Not Your Mother's Common Cold
In an ideal world, big business would have a heart, and bottom lines and profit margins would play backseat to the overall good of community and fellow man. A reality check convinces us of the entirely opposite, and nowhere is this more true than in the for-profit pharmaceutical industry, where marketing of popular cholesterol-lowering, antidepressant, heartburn, or erectile dysfunction medications can net thousands of dollars per year of treatment. So, it’s no wonder that tropical diseases in poor nations of the world are unarmed Davids on a field of pharmaceutical Goliaths. Infectious diseases like tuberculosis, malaria, trypanosomiasis, leishmaniosis, and schistosomiasis, which are as bad as they sound, are of little or no priority on a pharmaceutical company’s agenda, as any gains made in the expensive research and development arena to come up with new and efficacious medications to combat them, cannot be offset by sales receipts from the resource-poor, healthcare-deprived, developing nations that stand to benefit most from the new drugs. Therefore, it comes as no surprise that of the 1,393 new pharmaceuticals developed between 1975 and 1999, only 16 specifically targeted diseases endemic to tropical and/or underdeveloped areas.
The problem is clear. Now, what has the U.S., as moral champion and outspoken political leader of the free world, done to lead by example, in this area of grave international calamity, that risks even greater repercussions for peaceful and warlike nations alike, due to the looming threat of bioterrorism? The Food and Drug Administration (FDA) took the lead in September 2008, by implementing its Amendments Act of 2007, which called for the issuing of “vouchers,” to accelerate FDA regulatory review of new, prospectively lucrative drugs, to those pharmaceutical companies also willing to develop new drugs targeting tropical and/or infectious diseases, on a “1-for-1,” “tit-for-tat” basis. A policy of that nature is in keeping with current social, economic, political, and public health trends to rely on financial incentives to achieve socially desirable outcomes. A policy of that nature, while developed with the best of intentions on the part of the FDA, neither guarantees that pharmaceutical companies will, indeed, implement research and development on drugs destined for geographically isolated and impoverished nations, nor lacks the “teeth” necessary to force distribution of those drugs once they have been developed.
Critics of review vouchers abound, and their arguments against the employment of such incentives run the gamut from uncertainty that a drug company will have a potentially profitable medication in its research and development pipeline to make a voucher worthwhile to the fact that traditionally it has been small drug companies that develop and distribute medications for neglected diseases, and it is precisely those small companies that usually do not develop “blockbuster” drugs that make the voucher system lucrative and attractive. Furthermore, were the latter to be the case, collusion between large and small pharmaceutical companies might lead to “deals” of dubious transparency, with vouchers and voucher rights being sold (which is legal) to the highest bidder, and patent and intellectual property rights dictating restraint in sales of needed pharmaceuticals to nations ill-equipped financially to afford them. “Cash and carry” is the name of the game, and countries financially “strapped” would be left to fend for themselves, and face possible epidemics of infectious disease with underdeveloped health care systems lacking the latest pharmaceutical formulations in those regards. Were that not enough, speedy FDA review, via vouchers, of new drugs might just be bad policy, leading to poor decision-making, consideration of drugs with very little or no clinical urgency or practicality, and inadequate consideration, testing, and clinical trials in order to rush to market. We might, in effect, be opening a veritable Pandora’s Box of not only disease, but also of its treatment.
To guard against this, and to place critical pharmaceuticals in the hands, minds, and bodies of those who most need them, a revamping or perhaps a complete revision of the voucher system from the ground up might be necessary. One proposal has been to set up independent health funds, financed by wealthier nations and overseen by international public health groups, to compensate drug companies for development of medications against ills far greater than “your mother’s common cold” in poorer nations, and then continue to reward those companies for appropriate implementation of successful treatment programs. Another idea might be for governments to work with nonprofit organizations to first develop new drugs, and then license them to pharmaceutical companies for production, distribution, and eventual earnings.
