Latest Drugwonks' Blog
Representatives Tom Allen (D-ME) and Jo Ann Emerson (R-MO) held a press conference this morning to announce the introduction of their Enhanced Health Care Value for All Act of 2007.
Representatives of interest groups supporting the legislation and congressional staff out-numbered reporters.
Allen and Emerson mentioned the $3 billion over five years that would be turned over to the Agency for Healthcare Research and Quality (AHRQ) to conduct comparative effectiveness studies.
They did not mention that only one third of this funding would be allocated from the federal budget; two-thirds of the money would come from taxes on health insurance policies.
Oops.
Emerson said the program is needed to combat pharmaceutical company marketing to physicians. She accused physicians of being on the take and encouraged patients to “challenge prescription decisions†made by their physicians.
Funny, last we encountered Representative Emerson, she was trying to limit the information that patients could get on their medicines.
Emerson claimed that the legislation is solely aimed at providing enhanced evidence, but also said it would save Medicare “billions and billions, maybe trillions of dollars.â€
That's a boatload of "maybe."
David Helms, president of AcademyHealth said that the U.S. lags other countries in evidence-based medicine, and that it could learn a lot from countries like Australia and the U.K.
He didn’t say what the U.S. could learn from countries that routinely deny their citizens access to breakthrough life-saving and life-extending therapies.
That's why this piece of legislation should more appropriately be called "The Denial of Care Act."
Representatives of interest groups supporting the legislation and congressional staff out-numbered reporters.
Allen and Emerson mentioned the $3 billion over five years that would be turned over to the Agency for Healthcare Research and Quality (AHRQ) to conduct comparative effectiveness studies.
They did not mention that only one third of this funding would be allocated from the federal budget; two-thirds of the money would come from taxes on health insurance policies.
Oops.
Emerson said the program is needed to combat pharmaceutical company marketing to physicians. She accused physicians of being on the take and encouraged patients to “challenge prescription decisions†made by their physicians.
Funny, last we encountered Representative Emerson, she was trying to limit the information that patients could get on their medicines.
Emerson claimed that the legislation is solely aimed at providing enhanced evidence, but also said it would save Medicare “billions and billions, maybe trillions of dollars.â€
That's a boatload of "maybe."
David Helms, president of AcademyHealth said that the U.S. lags other countries in evidence-based medicine, and that it could learn a lot from countries like Australia and the U.K.
He didn’t say what the U.S. could learn from countries that routinely deny their citizens access to breakthrough life-saving and life-extending therapies.
That's why this piece of legislation should more appropriately be called "The Denial of Care Act."
A lot of coverage about the risks of using EPO -- the anti-anemia drug produced by Amgen and J and J mainly in the news. Much of the coverage is the typical "the drug companies pushed over and off-label use so people died" which is probably 5 percent accurate in that you can always find the cowboys and bad apples in any endeavor.
For the most part the use of EPO in treating patients with chronic kidney failure and patients at risk for anemia has been safe, sane and subject to study via observational and randomized clinical trials. Indeed, reading accounts of the cautions placed on the use of EPO you would think the companies were bribing docs to pump as much of the stuff into people as they could. Quite the contrary. Medical literature abounds with studies about what is the right dose to increase survival while not risk the lives of very sick patients. This research in turn is then evaluated, transparently and independently, into guidelines that are continuously adjusted. In some cases, physicians believed that super-corrective hemo-levels were preferable or tried, with very sick and anemic patients, to give them additional strength even through they were not receiving chemotherapy. It may be not be a perfect approach but patient concerns are and were front and center in most cases.
The most recent clinical trials are a culmination of this ongoing effort. That it might lead to a decline in sales should not be a consideration. Finding the right dose for the right patient should be.
