Latest Drugwonks' Blog
CMS Floats Trial Balloon for Part D Data Sharing Initiative
Drug Industry Daily
By: Stephen Langel
The Centers for Medicare & Medicaid Services (CMS) is using a proposed rule issued today to test the legal waters for its plan to collect and share prescription drug plan data to base Medicare reimbursements on product comparisons, sources say.
The proposed rule would require any entities offering prescription drug coverage under the Medicare Rx law to provide the CMS with data about the products they offer, including drugs, biologics and medical devices, as part of their contracts with the government. "Through the appropriate use of the new prescription drug claims data, we have an unprecedented resource to help us learn more about prescription drug usage by seniors and how we can help seniors get the most benefit from prescription drugs," former CMS Administrator Mark McClellan said.
The CMS would then use the data, which includes various measures of the products' cost, to improve the workings of the Medicare program, according to the rule. The agency would also share this data with the FDA to "provide protection against adverse drug events" and with HHS' Agency for Healthcare Research and Quality's (AHRQ) to do comparative drug studies.
This development comes weeks after the initiative seemed dead because of questions regarding CMS' statutory authority (DID, Oct. 2). The agency is using the proposed rule to make legal arguments supporting the policy. "We are engaging in this rulemaking in order to resolve the statutory ambiguity," the rule said.
The agency believes that it has "broad authority" under the Medicare Rx law to share such data. Section 1860D-12(b)(3)(D) of the law provides the HHS secretary with the authority to "collect a broad array of data in order to properly carry out his responsibilities," the rule said. But the section also limits use of the data to work necessary to carry out the act.
However, the agency believes the law gives it some leeway, saying that if the secretary believes it is necessary and appropriate to carry out responsibilities even outside the scope of the section, he has the authority to do so.
The proposed rule prompted a strong response by both supporters and opponents of comparative trials. Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, told DID the rule is the foundation for cost-based medical coverage that shortchanges the public and "sets an extremely dangerous precedent." The CMS is "trying to take authority away from the doctors and give it to the accountants."
While McClellan had proposed comparative trials as a way to ensure the best medicines were covered, without him leading the agency this decision will devolve into a purely cost-based decision, Pitts added. "Once he's out the door, there's no guarantee" that this program will be run correctly. McClellan left the CMS last week for the American Enterprise Institute-Brookings Joint Center for Regulatory Studies.
PhRMA is cautiously optimistic about the rule. Comparative data "can offer a valuable source of information," a spokesman said. But research based on that data has a number of limitations, he added.
However, public interest groups such as Consumers Union have long supported this strategy and lauded the rule. "The CMS initiative is very exciting, and holds out the promise for major advances in understanding what works and doesn't work in the world of pharmaceuticals, and where short-term adverse reactions and long-term dangers may be lurking," Bill Vaughan, the group's senior health analyst, told DID.
The key to the program's success is not the rule itself, but the FDA obtaining sufficient funding to use the data, he added. The agency needs money from the Prescription Drug User Fee Act to "mine the CMS data for the gold nuggets of knowledge that it can offer. With adequate support, the FDA can use the CMS database to make the adverse event reporting system and
other postmarket approval monitoring work the way that consumers hope and expect."
Drug Industry Daily
By: Stephen Langel
The Centers for Medicare & Medicaid Services (CMS) is using a proposed rule issued today to test the legal waters for its plan to collect and share prescription drug plan data to base Medicare reimbursements on product comparisons, sources say.
The proposed rule would require any entities offering prescription drug coverage under the Medicare Rx law to provide the CMS with data about the products they offer, including drugs, biologics and medical devices, as part of their contracts with the government. "Through the appropriate use of the new prescription drug claims data, we have an unprecedented resource to help us learn more about prescription drug usage by seniors and how we can help seniors get the most benefit from prescription drugs," former CMS Administrator Mark McClellan said.
The CMS would then use the data, which includes various measures of the products' cost, to improve the workings of the Medicare program, according to the rule. The agency would also share this data with the FDA to "provide protection against adverse drug events" and with HHS' Agency for Healthcare Research and Quality's (AHRQ) to do comparative drug studies.
This development comes weeks after the initiative seemed dead because of questions regarding CMS' statutory authority (DID, Oct. 2). The agency is using the proposed rule to make legal arguments supporting the policy. "We are engaging in this rulemaking in order to resolve the statutory ambiguity," the rule said.
