Latest Drugwonks' Blog
Peter Rost and I do not agree on many things, but here's something we both seem to appreciate -- a good laugh that makes you think.
Such is a "must see" photo and caption titled, "Some People Just Don't Get It." Made me smile ... and then grimace.
Worth a look at http://www.brandweeknrx.com
Peter -- why don't you link to us?
Such is a "must see" photo and caption titled, "Some People Just Don't Get It." Made me smile ... and then grimace.
Worth a look at http://www.brandweeknrx.com
Peter -- why don't you link to us?
Grace-Marie Turner, Galen’s Grande Dame reports that ...
“In Rome last week, I debated Italian politicians on national radio, tried to explain our health system to government and industry leaders, and spoke at a conference at the Vatican about the fundamental values of health care and the common good.
Some take-aways: Europeans truly believe that we have a permanent underclass in the U.S. of 47 million poor citizens who have absolutely no access to health care. They are shocked at how barbaric we are and that any civilized country would tolerate such a thing. When I tried to explain the facts -- through a translator -- to an Italian senator on RAI radio, he was incensed.
He didn't want to hear that we spend nearly as much as a percentage of our GDP on public programs -- to cover about one-third of our people -- as many European countries spend of their GDPs in total on health care. Or that almost half of our more than $2 trillion in health expenditures are primarily through these public programs that cover the poor, the aged, the disabled, veterans, and lower-income children. Or that many of the uninsured are temporarily without coverage in a system that ties health insurance to the workplace. Or that the uninsured do get care -- albeit in a far from ideal system -- through hospitals, private physicians, community health centers, charity clinics, and other means. Or that Americans value private coverage with its broader access to new technologies and medicines and faster access to surgeries and treatments.
It seemed almost as if he wanted people to believe that there is nothing at all to be learned from Americans so as not to crack the veneer of socialized systems.â€
Attention must be paid by American officials – particularly by thoughtful legislators such as Senator Max Baucus (the Chairman of the Finance Committee -- with jurisdiction over the major public health insurance programs) -- whose “five broad principles of reform†are, whether you agree with the basic premise or all or none, worthy of intense scrutiny and robust debate. They are:
Universal coverage. (“We cannot address the health care system, and leave a growing portion of the country behind. Though this much be a public and private sector mix.â€)
Sharing the burden. (“The way to ensure affordable coverage is to create pooling arrangements.â€)
Controlling costs. (“Any serious proposal must reduce the rate of growth of health care costs.â€)
Prevention. (“By making prevention the foundation of our health care system, we can spare patients needless suffering. We can avoid the high costs of treating an illness that has been allowed to progress.â€)
Shared responsibility. (“Health coverage is a shared responsibility and all should contribute.â€)
Note: Parenthetical quotes come directly from Senator Baucus' website.
The one thing we should all be able to agree upon is that there are no easy solutions … America’s SiCKO Apologists notwithstanding.
“In Rome last week, I debated Italian politicians on national radio, tried to explain our health system to government and industry leaders, and spoke at a conference at the Vatican about the fundamental values of health care and the common good.
Some take-aways: Europeans truly believe that we have a permanent underclass in the U.S. of 47 million poor citizens who have absolutely no access to health care. They are shocked at how barbaric we are and that any civilized country would tolerate such a thing. When I tried to explain the facts -- through a translator -- to an Italian senator on RAI radio, he was incensed.
He didn't want to hear that we spend nearly as much as a percentage of our GDP on public programs -- to cover about one-third of our people -- as many European countries spend of their GDPs in total on health care. Or that almost half of our more than $2 trillion in health expenditures are primarily through these public programs that cover the poor, the aged, the disabled, veterans, and lower-income children. Or that many of the uninsured are temporarily without coverage in a system that ties health insurance to the workplace. Or that the uninsured do get care -- albeit in a far from ideal system -- through hospitals, private physicians, community health centers, charity clinics, and other means. Or that Americans value private coverage with its broader access to new technologies and medicines and faster access to surgeries and treatments.
It seemed almost as if he wanted people to believe that there is nothing at all to be learned from Americans so as not to crack the veneer of socialized systems.â€
Attention must be paid by American officials – particularly by thoughtful legislators such as Senator Max Baucus (the Chairman of the Finance Committee -- with jurisdiction over the major public health insurance programs) -- whose “five broad principles of reform†are, whether you agree with the basic premise or all or none, worthy of intense scrutiny and robust debate. They are:
Universal coverage. (“We cannot address the health care system, and leave a growing portion of the country behind. Though this much be a public and private sector mix.â€)
Sharing the burden. (“The way to ensure affordable coverage is to create pooling arrangements.â€)
Controlling costs. (“Any serious proposal must reduce the rate of growth of health care costs.â€)
Prevention. (“By making prevention the foundation of our health care system, we can spare patients needless suffering. We can avoid the high costs of treating an illness that has been allowed to progress.â€)
Shared responsibility. (“Health coverage is a shared responsibility and all should contribute.â€)
Note: Parenthetical quotes come directly from Senator Baucus' website.
