Latest Drugwonks' Blog
Though you wouldn't know if by the defiant tone of the editorials...
Link
Nissen did a meta-analysis looking at the increased risk of myocardial infarction and death from cardiovascular causes from Avandia and found a 41 percent greater risk and his analysis excluded anyone with a high risk of or a prior MI. The RECORD team released interim results showing that there was little difference in the risk of MI or death of all people on the drug with or without a history of MI... "As compared with the control group, the rosiglitazone group had no evidence of an increased risk of death, either from any cause (hazard ratio, 0.93; 95% CI, 0.67 to 1.27) or from cardiovascular causes (hazard ratio, 0.80, 95% CI, 0.52 to 1.24). The primary end point included all first hospitalizations or deaths from cardiovascular causes and as such included myocardial infarction and congestive heart failure. "
NEJM changes the goal post and definition of safety by demanding that Avandia show that it is cardioprotective...to wit; David Nathan's unctuous editorial comment: "Considering the low power of the study and the trend for more adverse cardiovascular outcomes in the rosiglitazone-treated group, it is highly unlikely that the study will ever establish a cardiovascular benefit for rosiglitazone." Thanks David and maybe it will be a source of renewable energy too.
Nathan goes on to write: "It is reasonable to ask whether physicians should feel comfortable using a drug that might have an 8% excess risk of severe cardiovascular disease or death from cardiovascular causes. " And as we all know, there are subpopulations that will carry about 80 percent of that risk.
In patients that have a 50 percent greater chance of having a stroke, heart attack or heart failure if they stop taking the medcine? No one is doubting that there are other tools out there for controlling diabetes but the last time I checked the incidence of the disease was increasing as was the prevalence. More people are dying from the disease and if a PPAR can reduce that a 50 percent increase in absolute risk of stroke with a drug that carries a 2 percent or less risk of MI and other treatments are not working....
Link
Nissen did a meta-analysis looking at the increased risk of myocardial infarction and death from cardiovascular causes from Avandia and found a 41 percent greater risk and his analysis excluded anyone with a high risk of or a prior MI. The RECORD team released interim results showing that there was little difference in the risk of MI or death of all people on the drug with or without a history of MI... "As compared with the control group, the rosiglitazone group had no evidence of an increased risk of death, either from any cause (hazard ratio, 0.93; 95% CI, 0.67 to 1.27) or from cardiovascular causes (hazard ratio, 0.80, 95% CI, 0.52 to 1.24). The primary end point included all first hospitalizations or deaths from cardiovascular causes and as such included myocardial infarction and congestive heart failure. "
NEJM changes the goal post and definition of safety by demanding that Avandia show that it is cardioprotective...to wit; David Nathan's unctuous editorial comment: "Considering the low power of the study and the trend for more adverse cardiovascular outcomes in the rosiglitazone-treated group, it is highly unlikely that the study will ever establish a cardiovascular benefit for rosiglitazone." Thanks David and maybe it will be a source of renewable energy too.
Nathan goes on to write: "It is reasonable to ask whether physicians should feel comfortable using a drug that might have an 8% excess risk of severe cardiovascular disease or death from cardiovascular causes. " And as we all know, there are subpopulations that will carry about 80 percent of that risk.
In patients that have a 50 percent greater chance of having a stroke, heart attack or heart failure if they stop taking the medcine? No one is doubting that there are other tools out there for controlling diabetes but the last time I checked the incidence of the disease was increasing as was the prevalence. More people are dying from the disease and if a PPAR can reduce that a 50 percent increase in absolute risk of stroke with a drug that carries a 2 percent or less risk of MI and other treatments are not working....
because it will seal the fate for thousands of others who will die hoping for a chance at life. The House bill makes safety superior to drug approvals and makes the pseudo analysis of Steve Nissen -- which gives the meta-reality of danger -- pre-eminence in the drug approval process. Given this additional hurdle more drugs that show a targeted benefit will be pulled because all fear mongers will have to do is lump all the questionable safety risks into one sample to create a signal of danger.
Provenge protesters interested in getting access to the new drug should direct their phone calls to the following individuals who now constitute the new drug regulatory regime in America
Congress Henry Waxman (202) 225-3976
Dr. Steve Nissen (216) 445-6852
Senator Charles Grassley 202.224.3744
Gardiner Harris, The New York Times 212-556-1234
Provenge protesters interested in getting access to the new drug should direct their phone calls to the following individuals who now constitute the new drug regulatory regime in America
Congress Henry Waxman (202) 225-3976
Dr. Steve Nissen (216) 445-6852
Senator Charles Grassley 202.224.3744
Gardiner Harris, The New York Times 212-556-1234
While it's very nice to have Dr.Goldberg recognized as one of health care's most influential bloggers (see Boston Globe article in previous blog) -- it's downright frightening to see one of our nation's most aggressive tort lawyers supporting Dr. Steve Nissen as the next Commssioner of the FDA.
As the Globe article states,
"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."
Thus the King of Torts dubs Steven Nissen, Doctor of Torts.
As the Globe article states,
"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."
Thus the King of Torts dubs Steven Nissen, Doctor of Torts.
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.
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.
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?
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?
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.
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.
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?
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?
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.
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.
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.
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.
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.
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.
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