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Journal of the Academy of Hospital Administration

Notes, News and Journal Scans

Author(s): Dr. Sidhartha Satpathy

Vol. 16, No. 1 (2004-01 - 2004-06)

1. Special issue of BMJ on South Asia

The prestigious British Medical Journal (BMJ) took out a special issue focusing on South Asia health scenario on 3rd April 2004.Editorials captioned “Is there hope for South Asia ?” and “Marketing of medicines in India – informing, influencing or inducing ?” were noteworthy and focused on India. The first editorial states that the special issue provides an insight into the regions myriad difficulties, the disease mix of non-communicable and communicable diseases ; industry’s exploitation of weak legislation to nurture new markets, the slow progress of surgery, health research and post graduate medical education. However, the most pressing problem which has been highlighted is maternal and child health with several articles reinforcing the message that the scale of morbidity and mortality caused by neglect to mothers and children is doing the region to disaster.

However, it also a fact that the answers to the region’s problems may already be with us. Despite a civil war, Sri Lanka has the best health indicators in the region (also beating those of most other countries with comparable incomes), with average life expectancy at 73 years, infant mortality at 16 per 1000, and maternal mortality at 30 per 1,00,000 live births. India’s Kerala state has achieved health and demographic indicators far ahead of Indian national averages, with similar levels to Sri Lanka ; over 80% of infants receive all routine vaccines by 1 year, use of family planning services is high, and population growth is steady at replacement levels. The genesis of this success is an object lesson for the entire region. Sri Lanka’s success story was scripted by heavy investments in health and education after gaining independence. Both Sri Lanka and Kerala have maintained policies to achieve social and gender egnity reflected in outstanding indicators for women. Political will and grass root support have stimulated development, underpinning largely consistent health and investment strategies. Agricultural reforms ending feudal land holdings helped in alleviating poverty and promoting equity.

Can the rest of South Asia learn from these two success ? The answer is ‘Yes’, but doing so requires setting aside political differences, resolving regional conflicts, and creating an atmosphere that reduces spending on defence and nuclear arsenals. This may sound like wishful thinking but how else will we create hope from the despair of untold child death, wanton neglect of girls and women, and a rich elite feasting on the misery of millions in poverty ? Health professionals in the region have an opportunity to join hands across national boundaries, cast aside historic divisions that suffocate progress, and begin to realize this vision of something better-a vision crystal clear in the heady days of independence, since lost in the intervening years of poverty, conflict, and nationalism.

The second editorial focuses on the pharmaceutical industry which experienced a major expansion in ‘early 70’s when the Indian Government took two fateful decisions. Firstly, it decided to permit domestic manufacturers to produce generic versions of patented molecules without permission from overseas innovators-provided a different manufacturing process was employed. Secondly, small scale pharmaceutical units were eligible for huge fiscal incentives and state subsidies. The new policy led to an unprecedented growth of medicine makers. Today an estimated 17,000 pharmaceutical companies produce over 40,000 branded formulations, many times more than the rest of the world.

It states that since the industry has free access to medicines discovered abroad, there is little incentive to undertake research to make new drugs. Consequently, nearly all companies are engaged in vicious competition to sell the same molecules under different brand names. Over 140 brands of omeprazole and over 120 brands of cefadroxil exist in India. As companies resort to unconventional methods to sell their brands, ethics take a back seat. Expanding indications, exaggerating efficacy, ignoring contraindications, and underplaying adverse effects have become routine practice.

Some recent examples illustrate questionable marketing methods like Nimesulide (NSAID) being used for undiagnosed fever in neonates and infants, even though the European Medicine Evaluation agency has contraindicated its use in children under 12 years of age due to hepatotoxicity. Companies find it hard to generate prescriptions based solely on science. Relying on published datasheets issued by the inventing companies reduces the scope of a drug because of the inconvenience of contraindications, precautions, drug interactions, and adverse effects. Sometimes, for purely promotional purposes local data are generated, as happened with letrozole, which was given to over 430 young women to test is efficacy in inducing ovulation.

Just as elsewhere, gifts and other incentives to prescribers are used by manufacturers to promote their products-and the methods are often ingenious. There is little consumer resistance to these practices for two reasons : faith in the perceived integrity of the medical profession, and lack of information. An examination of 1200 randomly selected formulations showed that only 316 had package inserts, and none had patient information leaflets. Many poor, illiterate people in India ask pharmacists for medicines for common problems such as colds, cough, aches, and pains. In order to tap this lucrative market, companies produce “branded generics”. These are not promoted to the medical profession, but to pharmacies, which are offered huge discounts. In the process it is conveniently forgotten that inducing pharmacies to sell prescription drugs without prescriptions is unethical and illegal. The fiercely competition market have led many companies to depend as the 3C’s i.e. convince if possible; confuse if necessary and corrupt if nothing else is works. Although it is easy to find fault with the policies adopted decades ago, the fault may actually lie with the regulatory system failing to keep pace with innovation in pharma industry.