The one thing we should all be able to agree upon is that there are no easy solutions … America’s SiCKO Apologists notwithstanding.
Here's Marc's piece...
THE WORLD'S TOP MEDICINE
By MARC SIEGEL
October 5, 2007 -- CRITICS of the U.S. health-care system point to the 100,000 or so Americans who go overseas for treatment each year, typically citing lower costs. Fair enough - but they should also consider why 70,000 foreigners a year come here for medical care.
America has better tools of diagnosis and treatment than any other nation. Consider one of my patients - Paul, an American professor living in Europe.
Paul fell and smashed his wrist in 2002; the blood supply to the joint was compromised. He was operated on in New York by Charles Melone - the same highly successful hand surgeon who had also fixed the limbs of Patrick Ewing, Don Mattingly and Zaro the baker. Afterward, proudly flexing his wrist, Paul proclaimed Europe's "no frills" system as his "health care of last resort."
In 2003, Paul developed an elevated prostate test (PSA). I urged him to return to New York for a biopsy, to rule out prostate cancer. But he couldn't afford the trip or the procedure. He was living in Copenhagen, and the doctors there told him they thought the abnormal result was due to benign prostatic hypertrophy, not cancer.
Only in late 2005, as his PSA continued to rise, was I finally able to convince Paul's Danish urologist to perform the biopsy. The results were normal - but it was a "no-frills" biopsy with only four samples taken, half what's usual here.
Sure enough, Paul's PSA rose even higher, and he began to have more trouble urinating. He finally had the biopsy repeated in Greece (where he now lives) this summer - and it was positive for cancer in both lobes of the gland.
Paul's doctors in Greece recommended immediate radical prostatectomy to remove the diseased prostate. After Paul called me, I contacted Dr. Herb Lepor, the chairman of urology at NYU, who has done more than 3,000 of these procedures and is a pioneer of the nerve-sparing technique that helps preserve sexual function. Lepor said he didn't know of a surgeon as specialized and experienced in Greece.
Unfortunately, Paul's European insurance wouldn't cover an American operation, and Paul could no longer afford it (he'd barely been able to afford the wrist work years before). Instead, he had to settle for a local surgeon at the state hospital in Athens (who came well recommended by other Greek doctors and patients). The operation is next week, and I nervously await the result.
Paul's insurance will cover everything, so his choice seems reasonable - but far from perfect. The latest study shows that survival rates after five years with prostate cancer are 77.5 percent in Europe, versus 99.3 percent here.
One more anecdote: I arranged the medical care for the prime minister of a large Asian country during his recent diplomatic mission here. His personal physician from home stood idly by as the patient visited one top U.S. specialist after another. The PM ended his visit waiting behind another Asian prime minister for a special brain procedure they both knew they could never get back home.
Dr. Marc Siegel teaches at the NYU School of Medicine.
THE WORLD'S TOP MEDICINE
By MARC SIEGEL
October 5, 2007 -- CRITICS of the U.S. health-care system point to the 100,000 or so Americans who go overseas for treatment each year, typically citing lower costs. Fair enough - but they should also consider why 70,000 foreigners a year come here for medical care.
America has better tools of diagnosis and treatment than any other nation. Consider one of my patients - Paul, an American professor living in Europe.
Paul fell and smashed his wrist in 2002; the blood supply to the joint was compromised. He was operated on in New York by Charles Melone - the same highly successful hand surgeon who had also fixed the limbs of Patrick Ewing, Don Mattingly and Zaro the baker. Afterward, proudly flexing his wrist, Paul proclaimed Europe's "no frills" system as his "health care of last resort."
In 2003, Paul developed an elevated prostate test (PSA). I urged him to return to New York for a biopsy, to rule out prostate cancer. But he couldn't afford the trip or the procedure. He was living in Copenhagen, and the doctors there told him they thought the abnormal result was due to benign prostatic hypertrophy, not cancer.
Only in late 2005, as his PSA continued to rise, was I finally able to convince Paul's Danish urologist to perform the biopsy. The results were normal - but it was a "no-frills" biopsy with only four samples taken, half what's usual here.
