Latest Drugwonks' Blog
The version of comparative effectiveness legislation is a bit better than the previous... it mentions genomics, genetics, personalized medicine.. but most of the dough goes and is going to the usual suspects and slush funds. And molecular diagnostics are still being stiffed by demands for randomized clinical trials that have nothing to do with how they would be used to fill in knowledge gaps in the real world....
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President Obama says that, minus reform, healthcare will become like GM. But GM is already run by Uncle Sam.
A new report out of the CBO (Congressional Budget Office) throws some cold water reality on President Obama’s claim that the $2 trillion in healthcare costs he claims his“coalition partners” (PhRMA, AdvaMed, America's Health Insurance Plans, American Hospital Association, American Medical Association and Service Employees International Union) said they could trim will make much of a difference in long-term healthcare cost savings.
"What was originally offered up as a down payment on healthcare reform simply can't be accurately estimated by the CBO and will result in far less savings than the originally promised $2 trillion," said Republican senator Mike Enzi of Wyoming, the ranking member of the Senate health committee. "The administration will need to come up with far greater savings proposals – savings that Congress can take to the bank – to achieve the massive healthcare bill Democrats are proposing."
(In May, President Obama announced that six groups– had pledged to reduce healthcare spending growth by 1.5 percentage points annually over 10 years, saving an estimated $2 trillion. Within days of the announcement, reports surfaced that the groups had planned to ramp up to the 1.5 percentage point level over time, rather than committing to such savings annually.)
According to the CBO, extending prescription drug coverage to the entire population "would probably increase the deficit significantly", the CBO said. It also cited its December 2008 estimate that establishing a biosilimar approval pathway would yield federal savings of about $10 billion over the next decade. The December report estimated that an FOB measure with 12 years of innovator exclusivity would generate federal healthcare savings of $9.1-11.7 billion, with the larger figure contingent upon placement of FOBs in the same billing code as their branded counterparts for payments under the Medicare Part B program.
According to a story in SCRIP World Pharmaceutical News, “The budget office's brief analysis was released as healthcare reform activity in Washington reached a fevered pitch, much of it focused on the costs of a massive overhaul. Among the activity of note, the CBO released higher-than-expected cost estimates for reform legislation being considered by the Senate health committee, and the Obama Administration said it was working with Congress to extract $22 billion in savings over 10 years from the Part D drug programme, including lowering reimbursement of medicines for "dually eligible" individuals who qualify for both Medicare and Medicaid.”
Relative to the Affordable Health Choices Act, the CBO estimated the measure would cost the federal government $1 trillion over 10 years and result in a net decrease in the number of uninsured people by only 16 million.
Yeah – reality bites.
"What was originally offered up as a down payment on healthcare reform simply can't be accurately estimated by the CBO and will result in far less savings than the originally promised $2 trillion," said Republican senator Mike Enzi of Wyoming, the ranking member of the Senate health committee. "The administration will need to come up with far greater savings proposals – savings that Congress can take to the bank – to achieve the massive healthcare bill Democrats are proposing."
(In May, President Obama announced that six groups– had pledged to reduce healthcare spending growth by 1.5 percentage points annually over 10 years, saving an estimated $2 trillion. Within days of the announcement, reports surfaced that the groups had planned to ramp up to the 1.5 percentage point level over time, rather than committing to such savings annually.)
According to the CBO, extending prescription drug coverage to the entire population "would probably increase the deficit significantly", the CBO said. It also cited its December 2008 estimate that establishing a biosilimar approval pathway would yield federal savings of about $10 billion over the next decade. The December report estimated that an FOB measure with 12 years of innovator exclusivity would generate federal healthcare savings of $9.1-11.7 billion, with the larger figure contingent upon placement of FOBs in the same billing code as their branded counterparts for payments under the Medicare Part B program.
