DrugWonks on Twitter
Tweets by @PeterPittsDrugWonks on Facebook
CMPI Videos
Video Montage of Third Annual Odyssey Awards Gala Featuring Governor Mitch Daniels, Montel Williams, Dr. Paul Offit and CMPI president Peter Pitts
Indiana Governor Mitch Daniels
Montel Williams, Emmy Award-Winning Talk Show Host
Paul Offit, M.D., Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, for Leadership in Transformational Medicine
CMPI president Peter J. Pitts
CMPI Web Video: "Science or Celebrity"
Tabloid Medicine
Check Out CMPI's Book
Physician Disempowerment:
A Transatlantic Malaise
Edited By: Peter J. Pitts
Download the E-Book Version Here
A Transatlantic Malaise
Edited By: Peter J. Pitts
Download the E-Book Version Here
CMPI Events
Donate
CMPI Reports
Blog Roll
Alliance for Patient Access
Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
DrugWonks Blog
06/05/2007 08:14 AM |
Diedtra Henderson interviews Steve Nissen who responds -- sort of-- to my blog calling him "small and craven" as he shifts positions and engages in self promotion in a campaign to become defacto FDA commissioner....
Just remember these words from St. Steven the Pure because they will come back to haunt him and those who have annointed him the savior of drug safety in the weeks ahead:
“Even the appearance of bias can damage trust as actual impropriety"
Watchdog draws growls in return
Cardiologist-FDA adviser says his goal is drug safety; critics say he's bucking to run agency
By Diedtra Henderson, Globe Staff | June 5, 2007
WASHINGTON -- Vioxx . Ritalin. Drug-eluting stents .
Those popular drugs and medical devices are on a growing list of therapies used by millions of people that have shown up on the radar of Dr. Steven E. Nissen , a prominent heart specialist.
Leveraging his power as a federal adviser, tapping the reach of medical publications, and whispering in the ears of key members of Congress, the Cleveland Clinic cardiologist has questioned the heart safety of each product. In doing so, he's chipped away at the credibility of the Food and Drug Administration as the nation's top drug safety watchdog.
Avandia , the world's best-selling oral diabetes treatment, is the latest drug targeted by Nissen. In a New England Journal of Medicine article last month, he said it increases the risk of heart attack. Avandia's manufacturer, GlaxoSmithKline , called Nissen's analysis flawed. But Nissen is scheduled to testify tomorrow at a congressional hearing on Avandia , again commanding the media spotlight.
Nissen, son of a physician and husband of a journalist , calls himself the "point on the end of the spear" during drug safety debates, raising awareness on matters he says the FDA has overlooked. Time magazine last month included the 58-year-old among 100 people "whose power, talent, or moral example is transforming the world."
Others say his motivation has more to do with wanting to run the FDA. And that worries the drug industry. If a Democrat is elected president next year and Nissen -- or someone like him -- becomes FDA commissioner, they say it could make the FDA more cautious, slowing new product approvals to a crawl and stifling innovation.
Nissen, who joined the Cleveland Clinic in 1992 , now chairs its department of cardiovascular medicine . He is immediate past president of the board of trustees of the American College of Cardiology . He has been published more than 250 times, including books and journals, and has been an early leader in the development of a type of imaging that spots artery damage at its earliest stage and can determine whether anti cholesterol medicines are effective.
But on Capitol Hill and in pharmaceutical company boardrooms, those achievements are trumped by his role as a drug-safety watchdog.
Years before Vioxx was pulled from the market in 2004, Nissen pointed to its heightened heart attack and stroke risks. In 2005, as the FDA was on the verge of approving Pargluva, a diabetes drug known generically as muraglitazar that works like Avandia , Nissen pointed out cardiovascular problems, effectively killing the drug's development. And he also rallied other federal advisers to prod the FDA to put its harshest warnings on attention- deficit hyperactivity disorder drugs, like Ritalin and Adderall , due to cardiovascular risks.
Such public stands have unleashed a firestorm of criticism. FDA spokesman Douglas Arbesfeld , in an e-mail to reporters days after Nissen's Avandia analysis was published by the New England Journal -- derisively dubbed him "St. Steven ," and wondered whether his feet were made of clay.
Arbesfeld, responding to a Boston Globe question about the e-mail message, said the correspondence -- sent using his FDA e-mail address -- reflected his personal views and not the agency's.
After the Avandia news broke, Robert Goldberg , a conservative pundit and vice president of the Center for Medicine in the Public Interest New York, posted a message on his blog, DrugWonks.com, that said Nissen is campaigning to become FDA commissioner in a way that "makes him look craven and small."
Told of Goldberg's blog entry, Nissen asked, "Who would say such a thing?"
"I'm not running for anything," Nissen added. "I've got a great job here, and I'm not going anywhere."
Goldberg, however, does have more clout than the average blogger. As a senior fellow at New York's Manhattan Institute , he once wrote that a front-runner to become FDA commissioner would so stymie the drug-approval process that the shorthand message to patients would be: "Drop dead." The candidate, Dr. Alastair J.J. Wood, foundered in the face of stiff industry opposition.
In an interview, Goldberg said the cardiovascular risks of such drugs as Vioxx have been highlighted by others, but Nissen is "the most aggressive in promoting himself, whether he is accurately depicting the risks and benefits of products."
Nissen's word carries weight with influential members of Congress intent on FDA reform, including US Representative Henry A. Waxman , a California Democrat, whose assistance Nissen sought when he had difficulty obtaining details about Avandia, and US Senator Charles E. Grassley , an Iowa Republican, who wants to create a separate drug safety center at the FDA.
In a key switch, Nissen now agrees with Grassley on the need for such separation.
Nissen has also earned the praise of US Senator Hillary Rodham Clinton of New York , a Democratic front-runner in the 2008 presidential race.
Like other FDA critics, he says the agency is so reliant on drug industry funding that it is reluctant to swiftly tamp down on drug-safety problems. He seeks to reduce the number of FDA advisers with financial ties to drug and device companies, and wants more and larger clinical trials conducted after drugs are approved for sale. He favors restricting advertising for products that have questionable safety records. And he champions public access to results of the clinical trials that drug makers conduct to gain FDA approval for their products.
