Latest Drugwonks' Blog
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In March 2006, FDA issued two draft guidance documents for public comment — one for seasonal influenza vaccines and another for pandemic influenza vaccines.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.
"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.
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.
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. "
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.
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.
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.
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.
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.
