Latest Drugwonks' Blog
From today's edition of the New York Times ...
A Test of Bad Health
By PETER PITTS
IF Congress overrides President Bush’s veto of the State Children’s Health Insurance Program, a little-known provision of the original House bill could be revived.
As written, the provision would allocate $300 million to create a Center for Comparative Effectiveness that would test whether newer, more expensive drugs work better than their older and cheaper counterparts. Medicare would use the center’s findings to help decide which drugs to cover. If the center found that a newer, pricier pill was no more effective than the older, cheaper version, Medicare would probably refuse to pay for it.
This sounds reasonable. But it will most likely result in Medicare covering fewer breakthrough medicines, which would, in turn, force doctors to prescribe only the drugs that Medicare will pay for — not the ones that are best for the patient.
Why? Drugs must be tested on large, representative populations that must be monitored for years. Because conducting these studies is so tricky, their findings are regularly overturned or modified by further research. In fact, some are so off the mark that doctors ignore them.
But if Medicare starts using flawed studies like these to determine its list of covered drugs, doctors will have to give them respect they probably don’t deserve. There’s also an inherent conflict of interest when the government conducts comparative-effectiveness studies and then uses those studies to determine which pills are worth buying. The more drugs the government classifies as “wasteful,†the more money it saves.
Look what happened in Britain. In 2001, contrary to expert findings by licensing authorities around the world, the British comparative-effectiveness agency cited “insufficient evidence†for recommending the use of Gleevec in both early- and late-phase chronic leukemia patients.
In 2002, the United States approved Gleevec for another purpose: to treat a rare stomach cancer. It wasn’t until 21 months later that Britain approved the use of Gleevec for victims of the disease.
What aside from cost concerns could explain such restrictions? And what could stop something like this from happening here? The center’s supporters say it will be financed through an independent “trust fund.†But this won’t solve the problem. The center would still be part of the government — and still get in the way of medical innovation.
A Test of Bad Health
By PETER PITTS
IF Congress overrides President Bush’s veto of the State Children’s Health Insurance Program, a little-known provision of the original House bill could be revived.
As written, the provision would allocate $300 million to create a Center for Comparative Effectiveness that would test whether newer, more expensive drugs work better than their older and cheaper counterparts. Medicare would use the center’s findings to help decide which drugs to cover. If the center found that a newer, pricier pill was no more effective than the older, cheaper version, Medicare would probably refuse to pay for it.
This sounds reasonable. But it will most likely result in Medicare covering fewer breakthrough medicines, which would, in turn, force doctors to prescribe only the drugs that Medicare will pay for — not the ones that are best for the patient.
Why? Drugs must be tested on large, representative populations that must be monitored for years. Because conducting these studies is so tricky, their findings are regularly overturned or modified by further research. In fact, some are so off the mark that doctors ignore them.
But if Medicare starts using flawed studies like these to determine its list of covered drugs, doctors will have to give them respect they probably don’t deserve. There’s also an inherent conflict of interest when the government conducts comparative-effectiveness studies and then uses those studies to determine which pills are worth buying. The more drugs the government classifies as “wasteful,†the more money it saves.
Look what happened in Britain. In 2001, contrary to expert findings by licensing authorities around the world, the British comparative-effectiveness agency cited “insufficient evidence†for recommending the use of Gleevec in both early- and late-phase chronic leukemia patients.
In 2002, the United States approved Gleevec for another purpose: to treat a rare stomach cancer. It wasn’t until 21 months later that Britain approved the use of Gleevec for victims of the disease.
What aside from cost concerns could explain such restrictions? And what could stop something like this from happening here? The center’s supporters say it will be financed through an independent “trust fund.†But this won’t solve the problem. The center would still be part of the government — and still get in the way of medical innovation.
Merrill Goozner is a nice guy. We rarely agree -- but he's a nice guy.
Now he shows his colours as a NICE guy with a statement like, ""Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies."
At least he's honest about where his path leads -- not to "universal" health care but rather to "government" care.
Bad idea.
Now he shows his colours as a NICE guy with a statement like, ""Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies."
At least he's honest about where his path leads -- not to "universal" health care but rather to "government" care.
Bad idea.
Here's Merrill Goozner of the Center for Science in The Tort Lawyer's Interest giving full voice to a totalitarian view of regulation:
"Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies."