To W. Mark Lanier , an attorney nationally known for representing patients in cases against drug companies, such positions would make Nissen a fine candidate for FDA commissioner.
"The current FDA commissioner is, at best, a passivist before a ravenous beast named Big Pharma. At worst, he is their actual lap dog," Lanier said. Read More & Comment...
Just remember these words from St. Steven the Pure because they will come back to haunt him and those who have annointed him the savior of drug safety in the weeks ahead:
“Even the appearance of bias can damage trust as actual impropriety"
Watchdog draws growls in return
Cardiologist-FDA adviser says his goal is drug safety; critics say he's bucking to run agency
By Diedtra Henderson, Globe Staff | June 5, 2007
WASHINGTON -- Vioxx . Ritalin. Drug-eluting stents .
Those popular drugs and medical devices are on a growing list of therapies used by millions of people that have shown up on the radar of Dr. Steven E. Nissen , a prominent heart specialist.
Leveraging his power as a federal adviser, tapping the reach of medical publications, and whispering in the ears of key members of Congress, the Cleveland Clinic cardiologist has questioned the heart safety of each product. In doing so, he's chipped away at the credibility of the Food and Drug Administration as the nation's top drug safety watchdog.
Avandia , the world's best-selling oral diabetes treatment, is the latest drug targeted by Nissen. In a New England Journal of Medicine article last month, he said it increases the risk of heart attack. Avandia's manufacturer, GlaxoSmithKline , called Nissen's analysis flawed. But Nissen is scheduled to testify tomorrow at a congressional hearing on Avandia , again commanding the media spotlight.
Nissen, son of a physician and husband of a journalist , calls himself the "point on the end of the spear" during drug safety debates, raising awareness on matters he says the FDA has overlooked. Time magazine last month included the 58-year-old among 100 people "whose power, talent, or moral example is transforming the world."
Others say his motivation has more to do with wanting to run the FDA. And that worries the drug industry. If a Democrat is elected president next year and Nissen -- or someone like him -- becomes FDA commissioner, they say it could make the FDA more cautious, slowing new product approvals to a crawl and stifling innovation.
Nissen, who joined the Cleveland Clinic in 1992 , now chairs its department of cardiovascular medicine . He is immediate past president of the board of trustees of the American College of Cardiology . He has been published more than 250 times, including books and journals, and has been an early leader in the development of a type of imaging that spots artery damage at its earliest stage and can determine whether anti cholesterol medicines are effective.
But on Capitol Hill and in pharmaceutical company boardrooms, those achievements are trumped by his role as a drug-safety watchdog.
Years before Vioxx was pulled from the market in 2004, Nissen pointed to its heightened heart attack and stroke risks. In 2005, as the FDA was on the verge of approving Pargluva, a diabetes drug known generically as muraglitazar that works like Avandia , Nissen pointed out cardiovascular problems, effectively killing the drug's development. And he also rallied other federal advisers to prod the FDA to put its harshest warnings on attention- deficit hyperactivity disorder drugs, like Ritalin and Adderall , due to cardiovascular risks.
Such public stands have unleashed a firestorm of criticism. FDA spokesman Douglas Arbesfeld , in an e-mail to reporters days after Nissen's Avandia analysis was published by the New England Journal -- derisively dubbed him "St. Steven ," and wondered whether his feet were made of clay.
Arbesfeld, responding to a Boston Globe question about the e-mail message, said the correspondence -- sent using his FDA e-mail address -- reflected his personal views and not the agency's.
After the Avandia news broke, Robert Goldberg , a conservative pundit and vice president of the Center for Medicine in the Public Interest New York, posted a message on his blog, DrugWonks.com, that said Nissen is campaigning to become FDA commissioner in a way that "makes him look craven and small."
Told of Goldberg's blog entry, Nissen asked, "Who would say such a thing?"
"I'm not running for anything," Nissen added. "I've got a great job here, and I'm not going anywhere."
Goldberg, however, does have more clout than the average blogger. As a senior fellow at New York's Manhattan Institute , he once wrote that a front-runner to become FDA commissioner would so stymie the drug-approval process that the shorthand message to patients would be: "Drop dead." The candidate, Dr. Alastair J.J. Wood, foundered in the face of stiff industry opposition.
In an interview, Goldberg said the cardiovascular risks of such drugs as Vioxx have been highlighted by others, but Nissen is "the most aggressive in promoting himself, whether he is accurately depicting the risks and benefits of products."
Nissen's word carries weight with influential members of Congress intent on FDA reform, including US Representative Henry A. Waxman , a California Democrat, whose assistance Nissen sought when he had difficulty obtaining details about Avandia, and US Senator Charles E. Grassley , an Iowa Republican, who wants to create a separate drug safety center at the FDA.
In a key switch, Nissen now agrees with Grassley on the need for such separation.
Nissen has also earned the praise of US Senator Hillary Rodham Clinton of New York , a Democratic front-runner in the 2008 presidential race.
Like other FDA critics, he says the agency is so reliant on drug industry funding that it is reluctant to swiftly tamp down on drug-safety problems. He seeks to reduce the number of FDA advisers with financial ties to drug and device companies, and wants more and larger clinical trials conducted after drugs are approved for sale. He favors restricting advertising for products that have questionable safety records. And he champions public access to results of the clinical trials that drug makers conduct to gain FDA approval for their products.
To W. Mark Lanier , an attorney nationally known for representing patients in cases against drug companies, such positions would make Nissen a fine candidate for FDA commissioner.
"The current FDA commissioner is, at best, a passivist before a ravenous beast named Big Pharma. At worst, he is their actual lap dog," Lanier said. Read More & Comment...
