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With all the bad news (or rather reporting and opining about the bad news) regarding vaccine "shortages" it is important to put into perspective how far we have come and how well we are prepared for a highly unpredictable and relatively lethal form of flu. Contrary to the uninformed claims of people like Shannon Brownlee who insist that vaccines will not reduce mortality by 50 percent in high risk populations (only look at averages is misleading and deliberately so Shannon), the vaccine for swine flu delivered to people who need it most, (kids, pregnant women and immune compromised people) will be life saving. And we have a plan that -- like any plan -- will change on contact but will do what it is supposed to do because it has learned from past pandemic response efforts.
The following testimony delivered by Paul Offit in 2006 about how an outbreak of Asian flu was prevented in 1957 provides a perspective on how well we are doing today. Now if only CDC would tell the anti-vaccine and thimerasol scaremongers to go shove it!
www.fas.org/irp/congress/2006_hr/biodefense.html
PHILADELPHIA
Dr. Offit. Good morning, Senator. My name is Paul Offit. I am Chief of Infectious Diseases at Children's Hospital in Philadelphia and a former member of the Advisory Committee on Immunization Practices to the CDC.
I would like to talk briefly today about an event that occurred 50 years ago in 1957, the only time in our history that we have made influenza vaccine in advance of a pandemic, because I think there are several lessons that can be learned from that event. On April 17, 1957, Maurice Hilleman, a scientist working at the Walter Reed Army Medical Research Institute, read an article in the New York Times titled ``Hong Kong Battling Influenza Epidemic.'' The article stated that 250,000 people, 10 percent of the entire population of Hong Kong, had suddenly come down with the flu.
Hilleman found that this outbreak signaled--feared that this outbreak signaled the start of the next pandemic. So the next day he sent a telex to the Army's 406th Medical General Laboratory in Zama, Japan, asking them to send him specimens from people infected with the virus. The first specimens arrived 1 month later on May 17, 1957.
For 5 days and nights, Hilleman worked to determine whether the influenza virus circulating in Hong Kong could be a pandemic strain. He tested sera from members of the American military and adults in the general population, but could not find anyone whose immune systems had seen this virus before. Hilleman then sent the virus for testing to the United States Public Health Service, the Commission on Influenza of the Armed Forces Epidemiological Board, and the World Health Organization. They found that only a handful of people in the United States and the Netherlands had antibodies to the virus. Because few people in the world had antibodies to stop it, the influenza virus circulating in Hong Kong in 1957 could spread from one country to the next unchecked.
Hilleman then sent the virus, now called Asian flu, to six American-based companies. He figured that if he were to have any chance of saving lives companies would have to make and distribute tens of millions of doses in only 4 months. Hilleman sped up the process by ignoring the Division of Biologic Standards, the Federal agency responsible for regulating vaccines.
He also asked vaccine makers to advise chicken producers not to kill their roosters, even though it was late in the hatching season. He knew that production of tens of millions of doses of vaccine would require at least 200,000 eggs a day.
As predicted, in September 1957 Asian flu entered the United States from both coasts. The first laboratory-proven cases occurred aboard naval vessels in Newport, Rhode Island, and San Diego, California. The first outbreak was triggered by a San Diego girl who carried the virus to an international church conference in Grinnell, Iowa. The second occurred in Valley Forge, Pennsylvania.
Companies made the first lots of Asian influenza vaccine in June 1957 and vaccination began in July. By late fall, 40 million doses were distributed in the United States. Within a few months, influenza infected 20 million Americans. 70,000 died from the disease. Worldwide, the pandemic killed at least 4 million people.
The Surgeon General of the United States, Leonard Burney, later said, quote: ``Many millions of persons we can be certain did not contact Asian flu because of the protection of the vaccine.'' For his efforts, Maurice Hilleman won the Distinguished Service Medal from the American military.
Several features of this outbreak and our response to it are instructive. First, Hilleman had to rely on reading an article in a newspaper to know what was happening in Southeast Asia and he had to wait 1 month before he received samples of the virus. Today the international community of scientists, clinicians, and public health officials, armed with sophisticated virological techniques, are much better at surveillance of outbreaks and characterization of possible pandemic strains.
Second, Hilleman called on six U.S.-based influenza vaccine makers. Today no U.S.-based companies make the inactivated vaccine. Sanofi Pasteur has a manufacturing facility in Swiftwater, Pennsylvania, but is not a U.S.-based company.
Third, Hilleman had to rely on eggs to produce vaccines. Recognizing that egg production is unreliable, the President's pandemic flu plan has effectively encouraged vaccine makers to gear up facilities to grow influenza virus in mammalian rather than avian cells. For example, GlaxoSmithKline recently purchased a manufacturing facility in Marietta, Pennsylvania, and MedImmune, the makers of a live attenuated influenza vaccine, will manufacture vaccine in mammalian cells in Maryland. Given that the influenza vaccine is generic and inexpensive, it is unlikely that vaccine makers would have done this without financial encouragement.
Fourth, Hilleman completely ignored the Division of Biologic Standards, the Federal agency responsible for regulating vaccines. At the time vaccine regulation was in its infancy, regulated by a small division within the National Institutes of Health. Today vaccines are regulated by the Food and Drug Administration and they do an excellent job. Vaccine regulation I think has helped to make vaccines arguably the safest and best-tested products that we put into our bodies. But the process is slow and if we are to make vaccine quickly the regulatory process would have to be streamlined significantly.