For the most part the use of EPO in treating patients with chronic kidney failure and patients at risk for anemia has been safe, sane and subject to study via observational and randomized clinical trials. Indeed, reading accounts of the cautions placed on the use of EPO you would think the companies were bribing docs to pump as much of the stuff into people as they could. Quite the contrary. Medical literature abounds with studies about what is the right dose to increase survival while not risk the lives of very sick patients. This research in turn is then evaluated, transparently and independently, into guidelines that are continuously adjusted. In some cases, physicians believed that super-corrective hemo-levels were preferable or tried, with very sick and anemic patients, to give them additional strength even through they were not receiving chemotherapy. It may be not be a perfect approach but patient concerns are and were front and center in most cases.
The most recent clinical trials are a culmination of this ongoing effort. That it might lead to a decline in sales should not be a consideration. Finding the right dose for the right patient should be.
Absent in the debate over FDA reform is reform of DSHEA.
Yesterday, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
This ruling is good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
The answer -- DSHEA. And it's time for a change.
Yesterday, the Supreme Court rejected an appeal from a unit of Nutraceutical International Corp. to overturn a Food and Drug Administration ban on its ephedra dietary supplements.
Nutraceutical sued the FDA in 2004 to block the agency's action on ephedra, arguing it was abusing its authority and misusing federal regulations in order to take action on the dietary supplement, which is generally regulated more like a food than a drug.
A U.S. district court sided with Nutraceutical, Salt Lake City, but the 10th Circuit overturned that ruling.
"This case offers a key test of whether the FDA will be required to observe the statutory boundary between foods and drugs," Nutraceutical said in its appeal, arguing that the FDA never met the "burden of proof" necessary to force the supplements off the market. The company
This ruling is good news for the public health -- but it raises the issue of why so-called "supplements" are regulated as food in the first place.
The answer -- DSHEA. And it's time for a change.
My op-ed in today's Washington Times on how Bill Clinton legitimitized Brazil and Thailand self serving attack on pharma IP. The NGO's who give this exercise moral cover should be doubly ashamed...
http://washingtontimes.com/op-ed/20070514-093346-6396r.htm
http://washingtontimes.com/op-ed/20070514-093346-6396r.htm
Here we go again. Just got this via e-mail:
"Washington, D.C.-- U.S. Representatives Tom Allen (D-ME) and Jo Ann Emerson (R-MO) will hold a PRESS CONFERENCE TOMORROW (Tuesday, May 15th) at 11:15 a.m. at Cannon Terrace venue to announce the introduction of H.R. 2184, The Advanced Health Care Value for All Act of 2007.
This bipartisan legislation would authorize the investment of $3 billion in new research and syntheses of existing research by the Agency for Healthcare Research and Quality (AHRQ) within the Department of Health and Human Services on the comparative effectiveness of health care services (including prescription drugs, medical devices, procedures, and other treatments) to inform health care providers' decisions.
Joining Representatives Allen and Emerson will be representatives from organizations which support the bill, including AARP, AcademyHealth, Aetna, American Academy of Family Physicians, American Osteopathic Association, American Society of Health-System Pharmacists, Consumers Union, National Business Group on Health and United Health Group."
Folks, don't let the rhetoric fool you. This is legislation should really be named the Denial of Care Act -- because that is precisely what it will do and precisely what it is currently doing across Europe.
What about funding a study on the comparative effectiveness of insurance plans? Wonder how the AARP and AHIP would respond to that?
"Washington, D.C.-- U.S. Representatives Tom Allen (D-ME) and Jo Ann Emerson (R-MO) will hold a PRESS CONFERENCE TOMORROW (Tuesday, May 15th) at 11:15 a.m. at Cannon Terrace venue to announce the introduction of H.R. 2184, The Advanced Health Care Value for All Act of 2007.
This bipartisan legislation would authorize the investment of $3 billion in new research and syntheses of existing research by the Agency for Healthcare Research and Quality (AHRQ) within the Department of Health and Human Services on the comparative effectiveness of health care services (including prescription drugs, medical devices, procedures, and other treatments) to inform health care providers' decisions.
