Latest Drugwonks' Blog
In light of the pro-generic tilt of public policy these days the following sidebar from the Pharmaceutical Business Review might be of interest:
Ranbaxy has revealed that federal officials have conducted a surprise raid at its New Jersey offices and manufacturing site, during which paper and electronic documents were taken. Although the raid is believed to have been carried out by the Food and Drug Administration, the agency has not confirmed this report. The Indian-based generic drug firm claims to be mystified by the raid, and insisted that it was not aware of any wrongdoing. As the FDA refuses to comment on ongoing investigations, the reasons behind the swoop will remain a mystery for the time being.
It should be noted that Ranbaxy told the Indian press that they think the brand companies are behind the raid. Maybe Jamie Love can explain this connection.
The PBR report does not note that the Department of Justice is conducting the investigation and it does not rush in unless it has good reason to do so. My guess is that it might have something to do with fudging on filings, something Ranbaxy has done before.
Memories are short but some might recall that in 2004 the WHO had to delist Ranbaxy's HIV drugs when it found that it had no safety and efficacy data for them. As the WHO noted then: "The drugs will be delisted until Ranbaxy can submit data of new studies providing unequivocal evidence of the products' bioequivalence with the originator medicines."
Ouch.
Ranbaxy did get FDA approval for a couple of HIV drugs in 2005. But what does that say about all those patients taking drugs based on files that the WHO couldn't even accept...
This is a story worth following in light of the corruption and shoddy products the junta-run drug company in Thailand is getting ready to pump out...
And these are the good guys Waxman, Love and co are supporting.
Ranbaxy has revealed that federal officials have conducted a surprise raid at its New Jersey offices and manufacturing site, during which paper and electronic documents were taken. Although the raid is believed to have been carried out by the Food and Drug Administration, the agency has not confirmed this report. The Indian-based generic drug firm claims to be mystified by the raid, and insisted that it was not aware of any wrongdoing. As the FDA refuses to comment on ongoing investigations, the reasons behind the swoop will remain a mystery for the time being.
It should be noted that Ranbaxy told the Indian press that they think the brand companies are behind the raid. Maybe Jamie Love can explain this connection.
The PBR report does not note that the Department of Justice is conducting the investigation and it does not rush in unless it has good reason to do so. My guess is that it might have something to do with fudging on filings, something Ranbaxy has done before.
Memories are short but some might recall that in 2004 the WHO had to delist Ranbaxy's HIV drugs when it found that it had no safety and efficacy data for them. As the WHO noted then: "The drugs will be delisted until Ranbaxy can submit data of new studies providing unequivocal evidence of the products' bioequivalence with the originator medicines."
Ouch.
Ranbaxy did get FDA approval for a couple of HIV drugs in 2005. But what does that say about all those patients taking drugs based on files that the WHO couldn't even accept...
This is a story worth following in light of the corruption and shoddy products the junta-run drug company in Thailand is getting ready to pump out...
And these are the good guys Waxman, Love and co are supporting.
Follow on biologics (generic biologics) will be a safe scientific fact of life in the near future. But that's not fast enough for Congressional Democrats who want to use the biotech industry as a source of income redistribution and a cash cow for expanding SCHIP. So it has turned to Bill Haddad, an individual who is the godfather of the Hatch-Waxman act and whose company Biogenerics, stands to profit from the creation of FDA approval of generic biotech medicines to write the legislation for followon biologics. In its current form it is sweetheart deal for generics firm: No testing requirements, no postmarket studies, just show up with the files from the innovator company and your own brew. As for the $70 billion in savings, which just coincidentally equals the amount needed to fund the SCHIP expansion, Dems have turned to the PBM trade group -- which will profit from early termination of biotech patent -- to come up with projections of how much cash will be saved by swiitching patienets to knockoffs.