The agency believes that it has "broad authority" under the Medicare Rx law to share such data. Section 1860D-12(b)(3)(D) of the law provides the HHS secretary with the authority to "collect a broad array of data in order to properly carry out his responsibilities," the rule said. But the section also limits use of the data to work necessary to carry out the act.
However, the agency believes the law gives it some leeway, saying that if the secretary believes it is necessary and appropriate to carry out responsibilities even outside the scope of the section, he has the authority to do so.
The proposed rule prompted a strong response by both supporters and opponents of comparative trials. Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, told DID the rule is the foundation for cost-based medical coverage that shortchanges the public and "sets an extremely dangerous precedent." The CMS is "trying to take authority away from the doctors and give it to the accountants."
While McClellan had proposed comparative trials as a way to ensure the best medicines were covered, without him leading the agency this decision will devolve into a purely cost-based decision, Pitts added. "Once he's out the door, there's no guarantee" that this program will be run correctly. McClellan left the CMS last week for the American Enterprise Institute-Brookings Joint Center for Regulatory Studies.
PhRMA is cautiously optimistic about the rule. Comparative data "can offer a valuable source of information," a spokesman said. But research based on that data has a number of limitations, he added.
However, public interest groups such as Consumers Union have long supported this strategy and lauded the rule. "The CMS initiative is very exciting, and holds out the promise for major advances in understanding what works and doesn't work in the world of pharmaceuticals, and where short-term adverse reactions and long-term dangers may be lurking," Bill Vaughan, the group's senior health analyst, told DID.
The key to the program's success is not the rule itself, but the FDA obtaining sufficient funding to use the data, he added. The agency needs money from the Prescription Drug User Fee Act to "mine the CMS data for the gold nuggets of knowledge that it can offer. With adequate support, the FDA can use the CMS database to make the adverse event reporting system and
other postmarket approval monitoring work the way that consumers hope and expect."
George Orwell said, “Saints should always be judged guilty until they are proved innocent.†Les Crawford is no saint. He is just an American who served his country and the public health well over many years.
Hang in there Lester.
Hang in there Lester.
How is the spread of counterfeit prescription drugs being addressed in China?
Interesting new article in "Insight" (the official publication of the American Chamber of Commerce in Shanghai) that, indeed, offers insight into the views of PRC officials -- and the actions they are taking (or say they are taking) to combat the issue of prescription drug counterfeiting (aka: international health care terrorism).
See for yourself:
COVER STORY: Counterfeit Cures
Interesting new article in "Insight" (the official publication of the American Chamber of Commerce in Shanghai) that, indeed, offers insight into the views of PRC officials -- and the actions they are taking (or say they are taking) to combat the issue of prescription drug counterfeiting (aka: international health care terrorism).
See for yourself:
COVER STORY: Counterfeit Cures
The announcement that Genentech is going to cap the cost of Avastin was met with derision and skepticism -- if you read the accounts in MSM. Critics assert that drugs like Avastin and Revlimid are not worth their price. But a complaint is not a statement supported by analysis. The Lenny Saltz school of public policy is to use the price of 25 year old cancer drugs as a benchmark and then loudly bleat that new drugs don't add anything in terms of survival.
A more thoughtful and scholarly approach is taken by Richard Gralla of the NY Lung Cancer Alliance. Dr. Gralla was quoted by Andrew Pollack of the NY Times as say that Avastin is not "cost effective to society." But that is not what Dr. Gralla said exactly. I called Dr. Gralla up because in light of his research with other drugs to treat lung cancer -- which focused on improving quality of life -- the statement seemed cold and too dispassionate. What Gralla told me -- and I am paraphrasing here -- is that most new cancer drugs that are based on new pathways and novel mechanisms while only improving survival by a couple of months in the sickest patients are by definition advances. Are they cost-effective? By virtue of the fact that they add -- on average -- little to life expectancy most new targeted therapies are NOT cost effective to society if you use the old measure of a quality adjusted life year being worth $50000 or less.
But University of Chicago economists Kevin Murphy and Robert Topel have found that: "eliminating deaths from cancer would be worth $47 trillion to Americans. In other words, Americans would be willing to pay this amount to achieve such an increase in the length and quality of their lives."
