Saturday, December 13, 2008

The Vampire Companies In Drug Trials

It was an innocuous small news item buried in the local pages of the Hyderabad based newspapers a few days back. The news was that a person undergoing drug trials complained of chest pain and died before he was shifted to a corporate hospital. Hardly any news, when in our country only double digit deaths find space on the front page. However, this is no ordinary death. The death is due to the plague that is the hallmark of a majority of Indian entrepreneurs. The plague of greed for money at any cost. At the cost of the lives of thousands of poor citizens of this country through clinical trials, which are outsourced by the giant global pharma and bio technology companies. A city based bio company has been conducting drug trials on this person, which the company spokesperson accepted and added he was a “Volunteer” who was administered a dose one day earlier, was put under observation for 24 hours and released. So he argued the reasons for the death of this “Volunteer” cannot be attributed to the drug trials. Shockingly, he also added that this “Volunteer” was also undergoing a drug trial for another company. As a spin doctor of the bio company, he should have known that the rules of the Central Drugs Standard Control Organization clearly forbid clinical trials of more than one drug in a span of 90 days on the same person. But that is only the Law and in this country it is the least respected, especially by the money-making class.

So what in essence are these drug trials, called as clinical trials? When a new drug is formulated in the research labs of the pharma companies, it needs to be extensively used on human beings to determine dosage, efficacy and after affects. In the US and Europe, trials for one drug costs anywhere from 100 to 150 million dollars because of the stringent conditions and high hospital costs. To save such a huge spending, these corporations have started outsourcing to Indian companies at one –tenth of the cost. Where on Earth can one find a nation with a deadly cocktail of half a billion people mired in rampant poverty and illiteracy, a plethora of diseases, two million private hospital beds , completely unethical and greedy entrepreneurs, lack of proper regulation, blatant corruption and a slipshod state machinery to enforce whatever little regulations are in force. So almost all the giant pharma . corporations have zeroed in on India. According to a Confederation of Indian Industry study, clinical trials in India in 2002 generated $70 million in revenues and reached $200 million by 2007. McKinsey estimates that by 2010, global pharma majors would spend around $1 billion for drug trials in the country.
How do the Indian clinical trial companies which grab the outsourcing deals conduct the clinical trials? The modus operandi is simple. Middle men sift through the records at the government hospitals to identify those with a particular disease or a combination of diseases. They are then filtered as per the need of the age / gender group. Since most of the visitors to the government hospitals are poorest of the poor, it becomes a cake walk for the middle men to cut a deal. For as little as 100 to 150 rupees a day!! The “Volunteers” are regularly monitored with changes in dosage. At prior defined periods, the “Volunteers” are examined for any symptoms of side effects and the progress of the disease. If there are indeed side effects, sometimes fatal, they are disposed off with a few thousand rupees. Since the law stipulates that drug trials can be conducted only on “Volunteers”, the illiterate “Volunteers” are made to sign /put thumb impressions on the declaration of volunteerism absolving the companies from any legal consequences. The poor “Volunteers” get a few thousand rupees each in a year and in most cases life time misery with side effects, the middlemen get a few lakhs each for supplying the “Volunteers” and the company profits by a few million dollars. The entire process or the findings need not be registered with or divulged to any regulatory body. Perfect, isn’t it?

What has happened as a stray incident in 2000 has become rampant today across India. In 2000, the use of a banned drug on unsuspecting poor cancer patients by the prestigious U.S. John Hopkins’ Hospital in collaboration with the Regional Cancer Treatment Centre in Kerala was exposed by the centre’s radiology head. Two patients died as a result of the drug trial. Bowing to the public demand, the Kerala Government requested Dr Parikh of the Tata Memorial Hospital in Mumbai to probe the incident. Dr Parikh collected documentary evidence of JHU releasing funds for the drug trials with the conscious knowledge of that drug having been banned by the US Food and Drug Administration. The drug was developed by a team of researchers of JHU's department of biology. This has forced the Indian Council of Medical Research (ICMR) to inquire into the trials. As usual, the results are still not public and no action has been taken against those responsible, where as the Johns Hopkins University barred the principal investigator from heading future research with human subjects. NGOs estimate that at any given point of time, clinical trials are being conducted for more than 100 new drugs in India involving thousands of “Volunteers” across multiple cities. They fear several of these drugs are either banned in the developed countries or new experimental component mixtures derived from the banned drugs.
Recently, India has made some regulatory attempts, amending its Drugs and Cosmetics Act to require compliance by trial conductors with a set of good clinical practices / guidelines along with the ethics committee that the ICMR formulated. But this is clearly not enough. The government should make registration of every drug trial compulsory, the findings to be divulged, mandatory compensation payment for those affected and strong penalties against the defaulting companies.