2. India pressed to relax rules on clinical trials

Dinesh C Sharma states in a Lancet ‘Feature’ that India’s pharmaceutical companies are pressuring the Indian government to relax regulations governing clinical trials. If these changes go through, Indian companies will be able to capture lucrative outsourcing contracts from European and North American companies, and boost India’s research and development capacity.

India offers many advantages for companies interested in conducting clinical trials. The country has a vast population of patients with common communicable diseases that affect poor countries, but it also has increasing numbers of patients who have the so-called “diseases of affluence” that are common in wealthy countries, and are of particular interest to drug companies. Besides, many patients in India are “treatment naïve” meaning they have never received drug treatment for their conditions, a fact that simplifies patient enrolment and trial management. India has its own well-developed drug industry, scores of well-equipped hospitals, a large pool of western-trained, English-speaking doctors, and auxiliary staff experienced in organizing trials to international research standards.

According to the Confederation of Indian Industry (CII), more than 80 government and private hospitals in India are participating in international trials and the New Delhi-based industry group predicts this figure will grow “exponentially” by next year. Several international clinical research organizations (CROs) have already set up shop and are running projects for European and American clients. They are finding they can recruit patients with surprising speed Quintiles Transnational, a USA-based CRO headquartered in Research Triangle Park, North Carolina, which operates through its offices in Ahmedabad, Mumbai, and Bangalore, recently completed a Parkinson’s disease study involving 30 patients ; recruitment from four sites took just 17 days. The company has also recruited around 100 patients in just 12 months in two major breast cancer studies. For American & European countries looking for lower costs and faster time-to-market for new drugs, India holds a great appeal and tremendous potential as the costs of trials are reduced to about one tenth as determined by a government task force study. But, Industry representatives say India will not be able to take advantage of its position unless it relaxes its laws regarding clinical trials. Under these regulations-which were set up to protect Indian citizens from exploitation by foreign companies-phase I trials of drugs developed outside India are forbidden, and phase II and III trials of such drugs are allowed only after similar studies have been completed elsewhere. The government seems to be willing to go along the government seems to be willing to go along with industry demands. Last year, officials said they would allow phase I clinical trials of drugs developed outside India, provided phase I trials have been completed elsewhere and data from those trials are submitted to the licensing authority. Thus, under the new rules, foreign companies will be permitted to repeat phase I trials in India and then do phase II and III trials concurrently with trials being done abroad-as opposed to a step behind. This should cut the time-to-market for new drugs in India, and, it is hoped, encourage more pharmaceutical research in the country.

A review panel headed by RA Mashelkar, Director General of the Council of Scientific and Industrial Research, concluded that the government needs to be even more aggressive, recommending that regulators expedite approval for phase II and III trials on the basis of approvals given in countries that are signatories to the International Conference on Harmonisation, an organization that standardizes drug-approval regulations between countries.

However, critics argue that India is not ready for looser regulations, as the regulatory agency that oversees drug development, the Drug Controller General of India (DCGI), is not technically equipped to deal with the likely deluge of clinical-trial applications. Already, the critics claim, agency reviews are often cursory, leading to approval of poorly designed trials. In addition, they contend, the agency lacks the enforcement mechanisms needed to ensure legal and ethical trials. The Judicial, viewpoint is highlighted by Hon’ble Justice (Retd.) K.N.Kurup, a former judge of Madras High Court and a human-rights expert, warns that there is a serious danger that unscrupulous researchers will take advantage of India’s poor. “In a country where people sell their blood-even organs like kidneys for a few thousand rupees-it will not be difficult to lure them into trying out new drugs”.

Lancet-Vol. 363 ; 8 May 2004


3. Indian Medical Association (IMA) wants “off label” prescribing
Ganapati Mudur reports in BMJ that the IMA has sought legislative changes for doctors in India to be able to lawfully prescribe drugs for treatments other than those for which the drugs were initially approved, a demand some doctors have called “irresponsible” and “dangerous”.

In a policy statement submitted to the health ministry the association said doctors in India should be allowed to prescribe drugs for unapproved indications when there is scientific evidence and medical opinion to justify such “off-label” treatment.

“Doctors should have the right to provide patients the benefits associated with off-label use of drugs as long as unflinching medical literature has given them confidence for such therapy,” said Dr. Sanjiv Malik, secretary general of the association. “Doctors write off-label prescriptions in the best interest of patients, but they have a responsibility to interpret information received from any source before making clinical decisions,” the association said.

