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02/06/2007 08:17 AM |
A couple of months ago was attacked by a group called Breast Cancer Action for their scaremongering about the risks of mammograms for women under 50. Now it seems like that organization's efforts are also paying off:
Fewer Mammograms Means More Breast Cancer Deaths
It is a small statistic in a straightforward report. But its impact and implications are potentially huge.
From 2000 to 2005, the percentage of women age 40 and over who received a mammogram within the previous two years fell from 76.4 percent to 74.6 percent — a 1.8 percent drop.
Because in real terms, this means that thousands of women may have undetected breast cancer and could potentially miss the opportunity to save their own lives.
This wasn't really unexpected by those of us who try to keep up with current mammography practices.
My colleagues at the American Cancer Society noted a year ago that there had been a decline in mammography-screening compliance. We were also aware that there appeared to be a decline in mammography in women on Medicare, a group that is at particularly high risk of developing breast cancer."
I would like to attribute the decline to complacency (mammograms are paid for) or a fear of finding out but studies suggest otherwise. Instead, the small fall off reflects an offshoot of a growing trend of people getting medical advice from scam artists and enemies of medical progress who themselves have a financial or ideological agenda....
Now, who would you trust? Organizations that ultimately have a goal in making people healthy who make money in the process or people who make their money and get their publicity by scaring people away from seeking out and obtaining care that can save their lives? (Scientologists, Breast Cancer Action, Joseph Mercola, Kevin Trudeau, Public Citizen) Read More & Comment...
Fewer Mammograms Means More Breast Cancer Deaths
It is a small statistic in a straightforward report. But its impact and implications are potentially huge.
From 2000 to 2005, the percentage of women age 40 and over who received a mammogram within the previous two years fell from 76.4 percent to 74.6 percent — a 1.8 percent drop.
Because in real terms, this means that thousands of women may have undetected breast cancer and could potentially miss the opportunity to save their own lives.
This wasn't really unexpected by those of us who try to keep up with current mammography practices.
My colleagues at the American Cancer Society noted a year ago that there had been a decline in mammography-screening compliance. We were also aware that there appeared to be a decline in mammography in women on Medicare, a group that is at particularly high risk of developing breast cancer."
I would like to attribute the decline to complacency (mammograms are paid for) or a fear of finding out but studies suggest otherwise. Instead, the small fall off reflects an offshoot of a growing trend of people getting medical advice from scam artists and enemies of medical progress who themselves have a financial or ideological agenda....
Now, who would you trust? Organizations that ultimately have a goal in making people healthy who make money in the process or people who make their money and get their publicity by scaring people away from seeking out and obtaining care that can save their lives? (Scientologists, Breast Cancer Action, Joseph Mercola, Kevin Trudeau, Public Citizen) Read More & Comment...
02/06/2007 07:43 AM |
I guess Gardiner Harris, the Scientologists, Eliot Spitzer, Shankar Vendantam, The New York Times editorial page, the British Medical Journal, David Graham, and everyone else who hyperventilated about the link between SSRI's and suicide were right, finally. It was hard work but it all paid off.
According to Drug Benefit Trends.."data from Medco Health Solutions showed that at the end of the first quarter of 2004, the number of persons younger than 18 receiving antidepressants declined by 18% compared with the fourth quarter of 2003; the number dropped another 5% in the second quarter of 2004.[1] This decline contrasts sharply with what had been a 77% increase in the number of filled prescriptions for antidepressants and other psychotropic medications for children and adolescents from 2000 to 2003."
http://www.medscape.com/viewarticle/504164
The result?
Kids' Suicides Rise, CDC Report Finds
By LINDSEY TANNER Tuesday, February 06, 2007
CHICAGO - New government figures show a surprising increase in youth suicides after a decade of decline, and some mental health experts think a drop in use of antidepressant drugs may be to blame.
The suicide rate climbed 18 percent from 2003 to 2004 for Americans under age 20, from 1,737 deaths to 1,985. Most suicides occurred in older teens, according to the data _ the most current to date from the federal Centers for Disease Control and Prevention.
By contrast, the suicide rate among 15- to 19-year-olds fell in previous years, from about 11 per 100,000 in 1990 to 7.3 per 100,000 in 2003.
Suicides were the only cause of death that increased for children through age 19 from 2003-04, according to a CDC report released Monday. (It should be noted that many in the media confused suicidality with suicide and never explained the difference thereafter in fanning the flames of fear.)
Here's the link to the AP article:
http://www.casperstartribune.net/articles/2007/02/06/ap/health/d8n3tp7o0.txt Read More & Comment...
According to Drug Benefit Trends.."data from Medco Health Solutions showed that at the end of the first quarter of 2004, the number of persons younger than 18 receiving antidepressants declined by 18% compared with the fourth quarter of 2003; the number dropped another 5% in the second quarter of 2004.[1] This decline contrasts sharply with what had been a 77% increase in the number of filled prescriptions for antidepressants and other psychotropic medications for children and adolescents from 2000 to 2003."
http://www.medscape.com/viewarticle/504164
The result?
