Latest Drugwonks' Blog
Smokin!
The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has recommended Champix (varenicline) for use on the National Health Service for adult smokers who have expressed a desire to quit. This gives smokers across England, Wales and Northern Ireland access to another important treatment option to help them quit smoking.
In its Final Appraisal Determination, NICE concluded that varenicline was “superior to NRT [nicotine replacement therapy] and bupropion in achieving continuous abstinence†and that its use in smoking cessation was “likely to be a cost-effective use of National Health Service resources.â€
“This guidance means that smokers who are serious about stopping have another choice from a good range of clinically proven treatments, said Professor Robert West, Professor of Health Psychology at University College London. “Smokers who combine treatments with the right support – for instance from smoking cessation services - could significantly increase their odds of successfully quitting for life.â€
The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has recommended Champix (varenicline) for use on the National Health Service for adult smokers who have expressed a desire to quit. This gives smokers across England, Wales and Northern Ireland access to another important treatment option to help them quit smoking.
In its Final Appraisal Determination, NICE concluded that varenicline was “superior to NRT [nicotine replacement therapy] and bupropion in achieving continuous abstinence†and that its use in smoking cessation was “likely to be a cost-effective use of National Health Service resources.â€
“This guidance means that smokers who are serious about stopping have another choice from a good range of clinically proven treatments, said Professor Robert West, Professor of Health Psychology at University College London. “Smokers who combine treatments with the right support – for instance from smoking cessation services - could significantly increase their odds of successfully quitting for life.â€
Ex-China Drug Regulator to Be Executed
Tuesday May 29, 2007
By AUDRA ANG
Associated Press Writer
BEIJING (AP) - China's former top drug regulator was sentenced to death Tuesday in an unusually harsh punishment for taking bribes to approve substandard medicines, including an antibiotic blamed for at least 10 deaths.
Seeking to address broadening concerns over food, the government also announced plans for its first recall system for unsafe products.
The developments are among the most dramatic steps Beijing has taken to address domestic and international alarm over shoddy and unsafe Chinese goods - from pet food ingredients and toothpaste mixed with induso trial chemicals to tainted antibiotics.
Beijing's No. 1 Intermediate People's Court convicted Zheng Xiaoyu of taking bribes in cash and gifts worth more than $832,000 while he was director of the State Food & Drug Administration, the official Xinhua News Agency said. Those bribes allowed eight companies to get around drug approval standards, it said.
It was not immediately clear if Zheng would appeal. Under Chinese law, a death sentence meted out by an intermediate court automatically will be reviewed by a higher court and ultimately has to be approved by the state supreme court.
The sentence was unusually heavy even for China, which is believed to carry out more court-ordered executions than all other nations combined - and likely indicates the leadership's determination to deal with the recent scares involving unsafe food and drugs.
``The Chinese government attaches great importance to the safety and security of food,'' Foreign Ministry spokeswoman Jiang Yu said at a regular briefing Tuesday when asked about Zheng's case.
We'll see about that.
Tuesday May 29, 2007
By AUDRA ANG
Associated Press Writer
BEIJING (AP) - China's former top drug regulator was sentenced to death Tuesday in an unusually harsh punishment for taking bribes to approve substandard medicines, including an antibiotic blamed for at least 10 deaths.
Seeking to address broadening concerns over food, the government also announced plans for its first recall system for unsafe products.
The developments are among the most dramatic steps Beijing has taken to address domestic and international alarm over shoddy and unsafe Chinese goods - from pet food ingredients and toothpaste mixed with induso trial chemicals to tainted antibiotics.
Beijing's No. 1 Intermediate People's Court convicted Zheng Xiaoyu of taking bribes in cash and gifts worth more than $832,000 while he was director of the State Food & Drug Administration, the official Xinhua News Agency said. Those bribes allowed eight companies to get around drug approval standards, it said.
