Latest Drugwonks' Blog
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
We've said it before, but Kim Strassel says is best. Here's her excellent piece from today's edition of the Wall Street Journal.
Canadian Drugs, Eh?
Listen to Maine Sen. Olympia Snowe discuss importing drugs from Canada, and you'll hear endless happy talk about "more competitive prices," "substantial savings" and how "crucial" reimportation is to "the American consumer." What you won't hear Ms. Snowe mention much is the drug-import program of Portland, Maine.
Interesting that, since Portland was one of those cities that gained notoriety a few years back for defying federal law and setting up a Canada import program that it promised would save its thousands of city employees and their dependents a bundle on drugs. Three years in, it has attracted all of 350 participants.
That was also the flame-out fate of a statewide plan by Gov. John Baldacci to empower the Penobscot Indian Nation to build a distribution center to import price-controlled Canadian drugs for some 325,000 uninsured and underinsured Mainers. The tribe in February unceremoniously closed the program (which never got its hands on Canadian drugs, but morphed into a domestic mail-order business), having attracted just 3,000 Medicaid recipients.
Ditto, all across America. Three years ago, grandstanding governors and mayors vowed to break federal law and set up state-run drug import programs, giving millions of citizens the "opportunity" to buy cheap Canadian drugs. The media showered these souls with headlines, praised them for being on the side of poor, strapped U.S. consumers -- then forgot all about it. Today, most state-import programs are on life support, while some have closed completely. Never mind all Washington's hifalutin arguments about intellectual property, free trade and safety; the overwhelming majority of Americans appear to have little use for import programs that offer few drugs at long wait times, under suspect safety conditions and with minimal savings.
All of which helps explain this week's bizarre, and highly cynical, Senate votes on drug imports. Many of the very senators who supported or co-sponsored Ms. Snowe's amendment to change federal law and allow Canadian imports hail from states that have seen their own high-profile programs wither or die. That includes Wisconsin's Herb Kohl and Russ Feingold, Missouri's Claire McCaskill and Dick Durbin of Illinois.
These folks know firsthand that Canadian imports aren't really that popular and won't save much, if any, money. But they do like what this debate offers, namely the chance to bash U.S. pharma companies and to stand with "overcharged" U.S. consumers. The votes are more a sideshow, and it explains why some senators, who publicly support the easing of drug-import laws, also voted for a poison pill that gutted Ms. Snowe's amendment on safety concerns. It isn't as if masses of Canadian drug fans will come storming down their doors.
If anything, Portland is a success compared to the more high-profile state programs that got rolling in 2004. When Illinois Gov. Rod Blagojevich introduced his I-Save-RX program, which was initially joined by neighboring Wisconsin, he dramatically declared that "the nearly 13 million people who live in Illinois and the more than five million people who live in Wisconsin will have the opportunity to save hundreds -- and in some cases even thousands -- of dollars each year on the high cost of their medicine." Mr. Blagoevich spent nearly $1 million in taxpayer dollars developing it, including some 500 state workers from two dozen agencies who spent 5,600 hours flacking the program.
All this caused Illinois Auditor General William Holland to get curious about just how much benefit this wonder program was producing, and last fall he issued a stunning report. Over 19 months of operation, a grand total of 3,689 Illinois residents had used the program, which equals approximately 0.02% of the population. Results from the four other participating states were even more laughably dismal. Wisconsin had 321 people use the program; Kansas 267; Missouri 460; and Vermont 217. Mr. Holland also noted that the program was, er, illegal, and that the state had failed to implement quality control.
Things haven't been much rosier for Minnesota Gov. Tim Pawlenty, a Republican who felt it expedient to throw over the U.S. drug industry in favor of a few populist headlines. Mr. Pawlenty promised in 2003 that his Minnesota RxConnect program would serve some 700,000 people. A representative from Minnesota's department of human services explained to me this week that the state (conveniently) does not break out the number of people who use its program. But according to its latest statistics, Minnesota RxConnect last month filled a total of 138 prescriptions. That's for the whole state. Programs like those in Springfield, Mass., have simply closed.
Ask program administrators why so few people use Canadian imports, and they'll give you a frank, and long, list. Many consumers are wary about safety issues. They like having a relationship with a local pharmacist, and like knowing their drugs have undergone a U.S. quality check. Many drugs aren't available: that includes anything that needs to be taken immediately (antibiotics, for instance), or specialty drugs (such as injections for diabetics, which are hard to ship). It's also the case that many chronic diseases are today managed with generics, which remain cheaper in the U.S. Those that do use import programs tend to be a very small population that take maintenance drugs, say for high blood pressure, or cholesterol.