Kids' Suicides Rise, CDC Report Finds
By LINDSEY TANNER Tuesday, February 06, 2007
CHICAGO - New government figures show a surprising increase in youth suicides after a decade of decline, and some mental health experts think a drop in use of antidepressant drugs may be to blame.
The suicide rate climbed 18 percent from 2003 to 2004 for Americans under age 20, from 1,737 deaths to 1,985. Most suicides occurred in older teens, according to the data _ the most current to date from the federal Centers for Disease Control and Prevention.
By contrast, the suicide rate among 15- to 19-year-olds fell in previous years, from about 11 per 100,000 in 1990 to 7.3 per 100,000 in 2003.
Suicides were the only cause of death that increased for children through age 19 from 2003-04, according to a CDC report released Monday. (It should be noted that many in the media confused suicidality with suicide and never explained the difference thereafter in fanning the flames of fear.)
Here's the link to the AP article:
http://www.casperstartribune.net/articles/2007/02/06/ap/health/d8n3tp7o0.txt Read More & Comment...
02/06/2007 07:30 AM |
Here's a story about the regime that is seizing drug patents in Thailand. It's clear to me that the junta is taking a page from Hugo Chavez and trying to win support internationally from NGO's and liberal Dems event as popular support at home plummets. As soon as the junta, which has suppressed political freedoms and individual liberties, announced it was taking drug patents NGOs led by Jamie Love and Dems lead by Henry Waxman applauded, ignoring the lack of democracy and bolstering the junta in the process.
http://www.worldpoliticswatch.com/article.aspx?id=468 Read More & Comment...
http://www.worldpoliticswatch.com/article.aspx?id=468 Read More & Comment...
02/05/2007 09:32 PM |
The real story about Thailand's seizure of drug patents is that support for the military junta that took power and imposed martial law in 2006 is collapsing under is misrule, corruption and oppression. The compulsory licensing moves are an effort to win support for the regime from human rights groups, NGOs and the international press who see any attempt to nationalize industries or seize IP, particularly pharmaceutical IP, as a strike against globallization and capitalism.
The NGOs, led by Jamie Love, have taken the bait. They are giving aid and comfort to an increasingly repressive and unpopular regime, one that is succeeding in making all foreign investors nervous. (Leave it to Big Pharma to behave like is doing something wrong and nearly apologizing. When will it ever learn?) They are joined, incredibly by six Democratic members of Congress who are urging the administration to let the junta proceed with its seizure of the patent of Abbott's HIV drug Kaletra which has had it's own policy travails in the US.
Sadly, the NGOs are quite willing to allly themselves with any government willing to break patents. That is all they care about, human rights and democracy be damned. Sad to say, the same goes for certain members of Congress.
http://www.worldpoliticswatch.com/article.aspx?id=468 Read More & Comment...
The NGOs, led by Jamie Love, have taken the bait. They are giving aid and comfort to an increasingly repressive and unpopular regime, one that is succeeding in making all foreign investors nervous. (Leave it to Big Pharma to behave like is doing something wrong and nearly apologizing. When will it ever learn?) They are joined, incredibly by six Democratic members of Congress who are urging the administration to let the junta proceed with its seizure of the patent of Abbott's HIV drug Kaletra which has had it's own policy travails in the US.
Sadly, the NGOs are quite willing to allly themselves with any government willing to break patents. That is all they care about, human rights and democracy be damned. Sad to say, the same goes for certain members of Congress.
http://www.worldpoliticswatch.com/article.aspx?id=468 Read More & Comment...
02/05/2007 09:19 PM |
The FDA fares fairly well in the President's 2008 budget. Critical path gets $6.8 mill and there is an increase for other initiatives tied to modernizing drug review. And from my perspective the user fee money is tied to Critical Path type projects. So as long as it user fees are not squandered on useless book-keeping activities proposed in Kenzi and devoted to activities that truly improve the risk-benefit profile of medicines the FDA should be in decent shape. Now it's time for industry to ramp up participation in programs that make adoption of CP tools possible at the reviewer level.
By comparison the proposals put forth to turn the FDA into a parcel inspection service and fencing operation for foreign drug wholesalers, or creating a whole new drug safety agency or creating what amounts to a Smithsonian Institution for data mining of HMO data for David Graham and other risk averse zealots (proposed by IOM )will never make it past congressional budgeteers. Read More & Comment...
By comparison the proposals put forth to turn the FDA into a parcel inspection service and fencing operation for foreign drug wholesalers, or creating a whole new drug safety agency or creating what amounts to a Smithsonian Institution for data mining of HMO data for David Graham and other risk averse zealots (proposed by IOM )will never make it past congressional budgeteers. Read More & Comment...
