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As the Intergovernmental Working Group (IGWG) of the WHO prepares to meet and discuss how to best facilitate the expropriation of intellectual property rights (in this case the IPR of pharmaceutical patents) it's important to consider the unintended consequences -- the death of medical innovation.
The global purloiners of patents -- led by Jamie Love -- are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals -- but are far less keen to explain how the fruit tree got there in the first place -- or how they are nurtured. In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all. In other words, the elimination of patent rights doesn’t produce greater access to medicines. There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive.
Intellectual property rights are the fertile soil that allowed the tree to grow in the first place -- and to thrive. To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation. Jamie Love and Company may very well say, "A world without patents, amen." And they're right, because minus pharmaceutical IPR we'd all better start saying our prayers -- because that's the only way we're going to battle disease and improve the health of our global fraternity. If the IGWG succeeds, pharmaceutical innovation dies. And that's a Silent Spring we cannot afford.
The global purloiners of patents -- led by Jamie Love -- are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals -- but are far less keen to explain how the fruit tree got there in the first place -- or how they are nurtured. In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all. In other words, the elimination of patent rights doesn’t produce greater access to medicines. There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive.
Intellectual property rights are the fertile soil that allowed the tree to grow in the first place -- and to thrive. To borrow an over-used adjective from the world of global climate change -- we must protect "sustainable" innovation. Jamie Love and Company may very well say, "A world without patents, amen." And they're right, because minus pharmaceutical IPR we'd all better start saying our prayers -- because that's the only way we're going to battle disease and improve the health of our global fraternity. If the IGWG succeeds, pharmaceutical innovation dies. And that's a Silent Spring we cannot afford.
Some people will do anything to shove price controlled drugs from parts unknown down the the throats of unsuspecting Americans...that includes the editors at the San Jose Mercury News (there goes my chances for an oped placement)
From that august body:
"The Food and Drug Administration should be embarrassed by its lack of attention to the ingredients in prescription drugs.
The latest evidence is the 19 deaths and hundreds of allergic reactions reported by Americans using a bad batch of the drug thinner heparin. Some ingredients were contaminated, and the FDA admitted violating its own rules by not inspecting the Chinese factory where they were made.
This at the same time the FDA stubbornly refuses to allow cheaper prescription drugs to be imported. What hypocrisy."
http://www.hollandsentinel.com/stories/040808/opinion_20080408035.shtml
Some truth is in order by way of Andy von Eschenbach, FDA Commish:
"Our records at FDA indicated that we had inspected that facility in China, but that was incorrect. The inspection records we reviewed were on a facility with a very similar name. But having done the inspection in 2004 probably wouldn’t have prevented this problem, because this chemical contaminant cannot be detected using the standard testing methods for heparin. We have now developed new test methods to screen heparin for this new contaminant and regulators around the world are using those tests to protect their citizens. "
http://www.fda.gov/oc/vonEschenbach/andys_take/lifecycle.html
So much for the canard that the FDA "lied". What do you call a paper that calls someone else a liar when it knows that the very statement is not factual?
Now as to "hypocrisy", why would the FDA allow the importation of drugs from companies that are not producing for the US market when it's first priority is to improve the monitoring of the supply and production chain of products that are approved for US sale and distribution? Why indeed given the fact that counterfeit products are a growing problem worldwide and given the fact that importation will, according to the Congressional Budget Office and the Commerce Department hardly make a dent in health care spending?
Because some people can't understand that there are benefits to having a free and global market for medicines and that such conditions are not inconsistent with a bi-partisan effort to improve the FDA's ability to track and trace the production of such goods.
Now that's hypocrisy for you.
From that august body:
"The Food and Drug Administration should be embarrassed by its lack of attention to the ingredients in prescription drugs.
The latest evidence is the 19 deaths and hundreds of allergic reactions reported by Americans using a bad batch of the drug thinner heparin. Some ingredients were contaminated, and the FDA admitted violating its own rules by not inspecting the Chinese factory where they were made.
