Latest Drugwonks' Blog
People keep telling me that the only major difference between the "first 100 hours" House bill on the abolition of non-interference and the Senator Baucus' pending piece of legislation is that the the House bill says that the Secretary "shall" and the Baucus bill says that the Secretary "can."
No matter how you look at it, it's still momentum in the wrong direction. As Senator John Kyl commented, “I think that Chairman Baucus is in a difficult position. I think he's being required by his caucus to fulfill a campaign promise which is not very wise or popular. We've reduced costs and prices dramatically by the [MMA]. We don't need to mess it up by having direct negotiation by the U.S. government.â€
Well said,but there's something else -- comparative effectiveness.
Senator Baucus' bill (which I have not seen -- so my comments here are based on what I've heard) would also require HHS to set comparative effectiveness priorities without mandating additional ressearch. In other words, comparative effectiveness based on existing RCTs.
Another example of evidence-based medicine being hijacked by cost-based medicine -- while patient-centric care goes unnoticed and unheeded.
How about a bill that would fund research into adaptive clinical trial design and the development of gene tests for the purpose of getting the right medicine in the right dose to the right patient at the right time?
No matter how you look at it, it's still momentum in the wrong direction. As Senator John Kyl commented, “I think that Chairman Baucus is in a difficult position. I think he's being required by his caucus to fulfill a campaign promise which is not very wise or popular. We've reduced costs and prices dramatically by the [MMA]. We don't need to mess it up by having direct negotiation by the U.S. government.â€
Well said,but there's something else -- comparative effectiveness.
Senator Baucus' bill (which I have not seen -- so my comments here are based on what I've heard) would also require HHS to set comparative effectiveness priorities without mandating additional ressearch. In other words, comparative effectiveness based on existing RCTs.
Another example of evidence-based medicine being hijacked by cost-based medicine -- while patient-centric care goes unnoticed and unheeded.
How about a bill that would fund research into adaptive clinical trial design and the development of gene tests for the purpose of getting the right medicine in the right dose to the right patient at the right time?
In 2002, Oxfam International announced a boycott of Israeli goods grown or manufactured in what its literature refers to as the "occupied territories." Last year it blamed Tony Blair for his one sided support of Israel in it's war against Hezbollah. Now of course it supports the Thai dictatorship's effort to seize the IP of drug companies even as they give away free drugs to poor countries.
Just my effort to maintain moral clarity.
Just my effort to maintain moral clarity.
an interesting study about one of a new wave of vaccines for influenza. I am glad to see the move starting away from egg-based technologies to more genetic technologies. It will enable us to respond to an emerging virus rather than have to anticipate one. I am quoted accurately on this here in the HealthDay piece about it:
http://www.forbes.com/forbeslife/health/feeds/hscout/2007/04/10/hscout603589.html
http://www.forbes.com/forbeslife/health/feeds/hscout/2007/04/10/hscout603589.html
Catch the last episode of "The Sopranos?" Yeah, the one where Tony and crew go to Canada and discuss how they can make a pile of dough by importing fake/expired Fosamax.
Could James Gandolfini be positioning himself as the next actor to turn politician? After all, since everyone seems to support pols who support "drugs from Canada," his odds for election might be pretty good.
Perhaps the next step will be to see if he's called by the HELP committee to testify on whether or not importation should be written into PDUFA IV.
Bada Bing!
We'll keep a drugwonks eye on Mr. Gandolfini's activities -- cautiously.
Could James Gandolfini be positioning himself as the next actor to turn politician? After all, since everyone seems to support pols who support "drugs from Canada," his odds for election might be pretty good.
Perhaps the next step will be to see if he's called by the HELP committee to testify on whether or not importation should be written into PDUFA IV.
Bada Bing!
We'll keep a drugwonks eye on Mr. Gandolfini's activities -- cautiously.