Hence, the potential benefits of increased spending on medical innovation are so huge, especially compared with the cost or illnes, that much higher expenditures on medicines, diagnostics, etc are justified, along with the prices that are required to sustain investment "even if they only yield small declines in death rates." See the article "The Cost of Living" in Chicago Business School magazine.
http://chicagogsb.edu/magazine/S00/research1.html
One other point: the Avastin cost cap reflects an acknowledgement that different groups of people, with different diseases at different stages, genetic and clinical characteristics will require variations in doses. Drugs are going to have be part of solution and not sold as a stand alone product. "More" will be replaced with "optimal" and the standard will be "value" not "cost-effective."
A more thoughtful and scholarly approach is taken by Richard Gralla of the NY Lung Cancer Alliance. Dr. Gralla was quoted by Andrew Pollack of the NY Times as say that Avastin is not "cost effective to society." But that is not what Dr. Gralla said exactly. I called Dr. Gralla up because in light of his research with other drugs to treat lung cancer -- which focused on improving quality of life -- the statement seemed cold and too dispassionate. What Gralla told me -- and I am paraphrasing here -- is that most new cancer drugs that are based on new pathways and novel mechanisms while only improving survival by a couple of months in the sickest patients are by definition advances. Are they cost-effective? By virtue of the fact that they add -- on average -- little to life expectancy most new targeted therapies are NOT cost effective to society if you use the old measure of a quality adjusted life year being worth $50000 or less.
But University of Chicago economists Kevin Murphy and Robert Topel have found that: "eliminating deaths from cancer would be worth $47 trillion to Americans. In other words, Americans would be willing to pay this amount to achieve such an increase in the length and quality of their lives."
Hence, the potential benefits of increased spending on medical innovation are so huge, especially compared with the cost or illnes, that much higher expenditures on medicines, diagnostics, etc are justified, along with the prices that are required to sustain investment "even if they only yield small declines in death rates." See the article "The Cost of Living" in Chicago Business School magazine.
http://chicagogsb.edu/magazine/S00/research1.html
One other point: the Avastin cost cap reflects an acknowledgement that different groups of people, with different diseases at different stages, genetic and clinical characteristics will require variations in doses. Drugs are going to have be part of solution and not sold as a stand alone product. "More" will be replaced with "optimal" and the standard will be "value" not "cost-effective."
That's the headline of an article in today's USA Today. Yes, USA Today. Welcome to the mainstream debate over whether "evidence-based medicine" means cost-based reimbursement or patient-centric treatment.
Have a look:
http://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm
Have a look:
http://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm
The word is that drug companies are now seeking to determine whether diabetes drugs can be used to prevent diabetes in those people who are on the cusp of the condition. I am waiting for the Seattle Times or another media outlet to run a story claiming that this effort to treat diabetes before it progresses is disease mongering designed to "get rich" just as it slimed effort to treat "pre-hypertension" as disease mongering a while ago. But of course, rolling out high priced products to treat people who are very sick is gouging those who have no choice. And since the data comes from drug companies or researchers who receive drug company money, the results can't be trusted in any event.
So we should simply ignore the evidence and medicine until truly pure research conducted on people at death's door is generated and results in medicines that are given away for free or at a generic price are made available.
But maybe I am being too idealistic....
So we should simply ignore the evidence and medicine until truly pure research conducted on people at death's door is generated and results in medicines that are given away for free or at a generic price are made available.
But maybe I am being too idealistic....
Another example of how and why drug safety is divorced from personal responsibility...talk shows seeking to depict those who abuse them as victims. This is post from an Ambien addiction website:
Hi Everyone,
I've been reading everyone's posts and I can truly say that Ambien seems to be affecting more and more people in this regard than many might think. I'm an associate producer for the Montel Williams Show and we're currently doing research on Ambien addiction and sleep disorders in conjunction with a sleep clinic here in NY. If you're interested in trying to beat this addiction or if you would like to share your story regarding sleep disorders, you're not alone and maybe we can help.
Feel free to contact me any time for more information
mike@montelshow.com
Now in fairness Montel Williams usually plays this kind of thing straight but to suggest that "Ambien affects more and more people..." is the sort of claim that one hopes is placed in context.
