Latest Drugwonks' Blog
What? You haven't already read CBO's just released "The Budget and Economic Outlook: Fiscal Years 2008 to 2017!
Great prose? Certainly not. Great news? Absolutely (if you know where to look).
Consider this snippet which appears on pages 58-59 ...
"The current estimate for Part D spending is significantly lower than CBO's 2006 estimates, for two reasons. First, Medicare's payments for prescription drugs under Part D are largely based on competitive bids that drug plans submit to provide coverage. The bids submitted for calendar year 2007 are much lower than expected-about 15 percent below the 2006 bids, on average. As a result, CBO reduced its projection of the per capita costs of providing drug coverage. In addition, recent information from the Department of Health and Human Services' Centers for Medicare and Medicaid Services indicates that a larger-than-expected number of the Medicare beneficiaries who are not enrolled in Part D have some other form of drug coverage that is comparable to Part D. Because CBO expects that many of those beneficiaries will retain their existing coverage rather than enroll in Part D, it has lowered its estimate of the ultimate participation rate from 87 percent to 78 percent of Medicare beneficiaries."
"In its estimate for the Medicare Modernization Act, which established Part D benefits, CBO projected net spending for Part D at $32 billion for 2006 and $518 billion for 2007 to 2013. (CBO's overall estimate that the legislation would cost $395 billion from 2004 to 2013 included savings that would occur elsewhere in the budget that would be attributable to the creation of Part D and to the effects of other provisions unrelated to the drug benefit.) CBO's current estimate of net spending for Part D for 2007 to 2013 is $136 billion lower than the original forecast, a difference of about 26 percent."
Amazing as that news is, I do not predict a movie deal for the book.
Great prose? Certainly not. Great news? Absolutely (if you know where to look).
Consider this snippet which appears on pages 58-59 ...
"The current estimate for Part D spending is significantly lower than CBO's 2006 estimates, for two reasons. First, Medicare's payments for prescription drugs under Part D are largely based on competitive bids that drug plans submit to provide coverage. The bids submitted for calendar year 2007 are much lower than expected-about 15 percent below the 2006 bids, on average. As a result, CBO reduced its projection of the per capita costs of providing drug coverage. In addition, recent information from the Department of Health and Human Services' Centers for Medicare and Medicaid Services indicates that a larger-than-expected number of the Medicare beneficiaries who are not enrolled in Part D have some other form of drug coverage that is comparable to Part D. Because CBO expects that many of those beneficiaries will retain their existing coverage rather than enroll in Part D, it has lowered its estimate of the ultimate participation rate from 87 percent to 78 percent of Medicare beneficiaries."
"In its estimate for the Medicare Modernization Act, which established Part D benefits, CBO projected net spending for Part D at $32 billion for 2006 and $518 billion for 2007 to 2013. (CBO's overall estimate that the legislation would cost $395 billion from 2004 to 2013 included savings that would occur elsewhere in the budget that would be attributable to the creation of Part D and to the effects of other provisions unrelated to the drug benefit.) CBO's current estimate of net spending for Part D for 2007 to 2013 is $136 billion lower than the original forecast, a difference of about 26 percent."
Amazing as that news is, I do not predict a movie deal for the book.
When is a drug risk not a drug risk? When you don't understand it. I refer, of course, to the so-called "Brief Summary" which, as some say, is like the Holy Roman Empire -- neither brief nor a summary.
A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.
The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org
Not rocket science. Social science
A new paper (of which I am a co-author), in the January edition of Drug Information Journal, relates new research demonstrating that as the number of listed side effects increases, patient recall decreases.
The paper, "A New Model for Communicating Risk Information in Direct-to-Consumer Print Advertisements" can be found at http://www.cmpi.org
Not rocket science. Social science
President Bush's State of the Union discussion of tax credits for health insurance should remind us all that the goal of health care shouldn't be, exclusively, to deal with acute medical problems -- but rather to provide patients with both the opportunity and the incentive to pursue care for chronic conditions (such as hypertension). Because, even with all of the advances in hospital care, it's still a much better deal -- both financially and personally -- to address a condition (such as hypertension) before it results in an acute, life-threatening event.