02/05/2007 09:51 AM |
Four members of Congress have introduced bills to bar drug companies from introducing generic versions of their own drugs during the time another generic firm are marketing their own version of that drug during the so-called 180 day market exclusivity period. I call it so-called because two generic companies can already share that exclusivity and it is clear that the exclusivity only applies to a generic company's monopoly relative to other firms that seek to challenge an innovator patent. Authorized generics promotes competition which is what the original Hatch-Waxman bill sought to do. Are these elected representatives now doing the bidding of "Big Generics?" Read More & Comment...
02/05/2007 09:36 AM |
I was struck by the petulance of the response of Kurt Strange, the Annals of Family Medicine's editor in response to John Kamp's letter criticizing a "content analysis" of DTC ads (one person's opinion of TV ads in plain English):
DTC ads are a "tremendous intrusion" into the clinician-patient relationship, he said.
These ads "suck precious time, motivation and energy from the patient visit, forcing clinicians to educate patients about why a slickly promoted drug is not as important as a less sexy lifestyle change or even a cheaper but equally effective alternative medication.
Two insights can be gleaned from this temper tantrum:
Strange would have been, is or was a lousy and imperious physician that takes any questions from patients a direct challenge to his authority. The scenario he sets up of patients coming in asking for a drug instead of a lifestyle change or a generic drug is a fantasy. As if everyone who needs medication is either taking it or taking it properly or if patients come in just asking for a drug without a diagnosis!
The idea that educating patients is not part of the physician's duty ultimately reflects the elitist and authoritarian view of Strange and his ilk. I am not a big fan of DTC ads in general but I would rather get information on my own than instruction from a physician who regards educating patients about new medicines he or she may have found out about on their own as a waste of time or as a sign of stupidy... Read More & Comment...
DTC ads are a "tremendous intrusion" into the clinician-patient relationship, he said.
These ads "suck precious time, motivation and energy from the patient visit, forcing clinicians to educate patients about why a slickly promoted drug is not as important as a less sexy lifestyle change or even a cheaper but equally effective alternative medication.
Two insights can be gleaned from this temper tantrum:
Strange would have been, is or was a lousy and imperious physician that takes any questions from patients a direct challenge to his authority. The scenario he sets up of patients coming in asking for a drug instead of a lifestyle change or a generic drug is a fantasy. As if everyone who needs medication is either taking it or taking it properly or if patients come in just asking for a drug without a diagnosis!
The idea that educating patients is not part of the physician's duty ultimately reflects the elitist and authoritarian view of Strange and his ilk. I am not a big fan of DTC ads in general but I would rather get information on my own than instruction from a physician who regards educating patients about new medicines he or she may have found out about on their own as a waste of time or as a sign of stupidy... Read More & Comment...
02/05/2007 08:13 AM |
Today's New York Times editorial, "Moving Toward Greater Drug Safety," makes some good points and some bad ones.
On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.
On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Note to New York Times editorial board: The FDA already has all those powers.
But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:
"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."
Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.
But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."
Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.
But, hey, it's the editorial page right? Read More & Comment...
On the "good" side, the editorial recognizes that "Congress needs to give the agency more money ..." Huzzah.
On the bad side, "... and more teeth: including explicit powers to impose conditions on drugs that begin to look risky, to require additional testing and even to yank drugs from the market."
Note to New York Times editorial board: The FDA already has all those powers.
But, I suppose, the Gray Lady feels that without some anti Big Pharma rhetoric an editorial on drug safety just wouldn't be an article on drug safety. Consider how the editorial characterizes clinical trials:
"The agency has traditionally focused on the drug-approval process to determine if a drug is safe and effective. Unfortunately, by that time a drug has typically been tested in only a few hundred or a few thousand patients — too few for many kinds of adverse effects to become apparent."
Um, how about, generally speaking, tens of thousands of patients for drugs with broad population indications.
But my particular favorite is the editorialist's view of patients, "But the changes fall far short of what’s needed to protect millions of unsuspecting patients whose adverse effects may show up only after years of use."
Unsuspecting? What does that mean? I find this particularly amusing in light of the views often expressed on the pages of the New York Times on issues relating to patient empowerment and education. Yes, I mean DTC.
But, hey, it's the editorial page right? Read More & Comment...
02/03/2007 01:00 PM |
Here's why...
1.Treaties are based on trust. Thailand has violated the principle of the Doha agreement with this patent grab and in light of previous good faith efforts to negotiate partnerships with companies to promote comprehensive programs to speed access to medicines in the past, the outright seizure is akin to kicking private firms right in the ....intellectual property.
2. The patent seizure is based on a novel economic theory pursued by the not so smart Nobel Prize winner Joe Stieglitz, namely that generic companies that make drugs for profit are okay but innovator companies that do so are like Ebenezer Scrooge. That is generic companies are entitled to make a profit on drugs because they charge a "just price" for drugs but not innovator companies. Indeed, Jamie Love and others have argued that compulsory licensing should be invoked by any country, for any product, for any public use as long as a royalty is paid (just compensation).
WHO's president knows -- as does the Gates Foundation -- that the spread of this approach would leave only Jamie Love, Doctors Without Brains and a handful of generic companies in India in the business of developing new drugs for the developing world. Which means no new drugs at all.
