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The Kingdom of Norway, one of the world's richest nations (due to oil, not salmon) is rewarding bad behavior. Hans Christian Anderson isn't smiling and neither are many of that nation's best trading partners.
In direct contradiction of the spirit of the TRIPS agreement, the government of King Harald V is apparently unwilling to protect pharmaceutical patents. Now it's one thing when the military junta in Thailand decides to demonstrate jack-boot behavior towards intellectual property rights – it’s quite another when it comes from one of the world's wealthiest countries.
The problem arises from Norway's dual system of patent coverage for pharmaceuticals. Prior to January 1, 1992, Norway granted analogous "process" patent protection that applied only to the manufacturing process for a drug's active ingredient. Though Norway began granting full "product" patents for pharmaceuticals after that date, the great majority of drugs sold in Norway today are still covered by weaker process patents.
Analogous process patents provide much weaker protection than product patents, making branded pharmaceuticals vulnerable to generic "copycat" competition. Generic manufacturers have claimed that they have found alternative methods to produce certain branded products that do not infringe the process patent and are attempting to introduce the copycat drugs into the Norwegian market.
The United States and most European nations provide full product patent protections for pharmaceuticals. European countries where this difficulty once existed have taken remedial measures. Finland, for example, recently took action to rectify an identical weakness in its patent laws respecting pharmaceuticals.
Norway wants the full benefit of international pharmaceutical innovation, but is unwilling to contribute its fair share to global costs of biomedical innovation. This is free-riding of the worst order. And what's worse is that the Kingdom's Jamie Love-like behavior punishes many of its best trading partners (those nations home to innovator pharmaceutical companies) while rewarding countries willing to provide anti-TRIPS drugs (such as India and China).
It's not a complicated proposition. Under TRIPS Article 27, Norway has an obligation to provide protection to “any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.â€
And Norway has an obligation under TRIPS Article 70.2 to grant enhanced rights to existing subject matter that either is already protected in Norway or which meets the criteria for protection under the provisions of TRIPS. The pharmaceutical products under debate existed and were patentable subject matter on the date that TRIPS first applied in Norway. So, once again, Norway has an obligation to provide patent protection.
Does the government of Norway think that just because they are a major oil producer they can disregard their international agreements in the same fashion the Thai junta treats its international agreements? It's shameful that a First World economy should embrace a Third World philosophy of blatant disregard for intellectual property.
In Norway, if it's war against the patent rights of innovator pharmaceutical firms today, who's next?
In direct contradiction of the spirit of the TRIPS agreement, the government of King Harald V is apparently unwilling to protect pharmaceutical patents. Now it's one thing when the military junta in Thailand decides to demonstrate jack-boot behavior towards intellectual property rights – it’s quite another when it comes from one of the world's wealthiest countries.
The problem arises from Norway's dual system of patent coverage for pharmaceuticals. Prior to January 1, 1992, Norway granted analogous "process" patent protection that applied only to the manufacturing process for a drug's active ingredient. Though Norway began granting full "product" patents for pharmaceuticals after that date, the great majority of drugs sold in Norway today are still covered by weaker process patents.
Analogous process patents provide much weaker protection than product patents, making branded pharmaceuticals vulnerable to generic "copycat" competition. Generic manufacturers have claimed that they have found alternative methods to produce certain branded products that do not infringe the process patent and are attempting to introduce the copycat drugs into the Norwegian market.
The United States and most European nations provide full product patent protections for pharmaceuticals. European countries where this difficulty once existed have taken remedial measures. Finland, for example, recently took action to rectify an identical weakness in its patent laws respecting pharmaceuticals.
Norway wants the full benefit of international pharmaceutical innovation, but is unwilling to contribute its fair share to global costs of biomedical innovation. This is free-riding of the worst order. And what's worse is that the Kingdom's Jamie Love-like behavior punishes many of its best trading partners (those nations home to innovator pharmaceutical companies) while rewarding countries willing to provide anti-TRIPS drugs (such as India and China).
It's not a complicated proposition. Under TRIPS Article 27, Norway has an obligation to provide protection to “any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.â€
And Norway has an obligation under TRIPS Article 70.2 to grant enhanced rights to existing subject matter that either is already protected in Norway or which meets the criteria for protection under the provisions of TRIPS. The pharmaceutical products under debate existed and were patentable subject matter on the date that TRIPS first applied in Norway. So, once again, Norway has an obligation to provide patent protection.
Does the government of Norway think that just because they are a major oil producer they can disregard their international agreements in the same fashion the Thai junta treats its international agreements? It's shameful that a First World economy should embrace a Third World philosophy of blatant disregard for intellectual property.