It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).
Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).
And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union.
It's the same logic that propels Part D. Keep seniors healthy by providing low-cost access to the medicines they need and they (1) will be healthier, more productive citizens, and (2) will not need far more costly health care interventions (i.e., hospital procedures).
Eureka -- it works. Part D has propelled millions of seniors, for the first time, to seek out and receive appropriate treatment for their chronic conditions (such as hypertension).
And that's a success that demands greater attention. It's a success that goes a long way to improving the State of the Union.
I was both an attendee and speaker at the MedAdNews Drug Development Summit.
Two important takeaway points. Make that three. Ok four.
1. Companies are refilling their pipelines with new drugs that will hit new targets for unmet medical needs in areas like Alzheimer's, cancer, schizophrenia, Parkinson's, respiratory infections and stroke.
2. Companies are doing a better job of weeding out medicines that won't work or would "fail" because of toxicity issues earlier than ever. Drug development is becoming more predictive.
3. Many of the Critical Path recommendations are being adopted. Adaptive trial designs, bio-imaging, exploratory INDs are all being used.
4. Companies are interested in doing more collaborative work to identify biomarkers, both efficacy and safety. Creating the framework for doing so is difficult.
The takeaway: this is an industry furiously seeking to change. It probably should be more transparent and collaborative and find a better way to market its medicines but that will happen too.
The question is, why do some many people still believe that drug companies are sitting on cures for diseases so they can make money? I can't tell you how many otherwise intelligent people have actually asked me if this is true.... Another reason that biotech and drug companies need to tell the public what they do.
Two important takeaway points. Make that three. Ok four.
1. Companies are refilling their pipelines with new drugs that will hit new targets for unmet medical needs in areas like Alzheimer's, cancer, schizophrenia, Parkinson's, respiratory infections and stroke.
2. Companies are doing a better job of weeding out medicines that won't work or would "fail" because of toxicity issues earlier than ever. Drug development is becoming more predictive.
3. Many of the Critical Path recommendations are being adopted. Adaptive trial designs, bio-imaging, exploratory INDs are all being used.
4. Companies are interested in doing more collaborative work to identify biomarkers, both efficacy and safety. Creating the framework for doing so is difficult.
The takeaway: this is an industry furiously seeking to change. It probably should be more transparent and collaborative and find a better way to market its medicines but that will happen too.
The question is, why do some many people still believe that drug companies are sitting on cures for diseases so they can make money? I can't tell you how many otherwise intelligent people have actually asked me if this is true.... Another reason that biotech and drug companies need to tell the public what they do.
The left has been complaining for years about how the tax system is unfair to the poor and working class. So when the president comes along with a plan level the playing field where it really counts -- a tax cut that makes health care affordable no matter where you are or whether you are working -- their reaction is predictable: spend money (either directly or in the form of tax credits) to shove people into Medicaid.
Here's Ron Pollack's predictable response to the tax cut:
“Instead of this ill-advised proposal, the President should expand health coverage for the 9 million children who are uninsured when Congress reauthorizes the State Children’s Health Insurance Program (SCHIP) later this year.â€
Right. The same 9 million kids who have not been enrolled since SCHIP started in 1997. Hey Ron, Families USA has been shoveled millions of bucks to do outreach and enrollment over the past decade.
Wonder why people didn't sign up despite your winning personality?
Because SCHIP equals Medicaid. Pollack and other child "advocates" call SCHIP a medical home for uninsured kids but that's like calling public housing as good as a private home. People want to buy into the real thing, something they can own, not some government assistance they have to apply for.