3. The screw the drug company approach ignores the fact that most of these countries still underinvest in their public health systems and require NGO involvement above and beyond the rhetorical contributions of leftist and anti-globalist groups that have the ear of reporters at Le Figaro and The Guardian. The WHO President's rebuke of Thailand's health ministry reflects an effort the need for greater international and corporate investment and incentives to support such investment. Outright patent seizures are not an incentive the last time I checked. Read More & Comment...
1.Treaties are based on trust. Thailand has violated the principle of the Doha agreement with this patent grab and in light of previous good faith efforts to negotiate partnerships with companies to promote comprehensive programs to speed access to medicines in the past, the outright seizure is akin to kicking private firms right in the ....intellectual property.
2. The patent seizure is based on a novel economic theory pursued by the not so smart Nobel Prize winner Joe Stieglitz, namely that generic companies that make drugs for profit are okay but innovator companies that do so are like Ebenezer Scrooge. That is generic companies are entitled to make a profit on drugs because they charge a "just price" for drugs but not innovator companies. Indeed, Jamie Love and others have argued that compulsory licensing should be invoked by any country, for any product, for any public use as long as a royalty is paid (just compensation).
WHO's president knows -- as does the Gates Foundation -- that the spread of this approach would leave only Jamie Love, Doctors Without Brains and a handful of generic companies in India in the business of developing new drugs for the developing world. Which means no new drugs at all.
3. The screw the drug company approach ignores the fact that most of these countries still underinvest in their public health systems and require NGO involvement above and beyond the rhetorical contributions of leftist and anti-globalist groups that have the ear of reporters at Le Figaro and The Guardian. The WHO President's rebuke of Thailand's health ministry reflects an effort the need for greater international and corporate investment and incentives to support such investment. Outright patent seizures are not an incentive the last time I checked. Read More & Comment...
02/03/2007 08:19 AM |
Those who think there's health care nirvana Over There, should consider this article from today's edition of the Financial Times:
NICE faces inquiry by Commons group
By Nicholas Timmins
The Commons health committee yesterday announced terms of reference for a broad inquiry into the work of NICE, the National Institute for Health and Clinical Excellence.
The committee said it wanted to examine "why NICE's decisions are increasingly being challenged" after recent controversial recommendations that the NHS should not use certain costly cancer drugs and should restrict the use of drugs to treat Alzheimer's to those with moderate forms of the disease.
The committee said it wanted to know "whether public confidence in the institute is waning, and if so why", and said it would be looking at both NICE's evaluation process and the appeal system.
At the same time it will compare the work of NICE with that of the body that is roughly its Scottish equivalent. In some cases the latter has approved treatments that NICE has rejected.
The pharmaceutical industry's concerns that the NHS fails fully to implement NICE's recommendations when it does back new treatments and procedures will also be addressed.
The committee said it wanted to look at "which guidance is acted on, which is not and the reasons for this".
NICE is currently facing a judicial review backed by pharmaceutical companies and the Alzheimer's Society over its decision on Alzheimer's products.
The society said yesterday that the inquiry "should put a long-overdue spotlight on NICE's methods" and the "glaring absence" of an independent appeals process. Read More & Comment...
NICE faces inquiry by Commons group
By Nicholas Timmins
The Commons health committee yesterday announced terms of reference for a broad inquiry into the work of NICE, the National Institute for Health and Clinical Excellence.
The committee said it wanted to examine "why NICE's decisions are increasingly being challenged" after recent controversial recommendations that the NHS should not use certain costly cancer drugs and should restrict the use of drugs to treat Alzheimer's to those with moderate forms of the disease.
The committee said it wanted to know "whether public confidence in the institute is waning, and if so why", and said it would be looking at both NICE's evaluation process and the appeal system.
At the same time it will compare the work of NICE with that of the body that is roughly its Scottish equivalent. In some cases the latter has approved treatments that NICE has rejected.
The pharmaceutical industry's concerns that the NHS fails fully to implement NICE's recommendations when it does back new treatments and procedures will also be addressed.
The committee said it wanted to look at "which guidance is acted on, which is not and the reasons for this".
NICE is currently facing a judicial review backed by pharmaceutical companies and the Alzheimer's Society over its decision on Alzheimer's products.
The society said yesterday that the inquiry "should put a long-overdue spotlight on NICE's methods" and the "glaring absence" of an independent appeals process. Read More & Comment...
02/02/2007 03:32 PM |
I have had the chance to read both Kenzi 2.0 and the FDA's response to the scientifically illiterate IOM report. It reads like a Nobel Prize winner grading a high school essay....
http://www.fda.gov/oc/reports/iom013007.pdf
Kenzi 2.0 is an improvement, but not by much. It would be a better product if it was rewritten to fund and support Critical Path and what the FDA suggests in its IOM response.