Only one problem, the standards in the bill are nearly a half century old. The same members of Congress bawling about how FDA can't protest the public against unsafe drugs would expose people to biotech products produced in ways that have caused seizures, paralysis, and incurable blood disorders in thousands of patients over the years. The other problem is that the biotech drugs they want to copy are not even off patent. They want to make that problem disappear by just legislating the right of some companies to contest their patent claims out of existentence. Why the disregard of IP and public health? To reward political cronies and appease constituencies who want to expand Medicaid as a way of advancing national health care.
Only one problem, the standards in the bill are nearly a half century old. The same members of Congress bawling about how FDA can't protest the public against unsafe drugs would expose people to biotech products produced in ways that have caused seizures, paralysis, and incurable blood disorders in thousands of patients over the years. The other problem is that the biotech drugs they want to copy are not even off patent. They want to make that problem disappear by just legislating the right of some companies to contest their patent claims out of existentence. Why the disregard of IP and public health? To reward political cronies and appease constituencies who want to expand Medicaid as a way of advancing national health care.
Protecting people against disease or the drugs that are developed to treat the illnesses in the first place?
Here's a new article (by me) from this week's edition of Barron's. The title says it all, "Even Safety Needs Limits."
To read the article, click on the link below:
Download file
To entice you on, here's the closing paragraph:
"FDA decisions can be made more transparent to all interested parties. The agency can improve cooperation with the industry, patient groups, physicians, hospitals, academia, and other government agencies. The goal should not be conducting more time-consuming discussion, but finding more effective ways to bring medical advances to patients as quickly as possible."
To read the article, click on the link below:
Download file
To entice you on, here's the closing paragraph:
"FDA decisions can be made more transparent to all interested parties. The agency can improve cooperation with the industry, patient groups, physicians, hospitals, academia, and other government agencies. The goal should not be conducting more time-consuming discussion, but finding more effective ways to bring medical advances to patients as quickly as possible."
From today's edition of the Boston Globe, our rebuttal to Marcia Angell's most recent me-too mania:
Similar drugs, but world of difference
Take away message: There is no such thing as a "me-too" drug" because there is no such thing as a "me-too" patient.
Similar drugs, but world of difference
Take away message: There is no such thing as a "me-too" drug" because there is no such thing as a "me-too" patient.
FDA Warns of Wrong Drugs
Being Sold Over the Internet
Associated Press
February 16, 2007 6:03 p.m.
Consumers who thought they were purchasing sleep aids, antidepressants and other drugs over the Internet instead were shipped a powerful antipsychotic, sending some unwitting victims to the emergency room, federal health officials warned Friday.
The Food and Drug Administration said a number of consumers took the schizophrenia drug, haloperidol, after being shipped what they thought were a variety of different pills, including Ambien, a sleep aid, and the anti-anxiety medications Xanax and Ativan. Others thought they were getting the antidepressant Lexapro.
Preliminary analysis of the pills, packaged in plain plastic bags and mailed in envelopes bearing Greek postmarks, suggest they contain haloperidol. The
FDA said it had reports of several consumers seeking emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after taking the pills.
The FDA used the occasion to remind consumers of the possible dangers of buying prescription drugs on the Web.
The FDA posted images of the suspect pills and their shipping packages on its Web site to help consumers identify any suspect product they may have ordered.
Consumers apparently ordered the drugs through a variety of commercial Web sites. The FDA said it was investigating.
Being Sold Over the Internet
Associated Press
February 16, 2007 6:03 p.m.
Consumers who thought they were purchasing sleep aids, antidepressants and other drugs over the Internet instead were shipped a powerful antipsychotic, sending some unwitting victims to the emergency room, federal health officials warned Friday.
The Food and Drug Administration said a number of consumers took the schizophrenia drug, haloperidol, after being shipped what they thought were a variety of different pills, including Ambien, a sleep aid, and the anti-anxiety medications Xanax and Ativan. Others thought they were getting the antidepressant Lexapro.
Preliminary analysis of the pills, packaged in plain plastic bags and mailed in envelopes bearing Greek postmarks, suggest they contain haloperidol. The
FDA said it had reports of several consumers seeking emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after taking the pills.