But the Left hates giving people control over health care dollars because that means they lose control over them. I once debated one of the advocates and asked them why they opposed just giving people money to buy health care. Did she think the same people they believe should have the choice about abortion were too stupid to choose which health plan to have the abortion in? She had no answer.
Here's Ron Pollack's predictable response to the tax cut:
“Instead of this ill-advised proposal, the President should expand health coverage for the 9 million children who are uninsured when Congress reauthorizes the State Children’s Health Insurance Program (SCHIP) later this year.â€
Right. The same 9 million kids who have not been enrolled since SCHIP started in 1997. Hey Ron, Families USA has been shoveled millions of bucks to do outreach and enrollment over the past decade.
Wonder why people didn't sign up despite your winning personality?
Because SCHIP equals Medicaid. Pollack and other child "advocates" call SCHIP a medical home for uninsured kids but that's like calling public housing as good as a private home. People want to buy into the real thing, something they can own, not some government assistance they have to apply for.
But the Left hates giving people control over health care dollars because that means they lose control over them. I once debated one of the advocates and asked them why they opposed just giving people money to buy health care. Did she think the same people they believe should have the choice about abortion were too stupid to choose which health plan to have the abortion in? She had no answer.
We are not making this up.
AIDS group sues over Viagra ads
Andrew Bridges
The Associated Press
Tuesday, January 23, 2007
WASHINGTON -- An AIDS organization sued Pfizer Inc. on yesterday over ads the group says encourage use of Viagra as a party drug. The nonprofit group said such recreational use furthers the spread of HIV and other sexually transmitted diseases.
The suit, filed in Los Angeles by the AIDS Healthcare Foundation, calls Pfizer's ads for the impotence drug false and misleading. The suit echoes allegations made in an ad campaign announced by the group last month.
The nonprofit group alleges the marketing of Viagra has fostered an increase in the spread of STDs. Studies have found the drug is used -- illegally -- in conjunction with crystal methamphetamine to form a party drug "cocktail."
Drugwonks believes that the combo of crystal meth and Viagra is an off-label use that Pfizer has never promoted. There is no truth to the rumor that the company sought product placement in episodes of Six Feet Under, Entourage or Queer as Folk....
AIDS group sues over Viagra ads
Andrew Bridges
The Associated Press
Tuesday, January 23, 2007
WASHINGTON -- An AIDS organization sued Pfizer Inc. on yesterday over ads the group says encourage use of Viagra as a party drug. The nonprofit group said such recreational use furthers the spread of HIV and other sexually transmitted diseases.
The suit, filed in Los Angeles by the AIDS Healthcare Foundation, calls Pfizer's ads for the impotence drug false and misleading. The suit echoes allegations made in an ad campaign announced by the group last month.
The nonprofit group alleges the marketing of Viagra has fostered an increase in the spread of STDs. Studies have found the drug is used -- illegally -- in conjunction with crystal methamphetamine to form a party drug "cocktail."
Drugwonks believes that the combo of crystal meth and Viagra is an off-label use that Pfizer has never promoted. There is no truth to the rumor that the company sought product placement in episodes of Six Feet Under, Entourage or Queer as Folk....
Ask the 10,000 people at Pfizer who are losing their jobs.
After hearing from Representative Emerson, perhaps it's time to listen to the other famous American of the same name -- Ralph Waldo Emerson -- who said:
"No one cares how much you know until they know how much you care."
Words to remember as we fight for the future of America's health and health care system.
"No one cares how much you know until they know how much you care."
Words to remember as we fight for the future of America's health and health care system.
Story Landis, director of the NIH's National Institute of Neurological Disorders and Stroke testified before a Senate committee today that need for federal funding for embyronic stem cell research was compelling:
"Science works best when scientists can pursue all avenues of research," Landis said. "If the cure for Parkinson's disease or juvenile diabetes lay behind one of four doors, wouldn't you want the option to open all four doors at once instead of one door?"