Regular doctors -- those who are not scientists at our nation's health agencies are, by definition, too stupid, corrupt, tainted by Big Pharma to be trusted and consumers, well, why have consumer groups if you could trusts you and me to act on our own behalf. Thank goodness we have people like Merrill Goozner to lead the way.
Mind you,these are the same consumer groups that were screeching during the run up to PDUFA renewal that the FDA is a tool of Big Pharma and can't be trusted to protect the public.
I guess if you say you are a consumer group you can be as hypocritical all you want.
Here's the the post:
Dr. Congress Makes a House Call
GoozNews: October 17, 2007
As I mentioned yesterday, the Food and Drug Administration wrote a strong letter to Capitol Hill last week backing the Center for Medicare and Medicaid Services' restrictions on the use of erythropoietin-stimulating drugs like Aranesp and Procrit during cancer chemotherapy. The FDA black box warning, the letter pointed out, called on oncologists to use the lowest possible dose for avoiding blood transfusions since higher doses of the drugs to boost energy -- which, of course, results in higher sales for their makers, Amgen and J&J -- leads to more deaths and faster tumor growth in cancer patients.
Despite this evidence, Congress is considering a resolution to overturn the CMS payment decision, which went into effect late last month. It has at least 26 co-sponsors already and the drug companies' lobbyists are out in force trying to get it passed. So is the American Society of Clinical Oncologists, whose members profit from greater sales of the drugs.
Yesterday, a coalition of consumer groups including the Center for Medical Consumers, the Center for Science in the Public Interest, Consumers Union,
National Research Center for Women & Families, National Women’s Health Network, the TMJ Association and U.S. PIRG wrote every member of Congress asking them to vote no on H.J. Res. 54, which would overturn the CMS decision. I thought it worth reprinting here because of the principles at stake, which are outlined in the letter:
October 16, 2007
Dear Member:
We urge Congress not to interfere in the efforts of the Centers for Medicare & Medicaid Services and the Food and Drug Administration to use the best available science to determine the proper dosing of erythropoietin stimulating agents (ESAs). The safe and proper dosage of this drug in very vulnerable cancer patients is an extremely technical issue. Congress should leave these life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies.
H.J. Res. 54 or similar proposals in the Senate are a direct violation of this principle. The FDA has issued a “black box†label warning against excessive use of ESAs. There is significant evidence that the overuse of ESAs can actually speed tumor growth and early death in cancer patients. After more than a year of study, CMS issued a national coverage decision (NCD) in July that took this latest evidence into account. Congress should not substitute its own judgment for that of CMS and the FDA on these issues.
While it is true that the American Society of Clinical Oncologists, which represents the nation’s cancer physicians, protested the CMS decision, we cannot help but note that companies and physicians make enormous windfall profits from the sale and use of ESAs. Now they are trying to convince Congress that Medicare is denying a needed medical service.
This is not the proper venue for their objections. In late September, CMS invited ASCO to submit evidence to support the agency reopening its coverage decision. It is altogether fitting and proper that physicians in community practice and physicians at CMS who determine payment policy adjudicate their differences in this manner, rather than through Congressional intervention.
We also must note that some provider groups opposed previous reductions in the windfall profits that came from the reimbursement system of various cancer drugs. They said it would radically reduce treatment options and hurt patients. Those statements have been proven untrue. Self-serving arguments about the negative consequences of a proposed payment policy is no substitute for objective, scientific evidence.
Congress should set broad policy objectives and standards for Medicare, but Congressional interference regarding coverage policies for specific medical products would set a terrible precedent. It would encourage companies making medical products as well as medical specialty organizations to constantly ask Members of Congress to override scientific evidence and spend taxpayer dollars needlessly on products whose sale would benefit those companies or specialties more than they benefit patients. In some cases, such overrides could promote the use of medical products in ways that are potentially dangerous to patients because they are unsafe or ineffective.
Health care costs are the leading domestic consumer issue. Congressional interference on individual reimbursement decisions at CMS will just feed those health inflation fires while possibly causing harm to patients.
Please reject H.J. Res. 54.
Sincerely,
http://www.gooznews.com
"Congress should leave...life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies."
