Fast growing business: Unethical clinical trials in India_Asia Times

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> JustSayNo

> Wed, 28 Jul 2004 11:39:31 -0000

> [sSRI-Research] Fast growing business:

> Unethical clinical trials in India_Asia Times

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

> Asia Times reports: " India increasingly emerges as a

> preferred

> destination for outsourcing clinical trials -

> testing of new drugs on

> humans - the country may also be heading toward

> providing the

> greatest source of human guinea pigs for the global

> drug industry. "

>

> Globally, clinical research was estimated to be a $5

> billion to $6

> billion market in 2002, and according to the CEO of

> Biocon, India's

> premier biotechnology company (est. 1978) clinical

> research spending

> is expected to touch $10 billion by 2005. According

> to a 2003 study

> by Connecticut-based Business Communications Co

> (BCC), US-based

> spending on clinical trials is growing at 12% per

> year - and should

> generate $26.5 billion by 2007.

>

> The reason that the business of clinical trials has

> grown so rapidly,

> is that it provides the pharmaceutical industry with

> the necessary

> underpinning for obtaining a license to market

> drugs. But the

> clinical trial business is dependent upon a large

> pool of human

> subjects-or, a stable of human guinea pigs-in who

> the drugs are

> tested. But with increased awareness of the risks

> involved in

> testing drugs under development, the pool of human

> volunteers in

> industrialized countries has shrunk. The drug

> industry is

> increasingly moving to underdeveloped countries

> where they are

> enrolling uninformed, non-consenting people who have

> few choices in

> life. India is a target drug testing population.

>

> " A spate of unfortunate events over the past few

> years has brought to

> the fore the rampant practice of conducting

> unethical and even

> illegal clinical trials in India, which is fueling

> immense concerns

> culminating into a huge public outcry over the

> regulatory

> authorities' failure to check such practices, and

> even lawsuits. "

>

> " Although the Streptokinnese case was a shocking

> revelation, it

> wasn't an isolated one. According to Monthly Index

> of Medical

> Specialities in India, an independent

> pharmaceuticals journal, more

> than 400 women who had been trying in vain to

> conceive were enrolled

> in 2003 without their knowledge or consent to take

> part in clinical

> trials across India to see if a drug called

> Letrozole induced

> ovulation. "

>

> " in India particularly, unethical and illegal

> clinical trials are

> most rampant and are conducted without fear because,

> say critics,

> there is no law to safeguard the interests of

> volunteers, while

> regulatory authorities, " by design or default " , fail

> to take action

> against such trials. "

>

> Unethical experimentation on human beings threatens

> the fabric of

> civilization. In 1947, an international tribunal at

> Nuremburg

> declared such activities crimes against humanity.

>

> Asia News reports: " Almost all top names, including

> Novo Nordisk,

> Aventis, Novartis and GlaxoSmithKline, have started

> running clinical

> drug trials in India lately, while some, such as Eli

> Lilly and

> Pfizer, which started much earlier, conduct tests on

> a number of

> their new drugs. "

>

> Understandably, the American public is repelled by

> the unethical

> conduct and corrupt practices of the pharmaceutical

> industry--as

> documented by a new Harris Poll:

> " No industry has fallen as far or as fast in public

> esteem in recent

> years as the pharmaceutical industry, " which ranks

> with tobacco.

>

> Since the pharmaceutical industry earns nearly

> two-thirds of its

> profits in the US, because drug prices in the rest

> of the

> industrialized world are largely government

> controlled, the US can

> apply pressure on the industry. The FDA, for

> example, has the legal

> authority--we believe, the moral obligation--not to

> accept

> unethically obtained clinical trial data. That would

> put an end to

> many of the deplorable experiments that are

> conducted without

> informed consent.