Joining Representatives Allen and Emerson will be representatives from organizations which support the bill, including AARP, AcademyHealth, Aetna, American Academy of Family Physicians, American Osteopathic Association, American Society of Health-System Pharmacists, Consumers Union, National Business Group on Health and United Health Group."
Folks, don't let the rhetoric fool you. This is legislation should really be named the Denial of Care Act -- because that is precisely what it will do and precisely what it is currently doing across Europe.
What about funding a study on the comparative effectiveness of insurance plans? Wonder how the AARP and AHIP would respond to that?
We've referred to the Illinois governor by the moniker "Wrong-Way Rod" because of his stance on drug importation -- the theory being that his compass on the issue of safety was broken.
But we were wrong.
The problem is that he's using the wrong compass. Rather than relying on the Compass of Public Health, Governor Blagojevich has been using the Compass of Political Calculation.
But it seems as though that, latter compass, is broken as well.
Witness Wrong-Way Rod's most recent gambit for attention -- a proposal to fund universal government health care in Illinois via a $7.6 billion "gross receipts tax" on Illinois businesses.
As the Wall Street Journal notes in an editorial, "... a funny thing happened on this road to Canadian health care. The state's more rational Democrats revolted, arguing it would drive businesses out of Illinois."
Aha.
The bigger issue is that, when it comes to health care, calls for "universal coverage," whether for insurance or medicines, sound good as soundbites -- but when people realize that "free" actually means "higher taxes" they think twice.
And this isn't even mentioning the chilling effect such schemes have on innovation.
The Democrat-controlled house in Springfield, voted down Wrong-Way Rod's proposal 107-0 ... after the Governor came out against his own idea.
It seems that Wrong-Way Rod is dealing with two compasses, both of which are broken .
As the Journal opinied, " 'Universal' government health care has once again returned as a political cause, with many Democrats believing it's the key to White House victory in 2008. They might want to study last week's news from Illinois, where Democratic Governor Rod Blagojevich's tax increase to finance health care became the political rout of the year."
Important to remember for many reasons, not the least of which is to see how the Governor's friend and ally, Representative Rahm Emanuel, reacts to Blago's Dilemma.
But we were wrong.
The problem is that he's using the wrong compass. Rather than relying on the Compass of Public Health, Governor Blagojevich has been using the Compass of Political Calculation.
But it seems as though that, latter compass, is broken as well.
Witness Wrong-Way Rod's most recent gambit for attention -- a proposal to fund universal government health care in Illinois via a $7.6 billion "gross receipts tax" on Illinois businesses.
As the Wall Street Journal notes in an editorial, "... a funny thing happened on this road to Canadian health care. The state's more rational Democrats revolted, arguing it would drive businesses out of Illinois."
Aha.
The bigger issue is that, when it comes to health care, calls for "universal coverage," whether for insurance or medicines, sound good as soundbites -- but when people realize that "free" actually means "higher taxes" they think twice.
And this isn't even mentioning the chilling effect such schemes have on innovation.
The Democrat-controlled house in Springfield, voted down Wrong-Way Rod's proposal 107-0 ... after the Governor came out against his own idea.
It seems that Wrong-Way Rod is dealing with two compasses, both of which are broken .
As the Journal opinied, " 'Universal' government health care has once again returned as a political cause, with many Democrats believing it's the key to White House victory in 2008. They might want to study last week's news from Illinois, where Democratic Governor Rod Blagojevich's tax increase to finance health care became the political rout of the year."
Important to remember for many reasons, not the least of which is to see how the Governor's friend and ally, Representative Rahm Emanuel, reacts to Blago's Dilemma.
Check out this Hollywood-inspired look at the VA. It ran over the weekend in the Manchester Union Leader. (Yes, New Hampshire -- for all the obvious reasons).
If you like Medicare, you'll love Moviecare
Imagine turning 65 and finding a letter tucked in your mailbox offering unlimited movie tickets for just $25 a month. You read through the fine print, and amazingly, the offer isn't a scam. It's a new federal program called "MovieCare."
