I start off by mentioning some of a very large number of recent disappointments with the current mode of functioning of the Pharmaceutical industry.
Indian Med. Assoc. Bull. of Sept. 14, 04 carried the story of a suit filed by David Franklin (an insider) against Pfizer on the charge of suppression of a 1998 study of results regarding the drug Gabapentin. It had shown that the drug did not work for the advertised Bipolar Disorder. This was sought to be done by lavishing perks on doctors, giving generous fees to thought leaders, using ghostwriters, and planting people to ask favourable questions. The study report had also mentioned that a 16 year old committed suicide while taking this drug. The company paid $ 240 million as criminal fine and another 152 million as fine to State & Federal Healthcare.
The Tribune of Chandigarh reported on Aug. 21, 05 that a Vioxx widow in USA received $ 253.4 million from Merck. It also mentioned that 4200 more cases were pending. The drug was taken by 20 million people before it was ordered to be withdrawn.
The New York Times of June 13, 07 reported that Eli Lilly paid $750 million to settle a lawsuit alleging that Zyprexa caused Diabetes.
The seemingly big fines are like a gambler's risk. The winnings being the astronomical profits the company hopes to go on making. The same NYT report also mentioned that the official financing for continuing medical education had gone up from $ 302 million in 1998 to 1.92 billion last year and that half of this came from the trade. The story contains examples of how courses are used for advertisement, and how expression of doubt about efficacy or safety results in discontinuation of the course. The issue of June 28 contains another facet. This is about Astra Zenca invited doctors to a weekend training session to learn to promote its drug Symbicort. The participants' expenses on car, plane and stay at Hyatt Regency, and also $ 2700 per head were paid by the company. The current estimate of advertising by US companies is $ 12 billion.
The San Diego Union Tribune July 5, reminded readers that The US Food & Drug Administration (FDA) had modified its regulation procedure 15 years back in the form of Drug Users Fee Act to speed up approval with payment of extra fee. In a way this amounts to bribing the Authority, because FDA hopes to collect $ 393 million next year, up 87 million over the current year, and more than half of these funds will be spent on staff salaries. The rest is for post-market surveillance. One example of the effect of this procedure (NYT, June 7&12,07) is the uncertainty regarding GlaxoSmithKline's Avandia. Its potential to cause heart disease continues to haunt countless millions including 7 million in USA. The drug has been around for 8 years even after Dr. John B. Buse, a famous medical researcher formally criticized it at a medical meeting. Dr. Buse recently informed a House hearing that he had received veiled threats from a high-ranking company executive. The report goes on to allege 'FDA having cozy relationship with the manufacturers'. The issue of June 13 contains far more disturbing reports about the side effects.
The report under reference also says that the law is now sought to be modified and made more 'company friendly’. It proposes to increase fees, hire more people and further lessen approval time. Already, from 1993 to 2003, the average approval time has gone down from 22 months to 14 months. The advantage touted being: the saving of processing time results in doing good that much sooner. My comment: this would also speed up possible hazardous consequences. David Carpenter, a government Professor at Harvard medical school found that drugs approved before deadlines were 3 to 5 times more likely to be taken off as those approved after. An example is the story of the antibiotic Ketek (Sanofi Aventis). It was withdrawn as hastily as approved after it caused liver failures (New England J. Med., April 19, 07)
The 15-year period in the above paragraph more or less coincides with globalization of Trade Related Intellectual Property Rights, whereby a patent granted in one country is valid in all WTO member states. The speedier approval leads to economic gains for the manufacturer as well as the country in which patented. This, in turn, pressurizes the national regulatory authority to join in the gamble. This is a danger to mankind. It would require a credible international regulatory mechanism. The experience with continuing Doha round deadlock over less critical trade matters shows that this is impossible in foreseeable future. As it is the withdrawal of a failed drug in one country does not lead to automatic withdrawal everywhere. I give two examples: co proxamol withdrawn in UK continues in India (Tribune Chandigarh Feb. 7, 05); Phenylpropalinine (PPA) withdrawn in USA, but continues to sell in India (Times of India, March, 05).
We have, obviously, to examine the basic ideas. The idea of patenting is based on the hypothesis that Science progresses more rapidly with greater monetary incentive. For hundreds of years peer appreciation has been incentive enough for some of the greatest inventions. Dishonesty in Science is a contemporary phenomenon, thanks to the big money generated by patents. This money is also a threat to the noble medical profession. Of all the patents those that make money from fighting disease and hunger seem the most immoral. Just look at the lack of interest among manufacturers for innovative work towards fighting diseases that affect people from whom they cannot hope to make much money from. Moreover, the trade does not wish to manufacture simple and inexpensive drugs like Dichloroacetate .