06/04/2007 03:08 PM |
The media tried to turn John Buse into another Nissen, but he wouldn't bite. The scuffle he had about Avandia back in 2000? Old history, not a open sore that will fester and explode like a bombshell against Glaxo when he testifies June 6
Rather he said the patients should stay on Avandia until all the data was in and that Nissen's article was just one of many.
He devotion is to patients, not to the press or to Congressman Waxman. His unwillingness not to be manipulated has left the Stephanie Saul's perplexed.
Again, in the wake of the media's shoddy handling of the SSRI and Vioxx issues who would have thought it would have reached new lows on Avandia? Read More & Comment...
Rather he said the patients should stay on Avandia until all the data was in and that Nissen's article was just one of many.
He devotion is to patients, not to the press or to Congressman Waxman. His unwillingness not to be manipulated has left the Stephanie Saul's perplexed.
Again, in the wake of the media's shoddy handling of the SSRI and Vioxx issues who would have thought it would have reached new lows on Avandia? Read More & Comment...
06/04/2007 12:45 PM |
Hallmark had an interesting movie on pandemics a week ago. Here's my take, published in my LA Times column, the Unreal World. It is interesting to note that at least the last 3 flu pandemics have been caused by low path avian viruses H1, H2, H3, which transformed to human killers, rather than by highly pathogenic AI, like H5N1
Marc Siegel:
The Unreal World
Killer flu may not be the one we've feared
'Pandemic' points out that H5N1 bird flu isn't the only danger to public health.
June 4, 2007
"Pandemic," the Hallmark Channel, May 26.
The premise: On an island off the north coast of Australia, as surfer Charley Williams begins to cough, he is unaware that several dead seagulls and a dead dog lie near him. They are infected with a new form of flu virus, later determined to be an H3N7 mutated variant named "Riptide." Fellow surfer Ames Smith leaves the island and boards a plane to Los Angeles. While on board, he develops a high fever, coughs up blood and dies. The plane and its passengers are quarantined by the Centers for Disease Control and Prevention. A passenger escapes and spreads the virus. Five days later, as several more passengers escape, L.A. has 154 dead and 1,400 sickening. Schools and shops are closed, paper masks are everywhere, mass graves are dug. The city is placed under quarantine. The anti-viral drug "Tana-Flu" is found to be largely ineffective, and a more useful newer drug, "CoToxil," is in short supply. As Riptide spreads, the governor declares martial law and brings in the National Guard. The CDC finally determines that antibodies against tuberculosis bacteria prevent this virus from attaching to the lung, so the blood of TB survivors can be used as a vaccine. The world is saved.
The medical questions: Isn't the H5N1 bird flu our greatest risk for a massive pandemic? What is the typical incubation period for a deadly influenza? Are masks or quarantine effective? Is coughing up blood (hemoptysis) characteristic of a highly virulent influenza such as the devastating, 1918 Spanish flu or this new Riptide virus? Does a sudden "antigenic shift" (as a scientist suggests) bring about the pandemic because the public lacks immunity to the new virus? Can TB antibodies protect against a deadly flu?
The reality: Though the H5N1 highly pathogenic avian influenza strain has been much publicized and has worried many scientists, it is still primarily a disease in birds, and may not mutate sufficiently to cause the next human pandemic. "If we put all our eggs in this one basket, we can easily miss a mutation in a different virus which becomes the next pandemic strain," says flu researcher Dr. Jeffrey Taubenberger of the National Institutes of Health. The movie sends an important message to the public when it shows a non-H5N1 influenza transforming into the pandemic virus.
The incubation time — or period between exposure and the onset of symptoms — for influenza is two to four days, sometimes longer. The film depicts this waiting period fairly accurately. In real life, scientists are not always sure exactly how influenza is transmitted, and it is unlikely that paper masks would provide much of a barrier to infection. More sophisticated N-95 respirator masks are only occasionally shown in the movie and must be fitted properly to be effective. The movie correctly illustrates the significant downside to quarantining whole regions (as opposed to the more effective strategy of isolating sick patients and their contacts), where people under suspicion become fearful and may take fewer precautions and thereby may spread the virus more widely.
The imagined Riptide virus, like the Spanish flu of 1918, kills a high percentage of older teens and young adults. Some scientists have theorized that this phenomenon is due to a hyperinflammatory response, which causes victims (often young and healthy) to drown in their own respiratory secretions. But Taubenberger believes that the high mortality in young adults in 1918 was likely due to an absence of immunity to the flu strain in those ages as compared to the older population who may have been exposed to a related virus earlier in life.
Coughing up blood is commonly associated with a virus that damages lungs so severely and quickly. But this doesn't happen as commonly as shown in the movie, where practically everyone infected is experiencing hemoptysis.
A virus experiencing a sudden antigenic shift or significant mutation is believed to be the cause of all pandemics. Bringing up this genetic term to explain the suddenly deadly Riptide" virus is a fine bit of scientific detail.
Less believable is the movie's optimistic portrayal of cooperating government officials, or the science-fiction contention that antibodies against tuberculosis can somehow prevent Riptide from attaching to lungs of potential victims. True, some immunity can be provided by extracting antibodies from the blood of survivors. In Asia, the blood of bird flu survivors has just been shown to protect mice from the disease. But TB is an entirely different disease. You wouldn't expect antibodies of TB sufferers to help fight flu.
Finally, viewers should know that the next flu pandemic may be mild, not massive. Not all pandemics kill many millions like the 1918 Spanish flu. Read More & Comment...
Marc Siegel:
The Unreal World
Killer flu may not be the one we've feared
'Pandemic' points out that H5N1 bird flu isn't the only danger to public health.
June 4, 2007
"Pandemic," the Hallmark Channel, May 26.