This at the same time the FDA stubbornly refuses to allow cheaper prescription drugs to be imported. What hypocrisy."
http://www.hollandsentinel.com/stories/040808/opinion_20080408035.shtml
Some truth is in order by way of Andy von Eschenbach, FDA Commish:
"Our records at FDA indicated that we had inspected that facility in China, but that was incorrect. The inspection records we reviewed were on a facility with a very similar name. But having done the inspection in 2004 probably wouldn’t have prevented this problem, because this chemical contaminant cannot be detected using the standard testing methods for heparin. We have now developed new test methods to screen heparin for this new contaminant and regulators around the world are using those tests to protect their citizens. "
http://www.fda.gov/oc/vonEschenbach/andys_take/lifecycle.html
So much for the canard that the FDA "lied". What do you call a paper that calls someone else a liar when it knows that the very statement is not factual?
Now as to "hypocrisy", why would the FDA allow the importation of drugs from companies that are not producing for the US market when it's first priority is to improve the monitoring of the supply and production chain of products that are approved for US sale and distribution? Why indeed given the fact that counterfeit products are a growing problem worldwide and given the fact that importation will, according to the Congressional Budget Office and the Commerce Department hardly make a dent in health care spending?
Because some people can't understand that there are benefits to having a free and global market for medicines and that such conditions are not inconsistent with a bi-partisan effort to improve the FDA's ability to track and trace the production of such goods.
Now that's hypocrisy for you.
According to Congressional Quarterly, Chairman Dingell is aggressively pursuing efforts to require the FDA to take a much more aggressive role in monitoring food and drug production and safety abroad, with stiff penalties for companies that import tainted products. The article says: “Dingell’s plan would also crack down on companies that violate drug import regulations. Manufacturers and importers could be fined as much as $500,000 for bringing contaminated or adulterated food or drugs into the country, and individuals could be subject to fines as high as $100,000 for similar offenses.â€
You may ask, How is that statement compatible with legislators’ calls for liberalized prescription drug importation? Good question.
Hopefully Mr. Dingell will point this out when his colleagues raise the subject.
You may ask, How is that statement compatible with legislators’ calls for liberalized prescription drug importation? Good question.
Hopefully Mr. Dingell will point this out when his colleagues raise the subject.
Is Leonard Saltz of Sloan Memorial more interested in attacking drug companies or caring for patients...Rather than pushing insurance companies to cover new cancer drugs, Saltz has devoted time decrying the price of new medications. And now he has taken his ideologically driven campaign to a new low, scaring patients into choosing a treatment based on price. In doing so, Saltz provides an example that even someone with no background in oncology should find shocking and a signal to stay away from Saltz as a treating physician: (From the Pharmamarket Newsletter)
"One example given was for metastatic colon cancer, where the price differential is $60,000 for a treatment course, depending on which of two drugs a patient is prescribed. According to Leonard Saltz of the Memorial Sloan-Kettering Cancer Center, the cheaper generic drug, irinotecan (previously marketed as Campto/Camptosar), causes hair loss. However, he adds that the more expensive agent, Sanofi-Aventis' Eloxatin (oxaliplatin), can cause nerve damage to hands or feet. Depending on one's professional occupation one or the other drug might be easier to accommodate. However, in cases where a patient is concerned about using up savings that might otherwise be left to dependents, the ASCO guidelines are intended to allow for an informed choice with the assistance of a specialist.
Dr Saltz argues that the logical result of such a change in approach must be to have more price transparency, at least so that specialists are able to provide patients with the necessary data."
Where to begin? How about that the two drugs are used in combination in many cases. Or that pharmacogenetics suggests one drug is better than the other. Or clinical trials suggesting longer survival with Eloxatin? Does Lenny Saltz suggest making that information transparent.
Or how about making this information transparent instead of scaring people about prices:
"Since 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual drugmakers has approached the problem by matching nearly five million patients with free drugs in cases where there is an inability to pay (Marketletters passim). "
I will talk Saltz seriously when he speaks out strongly against huge cancer drug co-pays, particularly when genetic tests indicate a drug works....Until then, I would avoid him, both as a source of policy advice and cancer care.