>

>

> Contact: Vera Hassner Sharav

> Tel: 212-595-8974

> e-mail: veracare

>

>

>

http://www.atimes.com/atimes/South_Asia/FG23Df03.html

> ASIA TIMES

> South Asia

>

> India's clinical trials and tribulations

> By Indrajit Basu

>

> KOLKATA - The potential is huge, multinationals are

> willing and

> Indian companies are eager. Moreover, it is a type

> of outsourcing

> that is not likely to draw the protests of the

> anti-outsourcing

> brigade in rich economies. Yet even as India

> increasingly emerges as

> a preferred destination for outsourcing clinical

> trials - testing of

> new drugs on humans - the country may also be

> heading toward

> providing the greatest source of human guinea pigs

> for the global

> drug industry.

>

> A spate of unfortunate events over the past few

> years has brought to

> the fore the rampant practice of conducting

> unethical and even

> illegal clinical trials in India, which is fueling

> immense concerns

> culminating into a huge public outcry over the

> regulatory

> authorities' failure to check such practices, and

> even lawsuits.

>

> For instance, in early March, the Supreme Court of

> India hauled up

> two top biotech companies in India, the

> Hyderabad-based Shanta

> Biotech and Bangalore-based Biocon India, for

> " openly conducting

> illegal clinical trials of new drugs on unsuspecting

> patients " after

> a litigation filed by the Aadar Destitute and Old

> People's Home, a

> Delhi-based social organization. This

> non-governmental organization

> (NGO) alleged that the two companies had conducted

> improper clinical

> trials of Streptokinnese - a new clot-busting drug

> used in heart

> attacks - last November without requisite

> permissions (of the Genetic

> Engineering Approval Committee), as a consequence of

> which eight

> people lost their lives.

>

> Although the Streptokinnese case was a shocking

> revelation, it wasn't

> an isolated one. According to Monthly Index of

> Medical Specialities

> in India, an independent pharmaceuticals journal,

> more than 400 women

> who had been trying in vain to conceive were

> enrolled in 2003 without

> their knowledge or consent to take part in clinical

> trials across

> India to see if a drug called Letrozole induced

> ovulation. Letrozole

> used in India was copied (with

> permission) by Sun Pharmaceuticals, a large Indian

> generic drug

> company, from a patented product of the same name of

> Novartis, which

> the multinational drug maker introduced globally for

> solely treating

> breast cancer and not for any other use in any

> country, including

> India. A complaint on the Letrozole case, too, was

> filed in the

> Supreme Court by yet another Delhi-based NGO.

>

> And in 2001, another trial that made headlines

> involved the clinical

> trial of nordihydroguairetic acid, a chemical with

> anti-cancer

> properties that was tested by a regional

> cancer-treatment center

> (RCC) in the Indian state of Kerala for a US-based

> researcher then

> associated with Johns Hopkins Hospital in the United

> States. The drug

> was allegedly tried on 26 unsuspecting cancer

> patients, two of whom

> died. Subsequently, a 60-year-old woman was again

> included for a

> trial for which the RCC provided five doses of the

> experimental drug,

> worth Rs10,000 (about US$200), free. The woman's

> condition turned

> critical as well before the fifth dose, although she

> escaped death.

>

> These instances indicate that in the absence of

> adequate regulations

> and proper laws, a developing country eager to cash

> in on the

> opportunities of globalization can be used for

> indulging in rash and

> risky practices. A recent survey of 200 health

> researchers globally

> that was commissioned by the former US National

> Bioethics Advisory

> Commission and published in February's edition of

> the Journal of

> Medical Ethics revealed that a quarter of clinical

> trials conducted

> in developing countries did not undergo ethical

> review.

>

> However, in India particularly, unethical and

> illegal clinical trials

> are most rampant and are conducted without fear

> because, say critics,

> there is no law to safeguard the interests of

> volunteers, while

> regulatory authorities, " by design or default " , fail

> to take action

> against such trials.