In Norway, if it's war against the patent rights of innovator pharmaceutical firms today, who's next?
Bart Stupak had his little show trial on drug safety yesterday with his sidecar of disgruntled FDA numbers crunchers who see an industry-agency conspiracy behind every adverse event. That includes the increasingly insufferable and self-righteous David Graham who, according to USA Today, "more than two years after (telling) a Senate panel that the Food and Drug Administration was "incapable of protecting America against another Vioxx," the FDA scientist was back on Capitol Hill on Tuesday to tell a House panel that "nothing has really changed." Graham made it sound as if he is the sole repository of truth on whether a drug is safe and indeed claimed that the entire class
Actually, Graham has gotten more hypocritical. Here he is on Vioxx before real scientists at the FDA Advisory Committee hearing on COX-2 safety back in Feb 2005 instead of the self-aggrandizing Stupak:
Dr. Abrahamson: There are data that we have seen that ibuprofen might increase risk. We didn't talk about the McDonald and Way paper that in cardiovascular discharge patients, people give ibuprofen had a higher mortality 2-fold. So, as the smoke clears, I am not sure that the simple answer that the coxibs were different was actually supported by your data, nor
your ultimate explanation. Can you defend that?
Dr. Graham: I think you are accurate. I think what you are saying is fair. Maybe a better thing to say is, in the end, that you do need to look at it drug by drug.
Maybe the better thing is to actually run a balanced hearing instead of phoney three-ring circus that bears no relationship to the science.
Actually, Graham has gotten more hypocritical. Here he is on Vioxx before real scientists at the FDA Advisory Committee hearing on COX-2 safety back in Feb 2005 instead of the self-aggrandizing Stupak:
Dr. Abrahamson: There are data that we have seen that ibuprofen might increase risk. We didn't talk about the McDonald and Way paper that in cardiovascular discharge patients, people give ibuprofen had a higher mortality 2-fold. So, as the smoke clears, I am not sure that the simple answer that the coxibs were different was actually supported by your data, nor
your ultimate explanation. Can you defend that?
Dr. Graham: I think you are accurate. I think what you are saying is fair. Maybe a better thing to say is, in the end, that you do need to look at it drug by drug.
Maybe the better thing is to actually run a balanced hearing instead of phoney three-ring circus that bears no relationship to the science.
The WSJ has an article about how Mayo and Medco are partnering to screen patients BEFORE they take drugs to avoid side effects but meanwhile it sounds like the FDA is making it hard for such diagostics -- critical to the Critical Path and better health -- to get approved (and funding).
This in turn only gives ammunition and power to the critics of the industry and the agency that molecular medicine is not ready for prime time, that user fees are too user friendly, and that most of the money should go to policing products after they are on the market and not before they are developed or dispensed. All of which means fewer dollars spent on getting people new medicines for lifesaving medicines...
The FDA has a responsibility to get its act together on molecular diagnostics but Congress should understand that to drain the agency from money to advance such discussions and developments and invest in IOM-type idiocy will come at the expense of patient health and safety.
This in turn only gives ammunition and power to the critics of the industry and the agency that molecular medicine is not ready for prime time, that user fees are too user friendly, and that most of the money should go to policing products after they are on the market and not before they are developed or dispensed. All of which means fewer dollars spent on getting people new medicines for lifesaving medicines...
The FDA has a responsibility to get its act together on molecular diagnostics but Congress should understand that to drain the agency from money to advance such discussions and developments and invest in IOM-type idiocy will come at the expense of patient health and safety.
Marcia Angell claims that Medicare Part D was a giveaway to brand name drug companies and me-too drugs....
According to Business Monitor International..."The US-based Generic Pharmaceutical Association (GPhA) has announced that around 60% of all prescriptions on the Part D benefit programme are for generic drugs."
I wonder if Ms. Marcia's fact checking was any better when she was riding the bull at NEJM
According to Business Monitor International..."The US-based Generic Pharmaceutical Association (GPhA) has announced that around 60% of all prescriptions on the Part D benefit programme are for generic drugs."
I wonder if Ms. Marcia's fact checking was any better when she was riding the bull at NEJM
Wikipedia is running out of money. But instead of accepting ads it will pull the plug if it doesn't receive enough donations to keep it going. Which means that the founders will put to sleep the fastest growing common grounds for sharing information around the globe out of principle.
http://www.calacanis.com/2007/02/10/wikipedias-got-3-4-months-to-live-and-wikipedias-technolo/
Sounds a lot like the purists who continue to seek a purge of all industry "sponsored" support of any kind of any medical research or activity. At some point the lack of commercial investment and the possibility of return will cause new information to dry up.