Regular doctors -- those who are not scientists at our nation's health agencies are, by definition, too stupid, corrupt, tainted by Big Pharma to be trusted and consumers, well, why have consumer groups if you could trusts you and me to act on our own behalf. Thank goodness we have people like Merrill Goozner to lead the way.
Mind you,these are the same consumer groups that were screeching during the run up to PDUFA renewal that the FDA is a tool of Big Pharma and can't be trusted to protect the public.
I guess if you say you are a consumer group you can be as hypocritical all you want.
Here's the the post:
Dr. Congress Makes a House Call
GoozNews: October 17, 2007
As I mentioned yesterday, the Food and Drug Administration wrote a strong letter to Capitol Hill last week backing the Center for Medicare and Medicaid Services' restrictions on the use of erythropoietin-stimulating drugs like Aranesp and Procrit during cancer chemotherapy. The FDA black box warning, the letter pointed out, called on oncologists to use the lowest possible dose for avoiding blood transfusions since higher doses of the drugs to boost energy -- which, of course, results in higher sales for their makers, Amgen and J&J -- leads to more deaths and faster tumor growth in cancer patients.
Despite this evidence, Congress is considering a resolution to overturn the CMS payment decision, which went into effect late last month. It has at least 26 co-sponsors already and the drug companies' lobbyists are out in force trying to get it passed. So is the American Society of Clinical Oncologists, whose members profit from greater sales of the drugs.
Yesterday, a coalition of consumer groups including the Center for Medical Consumers, the Center for Science in the Public Interest, Consumers Union,
National Research Center for Women & Families, National Women’s Health Network, the TMJ Association and U.S. PIRG wrote every member of Congress asking them to vote no on H.J. Res. 54, which would overturn the CMS decision. I thought it worth reprinting here because of the principles at stake, which are outlined in the letter:
October 16, 2007
Dear Member:
We urge Congress not to interfere in the efforts of the Centers for Medicare & Medicaid Services and the Food and Drug Administration to use the best available science to determine the proper dosing of erythropoietin stimulating agents (ESAs). The safe and proper dosage of this drug in very vulnerable cancer patients is an extremely technical issue. Congress should leave these life-and-death medical decisions to the professional, objective physician-scientists at our nation’s health agencies.
H.J. Res. 54 or similar proposals in the Senate are a direct violation of this principle. The FDA has issued a “black box†label warning against excessive use of ESAs. There is significant evidence that the overuse of ESAs can actually speed tumor growth and early death in cancer patients. After more than a year of study, CMS issued a national coverage decision (NCD) in July that took this latest evidence into account. Congress should not substitute its own judgment for that of CMS and the FDA on these issues.
While it is true that the American Society of Clinical Oncologists, which represents the nation’s cancer physicians, protested the CMS decision, we cannot help but note that companies and physicians make enormous windfall profits from the sale and use of ESAs. Now they are trying to convince Congress that Medicare is denying a needed medical service.
This is not the proper venue for their objections. In late September, CMS invited ASCO to submit evidence to support the agency reopening its coverage decision. It is altogether fitting and proper that physicians in community practice and physicians at CMS who determine payment policy adjudicate their differences in this manner, rather than through Congressional intervention.
We also must note that some provider groups opposed previous reductions in the windfall profits that came from the reimbursement system of various cancer drugs. They said it would radically reduce treatment options and hurt patients. Those statements have been proven untrue. Self-serving arguments about the negative consequences of a proposed payment policy is no substitute for objective, scientific evidence.
Congress should set broad policy objectives and standards for Medicare, but Congressional interference regarding coverage policies for specific medical products would set a terrible precedent. It would encourage companies making medical products as well as medical specialty organizations to constantly ask Members of Congress to override scientific evidence and spend taxpayer dollars needlessly on products whose sale would benefit those companies or specialties more than they benefit patients. In some cases, such overrides could promote the use of medical products in ways that are potentially dangerous to patients because they are unsafe or ineffective.
Health care costs are the leading domestic consumer issue. Congressional interference on individual reimbursement decisions at CMS will just feed those health inflation fires while possibly causing harm to patients.
Please reject H.J. Res. 54.