According to a story in SCRIP World Pharmaceutical News, “The budget office's brief analysis was released as healthcare reform activity in Washington reached a fevered pitch, much of it focused on the costs of a massive overhaul. Among the activity of note, the CBO released higher-than-expected cost estimates for reform legislation being considered by the Senate health committee, and the Obama Administration said it was working with Congress to extract $22 billion in savings over 10 years from the Part D drug programme, including lowering reimbursement of medicines for "dually eligible" individuals who qualify for both Medicare and Medicaid.”
Relative to the Affordable Health Choices Act, the CBO estimated the measure would cost the federal government $1 trillion over 10 years and result in a net decrease in the number of uninsured people by only 16 million.
Yeah – reality bites.
President Barack Obama, at a June 15 address on health care reform to the American Medical Association in Chicago, said that investments in expanding comparative effectiveness research and evidence-based medicine will not be used to limit physician flexibility in treatment decisions,
"Let me be clear, I want to clear something up here: identifying what works is not about dictating what kind of care should be provided," the president declared. "It's about providing patients and doctors with information they need to make the best medical decisions. I have the assumption that if you have good information about what makes your patients well, that's what you're going to do. I have confidence in that. We're not going to need to force you to do it; we just need to make sure you've got the best information available."
The words are the right words. But actions, as they say, speak louder.
"Let me be clear, I want to clear something up here: identifying what works is not about dictating what kind of care should be provided," the president declared. "It's about providing patients and doctors with information they need to make the best medical decisions. I have the assumption that if you have good information about what makes your patients well, that's what you're going to do. I have confidence in that. We're not going to need to force you to do it; we just need to make sure you've got the best information available."
The words are the right words. But actions, as they say, speak louder.
Here’s the media headline:
“The Food and Drug Administration told the makers of one of the country's most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam.”
Here’s the public health headline – It’s time to reform DSHEA.
In May 2007, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
That ruling was good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
It was a good question in May 2007; it’s a crucial public health question in June 2009. As an advisor to President Obama’s FDA transition team I raised the issue of DSHEA and at a recent meeting with Drs. Hamburg and Sharfstein I raised it again.
Oftentimes it takes an event (such as the Zicam action) to drive legislative change. Hopefully this will be one such opportunity.
DSHEA -- It's time for a change.
“The Food and Drug Administration told the makers of one of the country's most popular cold medications, Zicam, to stop selling its nasal spray and swabs. In the last ten years, about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using Zicam.”
Here’s the public health headline – It’s time to reform DSHEA.
In May 2007, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
That ruling was good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
It was a good question in May 2007; it’s a crucial public health question in June 2009. As an advisor to President Obama’s FDA transition team I raised the issue of DSHEA and at a recent meeting with Drs. Hamburg and Sharfstein I raised it again.
Oftentimes it takes an event (such as the Zicam action) to drive legislative change. Hopefully this will be one such opportunity.
DSHEA -- It's time for a change.
I chatted with members of the The Council for American Medical Innovation
It is a decidely bi-partisan and eclectic group that share a geniune concern about the future of biomedical innovation and whether it will come out whole in health care reform. I am an a priori skepticism about the value of such entities (my feeling about rock group re-union tours) but sincerity counts for a lot and this group has a passion for the issue, which of course I share. And they have framed the issues clearly as you can tell from the video. Coming to a town near you.
Click Here to View the Video
It is a decidely bi-partisan and eclectic group that share a geniune concern about the future of biomedical innovation and whether it will come out whole in health care reform. I am an a priori skepticism about the value of such entities (my feeling about rock group re-union tours) but sincerity counts for a lot and this group has a passion for the issue, which of course I share. And they have framed the issues clearly as you can tell from the video. Coming to a town near you.
Click Here to View the Video
A Trillion Dollars in Incompetence
By Robert M. Goldberg
Posted June 16, 2009
Bonaparte famously said to "never ascribe to malice that which can adequately be explained by incompetence."
Thus stands the Kennedy health care bill, placeholder for the hard left dream of a government takeover of the American health system. The bill is a taxpayer-supported monument to the lethal stupidity of this statist objective that will leave Americans with fewer choices, more government control over medical decisions, higher taxes, and a smaller private health insurance market (mostly union health plans paid for by taxes on the health benefits of non-union workers) that punishes efforts to reward healthy behavior.