Sure enough, Paul's PSA rose even higher, and he began to have more trouble urinating. He finally had the biopsy repeated in Greece (where he now lives) this summer - and it was positive for cancer in both lobes of the gland.
Paul's doctors in Greece recommended immediate radical prostatectomy to remove the diseased prostate. After Paul called me, I contacted Dr. Herb Lepor, the chairman of urology at NYU, who has done more than 3,000 of these procedures and is a pioneer of the nerve-sparing technique that helps preserve sexual function. Lepor said he didn't know of a surgeon as specialized and experienced in Greece.
Unfortunately, Paul's European insurance wouldn't cover an American operation, and Paul could no longer afford it (he'd barely been able to afford the wrist work years before). Instead, he had to settle for a local surgeon at the state hospital in Athens (who came well recommended by other Greek doctors and patients). The operation is next week, and I nervously await the result.
Paul's insurance will cover everything, so his choice seems reasonable - but far from perfect. The latest study shows that survival rates after five years with prostate cancer are 77.5 percent in Europe, versus 99.3 percent here.
One more anecdote: I arranged the medical care for the prime minister of a large Asian country during his recent diplomatic mission here. His personal physician from home stood idly by as the patient visited one top U.S. specialist after another. The PM ended his visit waiting behind another Asian prime minister for a special brain procedure they both knew they could never get back home.
Dr. Marc Siegel teaches at the NYU School of Medicine.
I was in Israel visiting my son and had limited access to news and the internet. Of course I return to see the Yankees took a pounding and the same sloppy causality that fits pre-existing biases in health exist.
Leave to Health Despairs to claim that the major reason the US spends more on health care is because we are sicker. Confusing diagnosis (which is a function of being able to see a doctor multiplied by what the doctor can do time what the doctor gets paid for) for prevalence Ken Thorpe et al. claim that at least part of the underlying difference in prevalence is poorer health status. Really? He goes on to estimate that the prevalence of diagnosed cancer was 12.2 percent in the United States but only 5.4 percent in Europe in 2004. A huge difference. Even Thorpe has to write: "Are Americans really more likely to develop malignant tumors, or are they just screened more intensely than Europeans are? Comparisons of breast cancer screening rates and five-year cancer survival rates suggest the latter"
So of course I and Marc Siegel, who wrote just a brilliant op-ed in the NY Post that puts a human face on all this, (namely, there is widespread rationing plus a conservatism and passivity in European patients you woud NEVER see here or in Israel for that matter) get emails from ABC news asking about the Health Affairs piece about why Americas are sicker than Europeans....
Why not just do a re-run of Sicko and get it over with instead of looking at the facts.
Leave to Health Despairs to claim that the major reason the US spends more on health care is because we are sicker. Confusing diagnosis (which is a function of being able to see a doctor multiplied by what the doctor can do time what the doctor gets paid for) for prevalence Ken Thorpe et al. claim that at least part of the underlying difference in prevalence is poorer health status. Really? He goes on to estimate that the prevalence of diagnosed cancer was 12.2 percent in the United States but only 5.4 percent in Europe in 2004. A huge difference. Even Thorpe has to write: "Are Americans really more likely to develop malignant tumors, or are they just screened more intensely than Europeans are? Comparisons of breast cancer screening rates and five-year cancer survival rates suggest the latter"
So of course I and Marc Siegel, who wrote just a brilliant op-ed in the NY Post that puts a human face on all this, (namely, there is widespread rationing plus a conservatism and passivity in European patients you woud NEVER see here or in Israel for that matter) get emails from ABC news asking about the Health Affairs piece about why Americas are sicker than Europeans....
Why not just do a re-run of Sicko and get it over with instead of looking at the facts.
Kate Rawson of RPM has written a must-read omnibus on the current state of affairs vis-a-vis comparative effectiveness.
Here's a link ...
http://cmpi.org/archives/2007/10/rpm_report_discusses_groundbre.php
And here's a snippet about a NICE-like body in the US provided to provoke your perspicacity ...
"Some policy experts object to the idea of a center being tied to a government agency because of the inherent bias of the funder (the government) making research decisions to save the payor (the government) money."
See for yourself. A very worthwhile read.
Here's a link ...
http://cmpi.org/archives/2007/10/rpm_report_discusses_groundbre.php
And here's a snippet about a NICE-like body in the US provided to provoke your perspicacity ...
"Some policy experts object to the idea of a center being tied to a government agency because of the inherent bias of the funder (the government) making research decisions to save the payor (the government) money."
See for yourself. A very worthwhile read.
The U.S. Food and Drug Administration today outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.
As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.
Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.
The agency approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year
As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.
Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.
The agency approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year
It's time for the best and the brightest to serve their country ...
