Thomas R. Frieden, MD, MPH - Contact CDC Director re XMRV and CFIDS
One last comment: I am one of those people who takes the most shots at the CDC on this forum. I want it made clear that I do not want the CDC damaged, destroyed or dismantled. I want the CDC to be fixed, dead wood gotten rid of, the best and brightest brought in and allowed to do the right science/research w/o politics involved. I want the CDC to go back to being one of our most important and critical health organizations. None of the previous directors could get the CDC cleaned up and straightened out. In fact, most of them made a bigger mess of it. I pray that the current guy (Thomas R. Frieden, MD, MPH) has the strength of will and character to do what is right and best for the CDC and the American public - despite the politics right now. If Frieden were to do what was right and best for CFIDS/XMRV, I do believe that the CDC's credibility in the scientific/research/CFIDS sick communities would be returned. And continued clean up by Frieden at the CDC would also help restore credibility lost by the American public.
Are you all aware of the number of Swine Flu vaccines that have been destroyed due to overproduction and non-use? The numbers will hit over $500 million lost to incinerated H1N1 vaccines in the US alone (See below for article). Why so much waste? The American public stopped listening and believing what came out of the CDC and then they could not give those vaccines away for free - the drug stores in my area were giving them away free and no one was in the line to get the vaccine.
I recognize that there is no crystal ball for knowing what viruses are going to turn deadly and hit in major waves. But, the CDC has yet to call it right in the last couple of decades. This tells me something is so terribly wrong at the CDC and it must be cleaned up, the priorities re-looked at (as Frieden is doing), the budgets cleaned up and made transparent with appropriate paper trails, and politics left out of any and all research done by the CDC. And this means the CFIDS and XMRV programs and the politics that have damaged super critical research on both the disease and the retrovirus(es).
I so hope that Frieden is strong enough and smart enough to stop the politics that go on at the CDC, once and for all. Frieden is THE guy that we need to get at and make it clear to him the damage that has been done to the CDC because of little programs like CFS. ((Small funding for CFS was deliberate in my opinion to keep it under the funding/inspection radar and reduced by Reeves each year to ensure CFS was a low priority/low funded program with no oversight so they could keep CFS a crazy/lazy disease)).
I really do want what is best for the CDC as it affects the US Population as well as the rest of the world that follows the CDC's lead.
Enough rambling. Email Frieden and ask that he personally takes a good, long look at the whole CFS program and the XMRV study. We need him to do his job for CFIDS and the rest of the public.
----------------------------------------------------------------------------------------
Swine Flu Vaccine: 40 Millions Doses To Be Burned
MIKE STOBBE | 07/ 1/10 04:17 PM |
http://www.huffingtonpost.com/2010/0..._n_632023.html
ATLANTA About a quarter of the swine flu vaccine produced for the U.S. public has expired meaning that a whopping 40 million doses worth about $260 million are being written off as trash.
"It's a lot, by historical standards," said Jerry Weir, who oversees vaccine research and review for the U.S. Food and Drug Administration.
The outdated vaccine, some of which expired Wednesday, will be incinerated. The amount, as much as four times the usual leftover seasonal flu vaccine, likely sets a record. And that's not even all of it.
About 30 million more doses will expire later and may go unused, according to one government estimate. If all that vaccine expires, more than 43 percent of the supply for the U.S. public will have gone to waste.Federal officials defended the huge purchase as a necessary risk in the face of a never-before-seen virus. Many health experts had feared the new flu could be the deadly global epidemic they had long warned about, but it ended up killing fewer people than seasonal flu.
"Although there were many doses of vaccine that went unused, it was much more appropriate to have been prepared for the worst case scenario than to have had too few doses," said Bill Hall, spokesman for U.S. Department of Health and Human Services.
Most leading health experts generally agree with that.
"We were faced with the first pandemic we'd had in 40 years. We had to ensure there would be enough vaccine for our nation," said Dr. Mark Mulligan, an Emory University researcher who was involved in testing the vaccine.
Many average Americans also agreed earlier this year, said Robert Blendon, a Harvard University professor who conducts polls on public health. He said a Harvard poll in January found that 59 percent of Americans would prefer the flu vaccine be over-ordered to ensure enough was available, even if it meant doses went unused.
Millions of doses of flu vaccine typically go unused every year and are marked for burning, but in recent years the leftovers amounted to closer to 10 percent of the supply, rather than the 25 percent expiring now. Government flu experts couldn't recall throwing away anything close to 40 million doses before.
The new H1N1 swine flu emerged in April last year, hitting children and young adults particularly hard. It was difficult to predict how deadly it might be or how easily it might spread. Federal health officials pushed five vaccine manufacturers to quickly produce a vaccine. What's more, they wanted a lot of it many experts thought most people would need two doses for it to work.
The government placed three orders last year for a combined total of nearly 200 million doses an unprecedented amount and almost double the amount of vaccine made in recent years for seasonal flu.
