Latest Drugwonks' Blog
Where's Senator Grassley when you need him?
Last week we wrote about “Tamiflurry.”
A brief recap:
On May 4-5 the Harvard Business School Health Alumni Association along with the Young Presidents Organization/World Presidents' Organization (YPO/WPO) sponsored a conference in Washington, DC, "Health Reform at the Intersection of Government and Markets.” After two days of robust debate and discussion over a wide range of issues, the event ended with a troubling episode.
So troubling, in fact, that one physician in attendance along with another independent businessman felt obligated to write to Randy Cohen, who pens “The Ethicist” column at the New York Times, with the following query:
“We were attending a conference on health reform which had included an impromptu presentation on the swine flu pandemic. As the conference was closing, a physician was introduced and he said that as a “treat” for all his fellow attendees he would write prescriptions for TAMIFLU and that if he ran out of scripts, he would send one to anyone who emailed him a request. A large line immediately formed of people eager to avoid the risk of shortages or rationing. When confronted with our question as to the ethics and legality of his offer, he explained that he was a physician and had worked with the CDC and was confident he was acting in a morally and professionally correct manner – was he? For that matter, were the conference organizers in ethically troubling territory?”
The full post can be found here.
Our post was directed at Dan Brock, the Director of the Harvard University Program in Ethics and Health.
Herewith (and with permission) is Dr. Brock’s response:
“If your description of what transpired is accurate, then the action of offering an Rx for Tamiflu to all the attendees at this meeting was in my view clearly unethical, and essentially for the reasons you and Randy Cohen cite. Physicians should not be writing prescriptions for persons who are not their patients, nor should they be encouraging others to stockpile a potentially scarce drug. Why the organizers of this event permitted it I have no idea, nor do I know who they were.
You ask what can I do about this. The answer is probably not much, and that is not because I do not believe that what you describe as transpiring was not wrong. But neither of the two ethics programs at Harvard that I direct put them or me in the role of "ethics police" for everything that goes on connected with Harvard Medical School. The obvious parties with whom a complaint should initially be lodged are the organizers of the event who apparently permitted this to go on at the meeting.
If the physician offering the prescriptions was a member of the Harvard Medical School faculty then a complaint could also be lodged with the medical school. HMS has procedures for responding to allegations of faculty misconduct, but neither I nor my programs are involved in that process. I agree that an investigation of the matter is appropriate and one or both of these parties should be in a position to do so.”
Senator Grassley – how about an investigation?
Last week we wrote about “Tamiflurry.”
A brief recap:
On May 4-5 the Harvard Business School Health Alumni Association along with the Young Presidents Organization/World Presidents' Organization (YPO/WPO) sponsored a conference in Washington, DC, "Health Reform at the Intersection of Government and Markets.” After two days of robust debate and discussion over a wide range of issues, the event ended with a troubling episode.
So troubling, in fact, that one physician in attendance along with another independent businessman felt obligated to write to Randy Cohen, who pens “The Ethicist” column at the New York Times, with the following query:
“We were attending a conference on health reform which had included an impromptu presentation on the swine flu pandemic. As the conference was closing, a physician was introduced and he said that as a “treat” for all his fellow attendees he would write prescriptions for TAMIFLU and that if he ran out of scripts, he would send one to anyone who emailed him a request. A large line immediately formed of people eager to avoid the risk of shortages or rationing. When confronted with our question as to the ethics and legality of his offer, he explained that he was a physician and had worked with the CDC and was confident he was acting in a morally and professionally correct manner – was he? For that matter, were the conference organizers in ethically troubling territory?”
The full post can be found here.
Our post was directed at Dan Brock, the Director of the Harvard University Program in Ethics and Health.
Herewith (and with permission) is Dr. Brock’s response:
“If your description of what transpired is accurate, then the action of offering an Rx for Tamiflu to all the attendees at this meeting was in my view clearly unethical, and essentially for the reasons you and Randy Cohen cite. Physicians should not be writing prescriptions for persons who are not their patients, nor should they be encouraging others to stockpile a potentially scarce drug. Why the organizers of this event permitted it I have no idea, nor do I know who they were.
You ask what can I do about this. The answer is probably not much, and that is not because I do not believe that what you describe as transpiring was not wrong. But neither of the two ethics programs at Harvard that I direct put them or me in the role of "ethics police" for everything that goes on connected with Harvard Medical School. The obvious parties with whom a complaint should initially be lodged are the organizers of the event who apparently permitted this to go on at the meeting.