The FDA used the occasion to remind consumers of the possible dangers of buying prescription drugs on the Web.
The FDA posted images of the suspect pills and their shipping packages on its Web site to help consumers identify any suspect product they may have ordered.
Consumers apparently ordered the drugs through a variety of commercial Web sites. The FDA said it was investigating.
We have been saying this all along.
Part D is working...drugs save money in the long run. Giving people choices to steer dollars to in ways that actually prevent disease (more drugs, newer drugs, better drugs) is a great investment.
It doesn't take a Nobel Prize economist to say that (some like Joe Stiglitz still can't figure it out) but it's great when they do.
http://online.wsj.com/article/SB117159975453110920.html?mod=opinion_main_commentaries
Part D is working...drugs save money in the long run. Giving people choices to steer dollars to in ways that actually prevent disease (more drugs, newer drugs, better drugs) is a great investment.
It doesn't take a Nobel Prize economist to say that (some like Joe Stiglitz still can't figure it out) but it's great when they do.
http://online.wsj.com/article/SB117159975453110920.html?mod=opinion_main_commentaries
A courageous interview with Paul Herring, head of corporate research for Novartis, regarding India's denial of a patent for Gleevec... A case study why more companies should get more scientists to speak out about the savaging of their industry by junta loving NGOs...
We are Not Doing This Out of Spite’
The Business World (India)
India, 2/16/2007 - In a case that has got the world’s attention, Swiss multinational Novartis AG has challenged the Indian Patent Office’s decision to deny it a patent on cancer drug Glivec, in the Madras High Court. Novartis has also questioned provisions in the Indian Patent Act under which the patent was denied (under these provisions, incremental improvements to existing drugs cannot be patented). The $37-billion drug maker, best known here for Calcium Sandoz and pain-killer Voveran, had earlier won an exclusive marketing right— now lapsed — on Glivec in India. With its patent claim rejected, cheaper copies of Gli-vec are free to sell in the Indian market. The lawsuit has drawn the ire of humanitarian organisations such as Medicins Sans Frontieres (MSF) and Cancer Patients’ Aid Association (CPAA) for its potential to deny these cheaper generics to patients and for its possible impact on the Indian Patent Act, which currently restricts patenting to completely new drugs. Recently, a quarter of a million people signed a petition demanding that Novartis drop the case. Activists have held protests against the company in India and Switzerland. The backlash is reminiscent of a time, not too long ago, when 39 multinationals, including Novartis, sued the South African government to drop certain provisions in its law that governed access to medicines that the companies thought threatened their patents. Those companies were eventually forced to withdraw the lawsuit. Will this case go the same way? Paul Herrling, Novartis’ head of corporate research, who is also in charge of the Singapore-based Novartis Institute for Tropical Diseases, was in India for a day to address members of a business association. In an interview with BW’s Gauri Kamath, Herrling explains why Novartis is fighting tooth and nail for a case that is, no doubt, causing great harm to its public image.
Your visit is against the backdrop of the Glivec lawsuit. Any comments?
Fundamentally, this is about patents. And I am in research. Our view in research is that patents save lives. You need to invest for 15 years to translate a scientific idea into a breakthrough medicine such as Glivec. Nobody could or would do that kind of research if there was not a hope to recover the investment at the end of the day.
Do you think that the price that you have paid in terms of your public image is worth this patent that you might get if you win?