The premise: On an island off the north coast of Australia, as surfer Charley Williams begins to cough, he is unaware that several dead seagulls and a dead dog lie near him. They are infected with a new form of flu virus, later determined to be an H3N7 mutated variant named "Riptide." Fellow surfer Ames Smith leaves the island and boards a plane to Los Angeles. While on board, he develops a high fever, coughs up blood and dies. The plane and its passengers are quarantined by the Centers for Disease Control and Prevention. A passenger escapes and spreads the virus. Five days later, as several more passengers escape, L.A. has 154 dead and 1,400 sickening. Schools and shops are closed, paper masks are everywhere, mass graves are dug. The city is placed under quarantine. The anti-viral drug "Tana-Flu" is found to be largely ineffective, and a more useful newer drug, "CoToxil," is in short supply. As Riptide spreads, the governor declares martial law and brings in the National Guard. The CDC finally determines that antibodies against tuberculosis bacteria prevent this virus from attaching to the lung, so the blood of TB survivors can be used as a vaccine. The world is saved.
The medical questions: Isn't the H5N1 bird flu our greatest risk for a massive pandemic? What is the typical incubation period for a deadly influenza? Are masks or quarantine effective? Is coughing up blood (hemoptysis) characteristic of a highly virulent influenza such as the devastating, 1918 Spanish flu or this new Riptide virus? Does a sudden "antigenic shift" (as a scientist suggests) bring about the pandemic because the public lacks immunity to the new virus? Can TB antibodies protect against a deadly flu?
The reality: Though the H5N1 highly pathogenic avian influenza strain has been much publicized and has worried many scientists, it is still primarily a disease in birds, and may not mutate sufficiently to cause the next human pandemic. "If we put all our eggs in this one basket, we can easily miss a mutation in a different virus which becomes the next pandemic strain," says flu researcher Dr. Jeffrey Taubenberger of the National Institutes of Health. The movie sends an important message to the public when it shows a non-H5N1 influenza transforming into the pandemic virus.
The incubation time — or period between exposure and the onset of symptoms — for influenza is two to four days, sometimes longer. The film depicts this waiting period fairly accurately. In real life, scientists are not always sure exactly how influenza is transmitted, and it is unlikely that paper masks would provide much of a barrier to infection. More sophisticated N-95 respirator masks are only occasionally shown in the movie and must be fitted properly to be effective. The movie correctly illustrates the significant downside to quarantining whole regions (as opposed to the more effective strategy of isolating sick patients and their contacts), where people under suspicion become fearful and may take fewer precautions and thereby may spread the virus more widely.
The imagined Riptide virus, like the Spanish flu of 1918, kills a high percentage of older teens and young adults. Some scientists have theorized that this phenomenon is due to a hyperinflammatory response, which causes victims (often young and healthy) to drown in their own respiratory secretions. But Taubenberger believes that the high mortality in young adults in 1918 was likely due to an absence of immunity to the flu strain in those ages as compared to the older population who may have been exposed to a related virus earlier in life.
Coughing up blood is commonly associated with a virus that damages lungs so severely and quickly. But this doesn't happen as commonly as shown in the movie, where practically everyone infected is experiencing hemoptysis.
A virus experiencing a sudden antigenic shift or significant mutation is believed to be the cause of all pandemics. Bringing up this genetic term to explain the suddenly deadly Riptide" virus is a fine bit of scientific detail.
Less believable is the movie's optimistic portrayal of cooperating government officials, or the science-fiction contention that antibodies against tuberculosis can somehow prevent Riptide from attaching to lungs of potential victims. True, some immunity can be provided by extracting antibodies from the blood of survivors. In Asia, the blood of bird flu survivors has just been shown to protect mice from the disease. But TB is an entirely different disease. You wouldn't expect antibodies of TB sufferers to help fight flu.
Finally, viewers should know that the next flu pandemic may be mild, not massive. Not all pandemics kill many millions like the 1918 Spanish flu. Read More & Comment...
06/04/2007 10:12 AM |
Nissen and others wants to make Avandia the poster child for wants wrong with the FDA and their approach as the right way....
Do Nissen's supporters believe that regulation by meta analyses, by end-run to Congress and the media is an appropriate substitute. Should those who push such analyses be unaccountable -- as Nissen, Furberg, Psaty, Avorn have thus far -- to scrutiny by the media which is the current and only conduit for their warnings? Read More & Comment...
Do Nissen's supporters believe that regulation by meta analyses, by end-run to Congress and the media is an appropriate substitute. Should those who push such analyses be unaccountable -- as Nissen, Furberg, Psaty, Avorn have thus far -- to scrutiny by the media which is the current and only conduit for their warnings? Read More & Comment...
06/04/2007 06:43 AM |
Here's the latest Avandia/Nissen article from today's edition of the Newark Star-Ledger (Pharmaland's hometown newspaper):
Link
Unlike most coverage of this story, reporter Robert Cohen presents both sides of the story and carries this crucial sentence near the top of the story (in paragraph 6 ):
"The data was already available on Glaxo's Web site, and Nissen acknowledged he did not have access to all the information needed for a definitive conclusion."
Cohen continues, "Alternatives include Actos, a similar drug made by Takeda Pharmaceutical, which did not show a link to heart attacks and strokes in a 2005 study. Nissen has consulted for Glaxo and led a small clinical trial on Actos for Takeda, but insists this has not affected his view on Avandia."
Heavens no.
And then, curiously, Cohen reports that the usually media-friendly Nissen "... was unavailable for comment but plans to testify at the hearing Wednesday."
No doubt. Read More & Comment...
Link
Unlike most coverage of this story, reporter Robert Cohen presents both sides of the story and carries this crucial sentence near the top of the story (in paragraph 6 ):
"The data was already available on Glaxo's Web site, and Nissen acknowledged he did not have access to all the information needed for a definitive conclusion."
Cohen continues, "Alternatives include Actos, a similar drug made by Takeda Pharmaceutical, which did not show a link to heart attacks and strokes in a 2005 study. Nissen has consulted for Glaxo and led a small clinical trial on Actos for Takeda, but insists this has not affected his view on Avandia."
Heavens no.
And then, curiously, Cohen reports that the usually media-friendly Nissen "... was unavailable for comment but plans to testify at the hearing Wednesday."
No doubt. Read More & Comment...
06/01/2007 09:50 AM |
From the New York Times ...