It was not immediately clear if Zheng would appeal. Under Chinese law, a death sentence meted out by an intermediate court automatically will be reviewed by a higher court and ultimately has to be approved by the state supreme court.
The sentence was unusually heavy even for China, which is believed to carry out more court-ordered executions than all other nations combined - and likely indicates the leadership's determination to deal with the recent scares involving unsafe food and drugs.
``The Chinese government attaches great importance to the safety and security of food,'' Foreign Ministry spokeswoman Jiang Yu said at a regular briefing Tuesday when asked about Zheng's case.
We'll see about that.
Curt Furberg calls the idea of taking Avandia off the market "a no brainer." He is familiar with that condition...
Is the ANY self-examination on the part of the media in the wake of the way the NEJM, Nissen, Furberg and Psaty have colluded to push this false hysteria about Avandia on the public? In the wake of black boxes on SSRI's that are associated with a spike in teen suicides? Anyone?
Anyone reporting on this shoddy affair should read Steve Usdin's article in Biocentury on the Avandia article, Joseph Biederman's (a world expert on ADHD) letter to the NEJM (unpublished) after said journal allowed Nissen to continue his rampage against the use of stimulants to treat the disorder and previous reporting and political reaction to the initial finding of the Women's Health Initiative that taking Prempro (post menopausal women ages 50-79) had a 31 percent higher risk of stroke. PS Subsequent reanalysis of the WHI data showed lots of variation by subpopulation...something Nissen does not control for.
Here's a link to Biederman's scathing letter to the NEJM.....
http://www.massgeneral.org/pediatricpsych/docs/NEJMltr.pdf
And here's Nissen comparing ADHD drugs to ephedra....
"Closely related sympathomimetic amines, such as ephedra and phenylpropanolamine, have been deemed sufficiently risky that the FDA has recommended banning these agents to protect the public health."
Let's see if the media does it's job in the days leading up to the Waxman show trial....
Anyone reporting on this shoddy affair should read Steve Usdin's article in Biocentury on the Avandia article, Joseph Biederman's (a world expert on ADHD) letter to the NEJM (unpublished) after said journal allowed Nissen to continue his rampage against the use of stimulants to treat the disorder and previous reporting and political reaction to the initial finding of the Women's Health Initiative that taking Prempro (post menopausal women ages 50-79) had a 31 percent higher risk of stroke. PS Subsequent reanalysis of the WHI data showed lots of variation by subpopulation...something Nissen does not control for.
Here's a link to Biederman's scathing letter to the NEJM.....
http://www.massgeneral.org/pediatricpsych/docs/NEJMltr.pdf
And here's Nissen comparing ADHD drugs to ephedra....
"Closely related sympathomimetic amines, such as ephedra and phenylpropanolamine, have been deemed sufficiently risky that the FDA has recommended banning these agents to protect the public health."
Let's see if the media does it's job in the days leading up to the Waxman show trial....
How did Representative Henry Waxman (Congress' Oversighter-in-Chief) know about the NEJM's clarion call on Avandia before the FDA?
As Scott Gottlieb opines in today's edition of the Wall Street Journal ...
"NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's 'handling' of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic Cardiologist Steve Nissen, admitted to The Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study."
Dr. Steve Galson, the FDA's superb CDER Director, had some pretty unsubtle comments as well (courtesy of BioCentury's Steve Usdin), "What was the compelling public health purpose that justified rushing this study to publication -- an action that resulted in dozens of near-hysterical press reports ... Medical journals need to take their responsibility seriously to patients and physicians to publish information in a responsible and balanced manner. I'm not sure that responsibility was adeqautely executed in this instance."
Steve -- what do you really think?
Dr. Michael Weber, professor of medicine and associate dean at the State University of New York, Downstate College of Medicine, Brooklyn (and Chairman, we are proud to say, of the Center for Medicine in the Public Interest), was equally blunt. He said that Nissens's paper "verged on the sensational ... It is very disappointing that matters like this become opportunities for grandstanding rather than careful and thoughtful analysis of the data."
