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  Mens Sana Monographs
A Monograph Series Devoted To The Understanding Of Medicine, Mental Health, Man, Mind, Music And Their Matrix
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   2005| March  | Volume 3 | Issue 1  
 
 
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ARTICLES
The connection between academia and industry
Ajai R Singh, Shakuntala A Singh
March 2005, 3(1):5-35
DOI:10.4103/0973-1229.27876  PMID:22679346
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 they impact 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 growing 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.
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Public welfare agenda or corporate research agenda?
Ajai R Singh, Shakuntala A Singh
March 2005, 3(1):41-80
DOI:10.4103/0973-1229.27878  PMID:22679348
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 cliches 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.
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INTRODUCTION
The two revolutions in bio-medical research
Ajai R Singh, Shakuntala A Singh
March 2005, 3(1):0-0
  - 3,881 168
MUSINGS
The story of a young man
Ajai R Singh
March 2005, 3(1):39-40
PMID:22679347
  - 3,247 197
PREFACE
Second anniversary
Ajai R Singh, Shakuntala A Singh
March 2005, 3(1):3-4
PMID:22679345
  - 2,326 176
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