"One example given was for metastatic colon cancer, where the price differential is $60,000 for a treatment course, depending on which of two drugs a patient is prescribed. According to Leonard Saltz of the Memorial Sloan-Kettering Cancer Center, the cheaper generic drug, irinotecan (previously marketed as Campto/Camptosar), causes hair loss. However, he adds that the more expensive agent, Sanofi-Aventis' Eloxatin (oxaliplatin), can cause nerve damage to hands or feet. Depending on one's professional occupation one or the other drug might be easier to accommodate. However, in cases where a patient is concerned about using up savings that might otherwise be left to dependents, the ASCO guidelines are intended to allow for an informed choice with the assistance of a specialist.
Dr Saltz argues that the logical result of such a change in approach must be to have more price transparency, at least so that specialists are able to provide patients with the necessary data."
Where to begin? How about that the two drugs are used in combination in many cases. Or that pharmacogenetics suggests one drug is better than the other. Or clinical trials suggesting longer survival with Eloxatin? Does Lenny Saltz suggest making that information transparent.
Or how about making this information transparent instead of scaring people about prices:
"Since 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual drugmakers has approached the problem by matching nearly five million patients with free drugs in cases where there is an inability to pay (Marketletters passim). "
I will talk Saltz seriously when he speaks out strongly against huge cancer drug co-pays, particularly when genetic tests indicate a drug works....Until then, I would avoid him, both as a source of policy advice and cancer care.
I have great respect for the work of John Wennberg and Elliot Fisher at Dartmouth. Their work has underscored that some clinical practices which are entrenched by tradition or local relationships between doctors and hospitals are not the most effective compared to others. But there is a bit of hubris creeping into their more recent analyses which presume that if we standardized care to cheapest providers of care to those who die within 2 years of a subjectively determined time we could save 20 percent of Medicare spending.
First, as a patient I would like to know which care is associated with not dying within the two year time frame. And as a methodological issue, the failure to compare cost of patients receiving the same care for the same disease without adjusting for severity of illness is a big one. Accordingly, recommending ways to reduce overuse of acute hospital care without knowing what works to improve outcomes -- not always a cut and dried answer -- is probably beyond the data delivered by the Dartmouth group.
http://www.dartmouthatlas.org/
Second, Wennberg and Fisher have also looked at gaps in providing effective care that contributes to longer life. If those gaps were filled it would cost more money. And if people lived longer they would ultimately wind up with a disease that could be expensive to treat. More people receiving better care, more preventive screenings, etc. all adds up. They should be more persistent in coupling that message with their other "magic bullet" solutions.
Finally, to claim that more choices lead to higher costs as an article in the WSJ suggested perhaps mistates what the Dartmouth group concludes. The Dartmouth Atlas suggests that regional variations in utilization have nothing to do with better outcomes. But in fact not even the Dartmouth folks presume to tell everyone what sets of practices would work in all situations. Genomic and clinical insights suggest that tailoring treatments and prevention to individual variations improves outcomes. So how could choice be bad?
http://online.wsj.com/article/SB120752201349093441.html
First, as a patient I would like to know which care is associated with not dying within the two year time frame. And as a methodological issue, the failure to compare cost of patients receiving the same care for the same disease without adjusting for severity of illness is a big one. Accordingly, recommending ways to reduce overuse of acute hospital care without knowing what works to improve outcomes -- not always a cut and dried answer -- is probably beyond the data delivered by the Dartmouth group.
http://www.dartmouthatlas.org/
Second, Wennberg and Fisher have also looked at gaps in providing effective care that contributes to longer life. If those gaps were filled it would cost more money. And if people lived longer they would ultimately wind up with a disease that could be expensive to treat. More people receiving better care, more preventive screenings, etc. all adds up. They should be more persistent in coupling that message with their other "magic bullet" solutions.
Finally, to claim that more choices lead to higher costs as an article in the WSJ suggested perhaps mistates what the Dartmouth group concludes. The Dartmouth Atlas suggests that regional variations in utilization have nothing to do with better outcomes. But in fact not even the Dartmouth folks presume to tell everyone what sets of practices would work in all situations. Genomic and clinical insights suggest that tailoring treatments and prevention to individual variations improves outcomes. So how could choice be bad?
http://online.wsj.com/article/SB120752201349093441.html
I don’t know about you, but I get about 30+ e-mails a day from Jamie Love and his buddies telling me all about the public health benefits of compulsory licensing. If you buy the bunk, then you probably believe in the Easter Bunny. (Apologies to those of you who believe in the Easter Bunny.)
