people doctors and health
professionals, scientists and social activists, involved in improving
health care, especially for the deprived sections of people. FMES is an
association of doctors and health professionals which has been actively
campaigning for reform in the healthcare system and medical education, and
has been publishing the Indian Journal of Medical Ethics since 1995.

We very much appreciate that you want to uphold the dignity of the medical
profession. However we feel that denying or minimising the importance of
the issues raised by this show and demanding an apology from Aamir Khan is
definitely not the most appropriate way of upholding the dignity of
doctors. Instead, IMA should seriously try to reverse the current
widespread unregulated commercialisation of health care in India, and
should contribute to the process of health system reforms for eliminating
the distortions in medical practice. This would be immensely beneficial to
patients and would also raise the dignity of the medical profession
manifold. Instead of ‘silencing the messenger’, we need to listen to the
main message of this show and take steps to address problems which are very
real.

We would not go into the details of the content and form of this show. We
would rather point out that the critical issues raised regarding cut
practice and commissions, irrationality in investigations and surgical
practices, distorting influence of pharma industry on prescribing by
doctors, and inflation of patient bills consequent to all of these, are
extremely widespread. This has resulted in massive problems related to both
cost and quality of medical care for the people. There is no point in
dismissing these issues as just being related to a few ‘black sheep’ in the
profession. Besides the evidence from various studies on cesarean section
rates, injection practices, prevalence of hysterectomies and sex selective
abortions etc., most practicing doctors admit in private that malpractices
are a pervasive trend, not limited to a few isolated individuals. In
fact *distortions
in medical practice induced by unregulated commercialisation have become
systemic problems*.

Given this reality, let us move beyond the ‘few rotten eggs’ type of
defensive arguments focussed on individuals, and look at the systemic
problems which include-

· Astronomically high ‘donations’ charged by mushrooming capitation fee
medical colleges are a major influence which is pushing crass
commercialisation of medical practice, besides placing medical education
beyond the reach of many deserving poor and middle class students.

· Widespread cut practice, intense competition and defensive medicine
are causing dissatisfaction among many doctors, not only their patients.

· Pressures are imposed on doctors by hospitals, inducing them to advise
more than necessary investigations, procedures, intensive care admissions,
hospital stays.

· There are continuous tensions between doctors and patients over
payment issues, and even occasional outbreaks of violence against
hospitals.

These are serious problems going beyond just a few individuals, which are a
product of the increasingly commercialised, market oriented nature of
medical care in India today.

As good physicians, if we go beyond just addressing the ‘symptoms’ and make
a ‘comprehensive diagnosis’, it will be obvious that *all these disturbing
features are due to a system of unregulated commercialisation of medical
care*, which has emerged over the last few decades. Instead of being
foremost healers and protectors of their patient’s health, doctors are
increasingly forced to become hard-nosed businessmen, often in order to
repay large scale loans, to ensure their practice, and to remain ‘in the
system’ despite the fact that many would not have liked to depart from
their principles. In this situation, the increasing numbers of ‘black
sheep’ (and much larger numbers of ‘grey sheep’) are the inevitable
products of this system. Of course there is a role for individual
responsibility, but such an entrenched system cannot be changed just by
giving moral science lectures to individual doctors, by asking them to
follow rational principles in isolation. Instead of this, large numbers of
discontented individuals, *doctors as well as ordinary citizens, need to
come together and start changing this system through a large scale social
process.*

Of course, commercialisation and linked distortions are seen in all
professions. But doctors’ organizations are best placed to reform the
medical profession and health care sector, thereby contributing to wider
social reform. In fact IMA’s stated objectives include “improvement of
Public Health and Medical Education in India”. Hence we would suggest that
instead of rubbishing the SJ episode and ignoring its main message, IMA
should treat this as a ‘wake-up call’ for the medical profession as well as
for wider society, and we should all start a process at two levels. We need
to initiate *social regulation of medical practice* (which would include
elements of self-regulation by the profession and active involvement of
citizens, not just bureaucratic regulation) to ensure rational care and
patients rights. Further linked to this, we need to move from a
market-centred model of health care, towards a *socialised system of
universal health care*.

This letter will not go into details of how such social regulation of
medical practice and further, a system for universal health care (UHC)
might be developed in India, which could ensure decent and secure
livelihood for all doctors (though not super-profits for any!) and access
to good quality, free health care for all residents of the country. IMA
office bearers would be aware of UHC systems which are successfully working
in a wide diversity of contexts: developed countries like Canada, Australia
and Scandinavian countries, as well as developing countries like Brazil and
Thailand. Of course we will need to evolve a UHC model that is appropriate
to Indian conditions which will require broad based debate and inputs from
all stakeholders, especially from the medical profession. This process
has already been initiated by the High Level Expert Group on Universal
Health Coverage (HLEG-UHC) appointed by the Planning Commission, which has
published a detailed report which would be taken into account while
developing the upcoming 12th Five year plan. We may differ of the details
and specifics of the model, but we need to accept that Universal Health
Care is now emerging on the national agenda, and we should all start
engaging with this process.

Such a UHC system would eliminate widespread commercialisation, cut-throat
competition and insecurity among the majority of doctors, while ensuring
them a decent income and basic security. The price of not moving towards
such a system is colossal, not only for patients from all classes of
society, but also for the vast majority of doctors who would like to
practice their profession nobly and rationally, but are being sucked into a
money-centred system which trumps humane principles and rational practices.
The potential rewards of such an alternative health care system would be
similarly enormous for our entire country of 1.2 billion people, including
our doctors who could once again become respected and honored
professionals, instead of presently being often viewed by people with
suspicion and even resentment.

In short, the time has come to do some genuine introspection and
alternative thinking, and to address the widespread problems instead of
denying them. On the lines of the call for ‘Physician, heal thyself!’, the
time has come to say – ‘Physicians, heal thy system!’

Yours Sincerely,

Executive committee, Medico Friend Circle

Managing committee, Forum for Medical Ethics Society

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