Non-profits and generic firms have much difference incentives. They don't need to "market" new medicines or even want to. They spend very little here or overseas training or explaining to doctors how to use drugs. You won't see Teva investing in new uses for the generic form of Lovenox (regardless of how valid it's recent patent challenge might be) . And you would not see them invest any time or money in putting together the efficacy and safety data for a priority review of a new indication as Sanofi did.
http://www.pharmaceutical-business-review.com/article_news.asp?guid=DDDCA11E-497B-4979-A659-B8759752875E
The zealots don't care, either because they are healthy (and don't care about the need to commercialize innovation) or driven by drug company hatred. That's a disease too.
http://www.calacanis.com/2007/02/10/wikipedias-got-3-4-months-to-live-and-wikipedias-technolo/
Sounds a lot like the purists who continue to seek a purge of all industry "sponsored" support of any kind of any medical research or activity. At some point the lack of commercial investment and the possibility of return will cause new information to dry up.
Non-profits and generic firms have much difference incentives. They don't need to "market" new medicines or even want to. They spend very little here or overseas training or explaining to doctors how to use drugs. You won't see Teva investing in new uses for the generic form of Lovenox (regardless of how valid it's recent patent challenge might be) . And you would not see them invest any time or money in putting together the efficacy and safety data for a priority review of a new indication as Sanofi did.
http://www.pharmaceutical-business-review.com/article_news.asp?guid=DDDCA11E-497B-4979-A659-B8759752875E
The zealots don't care, either because they are healthy (and don't care about the need to commercialize innovation) or driven by drug company hatred. That's a disease too.
Shades of Chavez. And so much for the rule of law in Thailand.
According to the military junta in Bangkok, Thailand is planning to break the foreign patents of 14 HIV/AIDS, cancer and heart drugs.
The 14 drugs targeted by the Health Ministry also included antibiotics.The ministry has announced compulsory licences for three of the 14 drugs, allowing it to buy or make generic versions of the two HIV/AIDS drugs and a heart disease medicine.
Foreign drug makers say Thailand's military-appointed government gave no notice to the affected companies before issuing the compulsory licences.
Last month, the Health Ministry issued compulsory licences for the heart disease drug Plavix, made by Bristol-Myers Squibb and Sanofi-Aventis and Abbott Laboratories' Kaletra to treat HIV/AIDS, after a similar move on another AIDS drug last year.
Under World Trade Organization rules, a government is allowed to declare a national emergency and license the production or sale of a patented drug without the permission of the foreign patent owner.
I suppose a health care system that is a total disaster is an emergency -- but I don't think this is what the WHO had in mind.
According to the military junta in Bangkok, Thailand is planning to break the foreign patents of 14 HIV/AIDS, cancer and heart drugs.
The 14 drugs targeted by the Health Ministry also included antibiotics.The ministry has announced compulsory licences for three of the 14 drugs, allowing it to buy or make generic versions of the two HIV/AIDS drugs and a heart disease medicine.
Foreign drug makers say Thailand's military-appointed government gave no notice to the affected companies before issuing the compulsory licences.
Last month, the Health Ministry issued compulsory licences for the heart disease drug Plavix, made by Bristol-Myers Squibb and Sanofi-Aventis and Abbott Laboratories' Kaletra to treat HIV/AIDS, after a similar move on another AIDS drug last year.
Under World Trade Organization rules, a government is allowed to declare a national emergency and license the production or sale of a patented drug without the permission of the foreign patent owner.
I suppose a health care system that is a total disaster is an emergency -- but I don't think this is what the WHO had in mind.
Please join FDA Commissioner Andy von Eschenbach, Deputy Commissioner Janet Woodcock, Frank Burroughs of the Abigail Alliance, Dr. Scott Gottlieb, and many notables from the worlds of media and medicine for a day-long conference on how the media reports on medicine. The date is February 21. The place is the Hyatt Regency Capitol Hill in Washington, DC. For more details and a full agenda, please click on the icon on the top of this page.
(We did invite Senator Grassley, but he hasn't sent in his RSVP yet.)
(We did invite Senator Grassley, but he hasn't sent in his RSVP yet.)
Great commentary piece on expanding access to experimental therapies by CMPI board member Mark Thornton MD.
Drugwonks understands the need for well designed studies to prove safety and efficacy. But given the extent to which political pressure shapes what tools are used, we are skeptical when demands for longer, slower studies of the randomized type are constantly invoked. And when such studies turn away patients willing to enroll and ignore molecular /genetic diversity that can lead to better treatment, quality of life and knowledge, we are downright cynical...