Fifth, Hilleman was a committee of one. He took responsibility for shepherding each step of the process. It would be impossible for him to do that today, but it would certainly be of value for one central agency to be held accountable for making sure that vaccine was made, tested, and distributed quickly and efficiently.
Sixth, Hilleman never considered liability protection for vaccine makers. In 1957 pharmaceutical companies were not held liable if they were not negligent in the production or design of their product. Ironically, the birth of liability without negligence for pharmaceutical companies began with a jury verdict against a vaccine maker, Cutter Laboratories, only a few months later. However, it is clear that vaccine makers would not make a pandemic flu vaccine today without substantial protection from frivolous litigation.
Thanks for giving me an opportunity to speak before this committee.
The following testimony delivered by Paul Offit in 2006 about how an outbreak of Asian flu was prevented in 1957 provides a perspective on how well we are doing today. Now if only CDC would tell the anti-vaccine and thimerasol scaremongers to go shove it!
www.fas.org/irp/congress/2006_hr/biodefense.html
PHILADELPHIA
Dr. Offit. Good morning, Senator. My name is Paul Offit. I am Chief of Infectious Diseases at Children's Hospital in Philadelphia and a former member of the Advisory Committee on Immunization Practices to the CDC.
I would like to talk briefly today about an event that occurred 50 years ago in 1957, the only time in our history that we have made influenza vaccine in advance of a pandemic, because I think there are several lessons that can be learned from that event. On April 17, 1957, Maurice Hilleman, a scientist working at the Walter Reed Army Medical Research Institute, read an article in the New York Times titled ``Hong Kong Battling Influenza Epidemic.'' The article stated that 250,000 people, 10 percent of the entire population of Hong Kong, had suddenly come down with the flu.
Hilleman found that this outbreak signaled--feared that this outbreak signaled the start of the next pandemic. So the next day he sent a telex to the Army's 406th Medical General Laboratory in Zama, Japan, asking them to send him specimens from people infected with the virus. The first specimens arrived 1 month later on May 17, 1957.
For 5 days and nights, Hilleman worked to determine whether the influenza virus circulating in Hong Kong could be a pandemic strain. He tested sera from members of the American military and adults in the general population, but could not find anyone whose immune systems had seen this virus before. Hilleman then sent the virus for testing to the United States Public Health Service, the Commission on Influenza of the Armed Forces Epidemiological Board, and the World Health Organization. They found that only a handful of people in the United States and the Netherlands had antibodies to the virus. Because few people in the world had antibodies to stop it, the influenza virus circulating in Hong Kong in 1957 could spread from one country to the next unchecked.
Hilleman then sent the virus, now called Asian flu, to six American-based companies. He figured that if he were to have any chance of saving lives companies would have to make and distribute tens of millions of doses in only 4 months. Hilleman sped up the process by ignoring the Division of Biologic Standards, the Federal agency responsible for regulating vaccines.
He also asked vaccine makers to advise chicken producers not to kill their roosters, even though it was late in the hatching season. He knew that production of tens of millions of doses of vaccine would require at least 200,000 eggs a day.
As predicted, in September 1957 Asian flu entered the United States from both coasts. The first laboratory-proven cases occurred aboard naval vessels in Newport, Rhode Island, and San Diego, California. The first outbreak was triggered by a San Diego girl who carried the virus to an international church conference in Grinnell, Iowa. The second occurred in Valley Forge, Pennsylvania.
Companies made the first lots of Asian influenza vaccine in June 1957 and vaccination began in July. By late fall, 40 million doses were distributed in the United States. Within a few months, influenza infected 20 million Americans. 70,000 died from the disease. Worldwide, the pandemic killed at least 4 million people.
The Surgeon General of the United States, Leonard Burney, later said, quote: ``Many millions of persons we can be certain did not contact Asian flu because of the protection of the vaccine.'' For his efforts, Maurice Hilleman won the Distinguished Service Medal from the American military.
Several features of this outbreak and our response to it are instructive. First, Hilleman had to rely on reading an article in a newspaper to know what was happening in Southeast Asia and he had to wait 1 month before he received samples of the virus. Today the international community of scientists, clinicians, and public health officials, armed with sophisticated virological techniques, are much better at surveillance of outbreaks and characterization of possible pandemic strains.
Second, Hilleman called on six U.S.-based influenza vaccine makers. Today no U.S.-based companies make the inactivated vaccine. Sanofi Pasteur has a manufacturing facility in Swiftwater, Pennsylvania, but is not a U.S.-based company.
Third, Hilleman had to rely on eggs to produce vaccines. Recognizing that egg production is unreliable, the President's pandemic flu plan has effectively encouraged vaccine makers to gear up facilities to grow influenza virus in mammalian rather than avian cells. For example, GlaxoSmithKline recently purchased a manufacturing facility in Marietta, Pennsylvania, and MedImmune, the makers of a live attenuated influenza vaccine, will manufacture vaccine in mammalian cells in Maryland. Given that the influenza vaccine is generic and inexpensive, it is unlikely that vaccine makers would have done this without financial encouragement.
Fourth, Hilleman completely ignored the Division of Biologic Standards, the Federal agency responsible for regulating vaccines. At the time vaccine regulation was in its infancy, regulated by a small division within the National Institutes of Health. Today vaccines are regulated by the Food and Drug Administration and they do an excellent job. Vaccine regulation I think has helped to make vaccines arguably the safest and best-tested products that we put into our bodies. But the process is slow and if we are to make vaccine quickly the regulatory process would have to be streamlined significantly.