If the physician offering the prescriptions was a member of the Harvard Medical School faculty then a complaint could also be lodged with the medical school. HMS has procedures for responding to allegations of faculty misconduct, but neither I nor my programs are involved in that process. I agree that an investigation of the matter is appropriate and one or both of these parties should be in a position to do so.”
Senator Grassley – how about an investigation?
Depression Treatment Wanes Following FDA Warnings
Peter and I, among others, were attacked for pointing out that hijacking of science surrounding the risks of antidepressants would lead to public health problems including an increase in suicide. In particular Shannon Brownlee and Jeanne Lenzer unleashed an ad hominem attack on both of us and Dr. Fred Goodwin that resulted in a witch hunt on Goodwin's reputation. Meanwhile the pseudo-scientific biases of Brownlee and Lenzer about the use of SSRIs in particular -- Brownlee claims that biochemically, "the drugs might trigger suicide and bipolar disorder" -- and asserts that there is no biological link between serotonin and depression (Scientology claptrap) or that doctors do not know which patients will respond to which meds (see the STAR-D trial for that) were used to fuel an attack not on the merits of the position but on funding sources.
Well, facts are stubborn things, particularly in biology where observation is...well, as Groucho Marx used to say, "who do you believe? Me or your eyes?" Scaremongering by Brownlee and Lenzer, combined with the witchhunt against shrinks who received pharma money allows those who "know" despite the data that SSRIs are a holocaust in waiting to dominate both the media and the mainstream medical journals who feed on each other.
And meanwhile the connective tissue between patient and doctor is shredded by fear. The public health suffers. People get sicker. They kill themselves.
Perhaps the relationship between industry and academia needs or needed a shakeup to focus more on risks and benefits. Industry deserves blame for not staying ahead of the curve on many of these issues and responding in a more timely fashion to potential problems. But the Brownlee and Lenzer school have an ideological approach to medicine: industry corrupts all it touches and it buries its pollution (the risks of its products) as a matter of policy. Much like the anti-vaccine groupies, in the face of mounting evidence they are wrong they find new excuses to remain unconvinced and unpersuaded.
We have seen the damage of their approach. They are partly responsible for promoting the decline in treatment and are responsible for the consequences.
Advisories led to 'unintended consequences,' researchers say
Posted June 1, 2009
By Karen Pallarito
HealthDay Reporter
MONDAY, June 1 (HealthDay News) -- Newly diagnosed cases of depression in America have dropped sharply since the government's warning of an increased risk of suicidal behavior among children and teens taking antidepressants, a new analysis finds.
Read more herePeter and I, among others, were attacked for pointing out that hijacking of science surrounding the risks of antidepressants would lead to public health problems including an increase in suicide. In particular Shannon Brownlee and Jeanne Lenzer unleashed an ad hominem attack on both of us and Dr. Fred Goodwin that resulted in a witch hunt on Goodwin's reputation. Meanwhile the pseudo-scientific biases of Brownlee and Lenzer about the use of SSRIs in particular -- Brownlee claims that biochemically, "the drugs might trigger suicide and bipolar disorder" -- and asserts that there is no biological link between serotonin and depression (Scientology claptrap) or that doctors do not know which patients will respond to which meds (see the STAR-D trial for that) were used to fuel an attack not on the merits of the position but on funding sources.
Well, facts are stubborn things, particularly in biology where observation is...well, as Groucho Marx used to say, "who do you believe? Me or your eyes?" Scaremongering by Brownlee and Lenzer, combined with the witchhunt against shrinks who received pharma money allows those who "know" despite the data that SSRIs are a holocaust in waiting to dominate both the media and the mainstream medical journals who feed on each other.
And meanwhile the connective tissue between patient and doctor is shredded by fear. The public health suffers. People get sicker. They kill themselves.
Perhaps the relationship between industry and academia needs or needed a shakeup to focus more on risks and benefits. Industry deserves blame for not staying ahead of the curve on many of these issues and responding in a more timely fashion to potential problems. But the Brownlee and Lenzer school have an ideological approach to medicine: industry corrupts all it touches and it buries its pollution (the risks of its products) as a matter of policy. Much like the anti-vaccine groupies, in the face of mounting evidence they are wrong they find new excuses to remain unconvinced and unpersuaded.
