Latest Drugwonks' Blog
Peter's post on his importation briefing is Kafka-esque. You can't make up the kind of rationalizations the pro-importation forces have been reduced to -- because they are driven by polls and pure political objective, not facts, not reason, not concern for public health or safety. I think official Washington has created and thrives on a new form of communication, Truthspeak, where flacks, spin doctors, policy hatchets, et al., will say and do anything that advances their short term interests and/or protects their flank though it may contradict reality or what was said or done the day before. The past -- what once was history -- no longer exists and therefore one is no longer accountable or responsible for deeds or actions other than those in the very present.
This tactic has spread Ebola-like throughout politics as the number of media outlets needing content on a 24/7 basis have multiplied.
The importation forces are lead, not coincidentally by Truthspeaker-in-Chief Rahm Emanuel who turned parsing phrases and weasel words into lethal political weapons for the Clintons. (He's had much less success in helping his buddy, Illinois Governor "Wrong-Way Rod" Blagojevich, have any success in the Prairie State's ill-fated importation schemes.)
If you can convince people to open the US to unsafe practices that don't even save money in Europe -- you can do anything. Well, we hope not.
This tactic has spread Ebola-like throughout politics as the number of media outlets needing content on a 24/7 basis have multiplied.
The importation forces are lead, not coincidentally by Truthspeaker-in-Chief Rahm Emanuel who turned parsing phrases and weasel words into lethal political weapons for the Clintons. (He's had much less success in helping his buddy, Illinois Governor "Wrong-Way Rod" Blagojevich, have any success in the Prairie State's ill-fated importation schemes.)
If you can convince people to open the US to unsafe practices that don't even save money in Europe -- you can do anything. Well, we hope not.
Just because you say it enough times doesn't make it true.
Most recent example that proves this maxim is the attempt by certain members of Congress -- in this case U.S. Representatives Rahm Emanuel (D-IL), Jo Ann Emerson (R-MO), Rosa DeLauro (D-CT), and Marion Berry (D-AR) -- to hide the facts that drug importation is neither safe nor smart.
The Fearsome Four offer the following reasons why drug importation is a good idea. (We offer the facts in bold -- because the truth must be told boldly.)
The Fearsome Four claim that the same brand name drugs cost 35-55% less in other nations then they do in the US.
That's because the nation's of the EU (and Canada) have price controls that equal choice controls for their citizens. Also, the rest of the world unfairly shirks its responsibilities to shoulder their fair share of the burden of research and development. This is what members of Congress should be up in arms about.
The Fearsome Four say that drug importation has been in place in the European Union (where they call it "parallel trade") for more than 20 years with no safety problems.
Believe it or not, their "source" for this is Peter Rost. For the truth we prefer the European Commission who has identified parallel trade as the weak link in the chain for counterfeiters. It's also convenient (although not responsible) to forget that the British regulatory authorities have recently found counterfeit and substandard medicines in their island kingdom -- courtesy of parallel trade.
The Fearsome Four claim the pharmaceutical industry has imported drugs and sold them in the U.S. for decades. In fact, 40 percent of the drugs consumed by Americans today are made in foreign manufacturing plants.
That's right -- in plants authorized and inspected by the FDA. The Four conveniently omit the fact that their legislation would allow in medicines from plants not approved by the FDA. Oops.
The Fearsome Four claim that prescription drug importation will result in $50 billion in direct savings alone over the next decade, a $10 billion benefit to the federal budget.
For this fact they cite a Congressional Budget Office Study. But what the study actually says is that such a program woyuld reduce the drug spend in the US by .01%. And that doesn't include the monies needed to set up an entirely new, international system for drug regulation.
And finally, the Fearsome Four claim that passage of the Pharmaceutical Market Access and Drug Safety Act will finally assure the security of our drug supply.
Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few. Because what the Fearsome Four aren't saying is that "drugs from the United Kingdom" means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere. They should do their homework.
What happens when pesky facts get in the way of political grandstanding? Good things.
Most recent example that proves this maxim is the attempt by certain members of Congress -- in this case U.S. Representatives Rahm Emanuel (D-IL), Jo Ann Emerson (R-MO), Rosa DeLauro (D-CT), and Marion Berry (D-AR) -- to hide the facts that drug importation is neither safe nor smart.