Indian Med. Assoc. Bull. of Sept. 14, 04 carried the story of a suit filed by David Franklin (an insider) against Pfizer on the charge of suppression of a 1998 study of results regarding the drug Gabapentin. It had shown that the drug did not work for the advertised Bipolar Disorder. This was sought to be done by lavishing perks on doctors, giving generous fees to thought leaders, using ghostwriters, and planting people to ask favourable questions. The study report had also mentioned that a 16 year old committed suicide while taking this drug. The company paid $ 240 million as criminal fine and another 152 million as fine to State & Federal Healthcare.
The Tribune of Chandigarh reported on Aug. 21, 05 that a Vioxx widow in USA received $ 253.4 million from Merck. It also mentioned that 4200 more cases were pending. The drug was taken by 20 million people before it was ordered to be withdrawn.
The New York Times of June 13, 07 reported that Eli Lilly paid $750 million to settle a lawsuit alleging that Zyprexa caused Diabetes.
The seemingly big fines are like a gambler's risk. The winnings being the astronomical profits the company hopes to go on making. The same NYT report also mentioned that the official financing for continuing medical education had gone up from $ 302 million in 1998 to 1.92 billion last year and that half of this came from the trade. The story contains examples of how courses are used for advertisement, and how expression of doubt about efficacy or safety results in discontinuation of the course. The issue of June 28 contains another facet. This is about Astra Zenca invited doctors to a weekend training session to learn to promote its drug Symbicort. The participants' expenses on car, plane and stay at Hyatt Regency, and also $ 2700 per head were paid by the company. The current estimate of advertising by US companies is $ 12 billion.
The San Diego Union Tribune July 5, reminded readers that The US Food & Drug Administration (FDA) had modified its regulation procedure 15 years back in the form of Drug Users Fee Act to speed up approval with payment of extra fee. In a way this amounts to bribing the Authority, because FDA hopes to collect $ 393 million next year, up 87 million over the current year, and more than half of these funds will be spent on staff salaries. The rest is for post-market surveillance. One example of the effect of this procedure (NYT, June 7&12,07) is the uncertainty regarding GlaxoSmithKline's Avandia. Its potential to cause heart disease continues to haunt countless millions including 7 million in USA. The drug has been around for 8 years even after Dr. John B. Buse, a famous medical researcher formally criticized it at a medical meeting. Dr. Buse recently informed a House hearing that he had received veiled threats from a high-ranking company executive. The report goes on to allege 'FDA having cozy relationship with the manufacturers'. The issue of June 13 contains far more disturbing reports about the side effects.
The report under reference also says that the law is now sought to be modified and made more 'company friendly’. It proposes to increase fees, hire more people and further lessen approval time. Already, from 1993 to 2003, the average approval time has gone down from 22 months to 14 months. The advantage touted being: the saving of processing time results in doing good that much sooner. My comment: this would also speed up possible hazardous consequences. David Carpenter, a government Professor at Harvard medical school found that drugs approved before deadlines were 3 to 5 times more likely to be taken off as those approved after. An example is the story of the antibiotic Ketek (Sanofi Aventis). It was withdrawn as hastily as approved after it caused liver failures (New England J. Med., April 19, 07)
The 15-year period in the above paragraph more or less coincides with globalization of Trade Related Intellectual Property Rights, whereby a patent granted in one country is valid in all WTO member states. The speedier approval leads to economic gains for the manufacturer as well as the country in which patented. This, in turn, pressurizes the national regulatory authority to join in the gamble. This is a danger to mankind. It would require a credible international regulatory mechanism. The experience with continuing Doha round deadlock over less critical trade matters shows that this is impossible in foreseeable future. As it is the withdrawal of a failed drug in one country does not lead to automatic withdrawal everywhere. I give two examples: co proxamol withdrawn in UK continues in India (Tribune Chandigarh Feb. 7, 05); Phenylpropalinine (PPA) withdrawn in USA, but continues to sell in India (Times of India, March, 05).
We have, obviously, to examine the basic ideas. The idea of patenting is based on the hypothesis that Science progresses more rapidly with greater monetary incentive. For hundreds of years peer appreciation has been incentive enough for some of the greatest inventions. Dishonesty in Science is a contemporary phenomenon, thanks to the big money generated by patents. This money is also a threat to the noble medical profession. Of all the patents those that make money from fighting disease and hunger seem the most immoral. Just look at the lack of interest among manufacturers for innovative work towards fighting diseases that affect people from whom they cannot hope to make much money from. Moreover, the trade does not wish to manufacture simple and inexpensive drugs like Dichloroacetate .
Patenting medicines should be discontinued forthwith.
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(The author is a retired Director, UGC Centre for Advanced Study in Mathematics, Punjab University, Chandigarh. He currently works for Azadi Bachao Andolan)
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(The author is a retired Director, UGC Centre for Advanced Study in Mathematics, Punjab University, Chandigarh. He currently works for Azadi Bachao Andolan)
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