Lab rats? Drugs for US children tried on Indians

Discussion in 'Politics & Society' started by ajtr, Aug 24, 2010.

  1. ajtr

    ajtr Veteran Member Veteran Member

    Oct 2, 2009
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    Lab rats? Drugs for US children tried on Indians

    NEW YORK: A law intended to speed up development of new drugs for US kids has ended up financing clinical trials in poor countries, where the medicines might never become available.

    That’s the conclusion of a new report whose authors say the situation raises ethical concerns. More than a third of the published trials performed under 1997 legislation called the Pediatric Exclusivity Provision were carried out at least partly in developing or transitioning nations, such as Uganda and India, researchers found.

    “The trend that we describe brings up some scientific and ethical problems,” said Dr Sara Pasquali, a pediatrician at Duke University Medical Center in Durham, North Carolina, whose findings appear in the journal Pediatrics.
    “Oftentimes, access to a study may be the only access to medical care a family has,” she said of trial participants in developing countries. Once the testing is done, however, it’s unclear if effective drugs will be marketed in the country in question, and whether they will be affordable.

    Among the 174 trials the researchers examined, drugs against infectious diseases were most likely to be tested in the developing world, closely followed by heart, allergy and arthritis medications.
    “We are now using vulnerable people in vulnerable countries as drug laboratories,” Dr Marcia Angell, who was not involved in the new research, said. “It is all about dollars and cents.”

    The idea behind the Pediatric Exclusivity Provision is to incentivize development of drugs for children in the US.
    Because many diseases are rare in childhood, clinical trials usually target adults only, and their results don’t automatically extend to kids. The pediatric provision grants companies an extra six months of patent life if they test their drugs in kids as well.

    So far, those patent extensions have netted drugmakers an estimated $14 billion dollars, according to the US Food and Drug Administration. At the same time, more than 150 drugs have been approved for children since 1997, said Pasquali.
    According to the Pharmaceutical Research and Manufacturers of America, a trade association, there is no difference in the way trials are conducted in the US and abroad.

    M Nabeel Ghayur, a pharmacologist who worked in drug development in Pakistan before joining McMaster University in Hamilton, Ontario, Canada, said conditions are similar in India and Pakistan.

    “People actually have blind trust in their doctor in South Asia. They have no idea what drug development is, they have no idea what clinical trials are,” he said. reuters
  3. bhramos

    bhramos Elite Member Elite Member

    Mar 21, 2009
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    Thats true...... as a Bio-Technologist heard personally from some of the members.......
    do you know how they execute this?
    First they keep Free medical camp,
    they give free medicines and say come every week to this big hospital.
    you will be given free treatment as you attended this camp,
    every week they go to city Hospital and the tests are done free and be given a free meals. doctors takes their lab reports. this is the process..
    Warning to Pak people be careful at this time of Floods, the most of the US sent medicines will be testing of the above or similar type. US is Business Mind, noting comes for free not even aid..
  4. 171K

    171K Tihar Jail Banned

    Jul 3, 2010
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  5. Daredevil

    Daredevil On Vacation! Administrator

    Apr 5, 2009
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    This is morally and ethically wrong. People should take consent from the parents of the children before trying these medications on them and also explain to them of possible side-effects and unknown events that might occur due to use of such experimental medication. And finally, they should be appropriately compensated. This are the rules for clinical trials in developed countries and should be equally applicable to developing countries as well. But unfortunately the developing countries are exploited as usual due to weak or no regulation of such clinical trials.
  6. gogbot

    gogbot Regular Member

    Oct 2, 2009
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    Blame our government first ,
    Then blame the other nations that took advantage.

    LETHALFORCE Moderator Moderator

    Feb 16, 2009
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    The organ trade is an even bigger problem that the government is ignoring.
  8. Energon

    Energon DFI stars Stars and Ambassadors

    Jun 3, 2009
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    Drug development related clinical trials are highly susceptible to abuse and ought to be watched very, very carefully. Especially now that more of it is outsourced to select poorer nations on account of many barriers to clinical research within the United States. Having said that this ToI article only presents selective aspects for the sake of sensationalism. It doesn't hurt however to examine the other side of the coin once in a while.

    First, clinical trials in India are done at the behest of Indian institutions, many of whom (government and private) have turned it into a lucrative business. American or other Western companies don't just show up and surreptitiously slip pills down people's throats.

    It is a misnomer that evil Western companies use impoverished poor children as guinea pigs as a practice. The drugs that come up the pipelines are validated by set standards regardless of whether they're tested in India and or in early phase trials within the US (for the most part trials are conducted world wide including in the US itself.)

    The reason India and China are so popular for clinical trials is not because they're poor, but rather because their large and diverse populations offer up a wide array of pathologies enabling more sound research. Also because these countries have hospitals and staff capable of conducting research, which can be rather complex and arduous.

    It must be noted that most of the pediatric drugs for infectious diseases are intended for children in the developing world itself where communicable diseases claim innumerable precious lives (India is at the top of the list). Also children in developed nations do not present with diseases seen in the underdeveloped world making it virtually impossible to come up with a half decent sample size.

    Furthermore what the article forgets to mention is that India has benefited tremendously from modern drugs. Indian drug companies have increased their global presence exponentially over the past decade or so based on generics. Also, the vaccine industry is now heavily dominated by India. Thinly veiled reverse engineering has also enabled Indians access to the most state of the art and sophisticated drugs at throwaway prices. Medical tourism industry too owes a large part to the presence of multi national drug companies in India. Most of these developments either directly or indirectly be traced back to clinical trials being conducted in India.

    Frankly speaking, most of the unsavory aspects of clinical trials can be traced to structural and/or cultural deficiencies within India itself. Despite all the advances in India's pharmaceutical industry the access to decent medical care and drugs remains one of the worst in the world. As far as experimental research is concerned India doesn't even have a credible governing body and has to rely upon the US FDA for regulation. This is because most regulatory bodies in India are nothing more than magnets for corruption, which usually comes at the expense of the most vulnerable members of the populace. The near absolute power of the physician in decision making and the general lack of awareness within the patient is also very much an Indian cultural phenomenon which cannot be blamed upon the west. Interestingly enough a majority of the literature on this matter is published in Western peer reviewed journals. The Indian medical community itself seems rather disinterested in the matter and shows no sign of bringing change to the culture.

    This is not to say that drug companies are saints. Clearly their primary motivation is profit, and such is life. Sensationalist articles such as this one meant to stoke the nationalist fires (which it does quite successfully) are for the most part useless because it circumvents introspection, which is far more critical than seeking protection from supposed foreign predators.

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