Michael -- what do you really think?
And, here's another question -- why weren't either of these high-profile experts interviewed for the first round of stories last week?
The Lancet wrote that, "To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed. Alarmist headlines and confident declarations help nobody."
Which begs the question -- what do the experts know that the pols and pundits do not? Could the answer be that science is not a binary right/wrong, safe/unsafe proposition.
But the MSM doesn't like complicated -- there is rarely either the understanding or the space. Politicians certainly don't like complicated -- since it doesn't get headlines. Both groups prefer good guys and bad guys.
So much for not politicizing science.
And the Oversighter-in-Chief? Well, if you've got a hammer, every problem looks like a nail.
As Scott Gottlieb opines in today's edition of the Wall Street Journal ...
"NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's 'handling' of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic Cardiologist Steve Nissen, admitted to The Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study."
Dr. Steve Galson, the FDA's superb CDER Director, had some pretty unsubtle comments as well (courtesy of BioCentury's Steve Usdin), "What was the compelling public health purpose that justified rushing this study to publication -- an action that resulted in dozens of near-hysterical press reports ... Medical journals need to take their responsibility seriously to patients and physicians to publish information in a responsible and balanced manner. I'm not sure that responsibility was adeqautely executed in this instance."
Steve -- what do you really think?
Dr. Michael Weber, professor of medicine and associate dean at the State University of New York, Downstate College of Medicine, Brooklyn (and Chairman, we are proud to say, of the Center for Medicine in the Public Interest), was equally blunt. He said that Nissens's paper "verged on the sensational ... It is very disappointing that matters like this become opportunities for grandstanding rather than careful and thoughtful analysis of the data."
Michael -- what do you really think?
And, here's another question -- why weren't either of these high-profile experts interviewed for the first round of stories last week?
The Lancet wrote that, "To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed. Alarmist headlines and confident declarations help nobody."
Which begs the question -- what do the experts know that the pols and pundits do not? Could the answer be that science is not a binary right/wrong, safe/unsafe proposition.
But the MSM doesn't like complicated -- there is rarely either the understanding or the space. Politicians certainly don't like complicated -- since it doesn't get headlines. Both groups prefer good guys and bad guys.
So much for not politicizing science.
And the Oversighter-in-Chief? Well, if you've got a hammer, every problem looks like a nail.
Remember the Women's Health Initiative? It found that healthy post menopausal women who went on HRT had a 41 percent higher risk of stroke than women not on HRT (ages 50-79).
That was a randomized controlled trial.
I don't recall a spate of lawsuits, fearmongers and handwringing headlines about safety then.
Maybe it was all in the delivery. The WHI results were released responsibly and were followed up to allow tailoring of treatment based on new research.
The Nissen data dredging was like shouting death in a crowded doctor's office.
That was a randomized controlled trial.
I don't recall a spate of lawsuits, fearmongers and handwringing headlines about safety then.
Maybe it was all in the delivery. The WHI results were released responsibly and were followed up to allow tailoring of treatment based on new research.
The Nissen data dredging was like shouting death in a crowded doctor's office.
From The Onion.
Study: 38 Percent Of People Not Actually Entitled To Their Opinion
CHICAGO—In a surprising refutation of the conventional wisdom on opinion entitlement, a study conducted by the University of Chicago's School for Behavioral Science concluded that more than one-third of the U.S. population is neither entitled nor qualified to have opinions.
"On topics from evolution to the environment to gay marriage to immigration reform, we found that many of the opinions expressed were so off-base and ill-informed that they actually hurt society by being voiced," said chief researcher Professor Mark Fultz, who based the findings on hundreds of telephone, office, and dinner-party conversations compiled over a three-year period. "While people have long asserted that it takes all kinds, our research shows that American society currently has a drastic oversupply of the kinds who don't have any good or worthwhile thoughts whatsoever. We could actually do just fine without them."