Hi Everyone,
I've been reading everyone's posts and I can truly say that Ambien seems to be affecting more and more people in this regard than many might think. I'm an associate producer for the Montel Williams Show and we're currently doing research on Ambien addiction and sleep disorders in conjunction with a sleep clinic here in NY. If you're interested in trying to beat this addiction or if you would like to share your story regarding sleep disorders, you're not alone and maybe we can help.
Feel free to contact me any time for more information
mike@montelshow.com
Now in fairness Montel Williams usually plays this kind of thing straight but to suggest that "Ambien affects more and more people..." is the sort of claim that one hopes is placed in context.
do prices never increase...as in the average premiums of Medicare part D plans. In the first phase of the program some plans had some incredibly low monthly premiums...about $4 a month for a standard plan with $250 deductible. Now these plans are raising the deductible to about $11 a month -- the outrage! -- with some plans that have no deductible actually lowering their premiums. That's what Aetna and Humana have done with some plans that fill the coverage gap. And some managed care plans are lowering premiums for programs that include drugs and all other care -- integrating coverage in order to insure that drugs are used to reduce the total cost of care if possible. But that never enters into Waxman's calculations.
I've penned a new op-ed running in today's edition of the San Diego Union-Tribune on the issue that won't go away -- drug importation. Even though it says it's authored by Leonard Pitts, it's actually written by yours truly (note citation at the end of the article). We rarely get confused in person.
Click on this link and then go to "Today's Paper" and then to "Opinion."
http://www.signonsandiego.com
Have a look and spread the word that we must transcend the soundbites about drug importation.
Click on this link and then go to "Today's Paper" and then to "Opinion."
http://www.signonsandiego.com
Have a look and spread the word that we must transcend the soundbites about drug importation.
From today's edition of the Wall Street Journal ...
Faster FDA Cures
Whoever controls Congress next year, the Food and Drug Administration is sure to be a political battleground. The controversial Prescription Drug User Fee Act of 1992 is scheduled for reauthorization, and the conventional political wisdom holds that the FDA is too "cozy" with Big Pharma and thus overeager to rubber-stamp dangerous new drugs.
So allow us to draw attention to an important and undernoticed study, "Assessing the Safety and Efficacy of the FDA," published by the National Bureau of Economic Research. Its surprising conclusion is that the FDA does a pretty good job managing "the central speed-safety trade-off" involved in drug approvals -- and might even do well to move faster.
The authors looked at 662 drugs approved between 1979 and 2002, a period that included the passage of the Prescription Drug User Fee Act that allowed drug companies to help fund the FDA budget in exchange for faster reviews. They found that the resulting modest gains in drug review times have produced unambiguous public benefits.
In monetary terms, the authors estimate that the law improved consumer welfare by as much as $19 billion. But more importantly, they found that more rapid access to beneficial drugs saved between 180,000 and 310,000 "life-years." By contrast, assuming that every risky drug withdrawn in that period was the fault of the Prescription Drug User Fee Act produces an upper-bound estimate of only 56,000 life-years lost.
This study deserves a lot more attention than it's been getting, since the Washington debate is dominated by bad ideas about how to make FDA regulation much more onerous. In particular, a recent report from the National Academy of Science's Institute of Medicine (IOM) is being spun as evidence that the FDA is somehow "broken" and in need of fundamental reform.
We've looked at the IOM report in detail, and it's hardly as damning of the FDA as media reports suggest. For example, the report explicitly rejects the idea that high-profile drug withdrawals -- such as Vioxx -- "represent de facto failures of the drug safety regulatory system. . . This is not so." The IOM also rejects the basic idea behind legislation sponsored by Senators Chuck Grassley and Chris Dodd that the FDA should have a drug safety office separate from the office that approves drugs in the first place: "Risk and benefit cannot be considered in isolation from one another."
But despite these sensible observations, the IOM still wants more regulation. Among its recommendations are vastly increased levels of post-approval safety monitoring. That might make sense if the goal is making regulators comfortable with the idea of approving drugs more quickly. But that doesn't appear to be what the IOM and its cheering section want.
The IOM also proposes draconian restrictions on new-drug advertising and tighter conflict-of-interest standards for FDA advisory panel members. This despite the fact that the most qualified scientists and doctors have substantial sources of private income, and despite a study by the Naderite Public Citizen group that failed to find one instance of a panel recommendation that would have changed if allegedly conflicted members had been excluded.
