Latest Drugwonks' Blog
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.
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.
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.
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.
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.
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?
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?
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.
"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.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