Indian law does not currently allow drugs to be prescribed for indications for which they have not been approved. Amendments to the Indian Medical Council Act two years ago made off-label prescribing illegal. The association has said that off-label prescribing is widespread in many countries, including the United States.

BMJ-Vol. 328; 24 April 2004, p-974.


4. National reporting system for medical errors is launched

Vittal Katikireddi reports in BMJ that the world’s first natural system for collecting reports of health system failures and any error that compromises patients’ safety was launched this week.

The national reporting and learning system (NRLS), which aims to improve patients’ safety by collecting reports from health professionals across England and Wales, has been developed by the National Patient Safety Agency (NPSA), an organization established in 2001 to tackle the problem of errors in the NHS. The system will mostly extract information from existing local risk management systems. However, the NHS health professionals will be able to report directly to the system through an online form if no local risk management system exists or if they prefer to do it that way. The system will retain information only in an anonymous form, and individual staff or patients involved in any incident will not be identified, says the agency.

Susan Williams, who with Sue Osborn is joint chief executive of the agency, said : “Every day more than a million people are treated safely in the NHS. However, evidence tells us that in complex healthcare systems some things will go wrong. Research has also shown that errors fall into recurrent patterns regardless of the people involved.

“In developing the NRLS we have drawn from the experience of other sectors, such as the aviation industry, which shown clearly that as reporting levels rise the number of serious errors begins to decline”. The system was initially piloted in 28 trusts across England and Wales in 2001. After substantial problems with the pilot (BMJ 2002; 324:1473) the system was further tested in 39 trusts.

The system is expected to cost about £ 1m ($1.9m; € 1.5m) a year for the first eight years. “But we’re not expecting it to cost as much as that in the later years,” Ms Williams added.

BMJ-Vol. 363; 27 March 2004, p-1044.


5. Indian health groups demand “right to health”

Dinesh C. Sharma reports in Lancet that a coalition of health and medical voluntary organizations in India has demanded that the right to health should be included in the constitution, in light of diminishing state support for health care.

Although principles in the constitution provide the basis for such a right, there is no operational legal framework to ensure universal access to public health services. Therefore the groups spearheading Jan Swasthya Abhiyan (JSA; People’s Health Movement) have urged political parties to support their demand for a National Public Health Act, codifying right to health.

“If the public system fails to deliver, it should be treated as an offence and people should be able to seek legal remedy”, said JSA spokesperson Abhay Shukla. India has a three-tier public system-comprising PHCs in villages, district hospitals, and tertiary care hospitals-but the government expenditure is shrinking. At present, India spends about 0.9% of its gross domestic product (GDP) on health care, which is lower than the average of 2.8% of GDP spent by some less developed countries.

While the government is spending less, private health care is exploding. According to a World Bank study published in January, nearly 82% of all health spending in India is private. It also pointed to health inequities such as the poorest 20% getting only 10% of subsidies, while the richest 20% capture 33%.

Representatives of five smaller political parties who attended a public hearing convened by JSA (New Delhi, March 10, 2004) supported the demand for right to health and increasing health expenditure to 5% of GDP. But two main parties, the ruling Bhartiya Janata Party and the opposition Congress, stayed away.

Lancet-Vol. 363; 27 March 2004, p-1044


6. Political neglect in India’s health

Lancet reported in an editorial that although voting has ended in the world’s largest election, health did not feature very much in the agenda of the ruling party or opposition. The newspapers were largely devoid of reports on the political parties’ view on health issues. One exception was the Deccan Herald of April 11, which carried a story detailing the lack of interest in children’s rights and health in the elections, even though children make up 44% of India’s population. The website Doctor NDTV, which focuses on India, ran a poll on the importance of health in the election, but received little response. The start of May saw the Indian Government ban smoking in public places, so intentions are good even though such a ban will be widely flouted and hard to enforce.

Although gross domestic product in India is US$ 400 per head, such an average hides extremes of wealth and poverty. A quarter of the population is below the poverty line, and the riches tenth of households account for a third of the country’s income or consumption.

Worse still, India compares badly with its smaller neighbours in south Asia in spending on health. In 2001, the Indian Government spent $ 4 a head on health, compared with $ 8 in Bhutan and $ 15 in Sri Lanka. Between 1992 and 2001, the Indian Government allocated just 2% of its spending to health ; comparable figures in Bhutan and Sri Lanka were 10% and 6%, respectively. States in India also spend on health, and many people pay for private health-care. The Indian health spending for that period was overshadowed by 16% of Government funds going to defence.

Given the interplay between absolute poverty, extreme inequality, child survival, and risks for chronic diseases, health should have been a major component of public debate in this latest Indian election. The fact that it was not indicates a malaise in Indian democracy, one that must be urgently addressed by the new Government if it is truly concerned about the future of its people.

Lancet-Vol. 363; 15 May 2004, p-1565

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