Latest Drugwonks' Blog
It turns out that the politically incorrect Bill Maher is reportedly unhappy with the Baucus bill.
That’s the good news.
The bad news?
Bill Maher’s opposition to the Baucus bill is not based on the sentiment that it goes too far; rather, Maher doesn’t believe it goes far enough.
Earlier this year, Maher wrote this Op-Ed in which he decries the entire notion of a profit-motive in the practice of medicine.
Now Maher makes some points worthy of discussion.
But he goes on to lament the higher costs of medical treatment today and wrongly attributes the medical inflation associated with such procedures to Capitalism.
Yes, there are many new medicines and medical procedures that cost money. But these drugs and treatments produce favorable medical outcomes, otherwise they would not be profitable.
However, Maher utterly fails to connect the dots between the increase of government’s role in health care and medical price inflation.
Evan Falchuk writes: “In 2007, federal, state and local governments paid for more than 46 cents of every health care dollar – more than $1 trillion. In fact, since 1980, the government has paid at least 40 cents of every dollar, and as early as 1960 – 5 years before Medicare – government paid a quarter of health care expenses. Government is a massive health care customer and has the impact one might expect such a big customer to have.”
With that level of government spending, is it any wonder why medical spending is so high?
Yet Bill Maher wants to cede total control of the health care sector to the government. A brilliant idea!
How about this?
I think entertainment should be free. There should be no profit-motive in comedy and entertainment. Bill Maher has a moral obligation to entertain people for free. We all have a right to happiness. Comedy and entertainment makes us happy. Obscene profits must not be made on the backs of people in desperate need of humor and entertainment. Therefore we can all expect Bill Maher to forfeit his salary from HBO from this point on.
Sound good? Well, it's about as logical as Bill Maher asserting we can maintain a quality medical system free of profit.
Maher continues by suggesting that the existence of a public fire department is somehow reason enough for us to adopt a government-run health care system:
“And if medicine is for profit, and war, and the news, and the penal system, my question is: what's wrong with firemen? Why don't they charge? They must be commies. Oh my God! That explains the red trucks!”
Repetition of trite sound-bites from Michael Moore’s Sicko may qualify as proof of intellectual profundity in Hollywood but here in the real world, Bill, you’re going to have to do better than that.
Health care is very personal – apparently a fact that escapes Bill Maher. The doctor-patient relationship is about the individual and each person’s specific medical needs.
The Fire Department serves a community, a town, or city. The analogy is ludicrous on its face but that doesn’t stop the simple-minded from repeating it endlessly in arguing for government seizure of the health care sector.
Indeed, most of us exercise individual responsibility by keeping one or more fire extinguishers in our homes because to rely on the fire department to reach your place in time during an emergency would be taking a huge risk with one’s life.
Not to mention, there are private companies such as Rural/Metro Corporation which specialize in fire protection services and many volunteer fire departments serving communities across the country.
Does Maher mention all the volunteers, physicians, and charities dedicated to providing medical care to poor Americans every year free of charge? Of course not.
Suffice it to say, Bill Maher’s time would be better spent speaking to real physicians who work diligently every day to treat and care for patients and less time at his HBO studio if he has any interest in understanding our health care system.
Senator Schumer during Finance Committee mark up:
"People have unique needs. I take Lipitor, they put me on the generic, Zocor, my cholesterol went up. They put me back on Lipitor, my cholesterol went down."
You mean that all statins aren't the same? That different people respond to different drugs in different ways. That generic substitution can have ... unintended consequences? Holy cow! And who is the mysterious "they" the Senator refers to? Probably not his Uncle Sam.
(PS, "Zocor" is not the "generic." Simvastatin is the generic. Not the same thing. But that's another story for another time.)
"People have unique needs. I take Lipitor, they put me on the generic, Zocor, my cholesterol went up. They put me back on Lipitor, my cholesterol went down."