Not a bad deal. It's estimated that seniors spend between five and six percent of their income on entertainment, and this new program -- funded by the government -- would cover most of those expenses.
In some ways, Medicare Part D provides the same service, albeit for goods more important than movie tickets. Seniors used to spend about 3.2 percent of their total income on drugs. Thanks to Part D, those expenses have plummeted, and 20 million seniors who previously lacked prescription drug coverage now have it.
Not surprisingly, more than eight in ten beneficiaries are pleased with the drug benefit. If MovieCare were modeled on the Medicare drug benefit, more seniors than ever before would be able to go to the movies, the vast majority of movies would be available, and beneficiaries would likely enjoy the program as much as they enjoy Part D.
But before long, it's also likely that some congressional lawmakers would decide that MovieCare -- despite its enormous popularity -- was costing taxpayers too much because of heartless movie studio bosses.
We'd see speeches vilifying studio moguls and their "massive" profits. We'd see breathless reports of seniors who went to to see Flags of Our Fathers on a Friday night but ended up trapped in a showing of Man of the Year -- the horror!
Here's a link to the rest of the screenplay:
Download file
And we'll see you at the movies.
If you like Medicare, you'll love Moviecare
Imagine turning 65 and finding a letter tucked in your mailbox offering unlimited movie tickets for just $25 a month. You read through the fine print, and amazingly, the offer isn't a scam. It's a new federal program called "MovieCare."
Not a bad deal. It's estimated that seniors spend between five and six percent of their income on entertainment, and this new program -- funded by the government -- would cover most of those expenses.
In some ways, Medicare Part D provides the same service, albeit for goods more important than movie tickets. Seniors used to spend about 3.2 percent of their total income on drugs. Thanks to Part D, those expenses have plummeted, and 20 million seniors who previously lacked prescription drug coverage now have it.
Not surprisingly, more than eight in ten beneficiaries are pleased with the drug benefit. If MovieCare were modeled on the Medicare drug benefit, more seniors than ever before would be able to go to the movies, the vast majority of movies would be available, and beneficiaries would likely enjoy the program as much as they enjoy Part D.
But before long, it's also likely that some congressional lawmakers would decide that MovieCare -- despite its enormous popularity -- was costing taxpayers too much because of heartless movie studio bosses.
We'd see speeches vilifying studio moguls and their "massive" profits. We'd see breathless reports of seniors who went to to see Flags of Our Fathers on a Friday night but ended up trapped in a showing of Man of the Year -- the horror!
Here's a link to the rest of the screenplay:
Download file
And we'll see you at the movies.
here's my piece in yesterday's NY Post about the patrolling of anti-depressants and the larger issue of FDA pressures and responsibilities:
DANGEROUS WARNINGS
By MARC K. SIEGEL
May 12, 2007 -- CONGRESS may soon increase the Food and Drug Administration's oversight of pharmeceuticals. I certainly don't think we should simply trust what drug companies tell us, but I have my worries about the FDA, too.
Why? Consider one of my patients. Last year, the teen was in trouble - fighting with both parents during an ugly divorce and becoming severely depressed and violent. He'd had a fistfight with a relative and been expelled from his school
This year, he is not dead or in prison, but back in school. He's a much happier person who has been helped greatly by psychotherapy, time to heal his emotional wounds - and the anti-depressant Zoloft.
I can't say that he would have committed suicide without the medication, but the chances of his downhill spiral continuing would have been much greater. And the pill most certainly did not increase his chances of taking his own life.
Yet the FDA recently opted to impose its most serious "black box" warning on the prescription of anti-depressants to those aged 18 to 24. This sends the wrong message about drugs that are often life-saving.
What has led to these new warnings? An analysis of the use of 11 anti-depressants in 77,000 patients in this age group - which found an increased risk not of suicide but of suicidal thoughts for one patient in a thousand.