It is a problem that so many people are upset. We do not want to be seen the way we are being portrayed. One of the leaders of this petition against us is MSF. As you may also know, I am the chairman of the Novartis Institute for Tropical Diseases in Singapore that makes drugs against tuberculosis, dengue and malaria for patients in poor countries — which we will sell at no profit. I work with many people from MSF on projects. And, they are actually wonderful people. But they were never into drug discovery. They do not know the conditions that are needed to make a new drug. They think if one would weaken or abolish patents, then the problem of access for medicines would be solved. This is wrong. I do not think the patent issue is nowadays a major impediment to making drugs available. Novartis has the world’s best malaria drug— Coartem— which is a joint project with Chinese scientists. We give it at no profit, and in 2006 we delivered 62 million treatments, which make it the biggest selling Novartis drug ever. The reason why we can do this is because we have enough business in markets where people can afford (to pay more for) it. This enables us to allocate some of our earnings to access-to-medicine projects where we have life-saving drugs. And the same happens with Glivec in India. As much as 99 per cent of all the Glivec in India is given for free. So, patents have not prevented access, it is how you use them. We have patents on Coartem and there are companies that are now copying it and selling it. We have never done anything to stop them from doing it.
This case really is not about whether India respects product patents per se. It is challenging certain provisions that define what can be patented and what cannot.
The amendments (to the patent law) undermine a significant aspect of patents. They say if it is essentially the same idea and you make improvements on it, then you cannot patent it. But that is not the way science works. For example, children with thalassemia need a lot of blood transfusions. When you do frequent transfusions, iron accumulates in your body which could eventually ruin the liver. We had a drug that was able to take the iron back out of the blood, but it had to be given in continuous intravenous infusion. That meant these children had to have a pump, that was bigger than a cellular phone, on them all day and a needle that was going into one of their veins. So, here what would be considered an incremental innovation(under the Indian law) was to find a version of this drug that children could take as a pill. Under the current amendment, this would not get patent protection, which in turn means nobody would invest because when you do this new version you still have to do all the safety studies and prove that, in fact, the effect is the same.
What is the issue with the patent application on Glivec?
There are two aspects. In Glivec’s case, the issue is a new form of the drug. So, the active ingredient is the same and the salt is different. And we have seen that the absorption of this is better than the original. It is true that the original patent with the original salt form could not be granted for a technical reason because everything before 1995 could not. In this case, we patented this new salt form in 40 countries because we had evidence from our experiments that this would make it easier to absorb, which again means better levels in the body, less variability in the effect. So, that’s again an advantage to the patient. Now, India says, no, you are not going to patent that until you have proven in people that this really translates into the advantage that you foresee from animal studies. Patents (all over the world) are normally given at a time when a scientist can document any invention — a molecule in this case — and some of its effects. In this case, it was through animal experiments, solubility experiments and so on. Once I get the patent at this point —which is early in its life — then I invest. If I am being told that I have to first invest hundreds of millions, and then maybe I can get a patent, then I do not invest. That is the other issue.
Then, in this particular case, would Novartis be willing to do those human studies just to make a point?
Such studies are happening all over the world.
So, you have that supporting documentation.
No. Because that takes time to do.
Is there a point beyond which you don’t believe that this particular case is worth fighting for?
It is difficult to say what the future will look like. If we had solved 99 per cent of all the medical problems on this planet, we would not fight that much. Then there would not be any need for any new drugs and we would sell the old ones, fine. But the big problems are not solved. We believe if the system were to be undermined, it would not be to the advantage of humanity in general.
Does the rejection of the patent on Glivec, or the way people have broadly reacted to the lawsuit, affect your R&D investments or collaborations in India in any way?
Yes. When I was asked why we created our research institute in Singapore, not in India, which also has the talent, the same diseases and so on, that is the reason. We have announced the creation of a major research institute in Shanghai. There we see that it’s not perfect but the system is in place to get to a better and better improvement of intellectual properties.
What about the R&D collaborations that you already have?
They are successful, but because of this intellectual property (IP) insecurity we are not doing chemistry that leads directly to a potential medicine but only supportive work. If this point would be clarified in the positive, we could expand it. Then there would be no difference in the collaborations we do in India versus the US, China or any other place.
But not investing in a country just because of IP issues is like throwing the baby out with the bathwater. Just because pirated copies of Windows Vista sell in China, you don’t see Bill Gates saying he is going to stop investing there. The economics overrides everything else.
I cannot judge the computer industry at all.
There, too, it is the IP issue.
