Latest Drugwonks' Blog
Make that a Troy ounce.
According to the Wall Street Journal …
“Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.â€
A victory for Merck, sure – but more importantly, a victory for FDA authority -- and for sanity.
As Dan Troy has written:
“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations.â€
“FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.â€
Amen.
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations.
According to the Wall Street Journal …
“Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.â€
A victory for Merck, sure – but more importantly, a victory for FDA authority -- and for sanity.
As Dan Troy has written:
“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations.â€
“FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.â€
Amen.
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations.
What does the FDA do when a drug is demonstrably safe and efficacious compared to a placebo. It usually approves the drug. In the case of Merck's new COX-2, the AdCom reviewing the drug -- which now includes a lawyer suing Merck -- acknowledged that Arcoxia has the same risk profile as many other painkillers. But the FDA wanted evidence that it met some unmet medical need in a subpopulation.
How about people like me or millions of others who did well on Vioxx or Bextra that have neither?
Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.
According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.
In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.
Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims.
How about people like me or millions of others who did well on Vioxx or Bextra that have neither?
Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.
According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.
In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.
Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims.
Nevada legislators are once again rolling the dice on patient safety. This time it's not some half-baked and benighted scheme for cheap "Canadian" drugs, but rather an ill-considered plan to build a chinese wall around physician-prescribing data.
Here's the full news story:
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html
While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.†In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.
Here's the full news story:
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html
While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.†In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.
Liberal bloggers on health care who?
The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?
Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).
Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:
* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."
* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.
* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.
Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."
Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal (read "anti-Pharma") voice.
Here's a link to the complete report:
http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf
And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.
As far as I'm concerned -- the more the better.
The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?
Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).
Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:
* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."
* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.
* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.
Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."
Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal (read "anti-Pharma") voice.
Here's a link to the complete report:
http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf
And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.
As far as I'm concerned -- the more the better.
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.
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.
