Thursday, May 2, 2013

National License for access to The Cochrane Library in India renewed for another three years (2013 to 2016)

 The national provision for country-wide access to The Cochrane Library in India has just been renewed for a further three years. This will provide millions of people in India continued free access to the best available evidence on the effects of healthcare interventions. The Indian Council of Medical Research (ICMR) released the first installment of funding for a three-year national license on April 30th, and the period of the license will begin from when the previous subscription ended in December 2012. 

People in India continued to enjoy one-click free access from January to April 2013 due to the largesse of the publishers, who ensured continuity in the availability of this valuable resource, since the ICMR had indicated willingness to continue this subscription. People in India have now had uninterrupted access to the full contents of The Cochrane Library since 2007, except for a brief period in 2010, when access was halted for nearly a month due to delays in renewal of the national license. Usage took a full six-month period to build up to what it was before free access was stopped. Fortunately, freedom to access reliable evidence to inform health decisions did not stop at midnight on March 31, 2013, as I had earlier feared would happen.

The South Asian Cochrane Network and Centre thank the ICMR and Wiley-Blackwell for working together to ensure that all people in India, with access to an internet connection, will continue to have instant access to the resources provided by The Cochrane Collaboration to ensure that all health decisions may be informed by reliable evidence about what works, what does not work, what may harm, and what interventions require further evidence to support their wide-spread use. I am also personally grateful to the numerous people world-wide who wrote, or called in, to express their support for this initiative; to the many journalists who carried our concerns about a potential lapse in the renewal of the national provision to people in different parts of the world; and to the group of medical students in India who started an on-line petition to support the ICMR-funded national provision. Thank you.  

Freedom comes with obligations

National free access to reliable evidence is a privilege afforded to people in a region or country, where someone else has made this access possible. This privilege has limited value if the evidence is not used. Millions of Indians, including health professionals, are still unaware of the availability of this resource, or of how to access it, or how to interpret the evidence in The Cochrane Library. It behooves those of us who have enjoyed the fruits of this privilege to ensure that others in need of evidence to guide decisions about their health, or the health of others, who are unaware of this reliable source of evidence, also benefit from this opportunity made available by this prudent investment by the ICMR.

For instance, evidence from two Cochrane Review on the effects of long-term hormone replacement therapy in peri-menopausal and postmenopausal women and on hormone therapy for preventing cardiovascular disease in post-menopausal women found no evidence that HT provided any protective effects against the development of heart disease, either in healthy women or women with pre-existing heart disease. On the contrary, both single (oestrogen alone) and combination HT (oestrogen plus progestogen) given to relatively healthy post-menopausal women significantly increased the risk of stroke and venous blood clots, and gall bladder disease; while combination HT, additionally, significantly increased the risk of a heart attack or blood clots in the lungs (pulmonary embolism), fatal or nonfatal heart attacks after one year's use, stroke after three years' use, breast cancer, gallbladder disease, death from lung cancer; and dementia in women over 65 years. Among women with existing heart disease, combination HT significantly increased the risk of blood clots in the leg veins and in the lungs. However, even today, many post-menopausal women in India continue to be prescribed long-term HT by their physicians in the misguided belief that this may be beneficial. 

I urge the Federation of Obstetrics and Gynaecologists in India (FOGSI) to work with their members, and the Drug Controller General of India (DCGI), to ensure that appropriate steps are taken to ensure that long term HT is not prescribed in this country to unsuspecting women, since the dangers of its use surely merit immediate preventive action at a national level.

Numerous examples exist where Cochrane evidence indicates that health interventions that are harmful or of little benefit are continuing to be used in India, while interventions of little or uncertain benefit are prescribed, and others that are likely to be beneficial are not used enough, or not at all; some of these instances are due to best practice being sacrificed at the altar of profit-based medicine, while others are due to sheer ignorance of the existence of this evidence. Last year saw the inauguration of the The International Society for Evidence-Based Health Care (ISEHC), as well as the Indian Chapter of the ISEHC. We also now have an Indian Satellite of the Cochrane Public Health Review Group.  Numerous Cochrane Reviews of importance to public health in India exist that require dissemination; and the free national access to The Cochrane Library is an opportunity to ensure that the investment of the ICMR in providing access to reliable evidence is utilized by these bodies and their members, in order to improve health outcomes for the people of India.

Freedom also comes with responsibilities

 Reliable evidence indicates that about half of all clinical trials that have been conducted have never been published, and trials with negative results about a treatment are more likely to be not reported or selectively reported, so that adverse outcomes, and outcomes that did not favour the investigators’ experimental drug, are never revealed, to the detriment of people’s health. While the methods of the Cochrane Collaboration are robust and can identify trials with outcomes at high risk of bias, sometimes researchers and drug companies refuse to divulge data even when requested. To ensure that Cochrane Evidence is based on all relevant data from included studies, and not only what researchers wish for others to know, is a difficult task that requires an international commitment to transparency in research as being more important than the whims of researchers or their masters.

A global campaign was launched to combat selective reporting and publication of the results of trials. The All Trials Campaign seeks world-wide support to ensure that all trials are registered and their results reported in full. The Clinical Trials Registry-India (CTRI) has had some success in ensuring that trials in India are prospectively registered before recruitment of the first participant; but this is enforced only for industry funded trials due to a directive from the DCGI. Prospective registration not only helps prevent selective and distorted reporting of trial results but can also improve their design and conduct, since the template for registration in the CTRI facilitates the disclosure of methods that improve scientific validity, and ethical conduct of trials. However, India has no mechanism in place or on the anvil, to ensure that all trials are published in full, or for access to data from these trials, should the need arise.

India can support this world-wide effort in a number of ways. You can individually sign the on-line petition. The ICMR can pledge support to this initiative and join other international organizations and agencies, and even national research councils, such as the South African Medical Research Council, and student organization, such as the American Medical Student Association, in committing to this initiative. Ethics committees of universities, medical colleges, and clinical establishments that undertake researchers can also sign the petition and ensure that the goals of this campaign are fulfilled in their institutions. Medical journal editors can serve as effective gate-keepers by ensuring that all trials that they publish are prospectively registered, and that manuscripts of trials submitted for publication provide access to full trial results, including raw data, if required.