This number is quite small - and the FDA has a history of overestimating this kind of risk. It instituted a black-box warning against use of anti-depressants in children and younger adolescents in 2004. But a recent study in The Journal of the American Medical Association showed that the presence of "suicidal thoughts" in this group is less than half what the FDA had thought.
Is there any science behind the fears of these useful meds? Dr. John Mann, director of neuroscience at the New York State Psychiatric Institute and an expert on suicide, notes that starting an anti-depressant can occasionally remove inhibition and fear of death - "the person is no longer indecisive, and suicide may ensue."
But this theory is really a justification for careful observation by a trained professional like a psychiatrist, not for irrational fear of the drug. Any patient taking a drug for the first time may experience unexpected side effects, so early surveillance is always warranted.
And, while some caution about tiny theoretical risks may be in order, a growing fear of these drugs is hurting actual patients.
The pediatric warnings were instituted in March 2004; since then, the number of prescriptions of the common SSRI anti-depressants written for those under 19 has dropped by more than 10 percent. Meanwhile, childhood and adolescent suicides rose by nearly 20 percent in 2004 over the prior year. Fewer anti-depressants, that is, were followed by more suicides.
I worry that we'll now see that trend continue with the extension of the warnings to older patients. Worse, suicide grows more common among older teens, so the loss of life with the new warnings could be that much greater.
Warnings are only useful when they protect us against something dangerous. With untreated depression, the danger of suicide is far greater than the risk of the drugs that prevent it.
Dr. Marc K. Siegel is author of "False Alarm."
DANGEROUS WARNINGS
By MARC K. SIEGEL
May 12, 2007 -- CONGRESS may soon increase the Food and Drug Administration's oversight of pharmeceuticals. I certainly don't think we should simply trust what drug companies tell us, but I have my worries about the FDA, too.
Why? Consider one of my patients. Last year, the teen was in trouble - fighting with both parents during an ugly divorce and becoming severely depressed and violent. He'd had a fistfight with a relative and been expelled from his school
This year, he is not dead or in prison, but back in school. He's a much happier person who has been helped greatly by psychotherapy, time to heal his emotional wounds - and the anti-depressant Zoloft.
I can't say that he would have committed suicide without the medication, but the chances of his downhill spiral continuing would have been much greater. And the pill most certainly did not increase his chances of taking his own life.
Yet the FDA recently opted to impose its most serious "black box" warning on the prescription of anti-depressants to those aged 18 to 24. This sends the wrong message about drugs that are often life-saving.
What has led to these new warnings? An analysis of the use of 11 anti-depressants in 77,000 patients in this age group - which found an increased risk not of suicide but of suicidal thoughts for one patient in a thousand.
This number is quite small - and the FDA has a history of overestimating this kind of risk. It instituted a black-box warning against use of anti-depressants in children and younger adolescents in 2004. But a recent study in The Journal of the American Medical Association showed that the presence of "suicidal thoughts" in this group is less than half what the FDA had thought.
Is there any science behind the fears of these useful meds? Dr. John Mann, director of neuroscience at the New York State Psychiatric Institute and an expert on suicide, notes that starting an anti-depressant can occasionally remove inhibition and fear of death - "the person is no longer indecisive, and suicide may ensue."
But this theory is really a justification for careful observation by a trained professional like a psychiatrist, not for irrational fear of the drug. Any patient taking a drug for the first time may experience unexpected side effects, so early surveillance is always warranted.
And, while some caution about tiny theoretical risks may be in order, a growing fear of these drugs is hurting actual patients.
The pediatric warnings were instituted in March 2004; since then, the number of prescriptions of the common SSRI anti-depressants written for those under 19 has dropped by more than 10 percent. Meanwhile, childhood and adolescent suicides rose by nearly 20 percent in 2004 over the prior year. Fewer anti-depressants, that is, were followed by more suicides.
