Latest Drugwonks' Blog
In case you missed the news, SiCKO is now out on DVD – and it seems that New York Times columnist Paul Krugman made a beeline to Blockbuster.
Call it an early Hanukah present for a true believer.
His column, “Health Care Excuses,†replays the same tried and untrue arguments made in the Moore-ish cult classic. Here’s a link:
http://www.nytimes.com/2007/11/09/opinion/09krugman.html?ref=opinion
Looks like he read our November 5th blog, “Debunking Some Health Care Urban Myths" --
http://drugwonks.com/2007/11/debunking_some_health_care_urban_myths.html
-- where we take many of the more infamous Moore/Krugisms to task.
Well, at least he's reading -- if not learning.
(And we'll keep trying.)
Call it an early Hanukah present for a true believer.
His column, “Health Care Excuses,†replays the same tried and untrue arguments made in the Moore-ish cult classic. Here’s a link:
http://www.nytimes.com/2007/11/09/opinion/09krugman.html?ref=opinion
Looks like he read our November 5th blog, “Debunking Some Health Care Urban Myths" --
http://drugwonks.com/2007/11/debunking_some_health_care_urban_myths.html
-- where we take many of the more infamous Moore/Krugisms to task.
Well, at least he's reading -- if not learning.
(And we'll keep trying.)
ASCO/ASH, ACCC, EMEA and now the FDA all say the following with respect to ESA dosing
"The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL."
CMS stands alone -- along with insurers who jumped on board to save money -- as the only government agency to limit access based on safety.
Why does CMS think that ESAs are less safe at anything more than 10g/dL when everyone else thinks otherwise? Why does CMS think it can limit doctor discretion?
Here is the FDA label update.
http://www.fda.gov/cder/drug/infopage/RHE/default.htm
"The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL."
CMS stands alone -- along with insurers who jumped on board to save money -- as the only government agency to limit access based on safety.
Why does CMS think that ESAs are less safe at anything more than 10g/dL when everyone else thinks otherwise? Why does CMS think it can limit doctor discretion?
Here is the FDA label update.
http://www.fda.gov/cder/drug/infopage/RHE/default.htm
Peter and I are leaving for Israel today where will be participating in and co-sponsoring a three day program for Israeli biotech startups designed to help them improved their ability to become full fledged companies. Israel is home to some of the best translational science in the world and providing companies insights to the policy and regulatory environment in the US can help enhance value and improve efficiency. The conference is entitled Health Care Technological Innovation: From Idea to Commercialization. It's co-sponsored by the Israel Life Science Industry, The International Institute for Biotechnology Entrenpreneurship, Tel Aviv University's Recanti School of Business and CMPI.
It's Peter's first trip and as for me, I get to see my son who, as some of you know, is serving in the IDF.
Here's the conference agenda:
http://biomedmanagement.tau.ac.il/
We will blog from Israel!
It's Peter's first trip and as for me, I get to see my son who, as some of you know, is serving in the IDF.
Here's the conference agenda:
http://biomedmanagement.tau.ac.il/
We will blog from Israel!
Per the current shenanigans going in at the IGWG in Geneva, here's a breath of fresh air -- a thoughtful analysis on the actual state of affairs vis-Ã -vis drug development and patents. It's by Philip Stevens of the International Policy Network and appears in Investors Business Daily. It's a potent rebuttal of the various and sundry half-truths put forward by Jamie Love, the Pancho Villa of Patents, and his fellow travelers.
If R&D Ain't Broke, Why Break It?
BY PHILIP STEVENS
There is a long list of complaints against the current system of drug development:
• Patents and profits have failed to produce new medications for the diseases of poor countries.
• There are not enough groundbreaking new therapies.
• Profiteering companies routinely make tiny changes to drugs to extend patents and shut out competition.
• Not only that, the patent system allows companies to charge astronomical sums for the drugs they do produce.
These allegations come from a powerful group of ideological nongovernmental organizations, or NGOs, that abhor profit in medicine and are pushing the World Health Organization toward a global treaty that would completely change the way drugs are researched and developed.