We have seen the damage of their approach. They are partly responsible for promoting the decline in treatment and are responsible for the consequences.
I recently talked about what ‘free’ health care in countries like Britain, Canada, and Norway actually costs and showed that not only are they not free, they can also involve significant out of pocket costs. But the world has a lot of systems other than single payer and these systems too have important lessons for the US on controlling, or failing to control, citizens’ health care costs. As models for the US, they are far more instructive examples than single payer systems, since they share elements of the existing American system.
France has a two tier system with both government funded care and privately purchased insurance. Employers pay around 12.8 percent of payroll for health care. Employees pay 0.75% of their salaries towards health care, plus a 7.5 percent General Social Contribution, the majority of which is earmarked for the health system. This base coverage reimburses people for the majority of costs for visits to the doctor, usually 75-80 percent and for a portion of the costs of medications, with how much depending on the type of drug. On top of the government coverage, almost all French residents have supplementary coverage from a mutuelle, often also through their workplaces. While the cost of these plans varies based on a number of factors, it is approximately 2.5 percent of salary. The mutuelle reimburses much of the leftover cost of care. In total, an estimated 10 percent of household income is spent on health care, plus remaining un-reimbursed costs and money spent on treatments not eligible for coverage under the system.
In Germany, most people have coverage through work via a non-profit insurance company called a sickness fund. There is a public system and a private one that serves about 10 percent of the population. Prior to 1 January 2009, coverage from a public sickness fund could range significantly in cost, from around 12.2 to 16.7 percent and in 2007, an average German might pay 6.65 percent of income to the sickness fund and his employer would by 7.55 percent. As of fall 2008, premiums were standardized on the federal level at 15.5 percent. Due to the economic downturn, on 1 July 2009, they are reduced to 14.9 percent. Private sickness funds generally charge more. Germans also pay small co-pays for doctor’s visits and on drugs. Health insurance in the Netherlands is linked to employment. Each person pays an “income-related contribution,” 7.2 percent of income up to €31,200 for 2008, which is reimbursed by their workplace. This reimbursement money is taxable income. On top of this, the Dutch pay a premium per adult (children are free). They also pay taxes that are used to subsidize people who cannot afford health insurance on their own. Premiums for basic coverage cost around €1,028 in 2006 per adult, €1,100 in 2008 (~$1600) and usually has a deductible of €150, although those willing to accept higher deductibles can get lower premiums. However, around 90 percent of people in the Netherlands opt to get more expensive plans that offer greater coverage.
Finally, let’s look at Switzerland, where the system is unusual because it dispenses with employer provided health care and has residents buy their coverage themselves. It also is rare in that like the US insurance companies are allowed to be for profit. There are a wide variety of plans, but all insurers a basic plan, the components of which are federally determined. Families pay a premium for each person, with the prices varying by age, which comes out to an average $680 per month or around $8,167 annually for four people on the basic plan. Premiums are lower or higher depending on the deductible, which can be anywhere from around $250 to about $2000. Those who want more coverage (about 40 percent of the population), pay more, those who need help affording insurance are subsidized. Co-payments on drugs once the deductible has been reached are generally 10 percent and 20 percent if there is a comparable generic for those with the basic plan, up to 933 Swiss francs (~$745) annually in 2006.
Both structurally and in terms of priorities, countries like those discussed above are far more useful comparators for those determining how the US system can be made better than the UK and Canada are. And they are also proof that there is no panacea to the problems of balancing technology and choice with cost and access.
This is a test for Google Webmaster Tools
Former HHS DepSec Tevi Troy has an important article in the June edition of Commentary, "The End of Medical Miracles?"
Here's how it begins:
Here's how it begins:
"AMERICANS HAVE, at best, a love-hate relationship with the life-sciences industry—the term for the sector of the economy that produces pharmaceuticals, biologics (like vaccines), and medical devices. These days, the mere mention of a pharmaceutical manufacturer seems to elicit gut-level hostility. Journalists, operating from a bias against industry that goes as far back as the work of Upton Sinclair in the early years of the 20th century, treat companies from AstraZeneca to Wyeth as rapacious factories billowing forth nothing but profit. At the same time, Americans are adamant about the need for access to the newest cures and therapies and expect new cures and therapies to emerge for their every ailment—all of which result from work done primarily by these very same companies whose profits make possible the research that allows for such breakthroughs."