I worry that we'll now see that trend continue with the extension of the warnings to older patients. Worse, suicide grows more common among older teens, so the loss of life with the new warnings could be that much greater.
Warnings are only useful when they protect us against something dangerous. With untreated depression, the danger of suicide is far greater than the risk of the drugs that prevent it.
Dr. Marc K. Siegel is author of "False Alarm."
There may very well "always be an England," but there won't always be the drugs you need to survive if you live there. Welcome to the world of heathcare technology assessment aka comparative effectiveness aka evidence-based medicine.
When it comes down to brass tacks, what all these fancy phrases means for patients is "sorry -- no medicines for you." So much for "universal" health care. "Government" health care is more like it.
It's reached such a state in the UK that the following appears in today's edition of The Telegraph:
The drugs the NHS won't give you
Suninitib (Sutent)
For kidney cancer.
Licensed, but the Department of Health has yet to refer it to Nice for a recommendation.
John Quance, 57
The former fireman was told he could not have the drug Sutent because the NHS would not pay for it.
Mr Quance, who has been diagnosed with kidney cancer, cashed in his pension and remortgaged his house to pay for it privately, but fears that he may have to sell his home unless the NHS steps in. Cornwall Primary Care Trust said it was not prepared to pay the £22,000-a-year cost of the drug until it was approved by Nice.
Mr Quance said: "I have worked all my life, I have been in the forces, the prison service and the fire service for 30-odd years and I feel a little bit abandoned.
"The staff and the hospital have been excellent but it is a little disappointing not to get funding when it has been proved [the drug] is working."
--------------------------------------------------------------------------------
Bevacizumab (Avastin)
For bowel cancer.
Licensed for colon cancer in January 2005, but turned down on the grounds of cost-effectiveness in January.
Victoria Otley, 56
Miss Otley was diagnosed with bowel cancer at the end of 2005. She had complained of being in pain but doctors told her that it was nothing to worry about.
By the time her cancer was diagnosed it had spread. She took other drugs and later asked about getting Avastin after her sister read about it on the internet. Yesterday, Miss Otley, a former hairdresser from Dagenham, said: "I asked my consultant but he said it wasn't available on the NHS."
She and her sister paid £15,000 for a course of Avastin and the cancer shrunk, however they cannot afford to pay for any more. "You work all your life and pay your taxes and this is what you get. I think it's disgusting."
--------------------------------------------------------------------------------
Cetuximab (Erbitux)
For bowel cancer.
Licensed in June 2004 and turned down by Nice in January this year.
Ian MacDonald
The former bridge inspector's doctor told him that he would have liked to have prescribed Erbitux, but that he could not because it was not available on the NHS.
Mr Macdonald has tried various drugs and radiotherapy since being diagnosed with bowel cancer in the year 2000.
His wife Catherine, who has given up work to care for him full-time, said yesterday: "My husband has worked all his life in this country and never had a day off sick and yet he is refused a drug that might stabilise or shrink his tumour.
"I can't understand why it is not available here but it is in other countries. It's awful."
--------------------------------------------------------------------------------
Erlotinib (Tarceva)
For non-small cell lung cancer.
Licensed in Sept 2005, approved by the Scottish Medicines Consortium in June last year and rejected by Nice in March on the grounds that it was not clinically or cost effective. Manufacturers Roche are appealing against the decision.
Susan Allen, 43
She was told she had ten months to live after being diagnosed with lung cancer in December 2005.
A non-smoker, whose hobbies include cycling and running, the mother-of-one underwent chemotherapy and radiotherapy and was prescribed Tarceva by her oncologist in October last year. She had to pay for the daily pills herself initially, at a cost of £70 per day, until her local health authority eventually changed its mind.
She said: "Denying the drug is condemning patients to death."
--------------------------------------------------------------------------------
(Bortezomib) Velcade
For bone marrow cancer patients who have had at least one earlier therapy or are unsuitable for a bone marrow transplant.