Sincerely,
http://www.gooznews.com
A more complete response to the politically motivated, mean spirited, and just plain wrong comments by the so-called Union of Concerned Scientists ...
http://www.tjols.com/article-350.html
Here are some snippets:
* Twenty-five years ago, the success rate for a new drug used was about 14 percent. Today, a new medicinal compound entering early-stage testing – often after more than a decade of pre-clinical screening and evaluation – is estimated to have only an 8 percent chance of reaching the market. For very innovative and unproven technologies, the probability of an individual product's success is even lower.
* Better, more current and predictable scientific research and standards must be developed and devoted to streamlining the critical path. Investment in basic research is not enough. Specifically new development tools are needed to improve the predictability of the drug development cycle and to lower the cost of research by helping industry identify product failures earlier in the clinical trials process.
* New development tools in these areas will enable better through-put to commercial product development and will act as a productivity multiplier, increasing the returns on public and private investment in basic research. With improved scientific methods and a new, shared effort by all of us, we can develop and improve standards for product characterization and product safety testing, for both traditional and innovative products.
* Today only about 1 percent of the proteins in blood have been identified. Of that 1 percent only a fifth has FDA approved diagnostic utility. These proteins, after we understand them, could help predict disease remission. Currently academics and private companies collect data and establish correlations, but no one is responsible for organizing this information into the broader knowledge that could lead to generalized principles industry and FDA could use for broader, faster, and more accurate product evaluation.
* Think about the millions of dollars that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process. Using the lower end of the Tufts drug development number, a 10 percent improvement in predicting failure before clinical trials could save $100 million in development costs. Similarly, shifting 5 percent of clinical failures from late-stage to early-stage trials reduces out of pocket costs by $15-$20 million.
Next up on the Critical Path hit parade -- who will be named to the Reagan/Udall board of directors. Watch this space for more details.
http://www.tjols.com/article-350.html
Here are some snippets:
* Twenty-five years ago, the success rate for a new drug used was about 14 percent. Today, a new medicinal compound entering early-stage testing – often after more than a decade of pre-clinical screening and evaluation – is estimated to have only an 8 percent chance of reaching the market. For very innovative and unproven technologies, the probability of an individual product's success is even lower.
* Better, more current and predictable scientific research and standards must be developed and devoted to streamlining the critical path. Investment in basic research is not enough. Specifically new development tools are needed to improve the predictability of the drug development cycle and to lower the cost of research by helping industry identify product failures earlier in the clinical trials process.
* New development tools in these areas will enable better through-put to commercial product development and will act as a productivity multiplier, increasing the returns on public and private investment in basic research. With improved scientific methods and a new, shared effort by all of us, we can develop and improve standards for product characterization and product safety testing, for both traditional and innovative products.
* Today only about 1 percent of the proteins in blood have been identified. Of that 1 percent only a fifth has FDA approved diagnostic utility. These proteins, after we understand them, could help predict disease remission. Currently academics and private companies collect data and establish correlations, but no one is responsible for organizing this information into the broader knowledge that could lead to generalized principles industry and FDA could use for broader, faster, and more accurate product evaluation.
* Think about the millions of dollars that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process. Using the lower end of the Tufts drug development number, a 10 percent improvement in predicting failure before clinical trials could save $100 million in development costs. Similarly, shifting 5 percent of clinical failures from late-stage to early-stage trials reduces out of pocket costs by $15-$20 million.
Next up on the Critical Path hit parade -- who will be named to the Reagan/Udall board of directors. Watch this space for more details.
A letter from the FDA to Peter Stark and Henry Waxman lies about the benefits of EPO.
It claims that there no quality of life benefits associated with use of EPO among cancer patients undergoing chemotherapy.
That is a lie. Andy von Eschenbach should -- if he is around -- as a cancer patient and oncologist have the guts to squash Richard Padzur's assault on EPO and stand up for the truth.
The FDA has even allowed Amgen to make QOL claims on the label. The current label for EPO allows for QOL benefits. And just because the FDA does not allow them because of Padzur's pique does not make it so. There will likely be revisions but not a total rejection.
So the claim there is no QOL benefit approved by the FDA is also a lie. The fact that the FDA sees no benefit in terms of survival at a biological level does not mean such a correlation fails to exist overall. Cancer death rates are down. They are down because of earlier screening and better drugs. Better drugs can only be used because of a reduction in RBC and a corresponding optimization of hemoglobin levels. Take away ESAs and guess what happens?
