I distinctly remember that hot July afternoon in 2001, when I finished reading celebrated author John le Carré's fascinating book “The Constant Gardener”. With a number of counselling rounds lined up for various medical colleges of India, I stood dismayed. What was I getting into? Was it right for me to get into medicine, after knowing that the poorer sections are often exploited by the pharmaceutical companies through the help of medical professionals?
However, studying and practicing medicine for all these years has been a far cry from the horrors that the book and later the wonderful film had unleashed upon us. Probably because in our hospital the drug-trials were never undertaken. Specifically because in more than one ways, it undermines patient care. That being said, later on I also worked in a big medical labs facility for sometime and there I occasioned to see many a drug-trial going on, as patients regularly dropped in for their clinical monitoring.
I am not saying drug trials are not important or that they should be banned. Far from it. In fact every single medicine that patients take or are prescribed have undergone multi-stage human and animal trials to render them fit enough to be mass-marketed. They are like drug-advertising a necessary evil. It often risks a number of patients, but the benefits coming out of it, if after everything a successful drug is found out, is enormous. Millions of people stand to benefit when a a few hundred only need be exposed in the beginning. That being said, clinical drug trials are also the principle reasons for escalation of drug costs and delays in releasing efficacious products because the cycle lengths are tediously slow.
To say that India is presently the global hub of drug trials would be an understatement. Clinical research is the new name in outsourcing business with a global expansion by 12% per annum. The US companies manufacture the drugs and the molecules are then tested on human subjects in the underprivileged countries like India, Brazil, the African belt, Russia. It is much easier and cheaper to recruit and test new chemicals on people from these nations. And among these places India is emerging as the destination De jure.
- English is widely spoken by the professionals.
- The population is large with diseases of all kinds from the exotic to the commonplace.
- Vast sections are uneducated.
- The concept of informed consent and liability barely exists.
- Suing doctors or companies is unheard of.
- The people are desperately poor and hence being choosy is out of the question.
- Health insurance has not yet penetrated a sizeable section of the society.
I have herein prepared a small 'slide-show' to help get my points across:
This method of cost-cutting on the part of the pharma companies however has severe outcomes. In the past few years, the FDA has inspected just a handful out of the thousands of clinical trial sites in India. In fact even after numerous monumental failures to stop the launch of harmful drugs, FDA barely inspects 1% of all trails in US. Offshore, the number is far worse.
On the sites in India, it is impossible to find any independent institutions monitoring or auditing these drug trials. All these auditors are on the pay-roll of the pharma companies. Doctors, are also paid, based on how many patients they can bring into the whole system, rather than by the trial efficacy they maintain. As a result, not only the data collected, but even the quality of drugs administered, practices and follow-up patient care is called into question. The practice of cherry picking positive results and the penchant for concealing negative findings is nothing new for the drug industry. But such concealment often results in incorrect assessment of a drug’s safety and efficacy.
One well-known scandal occurred about eight years ago, when a Johns Hopkins University researcher injected an untested chemical in 27 patients at a public cancer hospital in the southern state of Kerala.
Lawyer Vincent Panikangulara represented an illiterate coolie labourer with throat cancer who unknowingly enrolled in the trial after signing a form in a language he did not understand. India's court dismissed his claim of a human rights violation, citing a statute of limitations of one year from the time of the injection. By the time the court ruled, the patient was dead.
"There was an institutional commitment to protect other institutions at the expense of the rights of individuals," Panikangulara said. "The question of human rights violation was never even on the agenda."
Asked whether India today offers a safer environment for clinical drug studies, the lawyer leaned back and smiled.
"Are you talking about safety for the patient or the corporation?" he asked. "For the corporation, it's 100 percent safe. For the patient, that is a matter for study and investigation. It's a sad situation here."
At this time, it must be remembered the US federal laws provide enough judicial opportunities in the form of Alien Tort Statute for allowing United States courts to hear human rights cases brought by foreign citizens for conduct committed outside the United States. But the destitte population of this country has no access to adequate legal representation to capitalise on these recourses.
In another example of the dire consequences going on here,
Dr. C. M. Gulhati, editor of an Indian medical journal, Monthly Index of Medical Specialities, said authorities cannot cope with the tsunami of trials. “India's drugs controller general's office is both understaffed and incompetent,” he said, citing a case where the agency claimed it reviewed an 800-page trial protocol in just five days. “How is that even possible?”
Gulhati, who fights unbridled drug testing from a dim and cluttered office above a busy Delhi shopping plaza, reeled off a litany of troubled trials:
In 2003 in Hyderabad, an unregistered study of a heart attack drug that resulted in six deaths.
In 2004 in Delhi, a first-in-human trial of a new suturing device on 13 patients without regulators' approval.
Last year, India's decision to become the only nation to allow domestic drug maker Sun Pharmaceutical Industries to market the anticancer drug Letrozole (which forms a very important part of anti-breast cancer regimens in postmenopausal women) for infertility in women despite the drug's originator, Novartis, warning that it may cause foetal harm and should be used only in post-menopausal women.
And in October in Bangalore, the death of a baby during the testing of a new Wyeth vaccine.
“It's a total farce,” said Gulhati, who could not think of a single case of an Indian doctor disciplined for mishandling a trial. “When I complain people have broken the law, they ask 'What harm have I done?' ”
Hope, though is not all lost. The new government has ushered in a few mandates that when enforced widely should result in much greater benefit and transparency in the entire scheme of things:
- The registration of drug trials is being made mandatory.
- The registration is to be made in a public registry, freely accessible to all, before the first volunteer is recruited.
- The knowledge of the fate of trials must be disclosed, so that it is known what drugs worked and what was abandoned.
Now all that remains to be seen is whether the agencies and other concerned parties (precisely here the NGOs, conscientious doctors and lawyers) armed with the newer laws can at least guarantee justice for all in case there are gross undermining of human rights. This is because, as far as totally transparent drug trials are concerned, they are still a distant dream.
Photo courtesy of Creative Commons
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