Genome of DNA Pioneer Is Deciphered
By NICHOLAS WADE
The full genome of James D. Watson, one of the discoverers of the structure of DNA in 1953, has been deciphered, marking what some scientists believe is the gateway to an impending era of personalized genomic medicine.
Here's the rest of the story.
http://www.nytimes.com/2007/05/31/science/31cnd-gene.html
Pay particular interest to the bit about Watson's apolipoprotein E gene. Read More & Comment...
Genome of DNA Pioneer Is Deciphered
By NICHOLAS WADE
The full genome of James D. Watson, one of the discoverers of the structure of DNA in 1953, has been deciphered, marking what some scientists believe is the gateway to an impending era of personalized genomic medicine.
Here's the rest of the story.
http://www.nytimes.com/2007/05/31/science/31cnd-gene.html
Pay particular interest to the bit about Watson's apolipoprotein E gene. Read More & Comment...
06/01/2007 09:01 AM |
One more time -- here's why the Critical Path is so critical.
FDA Finalizes Guidances for Pandemic and Seasonal Influenza Vaccines
The U.S. Food and Drug Administration (FDA) today issued final recommendations to increase the supply of safe and effective influenza vaccines for both seasonal and pandemic use.
FDA's goal with the guidances is to outline the regulatory pathways for the rapid development and approval of these products.
"FDA continues its commitment to help increase the supply of influenza vaccines and support the development of new approaches to vaccine production," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research (CBER). "Having additional manufacturers of licensed influenza vaccines will enhance the capacity to produce more doses of seasonal influenza vaccines, as well as contribute to the nation's pandemic preparedness, one of our top priorities."
In March 2006, FDA issued two draft guidance documents for public comment — one for seasonal influenza vaccines and another for pandemic influenza vaccines. The draft documents outline specific approaches for manufacturers to develop new vaccines that are safe, pure, and potent. The final guidances reflect public input, including vaccine companies and public health officials.
Both guidances recommend using recent technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also recommend adding substances that improve the immune response from the vaccine (novel adjuvants).
The guidances describe conventional and accelerated approval pathways to vaccine licensure. Companies selecting the conventional pathway must provide clinical evidence that the vaccine prevents influenza. Adequate and well-controlled clinical trials are also required for accelerated approval but companies may use a biological indicator — such as immune response to the vaccine — to predict effectiveness, an approach that may reduce the vaccine's development time. Further clinical studies are then required to verify the vaccine's clinical benefit.
The guidances indicate that manufacturers should submit a new Biologics License Application (BLA) for the initial licensure of a pandemic or seasonal influenza vaccine to ensure that each pandemic and seasonal vaccine has its own trade name and labeling.
For companies with U.S. licensed seasonal influenza vaccines, the pandemic guidance outlines the regulatory pathway for obtaining licensure for a new pandemic vaccine in which the manufacturing process is the same as for the seasonal vaccine. For manufacturers developing vaccines using a new manufacturing process, both guidance documents explain the process for obtaining licensure using the accelerated approval pathway.
The guidance documents represent the FDA's ongoing efforts under its Critical Path Initiative to translate scientific advances, such as cell-culture derived and recombinant vaccine technologies, into new medical products with shorter approval timeframes. Read More & Comment...
FDA Finalizes Guidances for Pandemic and Seasonal Influenza Vaccines
The U.S. Food and Drug Administration (FDA) today issued final recommendations to increase the supply of safe and effective influenza vaccines for both seasonal and pandemic use.
FDA's goal with the guidances is to outline the regulatory pathways for the rapid development and approval of these products.
"FDA continues its commitment to help increase the supply of influenza vaccines and support the development of new approaches to vaccine production," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research (CBER). "Having additional manufacturers of licensed influenza vaccines will enhance the capacity to produce more doses of seasonal influenza vaccines, as well as contribute to the nation's pandemic preparedness, one of our top priorities."
In March 2006, FDA issued two draft guidance documents for public comment — one for seasonal influenza vaccines and another for pandemic influenza vaccines. The draft documents outline specific approaches for manufacturers to develop new vaccines that are safe, pure, and potent. The final guidances reflect public input, including vaccine companies and public health officials.
Both guidances recommend using recent technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also recommend adding substances that improve the immune response from the vaccine (novel adjuvants).
The guidances describe conventional and accelerated approval pathways to vaccine licensure. Companies selecting the conventional pathway must provide clinical evidence that the vaccine prevents influenza. Adequate and well-controlled clinical trials are also required for accelerated approval but companies may use a biological indicator — such as immune response to the vaccine — to predict effectiveness, an approach that may reduce the vaccine's development time. Further clinical studies are then required to verify the vaccine's clinical benefit.
The guidances indicate that manufacturers should submit a new Biologics License Application (BLA) for the initial licensure of a pandemic or seasonal influenza vaccine to ensure that each pandemic and seasonal vaccine has its own trade name and labeling.
For companies with U.S. licensed seasonal influenza vaccines, the pandemic guidance outlines the regulatory pathway for obtaining licensure for a new pandemic vaccine in which the manufacturing process is the same as for the seasonal vaccine. For manufacturers developing vaccines using a new manufacturing process, both guidance documents explain the process for obtaining licensure using the accelerated approval pathway.
The guidance documents represent the FDA's ongoing efforts under its Critical Path Initiative to translate scientific advances, such as cell-culture derived and recombinant vaccine technologies, into new medical products with shorter approval timeframes. Read More & Comment...
06/01/2007 07:45 AM |
Steve Nissen says he got physically sick to his stomach when he saw the results of his Avandia "study." I felt the same way after seeing Nightline's Chris Burri do everything but kiss Nissen on air during this tribute to St. Steven. Somehow Nissen's irresponsible remarks and behavior regarding ADHD drugs never made it on air and Nightline never checked out the accuracy of the claim that Nissen was a critic of Celebrex (untrue).
For my money I would have loved to have seen how much time Nissen spent and was paid for flying around the country talking about Viagra back in the 1990s. How does that square with his rabble rousing image. Read More & Comment...
