Industry & Medical Profession:

The saga continues.....

The events, news and headlines of past few weeks have once again inspired me to focus on the issue that had featured several times in the past in this space. Whether it is the recent move by MCI to recommend Union Health ministry to make changes in Indian Medical Council Regulations bill to prohibit doctors from accepting gifts from Pharma companies or the industry reciprocation by formulating a self regulatory code of conduct or recent events where insinuations are made behind certain recommendations on vaccines/drugs by WHO, a premiere world health regulatory body or the ‘arm-twisting episode’ of a leading multinational pharma company on the issue of conference sponsorship! There have been several unending debates and discussions on this issue amongst the supporters and the detractors at several fora, but the issue is still far from settled. Interestingly, this is one relationship in which both the parties- the ‘donors’ and the ‘recipients’ draw immense pleasure.

How deep is the rot?

The lure of freebie seems quite irresistible. From a small-time practitioner based in a small non-descript town to the stalwarts working in big corporate hospitals in metro cities- all enjoy this practice. The worrisome aspect is that they even take pride in their felicitations and hardly feel apologetic or hide their ‘well-earned’ bonanza. The bigger the name the greater is the offering. While many argue that such individual sponsorship is detrimental to the profession, they do not see any harm if professional bodies/organizations receive hefty sums for the sponsorship of an event. However, on closer scrutiny, the latter may have much more serious consequences than the former. Here, through the scientific deliberations or through recommendations of scientific committees the sponsors have far greater maneuverability and may effect en mass change in the practice habits of thousands of followers of that organization.

Recently, a multinational pharma company went even as far as demanding ‘privileges’ in return of sponsoring a forthcoming IAP national conference. The company, not only wanted the prime spot for them and their speakers in the scientific sessions, but also demanded modification in what was offered to other sponsors. Obviously, it was asking too much and the current IAP leadership should be complimented for outrightly rejecting their unjust demand and cancelling their whopping sponsorship amount equal to Rs 1.1 crores! This episode should serve as an eye opener to all including the office bearers of professional bodies and delegates attending these conferences. The organizers should draw a line on how much they can go on compromising and accommodating to the sponsor’s demands, and the delegates should also be more discernable while attending these sponsored sessions. The sponsored speakers, howsoever reputed they may be, may not always be dwelling on real science and their recommendations may not always be unbiased, and hence should be taken with a pinch of salt. Not all the sponsors behave in this manner and this particular company has got dubious record in the past also (see Pediascene cover pages-Figures 1 & 2). It is high time; these acts of ‘arm twisting’ by the industry should be highlighted and made public, at least to the members of that association. However, it carries the risk of opening a Pandora ’s Box, and the revelation of negotiations in public, and how the deals are struck between the organizers and the industry may even embarrass many of these academic bodies.

The more sinister collusion

A. Swine Flu and WHO:

This sleazy association does not stop with academic bodies, but quite disturbingly, fingers are being pointed against some of the most respected and influential institutions considered pillars of international public health. Recently, two episodes (see associated articles on pages 5-7) have accused World Health Organization (WHO) in misleading not only government of a developing nation, but the entire world! This probably reflects the unhealthy association at few echelons higher up. Indeed, this is the most extreme form of covert liaison that can have far more serious consequences on public health and ultimately on the health of an entire nation or of globe than merely sponsoring an individual professional or a professional body.

In the first of these incidents, BMJ, another reputed establishment has accused one multinational drug giant, Roche in misleading the independent medical observers about the efficacy of their antiviral drug, Oseltamivir and its utility in treatment of swine flu cases. Not only this, the write-ups in the journal have gone further and accused how the company colluded with few influential health professionals of WHO in issuing warnings and recommendations on swine flu, and role of Oseltamivir, to treat and prevent it. One of the authors has reported links between the WHO and pharmaceutical companies where firms have been covertly paying top WHO scientists in favor of getting favorable recommendations from the agency.