It does less harm than 2.0 but it a lot of it has to do with wiggle words that contradict each other. For instance, claiming that Risk Aversion Managment Systems should not place a burden on patient's getting new meds and then on the next page goes on to detail how companies should set up a system to restrict access that includes " health providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restriction as well as those responsible for stopping the distribution of the drug..."
And by the way folks, Risk Aversion also applies to every new indication and supplemental approval. What if a doctor want's to use a drug in an off-label way based on his or her clinical judgement to help a dying or sick patient. Is that doctor a criminal under Kenzi? Is the company now responsible for any off-label use. Is this tort situation? Will purchase of this drug for off-label use be racketeering...?
As the ban of exchange of information about new drugs. Drugwonks wants to know if that extends to the internet. Does it mean that doctors who prescribe off-label outside the daisy-chain also violates the ban on commercial speech.
The Critical Path Institute proposal is still the strongest component. But it has weakened by the recommendation that it be kept within or the near the Beltway. The closer it is to DC the sooner it will become a captive of the political establishment.
It would be better to a non-profit organization that is already doing critical path work set up the Institute (I think that was in the original bill) like the C-Path Institute.
The 'limitation' on conflict of interests in advisory committees is guaranteed to attract more people who have other conflicts, interests and prejudices, particularly those that go largely unreported. Those include, prejudice about research methods, views about drug companies, the desire to conduct research and serve on boards for tenure or job advancement or to promote one own's agenda (Curt Furberg comes to mind). Since knowledge is power in academia, it is likely that investigators who come to the fore will use their position on advcomms to suppress or undermine results or views that refute findings or opinions they have. Thus, whatever credibility expert opinion has will become even less reliable.
Finally, Kenzi requires user fees to go to Risk Aversion. Another source of funding for critical path gone. And there is no sign of increasing funding for Critical Path or FDA to take on these new product life cycle responsibilities.
Finally, I still don't believe that we have a big crisis in drug safety.
We have a confidence problem that could be handled if companies took some steps I will describe in my next post. But with respect to the public health, the real crisis is that we have too few new medicines and too many sick people. Read More & Comment...
http://www.fda.gov/oc/reports/iom013007.pdf
Kenzi 2.0 is an improvement, but not by much. It would be a better product if it was rewritten to fund and support Critical Path and what the FDA suggests in its IOM response.
It does less harm than 2.0 but it a lot of it has to do with wiggle words that contradict each other. For instance, claiming that Risk Aversion Managment Systems should not place a burden on patient's getting new meds and then on the next page goes on to detail how companies should set up a system to restrict access that includes " health providers, pharmacists, patients, and other parties in the health care system who are responsible for implementing the restriction as well as those responsible for stopping the distribution of the drug..."
And by the way folks, Risk Aversion also applies to every new indication and supplemental approval. What if a doctor want's to use a drug in an off-label way based on his or her clinical judgement to help a dying or sick patient. Is that doctor a criminal under Kenzi? Is the company now responsible for any off-label use. Is this tort situation? Will purchase of this drug for off-label use be racketeering...?
As the ban of exchange of information about new drugs. Drugwonks wants to know if that extends to the internet. Does it mean that doctors who prescribe off-label outside the daisy-chain also violates the ban on commercial speech.
The Critical Path Institute proposal is still the strongest component. But it has weakened by the recommendation that it be kept within or the near the Beltway. The closer it is to DC the sooner it will become a captive of the political establishment.
It would be better to a non-profit organization that is already doing critical path work set up the Institute (I think that was in the original bill) like the C-Path Institute.
The 'limitation' on conflict of interests in advisory committees is guaranteed to attract more people who have other conflicts, interests and prejudices, particularly those that go largely unreported. Those include, prejudice about research methods, views about drug companies, the desire to conduct research and serve on boards for tenure or job advancement or to promote one own's agenda (Curt Furberg comes to mind). Since knowledge is power in academia, it is likely that investigators who come to the fore will use their position on advcomms to suppress or undermine results or views that refute findings or opinions they have. Thus, whatever credibility expert opinion has will become even less reliable.
Finally, Kenzi requires user fees to go to Risk Aversion. Another source of funding for critical path gone. And there is no sign of increasing funding for Critical Path or FDA to take on these new product life cycle responsibilities.
Finally, I still don't believe that we have a big crisis in drug safety.
We have a confidence problem that could be handled if companies took some steps I will describe in my next post. But with respect to the public health, the real crisis is that we have too few new medicines and too many sick people. Read More & Comment...
02/02/2007 03:11 PM |
The World Health Organization has cautioned Thailand over its move to adopt compulsory licensing for producing generic versions of heart disease and anti-Aids drugs.
''I'd like to underline that we have to find a right balance for compulsory licensing. We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity,'' said WHO director-general Margaret Chan.
Brava!
Speaking during a visit to the National Health Security Office, Dr Chan said she truly felt that the pharmaceutical industry was part of the solution to better drug access and that the government should open negotiations with drug firms over the issue.