We have to turn the tide against those who want to spend more gathering data on drugs we already know how to use safely -- starting with the imperious IOM report written by it's conflicted panel ( I will get to this issue, I promise!) --- and increase spending on tools that allow more people to become an "army of one" in the war to defeat cancer and other illnesses.
http://online.wsj.com/article/SB117124379156005353-search.html?KEYWORDS=disease&COLLECTION=wsjie/6month
Drugwonks understands the need for well designed studies to prove safety and efficacy. But given the extent to which political pressure shapes what tools are used, we are skeptical when demands for longer, slower studies of the randomized type are constantly invoked. And when such studies turn away patients willing to enroll and ignore molecular /genetic diversity that can lead to better treatment, quality of life and knowledge, we are downright cynical...
We have to turn the tide against those who want to spend more gathering data on drugs we already know how to use safely -- starting with the imperious IOM report written by it's conflicted panel ( I will get to this issue, I promise!) --- and increase spending on tools that allow more people to become an "army of one" in the war to defeat cancer and other illnesses.
http://online.wsj.com/article/SB117124379156005353-search.html?KEYWORDS=disease&COLLECTION=wsjie/6month
Thailand confiscates patents before talking to drug companies -- 20 patents under consideration and counting. No doubt the principal beneficiary will be the corrupt and poorly run government drug monopoly. Meanwhile, the military junta is eagerly reaching out to boost it's economic ties to one of the great democracies on the planet...Iran.
TEHRAN (Fars News Agency)- Thailand's Commerce Minister Kroekrai Chiraphaet stressed his country's strong support for Iran's membership in the World Trade Organization (WTO).
Speaking in a meeting with Iranian Ambassador to Bangkok Mohsen Pak Ayeen, the Thai official noted Iran's economic potentials and underlined, "Not only Thailand, but also all other Asian states view Iran's membership in the World Trade Organization positively."
He further voiced pleasure for the increasing volume of the two countries' trade exchanges, and welcomed endorsement of cooperation agreements by Iran and Thailand, particularly in the area of trade.
Chiraphaet reiterated that endorsement of trade contracts by Iran and his country can play a significant role in the boosting of the two sides' trade exchanges.
Highlighting the role of the private sector in the growth of the two sides' trade exchanges, he called for the reinvigoration of trade cooperation and frequent mutual visits by the two countries' private sectors.
For his part, Iran's Ambassador to Bangkok Mohsen Pak Ayeen wished success for the new government of Thailand, and expressed the hope that the two sides' growing trend of relations and cooperation would continue.
He stressed the need for the development of Iran-Thailand trade ties, and viewed holding of the 8th joint economic commission meeting in Bangkok as a crucial step for the strengthening of the two countries' trade cooperation.
Pak Ayeen further underscored that consolidation of relations with Asian countries, particularly with ASEAN member states, sets a priority for Iran's foreign policy.
http://www.irandefence.net/showthread.php?t=5773
Meanwhile, Israel's Natan Sharansky is calling for a world-wide mobilization against Iran and it's economy similar to that brought against South Africa and the USSR for its policies of repression. In Iran's case, it is leading a global effort to wipe out Israel.
http://www.jpost.com/servlet/Satellite?apage=2&cid=1170359835461&pagename=JPost%2FJPArticle%2FShowFull
Where do the NGO's stand on this important issue?
TEHRAN (Fars News Agency)- Thailand's Commerce Minister Kroekrai Chiraphaet stressed his country's strong support for Iran's membership in the World Trade Organization (WTO).
Speaking in a meeting with Iranian Ambassador to Bangkok Mohsen Pak Ayeen, the Thai official noted Iran's economic potentials and underlined, "Not only Thailand, but also all other Asian states view Iran's membership in the World Trade Organization positively."
He further voiced pleasure for the increasing volume of the two countries' trade exchanges, and welcomed endorsement of cooperation agreements by Iran and Thailand, particularly in the area of trade.
Chiraphaet reiterated that endorsement of trade contracts by Iran and his country can play a significant role in the boosting of the two sides' trade exchanges.
Highlighting the role of the private sector in the growth of the two sides' trade exchanges, he called for the reinvigoration of trade cooperation and frequent mutual visits by the two countries' private sectors.
For his part, Iran's Ambassador to Bangkok Mohsen Pak Ayeen wished success for the new government of Thailand, and expressed the hope that the two sides' growing trend of relations and cooperation would continue.