But before taking their medicine, we should take a close look at the label — and the nasty side effects.
This Medical Research and Development Treaty, proposed by Brazil and Kenya, would have a central U.N. bureaucracy deciding what diseases to research while allocating funds, contracts and prizes accordingly. Its expert scientists would ensure that all diseases are given appropriate resources, including the handful of "unprofitable" tropical diseases in poor counties.
NGOs, including humanitarian groups such as Medecins Sans Frontieres, hope this scheme will solve the failings of the current system at a stroke.
Because intellectual property would be owned by governments, drug prices would plummet. Less would be spent on frivolous ailments such as erectile dysfunction and baldness, and more on malaria and HIV/AIDS. Resources could be concentrated on groundbreaking "blockbuster" drugs, instead of the small molecular changes that are routinely patented now.
When the WHO first mooted the treaty in May 2006, MSF called it a "breakthrough" that "would ensure that patients' needs rather than profits drove innovation."
If the aim is to punish Big Pharma's stockholders, it will probably work. But as a way of producing cheap innovative drugs for the poor, it fails on several counts.
First, giving such discretionary power to bureaucrats would politicize R&D. In a centrally directed system — as in Britain's health service — resources tend to go to the loudest pressure groups. Other diseases would be neglected in favor of politically high-profile diseases such as HIV/AIDS.
Neither is it clear how an unelected body in Geneva would be better at setting priorities than the thousands of scientists and businessmen whose livelihoods depend on getting these decisions right.
Second, using state-funded prizes as the major incentive for R&D is problematic. The prize committee can never know the true market value of the drug it is hoping to create. If the prize is too low, companies will be reluctant to compete for future prizes, leading to fewer new drugs. If the prize is too high, the new system will squander taxpayers' money and divert effort from other areas of research.
Prizes were much favored in the Soviet Union, but they never resulted in much innovation.
Third, the treaty would turn drug manufacturers into utilities, living off government contracts. Removing the freedom to decide what to sell and at what price will discourage companies from risking capital to reap rewards, which is how innovation happens.
This is a clear lesson from regulated utilities such as water, electricity, telephones and gas. In a minimal-profit sector, companies do the bare minimum to fulfill their contractual obligations.
Most fundamentally, the treaty does not solve the greatest health care problem in poorer countries: how to actually get the drugs to patients in the face of crumbling hospitals and chronic shortages of doctors and nurses.
In 2006, the director of the World Health Organization's HIV division, Kevin De Cock, said "it is very obvious that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems. You have health infrastructure that is dilapidated, and supply chains that don't exist."
If prices are an issue, why not scrap taxes and tariffs on medicines, which can increase the manufacturer's price by up to 11 times? These taxes on the sick are levied by many poor countries, including Kenya.
Removing commercial incentives will make companies retreat from the difficult and expensive work on cures for cancer and the like, and try to regain lost profits in politically safe "lifestyle" ailments. And governments have yet to demonstrate that they can produce drugs themselves.
All this is worrying for the U.S., which has already allowed the draft treaty to progress too far. There are echoes of the Clinton administration's hapless negotiation of the TRIPS agreement in 1994, which is now coming back to haunt America.
That agreement on Trade-Related Aspects of Intellectual Property Rights includes a clause designed to allow emergency production of essential medicines in poor countries. In practice, its wording is so vague that it allows any government to override the patent on any drug it likes. Middle-income Brazil and Thailand are now doing exactly that.
If the negotiators from the Department of Health and Human Services do not firmly reject the proposals at the WHO's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property in Geneva this week, there won't be any pharmaceutical patent rights worth the name. This will be a body blow to innovation.
The current patent-based R&D model has produced most of the drugs that exist. It has a few problems, but there is no point junking it for an ill-conceived NGO fantasy. The biggest losers will not be stockholders, but patients.
Well said, Philip.
If R&D Ain't Broke, Why Break It?
BY PHILIP STEVENS
There is a long list of complaints against the current system of drug development:
• Patents and profits have failed to produce new medications for the diseases of poor countries.
