Singh A.R., Singh S.A. (2005), The Academia-Industry Symposium: Medical Practice, Psychiatry and the Pharmaceutical Industry: And Ever the Trio Shall Meet-I. The Connection Between Academia and Industry, Mens Sana Monographs, Vol II: 6, Vol III: 1, March-June 2005, p1-36.

 

ABSTRACT                                                                                          

  

 The growing commercialization of research with its effect on the ethical conduct of researchers, and the advancement of scientific knowledge with its effect on the welfare or otherwise of patients, are areas of pressing concern today and need a serious, thorough study. Biomedical research, and its forward march, is becoming increasingly dependent on industry-academia proximity, both commercial and geographic. A realization of the commercial value of academic biomedical research coupled with its rapid and efficient utilization by industry is the major propelling force here. A number of well-intentioned writers in the field look to the whole development with optimism. But this partnership is a double-edged sword, for it carries with it the potential of an exciting future as much as the prospect of misappropriation and malevolence. Moreover, such partnerships have sometimes eroded public trust in the research enterprise itself.

Connected to the growing clout of industry in institutions is concern about the commercialization of research and resolving the ‘patient or product’ loyalty.

There is ambivalence about industry funding and influence in academia, and a consequent ‘approach-avoidance’ conflict. If academia has to provide the patients and research talent, industry necessarily has to provide the finances and other facilities based on it. This is an invariable and essential agreement between the two parties that they can walk out of only at their own peril. The profound ethical concerns that industry funded research has brought center-stage need a close look, especially as it impacts patients, research subjects, public trust, marketability of products, and research and professional credibility.

How can the intermediate   ^{goal of industry (patient welfare) serve the purpose of the final goal of academia is the basic struggle for conscientious research institutions/associations. And how best the goal of maximizing profits can be best served, albeit suitably camouflaged as patient welfare throughout, is the concern of the pharmaceutical industry.}

 A very great potential conflict of interest lies in the fact that academia needs the sophisticated instruments that only big funding can provide, while at the same time resists the attempts of the fund provider to set the agenda of research, protocol, design, publication, the works. Conflicts arise at many steps and levels of functioning, and are related to the expectations, competing interests, and conflicting priorities of the different entities involved, whether they are the academic medical centers, the funding agencies, the patients and their families, or the investors and venture capitalists. The public expects access to new treatments. Its appetite for innovation has been bolstered by the constant attention given by the press to new treatments and by the implicit promise from researchers of continuing advances. Similarly, patients demand privacy and control over information about themselves.

It makes greater sense for genuine researchers to associate with large long-term industry players who have a track record of genuine hard-core discoveries, even if the process is slow (maybe), and the funding less (may not be).

The element of control venture capitalists exert over the pharmaceutical industry is an under researched area for obvious reasons.  But it needs further probing, for that will lay bare the pulls and pressures under which industry works.

It makes sense for ethically minded researchers and institutions not to fall in the trap of stocks and equity investments in industry, howsoever attractive they appear, and get rid of them as soon as possible if they have them. If at all they want, it makes more sense to own stocks of larger well established concerns, for the stock upheavals being less, the pressure of the market-place, and of venture sharks, is likely to be lower too.

While active participation by the researcher in the commercialization process may be greatly desired by industry, ostensibly in the name of creating value, academia must realize it is a bait it might find hard to swallow in the long run. It makes more sense for the researcher and institution to forego such temptations and/or walk out of such investments as soon as possible.

 While mainstream medicine and research are booming, as is connected industry, concerns about professional commitment to patient welfare are booming too. Increasing corporate influence is challenging certain long held and fundamental values of patient care, which will have far reaching implications for biomedical care and the future progress of mainstream medicine.

 KEY WORDS:

Academia, Pharmaceutical Industry, Academia-Industry Proximity, Biomedical Research, Commercialization of Research, Pharmaceutical Funding, Public Accountability and Academic Freedom of Universities, Commercial Value of Academic Innovations, Ethical Issues, Venture Capital, Stocks and Equity, Patients and Public Interests, Large and Small Pharmaceutical Firms

 

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Singh A.R., Singh S.A. (2005), The Academia-Industry Symposium: Medical Practice, Psychiatry and the Pharmaceutical Industry: And Ever the Trio Shall Meet-II. Public Welfare Agenda or Corporate Research Agenda? Mens Sana Monographs, Vol III: 2-3, July-October 2005, p37-90.

 

 ABSTRACT                                                                                          

  

As things stand today, whether we like it or not, industry funding is on the upswing. The whole enterprise of medicine in booming, and it makes sense for industry to invest more and more of one’s millions into it. The pharmaceutical industry has become the single largest direct funding agency of medical research in countries like Canada, the United Kingdom and the United States. Since the goals of industry and academia differ, it seems that conflicts of interest are inevitable at times.

The crucial decision is whether the public welfare agenda of academia, or the corporate research agenda of industry, should occupy center stage when they conflict.

There is enough evidence to show that funding by industry is very systematic, and results that are supportive of the safety and efficacy of sponsor’s products alone get the funds. It is no surprise, therefore, that one finds very few negative drug trials reports published, and whatever are, are likely to be by rival companies to serve their commercial interests.

