The Hindu Business Line : How open are the drug trials?

The US Department of Health Services is to establish a registry that will ensure that the results of all clinical trials conducted in the US are available to the public on an electronic database. Considering the factors that have made pharma MNCs set up base in India, there is an urgent need for similar legislation here.

THERE is a raging controversy in the US about making mandatory the publishing of the results of clinical trials of drugs. This followed the New York Attorney-General's accusation that GlaxoSmithKline suppressed negative results for an anti-depressant drug, Paxil, that was found ineffective in treating depression in children.

The company has since announced that it would make available online in six months time the results from trials of its marketed medicines. Slowly, a few other major companies have all come up with support to this idea. As a response to the fear expressed widely by doctors, medical journals and public, the American Medical Association has called upon the Department of Health and Human Services to establish a comprehensive registry for all clinical trials conducted in the US.

The new registry would ensure that the results of all trials, both positive and negative, are available to the public on an electronic database with unique identification number for each trial.

The new policy also enjoins upon the institutional review boards at hospitals, universities and medical centres that approve the clinical trials involving humans to make registration of clinical trial in the registry a precondition for approval. This may perhaps eliminate the possibility of multiple clinical trials run with only the results of positive trial being made public.

According to AMA trustee Dr Joseph M. Heyman, "studies with positive findings are more likely to be published than studies with negative or null results. We are concerned that this pattern of publication distorts the medical literature, affecting the validity and findings of systematic reviews, the decisions of funding agencies and, ultimately, the best practice of medicine."

The AMA's statement also expresses a genuine concern about delayed publication or deletion of information from publications. There could also be the bias from unreliable methods employed or inadequate sample size or comparison groups. There is also the likelihood of industry-funded studies using placebos or inactive controls, increasing the likelihood of achieving positive study results.

The new policy is based upon an extensive study of the available scientific literature on the relationship between pharmaceutical sponsorship and research outcome, quality or publication bias, including reviews of thousands of original studies.

There is, however, strong opposition from the drug companies to the idea of publishing the findings of their drug trials. Many biotech firms would not like to release negative clinical trials on a publicly accessible database for several reasons.

First, a mandatory requirement would result in bringing out into the open several studies that would indicate that the drugs either did not produce the desired results or even revealed that they can cause harm with deleterious side-effects. Suicidal tendencies were reported as a in certain antidepressant drugs that were not made known.

Second, there is a genuine apprehension that the publicising the negative data may trigger new areas of research for other drug companies or pass on proprietary information that they would fain keep with them. The smaller companies are scared of the bigger companies with ample financial resources exploiting the disclosure.

Nevertheless wherever the findings are favourable, no time is lost by companies, researchers and doctors in rushing to media or scientific journals to get publicity. This is a natural reaction as it favourably impacts a company's bottomline. The trials with negative results or those given up never see the light of the day, with medical practitioners continuing to prescribe the drugs unaware of the findings and endangering the health of the patients.

The biotech industry currently has about 5,000 companies all over the world, with 500 of them publicly owned with a revenue base of more than $50 billion and hundreds of products. These companies invest huge amount of money and work for several years to bring out a few drugs from the laboratory to the market.

Of the several drugs taken up for research only a very few enter the clinical trial stage. Even here out of forty drugs there is the possibility of only nine meeting the approval stage according to Tufts centre for the study of drugs development.

One can appreciate the anxiety and apprehensions of the drug companies that invest heavily on uncertain projects till the successful culmination of their efforts and the final outcome is known.

But this cannot preclude their ethical obligation to come clean on the findings in clinical trials whatever be their nature. It appears the world's biggest biotech company Amgen Inc. of California is planning to put on its website the information on clinical trials.

One company is supporting the disclosure of only Phase III trial results on the plea these contain "the pivotal results that are submitted to FDA for approval of the drug." It is, however, sceptical about making public Phase I or Phase IV trials.

While some express fears about "possible criminalisation of failures," there is the view that the database concept would kill all innovation.

There are a few others who feel that this transparency would be for the general good as the drug companies can share the information.

According to David Handelsman, lead strategist for clinical research and development at SAS Institute Inc., the advantages could be much more as the data could help bring down the cost of clinical trials with fewer volunteer patients and lesser time. It is learnt that a Congressional committee is expected to hold hearings in September on this matter.

India has about 150 biotech companies with investment of $150 million with potential for the market to grow to $4.3 billion by 2010.

Considering the abundant scientific skill, cheaper costs of clinical trials, the fertile ground to test for all diseases in the uncontaminated rural population, the short time to recruit the volunteer patients and the illiteracy, many foreign companies like Monsanto, Pfizer, AstraZeneca, Unilever, DuPont, Bayer, Novartis and Eli Lily have also set up their bases here.

It is not known what practices are being followed here There is perhaps a greater need for our government to emulate the AMA in this regard, keeping in mind the welfare of the patients vis-à-vis the growth of this sector.

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