Why would the FDA capitulate to Stark and Waxman?
Where is the leadership? Politics as usual should not apply when lives are on the line. Stark, Waxman and Padzur are distorting science and -- working together -- seeking to gain control over regulatory processes for political purposes. Where is the courage to put a stop to it.
Andy, your phone is ringing.
It claims that there no quality of life benefits associated with use of EPO among cancer patients undergoing chemotherapy.
That is a lie. Andy von Eschenbach should -- if he is around -- as a cancer patient and oncologist have the guts to squash Richard Padzur's assault on EPO and stand up for the truth.
The FDA has even allowed Amgen to make QOL claims on the label. The current label for EPO allows for QOL benefits. And just because the FDA does not allow them because of Padzur's pique does not make it so. There will likely be revisions but not a total rejection.
So the claim there is no QOL benefit approved by the FDA is also a lie. The fact that the FDA sees no benefit in terms of survival at a biological level does not mean such a correlation fails to exist overall. Cancer death rates are down. They are down because of earlier screening and better drugs. Better drugs can only be used because of a reduction in RBC and a corresponding optimization of hemoglobin levels. Take away ESAs and guess what happens?
Why would the FDA capitulate to Stark and Waxman?
Where is the leadership? Politics as usual should not apply when lives are on the line. Stark, Waxman and Padzur are distorting science and -- working together -- seeking to gain control over regulatory processes for political purposes. Where is the courage to put a stop to it.
Andy, your phone is ringing.
After Alex Berenson's sob story about the growing dental health crisis in America due to greedy dentists we have this from that health care paradise, Great Britain.
English 'pull own teeth' as dental service decays
Mon Oct 15, 7:19 AM ET
LONDON (AFP) - Falling numbers of state dentists in England has led to some people taking extreme measures, including extracting their own teeth, according to a new study released Monday.
Falling numbers of state dentists in England has led to some people taking extreme measures, including extracting their own teeth, according to a new study released Monday."
Maybe Jon Cohn of TNR wants to nibble on this one. I thought universal coverage made health care more accessible and affordable. (Don't forget the UK has nearly doubled spending on health care in the past decade so don't use the resource problem as an excuse.) When you pay people nothing and make services free you wind up with people expecting everything and getting nothing.
http://news.yahoo.com/s/afp/20071015/wl_uk_afp/britainhealthdentists
English 'pull own teeth' as dental service decays
Mon Oct 15, 7:19 AM ET
LONDON (AFP) - Falling numbers of state dentists in England has led to some people taking extreme measures, including extracting their own teeth, according to a new study released Monday.
Falling numbers of state dentists in England has led to some people taking extreme measures, including extracting their own teeth, according to a new study released Monday."
Maybe Jon Cohn of TNR wants to nibble on this one. I thought universal coverage made health care more accessible and affordable. (Don't forget the UK has nearly doubled spending on health care in the past decade so don't use the resource problem as an excuse.) When you pay people nothing and make services free you wind up with people expecting everything and getting nothing.
http://news.yahoo.com/s/afp/20071015/wl_uk_afp/britainhealthdentists
The Republicans are winning the battle on SCHIP and should not mistake the carpet bombing from the Left as a sign they are in trouble. It used the same tactics to run down Part D and now they see that in politics it is hard to add something, even harder to take it away. More to the point, Americans know when their tax dollars are being wasted. Part D to help seniors and reduce hospital visits, yes. Government subsidies and government run health plans to middle income families who could get insurance on their own, no.
But look at how USA Today tries to spin the war of ideas as a war of attrition against the GOP and Bush....
"Slim majorities back two positions at the core of the president's opposition to the expansion:
•52% agree with Bush that most benefits should go to children in families earning less than 200% of the federal poverty level — about $41,000 for a family of four. Only 40% say benefits should go to such families earning up to $62,000, as the bill written by Democrats and some Republicans would allow.
•55% are very or somewhat concerned that the program would create an incentive for families to drop private insurance. Bush and Republican opponents have called that a step toward government-run health care.
Taken together, the results show that while Bush may be losing the political battle with Democrats, he may be doing better on policy."
Slim majorities? I bet 50 dollars that if the poll was on Iraq and the same numbers signaled for withdrawal the adjective "slim" would nowhere to be found.
