With the average Indian taking some 11 antibiotic pills a year, the country consumed about 12.9 billion units in 2010. Credit: Bigstock

By Ranjita Biswas
KOLKATA, India, Aug 28 2014 (IPS)

In 2011, the World Health Organisation (WHO) warned: “Combat Drug Resistance – No Action Today, No Cure Tomorrow.” The slogan was coined in honour of World Health Day, urging governments to ensure responsible use of antibiotics in order to prevent drug-resistant viruses and bacteria, or ‘super bugs’.

The warning is even more salient in 2014, particularly in India, a country of 1.2 billion people that recently earned the dubious distinction of being the worst country in terms of antibiotic overuse in the world.

With the average Indian taking some 11 antibiotic pills a year, the country consumed about 12.9 billion units in 2010, up from eight billion units in 2001.

"It’s a delicate, personal, ethical, medical issue. We can’t live without antibiotics. What is needed is prudent use." -- Ashok J. Tamhankar, national coordinator for the Indian Initiative for Management of Antibiotic Resistance (IIMAR)
An analysis of national pharmaceutical sales data published in ‘The Lancet Infectious Diseases’ last month found that Brazil, Russia, India, China, and South Africa accounted for 76 percent of the increase in antibiotic use around the world.

Western countries are now waking up to the alarming impact of over-consumption of antibiotics, which results in drug resistance. In Europe alone, drug-resistant strains of bacteria are responsible for 25,000 deaths a year.

In July, British Prime Minister David Cameron warned that the world could be “cast back into the dark ages of medicine” due to deadly bacteria eventually developing resistance to drugs through mutation, and as a result of “market failure” to develop new classes of antibiotics over the last 25 years.

In developing countries like India, changing lifestyles are contributing to the casual and careless use of drugs.

Ramanan Laxminarayan, research scholar and lecturer at Princeton University, told IPS the reason behind the proliferation of antibiotics in this country is “a combination of increasing income and affordability, easy access without a prescription, willingness of physicians to prescribe antibiotics freely, and a high background of infections that should ideally be contained by better sanitation and vaccination.”

People forget, he said, that “antibiotics do have side effects and […] they are less likely to work for you when you really need them.”

According to the Lancet’s report, the largest absolute increases in consumption between 2000 and 2010 were observed for cephalosporins, broad-spectrum penicillins and fluoroquinolones.

The authors cautioned, “Many broad-spectrum antibiotic drugs (cephalosporins, fluoroquinolones, and carbapenems) are sold over the counter without [the] presence of a documented clinical need.”

Moreover, added Kolkata-based physician Surajit Ghosh of the Indian Public Health Association, some patients choose to refill their own prescriptions without consulting a proper physician, in a bid to reduce the burden of doctor’s fees.

For a country like India with limited healthcare facilities and a doctor-patient ratio of one doctor to every 1,700 people, as well as 29 percent of the population languishing below the poverty line, the emergence of super bugs could be disastrous, experts say.

“With our high background rate of infections, we rely on antibiotics more than developed countries do,” stated Laxminarayan.

“Therefore, the impact of super bugs is likely to be much greater for many in our country who cannot afford the newer, more powerful antibiotics. Think of it as the price of fuel or kerosene going up. The rich will manage wherever they are, but the poor will be hit hard.”

He predicts that the most common diseases to be affected by antibiotic overuse will likely be “hospital infections, particularly those causing sepsis, pneumonia and urinary tract infection.”

Wary of this possible development, many are shifting to alternative medicines, via the Indian Systems of Medicine and Homoeopathy (ISM&H), which includes Ayurveda, siddha, unani, homoeopathy and therapies such as yoga and naturopathy.

Currently, there are over 680,000 registered ISM&H practitioners in the country, most of who work in the private sector.

Swati Biswas* tells IPS, “My husband was ailing for sometime and an operation was advised. But he contracted an infection in the nursing home and his operation was postponed.

“He never recovered after coming home and expired after two months. I spent thousands of rupees on medication for him to no avail. Now I go to a doctor of homeopathy for my problems. I’ve had enough of Western doctors and hospitals,” she added.

Meanwhile, a network known as the Indian Initiative for Management of Antibiotic Resistance (IIMAR) has been formed to promote awareness on this issue.

Asked about the need for such an organisation, Ashok J. Tamhankar, IIMAR’s national coordinator, told IPS, “In a scientific meeting in Bangalore in 2008 many of the participants realised that antibiotic resistance is increasing in India. This is happening because there’s no awareness about it among the stakeholders.