Nice has agreed to review its rejection of the drug in March. Patients in Scotland, Wales and Northern Ireland have been able to get it since last year.
George King, 57
Mr King, who is terminally ill with bone marrow cancer was forced to consider moving to Scotland to get access to Velcade in an attempt to prolong his life.
Mr King, an electrical engineer from Teesside, said earlier this year: "People with terminal illnesses shouldn't have to fight for treatment. It's so frustrating. This drug is available not only in Europe, but just a few miles north of where I live. I don't have any option but to move away from my family, friends and the people who have helped me through the cancer until now."
--------------------------------------------------------------------------------
Pemetrexed (Alimta)
For mesothelioma, a cancer caused by exposure to asbestos, and small-cell lung cancer.
Patient groups are waiting for the results of an appeal against Nice's rejection of the treatment in February for lung cancer. A decision on funding for mesothelioma is expected in September.
Bernard Hoyland
The retired mechanical fitter spent the last years of his life fighting to make Alimta available for patients in his area.
After he was diagnosed with mesothelioma he was told his primary care trust would not pay for him to receive Alimta because it was too expensive. He launched a legal attempt for compensation against his former employers, began travelling to London every three weeks to receive cancer treatment and joined a campaign to force NHS bosses in Teesside to fund Alimta. Six months after funding was agreed, Nice ruled that it was too costly.
Mr Hoyland, who called the decision "simply unacceptable", died last November.
His son Paul said: "He ended up having to travel to central London after finding he could get the chemotherapy down there. He was a victim of the postcode lottery."
When it comes down to brass tacks, what all these fancy phrases means for patients is "sorry -- no medicines for you." So much for "universal" health care. "Government" health care is more like it.
It's reached such a state in the UK that the following appears in today's edition of The Telegraph:
The drugs the NHS won't give you
Suninitib (Sutent)
For kidney cancer.
Licensed, but the Department of Health has yet to refer it to Nice for a recommendation.
John Quance, 57
The former fireman was told he could not have the drug Sutent because the NHS would not pay for it.
Mr Quance, who has been diagnosed with kidney cancer, cashed in his pension and remortgaged his house to pay for it privately, but fears that he may have to sell his home unless the NHS steps in. Cornwall Primary Care Trust said it was not prepared to pay the £22,000-a-year cost of the drug until it was approved by Nice.
Mr Quance said: "I have worked all my life, I have been in the forces, the prison service and the fire service for 30-odd years and I feel a little bit abandoned.
"The staff and the hospital have been excellent but it is a little disappointing not to get funding when it has been proved [the drug] is working."
--------------------------------------------------------------------------------
Bevacizumab (Avastin)
For bowel cancer.
Licensed for colon cancer in January 2005, but turned down on the grounds of cost-effectiveness in January.
Victoria Otley, 56
Miss Otley was diagnosed with bowel cancer at the end of 2005. She had complained of being in pain but doctors told her that it was nothing to worry about.
By the time her cancer was diagnosed it had spread. She took other drugs and later asked about getting Avastin after her sister read about it on the internet. Yesterday, Miss Otley, a former hairdresser from Dagenham, said: "I asked my consultant but he said it wasn't available on the NHS."
She and her sister paid £15,000 for a course of Avastin and the cancer shrunk, however they cannot afford to pay for any more. "You work all your life and pay your taxes and this is what you get. I think it's disgusting."
--------------------------------------------------------------------------------
Cetuximab (Erbitux)
For bowel cancer.
Licensed in June 2004 and turned down by Nice in January this year.
Ian MacDonald
The former bridge inspector's doctor told him that he would have liked to have prescribed Erbitux, but that he could not because it was not available on the NHS.
Mr Macdonald has tried various drugs and radiotherapy since being diagnosed with bowel cancer in the year 2000.
His wife Catherine, who has given up work to care for him full-time, said yesterday: "My husband has worked all his life in this country and never had a day off sick and yet he is refused a drug that might stabilise or shrink his tumour.