How can you lose the policy battle and not the political battle . Who said anything about losing? See how that assumption just...crowds out the reality?
PS
The poll should have asked about the precedent settting $83K with no asset test ripoff and the numbers would have been lower. And all this despite the media painting the contest as one of Bush vs poor kids.
http://www.usatoday.com/printedition/news/20071016/a_chippoll16.art.htm
But look at how USA Today tries to spin the war of ideas as a war of attrition against the GOP and Bush....
"Slim majorities back two positions at the core of the president's opposition to the expansion:
•52% agree with Bush that most benefits should go to children in families earning less than 200% of the federal poverty level — about $41,000 for a family of four. Only 40% say benefits should go to such families earning up to $62,000, as the bill written by Democrats and some Republicans would allow.
•55% are very or somewhat concerned that the program would create an incentive for families to drop private insurance. Bush and Republican opponents have called that a step toward government-run health care.
Taken together, the results show that while Bush may be losing the political battle with Democrats, he may be doing better on policy."
Slim majorities? I bet 50 dollars that if the poll was on Iraq and the same numbers signaled for withdrawal the adjective "slim" would nowhere to be found.
How can you lose the policy battle and not the political battle . Who said anything about losing? See how that assumption just...crowds out the reality?
PS
The poll should have asked about the precedent settting $83K with no asset test ripoff and the numbers would have been lower. And all this despite the media painting the contest as one of Bush vs poor kids.
http://www.usatoday.com/printedition/news/20071016/a_chippoll16.art.htm
On September 23, 2005 we blogged on a grandstanding measure put forward in the DC City Council by David Catania — a lawyer at the mega-DC firm of Akin, Gump, Strauss, Hauer, Feld (“What does DC stand for?â€).
(Mr. Catania is also known by many inside-the-Beltway as “Rahm Emanuel, Jr.")
At the time Councilman Catania was calling for pharmaceutical price control legislation in the District of Columbia (since overturned in court). This prompted drugwonks to ask just what “DC†stood for. We posited that it stood for “drug catastrophe.â€
Well, Mr. Catania is at it again.
This time he’s proposing the District of Columbia “Safe Rx Act of 2007.†Besides the fact that many of its provisions are illegal (perhaps Mr. Catania should have asked one of his junior associates to do some background work), what’s most important is that the bill is contrary to both the public health and to common sense.
In other words, it’s all about politics.
I know – shocking.
Some sample content:
* Any person who educates physicians without a license shall be subject to a fine of $10,000. (This is in the section that calls for the licensing of pharmaceutical representatives.)
What about free speech, Mr. Catania? Were you absent during that law school lecture? And what about the fact that the FDA already regulates all educational efforts between physicians and sales reps? Inconvenient truths.
Also, nothing in the bill requires that evidence based “detailers†be held to any of the same standards as pharmaceutical representatives.
* The DC Department of Health will create a “Pharmaceutical Education Fund†for the “sole purpose of establishing and funding an evidence-based research, outreach, and education program within the DC DoH designed to provide information on the therapeutic and cost-effective utilization of prescription drugs.
Gadzooks, a DC DERP. Gee – I wonder who Mr. Catania has been talking to inside the majority Congressional leadership. Do the people of the District of Columbia really want cost-based rather than patient-centric care by statute?
* Pharmaceutical companies must disclose specific information on any clinical trials related to any drug or biologic product sold, delivered, dispensed, offered for sale, or given away in the District.
Oops again. Looks like Mr. Catania missed The FDA Amendments Act of 2007 (FDAAA), passed in September 2007, which expands the existing federal clinical trial registry administered by NIH by including more trials, more comprehensive information on each trial, and establishing a clinical trial results databank
Once rules for the federal expanded clinical trial registry and results database are promulgated the federal law will preempt any state clinical trial registry or results requirements.
Sloppy legal prep, counselor.
* Pharmaceutical companies must provide DC with FDA correspondence.
Um, all warning and untitled letters are already posted on the FDA website. But, hey, demanding such already publicly available letter it makes for good headlines, right?
Here’s my favorite …
* The bill requires prescribers to obtain written informed consent from patients when prescribing a prescription medication for a medically accepted indication.