“The ignorance and callousness are at every level of the society – from care providers like doctors, to pharmacists, lawmakers, manufacturers and [even] the consumers. So a platform was created to spread awareness through a blog.”

The initial group had only a handful of people, but now, he claims, it has more than 1,000 active members and many more passive ones from different walks of life.

“Only passing laws is not a solution,” Tamhankar stated.

“It’s the people who have to solve their problems with the help of the law. This is particularly important in the case of antibiotics. It’s a delicate, personal, ethical, medical issue. We can’t live without antibiotics. What is needed is prudent use,” he added.

People also hint at an unholy alliance between pharmaceutical companies and doctors that results in over-prescription of antibiotics for ailments that could easily be treated without them.

Back in 2012, IIMAR reported that the Medical Council of India (MCI) had received 702 complaints of such over-prescription in 2011-12, of which 343 were referred to state medical councils.

“In 2010-11, MCI received 824 such complaints, following which it cancelled the registration of 10 doctors and warned four others,” IIMAR reported.

“Chemist and [drug] associations are not interested in curbing their volume of business and the [pharmaceutical] industry is also silent for the sake of their profit,” says Ghosh.

According to the consulting firm Deloitte, pharmaceutical sales in India stood at 22.6 billion dollars in 2012, with a predicted rise to 23.6 billion in 2013. Sales are expected to touch 27 billion by 2016.

Ghosh feels there should be “antibiotic protocols for all hospital, clinics and dispensaries and this should be displayed in each healthcare-providing agency [and] institution. There should be statutory warnings on each pack of antibiotics, highlighting the hazards of misuse.”

“Time has come to raise [our] voices against the irrational use of antibiotics,” he concluded.

*Not her real name

Edited by Kanya D’Almeida

Patented drugs limit patients’ access to public health care. Credit: Kristin Palitza/IPS

By Brendon Bosworth
CAPE TOWN, South Africa, Dec 12 2013 (IPS)

Paul Anley, chief executive officer of Pharma Dynamics, one of South Africa’s leading generic drug companies, wants to sell a cheaper version of popular birth control pill Yasmin. But he legally cannot because German multinational Bayer has patent protection on the drug in South Africa, even though its initial patent expired in 2010.

Generic versions of the contraceptive are available in the United States and Europe, where Bayer’s patent has been revoked.

Anley says South Africa’s patent system makes it easy for multinational pharmaceutical companies to make minor changes to their products and get multiple patents, each spanning 20 years, and keep generics off the market.

“Multinational pharmaceutical companies undertake a process of what we call patent ‘evergreening,’” Anley told IPS. “They will literally flood the patent office with hundreds of patents for every single molecule or product they sell, and they do it over a protracted period.”

Pharma Dynamics lost a court case against Bayer over the validity of Bayer’s patent, which relates to the rate at which the drug’s active ingredient dissolves, in March 2013. It is barred from selling its generic and has filed an appeal against the decision.

“Bayer will continue to vigorously defend its patents,” Bayer’s medical director, Dr. Gené van den Ende, told IPS in an emailed response. Van den Ende did not comment on allegations of evergreening.

Since 2002, Bayer has filed for 11 different patents in South Africa for one of the active ingredients in Yasmin.

Plenty of patents?

In September, South Africa’s Department of Trade and Industry released a draft national policy on intellectual property that proposes changing South Africa’s patent system.

Anley and patent reform advocates like HIV advocacy group the Treatment Action Campaign and Médecins Sans Frontières hope the proposals will curb the number of patents granted and increase access to cheaper medicines.

“We grant far more patents than other countries, both developing and developed,” Catherine Tomlinson, a researcher with Treatment Action Campaign, told IPS. “A lot of what we’re providing patents on is not actually meeting patent standards to provide something new and innovative.”

In 2008, South Africa granted 2,442 pharmaceutical patents, according to research by Carlos Correa at the University of Buenos Aires’ South Centre. Brazil granted just 278 patents between 2003 and 2008.

Supporters of patent reform point to the price difference between originator drugs in South Africa and generics available in countries like India – which has been strict in denying patents for formulations of new medicines – as a consequence of South Africa’s patent laws.

The Treatment Action Campaign found that generic versions of popular cancer drugs are available in India for between four percent and 44 percent of the cost of originator versions in South Africa, based on a comparison of 2012 prices.