Fifth, Hilleman was a committee of one. He took responsibility for shepherding each step of the process. It would be impossible for him to do that today, but it would certainly be of value for one central agency to be held accountable for making sure that vaccine was made, tested, and distributed quickly and efficiently.
Sixth, Hilleman never considered liability protection for vaccine makers. In 1957 pharmaceutical companies were not held liable if they were not negligent in the production or design of their product. Ironically, the birth of liability without negligence for pharmaceutical companies began with a jury verdict against a vaccine maker, Cutter Laboratories, only a few months later. However, it is clear that vaccine makers would not make a pandemic flu vaccine today without substantial protection from frivolous litigation.
Thanks for giving me an opportunity to speak before this committee.
Public plan mirage
By Robert J. Samuelson
Monday, October 26, 2009
In the health-care debate, the "public plan" is all things to all people. For supporters, it would discipline greedy private insurers and make health-care coverage affordable. For detractors, it's a way station on the path to a single-payer insurance system of government-run health care. In reality, the public plan, also known as the public option, is mostly an exercise in political avoidance: It pretends to control costs and improve access to quality care when it doesn't.
As originally conceived by Yale political scientist Jacob Hacker, the public plan would be a government-created, nonprofit insurance company providing Medicare-like coverage to the under-65 population. But unlike Medicare, benefits would be paid for mainly by premiums -- not taxes. Americans could buy coverage from the public plan or a private insurer.
Competition and choice would increase, say liberals. Facing the low-cost public plan, private insurers would hold down their own premiums, the argument goes. Health-care costs for everyone would moderate. Government subsidies to provide universal coverage would be cheaper. By some estimates, Medicare's administrative costs are only 3 percent of spending, compared with 13 percent or more for private insurers. A new public plan is widely presumed to enjoy an advantage in overhead.
Nonsense, retort critics. The public plan's low costs would be artificial. Its main advantage would be the congressionally mandated requirement that hospitals and doctors be reimbursed at rates at or near Medicare's. These are as much as 30 percent lower than rates paid by private insurers, says the health-care consulting firm Lewin Group. With such savings, the public plan could charge much lower premiums and attract lots of customers. But health costs wouldn't subside; hospitals and doctors would offset the public plan's artificially low reimbursements by raising fees to private insurers, as already occurs with Medicare. Premiums would increase because private insurers must cover costs to survive.
As for administrative expenses, any advantage for the public plan is exaggerated, say critics. Part of the gap between private insurers and Medicare is statistical illusion: Because Medicare recipients have higher average health expenses ($10,003 in 2007) than the under-65 population ($3,946), its administrative costs are a smaller share of total spending. The public plan, with younger members, wouldn't enjoy this advantage.
Likewise, Medicare has low marketing costs because it's a monopoly. But a non-monopoly public plan would have to sell itself and would incur higher marketing costs. Private insurers' profits (included in administrative costs) also explain some of Medicare's cost advantage. But profits represent only 3 percent of the insurance industry's revenue. Moreover, accounting comparisons are misleading when they don't include the cost of Medicare's government-supplied investment capital. A public plan would also need investment capital. And suppose the public plan suffers losses. Congress would assuredly bail it out.
The promise of the public plan is a mirage. Its political brilliance is to use free-market rhetoric (more "choice" and "competition") to expand government power. But why would a plan tied to Medicare control health spending, when Medicare hasn't? From 1970 to 2007, Medicare spending per beneficiary rose 9.2 percent annually compared to the 10.4 percent of private insurers -- and the small difference partly reflects cost shifting. Congress periodically improves Medicare benefits, and there's a limit to how much squeezing reimbursement rates can check costs. Doctors and hospitals already complain that low payments limit services or discourage physicians from taking Medicare patients.
Even Hacker concedes that without reimbursement rates close to Medicare's, the public plan would founder. If it had to "negotiate rates directly with providers" -- do what private insurers do -- the public plan could have "a very hard time" making inroads, he writes. Hacker opposes such weakened versions of the public plan.
By contrast, a favored public plan would probably doom today's private insurance. Although some congressional proposals limit enrollment eligibility in the public plan, pressures to liberalize would be overwhelming. Why should only some under-65 Americans enjoy lower premiums? In one study that assumed widespread eligibility, the Lewin Group estimated that 103 million people -- half the number with private insurance -- would switch to the public plan. Private insurance might become a specialty product.
Many would say: Whoopee! Get rid of the sinister insurers. Bring on a single-payer system. But if that's the agenda, why not debate it directly? It's not insurers that cause high health costs; they're simply the middlemen. It's the fragmented delivery system and open-ended reimbursement. Would strict regulation of doctors, hospitals and patients under a single-payer system provide control? Or would genuine competition among health plans over price and quality work better?
That's the debate we need, but in truth, doctors, hospitals and patients don't want to be limited, whether by government or markets. Congress reflects public opinion. Fearing a real debate, we fake it.
By Robert J. Samuelson
Monday, October 26, 2009
In the health-care debate, the "public plan" is all things to all people. For supporters, it would discipline greedy private insurers and make health-care coverage affordable. For detractors, it's a way station on the path to a single-payer insurance system of government-run health care. In reality, the public plan, also known as the public option, is mostly an exercise in political avoidance: It pretends to control costs and improve access to quality care when it doesn't.