The Fearsome Four offer the following reasons why drug importation is a good idea. (We offer the facts in bold -- because the truth must be told boldly.)
The Fearsome Four claim that the same brand name drugs cost 35-55% less in other nations then they do in the US.
That's because the nation's of the EU (and Canada) have price controls that equal choice controls for their citizens. Also, the rest of the world unfairly shirks its responsibilities to shoulder their fair share of the burden of research and development. This is what members of Congress should be up in arms about.
The Fearsome Four say that drug importation has been in place in the European Union (where they call it "parallel trade") for more than 20 years with no safety problems.
Believe it or not, their "source" for this is Peter Rost. For the truth we prefer the European Commission who has identified parallel trade as the weak link in the chain for counterfeiters. It's also convenient (although not responsible) to forget that the British regulatory authorities have recently found counterfeit and substandard medicines in their island kingdom -- courtesy of parallel trade.
The Fearsome Four claim the pharmaceutical industry has imported drugs and sold them in the U.S. for decades. In fact, 40 percent of the drugs consumed by Americans today are made in foreign manufacturing plants.
That's right -- in plants authorized and inspected by the FDA. The Four conveniently omit the fact that their legislation would allow in medicines from plants not approved by the FDA. Oops.
The Fearsome Four claim that prescription drug importation will result in $50 billion in direct savings alone over the next decade, a $10 billion benefit to the federal budget.
For this fact they cite a Congressional Budget Office Study. But what the study actually says is that such a program woyuld reduce the drug spend in the US by .01%. And that doesn't include the monies needed to set up an entirely new, international system for drug regulation.
And finally, the Fearsome Four claim that passage of the Pharmaceutical Market Access and Drug Safety Act will finally assure the security of our drug supply.
Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few. Because what the Fearsome Four aren't saying is that "drugs from the United Kingdom" means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere. They should do their homework.
What happens when pesky facts get in the way of political grandstanding? Good things.
For those of us who enjoy waiting two hours in a doctor's office or using the ER room to getting care because we don't get sick between 10-5, you'll love how the AMA is responding to the grow of retail health clinics:
The American Medical Association should call for a ban on in-store clinics being opened by retail giants like Wal-Mart Stores Inc. and Walgreen Co., several doctors groups urged at the AMA's annual meeting in Chicago on Sunday.
Faced with an onslaught of competition that is forecast to bring several thousand retail health clinics to U.S. consumers, AMA members testified that such clinics are endangering patient care, particularly for children. The doctors say the clinics, largely staffed by advanced-degree nurses and physicians' assistants, are largely unregulated and, therefore, put patients' health at risk.
I have used the Redi-Clinics at Duane Reade and I can tell you MY health was put at risk. I was nearly knocked unconscious by how clean, convenient and excellent the care was. A PA whose previous experience was working at a community health center provided me a flu shot and quick look at my sinuses. She sent a copy of my record via email to me which I shared with my physician. Yeah, a real risk alright.
"There is no more urgent issue than this for the AMA," Dr. Kamran Hashemi, a family physician from South Barrington, said, urging the organization to push for more regulation of retail clinics. "This issue speaks to what all of us do every day in practice." If the AMA does nothing, Hashemi said, "in five years, the chairs [at the AMA] meeting will be filled with representatives from Walgreens, Wal-Mart" and other retail outlets.
It's called competition, Kamran. Get off your chair, change or get out of the way. People in rural areas, who work real jobs, who have sick kids need access to real care in real time, not when it's convenient to doctors who are interested in the status quo. Protectionism is not going to cut it.
http://www.chicagotribune.com/business/chi-clinics_bizjun25,0,4533626.story?coll=chi-business-hed
The American Medical Association should call for a ban on in-store clinics being opened by retail giants like Wal-Mart Stores Inc. and Walgreen Co., several doctors groups urged at the AMA's annual meeting in Chicago on Sunday.
Faced with an onslaught of competition that is forecast to bring several thousand retail health clinics to U.S. consumers, AMA members testified that such clinics are endangering patient care, particularly for children. The doctors say the clinics, largely staffed by advanced-degree nurses and physicians' assistants, are largely unregulated and, therefore, put patients' health at risk.