Perhaps an even bigger point is that huge numbers of Americans don't even pay for their drugs, but rather farm out their bills to an insurer. That's even more the case now that seniors are getting their drugs through Medicare. Joseph Bruno, the former Republican minority leader in Maine's legislature and now full-time CEO of a chain of pharmacies in that state, points out that 94.5% of his customers get prescriptions paid by a third party and so aren't price-sensitive.
"This is nothing but political posturing," he says of the U.S. Senate debate. He also notes that many of the infamous "bus trips" from Maine to Canada were in fact ginned up by labor unions that wanted to elevate drug prices into a political issue, and that successfully left the false impression that Americans were falling all over themselves for Canadian meds. "If you look at the numbers, that's just not the case."
Still, don't expect the political caterwauling over imports to go away any time soon. There's still too much political upside to talking up a program that few Americans really want to use.
Canadian Drugs, Eh?
Listen to Maine Sen. Olympia Snowe discuss importing drugs from Canada, and you'll hear endless happy talk about "more competitive prices," "substantial savings" and how "crucial" reimportation is to "the American consumer." What you won't hear Ms. Snowe mention much is the drug-import program of Portland, Maine.
Interesting that, since Portland was one of those cities that gained notoriety a few years back for defying federal law and setting up a Canada import program that it promised would save its thousands of city employees and their dependents a bundle on drugs. Three years in, it has attracted all of 350 participants.
That was also the flame-out fate of a statewide plan by Gov. John Baldacci to empower the Penobscot Indian Nation to build a distribution center to import price-controlled Canadian drugs for some 325,000 uninsured and underinsured Mainers. The tribe in February unceremoniously closed the program (which never got its hands on Canadian drugs, but morphed into a domestic mail-order business), having attracted just 3,000 Medicaid recipients.
Ditto, all across America. Three years ago, grandstanding governors and mayors vowed to break federal law and set up state-run drug import programs, giving millions of citizens the "opportunity" to buy cheap Canadian drugs. The media showered these souls with headlines, praised them for being on the side of poor, strapped U.S. consumers -- then forgot all about it. Today, most state-import programs are on life support, while some have closed completely. Never mind all Washington's hifalutin arguments about intellectual property, free trade and safety; the overwhelming majority of Americans appear to have little use for import programs that offer few drugs at long wait times, under suspect safety conditions and with minimal savings.
All of which helps explain this week's bizarre, and highly cynical, Senate votes on drug imports. Many of the very senators who supported or co-sponsored Ms. Snowe's amendment to change federal law and allow Canadian imports hail from states that have seen their own high-profile programs wither or die. That includes Wisconsin's Herb Kohl and Russ Feingold, Missouri's Claire McCaskill and Dick Durbin of Illinois.
These folks know firsthand that Canadian imports aren't really that popular and won't save much, if any, money. But they do like what this debate offers, namely the chance to bash U.S. pharma companies and to stand with "overcharged" U.S. consumers. The votes are more a sideshow, and it explains why some senators, who publicly support the easing of drug-import laws, also voted for a poison pill that gutted Ms. Snowe's amendment on safety concerns. It isn't as if masses of Canadian drug fans will come storming down their doors.
If anything, Portland is a success compared to the more high-profile state programs that got rolling in 2004. When Illinois Gov. Rod Blagojevich introduced his I-Save-RX program, which was initially joined by neighboring Wisconsin, he dramatically declared that "the nearly 13 million people who live in Illinois and the more than five million people who live in Wisconsin will have the opportunity to save hundreds -- and in some cases even thousands -- of dollars each year on the high cost of their medicine." Mr. Blagoevich spent nearly $1 million in taxpayer dollars developing it, including some 500 state workers from two dozen agencies who spent 5,600 hours flacking the program.
All this caused Illinois Auditor General William Holland to get curious about just how much benefit this wonder program was producing, and last fall he issued a stunning report. Over 19 months of operation, a grand total of 3,689 Illinois residents had used the program, which equals approximately 0.02% of the population. Results from the four other participating states were even more laughably dismal. Wisconsin had 321 people use the program; Kansas 267; Missouri 460; and Vermont 217. Mr. Holland also noted that the program was, er, illegal, and that the state had failed to implement quality control.
Things haven't been much rosier for Minnesota Gov. Tim Pawlenty, a Republican who felt it expedient to throw over the U.S. drug industry in favor of a few populist headlines. Mr. Pawlenty promised in 2003 that his Minnesota RxConnect program would serve some 700,000 people. A representative from Minnesota's department of human services explained to me this week that the state (conveniently) does not break out the number of people who use its program. But according to its latest statistics, Minnesota RxConnect last month filled a total of 138 prescriptions. That's for the whole state. Programs like those in Springfield, Mass., have simply closed.