India has made also use of compulsory licencing. In cases where government feels the price of a drug is too high, it can grant licenses that allow generics manufacturers to produce versions of drugs under patent protection without consent of the patent owner. The World Trade Organisation’s Trade-Related Aspects of Intellectual Property Rights Agreement allows for compulsory licencing.

As a signatory to the WTO agreement, South Africa can grant compulsory licences but has not done so in the past.

The draft national policy recommends introducing the use of compulsory licenses. But whether or not these are granted in the future depends on the interpretation of the courts, patent attorney Madelein Kleyn, who is the intellectual property manager for Oro Agri and a research fellow at Stellenbosch University’s Anton Mostert Chair of Intellectual Property Law, told IPS.

Long road to reform

Government’s draft intellectual property policy recommends introducing a search and examination process to the South African patent office that involves having experts assess the novelty or original merit of an invention.

Currently, those applying for patents in South Africa need to fill out the application documents correctly and pay the required fees. If a company or individual wishes to challenge the validity of a patent after it’s granted, the challenge must be done through the courts.

Intellectual property lawyers note that government does not have the staff required to perform search and examination procedures.

“The patent office, as it stands, currently lacks skilled force to implement such a system,” said Kleyn. “Patent examiners are highly qualified people who specialize in the different areas of technology and require an in-depth understanding of the patentability requirements to assess a new filed invention against the prior art of the specific technical area.”

Outsourcing this work to international or regional offices, as suggested in the draft policy, would make sense, she said.

Since patents can be revoked through the courts, and intellectual property professionals advise patent applicants to amend their claims based on foreign patent cases, the system in South Africa allows for strong and tested patents despite the lack of a search and examination process, Kleyn explained.

She recommended focusing on educating judges who deal with patent cases to make the legal system work more effectively instead. This shift would also be cheaper.

If introduced, the search and examination procedure would take a long time to alter the patent landscape.

“The system will not eliminate the weak patents that will be on the register by the time the system is introduced in say (being kind) five years,” wrote former deputy president of South Africa’s Supreme Court of Appeal Louis Harms in his comments on the draft policy. “This means that weak patents will still be around for 25 years.”

Anley, of Pharma Dynamics, agreed that the proposed changes would take time to take effect.

“We’re very encouraged that government recognises the problems facing generic pharmaceutical companies and has addressed most of them in the draft,” he said. “Our concern would be that the process of capacity building is a very long and difficult process.”

Residents of Sudan's Luri-Rokwe leper colony, which houses approximately 3,000 residents. The stigma of leprosy puts the people on the margins of society where they are reliant on limited food aid and other assistance while living in makeshift shelters. Credit: UN Photo/Tim McKulka

By Carey L. Biron
WASHINGTON, Dec 3 2012 (IPS)

International financial support aimed at counteracting the world’s “neglected diseases” increased by nearly a half-billion dollars over the past five years, according to new research released Monday, but changing funding dynamics could already be having a negative impact on the development of cures for diseases that affect a substantial proportion of the world’s poor.

More worrying, funding for research into these diseases remains highly dependent on a tiny number of players. This particularly includes the United States – both the public sector, in the form of the National Institutes of Health, and the philanthropic sector, in the form of the Bill & Melinda Gates Foundation – which continues to fund around 70 percent of investigations into these diseases.

The neglected diseases include a few dozen – leprosy, Guinea worm and other parasitic, viral and bacterial infections – that largely affect only poor communities in poor countries, and hence have traditionally received little attention from the entities that bankroll the extremely expensive process of drugs development.

While funding for these diseases had begun to pick up, the new Global Funding of Innovation for Neglected Diseases (G-FINDER) report finds that this assistance has decreased again following the international financial crisis.

Beyond the U.S. institutions, the report warns that the rest of this funding, which together accounts for just one percent of overall global disease-related research funding, comes from just a few European countries and one other philanthropy, the London-based Wellcome Trust. (The G-FINDER report itself is funded by the Gates Foundation.)

Meanwhile, the only non-Western country to make it into the top 10 funders for neglected disease is India (which recently overtook Brazil), which on average has spent around 5.6 million dollars per year on related research.

The new report “highlights our heavy reliance” on just a few institutions, Dr. Peter J. Hotez, president of the Sabine Vaccine Institute, a non-profit organisation based here in Washington, told IPS in an e-mail. “It’s a wake-up call that we need to engage new actors, including some new foundations, and to encourage some of the emerging market economies and some of the Middle Eastern nations to become more involved.”