You mean that all statins aren't the same? That different people respond to different drugs in different ways. That generic substitution can have ... unintended consequences? Holy cow! And who is the mysterious "they" the Senator refers to? Probably not his Uncle Sam.
(PS, "Zocor" is not the "generic." Simvastatin is the generic. Not the same thing. But that's another story for another time.)
And at the top of the list should be the growing and worrisome EU/US medtech gap.
FDA NEWS RELEASE
For Immediate Release: Sept. 23, 2009
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.
The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.
“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, M.D., acting director of CDRH. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”
The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:
* Make safe and effective devices available to consumers
* Promote innovation in the medical device industry.
During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for CDRH to review the adequacy of the premarket notification program in meeting these two goals.
Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.
As part of the study, the IOM will convene a committee to answer two principal questions:
* Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
* If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?
The $1.3 million IOM review is slated for completion in 2011, and is one of six priorities Dr. Shuren has outlined for CDRH. Others include:
* Creating an internal task force on the use of science in regulatory decision-making
* Developing an effective compliance strategy
* Optimally integrating premarket and postmarket information
* Increasing transparency in decision-making
* Establishing clear procedures to resolve differences of opinion.
The IOM will hold two public workshops during the next nine months as part of its review, and will publish a final report in March 2011 containing its conclusions and recommendations.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.
Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval.
Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
FDA NEWS RELEASE
For Immediate Release: Sept. 23, 2009
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.
The IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.
“Good government conducts periodic reviews and evaluations of its programs,” said Jeffrey Shuren, M.D., acting director of CDRH. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”
The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:
* Make safe and effective devices available to consumers
* Promote innovation in the medical device industry.
During the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for CDRH to review the adequacy of the premarket notification program in meeting these two goals.
Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.
As part of the study, the IOM will convene a committee to answer two principal questions:
* Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
* If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?
The $1.3 million IOM review is slated for completion in 2011, and is one of six priorities Dr. Shuren has outlined for CDRH. Others include:
* Creating an internal task force on the use of science in regulatory decision-making
* Developing an effective compliance strategy
* Optimally integrating premarket and postmarket information
* Increasing transparency in decision-making
* Establishing clear procedures to resolve differences of opinion.
The IOM will hold two public workshops during the next nine months as part of its review, and will publish a final report in March 2011 containing its conclusions and recommendations.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.
Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval.
Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require premarket approval.
From The Voice of San Diego:
My Grandmother Out-Tweets Your Biotech
By DAVID WASHBURN
Wednesday, Sept. 23, 2009 | Very few industries are as willing to take risks on new technologies as the biotech industry. Companies will spend millions, and even billions, developing a drug that has a chance to cure a cancer or a device that could change the face of heart surgery.
Yet when it comes to social media, the industry has proven to be risk adverse. In fact, your grandmother is probably more likely to be active on Twitter or Facebook these days than a pharmaceutical, medical device or contract research company.
"What we've got is the social media Maginot Line," said Peter Pitts, director of global health care for the public relations firm Porter Novelli, referring to the French army's strategy of fortifying its borders during World War II.
"If they avoid social media they are safe. But what is happening is that important discussions about the medications and how they affect patients are happening minus the participation of companies," Pitts said after a panel discussion hosted Wednesday by Biocom, the local biotech industry association.
The FDA has scheduled a two-day public meeting in November to solicit views regarding how it should deal with social media. Among other things, the agency wants to discuss how companies will fulfill their fair balance obligations in social media, how they will deal with inaccurate information posted about their products as well as adverse event reporting.
The meeting, Pitts said, is an acknowledgement by FDA officials that the agency is "behind the curve," and needs to address the issue. FDA officials involved in the planning of the meeting could not be reached for comment today.
Pitts and others hope a larger embrace of social media emerges from the FDA meetings, and that the industry realizes that it is "irresponsible not to use social media." They raised the issue of benefits that a drug may have that are not officially recognized by the FDA.