Most fundamentally, the IOM presents little evidence that there is even a problem to remedy. By contrast, the National Bureau authors at least attempt to put some real facts on the table. They note that the absence of other attempts at hard, quantitative analysis in the great FDA debate is "somewhat paradoxical, since despite the agency's strict adherence to evidence-based evaluation of products overseen, there is less evidence on its own safety and efficacy. Put differently, no product application would pass the FDA approval process with the quality and type of evidence that currently exists for evaluating the FDA policies themselves."
The upshot of the economists' report is that the 1992 Prescription Drug User Fee Act deserves reauthorization. But the evidence also suggests Congress should probably be looking for other ways to make FDA approvals still faster. Despite the high-profile Vioxx panic, the FDA is far more likely to kill by depriving you of a drug than allowing you to take a dangerous one.
Faster FDA Cures
Whoever controls Congress next year, the Food and Drug Administration is sure to be a political battleground. The controversial Prescription Drug User Fee Act of 1992 is scheduled for reauthorization, and the conventional political wisdom holds that the FDA is too "cozy" with Big Pharma and thus overeager to rubber-stamp dangerous new drugs.
So allow us to draw attention to an important and undernoticed study, "Assessing the Safety and Efficacy of the FDA," published by the National Bureau of Economic Research. Its surprising conclusion is that the FDA does a pretty good job managing "the central speed-safety trade-off" involved in drug approvals -- and might even do well to move faster.
The authors looked at 662 drugs approved between 1979 and 2002, a period that included the passage of the Prescription Drug User Fee Act that allowed drug companies to help fund the FDA budget in exchange for faster reviews. They found that the resulting modest gains in drug review times have produced unambiguous public benefits.
In monetary terms, the authors estimate that the law improved consumer welfare by as much as $19 billion. But more importantly, they found that more rapid access to beneficial drugs saved between 180,000 and 310,000 "life-years." By contrast, assuming that every risky drug withdrawn in that period was the fault of the Prescription Drug User Fee Act produces an upper-bound estimate of only 56,000 life-years lost.
This study deserves a lot more attention than it's been getting, since the Washington debate is dominated by bad ideas about how to make FDA regulation much more onerous. In particular, a recent report from the National Academy of Science's Institute of Medicine (IOM) is being spun as evidence that the FDA is somehow "broken" and in need of fundamental reform.
We've looked at the IOM report in detail, and it's hardly as damning of the FDA as media reports suggest. For example, the report explicitly rejects the idea that high-profile drug withdrawals -- such as Vioxx -- "represent de facto failures of the drug safety regulatory system. . . This is not so." The IOM also rejects the basic idea behind legislation sponsored by Senators Chuck Grassley and Chris Dodd that the FDA should have a drug safety office separate from the office that approves drugs in the first place: "Risk and benefit cannot be considered in isolation from one another."
But despite these sensible observations, the IOM still wants more regulation. Among its recommendations are vastly increased levels of post-approval safety monitoring. That might make sense if the goal is making regulators comfortable with the idea of approving drugs more quickly. But that doesn't appear to be what the IOM and its cheering section want.
The IOM also proposes draconian restrictions on new-drug advertising and tighter conflict-of-interest standards for FDA advisory panel members. This despite the fact that the most qualified scientists and doctors have substantial sources of private income, and despite a study by the Naderite Public Citizen group that failed to find one instance of a panel recommendation that would have changed if allegedly conflicted members had been excluded.
Most fundamentally, the IOM presents little evidence that there is even a problem to remedy. By contrast, the National Bureau authors at least attempt to put some real facts on the table. They note that the absence of other attempts at hard, quantitative analysis in the great FDA debate is "somewhat paradoxical, since despite the agency's strict adherence to evidence-based evaluation of products overseen, there is less evidence on its own safety and efficacy. Put differently, no product application would pass the FDA approval process with the quality and type of evidence that currently exists for evaluating the FDA policies themselves."
The upshot of the economists' report is that the 1992 Prescription Drug User Fee Act deserves reauthorization. But the evidence also suggests Congress should probably be looking for other ways to make FDA approvals still faster. Despite the high-profile Vioxx panic, the FDA is far more likely to kill by depriving you of a drug than allowing you to take a dangerous one.
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.
