Latest Drugwonks' Blog
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.
I just finished reading all of the testimony and MedPac's recommendations about a comparative effectiveness commission. By the time everything is set up and they appoint all the people to run the commission (no doubt the very people who recommended it's creation) personalized medicine will have become very, very real. Or more to the point, since personalized medicine means the right medicine for the right person at the right time, why aren't we investing and supporting that since that is where the science and our biological reality exists? See the following article from the NY Times on how personalized medicine will make comparative effectiveness useless. We need personalized evidence of personalized medicine:
http://www.nytimes.com/2007/06/19/health/psychology/19beha.html?ei=5088&en=8af3ca746369c4db&ex=1339905600&adxnnl=1&partner=rssnyt&emc=rss&adxnnlx=1182453053-RSDs6n8k6574ORFf9+woIw
http://www.nytimes.com/2007/06/19/health/psychology/19beha.html?ei=5088&en=8af3ca746369c4db&ex=1339905600&adxnnl=1&partner=rssnyt&emc=rss&adxnnlx=1182453053-RSDs6n8k6574ORFf9+woIw
EMMA. If you liked the Cliff's Notes, you'll love the medical device.
FDA Clears 'Computerized Medication Box' for U.S. Market
The U.S. Food and Drug Administration has cleared for marketing the INRange Systems' Electronic Medication Management Assistant (EMMA), a programmable device that stores and dispenses prescription medication for patients' use in the home.
Essentially a computerized medication box, EMMA was designed to be used under the supervision of a licensed health care provider. EMMA can reduce drug identification and dosing errors, and allow health care professionals to monitor patient adherence to medication regimens in an outpatient setting. It may be especially useful for aging patients, as well as those with complex medication regimens such as patients with HIV.
"FDA's clearance of the INRange remote medication management system puts an important safety tool directly in the hands of patients and their health care providers," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "It will help take away some of the confusion patients can experience when taking prescription medications, and allow care providers to more closely monitor their patients' medications between office visits."
A 2006 Institute of Medicine report estimated that medication errors harm at least 1.5 million people in the United States annually.
EMMA consists of a medication delivery unit and two-way communication software that allows a health care professional to remotely manage prescriptions stored and released by the patient-operated delivery unit. The delivery unit is about the size of a bread box and plugs into a standard power outlet.
EMMA stores prescription medications, emits an audible alert to the patient when the prescribed medications are scheduled to be taken, and releases them onto a delivery tray when activated by the patient at the appropriate time. It uses a Web-based application for a health care professional, such as a doctor or pharmacist, to remotely schedule or adjust a patient's prescribed medications, and provides the health care professional with a history of each time patients access their medications.
FDA reviewed safety and effectiveness information for EMMA under the "de novo" classification process. The ability to petition for "de novo" initial classification was added under the Food and Drug Administration Modernization Act of 1997 to establish an additional way for novel, but less risky, devices to get to market.
No surprises in every box.
FDA Clears 'Computerized Medication Box' for U.S. Market
The U.S. Food and Drug Administration has cleared for marketing the INRange Systems' Electronic Medication Management Assistant (EMMA), a programmable device that stores and dispenses prescription medication for patients' use in the home.
Essentially a computerized medication box, EMMA was designed to be used under the supervision of a licensed health care provider. EMMA can reduce drug identification and dosing errors, and allow health care professionals to monitor patient adherence to medication regimens in an outpatient setting. It may be especially useful for aging patients, as well as those with complex medication regimens such as patients with HIV.
"FDA's clearance of the INRange remote medication management system puts an important safety tool directly in the hands of patients and their health care providers," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "It will help take away some of the confusion patients can experience when taking prescription medications, and allow care providers to more closely monitor their patients' medications between office visits."
A 2006 Institute of Medicine report estimated that medication errors harm at least 1.5 million people in the United States annually.
EMMA consists of a medication delivery unit and two-way communication software that allows a health care professional to remotely manage prescriptions stored and released by the patient-operated delivery unit. The delivery unit is about the size of a bread box and plugs into a standard power outlet.