"I can't understand why it is not available here but it is in other countries. It's awful."
--------------------------------------------------------------------------------
Erlotinib (Tarceva)
For non-small cell lung cancer.
Licensed in Sept 2005, approved by the Scottish Medicines Consortium in June last year and rejected by Nice in March on the grounds that it was not clinically or cost effective. Manufacturers Roche are appealing against the decision.
Susan Allen, 43
She was told she had ten months to live after being diagnosed with lung cancer in December 2005.
A non-smoker, whose hobbies include cycling and running, the mother-of-one underwent chemotherapy and radiotherapy and was prescribed Tarceva by her oncologist in October last year. She had to pay for the daily pills herself initially, at a cost of £70 per day, until her local health authority eventually changed its mind.
She said: "Denying the drug is condemning patients to death."
--------------------------------------------------------------------------------
(Bortezomib) Velcade
For bone marrow cancer patients who have had at least one earlier therapy or are unsuitable for a bone marrow transplant.
Nice has agreed to review its rejection of the drug in March. Patients in Scotland, Wales and Northern Ireland have been able to get it since last year.
George King, 57
Mr King, who is terminally ill with bone marrow cancer was forced to consider moving to Scotland to get access to Velcade in an attempt to prolong his life.
Mr King, an electrical engineer from Teesside, said earlier this year: "People with terminal illnesses shouldn't have to fight for treatment. It's so frustrating. This drug is available not only in Europe, but just a few miles north of where I live. I don't have any option but to move away from my family, friends and the people who have helped me through the cancer until now."
--------------------------------------------------------------------------------
Pemetrexed (Alimta)
For mesothelioma, a cancer caused by exposure to asbestos, and small-cell lung cancer.
Patient groups are waiting for the results of an appeal against Nice's rejection of the treatment in February for lung cancer. A decision on funding for mesothelioma is expected in September.
Bernard Hoyland
The retired mechanical fitter spent the last years of his life fighting to make Alimta available for patients in his area.
After he was diagnosed with mesothelioma he was told his primary care trust would not pay for him to receive Alimta because it was too expensive. He launched a legal attempt for compensation against his former employers, began travelling to London every three weeks to receive cancer treatment and joined a campaign to force NHS bosses in Teesside to fund Alimta. Six months after funding was agreed, Nice ruled that it was too costly.
Mr Hoyland, who called the decision "simply unacceptable", died last November.
His son Paul said: "He ended up having to travel to central London after finding he could get the chemotherapy down there. He was a victim of the postcode lottery."
The New York Sun, that is.
In their house editorial, the Sun supports the Senate's vote on the FDA Revitalization Act and makes the point that:
"The thing to remember in all this is that when it comes to innovative medicines, safety is rarely an "either/or" question, as Peter Pitts, a former FDA associate commissioner and president of the market-oriented Center for Medicine in the Public Interest, pointed out recently in the Journal of Life Sciences. On a net basis, people are living longer and healthier than ever before, thanks in good part to the availability of remarkable new drugs. Keeping the innovations coming will only become more critical now that the first baby boomers are senior citizens. The Senate has demonstrated a willingness to do that, no help from our own senators."
Here's a link to the complete editorial:
http://www.nysun.com/article/54294
In their house editorial, the Sun supports the Senate's vote on the FDA Revitalization Act and makes the point that:
"The thing to remember in all this is that when it comes to innovative medicines, safety is rarely an "either/or" question, as Peter Pitts, a former FDA associate commissioner and president of the market-oriented Center for Medicine in the Public Interest, pointed out recently in the Journal of Life Sciences. On a net basis, people are living longer and healthier than ever before, thanks in good part to the availability of remarkable new drugs. Keeping the innovations coming will only become more critical now that the first baby boomers are senior citizens. The Senate has demonstrated a willingness to do that, no help from our own senators."
Here's a link to the complete editorial:
http://www.nysun.com/article/54294
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.