During the course of his article, Troy discusses the issues that threaten to derail medical progress (litigation, an overly cautious FDA and, of course, legislation to put Uncle Sam in charge of our healthcare). Troy concludes:
"Just as there is potential danger from the way in which Americans take the power of the antibiotic for granted, so, too, one of the greatest threats to our health and continued welfare is that Americans in the present day, and particularly their leaders, are taking for granted the power, potency, and progress flowing from life-saving medical innovations. And in so doing, they may unknowingly prevent the kind of advance that could contribute as vitally to the welfare of the 21st century as the discovery of the antibiotic altered the course of human history for the better in the century just concluded."
Tevi's complete article can be found here.
All the rest is, well, commentary.
Lately we’ve been discussing the issue of taxing employer-based healthcare benefits in order to finance Uncle Sam’s career change to Uncle Sam, MD.
We talked about it here:
“The Vast Reich Wing Conspiracy”
And here:
“Pink Cadillac”
And now we welcome the Wall Street Journal to the debate. Here’s what they had to say on this today:
Democrats have spent years arguing that proposals to equalize the tax treatment of health insurance are an outrage against the American people. Workers pay no income or payroll taxes on the value of job-based plans, but the same hand isn't extended to individuals who must buy coverage on their own. Last year liberals mauled John McCain for daring to touch the employer-based exclusion to finance more coverage for the individually uninsured. He was proposing "a multitrillion-dollar tax hike -- the largest middle-class tax hike in history," said Barack Obama, whose TV ads were brutal.
But now Democrats need the money to finance $1.2 trillion or more for their new health insurance entitlement. Last week Senate Finance Chairman Max Baucus released his revenue "policy options" and high on the list is . . . taxing health benefits. Or listen to White House budget director Peter Orszag, who recently told CNN's John King that the exclusion "was not in the President's campaign plan, it wasn't in our budget. Clearly, some Members of Congress are putting it on the table and we are going to have to let this play out."
Mr. King tried again. "Let this play out. But would the President sign a bill that includes a pretty significant tax increase? That would be a tax increase." Mr. Orszag: "We're not going to be -- I think it's premature to be commenting on individual items . . . There are lots of ideas that are being put on the table." Translation: You betcha he'd sign it.
The tax exclusion is such a big revenue prize because Mr. Baucus is scrubbing every other tax nook and cranny and only coming up with rounding errors. A sampler:
- Impose an excise tax on hard alcohol, beer and some kinds of wine. That would be in addition to a sin tax on beverages sweetened with sugar or high-fructose corn syrup, such as soda. Mr. Baucus doesn't offer revenue estimates, though the Congressional Budget Office says a $16 per proof gallon alcohol tax might raise $60 billion over 10 years, and another $50.4 billion at three cents per 12 ounces of sugary drink.
- End or limit the tax-exempt status of charitable hospitals, which only costs currently a mere $6 billion a year.
- Make college students in work-study programs subject to the payroll tax. Also targeted are medical residents, perhaps on the principle that they'll one day be "rich" doctors. CBO has no score on these.
- Reducing Medicare reimbursement rates for supposedly "over valued physician services," such as diagnostic imaging. CBO says that requiring doctors to get prior clearance could save $1 billion in 10 years.
- For individuals with high-deductible insurance plans, contributions to health savings accounts would no longer be tax deductible. That would penalize patients who choose plans that encourage them to be informed consumers. CBO says that banning HSA payments entirely would yield all of $10 billion.
By contrast, the employer-based exclusion offers a huge money pot -- an estimated $226 billion in 2008. Yet as liberal MIT economist Jonathan Gruber recently told Mr. Baucus's committee, "no health expert today would ever set up a health system with such an enormous tax subsidy to a particular form of insurance" (his emphasis). It creates a coverage gap between workers who receive it from their employers and those who pay -- or can't afford to pay -- with after-tax money.
The tax exclusion is also one reason health costs continue to rise. It encourages workers to take an extra dollar of compensation in fringe benefits instead of cash while also routing low-deductible health spending through third parties. Some 84 cents of every medical dollar is spent by someone other than the patient. The insured have no incentives to make cost-conscious decisions about care.