On April 9th the New York Times editorial page weighed on the issue of subsidized contraception for university students:
“For almost 20 years, college health centers have been able to purchase contraceptives at nominal prices. This was not a tax-funded subsidy. It was a financial incentive that gave drug manufacturers an exemption from Medicaid pricing rules so they could sell contraceptives and other products to certain charitable groups, like the college clinics, at an extreme discount. In response to concerns that drug companies were abusing this privilege, language was sewn into legislation in 2005 to close a loophole. It also inadvertently slashed this important benefit for clinics and their patients.â€
“On some college campuses, the price of brand-name contraceptives has risen from the neighborhood of $5 per month to $40 or even $50. Switching to a generic is an option in some cases, but it can still entail a 300 percent price increase. Generics often run at about $15 per month. Newer contraceptives, like the NuvaRing, which contains a very low hormone dose and does not require a daily action that is easily forgotten, are not yet available generically. Many students are priced out of the market.â€
“The spike in price affects more than just consumers of contraceptive devices and pills. College and university health clinics sold these products for a small profit — buying them at, say, $3 and selling them at $5. Even on a small campus, these dollars add up quickly. The money was an important part of health center operating budgets, paying for classes and even subsidizing more expensive medications.â€
“The Centers for Medicare and Medicaid Services could reapply these exemptions with the stroke of a pen. If they do not, Congress should restore this much-needed benefit.â€
Spot the inconsistency?
How can you be FOR a government program that provides access to new (and more expensive) treatments (like the NuvaRing) while at the same time being FOR a piece of legislation that would create restrictive formularies that would deny access to new (and more expensive) treatments (like on-patent statins)?
This is the same editorial page that is all gung-ho in support of reversing the non-interference clause and embracing comparative effectiveness measures. It seems that the Gray Lady considers contraception more important than cholesterol.
But you can’t have it both ways.
Further, when government dictates prices, what also goes by the boards is the incentive to develop new products at all.
But, when it comes to contraception, it seems there isn't any such thing as a "me too" product.
(And there isn't.)
“For almost 20 years, college health centers have been able to purchase contraceptives at nominal prices. This was not a tax-funded subsidy. It was a financial incentive that gave drug manufacturers an exemption from Medicaid pricing rules so they could sell contraceptives and other products to certain charitable groups, like the college clinics, at an extreme discount. In response to concerns that drug companies were abusing this privilege, language was sewn into legislation in 2005 to close a loophole. It also inadvertently slashed this important benefit for clinics and their patients.â€
“On some college campuses, the price of brand-name contraceptives has risen from the neighborhood of $5 per month to $40 or even $50. Switching to a generic is an option in some cases, but it can still entail a 300 percent price increase. Generics often run at about $15 per month. Newer contraceptives, like the NuvaRing, which contains a very low hormone dose and does not require a daily action that is easily forgotten, are not yet available generically. Many students are priced out of the market.â€
“The spike in price affects more than just consumers of contraceptive devices and pills. College and university health clinics sold these products for a small profit — buying them at, say, $3 and selling them at $5. Even on a small campus, these dollars add up quickly. The money was an important part of health center operating budgets, paying for classes and even subsidizing more expensive medications.â€
“The Centers for Medicare and Medicaid Services could reapply these exemptions with the stroke of a pen. If they do not, Congress should restore this much-needed benefit.â€
Spot the inconsistency?
How can you be FOR a government program that provides access to new (and more expensive) treatments (like the NuvaRing) while at the same time being FOR a piece of legislation that would create restrictive formularies that would deny access to new (and more expensive) treatments (like on-patent statins)?
This is the same editorial page that is all gung-ho in support of reversing the non-interference clause and embracing comparative effectiveness measures. It seems that the Gray Lady considers contraception more important than cholesterol.
But you can’t have it both ways.
Further, when government dictates prices, what also goes by the boards is the incentive to develop new products at all.
But, when it comes to contraception, it seems there isn't any such thing as a "me too" product.
(And there isn't.)
Let's get real -- a system in which a federal PBM "competes" with private-sector PBMs is unworkable and, over time, would result in a dysfunctional government monopoly.
PBMJ = Prescription Benefit Misjudgment.
At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.
At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.
Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.
This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.
Net/Net: a back-door route toward a VA-type pricing system.
Thanks to economist extraordinare Ben Zycher for the deep dive on PBM-land.
PBMJ = Prescription Benefit Misjudgment.
At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.
At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.
Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.
This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.