Till then, like vampires sucking blood out of the living, companies will continue to suck out profits from the misery of the Poor.


Anonymous said...

You are on the dot (again)!
Is there a solution?
Thoughts please.

Anonymous said...

Medicine today is a trade, the study of Medicine a business, the practice of medicine an Industry and the manufacturing of medicine – a Mafia!!
It is a vicious cycle. The drug manufacturers produce massive quantities of products and the demand for them is created by a well integrated distribution system, which has the noblest of professions by the scruff of the neck – thanks mainly to buying power of the mafia.
The entire eco system is a well linked chain. From the road side pharmacy, the scan centers, the test labs, the distributor to the manufacturer, there is a robust ‘Distribution based Commission Framework’ in place at every level of the transaction. The sales forces of these conglomerates use samples as a guise to meet doctors and actually end up transacting a business deal (rewards in cash, kind, holidays for families, gifts etc) for prescribing an agreed quantity of types of drugs. The doctor is linked to a local Pharmacist who are either attached to a hospital or has set up shop nearby. In most cases, the doctor’s themselves have some of their family members set up the pharmacy close to their hospitals or clinics. The doctor also has a hefty commission from the local labs, scan centers etc for every case registered through them.
Sheer statistics can be mind boggling. The cost of a CT Scan is anything between 9 to 10 thousand rupees in leading labs. Almost 50% of this cost is a commission to a Doctor!!!. The cost of a tablet for a common fever or a cold is less than 5 paise per tablet. The cost at which it is being sold in the retail stores vary between 1 to 5 Rupees. Now you know where our hard earned money between the 5 paise and the many rupees go . . . .
No wonder the colleges and institutions teaching the art of Medicine, are possibly one of the richest professions in the country charging hefty sums for admissions. This also has an cyclical effect on the students graduating out of these places, for they will need to recover the huge investments they have made to get into these colleges and the waiting Vultures, in terms of the Drug mafia have their best traps laid out fair and square, to grab these budding doctors into their vicious tentacles – adding another swine to the vicious system.
While we can keep adding to this vicious list, there is no simple solution to this. This is as serious as terrorism – only of a different kind and steps being taken currently to tackle terrorism will also be needed to address this global phenomenon – individually and collectively.


Shekhar Rajagopalan said...

One effective solution:
A law which allows NO IP rights for a successful drug that did illegal clinical trials inbn India.

Anonymous said...

In Niloufer Hospital an activity known as “Drugs Testing” or “Drugs Trials” or "Clinical Trials" with Government permission has been going on for some time. Santa Bio-Technology, Bharat Bio-Technology and GSK Technology among others conduct these trials. They use Niloufer Hospital patients as the platform to test the functioning and effectiveness of the vaccines produced by them. These are supplied to the patients free of cost and on their option. Poor patients prefer them to avoid expenditure for buying them. There is no evidence whether these vaccines are doing harm or benefit. There is certain amount of risk factor involved in this and to what extent it contributes to the deaths is hypothetical. There is no fool proof monitoring mechanism to ascertain that these vaccines do not cause drug effects". (From my article "Genocide of Infants in Nilofour Hospital" )


Bhandaru Srinivas Rao said...

Dear Shri Ramana - I like this article. It revealed many things long back which are being surfaced through media today.-Bhandaru Srinivas Rao