So much for the concept of the “learned intermediary.â€
And as far as off-label use is concerned …
* Prescriber must explain to the patient that the medication is being prescribed outside of the indications for that medication as approved by the FDA and provide the patient with information commonly known by the medical profession regarding potential risks and side-effects
Um, according to the Medicaid statute medications prescribed for a medically accepted indication may only be restricted if, based on the compendia, the drug does not have a significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome.
So much is wrong about so many things in this bill that it makes H.R. 380 (Rahm Emanuel’s “Pharmaceutical Market Access and Drug Safety Actâ€) look like the next coming of the Magna Carta.
“DC†may mean “David Catania,†but it mustn’t be allowed to mean “Drug Catastrophe†-- again.
(Mr. Catania is also known by many inside-the-Beltway as “Rahm Emanuel, Jr.")
At the time Councilman Catania was calling for pharmaceutical price control legislation in the District of Columbia (since overturned in court). This prompted drugwonks to ask just what “DC†stood for. We posited that it stood for “drug catastrophe.â€
Well, Mr. Catania is at it again.
This time he’s proposing the District of Columbia “Safe Rx Act of 2007.†Besides the fact that many of its provisions are illegal (perhaps Mr. Catania should have asked one of his junior associates to do some background work), what’s most important is that the bill is contrary to both the public health and to common sense.
In other words, it’s all about politics.
I know – shocking.
Some sample content:
* Any person who educates physicians without a license shall be subject to a fine of $10,000. (This is in the section that calls for the licensing of pharmaceutical representatives.)
What about free speech, Mr. Catania? Were you absent during that law school lecture? And what about the fact that the FDA already regulates all educational efforts between physicians and sales reps? Inconvenient truths.
Also, nothing in the bill requires that evidence based “detailers†be held to any of the same standards as pharmaceutical representatives.
* The DC Department of Health will create a “Pharmaceutical Education Fund†for the “sole purpose of establishing and funding an evidence-based research, outreach, and education program within the DC DoH designed to provide information on the therapeutic and cost-effective utilization of prescription drugs.
Gadzooks, a DC DERP. Gee – I wonder who Mr. Catania has been talking to inside the majority Congressional leadership. Do the people of the District of Columbia really want cost-based rather than patient-centric care by statute?
* Pharmaceutical companies must disclose specific information on any clinical trials related to any drug or biologic product sold, delivered, dispensed, offered for sale, or given away in the District.
Oops again. Looks like Mr. Catania missed The FDA Amendments Act of 2007 (FDAAA), passed in September 2007, which expands the existing federal clinical trial registry administered by NIH by including more trials, more comprehensive information on each trial, and establishing a clinical trial results databank
Once rules for the federal expanded clinical trial registry and results database are promulgated the federal law will preempt any state clinical trial registry or results requirements.
Sloppy legal prep, counselor.
* Pharmaceutical companies must provide DC with FDA correspondence.
Um, all warning and untitled letters are already posted on the FDA website. But, hey, demanding such already publicly available letter it makes for good headlines, right?
Here’s my favorite …
* The bill requires prescribers to obtain written informed consent from patients when prescribing a prescription medication for a medically accepted indication.
So much for the concept of the “learned intermediary.â€
And as far as off-label use is concerned …
* Prescriber must explain to the patient that the medication is being prescribed outside of the indications for that medication as approved by the FDA and provide the patient with information commonly known by the medical profession regarding potential risks and side-effects
Um, according to the Medicaid statute medications prescribed for a medically accepted indication may only be restricted if, based on the compendia, the drug does not have a significant, clinically meaningful therapeutic advantage in terms of safety, effectiveness, or clinical outcome.
So much is wrong about so many things in this bill that it makes H.R. 380 (Rahm Emanuel’s “Pharmaceutical Market Access and Drug Safety Actâ€) look like the next coming of the Magna Carta.
“DC†may mean “David Catania,†but it mustn’t be allowed to mean “Drug Catastrophe†-- again.
Article today on efforts to develop a biomarker based test to predict early onset of Alzheimer's underscores the valuable role the Reagan Udall Foundation can play and the extent to which its "critics" are engaged in ad hominem attacks that flow from rage instead of science.
Blood Test Might Spot Alzheimer's Early
By Jeffrey Perkel
HealthDay Reporter 2 hours, 10 minutes ago
MONDAY, Oct. 15 (HealthDay News) -- An international team of scientists has developed a blood test that could reveal which patients with mild cognitive impairment will go on to develop Alzheimer's disease.
