Latest Drugwonks' Blog
Waxman, Clinton and Schumer have introduced a bill to allow generic companies to introduce followon biologics sans assurances that they are as safe as the real thing and entrusting the approval process to an agency (FDA) that they say cannot be trusted to assure the safety of pharmaceuticals, let alone biologics.... And it turns out that the money to be saved from dumping these products on the market (assuming that innovator companies will accept the idea that their patents should be seized and can be easily challenged or have already expired) equals the amount $70 billion that Democrats were to extract from Part D price controls and were first use to fill the donut hole and then decided to use to expand SCHIP
Is there a biomarker for detecting hypocrisy?
Is there a biomarker for detecting hypocrisy?
Two stories that are frightening both because of their content and, even more so, because of their easy acceptance as “main stream.â€
The first is about an attempt in the Michigan legislature to allow residents of the Wolverine State to sue pharmaceutical companies if they suffer from an adverse event that is on the label of a prescription medicine. After all, patients shouldn’t be responsible for reading the PI and doctors shouldn’t be responsible for informing their patients about potential risks. The only responsibility, it seems, is to permit more and ever more law- suits.
Here’s the link:
http://www.dfw.com/mld/dfw/business/16697132.htm
The second news item comes from our friend, Congressman Henry Waxman, the U.S. House of Representatives new over-sighter-in-chief. It appears that Mr. Waxman doesn’t think Novartis should challenge an Indian law that trashes their IP protection.
But things, aren’t always as they appear, are they?
Here’s the full story:
http://www.business-standard.com/economy/storypage.php?leftnm=3&subLeft=1&chklogin=N&autono=274764&tab=r
And remember the old saw -- everything you read in the newspaper is true, except for those things you know about personally.
The first is about an attempt in the Michigan legislature to allow residents of the Wolverine State to sue pharmaceutical companies if they suffer from an adverse event that is on the label of a prescription medicine. After all, patients shouldn’t be responsible for reading the PI and doctors shouldn’t be responsible for informing their patients about potential risks. The only responsibility, it seems, is to permit more and ever more law- suits.
Here’s the link:
http://www.dfw.com/mld/dfw/business/16697132.htm
The second news item comes from our friend, Congressman Henry Waxman, the U.S. House of Representatives new over-sighter-in-chief. It appears that Mr. Waxman doesn’t think Novartis should challenge an Indian law that trashes their IP protection.
But things, aren’t always as they appear, are they?
Here’s the full story:
http://www.business-standard.com/economy/storypage.php?leftnm=3&subLeft=1&chklogin=N&autono=274764&tab=r
And remember the old saw -- everything you read in the newspaper is true, except for those things you know about personally.
Gottlieb speaks!
Lean New Pharma
By Scott Gottlieb, M.D.
Forbes Online
With 10,000 jobs and as much as $2 billion in costs set to disappear from Pfizer by the end of 2008, the pharmaceutical giant’s new chief executive is proving that he has a brain for bean counting and a body for Six Sigma.
The promotion of Pfizer’s Jeff Kindler to CEO from his former role as the company’s general counsel is of a piece with similar management makeovers inside big pharma’s boardrooms and may speak as much about where the industry is heading as where it has been.
Merck’s new chief executive, Richard Clark, was the president of his firm’s manufacturing division before he took the top job, and one of Clark’s first orders of business on his ascendancy was to announce the closure or sale of five of Merck’s manufacturing facilities as part of a package of efficiencies aimed at yielding pre-tax savings of up to $4 billion by 2010. About $2 billion of that will come from manufacturing reforms alone.
Once upon a time, a pharmaceutical CEO who did not hail from one of the creative parts of the drug business would have been met with skepticism on Wall Street. Certainly, a drug CEO would have been expected to have been schooled in the sales and marketing side of the business, if not originate from its core competency in research and development of new drugs.
Instead, Clark and Kindler, who have little comparative background in these disciplines, have been cheered. What gives?
Clark and Kindler are professional managers, and the administrative discipline they bring may be in order after the industry bloated itself on mergers--some cobbled together with little long-term vision beyond the urge to capture a few prized medicines. But this focus inside the executive suite on cost cutting cannot help but leave the impression that the drug industry is less a growth story than an aging industrial complex readying itself for life as a regulated public utility. Maybe it’s time the drug firms increase their dividends.
After all, if the prevailing political mood is any indication of the future, then the price of this industry’s core medical products will increasingly be a reckoning of government actuaries working for the Medicare drug benefit. And the Food and Drug Administration has always tightly regulated the manner in which pharma companies develop drugs, setting a close parameter on their cost.
In the end, this cost cutting is not a transformational strategy, just an exercise in defense to maintain the margin. These companies are treading water until they can start to grow again, which begs the question: When will the celebrated slump in the industry’s research productivity start to reverse itself.