Net/Net: a back-door route toward a VA-type pricing system.
Thanks to economist extraordinare Ben Zycher for the deep dive on PBM-land.
This from Biocentury which I thought was a send up or parody of the extremes to which the FDA would have to go or bottoms of the barrels to which they would have to scrape -- you can choose your image -- in a search for untainted members or at least bias balance rather than just finding the best scientific minds to determine the risks and benefits of a medicine:
Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.
"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.
Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.
The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.
A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.
The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.
According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.
The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."
So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?
We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?
The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys.
Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.
"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.
Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.
The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.
A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.
The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.
According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.
The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."
So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?
We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?
The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys.
Rule Britainia? Time to change the rule.
From today's edition of the London Daily Mail, another example of so-called "evidence-based medicine" focusing on saving costs rather than saving lives.
Cut-price statins linked to increase in patient deaths
By RHODRI PHILLIPS
10th April 2007
Health chiefs are reviewing evidence which apparently shows a link between a cut-price statin and an increased risk of death among heart patients.
The drug, simvastatin, is taken by more than a million people to combat high cholesterol. Doctors were advised in January last year to prescribe it instead of more expensive atorvastatin.
But analysis carried out at University Hospital of North Staffordshire in Stoke-on-Trent shows that three times more patients on the cheaper drug died compared to those taking atorvastatin a year earlier. In the three months from December 2004 to February 2005, five out of 100 patients - or five per cent - prescribed atorvastatin died. But 20 of 121 patients - 17 per cent - on simvastatin died between December 2005 and February 2006.
Now the National Institute for Health and Clinical Excellence (NICE) is reviewing the use of simvastatin.
Dr Giri Rajaratnam, Stoke-on-Trent's public health director said: "NICE are doing a full-scale review of statins, looking at the balance between safety and effectiveness and severity of illness."
Two million people in Britain take statins to lower their cholesterol and help protect against the risk of stroke or heart attack. Since simvastatin was introduced three years ago as a cheaper option, 60 per cent have made the switch.
NICE, which advises NHS trusts on the use of drugs, said a 28-day course of simvastatin given to patients in 40mg doses, costing £3.57, was the equivalent to a 28-day course of 10mg atorvastatin tablets, costing £18.03.
Last year the British Medical Journal predicted the NHS could save £2billion within five years if doctors prescribe the cheaper drug. Simvastatin can be bought over the counter, while atorvastatin is only available on prescription.
Cardiologist Dr Rob Butler, who carried out the research, said: "A decision was taken between the local primary care trusts and the local National Health Service trust to switch to generic simvastatin.
"We decided to audit the effects. We were principally looking for differences in numbers of patients needing to be readmitted following discharge. But we were surprised when we saw such a difference in the death rate."
Dr Butler, who has previously received payment from a number of drugs companies, including Pfizer - which makes atorvastatin under the brand name Lipitor - also noticed more patients returning to hospital for further treatment after using simvastatin.
Dr Rajaratnam has also ordered a review into the statin drugs following Dr Butler's research. However, simvastatin is still being used.
A joint statement issued by the hospital and Stoke-on-Trent Primary Care Trust last week said their policy on statin use was consistent with NICE guidance.
It added: "To determine whether our policy should be amended in light of further evidence, the health economics unit at Birmingham University will consider whether any sub-groups of patients would benefit from intensification of their statin treatment.
"The North Staffordshire guideline will be reviewed in the light of its results."
The NICE advice published in January 2006 advised doctors to prescribe simvastatin as a first resort but to use their judgment if they thought another drug such as atorvastatin was more appropriate.
From today's edition of the London Daily Mail, another example of so-called "evidence-based medicine" focusing on saving costs rather than saving lives.
Cut-price statins linked to increase in patient deaths
By RHODRI PHILLIPS
10th April 2007
Health chiefs are reviewing evidence which apparently shows a link between a cut-price statin and an increased risk of death among heart patients.
The drug, simvastatin, is taken by more than a million people to combat high cholesterol. Doctors were advised in January last year to prescribe it instead of more expensive atorvastatin.