EMMA stores prescription medications, emits an audible alert to the patient when the prescribed medications are scheduled to be taken, and releases them onto a delivery tray when activated by the patient at the appropriate time. It uses a Web-based application for a health care professional, such as a doctor or pharmacist, to remotely schedule or adjust a patient's prescribed medications, and provides the health care professional with a history of each time patients access their medications.
FDA reviewed safety and effectiveness information for EMMA under the "de novo" classification process. The ability to petition for "de novo" initial classification was added under the Food and Drug Administration Modernization Act of 1997 to establish an additional way for novel, but less risky, devices to get to market.
No surprises in every box.
Nova Scotia became the first province Wednesday to unveil plans for a publicly funded vaccine to protect young girls from the human papilloma virus - the leading cause of cervical cancer.
The announcement came as obstetricians and gynecologists from across Canada warned that more young women will die from the disease unless other provinces and territories act quickly. The latest federal budget included $300 million for such programs, but Nova Scotia is the first province to introduce one.
"There was no reason for not moving ahead (with the program)," Dr. Robert Strang, the province's acting deputy chief medical officer, said Wednesday.
Here's the full story:
http://www.canada.com/nationalpost/story.html?id=589d7feb-aea4-4c97-866d-c4cec272a45d&k=65541
The announcement came as obstetricians and gynecologists from across Canada warned that more young women will die from the disease unless other provinces and territories act quickly. The latest federal budget included $300 million for such programs, but Nova Scotia is the first province to introduce one.
"There was no reason for not moving ahead (with the program)," Dr. Robert Strang, the province's acting deputy chief medical officer, said Wednesday.
Here's the full story:
http://www.canada.com/nationalpost/story.html?id=589d7feb-aea4-4c97-866d-c4cec272a45d&k=65541
Why in the world would the Boston Globe run an op-ed by Lawrence Diller, whose unscientific views on ADHD and bi-polar disorder have now crystallized into an attack on Mass General's Joseph Biederman who, along with a handful of others, was able to steer child psychiatrists and pediatricians into an awareness of childhood manic depression. The Globe editorial accuses Biederman of being " morally culpable in providing the "science" that allowed Rebecca to die." Why not toss in dozens of others including CMPI board member Fred Goodwin who wrote the book on the treatment of bi-polar disorder, Herb Meltzer and others? I hear the black helicopters hovering in the background.
The Rebecca in question was given a fatal dose of clonodine by her parents. But Diller thinks it is the Biederman's fault. Why? Because he (and others) developed the standards " which include diagnosing preschool children as young as 2 with bipolar disorder and treating them with multiple medications."
How and why the Globe ran this cruel attack is beyond me. Biederman is a scholar and a caring, compassionate doctor. As for Diller's claim that of a "purported" diagnosis of bi-polar disorder, is there someone on the Globe editorial staff that is a closet Scientologist? Early onset bi-polar disorder has been clinicially documented, diagnosed and treated.
As the parent of a child who responded to the regimens developed by Biederman and others I can attest to it.
The Globe should be ashamed of itself for allowing it's reputation to be tarnished in this manner. As for Diller, he is beneath contempt and not worthy of further mention.
The Rebecca in question was given a fatal dose of clonodine by her parents. But Diller thinks it is the Biederman's fault. Why? Because he (and others) developed the standards " which include diagnosing preschool children as young as 2 with bipolar disorder and treating them with multiple medications."
How and why the Globe ran this cruel attack is beyond me. Biederman is a scholar and a caring, compassionate doctor. As for Diller's claim that of a "purported" diagnosis of bi-polar disorder, is there someone on the Globe editorial staff that is a closet Scientologist? Early onset bi-polar disorder has been clinicially documented, diagnosed and treated.
As the parent of a child who responded to the regimens developed by Biederman and others I can attest to it.
The Globe should be ashamed of itself for allowing it's reputation to be tarnished in this manner. As for Diller, he is beneath contempt and not worthy of further mention.
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.