Over ten years: 16 million more people with new insurance, 23 million forced into public plans. A trillion dollars at least. By way of comparison, from 1997 to 2006 the number of people with private health insurance grew by 5.4 million, while Medicaid and SCHIP coverage grew by 13 million for a total of 18.4 million. Total cost to the government: $40 billion. Total health care spending over that time period increased by one trillion. Meanwhile, most of the public health care coverage increase during that time -- 60 percent according to a Harvard University study -- displaced private health insurance coverage.
Could the Kennedy bill be any more inefficient at using taxpayer dollars to subsidize misshapen forms of health care coverage? Of course it could. And it is.
Yesterday President Obama told the American Medical Association that "a big part of what led General Motors and Chrysler into trouble were the huge costs they racked up providing health care for their workers -- costs that made them less profitable and less competitive with automakers around the world."
"If we do not fix our health care system America may go the way of GM -- paying more, getting less, and going broke."
Which is why Section 133 of the Kennedy bill grandfathers in every union-negotiated health plan that apes union health plans for workers and prohibits companies from transferring workers into the public "option."
Worried about the cost of retiree health benefits? No problem. "There is established in the Treasury of the United States a trust fund to be known as the Retiree Reserve Trust Fund that shall consist of such amounts as may be appropriated or credited to the Trust Fund as provided for in this subsection to enable the Secretary to carry out the program under this section. Such amounts shall remain available until expended." ("Such amounts" is Washingtonspeak for bottomless pit.) It pays for insurance benefits and 80 percent of claims from $15,000 to $90,000 for all retirees (ages 54-64). Initial cost of this "trust fund": $10 billion.
The Kennedy bill pays for $1 trillion in ineptitude in four ways.
First, it borrows. But who's counting or keeping track?
Second, it creates "Gateways" that are supposed to create groups of purchasers to reduce the cost of insurance. In fact, since insurance companies have already made it clear that they can provide guaranteed coverage without regard to the size of purchasing pools, why are such Gateways necessary? Because, as agents of the federal government, Gateways collect a tax on the insurance premiums of the young, healthy and health-conscious to subsidize the cost of insurance for those who now have no incentive to improve their health.
In fact, insurance plans that actually do a better job of controlling costs or keeping premiums low with better quality are punished under the Kennedy bill: "Any State or participating State shall assess a charge on health plans and health insurance issuer (with respect to health insurance coverage) if the actuarial risk of the enrollees of such plans or coverage for a year is less than the average actuarial risk of all enrollees in all plans or coverage in such State for such years."
Third, in order to subsidize the sort of health plans that broke the bank at GM, the Kennedy bill taxes the health benefits of others, particular those in self-insured corporations that are doing the most innovative things to improve quality and reduce costs.
Fourth, the Kennedy bill gives a Medical Advisory Council power to determine what new technologies and benefits can be covered and are introduced. It's the same technique Obama wants to use to curb the rate of growth in Medicare. John McCain suggested paying for his health care tax credit plan with Medicare savings. During the election, Obama said that "would mean fewer places to get care, and less freedom to choose your own doctors…. I don't think that's right."
Today, Obama would slash payments and choices to seniors -- mostly the sickest -- to help pay for GM-type health plans, retiree slush funds, and the mass relocation of middle-class Americans into a richer version of the Indian Health Service. On top of that, the Kennedy bill costs $1 trillion to "cover" 16 million new people in the process. By tossing 40 million out of private insurance no less. Not only is it not right. It's incompetent.
By Robert M. Goldberg
Posted June 16, 2009
Bonaparte famously said to "never ascribe to malice that which can adequately be explained by incompetence."
Thus stands the Kennedy health care bill, placeholder for the hard left dream of a government takeover of the American health system. The bill is a taxpayer-supported monument to the lethal stupidity of this statist objective that will leave Americans with fewer choices, more government control over medical decisions, higher taxes, and a smaller private health insurance market (mostly union health plans paid for by taxes on the health benefits of non-union workers) that punishes efforts to reward healthy behavior.