But analysis carried out at University Hospital of North Staffordshire in Stoke-on-Trent shows that three times more patients on the cheaper drug died compared to those taking atorvastatin a year earlier. In the three months from December 2004 to February 2005, five out of 100 patients - or five per cent - prescribed atorvastatin died. But 20 of 121 patients - 17 per cent - on simvastatin died between December 2005 and February 2006.
Now the National Institute for Health and Clinical Excellence (NICE) is reviewing the use of simvastatin.
Dr Giri Rajaratnam, Stoke-on-Trent's public health director said: "NICE are doing a full-scale review of statins, looking at the balance between safety and effectiveness and severity of illness."
Two million people in Britain take statins to lower their cholesterol and help protect against the risk of stroke or heart attack. Since simvastatin was introduced three years ago as a cheaper option, 60 per cent have made the switch.
NICE, which advises NHS trusts on the use of drugs, said a 28-day course of simvastatin given to patients in 40mg doses, costing £3.57, was the equivalent to a 28-day course of 10mg atorvastatin tablets, costing £18.03.
Last year the British Medical Journal predicted the NHS could save £2billion within five years if doctors prescribe the cheaper drug. Simvastatin can be bought over the counter, while atorvastatin is only available on prescription.
Cardiologist Dr Rob Butler, who carried out the research, said: "A decision was taken between the local primary care trusts and the local National Health Service trust to switch to generic simvastatin.
"We decided to audit the effects. We were principally looking for differences in numbers of patients needing to be readmitted following discharge. But we were surprised when we saw such a difference in the death rate."
Dr Butler, who has previously received payment from a number of drugs companies, including Pfizer - which makes atorvastatin under the brand name Lipitor - also noticed more patients returning to hospital for further treatment after using simvastatin.
Dr Rajaratnam has also ordered a review into the statin drugs following Dr Butler's research. However, simvastatin is still being used.
A joint statement issued by the hospital and Stoke-on-Trent Primary Care Trust last week said their policy on statin use was consistent with NICE guidance.
It added: "To determine whether our policy should be amended in light of further evidence, the health economics unit at Birmingham University will consider whether any sub-groups of patients would benefit from intensification of their statin treatment.
"The North Staffordshire guideline will be reviewed in the light of its results."
The NICE advice published in January 2006 advised doctors to prescribe simvastatin as a first resort but to use their judgment if they thought another drug such as atorvastatin was more appropriate.
http://www.tnr.com/doc.mhtml?i=w070409&s=cohn041007
According to Jonathan Cohn of The New Republic universal health care ala Europe (note he excludes Canada!) is a great model for America because....
"You don't see their citizens choosing between prescriptions and groceries, or declaring bankruptcy, because of medical bills. "
Well Jon, that's because the European bankruptcy system is based on a debt counseling model while in the US (and Canada) we have an easier path to permit public assumption of private debt. Given Canada's social safety net, in 1997, the incidence of personal bankruptcy was 3 in 1000 there cf to 5 in 1000 in the US.
Oh.
Moreover, according to the Federal Reserve, debt as a percentage of household income is higher in the UK, Japan and Canada than it is in the US (which has the same ratio as Germany and higher than France).
Oh.
There are surveys galore that also claim up to 35 percent of seniors choose between food and home heating bills.
Should we have universal food insurance or universal heating coverage too, with consumption and price levels set by government?
If Cohn and other liberals want to diddle around about whether you can get better care in the US or Europe or Canada or Japan that's fine. The reality is that everyone else waits longer than Americans for all kinds of care, particularly cancer care and low birth weight babies are less likely to receive life sustaining care anywhere else on the planet. We do have gaps and holes in our system of coverage but they are created because of duplication and regulations that protect corporations, insurance companies and unions from market competition.
America has a health system better prepared to deal with an aging society, better positioned to invest in the health of its citizens for long term prosperity and independence, more dedicated to extending and enriching life at both it's beginning and end and poised to achieve in greater gains against infectious diseases and chronic illnesses than any other nation in the history of mankind.
Europe's health care system is tethered to an unsustainable method of financing --a shrinking work force paying higher taxes -- and is propped up in the short term as it's military by an indirect subsidy from America's technological superiority and inventiveness. That too is coming to a quick end as health systems throughout the continent are explicitly and implicitly rationing access to the best and newer medicines.