She encouraged the Public Health Ministry to improve the public-private partnership in order to give the public better access to drugs. Public Health Minister Mongkol na Songkhla declined to comment on the issue. Read More & Comment...
''I'd like to underline that we have to find a right balance for compulsory licensing. We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity,'' said WHO director-general Margaret Chan.
Brava!
Speaking during a visit to the National Health Security Office, Dr Chan said she truly felt that the pharmaceutical industry was part of the solution to better drug access and that the government should open negotiations with drug firms over the issue.
She encouraged the Public Health Ministry to improve the public-private partnership in order to give the public better access to drugs. Public Health Minister Mongkol na Songkhla declined to comment on the issue. Read More & Comment...
02/02/2007 07:43 AM |
Here it is, Kenzi 2.0:
Download file
It's better. But is it reform?
The title of the legislation is "The Enhancing Drug Safety and Innovation Act of 2007." Let's look at innovation first.
Title II of the bill, the "Reagan-Udall Institute for Applied Medical Research" remains the most interesting part of the bill. It's, de minimus, a down-payment on the Critical Path. The major change from Kenzi 1.0 is that the funding/governance structure has changed to more closely model the NIH and CDC Foundations. In accordance with this change, the appropriations structure has also been modified.
The Institute would be headed by an Executive Director, under the guidance of the Board of Directors. The Board would develop the policies and by-laws of the Institute, and set the general direction of the Institute’s activities. The Board would be composed of individuals from the pharmaceutical and device industries, academic researchers, patient advocacy organizations, and members of the provider community.
Much like the NIH Foundation, the Institute’s administrative functions would be supported by Federal funds, while contributions from the pharmaceutical and device industries as well as from philanthropic organizations would be used to carry out the activities of the Institute.
But here's the question -- do we stiffle outside critical path efforts by NIH-tizing the process? Something to think about.
The "enhancing safety" side of the bill is somewhat more problematic. While REMS still bats lead-off, it gives the FDA almost complete flexibility in how to apply the various "mandates." While this will alleviate the angst of some, it doesn't do anything new. And the odious DTC section remains. Drugwonks does not believe that the FDA should have the authority to "mandate" that certain drugs can't advertise. Mandates lead to bad places -- and particularly when you're dealing with the First Amendment.
The section dealing with advisory committee conflict of interest issues is better than it was. That's good. But it doesn't help the process get any better either. Not so good. Better that the resolution of this issue be left to the forthcoming agency guidances on advisory committee process.
What do we think about Kenzi 2.0? We can do better. We must do better.
And time is running out. Read More & Comment...
Download file
It's better. But is it reform?
The title of the legislation is "The Enhancing Drug Safety and Innovation Act of 2007." Let's look at innovation first.
Title II of the bill, the "Reagan-Udall Institute for Applied Medical Research" remains the most interesting part of the bill. It's, de minimus, a down-payment on the Critical Path. The major change from Kenzi 1.0 is that the funding/governance structure has changed to more closely model the NIH and CDC Foundations. In accordance with this change, the appropriations structure has also been modified.
The Institute would be headed by an Executive Director, under the guidance of the Board of Directors. The Board would develop the policies and by-laws of the Institute, and set the general direction of the Institute’s activities. The Board would be composed of individuals from the pharmaceutical and device industries, academic researchers, patient advocacy organizations, and members of the provider community.
Much like the NIH Foundation, the Institute’s administrative functions would be supported by Federal funds, while contributions from the pharmaceutical and device industries as well as from philanthropic organizations would be used to carry out the activities of the Institute.
But here's the question -- do we stiffle outside critical path efforts by NIH-tizing the process? Something to think about.
The "enhancing safety" side of the bill is somewhat more problematic. While REMS still bats lead-off, it gives the FDA almost complete flexibility in how to apply the various "mandates." While this will alleviate the angst of some, it doesn't do anything new. And the odious DTC section remains. Drugwonks does not believe that the FDA should have the authority to "mandate" that certain drugs can't advertise. Mandates lead to bad places -- and particularly when you're dealing with the First Amendment.
The section dealing with advisory committee conflict of interest issues is better than it was. That's good. But it doesn't help the process get any better either. Not so good. Better that the resolution of this issue be left to the forthcoming agency guidances on advisory committee process.
What do we think about Kenzi 2.0? We can do better. We must do better.
And time is running out. Read More & Comment...
02/01/2007 05:33 PM |
I have Peter's back when it comes to his post on Kenzi. I wrote a piece in the Washington Times supporting the beta version of the bill and I got nothing but flack by everyone for it. I supported the bill in it's nascent form because it understood that safety and efficacy were linked and that Critical Path was, well, critical to making medicines safer as opposed to requiring mindless chain of custody and post market data dredging for every drug.
The current form of the bill - the mutation is a better term -- presumes that the current drug development and evaluation process is just peachy, that are not millions of people dying of cancer, Alzheimer's, infectious disease, stroke and other illnesses because of lack of effective medicines, that we have somehow perfectly translated the insights about disease mechanisms and the genomes into personalized medicines.