That's fine. Everyone's in favor of funding one form of stem cell research or another. But why then support a bill that would kill private sector funding of stem cell research or undermine private sector investment that complements or builds on federal funding. Namely the Wyden-Snowe bill requiring direct government negotiation -- meaning price controls, restricting/delaying access to new medicines -- under the following circumstances --
Under the Snowe-Wyden proposal, that ban would be lifted and the HHS Secretary would be required to negotiate if:
* A drug is a single source drug, which means there is only one brand name of the drug available;
* A drug was created with substantial taxpayer funding for its research and development;
* A private insurance plan requests help; and
* For any fallback plan for which the Secretary must provide.
A cure for Parkinson's would definitely pull a hat trick under this ingenious piece of legislation. Why not just hang out a sign that says: "Companies that successfully invest in stem cell research will be punished for doing so?"
"Science works best when scientists can pursue all avenues of research," Landis said. "If the cure for Parkinson's disease or juvenile diabetes lay behind one of four doors, wouldn't you want the option to open all four doors at once instead of one door?"
That's fine. Everyone's in favor of funding one form of stem cell research or another. But why then support a bill that would kill private sector funding of stem cell research or undermine private sector investment that complements or builds on federal funding. Namely the Wyden-Snowe bill requiring direct government negotiation -- meaning price controls, restricting/delaying access to new medicines -- under the following circumstances --
Under the Snowe-Wyden proposal, that ban would be lifted and the HHS Secretary would be required to negotiate if:
* A drug is a single source drug, which means there is only one brand name of the drug available;
* A drug was created with substantial taxpayer funding for its research and development;
* A private insurance plan requests help; and
* For any fallback plan for which the Secretary must provide.
A cure for Parkinson's would definitely pull a hat trick under this ingenious piece of legislation. Why not just hang out a sign that says: "Companies that successfully invest in stem cell research will be punished for doing so?"
Here's a story right out of the movie "The Barbarian Invasions" and it can be summed up in two words, "Hello Plattsburgh."
For those who think that we should adopt the Canadian health care model this should serve as yet another cold shower of reality or, in the words of Stephen Colbert, a "Truth Mitzvah."
MDs forced abroad for scanner training
Limited access to cancer-detecting machines spurs Ontario university to look elsewhere
LISA PRIEST
Toronto Globe and Mail
January 19, 2007
The use of crucial cancer-detecting PET machines is so restricted in Ontario that one university must send its medical residents to the United States and elsewhere for training. The low number of cancer patients eligible for PET screening means University of Western Ontario residents cannot obtain the experience they require. St. Joseph's Health Care in London scans as few as four patients a week, sometimes none. The rest of the time it experiments on laboratory-bred dogs and pigs.
Of all the provinces that have Positron Emission Tomography scanners, Ontario has the most restrictive access. That's because it is running clinical trials to determine how best to use them on cancer patients.
"It breaks our hearts to have to send them [students] away," said Damien Maharaj, program director of nuclear medicine at Western's Schulich School of Medicine & Dentistry. “We simply have to meet their [Royal College of Physicians and Surgeons of Canada] guidelines. Failure to do so would be noted and the potential to go on probation exists."
The development follows an evaluation conducted by the Royal College of Physicians and Surgeons of Canada, a body that accredits postgraduate medical programs in addition to certifying specialists. The college told the university that the lack of resident training in PET scanning was a weakness that required a remedy.
The university was asked to put in writing its plan for ensuring that nuclear-medicine residents receive the necessary PET training elsewhere, Dr. Maharaj confirmed. He stressed the program remains fully accredited and that London produces some of the best nuclear-medicine specialists in Canada. Ultimately, though, Dr. Maharaj said: "PET is not a research tool, it's a clinical tool. We really should be offering it to people."
Cancer patients can access Ontario's nine PET scanners under five clinical trials or through a patient registry introduced a year ago. The registry is limited to suspected recurrent colorectal, thyroid or germ-cell cancer and patients with certain solitary pulmonary nodules. As of Oct. 31, 408 Ontario patients had obtained PET scans through the registry and 926 patients had scans as part of the clinical trials.