I have used the Redi-Clinics at Duane Reade and I can tell you MY health was put at risk. I was nearly knocked unconscious by how clean, convenient and excellent the care was. A PA whose previous experience was working at a community health center provided me a flu shot and quick look at my sinuses. She sent a copy of my record via email to me which I shared with my physician. Yeah, a real risk alright.
"There is no more urgent issue than this for the AMA," Dr. Kamran Hashemi, a family physician from South Barrington, said, urging the organization to push for more regulation of retail clinics. "This issue speaks to what all of us do every day in practice." If the AMA does nothing, Hashemi said, "in five years, the chairs [at the AMA] meeting will be filled with representatives from Walgreens, Wal-Mart" and other retail outlets.
It's called competition, Kamran. Get off your chair, change or get out of the way. People in rural areas, who work real jobs, who have sick kids need access to real care in real time, not when it's convenient to doctors who are interested in the status quo. Protectionism is not going to cut it.
http://www.chicagotribune.com/business/chi-clinics_bizjun25,0,4533626.story?coll=chi-business-hed
As its costs continue to spiral upward, most people now agree that America's health care system is broken. And as the race for the White House heats up, politicians on both sides of the aisle are clamoring to propose ideas that rein in health spending.
Unfortunately, the policies offered thus far are misguided. As counterintuitive as it may sound, the answer to America's health care woes won't be found by harping over the price of care.
Here's the rest of the story via a new op-ed in the Baltimore Sun:
http://www.baltimoresun.com/news/opinion/oped/bal-op.prevention24jun24,0,2342454.story?coll=bal-oped-headlines
The conclusion?
"Prevention must be health care's first line of defense, as a proper diet and healthy lifestyle can stop many diseases in their tracks.
Failing prevention, earlier diagnosis and care are crucial. There are many effective treatments and maintenance medications that can stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives without breaking the bank.
In the coming weeks, the nation will learn more about the health care plans of each of the major presidential candidates. If lawmakers want to save lives, enhance the quality of care, and reduce costs, the focus needs to shift to prevention and early diagnosis."
SiCKO? How about WeLLO.
Unfortunately, the policies offered thus far are misguided. As counterintuitive as it may sound, the answer to America's health care woes won't be found by harping over the price of care.
Here's the rest of the story via a new op-ed in the Baltimore Sun:
http://www.baltimoresun.com/news/opinion/oped/bal-op.prevention24jun24,0,2342454.story?coll=bal-oped-headlines
The conclusion?
"Prevention must be health care's first line of defense, as a proper diet and healthy lifestyle can stop many diseases in their tracks.
Failing prevention, earlier diagnosis and care are crucial. There are many effective treatments and maintenance medications that can stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives without breaking the bank.
In the coming weeks, the nation will learn more about the health care plans of each of the major presidential candidates. If lawmakers want to save lives, enhance the quality of care, and reduce costs, the focus needs to shift to prevention and early diagnosis."
SiCKO? How about WeLLO.
Looks like you have to step away from the pharma bloggersphere to find a Kool-aid free zone on Avandia and Nissen:
From http://10qdetective.blogspot.com/
https://www.blogger.com/comment.g?blogID=19852159&postID=4016826588860183126
From http://10qdetective.blogspot.com/
https://www.blogger.com/comment.g?blogID=19852159&postID=4016826588860183126
Thirteen years in the making...GMP requirements for supplements and herbal products.
From http://www.thetansheet.com
Dietary supplement manufacturers will have to be in compliance with newly issued – and long anticipated – dietary supplement good manufacturing practices by June 24, 2008, while the smallest firms will have until June 2010.
FDA posted the regulation for advanced display on the Federal Register June 22, thirteen years after the Dietary Supplement Health and Regulation Act authorized its creation.
The final rule "includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product," FDA notes. The rule also includes "requirements for recordkeeping and handling consumer product complaints."
The rule does not apply to suppliers or producers of raw ingredients, but instead places the onus of GMP compliance completely on manufacturers.