We are talking about other things here. We are talking about products that potentially save lives. And in contrast to the IT industry, we are the most regulated industry on this planet. And the investment level that you have to have for each product is such that we have to look at the world and decide where are the best conditions (to invest).
Is there any attempt to meet with the government?
Oh, no. The courts will decide and we do not want to interfere with this process at all. But what we do is talk to you. It is very vital to us that people understand that we are not doing this out of spite. And we just want to explain our view to people who hear only one side in the press because NGOs are very vocal.
We are Not Doing This Out of Spite’
The Business World (India)
India, 2/16/2007 - In a case that has got the world’s attention, Swiss multinational Novartis AG has challenged the Indian Patent Office’s decision to deny it a patent on cancer drug Glivec, in the Madras High Court. Novartis has also questioned provisions in the Indian Patent Act under which the patent was denied (under these provisions, incremental improvements to existing drugs cannot be patented). The $37-billion drug maker, best known here for Calcium Sandoz and pain-killer Voveran, had earlier won an exclusive marketing right— now lapsed — on Glivec in India. With its patent claim rejected, cheaper copies of Gli-vec are free to sell in the Indian market. The lawsuit has drawn the ire of humanitarian organisations such as Medicins Sans Frontieres (MSF) and Cancer Patients’ Aid Association (CPAA) for its potential to deny these cheaper generics to patients and for its possible impact on the Indian Patent Act, which currently restricts patenting to completely new drugs. Recently, a quarter of a million people signed a petition demanding that Novartis drop the case. Activists have held protests against the company in India and Switzerland. The backlash is reminiscent of a time, not too long ago, when 39 multinationals, including Novartis, sued the South African government to drop certain provisions in its law that governed access to medicines that the companies thought threatened their patents. Those companies were eventually forced to withdraw the lawsuit. Will this case go the same way? Paul Herrling, Novartis’ head of corporate research, who is also in charge of the Singapore-based Novartis Institute for Tropical Diseases, was in India for a day to address members of a business association. In an interview with BW’s Gauri Kamath, Herrling explains why Novartis is fighting tooth and nail for a case that is, no doubt, causing great harm to its public image.
Your visit is against the backdrop of the Glivec lawsuit. Any comments?
Fundamentally, this is about patents. And I am in research. Our view in research is that patents save lives. You need to invest for 15 years to translate a scientific idea into a breakthrough medicine such as Glivec. Nobody could or would do that kind of research if there was not a hope to recover the investment at the end of the day.
Do you think that the price that you have paid in terms of your public image is worth this patent that you might get if you win?
It is a problem that so many people are upset. We do not want to be seen the way we are being portrayed. One of the leaders of this petition against us is MSF. As you may also know, I am the chairman of the Novartis Institute for Tropical Diseases in Singapore that makes drugs against tuberculosis, dengue and malaria for patients in poor countries — which we will sell at no profit. I work with many people from MSF on projects. And, they are actually wonderful people. But they were never into drug discovery. They do not know the conditions that are needed to make a new drug. They think if one would weaken or abolish patents, then the problem of access for medicines would be solved. This is wrong. I do not think the patent issue is nowadays a major impediment to making drugs available. Novartis has the world’s best malaria drug— Coartem— which is a joint project with Chinese scientists. We give it at no profit, and in 2006 we delivered 62 million treatments, which make it the biggest selling Novartis drug ever. The reason why we can do this is because we have enough business in markets where people can afford (to pay more for) it. This enables us to allocate some of our earnings to access-to-medicine projects where we have life-saving drugs. And the same happens with Glivec in India. As much as 99 per cent of all the Glivec in India is given for free. So, patents have not prevented access, it is how you use them. We have patents on Coartem and there are companies that are now copying it and selling it. We have never done anything to stop them from doing it.
This case really is not about whether India respects product patents per se. It is challenging certain provisions that define what can be patented and what cannot.