In 2002, Fultz's team shook the academic world by conclusively proving the existence of both bad ideas during brainstorming and dumb questions during question-and-answer sessions.
Have a nice Memorial Day weekend.
Study: 38 Percent Of People Not Actually Entitled To Their Opinion
CHICAGO—In a surprising refutation of the conventional wisdom on opinion entitlement, a study conducted by the University of Chicago's School for Behavioral Science concluded that more than one-third of the U.S. population is neither entitled nor qualified to have opinions.
"On topics from evolution to the environment to gay marriage to immigration reform, we found that many of the opinions expressed were so off-base and ill-informed that they actually hurt society by being voiced," said chief researcher Professor Mark Fultz, who based the findings on hundreds of telephone, office, and dinner-party conversations compiled over a three-year period. "While people have long asserted that it takes all kinds, our research shows that American society currently has a drastic oversupply of the kinds who don't have any good or worthwhile thoughts whatsoever. We could actually do just fine without them."
In 2002, Fultz's team shook the academic world by conclusively proving the existence of both bad ideas during brainstorming and dumb questions during question-and-answer sessions.
Have a nice Memorial Day weekend.
“Of course, a guy like me who’s living on Lipitor is in a hard place to criticize the drug companies.â€
-- Bill Clinton
-- Bill Clinton
Today's furor, as reported in the New York Times, comes from Italy where consumer groups are decrying high prices, calling them "absurd and shameful."
What they're upset about are ticket prices for the Barbara Streisand concert on June 15. (Prices range from $200 to $1200.)
The horror!
And we concur. After all, comparatively speaking, pretty good seats for the Dylan concert at Jones Beach cost under $200.
And since they're both music concerts by solo artists -- aren't they really the same thing?
Sure. Just like medicines.
That being said, consider the following from Democratic Presidential candidate, Senator Hillary Clinton, "A lot of these so-called blockbuster drugs are no more effective, and sometimes less effective, in treating conditions than old standbys."
In a speech at George Washington University, Senator Clinton said research is finding some drugs aren't worth the cost.
Really? Are some lives not worth saving?
Folks, the battle over the heart and soul of evidence-based medicine is crucial. The battle over what "comparative effectiveness" means is crucial. The battle over measurement tools is crucial.
Why? Because it's a battle between cost and care. Pols, pundits and payors are bashing life-saving medicines by using misleading metrics. And unless and until sound science raises its voice (and the media pays attention to the details) get ready for more of the same.
Ladies and gentlemen, political rhetoric is not the way to address the issue.
Unfortunately, it's rhetoric that is drving the debate and it's rhetoric that the MSM loves to report about.
But nobody said it was going to be easy.
What they're upset about are ticket prices for the Barbara Streisand concert on June 15. (Prices range from $200 to $1200.)
The horror!
And we concur. After all, comparatively speaking, pretty good seats for the Dylan concert at Jones Beach cost under $200.
And since they're both music concerts by solo artists -- aren't they really the same thing?
Sure. Just like medicines.
That being said, consider the following from Democratic Presidential candidate, Senator Hillary Clinton, "A lot of these so-called blockbuster drugs are no more effective, and sometimes less effective, in treating conditions than old standbys."
In a speech at George Washington University, Senator Clinton said research is finding some drugs aren't worth the cost.
Really? Are some lives not worth saving?
Folks, the battle over the heart and soul of evidence-based medicine is crucial. The battle over what "comparative effectiveness" means is crucial. The battle over measurement tools is crucial.
Why? Because it's a battle between cost and care. Pols, pundits and payors are bashing life-saving medicines by using misleading metrics. And unless and until sound science raises its voice (and the media pays attention to the details) get ready for more of the same.
Ladies and gentlemen, political rhetoric is not the way to address the issue.
Unfortunately, it's rhetoric that is drving the debate and it's rhetoric that the MSM loves to report about.
