Latest Drugwonks' Blog
Another sign that we have gone crazy...
Now who will track the kids who die because they don't get the meds they need or turn to alternative treatments or OTC products? At least following the signal and figuring out the source would have been more rational and compassionate...
I found this post from FiercePharma said it best...
1. Why don't you add the web address where the public can comment to the FDA?
2.How DARE this eletist godlike panel decide what legal drugs I am allowed to take for my asthma.
It is MY choice if the short term benefit of a LABA is worth the long term potential risk.
3. I am allergic to Advair (unable to digest the lactose based carrier), to get the LABA & steroid I have to take them separately.
The god damned FDA Panel has no right to limit or deny me this legal medicine that can save my life.
The FDA panel should NOT make decisions about how to deliver the drugs (separately or together.) If the LABA is legal in Advair, then it is legal. Denying the use in other (competitive) medicines is dicriminatory, increases the risks to my life, and raises the prices. It is also illegal for Advair to have a monopoly- even if the FDA created it.
FDA panel votes down two asthma meds
See Full StoryNow who will track the kids who die because they don't get the meds they need or turn to alternative treatments or OTC products? At least following the signal and figuring out the source would have been more rational and compassionate...
I found this post from FiercePharma said it best...
1. Why don't you add the web address where the public can comment to the FDA?
2.How DARE this eletist godlike panel decide what legal drugs I am allowed to take for my asthma.
It is MY choice if the short term benefit of a LABA is worth the long term potential risk.
3. I am allergic to Advair (unable to digest the lactose based carrier), to get the LABA & steroid I have to take them separately.
The god damned FDA Panel has no right to limit or deny me this legal medicine that can save my life.
The FDA panel should NOT make decisions about how to deliver the drugs (separately or together.) If the LABA is legal in Advair, then it is legal. Denying the use in other (competitive) medicines is dicriminatory, increases the risks to my life, and raises the prices. It is also illegal for Advair to have a monopoly- even if the FDA created it.
Wow. Healthcare reform.
President-Elect Obama, in officially introducing Tom Daschle as his HHS Secretary-designate, said (in effect) "if not now, when?"
Okay, got that. But many questions remain unanswered, like ... how.
One item that will be at the core of the agenda (even though the administration won't explicitly call it by its real name) will be pharmaceutical price controls.
There will be three immediate bites at the price control apple:
The first is the revocation of the Non-Interference Clause. By so doing the government will be able to "negotiate" prices for Part D drugs. That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head. There's also the potential for Uncle Sam to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.
Bite #2 is importation. Even though such a program won't save any money (less than .1% of drug spending according to OMB) and is fraught with safety issues, it does present the opportunity to import de facto price controls. Would a Secretary Daschle provide Secretarial Certification? Do the ends justify the means?
Bite #3 is comparative effectiveness. Senator Baucus has this as an integral part of his package and it would be surprising if others (specifically Senator Kennedy) wouldn't do the same. While comparative effectiveness isn't, per se, a price control mechanism -- it's the HOV lane to that destination a la healthcare technology assessment and a NICE-like proposition.
(Senator Baucus' legislation -- at least the 2008 version -- says the work of this new AHRQ-based body couldn't be used for CMS reimbursement decisions. Sure. And if you believe that one, I've got a Senate seat to sell you.)
And it's important to note that all three of these "bites" can happen simultaneously, separately, before, during, or as part of a more comprehensive Administration-reform initiative.
Let threedom ring -- but remember for whom the bell tolls.
President-Elect Obama, in officially introducing Tom Daschle as his HHS Secretary-designate, said (in effect) "if not now, when?"
Okay, got that. But many questions remain unanswered, like ... how.
One item that will be at the core of the agenda (even though the administration won't explicitly call it by its real name) will be pharmaceutical price controls.
There will be three immediate bites at the price control apple:
The first is the revocation of the Non-Interference Clause. By so doing the government will be able to "negotiate" prices for Part D drugs. That's kind of like negotiating with your hands tied behind your back and a gun pointed at your head. There's also the potential for Uncle Sam to dictate that Part D prices be tied to prices in other countries -- a kind of Medicare reference price.