Nowhere has the Love-Line rhetoric been more omnipresent than at the recent session of the WHO’s Intergovernmental Governmental Working Group (IGWG).
Not that it was an even-playing field. The IGWG discussions were completely void of innovators -- with pharmaceutical researchers relegated to the sidelines. In their place were activists who are unwilling (and seemingly unable) to engage in any discussion that does not begin and end with removing systems of intellectual property (IP) protection for innovative medicines.
As with many of their ilk, these activists believe in freedom of speech – as long as what you say supports their position. Otherwise you’re a capitalist tool. Their grasp on the truth is questionable and, to their minds, the end justifies the means.
So it comes as no small relief that a comprehensive new study debunks the myth that TRIPS-related pharmaceutical patent protection is somehow contrary to enhancing the health of the developing world. The opposite is true – and truth speaks louder (if not more frequently) than rhetoric.
“Investments in Pharmaceuticals Before and After TRIPS: Property Rights and New Drug Development†(Authors: Margaret Kyle, assistant professor, London Business School and Anita M. McGahan, Professor, Rotman School of Management, University of Toronto) examines the impact of TRIPS on investments in pharmaceutical R&D – with important and significant implications to the ongoing discussions at IGWG, regarding the benefits IP brings to the effort to enhance health in developing and less-developed countries.
Some extracts:
“TRIPS was central in the development of foundational pharmaceutical capabilities in least-developed and developing countries.â€
“TRIPS had a strong, consistent, and major impact on general and corporate investment at every phase of research on global disease.â€
But all is not rosy:
“There appears to be a gap that prevents the immediate efficacy of TRIPS in promoting the introduction of new drugs on poverty diseases.â€
They continue: “On the other hand, TRIPS has encouraged research on disease that are present but not dominant in least-developed and developed countries, such as cardiovascular diseases and cancers.â€
And they conclude by saying, “This research suggests an opportunity to implement policies that are complementary to TRIPS for filling this gap to promote research on poverty diseases immediately.â€
So let's move forward. Let's work together. Let's leave the rhetoric aside.
(And sorry about the Easter Bunny.)
Nowhere has the Love-Line rhetoric been more omnipresent than at the recent session of the WHO’s Intergovernmental Governmental Working Group (IGWG).
Not that it was an even-playing field. The IGWG discussions were completely void of innovators -- with pharmaceutical researchers relegated to the sidelines. In their place were activists who are unwilling (and seemingly unable) to engage in any discussion that does not begin and end with removing systems of intellectual property (IP) protection for innovative medicines.
As with many of their ilk, these activists believe in freedom of speech – as long as what you say supports their position. Otherwise you’re a capitalist tool. Their grasp on the truth is questionable and, to their minds, the end justifies the means.
So it comes as no small relief that a comprehensive new study debunks the myth that TRIPS-related pharmaceutical patent protection is somehow contrary to enhancing the health of the developing world. The opposite is true – and truth speaks louder (if not more frequently) than rhetoric.
“Investments in Pharmaceuticals Before and After TRIPS: Property Rights and New Drug Development†(Authors: Margaret Kyle, assistant professor, London Business School and Anita M. McGahan, Professor, Rotman School of Management, University of Toronto) examines the impact of TRIPS on investments in pharmaceutical R&D – with important and significant implications to the ongoing discussions at IGWG, regarding the benefits IP brings to the effort to enhance health in developing and less-developed countries.
Some extracts:
“TRIPS was central in the development of foundational pharmaceutical capabilities in least-developed and developing countries.â€
“TRIPS had a strong, consistent, and major impact on general and corporate investment at every phase of research on global disease.â€
But all is not rosy:
“There appears to be a gap that prevents the immediate efficacy of TRIPS in promoting the introduction of new drugs on poverty diseases.â€
They continue: “On the other hand, TRIPS has encouraged research on disease that are present but not dominant in least-developed and developed countries, such as cardiovascular diseases and cancers.â€
And they conclude by saying, “This research suggests an opportunity to implement policies that are complementary to TRIPS for filling this gap to promote research on poverty diseases immediately.â€
So let's move forward. Let's work together. Let's leave the rhetoric aside.
(And sorry about the Easter Bunny.)
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.