So reforming the exclusion would inject a dose of discipline into American medicine. But for most Democrats the goal isn't to create a more rational health-insurance market. They simply want the revenue for another government program. Mr. Baucus won't target gold-plated employer insurance plans in general, because union-negotiated benefits are usually gold-plated. Rather, he may cap or phase out the exclusion by income, starting with workers earning more than $200,000. Insurance options that don't conform to government diktats (health savings accounts) would also lose any tax advantage. This would do nothing for market efficiency, but it would be one more stealth tax increase.
Democrats owe an apology to Mr. McCain, and it'll be fascinating to see if they will now suffer a political backlash of their own making. Having told the country that this tax reform is really a tax increase, Democrats are opening themselves to the same attacks they leveled against Republicans.
They could avoid that fate if they used the tax exclusion money to finance, say, a tax credit for the uninsured. That would be a genuinely bipartisan reform. But liberals won't accept that because they want to take one giant step toward government-run health care. And the only way they can pay for it is by taxing everything in sight, including your current health insurance.
We talked about it here:
“The Vast Reich Wing Conspiracy”
And here:
“Pink Cadillac”
And now we welcome the Wall Street Journal to the debate. Here’s what they had to say on this today:
Taxing Health Care
Obama and Democrats owe John McCain an apology.
Democrats have spent years arguing that proposals to equalize the tax treatment of health insurance are an outrage against the American people. Workers pay no income or payroll taxes on the value of job-based plans, but the same hand isn't extended to individuals who must buy coverage on their own. Last year liberals mauled John McCain for daring to touch the employer-based exclusion to finance more coverage for the individually uninsured. He was proposing "a multitrillion-dollar tax hike -- the largest middle-class tax hike in history," said Barack Obama, whose TV ads were brutal.
But now Democrats need the money to finance $1.2 trillion or more for their new health insurance entitlement. Last week Senate Finance Chairman Max Baucus released his revenue "policy options" and high on the list is . . . taxing health benefits. Or listen to White House budget director Peter Orszag, who recently told CNN's John King that the exclusion "was not in the President's campaign plan, it wasn't in our budget. Clearly, some Members of Congress are putting it on the table and we are going to have to let this play out."
Mr. King tried again. "Let this play out. But would the President sign a bill that includes a pretty significant tax increase? That would be a tax increase." Mr. Orszag: "We're not going to be -- I think it's premature to be commenting on individual items . . . There are lots of ideas that are being put on the table." Translation: You betcha he'd sign it.
The tax exclusion is such a big revenue prize because Mr. Baucus is scrubbing every other tax nook and cranny and only coming up with rounding errors. A sampler:
- Impose an excise tax on hard alcohol, beer and some kinds of wine. That would be in addition to a sin tax on beverages sweetened with sugar or high-fructose corn syrup, such as soda. Mr. Baucus doesn't offer revenue estimates, though the Congressional Budget Office says a $16 per proof gallon alcohol tax might raise $60 billion over 10 years, and another $50.4 billion at three cents per 12 ounces of sugary drink.
- End or limit the tax-exempt status of charitable hospitals, which only costs currently a mere $6 billion a year.
- Make college students in work-study programs subject to the payroll tax. Also targeted are medical residents, perhaps on the principle that they'll one day be "rich" doctors. CBO has no score on these.
- Reducing Medicare reimbursement rates for supposedly "over valued physician services," such as diagnostic imaging. CBO says that requiring doctors to get prior clearance could save $1 billion in 10 years.
- For individuals with high-deductible insurance plans, contributions to health savings accounts would no longer be tax deductible. That would penalize patients who choose plans that encourage them to be informed consumers. CBO says that banning HSA payments entirely would yield all of $10 billion.
By contrast, the employer-based exclusion offers a huge money pot -- an estimated $226 billion in 2008. Yet as liberal MIT economist Jonathan Gruber recently told Mr. Baucus's committee, "no health expert today would ever set up a health system with such an enormous tax subsidy to a particular form of insurance" (his emphasis). It creates a coverage gap between workers who receive it from their employers and those who pay -- or can't afford to pay -- with after-tax money.
The tax exclusion is also one reason health costs continue to rise. It encourages workers to take an extra dollar of compensation in fringe benefits instead of cash while also routing low-deductible health spending through third parties. Some 84 cents of every medical dollar is spent by someone other than the patient. The insured have no incentives to make cost-conscious decisions about care.