FDA Seeks Nominations for Reagan-Udall Foundation
The U.S. Food and Drug Administration is seeking nominations from patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations to serve on the board of directors of the newly created Reagan-Udall Foundation.
Title VI of the recently enacted Food and Drug Administration Amendments Act of 2007 created the foundation to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.
The foundation will be a private, independent, nonprofit entity. The statute calls for a diverse 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic and biotechnology industries; three representatives from academic research organizations; two representatives from patient or consumer advocacy groups; one member representing health care providers; and, four at-large representatives with expertise or experience relevant to the purpose of the Reagan-Udall Foundation.
"A concerted effort by government, industry and academia is needed to modernize the scientific tools used to develop products and to monitor their safety once they go to market," said Commissioner of Food and Drugs Andrew C. von Eschenbach. "We are looking forward to foundation candidates who will work with us to embrace the transformational nature of future efforts to protect and promote the public health."
The foundation will identify unmet scientific needs in the development, manufacture, and evaluation of the safety and effectiveness of FDA regulated products, including post-market evaluation, and establish scientific projects and programs to address those needs. It will help accomplish the scientific work the FDA needs to support its regulatory mission. The foundation will be an important vehicle for private and public stakeholders to collaborate to address the priorities and opportunities identified in FDA's Critical Path reports, and to help modernize the product evaluation sciences.
FDA, the National Institutes of Health, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality have 30 days to appoint the foundation's board of directors. FDA will handle the submission process. Nine members are to be appointed from a list of candidates provided by the National Academy of Sciences. Five members are to be appointed from lists of candidates submitted by organizations mentioned above.
Interested persons may submit nominations by facsimile to Lisa Rovin or Nancy Stanisic at 301-443-9718, or by e-mail to Reagan-Udall-Board@fda.hhs.gov. All nominations must be received on or before Oct. 15, 2007.
FDA Seeks Nominations for Reagan-Udall Foundation
The U.S. Food and Drug Administration is seeking nominations from patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations to serve on the board of directors of the newly created Reagan-Udall Foundation.
Title VI of the recently enacted Food and Drug Administration Amendments Act of 2007 created the foundation to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.
The foundation will be a private, independent, nonprofit entity. The statute calls for a diverse 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic and biotechnology industries; three representatives from academic research organizations; two representatives from patient or consumer advocacy groups; one member representing health care providers; and, four at-large representatives with expertise or experience relevant to the purpose of the Reagan-Udall Foundation.
"A concerted effort by government, industry and academia is needed to modernize the scientific tools used to develop products and to monitor their safety once they go to market," said Commissioner of Food and Drugs Andrew C. von Eschenbach. "We are looking forward to foundation candidates who will work with us to embrace the transformational nature of future efforts to protect and promote the public health."
The foundation will identify unmet scientific needs in the development, manufacture, and evaluation of the safety and effectiveness of FDA regulated products, including post-market evaluation, and establish scientific projects and programs to address those needs. It will help accomplish the scientific work the FDA needs to support its regulatory mission. The foundation will be an important vehicle for private and public stakeholders to collaborate to address the priorities and opportunities identified in FDA's Critical Path reports, and to help modernize the product evaluation sciences.
FDA, the National Institutes of Health, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality have 30 days to appoint the foundation's board of directors. FDA will handle the submission process. Nine members are to be appointed from a list of candidates provided by the National Academy of Sciences. Five members are to be appointed from lists of candidates submitted by organizations mentioned above.
Interested persons may submit nominations by facsimile to Lisa Rovin or Nancy Stanisic at 301-443-9718, or by e-mail to Reagan-Udall-Board@fda.hhs.gov. All nominations must be received on or before Oct. 15, 2007.
Our pal Antoine Clarke (international editor of Pharma Marketletter) offers the following comment on today's post, "Plan B(TC)" ...
"Don’t worry, once Hillarycare gets introduced, all drugs will be either unavailable for cost reasons, or under the counter."
"Don’t worry, once Hillarycare gets introduced, all drugs will be either unavailable for cost reasons, or under the counter."
From the FDA web site ...
The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.
The award to Oakland, Calif.-based CPD is part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.
“This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention,†said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting center director.
The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.
The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.
The award to Oakland, Calif.-based CPD is part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.
“This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention,†said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting center director.
The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.
The FDA has announced, via the Federal Register, a November 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist."
The agency wants input on issues such as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.
A BTC category would almost certainly reopen the conversation about the “statin quo.â€
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
The agency wants input on issues such as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.
A BTC category would almost certainly reopen the conversation about the “statin quo.â€
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
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.