For my money I would have loved to have seen how much time Nissen spent and was paid for flying around the country talking about Viagra back in the 1990s. How does that square with his rabble rousing image. Read More & Comment...
06/01/2007 07:18 AM |
The FDA has determined that not only did tainted heparin from China infiltrate the US drug supply -- it did the same to 11 other nations as well. The facts are indisputable -- 12 different Chinese companies supplied contaminated heparin not only to the United States but to Australia, Canada, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand -- and China.
The response from China -- denial there even were any impurities and then to imply that the problem stems from contaminated vials used in the United States. And, get this, the Chinese authorities won't allow FDA officials to inspect any Chinese facilities unless they can, in turn, inspect the American plants where the product was prepared for distribution.
How do you say "chutzpah" in Mandarin?
It's hard to say what these Chinese Checkers might discover -- but it's likely they'd find that the GMPs in place in the United States are the global gold standard. Whether the tainted ingredients were used in error or to save money doesn't matter. What matters now is that the problem must be identified -- and that means that our trading partners in the Middle Kingdom must allow FDA inspectors in now -- and allow them to inspect plants that produce API or other ingredients bound for US shores.
It's not a question of national sovereignty -- it's a matter of responsibility and public health.
What does all this say about the realities of drug importation? It points out, once again, that it’s nothing other than a dangerous political charade. And when you look at the list of nations impacted by this crisis, they're many of the same countries on the "approved" list for many ill-conceived drug importation bills.
So much for eastern promises. Read More & Comment...
The response from China -- denial there even were any impurities and then to imply that the problem stems from contaminated vials used in the United States. And, get this, the Chinese authorities won't allow FDA officials to inspect any Chinese facilities unless they can, in turn, inspect the American plants where the product was prepared for distribution.
How do you say "chutzpah" in Mandarin?
It's hard to say what these Chinese Checkers might discover -- but it's likely they'd find that the GMPs in place in the United States are the global gold standard. Whether the tainted ingredients were used in error or to save money doesn't matter. What matters now is that the problem must be identified -- and that means that our trading partners in the Middle Kingdom must allow FDA inspectors in now -- and allow them to inspect plants that produce API or other ingredients bound for US shores.
It's not a question of national sovereignty -- it's a matter of responsibility and public health.
What does all this say about the realities of drug importation? It points out, once again, that it’s nothing other than a dangerous political charade. And when you look at the list of nations impacted by this crisis, they're many of the same countries on the "approved" list for many ill-conceived drug importation bills.
So much for eastern promises. Read More & Comment...
06/01/2007 07:18 AM |
As any assistant district attorney will tell you, the "some other guy did it" defense generally means "guilty."
Now, it seems, China is blaming Panama for the deaths of 51 people caused by cough syrup containing Diethylene glycol -- a chemical commonly used in antifreeze and brake fluid. But, it seems, there is plenty of blame to go around.
This is just the latest example of China-as-hub for the international trade in counterfeit API (Active Pharmaceutical Ingredient). And connecting the dots to the issue of "safe" drug importation is pretty obvious.
Here's the story off the AP wire:
China blames Panama for deadly tainted drugs
Papers altered to say glycerin was for medical use, Chinese official claims
BEIJING - Businesses in Panama, not China were "mainly responsible" for passing off an industrial chemical as a medical ingredient leading to the deaths of at least 51 people, a senior official in China's product-inspection agency said Thursday.
Wei Chuanzhong, vice minister of the Administration for Quality Supervision, Inspection and Quarantine, said Chinese companies sold the industrial solvent called 'TD glycerin' to Spanish companies who then sold it to Panamanian companies. The product was then used to make cough syrup and other medicine.
"The Panamanian business people are mainly responsible because they changed the scope of use and shelf-life of this product," Wei said.
The deaths in Panama, which began last year, have dramatically added to a growing international alarm about the safety of food and medicines exported by China.
Wei acknowledged that the Chinese manufacturer, Taixing Glycerin Factory, and the Chinese distributor, CNSC Fortune Way, "engaged in some misconduct," because they used the name TD glycerin for a mix of 15 percent diethylene glycol and "other substances."
Diethylene glycol is a chemical commonly used in antifreeze and brake fluid.
Misleading name
"They used the very confusing name of TD glycerin, which will mislead people to think it's glycerin," said Wei. "The markings on the package also used the name glycerin instead of TD glycerin."
But he said the Panama traders bore the brunt of the responsibility for the deadly substance ending up in medicine.
"The Panama trader changed or altered the paperwork to say the substance was medical glycerin that met U.S. standards for use in medical products and changed the shelf life of the already expired product from one year to four years," Wei said. "The responsibility here is very clear."
He said the Chinese investigation found that the Chinese side made it clear in their export paperwork that the material they were selling was for industrial, not medical, use. Wei said Taixing had been punished for its misbehavior but when pressed for details, he said the company was still being investigated. He said China would not continue to allow the use of the name TD glycerin, but no ban has been formally announced.
Glycerin, which is often processed from animal fats and occurs naturally in the human body, is a sweet liquid that can give cough syrup and other remedies thickness while preventing them from dissolving in water. It is used in many kinds of medicines all over the world.
The first documented poisonings were reported in October, but Panamanian authorities said there may have been earlier cases that went undetected. Fifty-one people died after taking the tainted medications and 68 were hospitalized.
Why isn't Senator Bernie Sanders asking, "Where are the dead Panamanians? Read More & Comment...
Now, it seems, China is blaming Panama for the deaths of 51 people caused by cough syrup containing Diethylene glycol -- a chemical commonly used in antifreeze and brake fluid. But, it seems, there is plenty of blame to go around.
This is just the latest example of China-as-hub for the international trade in counterfeit API (Active Pharmaceutical Ingredient). And connecting the dots to the issue of "safe" drug importation is pretty obvious.
Here's the story off the AP wire:
China blames Panama for deadly tainted drugs
Papers altered to say glycerin was for medical use, Chinese official claims
BEIJING - Businesses in Panama, not China were "mainly responsible" for passing off an industrial chemical as a medical ingredient leading to the deaths of at least 51 people, a senior official in China's product-inspection agency said Thursday.