Truth is, there have been some spectacular breakthroughs produced in recent years out of big pharma labs, including Merck and Pfizer--drugs aimed at specialized conditions and unmet medical needs. But these medicines have been given short shrift by the mass media because many have not been the kind of big primary care sellers that turn into multibillion-dollar blockbusters. Nevertheless, nobody can mistake the fact that big pharma’s spending on research and development has increased about 150% over the decade from 1993 to 2004, to more than $60 billion today, yet the number of drugs from the industry that reach the market has not changed measurably.
Some blame corporate bloat for the falloff, arguing that the drug companies got too big to be entrepreneurial. Others say the incessant focus on blockbusters prompted companies to prematurely cast aside promising but potentially niche molecules. Optimists say we are at a point when fundamental discoveries made in recent years in genomics and proteomics are just filtering into development programs. We will soon see a surge in productivity, similar to previous periods when the application of new sciences like combinatorial chemistry needed time to mature.
Here’s another theory. All of that increased R&D spending has been dwarfed by inflation. Over the past decade, the regulations on development and the demands of government payers have grown far faster than those research budgets, meaning we are not buying nearly as much science as we used to.
This is a fact of life that the National Institutes of Health has been bemoaning as it sees its own budget flatlined. The NIH has not had its budget “cut,†but it announced last week that it is closing swaths of research nonetheless because a dollar today does not buy nearly as much research as it did a few years ago. The furtive secret is that NIH trials are not even subject to the full brunt of Food and Drug Administration oversight. So they get away a lot cheaper than the industry does.
In this kind of regulated world, where the cost of development and the price of finished goods are increasingly controlled by the government, and where the cost of production goes up even as the selling price goes down, the drug companies will need to find additional ways to cast off more of their fixed costs to focus instead on core competencies in late development, distribution and marketing. This will push drugs firms increasingly toward a more disaggregated model, with work put to a growing legion of smaller outfits--from biotech firms that will continue to do research and early development and offload some of the scientific risks to contract organizations that do the testing and freelancers that sell.
Lean New Pharma
By Scott Gottlieb, M.D.
Forbes Online
With 10,000 jobs and as much as $2 billion in costs set to disappear from Pfizer by the end of 2008, the pharmaceutical giant’s new chief executive is proving that he has a brain for bean counting and a body for Six Sigma.
The promotion of Pfizer’s Jeff Kindler to CEO from his former role as the company’s general counsel is of a piece with similar management makeovers inside big pharma’s boardrooms and may speak as much about where the industry is heading as where it has been.
Merck’s new chief executive, Richard Clark, was the president of his firm’s manufacturing division before he took the top job, and one of Clark’s first orders of business on his ascendancy was to announce the closure or sale of five of Merck’s manufacturing facilities as part of a package of efficiencies aimed at yielding pre-tax savings of up to $4 billion by 2010. About $2 billion of that will come from manufacturing reforms alone.
Once upon a time, a pharmaceutical CEO who did not hail from one of the creative parts of the drug business would have been met with skepticism on Wall Street. Certainly, a drug CEO would have been expected to have been schooled in the sales and marketing side of the business, if not originate from its core competency in research and development of new drugs.
Instead, Clark and Kindler, who have little comparative background in these disciplines, have been cheered. What gives?
Clark and Kindler are professional managers, and the administrative discipline they bring may be in order after the industry bloated itself on mergers--some cobbled together with little long-term vision beyond the urge to capture a few prized medicines. But this focus inside the executive suite on cost cutting cannot help but leave the impression that the drug industry is less a growth story than an aging industrial complex readying itself for life as a regulated public utility. Maybe it’s time the drug firms increase their dividends.
After all, if the prevailing political mood is any indication of the future, then the price of this industry’s core medical products will increasingly be a reckoning of government actuaries working for the Medicare drug benefit. And the Food and Drug Administration has always tightly regulated the manner in which pharma companies develop drugs, setting a close parameter on their cost.
In the end, this cost cutting is not a transformational strategy, just an exercise in defense to maintain the margin. These companies are treading water until they can start to grow again, which begs the question: When will the celebrated slump in the industry’s research productivity start to reverse itself.
Truth is, there have been some spectacular breakthroughs produced in recent years out of big pharma labs, including Merck and Pfizer--drugs aimed at specialized conditions and unmet medical needs. But these medicines have been given short shrift by the mass media because many have not been the kind of big primary care sellers that turn into multibillion-dollar blockbusters. Nevertheless, nobody can mistake the fact that big pharma’s spending on research and development has increased about 150% over the decade from 1993 to 2004, to more than $60 billion today, yet the number of drugs from the industry that reach the market has not changed measurably.
Some blame corporate bloat for the falloff, arguing that the drug companies got too big to be entrepreneurial. Others say the incessant focus on blockbusters prompted companies to prematurely cast aside promising but potentially niche molecules. Optimists say we are at a point when fundamental discoveries made in recent years in genomics and proteomics are just filtering into development programs. We will soon see a surge in productivity, similar to previous periods when the application of new sciences like combinatorial chemistry needed time to mature.