While convinced that patents and intellectual property are the “stuff” of capitalism, we must also admit that such models are neither sound nor efficacious when the lives of the poor and destitute hang in the balance. A voucher system, conceived of with the best of intentions, nonetheless places a price on that, namely human life, which we have been taught has none. Perhaps it is the job of public health to open eyes and close pocketbooks.
© 2008, Albert M. Balesh, M.D. All rights reserved.
The problem is clear. Now, what has the U.S., as moral champion and outspoken political leader of the free world, done to lead by example, in this area of grave international calamity, that risks even greater repercussions for peaceful and warlike nations alike, due to the looming threat of bioterrorism? The Food and Drug Administration (FDA) took the lead in September 2008, by implementing its Amendments Act of 2007, which called for the issuing of “vouchers,” to accelerate FDA regulatory review of new, prospectively lucrative drugs, to those pharmaceutical companies also willing to develop new drugs targeting tropical and/or infectious diseases, on a “1-for-1,” “tit-for-tat” basis. A policy of that nature is in keeping with current social, economic, political, and public health trends to rely on financial incentives to achieve socially desirable outcomes. A policy of that nature, while developed with the best of intentions on the part of the FDA, neither guarantees that pharmaceutical companies will, indeed, implement research and development on drugs destined for geographically isolated and impoverished nations, nor lacks the “teeth” necessary to force distribution of those drugs once they have been developed.
Critics of review vouchers abound, and their arguments against the employment of such incentives run the gamut from uncertainty that a drug company will have a potentially profitable medication in its research and development pipeline to make a voucher worthwhile to the fact that traditionally it has been small drug companies that develop and distribute medications for neglected diseases, and it is precisely those small companies that usually do not develop “blockbuster” drugs that make the voucher system lucrative and attractive. Furthermore, were the latter to be the case, collusion between large and small pharmaceutical companies might lead to “deals” of dubious transparency, with vouchers and voucher rights being sold (which is legal) to the highest bidder, and patent and intellectual property rights dictating restraint in sales of needed pharmaceuticals to nations ill-equipped financially to afford them. “Cash and carry” is the name of the game, and countries financially “strapped” would be left to fend for themselves, and face possible epidemics of infectious disease with underdeveloped health care systems lacking the latest pharmaceutical formulations in those regards. Were that not enough, speedy FDA review, via vouchers, of new drugs might just be bad policy, leading to poor decision-making, consideration of drugs with very little or no clinical urgency or practicality, and inadequate consideration, testing, and clinical trials in order to rush to market. We might, in effect, be opening a veritable Pandora’s Box of not only disease, but also of its treatment.
To guard against this, and to place critical pharmaceuticals in the hands, minds, and bodies of those who most need them, a revamping or perhaps a complete revision of the voucher system from the ground up might be necessary. One proposal has been to set up independent health funds, financed by wealthier nations and overseen by international public health groups, to compensate drug companies for development of medications against ills far greater than “your mother’s common cold” in poorer nations, and then continue to reward those companies for appropriate implementation of successful treatment programs. Another idea might be for governments to work with nonprofit organizations to first develop new drugs, and then license them to pharmaceutical companies for production, distribution, and eventual earnings.
While convinced that patents and intellectual property are the “stuff” of capitalism, we must also admit that such models are neither sound nor efficacious when the lives of the poor and destitute hang in the balance. A voucher system, conceived of with the best of intentions, nonetheless places a price on that, namely human life, which we have been taught has none. Perhaps it is the job of public health to open eyes and close pocketbooks.
© 2008, Albert M. Balesh, M.D. All rights reserved.
posted by Dr. Al at
11/11/2008 10:06:00 AM
1 Comments:
A big jump from here to March. Was everything okay doctor? This was my last e-mail from you. Sorry if I didn't follow up to now but I been busy with my research over the Atlantic. Hope everything is going well for you doctor in old El Paso and hope to see you in a near future. Take care doctor!
P.S.: Is your old pal, that probably you forgot, Adrian from your Italian class and now doing my PhD in Physics in Washington, DC.
By
Unknown, at Wednesday, October 14, 2009 4:00:00 PM
Post a Comment
<< Home