While the rule applies to dietary supplements and not dietary ingredients, any dietary ingredient used in a supplement product will be required to pass "100 percent" identity testing. Firms will be required to verify the identity of any components that are dietary ingredients, and confirm the identity of "other components."
"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition. Under the final rule, manufacturers will be required to "evaluate the identity, purity, strength, and composition of their dietary supplements," the agency says. Supplements that contain contaminants or "do not contain the dietary ingredient they are represented to contain," would be adulterated or misbranded under the rule, FDA says.
Most of this stuff in made overseas or from material shipped overseas. As from China. No coincidence I'm sure. Now let's see how long compliance takes.
From http://www.thetansheet.com
Dietary supplement manufacturers will have to be in compliance with newly issued – and long anticipated – dietary supplement good manufacturing practices by June 24, 2008, while the smallest firms will have until June 2010.
FDA posted the regulation for advanced display on the Federal Register June 22, thirteen years after the Dietary Supplement Health and Regulation Act authorized its creation.
The final rule "includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product," FDA notes. The rule also includes "requirements for recordkeeping and handling consumer product complaints."
The rule does not apply to suppliers or producers of raw ingredients, but instead places the onus of GMP compliance completely on manufacturers.
While the rule applies to dietary supplements and not dietary ingredients, any dietary ingredient used in a supplement product will be required to pass "100 percent" identity testing. Firms will be required to verify the identity of any components that are dietary ingredients, and confirm the identity of "other components."
"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition. Under the final rule, manufacturers will be required to "evaluate the identity, purity, strength, and composition of their dietary supplements," the agency says. Supplements that contain contaminants or "do not contain the dietary ingredient they are represented to contain," would be adulterated or misbranded under the rule, FDA says.
Most of this stuff in made overseas or from material shipped overseas. As from China. No coincidence I'm sure. Now let's see how long compliance takes.
What's up with the FDA issuing an approvable letter on maraviroc? Well according to Peter Rost (who should know since he is the master of manipulating golden parachutes for himself. Rost's next book: How To Collect Fat Paychecks From ShortHills By Suing Those You Work For) it was to allow outgoing Pfizer R and D execs to short their options. Yeah right. And all those imported drugs made in China ARE safe, just like the toothpaste and petfood.
Anyways, if you were an FDA drug reviewer you now have two choices: become a snitch for Senator Grassley or Congressman Waxman or simply wait till the very last minute to approve a drug. You never know when -- in the words of the owner of the Steven E. Nissen Healthy Heart Fund -- you might be approving another 9=11.
Maraviroc was a targeted therapy for people facing multiple drug resistant HIV...but hey, what's a few months while the FDA sorts out an even lower incidence of liver problems than Tylenol? We now live in a country where in some parts you have to be 19 to buy cold medicines with dextromethorphan. That's right folks, you can fight for your country but you can't buy Robitussin.
The infantilization of American continues apace.
Anyways, if you were an FDA drug reviewer you now have two choices: become a snitch for Senator Grassley or Congressman Waxman or simply wait till the very last minute to approve a drug. You never know when -- in the words of the owner of the Steven E. Nissen Healthy Heart Fund -- you might be approving another 9=11.
Maraviroc was a targeted therapy for people facing multiple drug resistant HIV...but hey, what's a few months while the FDA sorts out an even lower incidence of liver problems than Tylenol? We now live in a country where in some parts you have to be 19 to buy cold medicines with dextromethorphan. That's right folks, you can fight for your country but you can't buy Robitussin.
The infantilization of American continues apace.
By now you've surely heard that the E&C vote on the FDA reform package was 39-0 and full House passage looks good.
But ...
The House version has some very dangerous language vis-a-vis advisory committee conflict of interest waivers. The House bill would only permit the FDA to grant one COI waiver per committee.
One? Why not two? Or three? What's the difference? After all, each adcomm member needs to be dealt with as a discreet case, yes?
We can't allow FDA adcomms to be made up of the second best and the almost brightest. Not ever.
Hopefully this can be resolved in conference -- and in the best interest of the public health.
But ...
The House version has some very dangerous language vis-a-vis advisory committee conflict of interest waivers. The House bill would only permit the FDA to grant one COI waiver per committee.