So reforming the exclusion would inject a dose of discipline into American medicine. But for most Democrats the goal isn't to create a more rational health-insurance market. They simply want the revenue for another government program. Mr. Baucus won't target gold-plated employer insurance plans in general, because union-negotiated benefits are usually gold-plated. Rather, he may cap or phase out the exclusion by income, starting with workers earning more than $200,000. Insurance options that don't conform to government diktats (health savings accounts) would also lose any tax advantage. This would do nothing for market efficiency, but it would be one more stealth tax increase.
Democrats owe an apology to Mr. McCain, and it'll be fascinating to see if they will now suffer a political backlash of their own making. Having told the country that this tax reform is really a tax increase, Democrats are opening themselves to the same attacks they leveled against Republicans.
They could avoid that fate if they used the tax exclusion money to finance, say, a tax credit for the uninsured. That would be a genuinely bipartisan reform. But liberals won't accept that because they want to take one giant step toward government-run health care. And the only way they can pay for it is by taxing everything in sight, including your current health insurance.
Churchill observed: "It is one thing to see the forward path and another to be able to take it." At The Brookings Institution, CMPI convened the Critical Path for Personalized Medicine, a small group that took the first transatlantlic steps towards harnessing the science of personalized medicine to the task of controlling health care costs and increasing the value of medical technology that the science itself made possible. It was lead by two remarkable individuals: Mark McClellan who ran both the FDA and Medicare and Sir Michael Rawlins, MD who for the past decade has been chair of the British National Health Service's National Institute for Clinical Excellence, the entity tasked with developing guidelines for preventative care and treatment of illnesses as well as evaluating the cost effectiveness of new technologies.
Sir Michael noted that comparative effectiveness cannot be conducted by relying on randomized clinical trials and should instead use tools that allow doctors to determine who responds best to what treatments over time. Predictive and interventional approaches are obviously the most valuable. Such tools can provide every one a clearer idea of the value of care.
Over the course of the four hours we spent together that the way forward requires an approach described artfully by Ralph Snyderman, Chairman Emeritus of Duke University Medical Center:
Ultimately the reimbursement for health care will have to be inverted to pay for prospective care and reward targeted therapies.
But our critical path group is committed to doing the hard work. We don't need any more conferences about comparative effectiveness. We need to take the first steps forward.
Sir Michael noted that comparative effectiveness cannot be conducted by relying on randomized clinical trials and should instead use tools that allow doctors to determine who responds best to what treatments over time. Predictive and interventional approaches are obviously the most valuable. Such tools can provide every one a clearer idea of the value of care.
Over the course of the four hours we spent together that the way forward requires an approach described artfully by Ralph Snyderman, Chairman Emeritus of Duke University Medical Center:
- Start with high power predictive tools for big time clinical decions with short term impact on major diseases
- Create model clinical settings where clinical data and genetic information can be collected and combined
- Use clinical setting to establish predictive reliability of clinical decision tools and measure clinical outcomes
- Measure value of such tools to employers, individuals and health plans
Ultimately the reimbursement for health care will have to be inverted to pay for prospective care and reward targeted therapies.
But our critical path group is committed to doing the hard work. We don't need any more conferences about comparative effectiveness. We need to take the first steps forward.
The May 20th memo from the President is unambiguous, "... preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption."
Specifically:
To ensure that executive departments and agencies include statements of preemption in regulations only when such statements have a sufficient legal basis:
1. Heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.
2. Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132.
And here's a direct slap at the FDA's New Labeling Rule preamble:
3. Heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.
The complete memo can be found here.
This should put to bed any lingering doubts as to the Administration's views on the topic. Happy Hour for the trial bar begins immediately.
Specifically:
To ensure that executive departments and agencies include statements of preemption in regulations only when such statements have a sufficient legal basis:
1. Heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.
2. Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132.
And here's a direct slap at the FDA's New Labeling Rule preamble:
3. Heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.
The complete memo can be found here.
This should put to bed any lingering doubts as to the Administration's views on the topic. Happy Hour for the trial bar begins immediately.
Health care costs money, a point that has been strongly reinforced from all directions over recent weeks and months. So why when you ask a lot of Americans what they want from health care reform do they answer “healthcare that’s free like in Europe”? I’ve already established that few people in America actually have the faintest idea what health care systems in Europe look like (and apparently cannot be bothered to do five minutes worth of research to find out) so today I want to talk about what health care actually costs beyond the borders of the US.