Compare that to Quebec, a province that provides the broadest access to PET scans; this year, it plans to do 21,000 scans. Patients can access PET scans in British Columbia, Alberta, Manitoba and New Brunswick. Nova Scotia also plans to purchase a scanner and expects to have it operating by the fall.
"It's terrible," said Christopher O'Brien, vice-president of the Canadian Association of Nuclear Medicine. "You have one of the major teaching programs that can't meet the Royal College standards because of a government moratorium on access to PET scanning."
Though Dr. Maharaj said the university will try to help defray the costs, ultimately it is a "financial hardship" for the residents who will have to pay rent in two cities, in addition to covering transportation and food costs for three months. Potential training spots include Duke University in North Carolina, Harvard in Boston and centres in Canada, possibly Winnipeg or Sherbrooke, he said.
Training in the United States poses a particular problem: malpractice insurance does not cover the residents so they can act only as observers and cannot interpret the scans. That is why J. C. Warrington, the chief nuclear-medicine resident at the University of Western Ontario, is hoping to relocate to another Canadian city. "We would prefer to not to have to go further than is absolutely required because of our expenses required with travel," said Dr. Warrington, a fourth-year nuclear-medicine resident, one of two who will have to relocate this July.
All other nuclear-medicine residents training at Western will also have to relocate for three months in their final year of training, until the hospital is able to provide more PET scans to patients, Dr. Maharaj said.
A PET scan can find a lung cancer that has spread, preventing a futile operation. Colorectal cancer patients may discover tumours on their liver can be safely removed. A scan can also help determine when chemotherapy is not working, prompting doctors to change a drug cocktail. It costs about $2,500.
Whatever the case, the results need to be carefully interpreted as non-cancerous conditions can resemble cancer; only a biopsy can confirm the presence of cancer.
Dr. Warrington said though relocating may pose an imposition, it is a far greater imposition for cancer patients to travel out of province or country to obtain PET scans. In 2005-2006, 82 Ontarians were sent out of country for PET scans at a cost of $653,255, while 42 others were denied, according to Health Ministry figures provided by John Letherby. However, the process of sending patients to the United States has been winding down since late August.
Figures obtained under a Freedom of Information and Protection of Privacy Act request reveals that Ontario has sent cancer patients to 20 different U.S. hospitals for PET scans for 18 different conditions, many of them cancers or suspected cases of cancer since April 1, 2002.
They include Duke University -- the very institution to which nuclear-medicine residents may be sent for training. As well, patients have been sent to Johns Hopkins in Baltimore; the Mayo Clinic in Rochester, Minn., and Scottsdale, Ariz.; Detroit Medical Centre; and Cleveland Clinic Foundation.
Of those sent to the United States, the patients had lymphoma and cancers of the breast, brain, esophagus, testes and lung.
For those who think that we should adopt the Canadian health care model this should serve as yet another cold shower of reality or, in the words of Stephen Colbert, a "Truth Mitzvah."
MDs forced abroad for scanner training
Limited access to cancer-detecting machines spurs Ontario university to look elsewhere
LISA PRIEST
Toronto Globe and Mail
January 19, 2007
The use of crucial cancer-detecting PET machines is so restricted in Ontario that one university must send its medical residents to the United States and elsewhere for training. The low number of cancer patients eligible for PET screening means University of Western Ontario residents cannot obtain the experience they require. St. Joseph's Health Care in London scans as few as four patients a week, sometimes none. The rest of the time it experiments on laboratory-bred dogs and pigs.
Of all the provinces that have Positron Emission Tomography scanners, Ontario has the most restrictive access. That's because it is running clinical trials to determine how best to use them on cancer patients.