Say, for example, that a clinical trial shows that a drug has an effectiveness against a certain type of cancer tumor that was not thought possible when the drug was submitted for FDA approval, and therefore isn't on the FDA label for the drug.
"If they choose not to share that information in the best way possible -- which is social media -- is that the ethical and moral thing to do?" Pitts said.
An even more vexing issue facing both the companies and the regulators is how they deal with adverse event reporting. Suppose, Pitts said, that someone taking a cancer drug develops numbness in their fingers, and then writes about it in a blog or on a Facebook wall.
"This is an opportunity in real time to understand adverse reporting issues," Pitts said.
"Rather than avoid it from a legal and regulatory standpoint, they should pursue it from a public health perspective. That, however, is a very contentious proposition."
The complete story can be found here.
My Grandmother Out-Tweets Your Biotech
By DAVID WASHBURN
Wednesday, Sept. 23, 2009 | Very few industries are as willing to take risks on new technologies as the biotech industry. Companies will spend millions, and even billions, developing a drug that has a chance to cure a cancer or a device that could change the face of heart surgery.
Yet when it comes to social media, the industry has proven to be risk adverse. In fact, your grandmother is probably more likely to be active on Twitter or Facebook these days than a pharmaceutical, medical device or contract research company.
"What we've got is the social media Maginot Line," said Peter Pitts, director of global health care for the public relations firm Porter Novelli, referring to the French army's strategy of fortifying its borders during World War II.
"If they avoid social media they are safe. But what is happening is that important discussions about the medications and how they affect patients are happening minus the participation of companies," Pitts said after a panel discussion hosted Wednesday by Biocom, the local biotech industry association.
The FDA has scheduled a two-day public meeting in November to solicit views regarding how it should deal with social media. Among other things, the agency wants to discuss how companies will fulfill their fair balance obligations in social media, how they will deal with inaccurate information posted about their products as well as adverse event reporting.
The meeting, Pitts said, is an acknowledgement by FDA officials that the agency is "behind the curve," and needs to address the issue. FDA officials involved in the planning of the meeting could not be reached for comment today.
Pitts and others hope a larger embrace of social media emerges from the FDA meetings, and that the industry realizes that it is "irresponsible not to use social media." They raised the issue of benefits that a drug may have that are not officially recognized by the FDA.
Say, for example, that a clinical trial shows that a drug has an effectiveness against a certain type of cancer tumor that was not thought possible when the drug was submitted for FDA approval, and therefore isn't on the FDA label for the drug.
"If they choose not to share that information in the best way possible -- which is social media -- is that the ethical and moral thing to do?" Pitts said.
An even more vexing issue facing both the companies and the regulators is how they deal with adverse event reporting. Suppose, Pitts said, that someone taking a cancer drug develops numbness in their fingers, and then writes about it in a blog or on a Facebook wall.
"This is an opportunity in real time to understand adverse reporting issues," Pitts said.
"Rather than avoid it from a legal and regulatory standpoint, they should pursue it from a public health perspective. That, however, is a very contentious proposition."
The complete story can be found here.
On Fox News Newt explains why Congress refuses to make the same 365 choices available to members of Congress as part of health care reform: "Because it doesn't increase the control government has over health care."
Which is also one reason why insurance under the health care proposals are 3 times more expensive than are available in the marketplace.
The other reason: legislation is nothing but a huge subsidy to large corporations, most union benefits and the liberal imagination. Heaven forbid, people choose health plans with higher deductibles, lower premiums, less coverage than the micromanagers want us to have.
On a related note: Here's President Obama's OMB director on what is really happening to health care costs:
"On the consumer side, and despite media portrayals to the contrary, the share of health care expenditures paid out of pocket, which is the relevant factor for evaluating the degree to which consumers are faced with cost sharing, has plummeted over the past few decades, from about 33% in 1975 to 15% today. All available evidence suggests that lower cost sharing increases health care spending overall. The result is that collectively we all pay a higher burden, although the evidence is somewhat mixed on the precise magnitude of the effect."