In the US, according to the 2008 Milliman Medical Index, a family of four with an employer-based PPO would pay around $15,609 total this year in health care costs. Of this amount, $9442 was paid by the employer and the employee contributed $3,492 in premiums and $2,675 on copays, etc.
Other sources put the cost of premiums for a four person family at $5,799 if buying directly or $3,281 via an employer, about 10 and 6 percent respectively of an average family income of $58,526.
When Americans talk about ‘free health care,’ they are really talking about a single payer system in the mold of Canada, the UK, or Scandinavia. So lets see what residents in thse countries really pay. In Canada, the system is mostly tax funded and while there is not a particular percentage allocated to health care, it is estimated that ~22% of taxes collected went to the health system in 2004. Several provinces also charge additional premiums, including Quebec, Ontario, Alberta, and British Columbia. The Organization for Economic Development and Cooperation estimated in 2008 that in Ontario these extra fees ranged from 300-950 Canadian dollars based on income, in addition to 6-25 percent of taxes being destined for the health care system, also dependent on income. Canadians also may spend money to receive private treatment for procedures or drugs that are not covered by the government system.
Citizens of the UK pay 11 percent of each pound they make in weekly income between £100 - £670 for the NHS, plus an addition 1 percent of income over £670 a week. Hidden fees, such as costs for parking at medical facilities, drive up the costs further. In 1998, NHS costs totaled £1.3 billion, today it is £3.7 billion, a rise of 186 percent. Prescriptions now cost Brits £459 million versus £321 million ten years ago. The co-pay for drugs is low, £7.10 as of April 2008, but many drugs are not covered, sometimes because NICE has decided that although they are efficacious, they are not cost-effective. And until recently anyone who used their own money to buy powerful but expensive uncovered drugs found himself shut out of the NHS and forced to pay for all care privately.
Figuring out what health care costs citizens is trickier when it comes to Norway, the system is tax funded but the government doesn’t designate a certain percentage to health care. However, the country spent 9.1 percent of GDP and $4328 per capita on health care in 2005 so the percentage of taxes it consumes is likely to be substantial. Even so, the costs Norwegians have to cover out of pocket are substantial, amounting to about 16.7 percent of expenditures in 2005. Patients are charged copays, about 125 to 235 kronorfor a visit to a GP depending on the reason and whether it is day or night, up to a given annual individual total, about 1615 kronor in 2006.
Once a person (or one parent plus children under 16) has reached this threshold, they get a special card and their care is then gratis for the rest of the year. Over 1 million Norwegians reached this point in 2005. Children are not charged copays for all or some medical services, depending on age, and those who are retired or disabled also are exempted. For care in areas outside the health system, such as dental and rehabilitation or treatment outside Norway, there is a separate threshold of 2500 kronor, which works the same way. Other costs to patients come from copays for medications, plus having to pay the difference if a patient wants a pricier drug than the system will reimburse for.
These are simply the straight financial costs levied on those covered by these systems, without reference to the other types of costs that result from participating in the system due to the ways it controls costs. And this is just single payer, the next installment will consider the costs of other types of international systems and how they compare to those in the US.
According to new FDA draft guidance, promotional material can be misleading even if specific individual claims or presentations aren't misleading. For example, if music plays over a voice-over of fair balance/adequate provision – the agency feels that can be misleading. Similarly, "discordant" images of happy patients (i.e., running through a field of daisies for an allergy medicine) while the risk information is detailed could also be viewed as violative.
Pretty subjective proposition.
The draft guidance (which can be found here) also introduces a new term, "net impression." DDMAC will now consider the “net impression” of consumer ads and physician detailing materials to determine if a piece conveys accurate information about a particular product.
In other words, rather than creating brighter lines so that industry can be in compliance, the agency is opting for even greater regulatory ambiguity.
Not good.
Pretty subjective proposition.
The draft guidance (which can be found here) also introduces a new term, "net impression." DDMAC will now consider the “net impression” of consumer ads and physician detailing materials to determine if a piece conveys accurate information about a particular product.
In other words, rather than creating brighter lines so that industry can be in compliance, the agency is opting for even greater regulatory ambiguity.
Not good.
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