As originally conceived by Yale political scientist Jacob Hacker, the public plan would be a government-created, nonprofit insurance company providing Medicare-like coverage to the under-65 population. But unlike Medicare, benefits would be paid for mainly by premiums -- not taxes. Americans could buy coverage from the public plan or a private insurer.
Competition and choice would increase, say liberals. Facing the low-cost public plan, private insurers would hold down their own premiums, the argument goes. Health-care costs for everyone would moderate. Government subsidies to provide universal coverage would be cheaper. By some estimates, Medicare's administrative costs are only 3 percent of spending, compared with 13 percent or more for private insurers. A new public plan is widely presumed to enjoy an advantage in overhead.
Nonsense, retort critics. The public plan's low costs would be artificial. Its main advantage would be the congressionally mandated requirement that hospitals and doctors be reimbursed at rates at or near Medicare's. These are as much as 30 percent lower than rates paid by private insurers, says the health-care consulting firm Lewin Group. With such savings, the public plan could charge much lower premiums and attract lots of customers. But health costs wouldn't subside; hospitals and doctors would offset the public plan's artificially low reimbursements by raising fees to private insurers, as already occurs with Medicare. Premiums would increase because private insurers must cover costs to survive.
As for administrative expenses, any advantage for the public plan is exaggerated, say critics. Part of the gap between private insurers and Medicare is statistical illusion: Because Medicare recipients have higher average health expenses ($10,003 in 2007) than the under-65 population ($3,946), its administrative costs are a smaller share of total spending. The public plan, with younger members, wouldn't enjoy this advantage.
Likewise, Medicare has low marketing costs because it's a monopoly. But a non-monopoly public plan would have to sell itself and would incur higher marketing costs. Private insurers' profits (included in administrative costs) also explain some of Medicare's cost advantage. But profits represent only 3 percent of the insurance industry's revenue. Moreover, accounting comparisons are misleading when they don't include the cost of Medicare's government-supplied investment capital. A public plan would also need investment capital. And suppose the public plan suffers losses. Congress would assuredly bail it out.
The promise of the public plan is a mirage. Its political brilliance is to use free-market rhetoric (more "choice" and "competition") to expand government power. But why would a plan tied to Medicare control health spending, when Medicare hasn't? From 1970 to 2007, Medicare spending per beneficiary rose 9.2 percent annually compared to the 10.4 percent of private insurers -- and the small difference partly reflects cost shifting. Congress periodically improves Medicare benefits, and there's a limit to how much squeezing reimbursement rates can check costs. Doctors and hospitals already complain that low payments limit services or discourage physicians from taking Medicare patients.
Even Hacker concedes that without reimbursement rates close to Medicare's, the public plan would founder. If it had to "negotiate rates directly with providers" -- do what private insurers do -- the public plan could have "a very hard time" making inroads, he writes. Hacker opposes such weakened versions of the public plan.
By contrast, a favored public plan would probably doom today's private insurance. Although some congressional proposals limit enrollment eligibility in the public plan, pressures to liberalize would be overwhelming. Why should only some under-65 Americans enjoy lower premiums? In one study that assumed widespread eligibility, the Lewin Group estimated that 103 million people -- half the number with private insurance -- would switch to the public plan. Private insurance might become a specialty product.
Many would say: Whoopee! Get rid of the sinister insurers. Bring on a single-payer system. But if that's the agenda, why not debate it directly? It's not insurers that cause high health costs; they're simply the middlemen. It's the fragmented delivery system and open-ended reimbursement. Would strict regulation of doctors, hospitals and patients under a single-payer system provide control? Or would genuine competition among health plans over price and quality work better?
That's the debate we need, but in truth, doctors, hospitals and patients don't want to be limited, whether by government or markets. Congress reflects public opinion. Fearing a real debate, we fake it.
I wonder if Dr. Collins is laying down a (bio) marker...
www.reuters.com/article/idUSTRE59P4UD20091026
Risks to personalized medicine seen in U.S. reform
By Julie Steenhuysen
CHICAGO (Reuters) - The federal government's push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual's genetic makeup, the chief of the National Institutes of Health said on Monday.
"There is a potential collision here," Dr. Francis Collins, director of the National Institutes of Health said at a forum sponsored by the American Association for the Advancement of Science.
Collins, a genetics pioneer tapped by President Barack Obama in July to head the NIH, said studies that lump together large groups of people to test the effectiveness of treatment A versus treatment B run the risk of overlooking clusters of people for whom a drug might have a dramatic effect.
"That's going to get lost in the wash by considering everybody equivalent, which we know they are not," said Collins, who helped lead the Human Genome Project that in 2003 produced a sequence of all the DNA in people.
"The antidote to that is pretty straightforward," said Collins, saying that studies need to include genetic information that allows researchers to find such responses.
Backers of comparative effectiveness research, who include insurers and large employers, see the government-funded studies as a way to learn which treatments work best. But Collins said the studies should be well crafted.
"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins told the meeting, which was broadcast on the Internet.
COST-CUTTING POTENTIAL
There is already evidence that personalized medicine can help reduce health costs, Collins said, pointing to Genomic Health's Oncotype DX, a genetic test that can predict the recurrence of breast cancer.
"This test allows those individuals at low risk for recurrence to know they are at low risk and make a decision about whether to forgo chemotherapy, with all of its adverse consequences, based on that information," Collins said.