B. WHO recommendations and Vaccine introduction in NIP:

In another recent development, few reputed health professionals, retired bureaucrats, public health experts, educationists, and intelligentsia filed a PIL against GOI on the proposed introduction of a pentavalent vaccine in the National Immunization Program (NIP) of the country. The petitioners claim that their move is meant to highlight how irrational vaccines are being introduced in the public health system by the Government, under the influence of vaccine manufacturers and international agencies like World Health Organization (WHO), without proper epidemiological and medical studies (see ‘PIL against vaccines’ on pages 6 &7). No doubt, we definitely need a healthy debate on the matters related to vaccination in the country which is indeed in a mess to say the least. We need to have an indigenous independent vaccination policy based on our own needs and free from extraneous pressure. However, in this particular case, the petitioners have chosen the wrong plea to target the both- GOI and WHO. It’s true that we do not have authentic/ robust data on the prevalence of almost all the vaccine preventable diseases (VPDs) barring polio. By that yardstick, we should not have undertaken mass vaccination against any of these diseases till the requisite data is obtained. The exact incidence of Hib disease in the country is not known, but the disease does exist for sure in large numbers. Absence of evidence does not mean absence of existence of a problem. Hib vaccine is licensed in the country for almost a decade now and used freely in the private sector. But the issue is that those who need it the most -the poorer sections of the society residing in remote areas where access to even primary health care is not readily available -are not able to get it considering the high price and inaccessibility. The ones who are able to afford this vaccine are probably, on closer scrutiny, the ones who do not need it. And this argument is true for almost all the newer vaccines. I do believe that if a vaccine is not able to reach the one who needs it the most, it is futile to introduce and license that particular vaccine in the market. The introduction of the vaccine through public health delivery system would at least ensure ‘equity’ among all sections of the society, sooner or later. And if we could indeed prevent deaths of few thousands of children who would have died otherwise, the intervention is worth investing in rather than giving it to those who have other avenues to thwart that eventuality. We should not bother the move would cost the government millions. Ultimately, how much percentage of its GDP the GOI is spending on health? And how much on monitoring the naked mountains of Kargil or Drass sector? No doubt, Hib is a lesser evil if we compare it to many other organisms responsible for childhood mortality. Though there are many policies (and recommendations) of WHO that raise eyebrows. But the petitioners have wrongly targeted a move of the government that might have even inadvertently helped in improving sagging routine immunization (RI) rates in the country. We can have multicenter studies under auspices of ICMR on exact incidence of Hib and pneumococcal diseases rather than asking for abandoning this initiative. Believe me; we can have adequate data within six months if the government shows urgency.

There are many issues, some even more serious than the above, that deserve to be debated publicly. For instance, the lingering of polio eradication program and uncertainty over its completion, the ethical issue of VAPP and persistent prejudice against IPV, the unavailability of many life-threatening drugs like anti-diphtheric serum, continued use of certain dangerous vaccines like nerve-tissue ARV in some parts of the country. Why did no one file a PIL against all these serious issues? Why a potentially dangerous vaccine like OPV was allowed to be fed to millions of unsuspecting kids of polio-free states? Why GOI listened only to international health experts sidelining Indian experts and their advice? The list can go on and on.

Indeed, the two above mentioned incidents are very serious issues when the credibility of a giant watchdog of international health gets eroded. It raises question on its mandate to work independently and authoritatively! At stakes are not only few million dollars, not the commitment and integrity of a government, but the lives and health of millions of unsuspecting individuals across the globe.

Is there a way-out?

From where and how this practice germinates, thrives and flourishes-from top to bottom or the other way round, I simply do not have a clue. Probably, everyone at different levels of interactions has to be blamed. To chalk out solutions, efforts are needed at all these levels. Once, a senior stalwart of IAP, dismayed by the large number of ‘freebie seekers’ at one of the IAP national conferences, suggested that delegates sponsored by the industry should wear a badge displaying their sponsored status. Considering the fact that majority would have belonged to this category, it would have been a better idea to ask those who fell in the other category to display their unsponsored status! This is one example of a solution offered probably in a lighter vein. However, the gravity of the problem desires a far serious effort with some sincerity. Those who are in charge of offering and framing ethical guidelines must also learn to inculcate similar virtues in their professional dealing otherwise the whole exercise would lose exact purpose and would seem yet another instance of hypocrisy. Be it an individual or an organization. At the individual level, we need to do ‘soul searching’ and to exercise some degree of self-restrain, resisting the materialistic temptations offered by the industry. Clichéd solution? Yes, may be. But it’s always better than imposing any moral policing. Many academic bodies have come out with ethical guidelines on this issue and one of these is also published in this issue (See “Ethical guidelines for industry sponsorship” on page 8). The move by the MCI and the response of the industry are welcome developments. However, there are certain grey areas and loopholes that may be exploited by those who thrive only through this association particularly the smaller companies. The MCI should be given more teeth to deal with this malpractice, and more stringent rules ought to be formed to plug the gaps. The pharma companies should also display more transparency while conducting trials and submitting them for publication in scientific journals. The data related to the trial of any new drug should be readily available for scientific scrutiny. The editors also need to display impartiality, honesty and integrity while reviewing and judging these reports. The international health bodies should also issue recommendations after obtaining and evaluating all the relevant data from different sources. It is high time the WHO sets its own house in order and frees itself from the clutches of outside funding mainly from industry. The UN should also help the agency in maintaining its sovereign status through generous allocation of funds. How should GOI spare itself from the charges of ignorance, indecision and inefficiency on public health issues? And from the issues of favoritism and corruption? The one solution could be to form an independent national commission for prevention and control of all the VPDs like the one suggested for polio (John TJ, et al in IJMR 2009) where all the issues related to all infectious diseases epidemiology are dealt simultaneously amongst the indigenous health workers and the pressures from different quarters mainly from the industry and international health organizations are kept at bay. This is indeed a very tall order considering the availability of resources at our disposal and the status of infectious diseases and their surveillance system in the country. We can take a leaf out of the books from some other countries such as China and Brazil that are having ‘closed’ and independent yet efficient policies to deal with VPDs with rational use of vaccines.

-Vipin M. Vashishtha
Dec 25, 2009