Renewed and continued funding by industry decides the future prospects of many academic researchers. At the same time there is now evidence that pharmaceutical companies attempt suppression of research findings, may be selective in publishing results, and may delay or stymie publication of unfavourable results. This is a major area of concern for all conscientious researchers and industry watchers.

Industry commonly decides which clinical research/trial gets done, not academia, much though the latter may wish to believe otherwise. It finds willing researchers to carry this out. This can be one area of concern. Another area of pressing concern is when industry decides to both design and control publication of research.

It makes sense for researchers to refuse to allow commercial interests to rule research reporting. Research having been reported, the commercial implications of such reporting is industry’s concern. But, doctoring of findings to suit commerce is to be resisted at all costs. In this even pliant researchers need have no fear, for if they indeed publish what will work, the concerned sponsor will benefit in the long run. The only decision academia has to make is refuse to comply with predestined conclusions of sponsors for the ‘thirty pieces of silver’. Instead do genuine research and make sixty for themselves.

The useful rule of thumb is: Keep the critical antenna on, especially with regard to drug trials, and more especially their methodology, and study closely the conflict of interest disclosed, and if possible undisclosed, before you jump on the band wagon to herald the next great wonder drug.

There are three important lessons to be learnt by academia in all academia-industry relationships:

i) Lesson number one: incorporate the right to publish contrary findings in the research contract itself. Which means, it makes great sense for academia to concentrate on the language and contractual provisions of sponsored research, to read the fine print very closely, and protect their research interests in case of conflict.

ii) Lesson number two:  a number of lawsuits successfully brought up against industry recently reflect earnest attempts by patient welfare bodies and others to remedy the tilt. It will result in a newfound confidence in academia that augurs well for academia-industry relationship in the long run. Hence the second lesson for academia: do not get browbeaten by threats of legal action.

iii) Lesson number three: Academia should keep itself involved right from inception of the clinical trial through to ultimate publication. And this must be an integral part of the written contract.

The time to repeat clichés about the exciting future of the academia-industry connect is past. A concerted effort to lay a strong foundation of the relationship on practical ethical grounds has become mandatory.

KEY WORDS:

Public Welfare or Corporate Research Agenda, The Olivieri Case, Doctoring of Research Findings, Selective publishing, Delay and Under reporting, Complete Disclosure, Multi-centered Trials, Ghost writing, Duplicate Publication, Access to Data, Control over Publication, Negative Drug Trials, The Porcupine Dance, Law Suits Against Industry, Design and Control of Publication, Connection between Funding and Positive Findings.

 

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 Singh A.R., Singh S.A. (2005-2006), Where is Medicine Heading? Pointers and Directions from Recent Law Suits Against Industry: Medicine As A Corporate Enterprise, Patient Welfare Centered Profession, Or Patient Welfare Centered Professional Enterprise? Mens Sana Monographs, III: 4-5, Nov 2005- Feb 2006, p1-70.

 

 

ABSTRACT                                                                                          

  

 The wants of the medical man have multiplied beyond imagination. The cost of organizing conferences is no longer possible on delegate fees. The bottom-line is: Crores for a Conference, Millions for a Mid-Term. However, the problem is that sponsors keep a discreet but careful tab on docs. All in all, costs of medicines escalate, and quality medical care becomes a luxury. The whole brunt of this movement is borne by the patient.

Companies like GlaxoSmithKline, Bayer, Pfizer, Bristol-Myers Squibb, AstraZeneca, Schering-Plough, Abbott Labs, TAP Pharmaceuticals, Wyeth and Merck have paid millions of dollars each as compensation in the last few years. The financial condition of many pharmaceutical majors is not buoyant either. Price deflation, increased Rand D spending, and litigation costs are the main reasons. In the future, the messy lawsuits situation would no longer be restricted to industry. It would involve academia and practicing doctors as well. Indian pharma industry captains, who were busy raking in the profits at present, would also come under the scanner. If nothing else, it means industry and docs will have to sit down and do some soul searching.

Both short and long-term measures will have to be put into place. Short-term measures involve reduction in i) pharma spending over junkets and trinkets; ii) hype over ‘me too’ drugs; iii) manipulation of drug trials; iv) getting pliant researchers into drug trials; iv) manipulation of Journal Editors to publish positive findings about their drug trials and launches; v) and for Indian Pharma, to conduct their own unbiased clinical trial of the latest drug projected as a blockbuster in the West, before pumping in their millions.

The long-term measures are related to the way biomedical advance is to be charted. We have to decide whether medicine is to become a corporate enterprise or remain a patient welfare centered profession. A third approach involves an eclectic resolution of the two. Such amount of patient welfare as also ensures profit, and such amount of profit as also ensures patient welfare is to be forwarded. For, profit, without patient welfare, is blind. And patient welfare, without profit, is lame. According to this approach, medicine becomes a patient welfare centered professional enterprise.

The various ramifications of each of these approaches are discussed in this monograph.

KEY WORDS: Law Suits Against Industry, Price Deflation, Increased R and D Spending, Litigation Costs, ‘Me Too’ Drugs, Medicine As A Corporate Enterprise, Medicine as a Patient Welfare Centered Profession, Medicine As A Patient Welfare Centered Professional Enterprise, Professional or Business Ethics in Medicine