• There are not enough groundbreaking new therapies.
• Profiteering companies routinely make tiny changes to drugs to extend patents and shut out competition.
• Not only that, the patent system allows companies to charge astronomical sums for the drugs they do produce.
These allegations come from a powerful group of ideological nongovernmental organizations, or NGOs, that abhor profit in medicine and are pushing the World Health Organization toward a global treaty that would completely change the way drugs are researched and developed.
But before taking their medicine, we should take a close look at the label — and the nasty side effects.
This Medical Research and Development Treaty, proposed by Brazil and Kenya, would have a central U.N. bureaucracy deciding what diseases to research while allocating funds, contracts and prizes accordingly. Its expert scientists would ensure that all diseases are given appropriate resources, including the handful of "unprofitable" tropical diseases in poor counties.
NGOs, including humanitarian groups such as Medecins Sans Frontieres, hope this scheme will solve the failings of the current system at a stroke.
Because intellectual property would be owned by governments, drug prices would plummet. Less would be spent on frivolous ailments such as erectile dysfunction and baldness, and more on malaria and HIV/AIDS. Resources could be concentrated on groundbreaking "blockbuster" drugs, instead of the small molecular changes that are routinely patented now.
When the WHO first mooted the treaty in May 2006, MSF called it a "breakthrough" that "would ensure that patients' needs rather than profits drove innovation."
If the aim is to punish Big Pharma's stockholders, it will probably work. But as a way of producing cheap innovative drugs for the poor, it fails on several counts.
First, giving such discretionary power to bureaucrats would politicize R&D. In a centrally directed system — as in Britain's health service — resources tend to go to the loudest pressure groups. Other diseases would be neglected in favor of politically high-profile diseases such as HIV/AIDS.
Neither is it clear how an unelected body in Geneva would be better at setting priorities than the thousands of scientists and businessmen whose livelihoods depend on getting these decisions right.
Second, using state-funded prizes as the major incentive for R&D is problematic. The prize committee can never know the true market value of the drug it is hoping to create. If the prize is too low, companies will be reluctant to compete for future prizes, leading to fewer new drugs. If the prize is too high, the new system will squander taxpayers' money and divert effort from other areas of research.
Prizes were much favored in the Soviet Union, but they never resulted in much innovation.
Third, the treaty would turn drug manufacturers into utilities, living off government contracts. Removing the freedom to decide what to sell and at what price will discourage companies from risking capital to reap rewards, which is how innovation happens.
This is a clear lesson from regulated utilities such as water, electricity, telephones and gas. In a minimal-profit sector, companies do the bare minimum to fulfill their contractual obligations.
Most fundamentally, the treaty does not solve the greatest health care problem in poorer countries: how to actually get the drugs to patients in the face of crumbling hospitals and chronic shortages of doctors and nurses.
In 2006, the director of the World Health Organization's HIV division, Kevin De Cock, said "it is very obvious that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems. You have health infrastructure that is dilapidated, and supply chains that don't exist."
If prices are an issue, why not scrap taxes and tariffs on medicines, which can increase the manufacturer's price by up to 11 times? These taxes on the sick are levied by many poor countries, including Kenya.
Removing commercial incentives will make companies retreat from the difficult and expensive work on cures for cancer and the like, and try to regain lost profits in politically safe "lifestyle" ailments. And governments have yet to demonstrate that they can produce drugs themselves.
All this is worrying for the U.S., which has already allowed the draft treaty to progress too far. There are echoes of the Clinton administration's hapless negotiation of the TRIPS agreement in 1994, which is now coming back to haunt America.
That agreement on Trade-Related Aspects of Intellectual Property Rights includes a clause designed to allow emergency production of essential medicines in poor countries. In practice, its wording is so vague that it allows any government to override the patent on any drug it likes. Middle-income Brazil and Thailand are now doing exactly that.
If the negotiators from the Department of Health and Human Services do not firmly reject the proposals at the WHO's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property in Geneva this week, there won't be any pharmaceutical patent rights worth the name. This will be a body blow to innovation.