He said the test costs $3,500, and most women who get tested and discover they are at low risk decide to forego chemotherapy, saving an average of $2,000 per patient in additional costs from chemotherapy treatment.
"In 2009, roughly 50,000 women are going through this process, predicting we will therefore save the healthcare system $100 million this year based on the availability of this kind of personalized medical test," Collins said.
Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, told the meeting that many clinical trials are structured to determine if a drug is safe and effective in a large group of patients, but the drugs often leave out the why -- why certain patients benefit while others do not.
The FDA increasingly is approving drugs with companion diagnostic tests using biomarkers -- such as specific proteins or genes -- that improve the odds that a new, high-cost biotechnology drug will work.
She said studies that look at the genetic profile of patients and its role in how drugs work could strengthen a drug's application, lending more scientific certainty about why a new drug works.
"Perhaps then we could see more new drug applications in the pipeline that are more likely to succeed," she said.
(Editing by Eric Walsh)
www.reuters.com/article/idUSTRE59P4UD20091026
Risks to personalized medicine seen in U.S. reform
By Julie Steenhuysen
CHICAGO (Reuters) - The federal government's push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual's genetic makeup, the chief of the National Institutes of Health said on Monday.
"There is a potential collision here," Dr. Francis Collins, director of the National Institutes of Health said at a forum sponsored by the American Association for the Advancement of Science.
Collins, a genetics pioneer tapped by President Barack Obama in July to head the NIH, said studies that lump together large groups of people to test the effectiveness of treatment A versus treatment B run the risk of overlooking clusters of people for whom a drug might have a dramatic effect.
"That's going to get lost in the wash by considering everybody equivalent, which we know they are not," said Collins, who helped lead the Human Genome Project that in 2003 produced a sequence of all the DNA in people.
"The antidote to that is pretty straightforward," said Collins, saying that studies need to include genetic information that allows researchers to find such responses.
Backers of comparative effectiveness research, who include insurers and large employers, see the government-funded studies as a way to learn which treatments work best. But Collins said the studies should be well crafted.
"We need to be mindful of the goal of comparative effectiveness research and not lose all that we have gained in understanding how individuals differ and how that could be factored into better diagnostics and preventive strategies," Collins told the meeting, which was broadcast on the Internet.
COST-CUTTING POTENTIAL
There is already evidence that personalized medicine can help reduce health costs, Collins said, pointing to Genomic Health's Oncotype DX, a genetic test that can predict the recurrence of breast cancer.
"This test allows those individuals at low risk for recurrence to know they are at low risk and make a decision about whether to forgo chemotherapy, with all of its adverse consequences, based on that information," Collins said.
He said the test costs $3,500, and most women who get tested and discover they are at low risk decide to forego chemotherapy, saving an average of $2,000 per patient in additional costs from chemotherapy treatment.
"In 2009, roughly 50,000 women are going through this process, predicting we will therefore save the healthcare system $100 million this year based on the availability of this kind of personalized medical test," Collins said.
Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, told the meeting that many clinical trials are structured to determine if a drug is safe and effective in a large group of patients, but the drugs often leave out the why -- why certain patients benefit while others do not.
The FDA increasingly is approving drugs with companion diagnostic tests using biomarkers -- such as specific proteins or genes -- that improve the odds that a new, high-cost biotechnology drug will work.
She said studies that look at the genetic profile of patients and its role in how drugs work could strengthen a drug's application, lending more scientific certainty about why a new drug works.
"Perhaps then we could see more new drug applications in the pipeline that are more likely to succeed," she said.
(Editing by Eric Walsh)
I spent an hour talking about health care reform with Indiana Governor Mitch Daniels today. Governor Daniels -- who won his second term as the Hoosier State's CEO in 2008 with over 60 percent of the vote even as Barack Obama was carring the state -- has taken an approach to providing health care coverage that is distinctly at odds with what is being proposed in Congress in three important ways:
1. It is not an entitlement.
2. It provides people with control over health care spending by funding health savings accounts
3. It both encourages and rewards healthy behavior and preventive care.
The program is modest in scope, limited now byt the fact that the federal government will allow Medicaid funds to be used only for less than ten percent of the chronically uninsured in the state. Part of the spending (the money put inton health savings accounts) comes from an increasein the tobacco tax.
But it is paired with the Daniels decision to add an HSA plan for all state employees and a program to encouage Hoosiers to improve their physicial condition through better diets, more exercise, etc.
Preliminary data shows that the state is spending less on healthcare and premiums are rising more slowly.
More important, before reforming or thinking about reforming an entire system, Daniels focused on:
1. the chronically uninsured who have the hardest time paying for coverage
2. changing the way health care isi paid for by focusing on rewarding health and giving consumers choice
In Washington just the oppostie is true. Healthcare reform is all encompassing and is an entitlement focusing on
1. the people who already have coverage
2. rewarding people for not getting insurance and postponing care
3. restricting choice
Also, Daniels has lowered the tax rate on biomedical innovation and created incentives for patent holders.
In Washington, taxes on innovators are going up and patent protection on innovative products will be cut in half.
1. It is not an entitlement.
2. It provides people with control over health care spending by funding health savings accounts
3. It both encourages and rewards healthy behavior and preventive care.
The program is modest in scope, limited now byt the fact that the federal government will allow Medicaid funds to be used only for less than ten percent of the chronically uninsured in the state. Part of the spending (the money put inton health savings accounts) comes from an increasein the tobacco tax.