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If replicated and validated -- and assuming the development of effective treatments against Alzheimer's in the future -- such a test could open the door to medicating at-risk patients earlier and slowing or limiting neurological damage, explained Dr. Allan Levey, chair of neurology at Emory University, Atlanta.
"If it can be replicated, then we will find out how important [the study] really is," said Levey, who was not involved in the research.
Reagan Udall would help not only in replication and validation but set up standards for its approval by the FDA. Sharing data from the test would lead to more specific and early treatment of people and new medicines. As a recent CMPI study found, if we delay onset of Alzheimer's by 5 years it would be worth nearly $2 trillion to the United States.
How sad that so many interest groups and professional cranks (like David Ross) have lined up so quickly to attack an institute with such a profound and humane mission and have condemned its biomarker based work as dangerous.
http://news.yahoo.com/s/hsn/20071015/hl_hsn/bloodtestmightspotalzheimersearly
Blood Test Might Spot Alzheimer's Early
By Jeffrey Perkel
HealthDay Reporter 2 hours, 10 minutes ago
MONDAY, Oct. 15 (HealthDay News) -- An international team of scientists has developed a blood test that could reveal which patients with mild cognitive impairment will go on to develop Alzheimer's disease.
ADVERTISEMENT
If replicated and validated -- and assuming the development of effective treatments against Alzheimer's in the future -- such a test could open the door to medicating at-risk patients earlier and slowing or limiting neurological damage, explained Dr. Allan Levey, chair of neurology at Emory University, Atlanta.
"If it can be replicated, then we will find out how important [the study] really is," said Levey, who was not involved in the research.
Reagan Udall would help not only in replication and validation but set up standards for its approval by the FDA. Sharing data from the test would lead to more specific and early treatment of people and new medicines. As a recent CMPI study found, if we delay onset of Alzheimer's by 5 years it would be worth nearly $2 trillion to the United States.
How sad that so many interest groups and professional cranks (like David Ross) have lined up so quickly to attack an institute with such a profound and humane mission and have condemned its biomarker based work as dangerous.
http://news.yahoo.com/s/hsn/20071015/hl_hsn/bloodtestmightspotalzheimersearly
The great news; Cancer rates are declining once again and falling faster than ever before thanks to advances in screening and treatment of lung, breast and colorectal cancer.
The bad news: The CMS decision -- made in an effort to position itself as Hillary Clinton's Best Practice Institute -- will deny cancer patients access to blood boosting drugs that make such treatments -- and the increased survival -- possible.
Here's what prospective randomized trial of colorectal cancer patients found:
"Anaemia was a strong predictor for activity of first-line 5FU-based chemotherapy especially in those groups that showed the best responses, for example high performance status, infusionally treated, higher 5FU dose and those with liver secondaries. Patients with higher haemoglobin levels recorded a greater response rate and a longer time to progression and survival than anaemic subjects. Prospective evaluation of role of correcting anaemia on response to therapy is justified by these results."
Br J Cancer. 2006 Jul 3;95(1):13-20. Epub 2006
CMS -- with it's decision to withhold access to ESAs that correct anemia in cancer patients - is sure to join the ranks of the UK is insuring that more people die of cancer than medical science would permit.
The bad news: The CMS decision -- made in an effort to position itself as Hillary Clinton's Best Practice Institute -- will deny cancer patients access to blood boosting drugs that make such treatments -- and the increased survival -- possible.
Here's what prospective randomized trial of colorectal cancer patients found:
"Anaemia was a strong predictor for activity of first-line 5FU-based chemotherapy especially in those groups that showed the best responses, for example high performance status, infusionally treated, higher 5FU dose and those with liver secondaries. Patients with higher haemoglobin levels recorded a greater response rate and a longer time to progression and survival than anaemic subjects. Prospective evaluation of role of correcting anaemia on response to therapy is justified by these results."
Br J Cancer. 2006 Jul 3;95(1):13-20. Epub 2006
CMS -- with it's decision to withhold access to ESAs that correct anemia in cancer patients - is sure to join the ranks of the UK is insuring that more people die of cancer than medical science would permit.
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.
