Pharmacutical companies exploit India's poor

By enquirewithin · Dec 20, 2005 · ·
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    India has been the focus of medical research since the time when sunburned men with pith helmets and degrees from prestigious European medical schools came to catalog tropical illnesses.

    The days of the Raj are long gone, but multinational corporations are riding high on the trend toward globalization by taking advantage of India's educated work force and deep poverty to turn South Asia into the world's largest clinical-testing petri dish.

    The sudden influx of drug companies to India resembles the gold rush frontier, according to Sean Philpott, managing editor of The American Journal of Bioethics.

    "Not only are research costs low, but there is a skilled work force to conduct the trials," he said. In the rush to reap profits, Philpott cautions that drug companies may not be sensitive to how poverty can undermine the spirit of informed consent. "Individuals who participate in Indian clinical trials usually won't be educated. Offering $100 may be undue enticement; they may not even realize that they are being coerced," he said.

    For decades, pharmaceutical research in India didn't rely on clinical testing. Scientists mostly reverse-engineered drugs already developed in other countries. But in March, everything changed when India submitted to pressure from the World Trade Organization to stop the practice and implement rules that prohibit local companies from creating generic versions of patented drugs.

    Now, pharmaceutical companies can rest assured they won't lose profits to a domestic market, and India is suddenly a profitable location for performing the expensive tests required for Food and Drug Administration clearance of any drug. Though it is still too soon to tell how much the legislative change has boosted drug development, observers say the number of studies conducted by multinational drug companies has sharply increased since March.

    Given the rising cost of drug research in the United States and Europe, more and more drug companies are conducting clinical trials in developing countries where government oversight is more lax and research can be done for a fraction of the cost. According to a 2004 study by Rabo India Finance, a subsidiary of the Netherlands-based Rabo Bank, clinical trials account for more than 40 percent of drug-development costs. The study also found that performing the studies in India can bring the price down by about 60 percent.

    By 2010, total spending on outsourcing clinical trials to India could top $2 billion, according to Ashish Singh, vice president of Bain & Co., a consulting firm that reports on the health-care industry.

    Regardless of where clinical trials are performed, the FDA requires the same evidence showing that a drug is safe and effective before it will approve any drug, according to a written comment from Ken Johnson, senior vice president of The Pharmaceutical Research and Manufacturers of America Foundation.

    And it's the responsibility of the institutional review boards at the medical institutions where the studies take place to "actively pursue issues of informed consent," according to another written comment from Jeff Trewhitt, a spokesman for the pharmaceutical industry trade group.


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  1. Alfa
    I don't see the problem. Wether the research is being done in a poor or a wealthy country. The same amount of people will be part of the study. I do not see a problem with offering this way of earning money to poor population instead of wealthy population.
    Besides that, lowering the costs of research might offer some chances for objective safety studies on Research chemicals.
  2. enquirewithin
    It doesn't necessarily matter. It would certainly be good if research chemicals were being researched in countries like India (they are being produced there), but the big pharmaceutical companies are more interested in the likes of Prozac than in MDMA. They are also likely to use a looser code of ethics than if they were operating in a 'developed' country. Pharmaceutical companies already sell products which are banned in more developed countries (not psychoactive drugs), simply because they can get away with it.
  3. Alfa
    The main reason why new drugs are banned is that they are not studied properly. It would be much harder for governments to ban a substance if proven not harmfull. Governments now get away with saying substance A is psychoactive and harmfull. Substance B is also psychoactive. Thus it will probably be harmfull. Therefore it is placed under control. (Banned)
    I have no doubt that there are many substances without considerable health risks. The myth that drugs are toxins and therefore harmfull by definition is utter bullshit. There is much money to be made from such research. Just look at the Piperazine situation in New Zealand. Piperazine sales are regulated under law. 20 million doses sold a year. Of substances which do have health risks. Which are judged as not very enjoyable by most users due to the side effects. Can you imagine what would happen with substances that do not have such side effects and health risks? The EU even gives exclusivity to those companies who prove a substances safe. If there is anybody out there who reads this and is in a position to invest in such research; consider the ethical and financial results from such a venture...
  4. robertone
    Tell me more !!!