Wei Chuanzhong, vice minister of the Administration for Quality Supervision, Inspection and Quarantine, said Chinese companies sold the industrial solvent called 'TD glycerin' to Spanish companies who then sold it to Panamanian companies. The product was then used to make cough syrup and other medicine.
"The Panamanian business people are mainly responsible because they changed the scope of use and shelf-life of this product," Wei said.
The deaths in Panama, which began last year, have dramatically added to a growing international alarm about the safety of food and medicines exported by China.
Wei acknowledged that the Chinese manufacturer, Taixing Glycerin Factory, and the Chinese distributor, CNSC Fortune Way, "engaged in some misconduct," because they used the name TD glycerin for a mix of 15 percent diethylene glycol and "other substances."
Diethylene glycol is a chemical commonly used in antifreeze and brake fluid.
Misleading name
"They used the very confusing name of TD glycerin, which will mislead people to think it's glycerin," said Wei. "The markings on the package also used the name glycerin instead of TD glycerin."
But he said the Panama traders bore the brunt of the responsibility for the deadly substance ending up in medicine.
"The Panama trader changed or altered the paperwork to say the substance was medical glycerin that met U.S. standards for use in medical products and changed the shelf life of the already expired product from one year to four years," Wei said. "The responsibility here is very clear."
He said the Chinese investigation found that the Chinese side made it clear in their export paperwork that the material they were selling was for industrial, not medical, use. Wei said Taixing had been punished for its misbehavior but when pressed for details, he said the company was still being investigated. He said China would not continue to allow the use of the name TD glycerin, but no ban has been formally announced.
Glycerin, which is often processed from animal fats and occurs naturally in the human body, is a sweet liquid that can give cough syrup and other remedies thickness while preventing them from dissolving in water. It is used in many kinds of medicines all over the world.
The first documented poisonings were reported in October, but Panamanian authorities said there may have been earlier cases that went undetected. Fifty-one people died after taking the tainted medications and 68 were hospitalized.
Why isn't Senator Bernie Sanders asking, "Where are the dead Panamanians? Read More & Comment...
05/31/2007 01:57 PM |
Woke up this morning to the New York Times quoting Curt "No Brainer" Furberg saying, "Safety is just not a high priority for them."
"Them" being the FDA.
That statement is untrue, unjust, and unfair to the staff of the FDA who put their heart and soul into their jobs -- and could walk out the door tomorrow for much better paying, lower stress jobs. And yet they stay.
And this is what people say about them. For shame.
I will go to bed this evening after the Nightline feature on Avandia. Curious to see how ABC edits the interviews they did with Scott Gottlieb and Steve Galson.
In fact, I am more than curious considering the clip of Steve Nissen that ABC has on their web site:
http://abcnews.go.com/Nightline/story?id=3225419&page=1
Dr. N. compares Avandia to 9-11.
Fearmongering at its worst.
And his you-know-what eating smile should tell you all you need to know about how much he's enjoying himself.
For shame. Read More & Comment...
"Them" being the FDA.
That statement is untrue, unjust, and unfair to the staff of the FDA who put their heart and soul into their jobs -- and could walk out the door tomorrow for much better paying, lower stress jobs. And yet they stay.
And this is what people say about them. For shame.
I will go to bed this evening after the Nightline feature on Avandia. Curious to see how ABC edits the interviews they did with Scott Gottlieb and Steve Galson.
In fact, I am more than curious considering the clip of Steve Nissen that ABC has on their web site:
http://abcnews.go.com/Nightline/story?id=3225419&page=1
Dr. N. compares Avandia to 9-11.
Fearmongering at its worst.
And his you-know-what eating smile should tell you all you need to know about how much he's enjoying himself.
For shame. Read More & Comment...
05/31/2007 12:08 PM |
"Nissen points to his outspoken criticism of Cox inhibitors including Celebrex -- a Pfizer product -- at the time he was the principal investigator for a Pfizer clinical trial."
Can anyone find any criticism of Celebrex by Nissen? Here is the full extent of Nissen's whining in advance of his Nightline puff piece tonight....
http://www.abcnews.go.com/Nightline/Story?id=3225419&page=2
Here is a contemporary account of who was outspoken and when:
"Following the decision to pull Vioxx from the market three years later, Topol continued to publicly criticize Vioxx-maker Merck for its slow response and for its decision to put the dangerous drug on the market in the first place. Dr. Nissen, however, was less vocal.
Subpoenaed in the first federal Vioxx trial in November 2005, Dr. Topol gave a three-hour videotaped deposition attacking Vioxx and accusing Merck of scientific misconduct. Less than a week after that deposition, Topol lost his position at the Cleveland Clinic.
There is one other important point to note here: At the same time Dr. Topol was being demoted, his past partner in protest, Dr. Nissen, was being asked to lead the $100 million study into the safety of Celebrex. "
http://www.newstarget.com/019333.html
Nissen has also voiced support for Pfizer's new ad campaign for Celebrex (we do too!)
I guess silence is golden. Read More & Comment...
Can anyone find any criticism of Celebrex by Nissen? Here is the full extent of Nissen's whining in advance of his Nightline puff piece tonight....
http://www.abcnews.go.com/Nightline/Story?id=3225419&page=2
Here is a contemporary account of who was outspoken and when:
"Following the decision to pull Vioxx from the market three years later, Topol continued to publicly criticize Vioxx-maker Merck for its slow response and for its decision to put the dangerous drug on the market in the first place. Dr. Nissen, however, was less vocal.
Subpoenaed in the first federal Vioxx trial in November 2005, Dr. Topol gave a three-hour videotaped deposition attacking Vioxx and accusing Merck of scientific misconduct. Less than a week after that deposition, Topol lost his position at the Cleveland Clinic.