Bite #2 is importation. Even though such a program won't save any money (less than .1% of drug spending according to OMB) and is fraught with safety issues, it does present the opportunity to import de facto price controls. Would a Secretary Daschle provide Secretarial Certification? Do the ends justify the means?
Bite #3 is comparative effectiveness. Senator Baucus has this as an integral part of his package and it would be surprising if others (specifically Senator Kennedy) wouldn't do the same. While comparative effectiveness isn't, per se, a price control mechanism -- it's the HOV lane to that destination a la healthcare technology assessment and a NICE-like proposition.
(Senator Baucus' legislation -- at least the 2008 version -- says the work of this new AHRQ-based body couldn't be used for CMS reimbursement decisions. Sure. And if you believe that one, I've got a Senate seat to sell you.)
And it's important to note that all three of these "bites" can happen simultaneously, separately, before, during, or as part of a more comprehensive Administration-reform initiative.
Let threedom ring -- but remember for whom the bell tolls.
According to the AP's Matt Perrone:
The AP (12/12, Perrone) (courtesy of the DIA briefing) the Food and Drug Administration (FDA) stated that it "will add the sternest safety warnings available" -- the so-called black-box warning -- "to prescription drugs used to cleanse the bowel before colonoscopies." The FDA was spurred into action after it "received more than 20 reports of a rare, but serious form of kidney failure among patients taking the drugs, known as oral phosphate products." Therefore, Salix Pharmaceuticals' Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous ) and OsmoPrep (sodium biphosphate, sodium phosphate) will now include a label that "warns that the drugs should be used with caution in older patients, those that suffer from dehydration and kidney disease, or those that take medications that affect the kidneys."
Wait there's more.
Oral sodium phosphate drugs, "sold with and without a prescription, have been associated with acute phosphate nephropathy, the kidney injury," and it "may lead to permanent kidney damage," Bloomberg News (12/12, Blum) adds. According to Joyce Korvick, M.D., deputy director of the agency's Division of Gastroenterology Products at the Center for Drug Evaluation and Research, "one reason for the risk might be that some people may be dehydrated and not drinking enough fluid when they use oral sodium phosphate products for bowel cleansing, despite the instructions on the products," WebMD (12/11, Hitti) reported. Meanwhile, the FDA is also recommending "that consumers not use over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, for bowel cleansing."
Those "treatments also shouldn't be used for bowel cleansing, and will get new warnings" as well, HealthDay (12/11, Reinberg) added. "At lower doses, however, they are safe for use as laxatives, the FDA said." But there "are alternatives to these preparations that can be used for bowel cleansing, including GoLYTELY and HalfLytely Bowel Prep," Dr. Korvick pointed out. Meanwhile, Hemant K. Roy, M.D., of Evanston-Northwestern Healthcare in Illinois, who wrote an editorial in the Archives of Internal Medicine that accompanied a study on "the risks of oral sodium phosphate" solutions, "stressed that warranted concerns about phosphate solutions shouldn't keep patients from undergoing colon cancer screening." The (NC) Triangle Business Journal (12/11, Coletta) and MedPage Today (12/11, Gever) also covered the story, as did the Los Angeles Times (12/11, Maugh) in its Booster Shots blog.
Doesn't the FDA have better things to do with it's time? Or put another way: has the regulatory apparatus of the nation state evolved to the point where it now has to tell people how to cleanse it's collective bowels safely and effectively? Apparently a manufacturer, in response to the black box put on the label because 20 people are too stupid to follow directions or not drink a case of beer before undergoing a colonoscopy, has pulled it's product. And thank goodness the media is there to cover this story.....
There's always my grandmother's recipe for fruit compote....
The AP (12/12, Perrone) (courtesy of the DIA briefing) the Food and Drug Administration (FDA) stated that it "will add the sternest safety warnings available" -- the so-called black-box warning -- "to prescription drugs used to cleanse the bowel before colonoscopies." The FDA was spurred into action after it "received more than 20 reports of a rare, but serious form of kidney failure among patients taking the drugs, known as oral phosphate products." Therefore, Salix Pharmaceuticals' Visicol (sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous ) and OsmoPrep (sodium biphosphate, sodium phosphate) will now include a label that "warns that the drugs should be used with caution in older patients, those that suffer from dehydration and kidney disease, or those that take medications that affect the kidneys."
