India: Popular destination for conducting clinical trials

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[Editor's note: The following news item should be read, juxtaposing

with the 2nd news item!]

India overtakes China as No.1 destination for clinical trials

5 Apr 2008, 0247 hrs IST , Kounteya Sinha , TNN

NEW DELHI: India has pipped China to become Asia's most popular

destination for conducting clinical trials. According to the

Planning Commission, around 139 new trials were outsourced to India

recently compared to 98 in China.

While the market value for clinical trials outsourced to India is

estimated at around $300 million, having increased by 65% in 2006,

it is expected to touch $1.5-2 billion by 2010.

Factors such as a diverse genetic pool, large patient pool, drug

naive population, competent medical professionals, high quality

hospitals where trials can be undertaken and low cost of services

have stimulated the flow of clinical research to India. The cost of

conducting research in India is 20%-60% lower than in developed

countries. Savings come from hiring clinical researchers, nurse and

IT staff at less than a third of wages in the industrialised

countries.

While 20 clinical research organisations and 80 hospitals are

engaged in trials, some CROs offer a menu of over 1,500

sophisticated tests under one roof.

Data furnished by the Indian Pharmaceutical Alliance showed that

pharma company GSK led the list with 22 trials followed by

and with 22, Eli Lily and BMS (17 each), Pfizer (16), Sanofi

Aventis (15), Astra Zeneac (10), Novartis (9), Merck (8) and Roche

(5). According to the plan panel, two other factors have contributed

to India becoming popular as a clinical research destination. First,

India put in place world-class laws on intellectual property rights

and second, the health ministry established a comprehensive

framework of rules for conducting clinical trials.

The document released by Montek Singh Ahluwalia, however, pointed to

one serious shortcoming — India is short by 30,000 to 50,000

research personnel, including trial investigators, auditors,

personnel to serve on ethics committees and data safety management

boards. The country's regulatory infrastructure has been found to be

weak and the office of the Drugs Controller is understaffed.

Chairman of the Institute of Clinical Research S R Dugal said

several factors had contributed to India's advancement in the field

of clinical trials. " India has a vibrant pharmaceutical market and

with patient protection in place since 2005, companies can introduce

drugs in India at the same time as other countries.

In comparison to China, India strictly follows ethical guidelines.

Also, India has a larger number of doctors with a far better

reputation than their Chinese counterparts, " he added. On shortage

of trained staff to conduct trials, Dugal said: " At present, 40

institutes teach clinical trials as a subject. They produce 5,000

students annually. We, however, need 11,000 annually. By 2010, India

will require 50,000 people specialising in clinical trials. "

http://timesofindia.indiatimes.com/India/India_overtakes_China_as_No1

_destination_for_clinical_trials/rssarticleshow/2927126.cms

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UK gets tough on pharma cos' clinical trials

25 Mar, 2008, 0045 hrs IST, AGENCIES

LONDON: Britain plans to force pharmaceutical companies to share

more information with regulators about clinical trials after an

investigation recently concluded that GlaxoKline deliberately

withheld information about an anti-depressant.

The four-year probe by the Medicines and Healthcare products

Regulatory Agency (MHRA), completed earlier this month, said the

British company should have revealed more quickly that Seroxat

sometimes increased the suicide risk in teenagers by more than six

times. But without stronger legislation in place, the MHRA admitted

there is no chance of prosecuting the company for what the agency

perceives as an ethical lapse.

" I remain concerned that GSK could and should have reported this

information earlier than they did, " MHRA chief executive Kent Woods

said in a statement.

GlaxoKline rejected the suggestion that it withheld

information. " We firmly believe we acted properly and responsibly, "

said Alastair Benbow, the company's European medical director.

British legislation only obliges companies to report side-effects in

patients for which drugs are officially recommended. Because Seroxat

was only recommended for adults, GlaxoKline was not required to

report on any dangerous side-effects it found in adolescents. But

Seroxat can still be given to adolescents if prescribed by a doctor.

About half of psychiatric drugs are prescribed " off-label, " meaning

that doctors give them to patients for whom the drug is not strictly

intended. The MHRA said it sifted through more than 1 million pages

of evidence after requesting details of clinical trials held between

1994 and 2002. In response, Britain's government declared that by

the end of the year, it will tighten laws forcing companies to share

all their relevant safety research with regulators.

" Companies that conduct clinical trials should not compromise

people's health by withholding information, " British public health

minister Dawn Primarolo said. The new laws will require companies to

disclose a drug's side effects in all patients tested, Primarolo

said.

The GlaxoKline case underlines a growing concern among many

health experts that drug companies' tendency to hide damaging data

could have disastrous consequences. " If we make the wrong licensing

decisions for whatever reasons, then patients may be put at risk,''

said Dr. Hans-Georg Eichler, senior medical officer at the European

Medicines Agency, which licenses drugs across Europe.

Others warn that without more complete information from drug

companies, consumers might see similar unpleasant surprises in the

future. " It would be unwise to assume that this particular case was

anomalous, " said Dr. Ike Iheanacho, editor of the Drug and

Therapeutics Bulletin, an independent publication of the British

Medical Journal that tracks drug treatments.

" It's perfectly reasonable for people to be anxious about what other

drugs on the market might be questionable, " he said. Patients could

be taking drugs they do not need or do not work, said Irving Kirsch,

a professor of psychology at Britain's University of Hull and lead

author of a study that concluded antidepressants like Prozac are

mostly ineffective.

Kirsch and colleagues analysed data about popular antidepressants

after submitting a Freedom of Information Act request to the US Food

and Drug Administration. They found that depressed patients taking

drugs did not actually do much better than those taking fake pills.

GlaxoKline, makers of numerous antidepressants, responded in a

statement that Kirsch's conclusions were incorrect because they

evaluated only " a small subset of the data available. "

But Kirsch and colleagues looked at nearly all the research

submitted to the FDA. If that was only a small subset, experts

wonder what other data might be out there. " If we don't know what

companies are doing, how do we know what's being reported? " said

Davina Ghersi, coordinator of the World Health Organisation's

clinical trials registry platform.

Britain's National Institute for Clinical Excellence, the agency

responsible for deciding what the health system pays for, issued

guidelines on antidepressants in 2004. At the time, it did not have

access to all the trial data.

" I shared with them the studies I had, but they did not have

sufficient information to do a complete review, " said Kirsch, then a

consultant to the agency.

In recent years, once-blockbuster drugs, such as the painkiller

Vioxx and the diabetes pill Avandia, have revealed worrying side

effects, including significantly boosting the risk of a heart

attack, years after being on the market.

" If we had seen all of the data in the first place, people might

have realised that the claims being made for the drug were overblown

and coy to the point of being fraudulent, " said Dr Healy, a

professor of psychiatry at Cardiff University in Wales.

But scapegoating of the drug companies may be too simplistic. " A

drug may turn out to be unsafe not because anyone has done anything

wrong, but because new knowledge surfaces, " Eichler said. Until a

drug has been used by millions of people, the rarest and deadliest

side effects may remain unknown.

Licences are granted for drugs based on limited testing, Eichler

said. Post-license monitoring should help sort out which drugs may

be particularly risky, he said. Without more data, people should be

wary of what medications they take, experts say. " If we had an

overall picture, we might have a very different view about how good

certain drugs are, " Healy said. " There's an awful lot of people

taking drugs that we don't know everything about. "

http://economictimes.indiatimes.com/News/International_Business/%

20UK_gets_tough_on_pharma_cos_clinical_trials/articleshow/2896310.cms

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