Over ten years: 16 million more people with new insurance, 23 million forced into public plans. A trillion dollars at least. By way of comparison, from 1997 to 2006 the number of people with private health insurance grew by 5.4 million, while Medicaid and SCHIP coverage grew by 13 million for a total of 18.4 million. Total cost to the government: $40 billion. Total health care spending over that time period increased by one trillion. Meanwhile, most of the public health care coverage increase during that time -- 60 percent according to a Harvard University study -- displaced private health insurance coverage.
Could the Kennedy bill be any more inefficient at using taxpayer dollars to subsidize misshapen forms of health care coverage? Of course it could. And it is.
Yesterday President Obama told the American Medical Association that "a big part of what led General Motors and Chrysler into trouble were the huge costs they racked up providing health care for their workers -- costs that made them less profitable and less competitive with automakers around the world."
"If we do not fix our health care system America may go the way of GM -- paying more, getting less, and going broke."
Which is why Section 133 of the Kennedy bill grandfathers in every union-negotiated health plan that apes union health plans for workers and prohibits companies from transferring workers into the public "option."
Worried about the cost of retiree health benefits? No problem. "There is established in the Treasury of the United States a trust fund to be known as the Retiree Reserve Trust Fund that shall consist of such amounts as may be appropriated or credited to the Trust Fund as provided for in this subsection to enable the Secretary to carry out the program under this section. Such amounts shall remain available until expended." ("Such amounts" is Washingtonspeak for bottomless pit.) It pays for insurance benefits and 80 percent of claims from $15,000 to $90,000 for all retirees (ages 54-64). Initial cost of this "trust fund": $10 billion.
The Kennedy bill pays for $1 trillion in ineptitude in four ways.
First, it borrows. But who's counting or keeping track?
Second, it creates "Gateways" that are supposed to create groups of purchasers to reduce the cost of insurance. In fact, since insurance companies have already made it clear that they can provide guaranteed coverage without regard to the size of purchasing pools, why are such Gateways necessary? Because, as agents of the federal government, Gateways collect a tax on the insurance premiums of the young, healthy and health-conscious to subsidize the cost of insurance for those who now have no incentive to improve their health.
In fact, insurance plans that actually do a better job of controlling costs or keeping premiums low with better quality are punished under the Kennedy bill: "Any State or participating State shall assess a charge on health plans and health insurance issuer (with respect to health insurance coverage) if the actuarial risk of the enrollees of such plans or coverage for a year is less than the average actuarial risk of all enrollees in all plans or coverage in such State for such years."
Third, in order to subsidize the sort of health plans that broke the bank at GM, the Kennedy bill taxes the health benefits of others, particular those in self-insured corporations that are doing the most innovative things to improve quality and reduce costs.
Fourth, the Kennedy bill gives a Medical Advisory Council power to determine what new technologies and benefits can be covered and are introduced. It's the same technique Obama wants to use to curb the rate of growth in Medicare. John McCain suggested paying for his health care tax credit plan with Medicare savings. During the election, Obama said that "would mean fewer places to get care, and less freedom to choose your own doctors…. I don't think that's right."
Today, Obama would slash payments and choices to seniors -- mostly the sickest -- to help pay for GM-type health plans, retiree slush funds, and the mass relocation of middle-class Americans into a richer version of the Indian Health Service. On top of that, the Kennedy bill costs $1 trillion to "cover" 16 million new people in the process. By tossing 40 million out of private insurance no less. Not only is it not right. It's incompetent.
CMPI’s Robert Goldberg Discusses Health Care Reform with PhRMA CEO Billy Tauzin
Click Here to View the Video
The Center for Medicine in the Public Interest's Dr. Robert Goldberg
Discusses Health Care Reform with PhRMA CEO Billy Tauzin
Preliminary score from CBO... $1 Trillion for 16 million additional insurance policies....
Read more here
Read more here
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.