Wait there's more.
Oral sodium phosphate drugs, "sold with and without a prescription, have been associated with acute phosphate nephropathy, the kidney injury," and it "may lead to permanent kidney damage," Bloomberg News (12/12, Blum) adds. According to Joyce Korvick, M.D., deputy director of the agency's Division of Gastroenterology Products at the Center for Drug Evaluation and Research, "one reason for the risk might be that some people may be dehydrated and not drinking enough fluid when they use oral sodium phosphate products for bowel cleansing, despite the instructions on the products," WebMD (12/11, Hitti) reported. Meanwhile, the FDA is also recommending "that consumers not use over-the-counter oral sodium phosphate products, such as Fleet Phospho-soda, for bowel cleansing."
Those "treatments also shouldn't be used for bowel cleansing, and will get new warnings" as well, HealthDay (12/11, Reinberg) added. "At lower doses, however, they are safe for use as laxatives, the FDA said." But there "are alternatives to these preparations that can be used for bowel cleansing, including GoLYTELY and HalfLytely Bowel Prep," Dr. Korvick pointed out. Meanwhile, Hemant K. Roy, M.D., of Evanston-Northwestern Healthcare in Illinois, who wrote an editorial in the Archives of Internal Medicine that accompanied a study on "the risks of oral sodium phosphate" solutions, "stressed that warranted concerns about phosphate solutions shouldn't keep patients from undergoing colon cancer screening." The (NC) Triangle Business Journal (12/11, Coletta) and MedPage Today (12/11, Gever) also covered the story, as did the Los Angeles Times (12/11, Maugh) in its Booster Shots blog.
Drugmaker recalls over-the-counter bowel cleansing solutions. In a separate article, Bloomberg News (12/12, Pollack, Blum) reports that "C.B. Fleet Co., a closely held maker of laxative products, said it was voluntarily withdrawing its oral, over-the-counter bowel cleansing solutions after U.S. health regulators warned such drugs may harm the kidneys." Specifically, the drugmakers are recalling "Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System used to clear the bowels before a colonoscopy," a "decision [that] was made because the Food and Drug Administration said...that this class of drugs should be available only by prescription."
Doesn't the FDA have better things to do with it's time? Or put another way: has the regulatory apparatus of the nation state evolved to the point where it now has to tell people how to cleanse it's collective bowels safely and effectively? Apparently a manufacturer, in response to the black box put on the label because 20 people are too stupid to follow directions or not drink a case of beer before undergoing a colonoscopy, has pulled it's product. And thank goodness the media is there to cover this story.....
There's always my grandmother's recipe for fruit compote....
But then again the girl couldn't bring herself to report that when Scott Gottlieb was at FDA -- and before -- he still saw patients in the ER. Her reporting in this piece, particularly her backhanded slap at Janet Woodcock as someone who hasn't or couldn't reform the FDA is short of slander....
"People close to the industry have been floating the names of other candidates to run the FDA -- including Janet Woodcock, a senior official at the agency -- who are seen as less likely to carry out a thorough overhaul of the FDA. Some Democratic aides have suggested Ms. Woodcock as a possible interim chief while a permanent leader is vetted."
Disgusting. And it just so happens that with the possible exception of Steve Nissen whose own conflicts, skeletons and yet to be revealed corrupt behavior while at Cleveland Clinic (most notably his not so veiled threats against companies that did not use him to conduct research), most of the other serious candidates for FDA commissioner have great respect for Dr. Woodcock. But then again, they are actual physicians, not journalists who failed to reveal they were at the same time working for left wing think tanks like Mundy...
Read article here
"People close to the industry have been floating the names of other candidates to run the FDA -- including Janet Woodcock, a senior official at the agency -- who are seen as less likely to carry out a thorough overhaul of the FDA. Some Democratic aides have suggested Ms. Woodcock as a possible interim chief while a permanent leader is vetted."