The amendments (to the patent law) undermine a significant aspect of patents. They say if it is essentially the same idea and you make improvements on it, then you cannot patent it. But that is not the way science works. For example, children with thalassemia need a lot of blood transfusions. When you do frequent transfusions, iron accumulates in your body which could eventually ruin the liver. We had a drug that was able to take the iron back out of the blood, but it had to be given in continuous intravenous infusion. That meant these children had to have a pump, that was bigger than a cellular phone, on them all day and a needle that was going into one of their veins. So, here what would be considered an incremental innovation(under the Indian law) was to find a version of this drug that children could take as a pill. Under the current amendment, this would not get patent protection, which in turn means nobody would invest because when you do this new version you still have to do all the safety studies and prove that, in fact, the effect is the same.
What is the issue with the patent application on Glivec?
There are two aspects. In Glivec’s case, the issue is a new form of the drug. So, the active ingredient is the same and the salt is different. And we have seen that the absorption of this is better than the original. It is true that the original patent with the original salt form could not be granted for a technical reason because everything before 1995 could not. In this case, we patented this new salt form in 40 countries because we had evidence from our experiments that this would make it easier to absorb, which again means better levels in the body, less variability in the effect. So, that’s again an advantage to the patient. Now, India says, no, you are not going to patent that until you have proven in people that this really translates into the advantage that you foresee from animal studies. Patents (all over the world) are normally given at a time when a scientist can document any invention — a molecule in this case — and some of its effects. In this case, it was through animal experiments, solubility experiments and so on. Once I get the patent at this point —which is early in its life — then I invest. If I am being told that I have to first invest hundreds of millions, and then maybe I can get a patent, then I do not invest. That is the other issue.
Then, in this particular case, would Novartis be willing to do those human studies just to make a point?
Such studies are happening all over the world.
So, you have that supporting documentation.
No. Because that takes time to do.
Is there a point beyond which you don’t believe that this particular case is worth fighting for?
It is difficult to say what the future will look like. If we had solved 99 per cent of all the medical problems on this planet, we would not fight that much. Then there would not be any need for any new drugs and we would sell the old ones, fine. But the big problems are not solved. We believe if the system were to be undermined, it would not be to the advantage of humanity in general.
Does the rejection of the patent on Glivec, or the way people have broadly reacted to the lawsuit, affect your R&D investments or collaborations in India in any way?
Yes. When I was asked why we created our research institute in Singapore, not in India, which also has the talent, the same diseases and so on, that is the reason. We have announced the creation of a major research institute in Shanghai. There we see that it’s not perfect but the system is in place to get to a better and better improvement of intellectual properties.
What about the R&D collaborations that you already have?
They are successful, but because of this intellectual property (IP) insecurity we are not doing chemistry that leads directly to a potential medicine but only supportive work. If this point would be clarified in the positive, we could expand it. Then there would be no difference in the collaborations we do in India versus the US, China or any other place.
But not investing in a country just because of IP issues is like throwing the baby out with the bathwater. Just because pirated copies of Windows Vista sell in China, you don’t see Bill Gates saying he is going to stop investing there. The economics overrides everything else.
I cannot judge the computer industry at all.
There, too, it is the IP issue.
We are talking about other things here. We are talking about products that potentially save lives. And in contrast to the IT industry, we are the most regulated industry on this planet. And the investment level that you have to have for each product is such that we have to look at the world and decide where are the best conditions (to invest).
Is there any attempt to meet with the government?
Oh, no. The courts will decide and we do not want to interfere with this process at all. But what we do is talk to you. It is very vital to us that people understand that we are not doing this out of spite. And we just want to explain our view to people who hear only one side in the press because NGOs are very vocal.
That's John F.P. Bridges and Christopher Jones, both of the Johns Hopkins Bloomberg School of Public Health.
Their new paper, "Patient-based health technology assessment: A vision of the future," is a timely discussion of how HTA and EBM can and must be used to advance patient health and reduce long-term health care costs -- rather than how it is currently being used -- as a way to reduce short-term, transitory health care spending.