About 162 million doses were meant for the general public. Another 36 million included doses for the military and other countries.
But demand never took off, for several reasons:
_Tests of the vaccine soon showed only one dose was enough to protect most people.
_Much of the vaccine was not ready until late 2009, after the largest wave of swine flu illnesses passed.
_Swine flu turned out not to be as deadly as was first feared. About 12,000 deaths have been attributed to it or roughly a third of the estimated annual deaths from seasonal flu.So while people were waiting hours for swine flu vaccinations in some cities in October and November, by January local health departments were trying gimmicks to get anyone at all to come in for a shot.Government officials have known for months that they were looking at a huge surplus. According to an Associated Press calculation based on federal purchasing information, the dollar value of the 40 million expired doses is about $261 million. The government didn't release an official figure, but Hall said the AP estimate was approximately correct.
In Europe, where nations also found themselves with millions of unused doses, some commentators have attacked the World Health Organization, which declared swine flu a global epidemic, or pandemic. The critics have questioned the motivation of some WHO advisers who had links to the pharmaceutical industry.Some critics have simply lamented that a lot of anxiety was raised and money wasted, not just during the swine flu scare but also in government responses to bird flu and SARS, a respiratory virus that swept parts of Asia in 2003.
"Each time the so-called experts told us that millions of people would be killed worldwide by the respective viruses. We have learned that the experts were utterly wrong," said Dr. Ulrich Keil, a professor at Germany's prestigious University of Muenster and a WHO adviser.
"This behavior is irresponsible because the angst campaigns ... confuse the priority setting in public health," he said. The death toll from influenza epidemics is much smaller than the number killed annually by chronic illnesses like heart disease, cancer, stroke and diabetes, he added, in an e-mail.Unused flu vaccine is a common problem. The June 30 expiration date is set by the FDA and has less to do with the vaccine's shelf life than the desire to tweak the recipe each year to protect against the three flu strains expected to cause the most illness.
"It's not necessarily because it's degraded or not potent," Mulligan said.
In the past year, about 114 million doses of seasonal flu vaccine were distributed. The government thinks most of that was used demand was unusually high because of fears about swine flu.
In the flu vaccination campaign for this coming fall, swine flu vaccine is being combined with two seasonal strains in single doses. Manufacturers have told the government they expect to make about 170 million doses.
An influential government advisory panel this year recommended that virtually all Americans get flu shots each year. Still, that doesn't mean it will all get used.
"No doubt there will be unused doses. This happens every time," said Dr. John Treanor, an immunology specialist at the University of Rochester Medical Center.
One last comment: I am one of those people who takes the most shots at the CDC on this forum. I want it made clear that I do not want the CDC damaged, destroyed or dismantled. I want the CDC to be fixed, dead wood gotten rid of, the best and brightest brought in and allowed to do the right science/research w/o politics involved. I want the CDC to go back to being one of our most important and critical health organizations. None of the previous directors could get the CDC cleaned up and straightened out. In fact, most of them made a bigger mess of it. I pray that the current guy (Thomas R. Frieden, MD, MPH) has the strength of will and character to do what is right and best for the CDC and the American public - despite the politics right now. If Frieden were to do what was right and best for CFIDS/XMRV, I do believe that the CDC's credibility in the scientific/research/CFIDS sick communities would be returned. And continued clean up by Frieden at the CDC would also help restore credibility lost by the American public.
Are you all aware of the number of Swine Flu vaccines that have been destroyed due to overproduction and non-use? The numbers will hit over $500 million lost to incinerated H1N1 vaccines in the US alone (See below for article). Why so much waste? The American public stopped listening and believing what came out of the CDC and then they could not give those vaccines away for free - the drug stores in my area were giving them away free and no one was in the line to get the vaccine.
I recognize that there is no crystal ball for knowing what viruses are going to turn deadly and hit in major waves. But, the CDC has yet to call it right in the last couple of decades. This tells me something is so terribly wrong at the CDC and it must be cleaned up, the priorities re-looked at (as Frieden is doing), the budgets cleaned up and made transparent with appropriate paper trails, and politics left out of any and all research done by the CDC. And this means the CFIDS and XMRV programs and the politics that have damaged super critical research on both the disease and the retrovirus(es).
I so hope that Frieden is strong enough and smart enough to stop the politics that go on at the CDC, once and for all. Frieden is THE guy that we need to get at and make it clear to him the damage that has been done to the CDC because of little programs like CFS. ((Small funding for CFS was deliberate in my opinion to keep it under the funding/inspection radar and reduced by Reeves each year to ensure CFS was a low priority/low funded program with no oversight so they could keep CFS a crazy/lazy disease)).
I really do want what is best for the CDC as it affects the US Population as well as the rest of the world that follows the CDC's lead.
Enough rambling. Email Frieden and ask that he personally takes a good, long look at the whole CFS program and the XMRV study. We need him to do his job for CFIDS and the rest of the public.