Rather than allowing people to choose plans that allow for cost sharing and accumulate cash (especially important for people who are chronically ill) and include health insurance premiums to lock in rates and pay for one time costs Orszag endorses the current solution: using an expert panel to determine what doctors should do and how much they should get paid for it:
"The real traction, though, will come from building the results of that research into financial incentives for providers. In other words, if we move from a “fee-for-service” to a “fee-for-value” system, where higher-value care is awarded with stronger financial incentives and low- or negative-value health care is penalized with smaller incentives or perhaps even penalties, the effects would be maximized."
All of which is at the heart of the Baucus bill and every other piece of legislation. Well since CER has been implemented elsewhere and costs have gone up, what has been the result on patients? Dr. Orszag let's it slip:
"... if all one did was, say, reduce payment rates under Medicare and Medicaid, and then tried to perpetuate that over time without a slowing of overall health care cost growth, the result would probably be that fewer doctors would accept Medicare and Medicaid patients, creating an access problem that would be inconsistent with the underlying premise and public understanding of these programs."
www.issues.org/24.3/orszag.html
Which brings us back to Newt. All of this happens because of government control. The unintended consequences of government run health care.
Which is also one reason why insurance under the health care proposals are 3 times more expensive than are available in the marketplace.
The other reason: legislation is nothing but a huge subsidy to large corporations, most union benefits and the liberal imagination. Heaven forbid, people choose health plans with higher deductibles, lower premiums, less coverage than the micromanagers want us to have.
On a related note: Here's President Obama's OMB director on what is really happening to health care costs:
"On the consumer side, and despite media portrayals to the contrary, the share of health care expenditures paid out of pocket, which is the relevant factor for evaluating the degree to which consumers are faced with cost sharing, has plummeted over the past few decades, from about 33% in 1975 to 15% today. All available evidence suggests that lower cost sharing increases health care spending overall. The result is that collectively we all pay a higher burden, although the evidence is somewhat mixed on the precise magnitude of the effect."
Rather than allowing people to choose plans that allow for cost sharing and accumulate cash (especially important for people who are chronically ill) and include health insurance premiums to lock in rates and pay for one time costs Orszag endorses the current solution: using an expert panel to determine what doctors should do and how much they should get paid for it:
"The real traction, though, will come from building the results of that research into financial incentives for providers. In other words, if we move from a “fee-for-service” to a “fee-for-value” system, where higher-value care is awarded with stronger financial incentives and low- or negative-value health care is penalized with smaller incentives or perhaps even penalties, the effects would be maximized."
All of which is at the heart of the Baucus bill and every other piece of legislation. Well since CER has been implemented elsewhere and costs have gone up, what has been the result on patients? Dr. Orszag let's it slip:
"... if all one did was, say, reduce payment rates under Medicare and Medicaid, and then tried to perpetuate that over time without a slowing of overall health care cost growth, the result would probably be that fewer doctors would accept Medicare and Medicaid patients, creating an access problem that would be inconsistent with the underlying premise and public understanding of these programs."
www.issues.org/24.3/orszag.html
Which brings us back to Newt. All of this happens because of government control. The unintended consequences of government run health care.
If you have not heard or read FDA commissioner's speech on regulatory science -- namely the Critical Path to promote personalized medicine in product review and post market management -- you should. It lays out vibrant vision of how the FDA can continue to adapt to and encourage companies to adopt genomics, biomarkers and other 21st century tools to make products safer and more effective.
We may disagree with the Obama vision of health care but we also share his commissoner's vision of how to sustain medical innovation.
Watch Commissioner Hamburg's remarks here.
We may disagree with the Obama vision of health care but we also share his commissoner's vision of how to sustain medical innovation.
Watch Commissioner Hamburg's remarks here.
It's back.