Bad old days

Although overall funding for neglected diseases has gone up by 443.7 million dollars, to about 2.9 billion dollars, since 2007, both public and philanthropic shares have gone down substantially. This is worrisome given that the public sector continues to make up around two-thirds of international funding for such research, almost all from high-income countries, and more than half of the top 20 governments cut their funding for such research in 2011 alone.

While the U.S. government remains the single largest public funder of research into neglected diseases (following only the Gates Foundation), Washington too cut its outlay in 2011, down 2.2 percent to around 30.6 million dollars.

“Some governments now appear to be in it for the long haul, which is great,” Dr. Mary Moran, one of the report’s authors and the executive director of Policy Cures, a London-based research group that published the G-FINDER, said Monday in unveiling the report.

“But we’re worried that their investment model seems to be shifting back to the ‘bad old days’, where the public sector funded basic research leaving product development to industry or philanthropy – and consequently almost no medicines, vaccines or diagnostics for neglected diseases were developed. This model doesn’t and can’t work for truly neglected non-commercial diseases.”

According to findings by Policy Cures, over the past five years, public money for basic research has increased by more than a quarter, to around 124 million dollars, and currently makes up about a third of all public investment in neglected diseases. Meanwhile, public investment in the costly and uncertain product development has actually gone down slightly.

Moran compares this model to putting a man on the moon, for which one needs both scientists to do the research and someone to actually build the physical rocket.

“Governments need to bite the bullet,” she says. “If they want products for neglected diseases, they need to fund product development as well as basic research, and their funding needs to be linked to what’s happening in product pipelines and to be prioritised based on need.”

Predictable, sustainable funding

The private sector in recent years has indeed shifted its research focus away from three of the most high-profile diseases – AIDS, malaria and tuberculosis – to instead focus on a second tier of “semi-commercial” diseases, including dengue and meningitis, which today receive about a quarter of global spending.

Yet according to the new report, funding for research for the third tier of diseases, including leprosy, trachoma and rheumatic fever, remains miniscule, with each receiving less than 0.5 percent of international commitments.

Meanwhile, funding from major philanthropies has also declined significantly in recent years, from 691.6 million dollars in 2009 to 551.4 million dollars in 2011. Much of this can actually be traced back to changes in funding flows from the Gates Foundation itself, which makes up around 80 percent of the sector’s contributions – again underlining the danger of relying so significantly on just a handful of donors.

“The lack of private-sector research and development for neglected diseases reflects the core problem that today’s R&D model relies on market incentives and high prices for a return on investment,” Dr. Manica Balasegaram, executive director of the Médecins Sans Frontières Access Campaign, said in a statement Monday.

“The G-FINDER survey clearly shows that steady funding for neglected diseases is vulnerable, making it essential that we agree to ways of promoting (research and development) through predictable, sustainable funding solutions.”

Although another round of discussions took place last week at the World Health Organisation towards a possible treaty on research and development, which would allow for greater coordination, the talks resulted in little movement.

Balasegaram called the negotiations a “profound disappointment”, noting that, despite of a decade of such attempts, governments merely “kicked the can down the road, agreeing only to business as usual for another four years.”

Four-year-old Deepak Yadav, a mentally disabled boy from Indore city in the Indian state Madhya Pradesh, was being treated for stomach problems at Chacha Nehru Bal Chikitsalaya, a government hospital for children attached to the M. G. M. Medical College.

(Right to left) Clinical trial victims with medical right activist Dr. Anand Rai. Credit: CTVA, Indore.

But when repeated administration of the anti-ulcer drug Rabeprazole started to exacerbate his condition, his parents stopped treatment and sought help from the Clinical Trial Victims Association (CTVA), which discovered that the boy had been a lab rat for an untested drug.

“We should have been told an unknown drug was being tested on our innocent child and given the choice to say no,” Deepak’s father Sooraj told IPS.

Deepak is now almost entirely reliant on his mother for survival. The family is poor, yet “doctors did not take any steps to get us compensation,” his father added.

This family’s tragic story is just one example of a sinister pattern unfolding across India.

A spate of deaths over the last four years caused by illegal clinical trials of untested drugs has ignited the wrath of rights activists and prompted prominent legal institutions to consider tightening the country’s drug regulation laws.

In response to a Right to Information query filed by Indore-based medical rights activist Anand Rai, the Drug Controller General of India (DGCI) disclosed that 2,031 people have died as a result of serious adverse events (SAEs) during drug trials in the past four years.