Here’s another theory. All of that increased R&D spending has been dwarfed by inflation. Over the past decade, the regulations on development and the demands of government payers have grown far faster than those research budgets, meaning we are not buying nearly as much science as we used to.
This is a fact of life that the National Institutes of Health has been bemoaning as it sees its own budget flatlined. The NIH has not had its budget “cut,†but it announced last week that it is closing swaths of research nonetheless because a dollar today does not buy nearly as much research as it did a few years ago. The furtive secret is that NIH trials are not even subject to the full brunt of Food and Drug Administration oversight. So they get away a lot cheaper than the industry does.
In this kind of regulated world, where the cost of development and the price of finished goods are increasingly controlled by the government, and where the cost of production goes up even as the selling price goes down, the drug companies will need to find additional ways to cast off more of their fixed costs to focus instead on core competencies in late development, distribution and marketing. This will push drugs firms increasingly toward a more disaggregated model, with work put to a growing legion of smaller outfits--from biotech firms that will continue to do research and early development and offload some of the scientific risks to contract organizations that do the testing and freelancers that sell.
I am trying to keep track of the arguments the media is making in favor of
1.Alex Berenson orchestrating the 'leaking' of a small slice of documents in a class action trial against Lilly to show that the company 'knew' of a possible relationship between it's atypical and weight gain and tried to cover it up and
2. That returning the illegally obtained documents is somehow a violation of the freedom of press.
According to the AP:
Last week, Judge Weinstein had requested that the reporter, Alex Berenson, appear in court Wednesday to discuss testimony that the judge said had implicated the writer in a "conspiracy" to obtain the documents, which had been placed under seal by the court.
Here's how the NY Times excuses sleazy conduct and avoids at least talking about in a way that they have hounded others to do so (such as Scooter Libby)
"We guard quite zealously our role as a member of a free and independent press and believe quite passionately that, consistent with the principles embodied in the First Amendment, it is not the role of the newspaper or its reporters to submit to cross-examination about such matters even where it may otherwise serve our particular interests in a particular case to do so,"
Note: this was not a cross-examination in open court. It was chance to clear
up what Berenson knew and did and when.
http://online.wsj.com/article/SB117079300102099942.html?mod=googlenews_wsj
Also note that "co-conspirators" like MindFreedom and other web-based ax-grinders now claim that being in possession and posting of stolen documents is okay. And of course none of this is related to lawsuits contemplated by state AGs in Illinois, Vermont and elsewhere to sue Lilly regarding Zyprexa. (Nothing like going to the well again.)
The idea that Lilly tried to hide the risk of weight gain associated with Zyprexa is nonsense. It's in the literature for anyone not lazy enough to search...
J Clin Psychiatry. 1998;59 Suppl 12:17-22. Links
Adverse effects of the atypical antipsychotics. Collaborative Working Group on Clinical Trial Evaluations.
This whole jihad is being driven by crackpots, money hungry state AGs and aided by a newspaper that is willing to sacrifice both national security and the truth to play to its shrinking readership.....
1.Alex Berenson orchestrating the 'leaking' of a small slice of documents in a class action trial against Lilly to show that the company 'knew' of a possible relationship between it's atypical and weight gain and tried to cover it up and
2. That returning the illegally obtained documents is somehow a violation of the freedom of press.
According to the AP:
Last week, Judge Weinstein had requested that the reporter, Alex Berenson, appear in court Wednesday to discuss testimony that the judge said had implicated the writer in a "conspiracy" to obtain the documents, which had been placed under seal by the court.
Here's how the NY Times excuses sleazy conduct and avoids at least talking about in a way that they have hounded others to do so (such as Scooter Libby)
"We guard quite zealously our role as a member of a free and independent press and believe quite passionately that, consistent with the principles embodied in the First Amendment, it is not the role of the newspaper or its reporters to submit to cross-examination about such matters even where it may otherwise serve our particular interests in a particular case to do so,"
Note: this was not a cross-examination in open court. It was chance to clear
up what Berenson knew and did and when.
http://online.wsj.com/article/SB117079300102099942.html?mod=googlenews_wsj
Also note that "co-conspirators" like MindFreedom and other web-based ax-grinders now claim that being in possession and posting of stolen documents is okay. And of course none of this is related to lawsuits contemplated by state AGs in Illinois, Vermont and elsewhere to sue Lilly regarding Zyprexa. (Nothing like going to the well again.)
The idea that Lilly tried to hide the risk of weight gain associated with Zyprexa is nonsense. It's in the literature for anyone not lazy enough to search...
J Clin Psychiatry. 1998;59 Suppl 12:17-22. Links
Adverse effects of the atypical antipsychotics. Collaborative Working Group on Clinical Trial Evaluations.
This whole jihad is being driven by crackpots, money hungry state AGs and aided by a newspaper that is willing to sacrifice both national security and the truth to play to its shrinking readership.....
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.
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.