There is one other important point to note here: At the same time Dr. Topol was being demoted, his past partner in protest, Dr. Nissen, was being asked to lead the $100 million study into the safety of Celebrex. "
http://www.newstarget.com/019333.html
Nissen has also voiced support for Pfizer's new ad campaign for Celebrex (we do too!)
I guess silence is golden. Read More & Comment...
05/31/2007 07:52 AM |
Dr. Nissen talks about how he donates all his drug industry honoraria to a private charity -- more on THAT later -- but no much later since he didn't start becoming pure until 2004. As Dr. Nissen wrote in his inaugural letter as Pres. of the American College of Cardiology -- which runs his private charity -- " you will sleep better at night and your favorite charity will be grateful for the support. " Read More & Comment...
05/30/2007 04:09 PM |
Dr. Nissen, it seems, can dish it out. But when it comes to "taking it," that's another thing entirely.
According to the man himself, "While I did spend a sleepless night about this, I'm not backing down."
What's causing Dr. Nissen to lose his zzzzs? An e-mail from an FDA spokesman to reporters challenging Dr. N's motives and credibility.
Yep -- he's losing sleep over a nasty e-mail.
In the correspondance in question, entitled "What are St. Steven's feet made of? Clay, perhaps?," FDA spokesman Doug Arbesfeld forwarded to reporters critical news articles, including an anonymous blog accusing Nissen of playing favorites among drug companies.
It's nice to share, right? Well not if you don't agree with Dr. Nissen.
According to The Man, "I'm a pretty tough guy, but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage."
Mommy!
Dr. Nissen, have you heard this one: Do unto others as you would have them do unto you.
This from the same guy who says he donates all his consulting fees to charity -- except that the "charity" resides within the American College of Cardiology -- an organization over which he holds tremendous sway. (Although, in fairness, it is certainly not the same as depositing the money into one's own piggy bank.)
As Mark Twain said, "The rule is perfect: in all matters of opinion our adversaries are insane."
An outrage indeed. Read More & Comment...
According to the man himself, "While I did spend a sleepless night about this, I'm not backing down."
What's causing Dr. Nissen to lose his zzzzs? An e-mail from an FDA spokesman to reporters challenging Dr. N's motives and credibility.
Yep -- he's losing sleep over a nasty e-mail.
In the correspondance in question, entitled "What are St. Steven's feet made of? Clay, perhaps?," FDA spokesman Doug Arbesfeld forwarded to reporters critical news articles, including an anonymous blog accusing Nissen of playing favorites among drug companies.
It's nice to share, right? Well not if you don't agree with Dr. Nissen.
According to The Man, "I'm a pretty tough guy, but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage."
Mommy!
Dr. Nissen, have you heard this one: Do unto others as you would have them do unto you.
This from the same guy who says he donates all his consulting fees to charity -- except that the "charity" resides within the American College of Cardiology -- an organization over which he holds tremendous sway. (Although, in fairness, it is certainly not the same as depositing the money into one's own piggy bank.)
As Mark Twain said, "The rule is perfect: in all matters of opinion our adversaries are insane."
An outrage indeed. Read More & Comment...
05/30/2007 12:27 PM |
Whether it's EBM or HTA or RUM or RUD ... it means the same thing ... putting cost before care. You can tell when this is happening when health ministers begin to act like junior finance ministers. Unfortunately it's happening all the time across the EU and it's pennywise and pound foolish. Oh yes -- it's also bad for patient care. Details. Details.
Don't let the alphabet soup of acronyms fool you -- it all spells care denied.
But you already know that.
Now this dangerous medicine threatens US health care policy with the current phrase de jour, "comparative effectiveness."
No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine.
But you know that already too.
Here's a new paper (published jointly via the Center for the New Europe and the Center for Medicine in the Public Interest) authored by Jacob Arfwedson (a leading European thinker on this topic) and yours truly. The paper discusses where this variously named and initialed concept came from and where it's going not only in Europe but also, via our buddies at the WHO, into the developing world.
http://www.cne.org/pub_pdf/2007_05_arfwedson_pitts_ebm.pdf
And, if you're listening carefully to the rhetoric from inside-the-beltway and from the various presidential campaigns, you'll see that the concept of comparative effectiveness is entering into the general parlance.
But it's more than just another simplistic answer to a complicated question -- it's a signal that we had better start paying attention and offering real, long-term solutions -- like personalized medicine via the Critical Path.
Like we keep saying -- it ain't called "critical" for nothing. Read More & Comment...
Don't let the alphabet soup of acronyms fool you -- it all spells care denied.
But you already know that.
Now this dangerous medicine threatens US health care policy with the current phrase de jour, "comparative effectiveness."
No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine.
But you know that already too.
Here's a new paper (published jointly via the Center for the New Europe and the Center for Medicine in the Public Interest) authored by Jacob Arfwedson (a leading European thinker on this topic) and yours truly. The paper discusses where this variously named and initialed concept came from and where it's going not only in Europe but also, via our buddies at the WHO, into the developing world.
http://www.cne.org/pub_pdf/2007_05_arfwedson_pitts_ebm.pdf
And, if you're listening carefully to the rhetoric from inside-the-beltway and from the various presidential campaigns, you'll see that the concept of comparative effectiveness is entering into the general parlance.
But it's more than just another simplistic answer to a complicated question -- it's a signal that we had better start paying attention and offering real, long-term solutions -- like personalized medicine via the Critical Path.
Like we keep saying -- it ain't called "critical" for nothing. Read More & Comment...
05/30/2007 11:49 AM |
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.†Read More & Comment...
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.†Read More & Comment...
05/29/2007 04:05 PM |
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. Read More & Comment...
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. Read More & Comment...
05/29/2007 02:27 PM |
Curt Furberg calls the idea of taking Avandia off the market "a no brainer." He is familiar with that condition... Read More & Comment...
05/29/2007 08:40 AM |
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.... Read More & Comment...
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.... Read More & Comment...
05/29/2007 08:40 AM |
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. Read More & Comment...
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. Read More & Comment...
Social Networks
Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS
Add This Blog to my Technorati Favorites