But nobody said it was going to be easy.
Here's the press release ...
Grassley, Baucus bill would enhance research on pharmaceutical safety and effectiveness
WASHINGTON — Responding to growing concerns about the safety of pharmaceuticals, Sens. Chuck Grassley and Max Baucus introduced legislation today to improve the study of medical treatments, including the effectiveness and safety of drugs.
Their proposal would give researchers at federal agencies and university-based and other research organizations highly controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries.
“The situation that’s unfolding this week with the popular diabetes drug Avandia emphasizes the value of making this sort of rich source of information available to experienced and credentialed researchers,†Grassley said. “The drug trials that go on before the Food and Drug Administration approves a drug are no match for the wealth of information that’s available after a drug is on the market and millions of people start taking it. This legislative initiative will tap that valuable information on behalf of public safety and public health. And, it does so in a way that makes sure the strongest safeguards are in place to protect privacy and confidentiality.â€
“Knowledge is power, and this bill will empower our health system to serve Americans better,†said Baucus. “The secure and efficient sharing of Medicare’s vast data among a number of Federal agencies will enable researchers to accurately examine the safety and effectiveness of many treatments patients receive. The data this bill would make available provides information that can create more watchdogs. More eyes might have helped us spot a situation like we learned about just this week with the FDA’s handling of the diabetes drug Avandia. This bill provides for this information-sharing with no other goal than to promote the public’s health and the public good.â€
Medicare processes 500 million claims for benefits every year, and millions of prescriptions are filled annually through the new Medicare prescription drug benefit. Grassley said information about these benefits would be a tremendous resource for qualified health services researchers, and it would help them conduct rigorous studies on the safety and effectiveness of various medical treatments.
Grassley and Baucus said that researchers could help policy makers better understand why services that we know can help people maintain good health are not being used and to develop policies to promote their use, for example.
Indeed, knowledge is power. But information without context and power without perspective is dangerous.
Let's watch this one and see where it goes.
Grassley, Baucus bill would enhance research on pharmaceutical safety and effectiveness
WASHINGTON — Responding to growing concerns about the safety of pharmaceuticals, Sens. Chuck Grassley and Max Baucus introduced legislation today to improve the study of medical treatments, including the effectiveness and safety of drugs.
Their proposal would give researchers at federal agencies and university-based and other research organizations highly controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries.
“The situation that’s unfolding this week with the popular diabetes drug Avandia emphasizes the value of making this sort of rich source of information available to experienced and credentialed researchers,†Grassley said. “The drug trials that go on before the Food and Drug Administration approves a drug are no match for the wealth of information that’s available after a drug is on the market and millions of people start taking it. This legislative initiative will tap that valuable information on behalf of public safety and public health. And, it does so in a way that makes sure the strongest safeguards are in place to protect privacy and confidentiality.â€
“Knowledge is power, and this bill will empower our health system to serve Americans better,†said Baucus. “The secure and efficient sharing of Medicare’s vast data among a number of Federal agencies will enable researchers to accurately examine the safety and effectiveness of many treatments patients receive. The data this bill would make available provides information that can create more watchdogs. More eyes might have helped us spot a situation like we learned about just this week with the FDA’s handling of the diabetes drug Avandia. This bill provides for this information-sharing with no other goal than to promote the public’s health and the public good.â€
Medicare processes 500 million claims for benefits every year, and millions of prescriptions are filled annually through the new Medicare prescription drug benefit. Grassley said information about these benefits would be a tremendous resource for qualified health services researchers, and it would help them conduct rigorous studies on the safety and effectiveness of various medical treatments.
Grassley and Baucus said that researchers could help policy makers better understand why services that we know can help people maintain good health are not being used and to develop policies to promote their use, for example.
Indeed, knowledge is power. But information without context and power without perspective is dangerous.
Let's watch this one and see where it goes.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