He stressed the need for the development of Iran-Thailand trade ties, and viewed holding of the 8th joint economic commission meeting in Bangkok as a crucial step for the strengthening of the two countries' trade cooperation.
Pak Ayeen further underscored that consolidation of relations with Asian countries, particularly with ASEAN member states, sets a priority for Iran's foreign policy.
http://www.irandefence.net/showthread.php?t=5773
Meanwhile, Israel's Natan Sharansky is calling for a world-wide mobilization against Iran and it's economy similar to that brought against South Africa and the USSR for its policies of repression. In Iran's case, it is leading a global effort to wipe out Israel.
http://www.jpost.com/servlet/Satellite?apage=2&cid=1170359835461&pagename=JPost%2FJPArticle%2FShowFull
Where do the NGO's stand on this important issue?
Wounded in battle, Alexander the Great's last words were, "I am dying at the hands of too many doctors." I know how he feels.
Marcia Angell weighs in on the Medicare prescription drug benefit, predictably calling it a giveaway to drug companies, claiming that the VA drug lists -- as well as drug formularies throughout the world -- only ditch drugs that are not cost-effective. Like Herceptin, Lipitor, Avastin, Gleevec... Angell is the only person in the world who doesn't know that Medicare Part D is ruthlessly shifting patients to generic medicines by the way, which is why she continues to flog me too drugs..
And she continues to talk about drugs that were first discovered 25 years ago instead of what companies are investing in now. Talking about the future means talking about genomics, targeted therapies, personalized medicine, translational research...all the activities companies are spending dough on. And she continues to perpetuate the lie that companies spend more on things other than R&D by lumping in the total cost (administration) of running a corporation to the cost of marketing.
My question is: what new drug has Dr. Angell invested in, worked on, discovered or developed in her lifetime? How would she make drug discovery and development more effective and efficient? Does she have special pre-knowledge about which medicines will work that other scientists do not? If so, I wish she would stop recycling the same old crappy op-ed and share the recipe for developing breakthrough drugs without have to develop all those me-too medicines...
High cost for me-too drugs
And speaking of recycling crap...Steve Nissen is once again claiming that he courageously warned America about the cardiovascular dangers of taking drugs for ADHD, drugs he still claims -- as someone who knows nothing about ADHD -- are way too overused. This time he is claiming this in front of Bart Stupak's Health subcommittee Feb 13th, joining other luminaries such as David Graham to trash the FDA.
I post a response from Dr. Joseph Biederman from Mass General Hospital, one of the nation's expert on treatment of ADHD and use of stimulants for treating the disease to Nissen's nonsense. I have sent it to members of the Health subcomm so they have an idea of what the facts about the risks and benefits of ADHD meds really are.
http://www.massgeneral.org/pediatricpsych/docs/NEJMltr.pdf
Marcia Angell weighs in on the Medicare prescription drug benefit, predictably calling it a giveaway to drug companies, claiming that the VA drug lists -- as well as drug formularies throughout the world -- only ditch drugs that are not cost-effective. Like Herceptin, Lipitor, Avastin, Gleevec... Angell is the only person in the world who doesn't know that Medicare Part D is ruthlessly shifting patients to generic medicines by the way, which is why she continues to flog me too drugs..
And she continues to talk about drugs that were first discovered 25 years ago instead of what companies are investing in now. Talking about the future means talking about genomics, targeted therapies, personalized medicine, translational research...all the activities companies are spending dough on. And she continues to perpetuate the lie that companies spend more on things other than R&D by lumping in the total cost (administration) of running a corporation to the cost of marketing.
My question is: what new drug has Dr. Angell invested in, worked on, discovered or developed in her lifetime? How would she make drug discovery and development more effective and efficient? Does she have special pre-knowledge about which medicines will work that other scientists do not? If so, I wish she would stop recycling the same old crappy op-ed and share the recipe for developing breakthrough drugs without have to develop all those me-too medicines...
High cost for me-too drugs
And speaking of recycling crap...Steve Nissen is once again claiming that he courageously warned America about the cardiovascular dangers of taking drugs for ADHD, drugs he still claims -- as someone who knows nothing about ADHD -- are way too overused. This time he is claiming this in front of Bart Stupak's Health subcommittee Feb 13th, joining other luminaries such as David Graham to trash the FDA.
I post a response from Dr. Joseph Biederman from Mass General Hospital, one of the nation's expert on treatment of ADHD and use of stimulants for treating the disease to Nissen's nonsense. I have sent it to members of the Health subcomm so they have an idea of what the facts about the risks and benefits of ADHD meds really are.
http://www.massgeneral.org/pediatricpsych/docs/NEJMltr.pdf
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.