Ask program administrators why so few people use Canadian imports, and they'll give you a frank, and long, list. Many consumers are wary about safety issues. They like having a relationship with a local pharmacist, and like knowing their drugs have undergone a U.S. quality check. Many drugs aren't available: that includes anything that needs to be taken immediately (antibiotics, for instance), or specialty drugs (such as injections for diabetics, which are hard to ship). It's also the case that many chronic diseases are today managed with generics, which remain cheaper in the U.S. Those that do use import programs tend to be a very small population that take maintenance drugs, say for high blood pressure, or cholesterol.
Perhaps an even bigger point is that huge numbers of Americans don't even pay for their drugs, but rather farm out their bills to an insurer. That's even more the case now that seniors are getting their drugs through Medicare. Joseph Bruno, the former Republican minority leader in Maine's legislature and now full-time CEO of a chain of pharmacies in that state, points out that 94.5% of his customers get prescriptions paid by a third party and so aren't price-sensitive.
"This is nothing but political posturing," he says of the U.S. Senate debate. He also notes that many of the infamous "bus trips" from Maine to Canada were in fact ginned up by labor unions that wanted to elevate drug prices into a political issue, and that successfully left the false impression that Americans were falling all over themselves for Canadian meds. "If you look at the numbers, that's just not the case."
Still, don't expect the political caterwauling over imports to go away any time soon. There's still too much political upside to talking up a program that few Americans really want to use.
Assuming that Kenzi is passed without amendments that make medicines less safe -- meaning importation or follow-on biologics -- the current bill will give FDA tons of money for new tools to monitor drug risks post market.
That should put the pressure on the agency and its overlords in Congress to allow medicines with targeted risk benefit profiles on the market right? (We know who is running the show absent real leadership at the FDA.) After all if we put REMS in place because all risks are unknown during and after a clinical trial, the same can and is true about benefits, nes pa? And who is to say whether the collective benefits are less important than the collective risks? Shouldn't patients in a subpopulation make that decision or do FDAers, the media, Hill staffers, etc in their infinite wisdom know in advance for everyone who will benefit and who will be harmed with such precision that they should be entrusted with making decisions for everyone else. Or are these REMS tools just for show?
That should put the pressure on the agency and its overlords in Congress to allow medicines with targeted risk benefit profiles on the market right? (We know who is running the show absent real leadership at the FDA.) After all if we put REMS in place because all risks are unknown during and after a clinical trial, the same can and is true about benefits, nes pa? And who is to say whether the collective benefits are less important than the collective risks? Shouldn't patients in a subpopulation make that decision or do FDAers, the media, Hill staffers, etc in their infinite wisdom know in advance for everyone who will benefit and who will be harmed with such precision that they should be entrusted with making decisions for everyone else. Or are these REMS tools just for show?
Many opinions out there on Kenzi.
Here's mine: Don't be dogmatic.
Change is not an all-or-nothing proposition. Small movement in the right direction is the beginning of momentum. (And small victories are better than explosive defeats.)
And remember the words of Plutarch, "Time is the wisest of all counselors."
Here's mine: Don't be dogmatic.
Change is not an all-or-nothing proposition. Small movement in the right direction is the beginning of momentum. (And small victories are better than explosive defeats.)
And remember the words of Plutarch, "Time is the wisest of all counselors."
When developing "evidence-based" guidelines, the World Health Organization routinely forgets one key ingredient: evidence. That is the verdict from a study published in The Lancet.
"This is a pretty seismic event," Lancet editor Dr. Richard Horton, who was not involved in the research for the article. "It undermines the very purpose of WHO."
Seismic, indeed. (But is it seismic enough to make the pages of Consumer Reports?)
WHO's Director of Research Policy Dr. Tikki Pang said that some of his WHO colleagues were shocked by The Lancet's study, but he acknowledged the criticism had merit, and explained that time pressures and a lack of both information and money sometimes compromised WHO work.
Gevalt!
"We know our credibility is at stake," Pang said, "and we are now going to get our act together."
Who's in charge over there? The Great Ballantine?
Here's the rest of the story:
http://www.miamiherald.com/852/story/99331.html
Evidence? We don't need no stinking evidence -- as long as our results provide back-up for evermore restrictive national formularies.
"This is a pretty seismic event," Lancet editor Dr. Richard Horton, who was not involved in the research for the article. "It undermines the very purpose of WHO."
Seismic, indeed. (But is it seismic enough to make the pages of Consumer Reports?)
WHO's Director of Research Policy Dr. Tikki Pang said that some of his WHO colleagues were shocked by The Lancet's study, but he acknowledged the criticism had merit, and explained that time pressures and a lack of both information and money sometimes compromised WHO work.
Gevalt!
"We know our credibility is at stake," Pang said, "and we are now going to get our act together."
Who's in charge over there? The Great Ballantine?
Here's the rest of the story:
http://www.miamiherald.com/852/story/99331.html
Evidence? We don't need no stinking evidence -- as long as our results provide back-up for evermore restrictive national formularies.