"It breaks our hearts to have to send them [students] away," said Damien Maharaj, program director of nuclear medicine at Western's Schulich School of Medicine & Dentistry. “We simply have to meet their [Royal College of Physicians and Surgeons of Canada] guidelines. Failure to do so would be noted and the potential to go on probation exists."
The development follows an evaluation conducted by the Royal College of Physicians and Surgeons of Canada, a body that accredits postgraduate medical programs in addition to certifying specialists. The college told the university that the lack of resident training in PET scanning was a weakness that required a remedy.
The university was asked to put in writing its plan for ensuring that nuclear-medicine residents receive the necessary PET training elsewhere, Dr. Maharaj confirmed. He stressed the program remains fully accredited and that London produces some of the best nuclear-medicine specialists in Canada. Ultimately, though, Dr. Maharaj said: "PET is not a research tool, it's a clinical tool. We really should be offering it to people."
Cancer patients can access Ontario's nine PET scanners under five clinical trials or through a patient registry introduced a year ago. The registry is limited to suspected recurrent colorectal, thyroid or germ-cell cancer and patients with certain solitary pulmonary nodules. As of Oct. 31, 408 Ontario patients had obtained PET scans through the registry and 926 patients had scans as part of the clinical trials.
Compare that to Quebec, a province that provides the broadest access to PET scans; this year, it plans to do 21,000 scans. Patients can access PET scans in British Columbia, Alberta, Manitoba and New Brunswick. Nova Scotia also plans to purchase a scanner and expects to have it operating by the fall.
"It's terrible," said Christopher O'Brien, vice-president of the Canadian Association of Nuclear Medicine. "You have one of the major teaching programs that can't meet the Royal College standards because of a government moratorium on access to PET scanning."
Though Dr. Maharaj said the university will try to help defray the costs, ultimately it is a "financial hardship" for the residents who will have to pay rent in two cities, in addition to covering transportation and food costs for three months. Potential training spots include Duke University in North Carolina, Harvard in Boston and centres in Canada, possibly Winnipeg or Sherbrooke, he said.
Training in the United States poses a particular problem: malpractice insurance does not cover the residents so they can act only as observers and cannot interpret the scans. That is why J. C. Warrington, the chief nuclear-medicine resident at the University of Western Ontario, is hoping to relocate to another Canadian city. "We would prefer to not to have to go further than is absolutely required because of our expenses required with travel," said Dr. Warrington, a fourth-year nuclear-medicine resident, one of two who will have to relocate this July.
All other nuclear-medicine residents training at Western will also have to relocate for three months in their final year of training, until the hospital is able to provide more PET scans to patients, Dr. Maharaj said.
A PET scan can find a lung cancer that has spread, preventing a futile operation. Colorectal cancer patients may discover tumours on their liver can be safely removed. A scan can also help determine when chemotherapy is not working, prompting doctors to change a drug cocktail. It costs about $2,500.
Whatever the case, the results need to be carefully interpreted as non-cancerous conditions can resemble cancer; only a biopsy can confirm the presence of cancer.
Dr. Warrington said though relocating may pose an imposition, it is a far greater imposition for cancer patients to travel out of province or country to obtain PET scans. In 2005-2006, 82 Ontarians were sent out of country for PET scans at a cost of $653,255, while 42 others were denied, according to Health Ministry figures provided by John Letherby. However, the process of sending patients to the United States has been winding down since late August.
Figures obtained under a Freedom of Information and Protection of Privacy Act request reveals that Ontario has sent cancer patients to 20 different U.S. hospitals for PET scans for 18 different conditions, many of them cancers or suspected cases of cancer since April 1, 2002.
They include Duke University -- the very institution to which nuclear-medicine residents may be sent for training. As well, patients have been sent to Johns Hopkins in Baltimore; the Mayo Clinic in Rochester, Minn., and Scottsdale, Ariz.; Detroit Medical Centre; and Cleveland Clinic Foundation.
Of those sent to the United States, the patients had lymphoma and cancers of the breast, brain, esophagus, testes and lung.
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.