But it is paired with the Daniels decision to add an HSA plan for all state employees and a program to encouage Hoosiers to improve their physicial condition through better diets, more exercise, etc.
Preliminary data shows that the state is spending less on healthcare and premiums are rising more slowly.
More important, before reforming or thinking about reforming an entire system, Daniels focused on:
1. the chronically uninsured who have the hardest time paying for coverage
2. changing the way health care isi paid for by focusing on rewarding health and giving consumers choice
In Washington just the oppostie is true. Healthcare reform is all encompassing and is an entitlement focusing on
1. the people who already have coverage
2. rewarding people for not getting insurance and postponing care
3. restricting choice
Also, Daniels has lowered the tax rate on biomedical innovation and created incentives for patent holders.
In Washington, taxes on innovators are going up and patent protection on innovative products will be cut in half.
In the heat of the healthcare reform debate, you might have missed the fact that President Obama signed an appropriations measure that provides the FDA (mostly CDER) with an additional $880.1 million in funding, of which at least $51.5 million will go to the generic drugs office -- a $10 million increase from fiscal 2009. CBER and related field activities will see a 12% budget increase to $305.2 million.
Importantly, the measure includes $18 million for the Critical Path initiative, with at least $6 million of this set aside for partnership activities. Huzzah! Of the $6 million, $2 million will support research partnerships for the treatment or rapid diagnosis of tropical diseases, particularly tuberculosis and drug-resistant TB. A bit of mission creep – but no complaints.
The fiscal 2010 appropriations bill also increases direct non-user fee funding to the agency by 15%, bringing the agency's total budget with user fees to $3.25 billion.
The FDA will receive about $2.35 billion in direct funding, plus $893 million in user fees. This includes $235 million in fees to fund the new tobacco products program.
Interestingly, and relative to the issue of generic drugs and bioequivalence, Congress also requires that FDA report on adverse events and seizures associated with branded and generic epilepsy medicines. According to the conference report, "Specifically, the agency should examine the pharmacokinetic properties of 'A' rated anti-epileptic drugs from different manufacturers of the same therapeutic agent," the states. The agency must submit a report by September 30th, 2010 detailing what changes, if any, should be made to the current bioequivalence testing.
Critical Path funding. Partnership activities. Bioeqivalence. That’s progress.
Importantly, the measure includes $18 million for the Critical Path initiative, with at least $6 million of this set aside for partnership activities. Huzzah! Of the $6 million, $2 million will support research partnerships for the treatment or rapid diagnosis of tropical diseases, particularly tuberculosis and drug-resistant TB. A bit of mission creep – but no complaints.
The fiscal 2010 appropriations bill also increases direct non-user fee funding to the agency by 15%, bringing the agency's total budget with user fees to $3.25 billion.
The FDA will receive about $2.35 billion in direct funding, plus $893 million in user fees. This includes $235 million in fees to fund the new tobacco products program.
Interestingly, and relative to the issue of generic drugs and bioequivalence, Congress also requires that FDA report on adverse events and seizures associated with branded and generic epilepsy medicines. According to the conference report, "Specifically, the agency should examine the pharmacokinetic properties of 'A' rated anti-epileptic drugs from different manufacturers of the same therapeutic agent," the states. The agency must submit a report by September 30th, 2010 detailing what changes, if any, should be made to the current bioequivalence testing.
Critical Path funding. Partnership activities. Bioeqivalence. That’s progress.
China will launch a one-year crackdown on fake drug ads on the Internet and sales of fake drugs through postal services, according to an inter-ministerial conference on October 23. The campaign will be jointly launched by 13 ministries including the Ministry of Health, the Ministry of Industry and Information Technology and the State Food and Drug Administration (SFDA).
Health Minister Chen Zhu said Web sites, advertisement companies, postal services, medical institutions and commercial banks involved in such illegal businesses are the main targets of the crackdown.
Shao Mingli, director of the State Food and Drug Administration, said the SFDA's official Web sites will name and shame those sites advertising fake drugs to alert the public. Most recently, the administration exposed six drug producers whose advertisements contain content of over-promised efficacy and guarantee in the name of consumers.
Shaming is good -- prison terms would be even better.
Health Minister Chen Zhu said Web sites, advertisement companies, postal services, medical institutions and commercial banks involved in such illegal businesses are the main targets of the crackdown.
Shao Mingli, director of the State Food and Drug Administration, said the SFDA's official Web sites will name and shame those sites advertising fake drugs to alert the public. Most recently, the administration exposed six drug producers whose advertisements contain content of over-promised efficacy and guarantee in the name of consumers.
Shaming is good -- prison terms would be even better.
When it comes to healthcare reform, bipartisanship begins with "D."
Consider this new op-ed from today's Detroit News:
Moderate Democrats, Republicans quietly work on health care bill
PETER PITTS
Consider this new op-ed from today's Detroit News:
Moderate Democrats, Republicans quietly work on health care bill
PETER PITTS
Republican Congressman Bill Cassidy recently broke some news that could turn the health care debate on its head. During a radio interview, he revealed that Blue Dog Democrats have been quietly reaching out to Republicans to draft an alternative health reform bill.
This isn't surprising. After all, neither Republicans nor centrist Democrats nor the majority of Americans approve of the clumsy hodgepodge of big-government policies that make up Sen. Max Baucus' health care bill.