According to Senate leadership aides, Senate Majority Leader Reid may bring a bill to the Senate floor in the next two weeks that would allow the importation of prescription drugs from Canada.
Wonder if Senator Reid has discussed this act of pharmaceutical imperialism with our neighbors to the North. Last conversation I had with Canadian officials left no doubt they are very concerned with how such an action would impact their domestic medicines supply.
And is this bill about drugs from Canada or drugs through Canada?
Here we go again.
According to Senate leadership aides, Senate Majority Leader Reid may bring a bill to the Senate floor in the next two weeks that would allow the importation of prescription drugs from Canada.
Wonder if Senator Reid has discussed this act of pharmaceutical imperialism with our neighbors to the North. Last conversation I had with Canadian officials left no doubt they are very concerned with how such an action would impact their domestic medicines supply.
And is this bill about drugs from Canada or drugs through Canada?
Here we go again.
AdvaMed’s Stephen J. Ubl, on Chairman Max’s Mark:
“Exempting Class I devices does not address the arbitrary nature of this tax. It will still cover scores of consumer products and medical devices used by millions of Americans every day. For instance, contact lenses and solution and battery powered breast pumps for nursing mothers will still be taxed.”
And, in a further feat of legislative legerdemain, maxi pads are not taxed, while scented maxi pads are.
“Exempting Class I devices does not address the arbitrary nature of this tax. It will still cover scores of consumer products and medical devices used by millions of Americans every day. For instance, contact lenses and solution and battery powered breast pumps for nursing mothers will still be taxed.”
And, in a further feat of legislative legerdemain, maxi pads are not taxed, while scented maxi pads are.
Time to get out and dust off your Part 15 mojo for the November 12-13 "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools" meeting.
It's about time.
According to the announcement:
"... FDA recognizes that the Internet possesses certain unique technological features and that some online tools that may be used for promotion offer novel presentation and content features. Another emerging issue involves the reporting of adverse event data because such information may initially be revealed using social media platforms in the context of Internet promotion for FDA-regulated medical products."
The complete announcement can be found here.
Groovy baby.
Writing in the Chicago-Sun Times Jesse Jackson claims that government healthcare is a proven success.
He starts off by saying of the VA, “Despite its many faults, it is very popular, as virtually any veteran will tell you.”
How many veterans do you suppose Jesse Jackson knows? Enough for him to assert that “virtually any veteran” will tell us that the VA is paradise on earth?
He goes on to list a litany of gratuitously partisan – not to mention fallacious - arguments in favor of the president’s health care overhaul.
Jackson then makes the following claims regarding the insurance reforms proposed:
“They can't refuse you insurance if you are already sick. They can't cut off your insurance if you get sick. They can't discriminate against women in health-care rates. These are big deals. And insurance companies have been ready to accept them so long as they could continue to ratchet up rates on millions of new customers. That's why they hate the public option so much. It would derail their gravy train.”
Scott Harrington argues in the Wall Street Journal that policy rescissions aren’t as widespread a problem as some would have us believe.
Equally absurd is the notion that discriminatory pricing is somehow “unfair” in the area of insurance. The potential medical risks are different for men compared to women. And, of course, insurance premiums are based on risks.
Several factors account for the price disparity in premiums for males and females:
1. Well, for one, males and females have different bodies, thus different reproductive systems.
2. Generally speaking, women tend to visit the doctor more often than men for check-ups and tests.
3. High use of oral contraceptives.
The good news is that women generally pay less for auto insurance, as young males are more likely to be reckless and irresponsible drivers.
On the issue of life insurance, males also tend to pay more than women.
And, if that’s not enough, you still have ladies’ night at bars and clubs, ladies!
You see, discriminatory pricing is all around us. It’s a function of that beautiful thing called a free market.
We need less commentators reducing the health care debate to this sort of childish thinking and more focused on advancing the best ideas for reform.
Reverend Jackson would be wise to focus on other issues and leave health care policy to the experts.
Can I get an Amen?
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.