Reading the current bill you would think that unsafe medicines are a major public health threat and are becoming even more so because of the way FDA approves and reviews drugs. The facts are that drug withdrawals are the same percentage of drug approvals today as they are now, that user fees are not associated with unsafe drugs and -- most important -- that most adverse events are due to poor prescribing practices and people not taking medicines as instructed.
Kenzi 1.0 and the IOM report put blind faith in administrative and regulatory solutions to make medicines safer, separate and apart from science-based effort to make medcines more effectice and more quickly available to sick and dying patients.
Peter and I hear from individuals all the time who are single parents with months to live who wonder why the FDA is moving faster. My mother spends her retirement caring for my aunt and two friends who have Alzheimer's. Kenzi is a cop-out. As Peter said, is it the opposite of political courage.
And those who complain that we should wait until the NEXT version of Kenzi should remember: we heard that one before and we told the people who depend on the FDA for faster cures the same thing.
As George Bush tried to say: Fool me once, shame on me. You are not going to fool me twice, only surprise me pleasantly. Read More & Comment...
The current form of the bill - the mutation is a better term -- presumes that the current drug development and evaluation process is just peachy, that are not millions of people dying of cancer, Alzheimer's, infectious disease, stroke and other illnesses because of lack of effective medicines, that we have somehow perfectly translated the insights about disease mechanisms and the genomes into personalized medicines.
Reading the current bill you would think that unsafe medicines are a major public health threat and are becoming even more so because of the way FDA approves and reviews drugs. The facts are that drug withdrawals are the same percentage of drug approvals today as they are now, that user fees are not associated with unsafe drugs and -- most important -- that most adverse events are due to poor prescribing practices and people not taking medicines as instructed.
Kenzi 1.0 and the IOM report put blind faith in administrative and regulatory solutions to make medicines safer, separate and apart from science-based effort to make medcines more effectice and more quickly available to sick and dying patients.
Peter and I hear from individuals all the time who are single parents with months to live who wonder why the FDA is moving faster. My mother spends her retirement caring for my aunt and two friends who have Alzheimer's. Kenzi is a cop-out. As Peter said, is it the opposite of political courage.
And those who complain that we should wait until the NEXT version of Kenzi should remember: we heard that one before and we told the people who depend on the FDA for faster cures the same thing.
As George Bush tried to say: Fool me once, shame on me. You are not going to fool me twice, only surprise me pleasantly. Read More & Comment...
02/01/2007 05:13 PM |
Alex Berenson, who took a leave of absence from writing fiction at the New York Times to write fiction has himself become a central character in story that I bet Alex himself wish he had written:
Judge Asks N.Y. Times Reporter to Appear
[ Associated Press · 2007-01-30 ]
By SETH SUTEL, AP Business Writer
A New York Times reporter has been asked to appear in federal court next month to answer testimony that a judge said implicated the writer in a "conspiracy" to obtain confidential documents regarding the anti-psychotic drug Zyprexa.
The reporter, Alex Berenson, wrote a number of articles starting late last year saying the drug's manufacturer, Indianapolis-based drug maker Eli Lilly and Co., downplayed Zyprexa's risks and marketed it for unapproved uses. Lilly has denied the charges.
Jack B. Weinstein, a judge in U.S. District Court for the Eastern District of New York, invited Berenson to appear voluntarily in the court on Feb. 7 to explain how he got the documents, which had been sealed by the court. In a filing Tuesday Weinstein said Berenson could be accompanied by his attorney and would be subject to cross-examination."
In the deposition upon which this "invitation" was based it appears that Alex told the so-called 'heroic' James Gottstein, ( a hero to Scientologists and others who believe that drug companies want to hook kids on meds for mental illness) who was suing Lilly and stood to gain millions in the process parties in question that he should subpoena the documents about Zyprexa, which ones to get and when to deliver them in order to insure that the NY Times ran the story first.
Bad enough Jayson Blair made up facts..... Read More & Comment...
Judge Asks N.Y. Times Reporter to Appear
[ Associated Press · 2007-01-30 ]
By SETH SUTEL, AP Business Writer
A New York Times reporter has been asked to appear in federal court next month to answer testimony that a judge said implicated the writer in a "conspiracy" to obtain confidential documents regarding the anti-psychotic drug Zyprexa.
The reporter, Alex Berenson, wrote a number of articles starting late last year saying the drug's manufacturer, Indianapolis-based drug maker Eli Lilly and Co., downplayed Zyprexa's risks and marketed it for unapproved uses. Lilly has denied the charges.
Jack B. Weinstein, a judge in U.S. District Court for the Eastern District of New York, invited Berenson to appear voluntarily in the court on Feb. 7 to explain how he got the documents, which had been sealed by the court. In a filing Tuesday Weinstein said Berenson could be accompanied by his attorney and would be subject to cross-examination."