----------------------------------------------------------------------------------------
Swine Flu Vaccine: 40 Millions Doses To Be Burned
MIKE STOBBE | 07/ 1/10 04:17 PM |
http://www.huffingtonpost.com/2010/0..._n_632023.html
ATLANTA About a quarter of the swine flu vaccine produced for the U.S. public has expired meaning that a whopping 40 million doses worth about $260 million are being written off as trash.
"It's a lot, by historical standards," said Jerry Weir, who oversees vaccine research and review for the U.S. Food and Drug Administration.
The outdated vaccine, some of which expired Wednesday, will be incinerated. The amount, as much as four times the usual leftover seasonal flu vaccine, likely sets a record. And that's not even all of it.
About 30 million more doses will expire later and may go unused, according to one government estimate. If all that vaccine expires, more than 43 percent of the supply for the U.S. public will have gone to waste.Federal officials defended the huge purchase as a necessary risk in the face of a never-before-seen virus. Many health experts had feared the new flu could be the deadly global epidemic they had long warned about, but it ended up killing fewer people than seasonal flu.
"Although there were many doses of vaccine that went unused, it was much more appropriate to have been prepared for the worst case scenario than to have had too few doses," said Bill Hall, spokesman for U.S. Department of Health and Human Services.
Most leading health experts generally agree with that.
"We were faced with the first pandemic we'd had in 40 years. We had to ensure there would be enough vaccine for our nation," said Dr. Mark Mulligan, an Emory University researcher who was involved in testing the vaccine.
Many average Americans also agreed earlier this year, said Robert Blendon, a Harvard University professor who conducts polls on public health. He said a Harvard poll in January found that 59 percent of Americans would prefer the flu vaccine be over-ordered to ensure enough was available, even if it meant doses went unused.
Millions of doses of flu vaccine typically go unused every year and are marked for burning, but in recent years the leftovers amounted to closer to 10 percent of the supply, rather than the 25 percent expiring now. Government flu experts couldn't recall throwing away anything close to 40 million doses before.
The new H1N1 swine flu emerged in April last year, hitting children and young adults particularly hard. It was difficult to predict how deadly it might be or how easily it might spread. Federal health officials pushed five vaccine manufacturers to quickly produce a vaccine. What's more, they wanted a lot of it many experts thought most people would need two doses for it to work.
The government placed three orders last year for a combined total of nearly 200 million doses an unprecedented amount and almost double the amount of vaccine made in recent years for seasonal flu.
About 162 million doses were meant for the general public. Another 36 million included doses for the military and other countries.
But demand never took off, for several reasons:
_Tests of the vaccine soon showed only one dose was enough to protect most people.
_Much of the vaccine was not ready until late 2009, after the largest wave of swine flu illnesses passed.
_Swine flu turned out not to be as deadly as was first feared. About 12,000 deaths have been attributed to it or roughly a third of the estimated annual deaths from seasonal flu.So while people were waiting hours for swine flu vaccinations in some cities in October and November, by January local health departments were trying gimmicks to get anyone at all to come in for a shot.Government officials have known for months that they were looking at a huge surplus. According to an Associated Press calculation based on federal purchasing information, the dollar value of the 40 million expired doses is about $261 million. The government didn't release an official figure, but Hall said the AP estimate was approximately correct.
In Europe, where nations also found themselves with millions of unused doses, some commentators have attacked the World Health Organization, which declared swine flu a global epidemic, or pandemic. The critics have questioned the motivation of some WHO advisers who had links to the pharmaceutical industry.Some critics have simply lamented that a lot of anxiety was raised and money wasted, not just during the swine flu scare but also in government responses to bird flu and SARS, a respiratory virus that swept parts of Asia in 2003.
"Each time the so-called experts told us that millions of people would be killed worldwide by the respective viruses. We have learned that the experts were utterly wrong," said Dr. Ulrich Keil, a professor at Germany's prestigious University of Muenster and a WHO adviser.
"This behavior is irresponsible because the angst campaigns ... confuse the priority setting in public health," he said. The death toll from influenza epidemics is much smaller than the number killed annually by chronic illnesses like heart disease, cancer, stroke and diabetes, he added, in an e-mail.Unused flu vaccine is a common problem. The June 30 expiration date is set by the FDA and has less to do with the vaccine's shelf life than the desire to tweak the recipe each year to protect against the three flu strains expected to cause the most illness.
"It's not necessarily because it's degraded or not potent," Mulligan said.
In the past year, about 114 million doses of seasonal flu vaccine were distributed. The government thinks most of that was used demand was unusually high because of fears about swine flu.
In the flu vaccination campaign for this coming fall, swine flu vaccine is being combined with two seasonal strains in single doses. Manufacturers have told the government they expect to make about 170 million doses.
An influential government advisory panel this year recommended that virtually all Americans get flu shots each year. Still, that doesn't mean it will all get used.
"No doubt there will be unused doses. This happens every time," said Dr. John Treanor, an immunology specialist at the University of Rochester Medical Center.