An alliance between Republicans and moderate Democrats could give Americans the reform package they're looking for -- one aimed at lowering costs while promoting competition and choice.
Polls show that public support for health care reform is at a new low. According to a Rasmussen poll from Sept. 28, 56 percent of Americans oppose the leading Democratic reform proposal.
They're not alone. Blue Dog Democrats -- a group of 52 moderate Democratic members of Congress -- have long been uneasy about health care reforms that give too much power to the federal government. In fact they were among the leading opponents of the government-run "public option." Although that idea seems to be off the table, there's still plenty in the Baucus legislation for these fiscally conservative Democrats to criticize.
The nonprofit health care cooperatives that the Baucus bill creates, for instance, would create many of the same problems as the public option. It's true that these co-ops wouldn't officially be part of the government, but they would benefit from federal financial backing (the Baucus bill provides $6 billion for the establishment of these co-ops) and an implied federal guarantee. Consequently, they would pose a serious threat to Americans' ability to purchase private coverage.
Since co-ops would be able to draw from a healthy supply of federal funds, they could push private insurers out of the market by offering artificially low rates. This would soon result in a health care sector with few alternatives to the federally chartered co-ops.
At the same time, the Senate bill -- which carries an $856 billion price tag -- also fails to sufficiently address the issue of cost. A recent Gallup poll showed that the No. 1 concern Americans have about health care is cost and affordability.
And a bipartisan alternative to Baucus' legislation has the potential to be the kind of practical, cost-lowering bill that American's want and America's healthcare system needs.
What would such a bill look like? It's hard to say, but one smart way to go about crafting a bipartisan bill would be to model it off existing successful health care policies -- namely, Medicare Part D.
By creating a system where private insurers could fairly compete to offer Medicare beneficiaries the best drug coverage, Part D has reduced the number of seniors without drug coverage by 17 percent, while still managing to cost about 30 percent less than originally estimated.
The program also enjoys a 92 percent satisfaction rating. This is largely because Part D provides seniors with a real choice over the kind of drug coverage they receive (the program offers over 1,800 plans).
This basic model could be used as the basis for a new bipartisan healthcare bill. Under such a program, the federal government would expand coverage to chronically uninsured -- those 8 million to 15 million Americans who can't afford private coverage but earn too much for government aid -- by creating a system of privately administered health insurance options. Customers would choose the plan most appropriate for them, and the federal government would help subsidize their premiums, depending on their need.
Such a program would keep costs down by rewarding insurance companies for providing the best coverage at the lowest price. It would also give Americans the freedom to choose from a wide array of different insurance plans.
The time is right for a real bipartisan reform to take shape.
Peter J. Pitts is president of the Center for Medicine in the Public Interest and a former Food and Drug Administration associate commissioner.
CMPI hosted a roundtable discussion with health policy leaders about the real impact of health care proposals being considered by Congress. We released new findings developed by Richard Cooper, MD a professor of medicine at U Penn challenging the claim made about every bill: that a public option or a “trigger”, health exchanges and Medicare commissions can cut “unnecessary” care, reduce spending on health by 30 percent of the total and pay for universal coverage.
Dr. Cooper's research (which can found on his blog buzcooper.com/2009/07/29/what-if-the-problem-is-poverty/ ) clearly shows that proposals to have government penalize doctors who use more services than the lowest ten percentile (or reward those who use less services), reimburse according to evidence-based guidelines which are skewed to the less is best bias inherent in comparative effectiveness research, cut back payments to doctors in Medicaid and Medicare based on this mindset, limit the introduction of new technologies where government payment predominates, and envision increasing the number of Americans receiving care under this framework will mean cutting back drastically on access to medical treatment for poor people in urban areas.
Our panel of experts, moderated by CMPI senior fellow and former Congressman Mike Ferguson observed that central features of the current bills in Congress will guarantee that health care gets worse for minorities and the chronically ill, not better.
Michael Cannon, who runs health policy studies at Cato Institute (www.cato.org/people/michael-cannon ) noted that because Medicare and Medicaid are already the largest single source of payment, expanding the model will make it even harder to shift resources or change thinking in ways to focus on illness or disease prevention. The political culture will simply reorganize around the larger bureaucracy.
Joe Antos, the Wilson H. Taylor Scholar in Health Care and Retirement Policy at the American Enterprise Institute (www.aei.org/antos) pointed out that health care is a series of choices about care, cost, coverage and behavior. The issue is who should make these choices. The current proposals are hell-bent in centralizing such important decisions into the hands of a few government planners. Choices made by many to allocate resources thereby become rationing.
Jim Frogue , who is deputy director of Newt Gingrich's Center for Health Transformation (www.healthtransformation.net/cs/jim_frogue) emphasized that behavior is the key to health status for most chronic illnesses. Reforms that fail to focus on health improvement in a signficant way, or fail to free people to pursue prevention will make matters worse. While best practices are not one size fits all, Frogue noted that prevention approaches can be shared, adapted and refined for specific populations.
Finally, Gary Puckrein, President of the National Minority Quality Forum noted that advances in medical technology explain a considerable amount of the increase in life expectancy and survival over the last 50 years. The forum www.nmqf.org has identified by zip code where the greatest incidence of the most serious and costly chronic disease exists. It has tracked to the patient level who will cost the most in terms of Medicare expenditures and why. The failure to prevent diabetes explains much of the growing cost of Medicare and it can be traced to specific urban areas, areas that will see money cut because it is defined as "wasteful" when it could be transformed into more effective forms of care.