In the deposition upon which this "invitation" was based it appears that Alex told the so-called 'heroic' James Gottstein, ( a hero to Scientologists and others who believe that drug companies want to hook kids on meds for mental illness) who was suing Lilly and stood to gain millions in the process parties in question that he should subpoena the documents about Zyprexa, which ones to get and when to deliver them in order to insure that the NY Times ran the story first.
Bad enough Jayson Blair made up facts..... Read More & Comment...
02/01/2007 03:20 PM |
As we await the new version of the Kennedy/Enzi (nee, Enzi/Kennedy) bill and the debate over its half-brother PDUFA IV, it’s important to reflect on what “victory†looks like.
Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.†Drugwonks says “yes.†Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.
Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.†Drugwonks says “yikes.†If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.
Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenziâ€) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst†alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.
Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?
Calling Dr. von Eschenbach ... Read More & Comment...
Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.†Drugwonks says “yes.†Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.
Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.†Drugwonks says “yikes.†If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.
Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenziâ€) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst†alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.
Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?
Calling Dr. von Eschenbach ... Read More & Comment...
02/01/2007 09:10 AM |
I get a kick out of politicians and policymakers who worship at the altar of evidence based medicine without knowing what the hell they are even talking about or even knowing the quality of the evidence. As if by default the information produced by a bunch of government paid contractors who punch up all the 'reliable' studies -- randomized clinical trials -- will come up with an objective answer that can be used to guide every doctor and every payment decision.
Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.
Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:
"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."
Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:
"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."
And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."
The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.
Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.
Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.
Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.
Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.
Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.
We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights. Read More & Comment...
Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.
Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:
"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."
Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:
"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."
And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."
The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.
Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.
Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.
Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.
Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.
Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.
We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights. Read More & Comment...
01/31/2007 03:39 PM |
Follow-on biologics is a matter of when not if. But if it's introduction and explanation is left to the political hacks representing the managed care plans and the generic drug industry, Ben Affleck will have a hit movie many times over before a follow on biotech product is approved.
That's because in their greed and haste to appease the new Democrat overlords, the political spinmeisters are introducing assumptions about the ease with which one can produce therapeutic analogues and break patents that just don't exist in nature. A look at the good science a company like Momenta Pharmaceuticals is undertaking to improve characterization of complex proteins and their analogues underscores that follow on products are years in the making and will not be the function of just handing over data.
But because the spinmeisters and staff approach the biologicals sciences -- deliberately at times -- with the neuronal sophistication of single cell oceanic life forms -- it looks like producing follow on biologics (and milking money to pay for social programs) should be as easy as tapping a keg at a Moveon.org fundraiser.
As usual, Steve Usdin's Biocentury steers us into reality with his trenchant analysis and factual reporting. Can anyone say gold standard for reporting on pharmaceutical and biotech policy issues?
Download file Read More & Comment...
That's because in their greed and haste to appease the new Democrat overlords, the political spinmeisters are introducing assumptions about the ease with which one can produce therapeutic analogues and break patents that just don't exist in nature. A look at the good science a company like Momenta Pharmaceuticals is undertaking to improve characterization of complex proteins and their analogues underscores that follow on products are years in the making and will not be the function of just handing over data.
But because the spinmeisters and staff approach the biologicals sciences -- deliberately at times -- with the neuronal sophistication of single cell oceanic life forms -- it looks like producing follow on biologics (and milking money to pay for social programs) should be as easy as tapping a keg at a Moveon.org fundraiser.
As usual, Steve Usdin's Biocentury steers us into reality with his trenchant analysis and factual reporting. Can anyone say gold standard for reporting on pharmaceutical and biotech policy issues?
Download file Read More & Comment...
01/30/2007 08:45 PM |
In his opening statement today on hearings about political interference with the work of government scientists (climate change) Henry Waxman said: I don't want politically correct science. I want the best science possible.
Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:
“Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,†said Rep. Waxman. “An antibiotic that is no better than a placebo can’t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.â€
It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....
In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.
Here's one effect of the Waxman peer review process...
Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.
The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process. Read More & Comment...
Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:
“Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,†said Rep. Waxman. “An antibiotic that is no better than a placebo can’t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.â€
It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....
In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.
Here's one effect of the Waxman peer review process...
Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.
The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process. Read More & Comment...
01/30/2007 04:53 PM |
It's called Pharmalot (no relation to Spamalot) but the guy producing it does live about five minutes away from me. He's Ed Silverman, who has covered the drug and biotech industry for the Star-Ledger of New Jersey for over a decade. Ed's reporting has been hard hitting and informative (full disclosure, we have bought each other a cup of Dunkin Donuts cover twice in the past eight years).
Ed will be a panelist at our Media and Medical Science conference by the way and I urge you to check out his new blog which is at http://pharmalot.com/ . We will be linking to it and encourage everyone to become a regular reader.
Best of luck, Ed! Read More & Comment...
Ed will be a panelist at our Media and Medical Science conference by the way and I urge you to check out his new blog which is at http://pharmalot.com/ . We will be linking to it and encourage everyone to become a regular reader.
Best of luck, Ed! Read More & Comment...
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