The current patent-based R&D model has produced most of the drugs that exist. It has a few problems, but there is no point junking it for an ill-conceived NGO fantasy. The biggest losers will not be stockholders, but patients.
Well said, Philip.
DrugWonks is proud to have been chosen by BioTech360 (a publication of The Scientist) as the #1 “must read†blog for those in the wonderful world of biotech.
According to Biotech360 blogger Yali Friedman, “As the forum for the Center for Medicine in the Public Interest, Drug Wonks covers policy affecting biotechnology. This blog also tracks and responds to Op-Eds and other news items, providing additional perspective on many important topics.â€
His top five list can be found at:
http://www.biotech360.com/biotechArticleDisplay.jsp?biotechArticleId=100039
Thanks Yali.
According to Biotech360 blogger Yali Friedman, “As the forum for the Center for Medicine in the Public Interest, Drug Wonks covers policy affecting biotechnology. This blog also tracks and responds to Op-Eds and other news items, providing additional perspective on many important topics.â€
His top five list can be found at:
http://www.biotech360.com/biotechArticleDisplay.jsp?biotechArticleId=100039
Thanks Yali.
Frank Lichtenberg published a study in Health Affairs demonstrating something that we already knew: a lot of the drug coverage of part D crowded out private drug coverage and increased utilization by about 12 percent. Much of the increase was in the area of generic drug spending. So much for the Big Pharma windfall. Part D was essentially what those of us who supported said it would be: a modernization of Medicare the goal of which would be to extend drug coverage to a program that did not have it and to milions of seniors who were poor and were receiving drug coverage through restrictive Medicaid formularies.
So what's the difference between supporting a Part D crowd out and not an SCHIP crowd out? Part D is a step towards privatizing Medicare -- full of choices and pasrt of an effort to get seniors to buy into private plans and everyone knows it. SCHIP is a step towards socializing healthcare and everyone knows it.
Lichtenberg points out also that Medicare Part D has the benefit of reducing Medicare spending overall. We need studies to demonstrate this happening at various income groups and disease states.
http://content.healthaffairs.org/cgi/content/abstract/26/6/1735
So what's the difference between supporting a Part D crowd out and not an SCHIP crowd out? Part D is a step towards privatizing Medicare -- full of choices and pasrt of an effort to get seniors to buy into private plans and everyone knows it. SCHIP is a step towards socializing healthcare and everyone knows it.
Lichtenberg points out also that Medicare Part D has the benefit of reducing Medicare spending overall. We need studies to demonstrate this happening at various income groups and disease states.
http://content.healthaffairs.org/cgi/content/abstract/26/6/1735
Those screams you heard came from "I hate Big Pharma" being hoisted on the drug safety petard of their own making as Momenta's hard to mimic version of Lovenox was being rejected by the FDA because of concerns that the company hadn't accounted for uncountrolled immune reactions to its version of the product. And of course that doesn't even begin to to address what sort of studies Momenta would have to undertake to deal with safety concerns, what risk mitigation system it would have to put in place, what post marketing surveillance it would have to conduct, what clinical trials data it would have to post, blah,blah blah.
FOBs will hit the market eventually. But it is great to see those who take drug companies to task about safety seek to rationalize rushing FOBs to market without similar consumer protections. And they care more about rushing FOBs to market than accelerating the review of new life saving medicines which Momemta is also working on. It's called I hate pharma hypocrisy.
FOBs will hit the market eventually. But it is great to see those who take drug companies to task about safety seek to rationalize rushing FOBs to market without similar consumer protections. And they care more about rushing FOBs to market than accelerating the review of new life saving medicines which Momemta is also working on. It's called I hate pharma hypocrisy.
Had a look at the Non-Prescription Drug Modernization yet? It was just introduced by Representative Henry Waxman (R, CA), Representative Tom Allen (D, ME), and Senator Ted Kennedy (D, MA.). It’s a well-meaning, but knee-jerk reaction in response to the recent FDA advisory committee vote over banning over-the-counter cough and cold medicines for children under six.