The battle of health care then is not "yes" or "no" but "how." Medical innovation is and should continue to be an American growth industry and a source of productivity. The current approach to reform undermines and discourages transformation, drives up cost and slows the development of the next generation of technologies.
More importantly, the mass of regulation assures that the health care equivalent of a Bill Gates or Eric Schmidt will not emerge to lead and transform a critical and competitive American industry.
Dr. Cooper's research (which can found on his blog buzcooper.com/2009/07/29/what-if-the-problem-is-poverty/ ) clearly shows that proposals to have government penalize doctors who use more services than the lowest ten percentile (or reward those who use less services), reimburse according to evidence-based guidelines which are skewed to the less is best bias inherent in comparative effectiveness research, cut back payments to doctors in Medicaid and Medicare based on this mindset, limit the introduction of new technologies where government payment predominates, and envision increasing the number of Americans receiving care under this framework will mean cutting back drastically on access to medical treatment for poor people in urban areas.
Our panel of experts, moderated by CMPI senior fellow and former Congressman Mike Ferguson observed that central features of the current bills in Congress will guarantee that health care gets worse for minorities and the chronically ill, not better.
Michael Cannon, who runs health policy studies at Cato Institute (www.cato.org/people/michael-cannon ) noted that because Medicare and Medicaid are already the largest single source of payment, expanding the model will make it even harder to shift resources or change thinking in ways to focus on illness or disease prevention. The political culture will simply reorganize around the larger bureaucracy.
Joe Antos, the Wilson H. Taylor Scholar in Health Care and Retirement Policy at the American Enterprise Institute (www.aei.org/antos) pointed out that health care is a series of choices about care, cost, coverage and behavior. The issue is who should make these choices. The current proposals are hell-bent in centralizing such important decisions into the hands of a few government planners. Choices made by many to allocate resources thereby become rationing.
Jim Frogue , who is deputy director of Newt Gingrich's Center for Health Transformation (www.healthtransformation.net/cs/jim_frogue) emphasized that behavior is the key to health status for most chronic illnesses. Reforms that fail to focus on health improvement in a signficant way, or fail to free people to pursue prevention will make matters worse. While best practices are not one size fits all, Frogue noted that prevention approaches can be shared, adapted and refined for specific populations.
Finally, Gary Puckrein, President of the National Minority Quality Forum noted that advances in medical technology explain a considerable amount of the increase in life expectancy and survival over the last 50 years. The forum www.nmqf.org has identified by zip code where the greatest incidence of the most serious and costly chronic disease exists. It has tracked to the patient level who will cost the most in terms of Medicare expenditures and why. The failure to prevent diabetes explains much of the growing cost of Medicare and it can be traced to specific urban areas, areas that will see money cut because it is defined as "wasteful" when it could be transformed into more effective forms of care.
The battle of health care then is not "yes" or "no" but "how." Medical innovation is and should continue to be an American growth industry and a source of productivity. The current approach to reform undermines and discourages transformation, drives up cost and slows the development of the next generation of technologies.
More importantly, the mass of regulation assures that the health care equivalent of a Bill Gates or Eric Schmidt will not emerge to lead and transform a critical and competitive American industry.
Ad Age reports:
SCRIP World Pharmaceutical News reports that, “The European pharmaceutical industry association, EFPIA, today launched its anti-counterfeiting pilot project in Sweden, raising concerns among parallel traders that should it be rolled out across the EU, the scheme's central database may be misused by manufacturers to curb sales to certain wholesalers.”) This follows up on the commission's legislative proposal for some sort of authentication process, but which stopped short of recommending an actual type.
The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.
The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.
The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.
Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."
Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.
The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.
The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.
The pilot scheme involves 25 pharmacies in the Stockholm area. Pharmacists will be scanning about 110,000 pharmaceutical packs that have a special two-dimensional barcode (similar to those found on airline boarding passes) using a scanning device at the point of dispensing.
The scanned product would be checked against the manufacturer's records in a central database to verify whether it is genuine, as the product would have a unique serial number. The data matrix would be enough to individually code each medicine pack with information including a product code, batch number, expiry date and a unique serial number.
The system has proven to be a cheaper and easier solution to implement than other authentication schemes such as track and trace and RFID tagging, believes EFPIA. It also offers advantages such as reducing dispensing errors and reimbursement fraud.
Heinz Kobelt, secretary general of the European parallel traders association, the EAEPC, is concerned about who is "master of the data" in the central database. "If pharmaceutical manufacturers get free access to the data, they can use it against parallel traders. We need an independent agency to run the central database."
Colin Mackay, EFPIA's spokesperson, told Scrip that it was uncertain who would fund the scheme if it were rolled out across Europe, but financers should include all stakeholders, including the pharmaceutical industry, wholesalers, pharmacists, parallel traders and member states.
The EFPIA system is being piloted in collaboration with the European wholesaler trade association, GIRP, and local Swedish full-line wholesalers Tamro and Kronans Droghandel. EFPIA has said that accredited full-line wholesalers would be able to access the database to check the status of the product at any time.
The European Parliament's Committee on the Environment, Public Health and Food Safety is expected to issue a report on the Commission's counterfeiting proposals next month. EFPIA plans to issue the results of the completed pilot early next year.
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.