Cohn and other liberals want us to believe universal health care leads to better health. But the gap in health status between rich and poor, educated and uneducated here and abroad are largely the same.. Health care might be free but if you lead a chaotic and disorganized life or engage in risky behavior or postpone seeking care your chances of survival decline. And time is not free to anyone regardless of income. Ultimately, time has a cost and it exacts a particularly heavy one on the poor and elderly. Countries that ration access to the right treatment at the optimal time through waiting, canceling appointments, gatekeepers etc, step therapy kill their society from within.
As quick PS added April 11... The tool the Euros use to ration? Comparative effectiveness analysis. Which is what the Dems are pushing for in order to push down drug prices and access to new drugs.
According to Jonathan Cohn of The New Republic universal health care ala Europe (note he excludes Canada!) is a great model for America because....
"You don't see their citizens choosing between prescriptions and groceries, or declaring bankruptcy, because of medical bills. "
Well Jon, that's because the European bankruptcy system is based on a debt counseling model while in the US (and Canada) we have an easier path to permit public assumption of private debt. Given Canada's social safety net, in 1997, the incidence of personal bankruptcy was 3 in 1000 there cf to 5 in 1000 in the US.
Oh.
Moreover, according to the Federal Reserve, debt as a percentage of household income is higher in the UK, Japan and Canada than it is in the US (which has the same ratio as Germany and higher than France).
Oh.
There are surveys galore that also claim up to 35 percent of seniors choose between food and home heating bills.
Should we have universal food insurance or universal heating coverage too, with consumption and price levels set by government?
If Cohn and other liberals want to diddle around about whether you can get better care in the US or Europe or Canada or Japan that's fine. The reality is that everyone else waits longer than Americans for all kinds of care, particularly cancer care and low birth weight babies are less likely to receive life sustaining care anywhere else on the planet. We do have gaps and holes in our system of coverage but they are created because of duplication and regulations that protect corporations, insurance companies and unions from market competition.
America has a health system better prepared to deal with an aging society, better positioned to invest in the health of its citizens for long term prosperity and independence, more dedicated to extending and enriching life at both it's beginning and end and poised to achieve in greater gains against infectious diseases and chronic illnesses than any other nation in the history of mankind.
Europe's health care system is tethered to an unsustainable method of financing --a shrinking work force paying higher taxes -- and is propped up in the short term as it's military by an indirect subsidy from America's technological superiority and inventiveness. That too is coming to a quick end as health systems throughout the continent are explicitly and implicitly rationing access to the best and newer medicines.
Cohn and other liberals want us to believe universal health care leads to better health. But the gap in health status between rich and poor, educated and uneducated here and abroad are largely the same.. Health care might be free but if you lead a chaotic and disorganized life or engage in risky behavior or postpone seeking care your chances of survival decline. And time is not free to anyone regardless of income. Ultimately, time has a cost and it exacts a particularly heavy one on the poor and elderly. Countries that ration access to the right treatment at the optimal time through waiting, canceling appointments, gatekeepers etc, step therapy kill their society from within.
As quick PS added April 11... The tool the Euros use to ration? Comparative effectiveness analysis. Which is what the Dems are pushing for in order to push down drug prices and access to new drugs.
In an effort to find a counterpoint to industry concerns about follow on biologic legislation (here's goes my chance to land on his speed dial) Robert Pear mis-characterizes Janet Woodcock's clear and unambiguous testimony stating that the FDA had the regulatory authority and know how to develop a pathway for the approval of FOBs. He makes it seem that Woodcock claims you don't need human testing to establish that two biologics are interchangeable.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''
Woodcock said nothing of the sort. Here is what she said:
"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."
Here is a link to Dr. Woodcock's testimony.
http://www.fda.gov/ola/2007/protein32607.html
Pear thinks it gave legislation for FOBs an "unexpected boost."
Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''
Woodcock said nothing of the sort. Here is what she said:
"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."
Here is a link to Dr. Woodcock's testimony.
http://www.fda.gov/ola/2007/protein32607.html
Pear thinks it gave legislation for FOBs an "unexpected boost."
Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings.
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