SAE-related deaths for 2008, 2009, 2010 and 2011 were 288, 637, 668 and 438 respectively.

Rai, who is currently spearheading a campaign against unethical drug tests on human beings, has urged legal authorities and activists to raise their voices against clinical trials in which desperate people become easy prey for multinational pharmaceutical companies.

He told IPS that most of the victims were illiterate and poor people.

“Clinical trials on citizens without their consent is considered a violation of basic human rights and often results in the death of innocent persons, who were not even aware of the kind of tests being (performed) on them, since clinical research organisations use roundabout ways of acquiring the consent of patients and their relatives,” he said.

Many of the institutions involved in the drug trials fail to “provide the patients with copies of the informed consent form, patient’s information sheet or clinical trial liability insurance policy,” according to the CTVA. As a result, very few victims have access to compensation.

An intervention by the Supreme Court of India last month further exposed the unethical practices of clinical researchers and pharmaceutical companies.

A division bench headed by Supreme Court Justice R M Lodha stated in early July that it was “unfortunate” that humans are being treated as “guinea pigs” for testing of drugs and vaccines produced by multinational corporations.

Lax regulations breed impunity

Experts on medical law assert that tight regulations in Europe and the U.S. prompt many pharmaceutical companies and research organisations to look to India and other developing countries as cheaper and less restrictive sites for drug trials.

Dr. Mohan Rao, professor at the centre for social medicine and community health at Jawaharlal Nehru University in New Delhi, told IPS that India did not have a proper regulatory authority to monitor the trials of new drugs.

“We have unfortunately opened our health sector to global pharmaceutical companies for trials without the infrastructure to monitor and regulate them. It is cheaper for transnationals to locate trials in India, which has a large and captive (drug) market, in addition to doctors not constrained by ethics,” he said.

“The growth of local clinical research organisations has also contributed to this. Above all, we have a large and unregulated private medical sector with a culture of impunity. For the general public, and the elites, the lives of the poor do not matter,” Rao added.

The CTVA said that many doctors give more importance to their earnings than to the lives of their patients.

“Lured by offers (from) big pharmaceutical companies, these doctors have deliberately violated all regulations and have reduced clinical trials to a money spinning exercise,” according to a statement on the CTVA website.

According to the Financial Express daily, stiff opposition from research organisations on how clinical trial victims should be compensated has dealt a blow to the health ministry’s efforts to legislate the practice.

The ministry was on the brink of making it mandatory for pharmaceutical companies sponsoring clinical trials to pay financial compensation to volunteers in case of a proven trial-related death or injury, the Financial Express reported on Jul. 4.

Eminent drug regulatory expert C M Gulhati believes compensation rules in the Motor Vehicle Act can serve as a basis to determine the amount of compensation, while other factors such as the age of the volunteer, number of dependents and prevalent morbidity in the community should also be taken into account in an effort to standardise such payments, according to the newspaper.

Activists say many clinical trials in the country have been conducted behind a veil of secrecy and with little transparency in clinical research.

One such dubious deal was brought to light in 2001, when a group of cancer patients was subjected to drug trials under an agreement between the Thiruvananthapuram-based Regional Cancer Centre and the renowned Johns Hopkins University in Baltimore.

Compounding the issue, according to Dr. Sree Kumar, a private medical practitioner in Chennai, “is the easy availability of a large population of patients in Indian hospitals displaying a broad spectrum of conditions.”

“Collaborative ventures between Indian hospitals and foreign pharmaceutical industries and academic institutions ensure that the lab-to-market journey of a new product is achieved at a low cost and shorter duration,” he added.

Ethical testing required

The flip side of the illegal testing coin can be equally problematic. A panel of lawmakers in the Indian Parliament headed by Brajesh Pathak recently discovered that many popular medicines were being sold without having undergone clinical trials at all.

Lambasting the collusive role of the Central Drugs Standard Control Organisation, the parliamentary standing committee for health and family welfare said that 33 new medicines were found to have been approved between January 2008 and October 2010 without undergoing trials.

Medical scientists claim that drug trials conducted on animals do not produce accurate results.

Dr. A. B. Salim, an independent researcher in Bangalore, told IPS that a drug tested successfully on animals could produce harmful side effects when administered to human beings.

“Therefore it is the duty of the ethics committee and the DCGI to monitor and ensure that the trials are done honestly,” he added.

(END)