Here’s a link to the legislation:
http://oversight.house.gov/documents/20071106143446.pdf
Among other things, this bill would allow the FDA to ban marketing of the drugs while the rulemaking process was still under way.
That’s right – “ban†advertising.
We’ve already covered how we feel about the recent AdComm vote (see two October 19th posts, “Dosing for Dummies†and “Cough, Sniffle, Sneeze – No OTC Meds for Children, Pleaseâ€). Per this new legislation, we concur with our friend Adonis Hoffman over at the American Association of Advertising Agencies.
Here’s what Adonis has to say:
"We are all concerned about the cough and cold medications for children that have been in the news reports lately. Nobody benefits from false or misleading advertising of any kind, whether it is for over-the-counter or prescription medications."
He also, wisely, point out that there are already "ample and appropriate regulatory penalties in place to handle these problems. The authority of both the Federal Trade Commission and the Food and Drug Administration is intact. I'm not sure whether there is a need for new changes."
Hopefully this will be a robust debate over how good communications can improve the public health -- not another public flogging of the industry.
Just call us starry-eyed optimists.
Here’s a link to the legislation:
http://oversight.house.gov/documents/20071106143446.pdf
Among other things, this bill would allow the FDA to ban marketing of the drugs while the rulemaking process was still under way.
That’s right – “ban†advertising.
We’ve already covered how we feel about the recent AdComm vote (see two October 19th posts, “Dosing for Dummies†and “Cough, Sniffle, Sneeze – No OTC Meds for Children, Pleaseâ€). Per this new legislation, we concur with our friend Adonis Hoffman over at the American Association of Advertising Agencies.
Here’s what Adonis has to say:
"We are all concerned about the cough and cold medications for children that have been in the news reports lately. Nobody benefits from false or misleading advertising of any kind, whether it is for over-the-counter or prescription medications."
He also, wisely, point out that there are already "ample and appropriate regulatory penalties in place to handle these problems. The authority of both the Federal Trade Commission and the Food and Drug Administration is intact. I'm not sure whether there is a need for new changes."
Hopefully this will be a robust debate over how good communications can improve the public health -- not another public flogging of the industry.
Just call us starry-eyed optimists.
Lots of info coming in about drugs in development then and now showing the (Critical) path forward is towards retargeting, retooling, repositioning drugs to specific groups and for monitoring risks and benefits post market...
1. Research from the studies showing that while Lilly's Prasugrel proved better able to prevent heart attacks than Plavix, the drug led to excess life threatening bleeding compared to Plavix at a statistically significant level in patients with acute coronary syndrome. But Lilly, consistent with a commitment to pharmacogenomics and targeted therapeutics has identified subgroups that are most likely to have that risk. The PI of the study, Dr. Elliot Antman, said that most of the bleeding was driven by two groups -- patients with a history of stroke or transient ischemic attacks and elderly, frail patients (older than 75 weighing less than 60 kg) -- who comprised 20% of the total population.
"For the remaining 80% of the patients, which I would say represented eight of 10 patients undergoing stenting, the drug works very well," Dr. Antman said in an interview.
Moreover, among one high-risk group -- diabetics -- "there was no excess bleeding and a 30% reduction in MIs compared with clopidogrel."
Wall Street sniffs that the market will be minimal. But Plavix goes off patent in 2011 while Lilly's drug could get a Pgx label with improved safety and benefit profiles. How minimal is that?
http://www.medpagetoday.com/MeetingCoverage/AHAMeeting/tb/7217
2. The CETP trilogy. Efforts to raise good cholesterol is the holy grail of the cardiovascular world Pfizer's drug sent torcetrapib chills down the spine of others developing drugs based this target. But further analysis shows that increased blood pressure and changes in electrolytes (which caused the heart attacks in Pfizer's drug study) signal the potential activation of the renin-angiotensin-aldosterone system (RAAS) by torcetrapib. The greater RAAS activation may weaken the benefit of raising HDL."