    Not that Swim has the resources to finance such research.
  5. Solidly-here
    I would much rather the citizens of India to have more money. Many US companies have set up Phone banks there. I call an 800 number (thinking I am talking to New York). An operator in India takes my call. Later they down-load the results to a computer in New York. US companies do this because Indians will work cheaper then US citizens. This does not mean that India has stupid people ... just cheaper workers.

    The same is true with drug testing (and many other purposes). If offering a person $100 is coersion, then 1000s of Americans are also coerced by Drug companies too (because in US testing, patients usually get a token $100 payment to participate in the drug study).

    If Enquirewithin's point is that poor people have no choice, except to take the money, then that is easily refuted: 99% of all citizens of India have never participated in a drug study.

    The absolute BEST thing anyone can do for a country with a lot of poor people in it, is offer them employment. 1000s of companies do this with India (and China ... and Eastern Europe). Bless each company who helps out the terrible hardship of being un-employed (or under-employed).
  6. Daeron
    actually youre wrong(you imperialistic bastard,so on, so forth). when the foreign companies start to grab the piece of the domestic market of a "poor" country, theyre kicking the domestic companies out of the business, which in turn generates even more unemployment. just look what WTO did to indian pharms
    plus the foreign companies are treating all cadres the same, as cheap work force, ie paying the specialized cadres w peanutz, as well as underpaying the rest of the labor force.

    what really is happening is that we have a new form of imperialism, now we dont have literally an occupation....well we do(iraq,afghanistan,etc), but apart from that you have the situation that foreign companies are literally milking and mining the countries good, be it land, ore or minds, and not investing in the development, thus having only a illusion of the improvement of the situation, whilst remaining on status quo.

    not to mention the fact that the "poor" countries are not only "mined", but used for dumps as well(will elaborate if someones interested)
  7. Alfa
    Back in the stone ages when I was in school, they thought me something like:
    more work -> more income -> more spendings -> healthier economy -> more work.
    Of course the larger companies put some small ones out of business, but with outsourcing the majority of the work does not relate to domestic competition. And what seems low income to us, is pretty substantial to the poor.

    Robertone: take the example of Noni. Noni was introduced to the EU after 1997. This means by EU law(Novel Food Act), that Noni is forbidden as a food supplement. Regardless of it's use for ages in other countries. A company did the research to prove Noni safe and got permission to export it to the EU. Technically they are the only ones allowed to export to the EU. But who's going to check where all noni comes from. Since Noni is allowed, it is below the radar.
  8. enquirewithin
    Daeron is right! The people who are really benefiting from the economic expansion of countries like India and China are an elite minority and foreign companies. India is full of desparately poor people wth no rights. The so-called 'democracy' there is is joke. It takes six months to get election results and corruption is endemic.
  9. enquirewithin
    A Nation of Guinea Pigs

    There is more to this story here for those interested, giving two sides to an argument:

    The town of Sevagram in central India has long been known for three things: its heat, which is oppressive even by Indian standards; its snakes, which are abundant; and its ashram, a derelict and increasingly malarial retreat preserved as a tribute to Mohandas Gandhi, who lived here and was known for tenderly relocating the poisonous vipers that slithered into his shack.
    Despite this intemperate setting, Sevagram's hospital has a good reputation. Though the power fails often, forcing medics to use the backlit screens of their cell phones for illumination, the standard of care is higher than at many of the country's public hospitals, and the facilities are comparatively plush. At the nearby government medical center in Nagpur, for instance, patients sometimes have to sleep on mattresses on the floor. Last year, Sevagram began garnering even more cachet. A German pharmaceutical company called Boehringer Ingelheim, whose latest stroke-prevention drug was making its way through the clinical pipeline, approved the town's hospital as a trial site - one of 28 in India recruiting stroke victims to round out the company's 18,500-person study.
    The drug regimen, known as Aggrenox, was being tested for its ability to forestall a second stroke. S. P. Kalantri, the doctor tapped to lead the trial in Sevagram, quickly grasped the offer's appeal. Patients in Sevagram are poor enough that the benefits of taking part in the study would amount to a health care windfall; among other things, Boehringer Ingelheim guaranteed participants two physicals during each of the three years that the trial would run. For each person enrolled, moreover, the hospital would receive 30,000 rupees (about $665) - no small amount, given the puny budget of the center's stroke ward, a single room of eight pallet beds. Kalantri talked the matter over with the chair of the hospital's ethics committee, and the two concluded that the trial drug itself, with its possible side effects and limited efficacy, would provide little benefit to their patients. Then they went ahead and signed up.
    When I arrive in Sevagram on a typically sweltering October afternoon, Kalantri is midway through a busy day. That morning, he attended to a farmer who had been bitten on the heel by a viper while sleeping, and then to a woman who had drunk a quart of insecticide in a suicide attempt. He also checked on his regular patients: a man with cerebral malaria, two women with unexplained fevers, and a stroke patient who had hemorrhaged. When I ask what treatment he gave to the stroke victim, he seems surprised. "Nothing," he says. "There's nothing we can do."
    Though hemorrhagic strokes are untreatable - drugs can't undo the damage - Kalantri's response echoed a more persistent frustration: that patients are too poor to pay for medicine. Because of this, one of the alluring features of a clinical trial is that subjects are supplied with the test drug for free. And while the medication on offer isn't always a very useful one, there's still the chance that it will do some good.
    This casual optimism contrasts sharply with the attitude in the West, where the number of patients willing to sign up for clinical trials is abysmally low. Just 3 percent of cancer patients opt to join trials, and the number of US patients who sign up for cardiac trials has plunged by half over the past five years.
    Such reticence has created a problem for the pharmaceutical industry. Modern drug design may be a sophisticated enterprise, harnessing technology that didn't even exist a decade ago, but one part of the process remains the same: The only way to tell how well a medication really works is to feed it to a sick person. This process, the human clinical trial, is the largest and creakiest part of the drug*making machine - a mammoth lab experiment that succeeds by brute statistical force. To make it run, companies have to round up a large number of ailing people and then convince them to swallow an unproven remedy with uncertain side effects.
    The experiment unfolds in three stages: Phase I, when a compound is safety-tested on a few dozen healthy people; Phase II, conducted on a slightly larger group of mildly ill subjects; and Phase III, which is the most extensive. Involving thousands of subjects and taking up to seven years to complete, Phase III trials are the make-or-break point for new medicines and, because of their size, the hardest to fill with patients. Exacerbating the problem is the fact that discoveries of rare side effects (including lethal ones, like strokes and heart attacks caused by the arthritis drug Vioxx) have pushed companies to conduct ever larger studies. In the 1980s, a new drug typically was tested on 1,300 volunteers in a total of 30 trials. By the mid-1990s, those numbers had swelled to 4,200 patients and 68 trials.
    "Twenty years ago, drugs were dropping the cardiac mortality rate from 20 percent to 15 percent," says Dhiraj Narula, medical director of Quintiles ECG, a contract-research firm that organizes trials for major multinationals. "Today we're looking at drugs that will take you from 6 percent mortality to 5 percent. To prove an effect that subtle, in a way that's statistically robust, you need a lot of patients in your sample." One cardiac drug study was conducted on a whopping 41,000 subjects.
    The result is a bottleneck that Narula argues is impeding the arrival of important cures. Herceptin - an exceptionally effective breast cancer drug - languished in trials for years because its maker, Genentech, reportedly couldn't recruit enough patients to test it.
    Like many in the pharmaceutical industry, Narula believes that the solution to the slow pace of drug trials lies in outsourcing. As many as half of all clinical trials are already conducted in locations far from the pharmaceutical companies' home base, in countries like India, China, and Brazil. And many industry analysts expect the market to skyrocket, particularly as expanding libraries of genetic information increase the number of drugs coming out of the lab. The consulting firm McKinsey calculates that the market in India for outsourced trials will hit $1.5 billion by 2010.
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