Here are two new publications (one from the new Journal of Life Sciences by yours truly and the other from Health Affairs by Scott Gottlieb, MD) that discuss the pharmaceutical risk/benefit equation.
Both articles ask and address the same question: Has "safety" become deliterious to the public health?
Here's a link to the Scott's Health Affairs paper:
Download file
And the link to my article in the Journal of Life Sciences:
http://www.tjols.com/commentary/may8_is_it_safe.jsp
Both articles ask and address the same question: Has "safety" become deliterious to the public health?
Here's a link to the Scott's Health Affairs paper:
Download file
And the link to my article in the Journal of Life Sciences:
http://www.tjols.com/commentary/may8_is_it_safe.jsp
Thomas Fleming, described my Matt Herper as a world reknown biostatistician who couldn't sleep the night of the FDA's Ad Comm vote on Provenge because he "knew" without randomized controlled trials the data on survival might be a fluke. Fleming wrote to Herper "Patients might drop out of the ongoing clinical trial in order to get the drug, not placebo. How, he asked, would that be good for prostate cancer patients?"
This is not a scientist writing, but a zealot trying to defend a religious position to himself by writing his Boswell. See Dendreon's Dilemma by Herper
http://www.forbes.com/home/sciencesandmedicine/2007/05/09/dendreon-provenge-fda-biz-sci_cx_mh_0509dendreon.html
This does not justify the FDA's deadly decision to delay Provenge but it speaks volumes about the slavish mindset regarding clinical trials -- both inside and outside the agency and how to determine safety and efficacy. A bigger push to change the paradigm to evaluate personalized treatments -- of which cancer immunotherapies are a subset -- is needed.
That said, Fleming's publish confession of anguish reminds me of Cotton Mather who sought to unburden his soul after unleashing the Salem Witch trials. Don't give us this "I was doing it for the cancer patients." This is you protecting the probabilistic priesthood by offering up sacrificial lambs.
Sleep well.
This is not a scientist writing, but a zealot trying to defend a religious position to himself by writing his Boswell. See Dendreon's Dilemma by Herper
http://www.forbes.com/home/sciencesandmedicine/2007/05/09/dendreon-provenge-fda-biz-sci_cx_mh_0509dendreon.html
This does not justify the FDA's deadly decision to delay Provenge but it speaks volumes about the slavish mindset regarding clinical trials -- both inside and outside the agency and how to determine safety and efficacy. A bigger push to change the paradigm to evaluate personalized treatments -- of which cancer immunotherapies are a subset -- is needed.
That said, Fleming's publish confession of anguish reminds me of Cotton Mather who sought to unburden his soul after unleashing the Salem Witch trials. Don't give us this "I was doing it for the cancer patients." This is you protecting the probabilistic priesthood by offering up sacrificial lambs.
Sleep well.
I had posted an entry from Martyn Postle, Director, Cambridge Healthcare & Biotech in the how the UK did compared to the European countries on providing cancer care. I received a request to take down the post because CHB didn't want others -- or maybe just us -- to share it. Rather, it wants people to crawl their way to the site on their own.
Have it your way.
Have it your way.
The Senate just passed the FDA Revitalization Act, S. 1082, Final vote was: 93/1 -- with the one "Nay" vote coming from Bernie Sanders, the junior senator from Ben & Jerry's.
Some notable amendment wrap-ups:
Grassley amendment: to require the Office of Surveillance and Epidemiology and the Office of New Drugs at FDA to make joint decisions with respect to an action related to post marketing safety issues, labeling changes, post-approval studies and restrictions or use of drugs with serious risks. In the case of disagreement between the two offices, the Commissioners office would have made the determination.
Failed by a vote of 46/47
Durbin amendment: to disallow members of FDA advisory committees with a conflict of interest to vote on consideration of approval of a drug where they have a financial interest, refines evaluation and criteria for term of appointment to an advisory committee, limits waivers for conflicts of interest per committee meeting.
Failed by a vote of 47/47
Needless to say, the additional amendment victories of free speech (DTC) and safety (importation) make Kenzi an exciting and important step forwards towards 21st century public health.
Some notable amendment wrap-ups:
Grassley amendment: to require the Office of Surveillance and Epidemiology and the Office of New Drugs at FDA to make joint decisions with respect to an action related to post marketing safety issues, labeling changes, post-approval studies and restrictions or use of drugs with serious risks. In the case of disagreement between the two offices, the Commissioners office would have made the determination.
Failed by a vote of 46/47
Durbin amendment: to disallow members of FDA advisory committees with a conflict of interest to vote on consideration of approval of a drug where they have a financial interest, refines evaluation and criteria for term of appointment to an advisory committee, limits waivers for conflicts of interest per committee meeting.
Failed by a vote of 47/47
Needless to say, the additional amendment victories of free speech (DTC) and safety (importation) make Kenzi an exciting and important step forwards towards 21st century public health.
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