>

>

> The moot question then is, why are multinational

> drug companies

> increasingly preferring India to other poorer

> countries to outsource

> their clinical research and trial needs? Almost all

> top names,

> including Novo Nordisk, Aventis, Novartis and

> GlaxoSmithKline, have

> started running clinical drug trials in India

> lately, while some,

> such as Eli Lilly and Pfizer, which started much

> earlier, conduct

> tests on a number of their new drugs. Besides, a

> variety of both

> India-based and global contract/clinical research

> organizations that

> specialize in outsourced clinical trials management

> are working to

> expand India's clinical-trials business. These

> include Quintiles,

> Omnicare, PharmaNet and Pharm-Olam (all US-based).

>

> The simple answer is India's huge billion-plus

> population and cheaper

> costs. According to a study by Rabo India Finance, a

> subsidiary of

> the Netherlands-based Rabo Bank, India's huge

> patient population also

> offers vast genetic diversity, making the country

> " an ideal site for

> clinical trials " . For example, India has the largest

> pool of diabetic

> patients, with more than 20 million citizens

> suffering from the

> ailment - small wonder that insulin is one of the

> most researched

> drugs in the country. Moreover, many in the

> country's large poor-

> patient population are " treatment naive " , which

> means they have never

> received drugs for treatment - a fact that

> simplifies patient

> enrollment and trial management. Besides this, the

> country also

> offers other facilities, such as nearly 700,000

> specialty hospital

> beds, 221 medical colleges and skilled

> English-speaking medical

> personnel.

>

> But obviously, India's most significant offering is

> cost

> savings. " More than 40% of drug development costs

> are incurred in

> clinical trials and India offers immense savings on

> that aspect, "

> says Alok Gupta, country head for life sciences and

> biotechnology of

> Yes Bank, adding, " and importantly the trials can

> get done fast " .

> Indeed, the cost-savings opportunity in the country

> is irresistible.

> For instance, in the US, trials for a standard drug

> can cost about

> $150 million, whereas the Rabo Bank study estimates

> that drugs could

> be tested in India for as little as 60% of that

> price.

>

> Indian industry sources say that clinical-trials

> outsourcing is

> a " tempting " opportunity for the country's drug

> industry. In 2002,

> clinical trials were reckoned to have generated $70

> million in

> revenues for the industry, which could grow to $200

> million by 2007

> and anywhere between $500 million and $1 billion by

> 2010. Globally,

> clinical research was estimated to be a $5 billion

> to $6 billion

> market in 2002, and according to Kiran Majumdar

> Shaw, chief executive

> officer of Biocon, it is expected to touch $10

> billion by 2005.

> However, a study done in 2003 by Connecticut-based

> Business

> Communications Co says US-based spending on clinical

> trials is

> growing fast

> - at 12% per year - and should generate $26.5

> billion by 2007.

>

> This is why local industry sources feel that despite

> the ills, India

> should embrace and encourage drug trials and

> research in India. But

> there are better reasons as well. Rajesh Jain,

> managing director of

> Panacea Biotec Ltd, a prominent drug maker, says

> that for a country

> like India, the potential benefits of clinical

> research are far more

> than its hazards. " It brings in the best in industry

> practices in

> clinical research for the benefit of our

> population's health-care

> needs while exposing the medical community to global

> processes and

> standards, " he says, adding: " If we are to benefit

> from the fruits of

> modern research, we, too, should be willing to pay

> the same price. "

>

> Nevertheless, rattled by the recent deaths and the

> public outcry,

> India's regulators have started sitting up. The Drug

> and Controller

> General of India

> (DCGI) said last week that beginning in September,

> it will put in

> place inspection systems to track the progress of

> drug trials from

> beginning to end. There will also be a new set of

> rules " to emphasize

> incorporating good clinical-practices protocols " , a

> DCGI release

> said.

>

> Industry critics are now hoping that the DCGI

> efforts will be the

> first step in making clinical trials more

> accountable in the country.

>

> Copyright 2004 Asia Times Online Ltd. All rights

> reserved.

>

>