One? Why not two? Or three? What's the difference? After all, each adcomm member needs to be dealt with as a discreet case, yes?
We can't allow FDA adcomms to be made up of the second best and the almost brightest. Not ever.
Hopefully this can be resolved in conference -- and in the best interest of the public health.
"Old Friends. Old Friends. Sat on a park bench like bookends ..."
You know the song. Now have a look at our latest podcast, "Saul & Freddy." They're two senior citizens (ages 86 and 90) who we interviewed about health care while they were enjoying a beautiful sunny day -- and each other's company -- in New York's Central Park.
Here's the link (look under the "Podcasts" section):
http://www.cmpi.org
They're older ... but wiser. And politicians and pundits would be wise to heed their words.
You know the song. Now have a look at our latest podcast, "Saul & Freddy." They're two senior citizens (ages 86 and 90) who we interviewed about health care while they were enjoying a beautiful sunny day -- and each other's company -- in New York's Central Park.
Here's the link (look under the "Podcasts" section):
http://www.cmpi.org
They're older ... but wiser. And politicians and pundits would be wise to heed their words.
The New York Post's Sue Edelman reports that the Ground Zero responders Michael Moore took to Cuba because they couldn't get health care in America -- didn't get much care in Cuba.
Read here
Now the, er, inconvenient truth -- they were actually eligible for free health care under not one -- but at least three programs operating today.
The WTC Medical Monitoring and Treatment Program is a consortium of providers, including: Bellevue Hospital, Mt. Sinai Medical Center, Nassau County University Medical Center, Queens College Ground Zero Health Watch, SUNY-Stony Brook, UMDNJ-Robert Wood Johnson University Hospital, and other providers nationwide. Call (888) 702-0630 or (212) 241-1554, or visit www.wtcexams.org . Nearly 40 percent of the people being served by the program do NOT have health insurance and are receiving free care. Even if they worked for one day or a couple of hours at Ground Zero they are receiving care.
The Association of Occupational and Environmental Clinics (AOEC) is a non-profit organization that provides occupational health referrals in your area. Contact AOEC at 1010 Vermont Ave., NW #513, Washington, DC 20005, call (888) 347-2632 or (202) 347-4976, or www.aoec.org. New York State Occupational Health Clinic Network. For more information, contact your local occupational health clinic or the New York State Department of Health at (800) 458-1158, x7900 or (518) 402-7900, or visit www.health.state.ny.us/nysdoh/environ/occupate.htm .
We provide these links in the hopes that those in need get the care they deserve instead of the misinformation that will be fed to them in Sicko. Moore's movie does a disservice to the compassion and hard work of the caring professionals who actually improve the lives of 9-11 workers instead of exploiting them.
Read here
Now the, er, inconvenient truth -- they were actually eligible for free health care under not one -- but at least three programs operating today.
The WTC Medical Monitoring and Treatment Program is a consortium of providers, including: Bellevue Hospital, Mt. Sinai Medical Center, Nassau County University Medical Center, Queens College Ground Zero Health Watch, SUNY-Stony Brook, UMDNJ-Robert Wood Johnson University Hospital, and other providers nationwide. Call (888) 702-0630 or (212) 241-1554, or visit www.wtcexams.org . Nearly 40 percent of the people being served by the program do NOT have health insurance and are receiving free care. Even if they worked for one day or a couple of hours at Ground Zero they are receiving care.
The Association of Occupational and Environmental Clinics (AOEC) is a non-profit organization that provides occupational health referrals in your area. Contact AOEC at 1010 Vermont Ave., NW #513, Washington, DC 20005, call (888) 347-2632 or (202) 347-4976, or www.aoec.org. New York State Occupational Health Clinic Network. For more information, contact your local occupational health clinic or the New York State Department of Health at (800) 458-1158, x7900 or (518) 402-7900, or visit www.health.state.ny.us/nysdoh/environ/occupate.htm .
We provide these links in the hopes that those in need get the care they deserve instead of the misinformation that will be fed to them in Sicko. Moore's movie does a disservice to the compassion and hard work of the caring professionals who actually improve the lives of 9-11 workers instead of exploiting them.
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.