Translation: if your drug (Merck and BMS) doesn't activate the RAAS pathway or you can develop a blood test that predict who won't or will have that effect you might be able to bring other HDL drugs to market.
http://www.drugresearcher.com/news/ng.asp?n=81155-pfizer-merck-bristol-myers-squib-bms-torcetrapib-cetp
It's biomarker based research at it's best. Good news for patients. Bad news for Merrill Goozner and others who want to claim biomarkers are just a tool for making drugs unsafe.
1. Research from the studies showing that while Lilly's Prasugrel proved better able to prevent heart attacks than Plavix, the drug led to excess life threatening bleeding compared to Plavix at a statistically significant level in patients with acute coronary syndrome. But Lilly, consistent with a commitment to pharmacogenomics and targeted therapeutics has identified subgroups that are most likely to have that risk. The PI of the study, Dr. Elliot Antman, said that most of the bleeding was driven by two groups -- patients with a history of stroke or transient ischemic attacks and elderly, frail patients (older than 75 weighing less than 60 kg) -- who comprised 20% of the total population.
"For the remaining 80% of the patients, which I would say represented eight of 10 patients undergoing stenting, the drug works very well," Dr. Antman said in an interview.
Moreover, among one high-risk group -- diabetics -- "there was no excess bleeding and a 30% reduction in MIs compared with clopidogrel."
Wall Street sniffs that the market will be minimal. But Plavix goes off patent in 2011 while Lilly's drug could get a Pgx label with improved safety and benefit profiles. How minimal is that?
http://www.medpagetoday.com/MeetingCoverage/AHAMeeting/tb/7217
2. The CETP trilogy. Efforts to raise good cholesterol is the holy grail of the cardiovascular world Pfizer's drug sent torcetrapib chills down the spine of others developing drugs based this target. But further analysis shows that increased blood pressure and changes in electrolytes (which caused the heart attacks in Pfizer's drug study) signal the potential activation of the renin-angiotensin-aldosterone system (RAAS) by torcetrapib. The greater RAAS activation may weaken the benefit of raising HDL."
Translation: if your drug (Merck and BMS) doesn't activate the RAAS pathway or you can develop a blood test that predict who won't or will have that effect you might be able to bring other HDL drugs to market.
http://www.drugresearcher.com/news/ng.asp?n=81155-pfizer-merck-bristol-myers-squib-bms-torcetrapib-cetp
It's biomarker based research at it's best. Good news for patients. Bad news for Merrill Goozner and others who want to claim biomarkers are just a tool for making drugs unsafe.
Maybe they should call it Médecins Avec Menteurs.
In an e-mail today from the folks over at Médecins Sans Frontières discuss this week's meeting in Geneva of the WHO's Intergovernmental Working Group for Public Health, Innovation, and Intellectual Property (IGWG).
Here's what MSF has to say about the current fight against "neglected" diseases:
"“The R&D system is broken. It is not delivering,†said Dr. Tido von Schoen-Angerer, Director of MSF’s Access to Essential Medicines Campaign."
And here's what the infamous Jamie Love said in an ensuing paragraph:
"We need new mechanisms and institutional responses to move toward a paradigm of innovation plus access, rather than a set of poorly functioning trade-offs. The big ideas in the negotiation are patent pools, prizes and a treaty on medical R&D. They are also the most
controversial."
What a terrific example of the "Big Lie."
Consider what Solomon Nwaka (leader of drug discovery activities at the Special Programme for Research and Training in Tropical Diseases at the WHO) wrote (along with other co-authors from Pfizer) on the subject of finding ways to battle tropical diseases:
"Scaling up drug-discovery capacity for neglected diseases means designing a mechanism that is attractive to all stakeholders — such as industry, academia, governments and international agencies — involved in drug discovery. Despite a lack of market incentive, about half of the research projects currently focusing on neglected diseases are conducted by pharmaceutical companies. Several large companies, most notably GlaxoSmithKline, Novartis, AstraZeneca and Eli Lilly, have founded research institutes dedicated to research into tropical diseases. Industry also makes a substantial contribution in kind to public–private product-development partnerships. Also, in recent years, funding from governments and philanthropic foundations has helped to establish new drug-discovery units for tropical diseases in developed and developing countries."