Here's a link to the paper:
Download file
Some snippets to entice your appetite for real reform:
"Objective: The aim of this study was to develop a working definition of patient-based HTA, to identify the current barriers to adopting a patient-based model, and to formulate a vision of how a patient-based HTA could be used to promote patient empowerment and patient-centered care."
"Whereas EBM categorizes and ranks all types of medical evidence by the quality of the results provided, the randomized controlled trial (RCT) is given preferential recognition because of its ability to identify (average) treatment effects. Unfortunately, RCTs are costly, frequently underpowered, and too often not representative of the broader population of patients who must receive treatments in different settings. In addition, RCTs may not adequately reflect values of patients, as they so often are focused solely on outcomes defined by the scientific and medical community, without consideration of the patient's needs and desires."
This paper delves into the doctines so often treated as dogma, shines a bright light on faulty assumptions, and calls into question the methods of EBM and HTA that have been hijacked to justify limited formularies and price controls.
It's based on a presentation given at the Third Annual Meeting of Health Technology Assessment International, held July 2-5, 2006 in Adelaide, Australia.
And it's worth a careful read.
Their new paper, "Patient-based health technology assessment: A vision of the future," is a timely discussion of how HTA and EBM can and must be used to advance patient health and reduce long-term health care costs -- rather than how it is currently being used -- as a way to reduce short-term, transitory health care spending.
Here's a link to the paper:
Download file
Some snippets to entice your appetite for real reform:
"Objective: The aim of this study was to develop a working definition of patient-based HTA, to identify the current barriers to adopting a patient-based model, and to formulate a vision of how a patient-based HTA could be used to promote patient empowerment and patient-centered care."
"Whereas EBM categorizes and ranks all types of medical evidence by the quality of the results provided, the randomized controlled trial (RCT) is given preferential recognition because of its ability to identify (average) treatment effects. Unfortunately, RCTs are costly, frequently underpowered, and too often not representative of the broader population of patients who must receive treatments in different settings. In addition, RCTs may not adequately reflect values of patients, as they so often are focused solely on outcomes defined by the scientific and medical community, without consideration of the patient's needs and desires."
This paper delves into the doctines so often treated as dogma, shines a bright light on faulty assumptions, and calls into question the methods of EBM and HTA that have been hijacked to justify limited formularies and price controls.
It's based on a presentation given at the Third Annual Meeting of Health Technology Assessment International, held July 2-5, 2006 in Adelaide, Australia.
And it's worth a careful read.
The NY Times used the First Amendment to keep Alex Berenson -- who seeking to turn his novel into a movie -- from explaining his behavior to federal judge Jack Weinstein, particularly his role in a conspiracy to illegally ferret documents out of a case (which makes him a hero in the addled minds of MindFreedom and other co-conspirators) .
As the following clip from Fox News suggests, Judge Weinstein, no arch-conservative, has found Berenson's contempt for legal procedure, defendant rights and the court, "reprehensible."
Drugwonks was attacked for criticizing those (Berenson included) involved in this sordid mess as well as those that called his accomplices "heroes."
We think we are owed an apology. As is Eli Lilly and Co. who, since we last checked, is still afforded the same rights and protections under the Constitution as any defendant in a civil suit.
We are not holding our breath. Maybe if we contacted the NY Times to steal one out of federal court documents we'd get one sooner.
Here's a link to the clip
FNC_02_14_2007_18.31.44.wmv
As the following clip from Fox News suggests, Judge Weinstein, no arch-conservative, has found Berenson's contempt for legal procedure, defendant rights and the court, "reprehensible."
Drugwonks was attacked for criticizing those (Berenson included) involved in this sordid mess as well as those that called his accomplices "heroes."
We think we are owed an apology. As is Eli Lilly and Co. who, since we last checked, is still afforded the same rights and protections under the Constitution as any defendant in a civil suit.
We are not holding our breath. Maybe if we contacted the NY Times to steal one out of federal court documents we'd get one sooner.
Here's a link to the clip
FNC_02_14_2007_18.31.44.wmv
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.