Here is a link to the complete article in Nature:
http://www.nature.com/nature/journal/v449/n7159/full/449166a.html
And let's not forget what Dr. Margaret Chan, WHO's Director-General had to say about why communicable diseases remain such a large problem in poor countries and are often neglected by research and development. One reason, she said, is that the pharmaceutical industry "has little incentive to develop drugs and vaccines for markets that cannot pay."
Indeedn if a company stands no chance of recouping even a portion of that investment, where is its incentive to tackle the many diseases that ravage the developing world?
And yet, according to MSF, "intellectual property is not a significant factor in contributing to innovation for diseases that disproportionately affect developing countries."
Thomas Carlyle said, "Our main business is not to see what lies dimly at a distance but to do what lies clearly at hand." Mr. Love and his friends at Médecins Sans Frontières are trying to sell a "vision" that, conveniently, blames the West for the problems of the developing world while what "lies clearly at hand" is almost exactly the opposite -- that the rule of law that has allowed for the development of the modern pharmaceutical industry via protection of interllectual property is what lights the road to victory over the scourge of neglected diseases.
In an e-mail today from the folks over at Médecins Sans Frontières discuss this week's meeting in Geneva of the WHO's Intergovernmental Working Group for Public Health, Innovation, and Intellectual Property (IGWG).
Here's what MSF has to say about the current fight against "neglected" diseases:
"“The R&D system is broken. It is not delivering,†said Dr. Tido von Schoen-Angerer, Director of MSF’s Access to Essential Medicines Campaign."
And here's what the infamous Jamie Love said in an ensuing paragraph:
"We need new mechanisms and institutional responses to move toward a paradigm of innovation plus access, rather than a set of poorly functioning trade-offs. The big ideas in the negotiation are patent pools, prizes and a treaty on medical R&D. They are also the most
controversial."
What a terrific example of the "Big Lie."
Consider what Solomon Nwaka (leader of drug discovery activities at the Special Programme for Research and Training in Tropical Diseases at the WHO) wrote (along with other co-authors from Pfizer) on the subject of finding ways to battle tropical diseases:
"Scaling up drug-discovery capacity for neglected diseases means designing a mechanism that is attractive to all stakeholders — such as industry, academia, governments and international agencies — involved in drug discovery. Despite a lack of market incentive, about half of the research projects currently focusing on neglected diseases are conducted by pharmaceutical companies. Several large companies, most notably GlaxoSmithKline, Novartis, AstraZeneca and Eli Lilly, have founded research institutes dedicated to research into tropical diseases. Industry also makes a substantial contribution in kind to public–private product-development partnerships. Also, in recent years, funding from governments and philanthropic foundations has helped to establish new drug-discovery units for tropical diseases in developed and developing countries."
Here is a link to the complete article in Nature:
http://www.nature.com/nature/journal/v449/n7159/full/449166a.html
And let's not forget what Dr. Margaret Chan, WHO's Director-General had to say about why communicable diseases remain such a large problem in poor countries and are often neglected by research and development. One reason, she said, is that the pharmaceutical industry "has little incentive to develop drugs and vaccines for markets that cannot pay."
Indeedn if a company stands no chance of recouping even a portion of that investment, where is its incentive to tackle the many diseases that ravage the developing world?
And yet, according to MSF, "intellectual property is not a significant factor in contributing to innovation for diseases that disproportionately affect developing countries."
Thomas Carlyle said, "Our main business is not to see what lies dimly at a distance but to do what lies clearly at hand." Mr. Love and his friends at Médecins Sans Frontières are trying to sell a "vision" that, conveniently, blames the West for the problems of the developing world while what "lies clearly at hand" is almost exactly the opposite -- that the rule of law that has allowed for the development of the modern pharmaceutical industry via protection of interllectual property is what lights the road to victory over the scourge of neglected diseases.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