Disgusting. And it just so happens that with the possible exception of Steve Nissen whose own conflicts, skeletons and yet to be revealed corrupt behavior while at Cleveland Clinic (most notably his not so veiled threats against companies that did not use him to conduct research), most of the other serious candidates for FDA commissioner have great respect for Dr. Woodcock. But then again, they are actual physicians, not journalists who failed to reveal they were at the same time working for left wing think tanks like Mundy...
Read article here
Word is from that some in healthcare policy land are upset that Peter wrote a piece critical of the Baucus proposal to examine the comparative effectiveness of new drugs the way NICE does which could lead to rationing. Note to Peter's critics -- our focus is on people and innovation, not a particular Beltway interest or position. No one tells us what to say or do.
Let’s be honest --the fundamental assumption behind the push for a comparative effectiveness agency in the US is that high drug prices are the primary reason American healthcare costs are on the rise. That's simply not true. Drug prices went up less than 1 percent last year, well below the rate of inflation. Pharmaceuticals are about 11% of our national healthcare spend – with on-patent medications representing only about 7 percent. (Something to remember when we debate the non-interference clause and drug importation.)
In theory, properly designed comparative effectiveness studies can be a valuable tool in patient care. In theory. But in practice, in an increasingly personalized world, do large scale studies such as ALLHAT and CATIE really help? Marginally – at best. But all they really end up accomplishing is reaffirming the outdated methodologies of a cost-based system, when what we really need are the proper tools for patient-centric medicine.
While it’s true that comparative effectiveness and healthcare technology assessment (HTA) aren’t the same thing – the question on the table is whether one inevitably leads to the other. And with all the attention being paid to the “need for a US NICE,” the answer is “yes.”
To read more on this topic – and why Senator Baucus needs to go back to the drawing board, click here.
In theory, properly designed comparative effectiveness studies can be a valuable tool in patient care. In theory. But in practice, in an increasingly personalized world, do large scale studies such as ALLHAT and CATIE really help? Marginally – at best. But all they really end up accomplishing is reaffirming the outdated methodologies of a cost-based system, when what we really need are the proper tools for patient-centric medicine.
While it’s true that comparative effectiveness and healthcare technology assessment (HTA) aren’t the same thing – the question on the table is whether one inevitably leads to the other. And with all the attention being paid to the “need for a US NICE,” the answer is “yes.”
To read more on this topic – and why Senator Baucus needs to go back to the drawing board, click here.
The out of touch editorial board of the NY Times writing from the only valuable asset left in the Sulzburger empire (the superfluous new building on 8th Avenue) tries to explain would use generic drugs but for the advertising efforts of brand name drug companies.
Which is sort of like saying the NYT readership should continue to decline as people just pick up the news from any old source even in the face of those annoying and relentless ads the paper keeps running...
What I find interesting is that there are actually still 40 pages in the paper's section A...
Read More
Which is sort of like saying the NYT readership should continue to decline as people just pick up the news from any old source even in the face of those annoying and relentless ads the paper keeps running...
What I find interesting is that there are actually still 40 pages in the paper's section A...
Read More
Wny not extend this concept to every aspect of health care possible? Why not pay people for NOT using health care services, for staying healthy, for exercising?
Stay healthy, pay less.
Get healthy, earn money
Prevent disease, get paid.
Read article here
Stay healthy, pay less.
Get healthy, earn money
Prevent disease, get paid.
Read article here
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Lest anyone forget, the indicted Democrat governor had lots of friends the last time he peddled his failed and fudged I-SaveRx program to reimport drugs from wholesalers in Canada, Ireland and other places that Blago made up on the fly....another scam:
"Blagojevich has been among a growing bipartisan group of politicians that is fighting Bush on the importation issue. He and U.S. Rep. Rahm Emanuel, D-Ill., contend that increasing drug imports will create competitive pressures that will force pharmaceutical companies to lower their prices in the United States. The two have even organized a program, so far lightly used, in which residents in Illinois and a few other states can purchase drugs through the Internet from Canada and Europe."
"Blagojevich has been among a growing bipartisan group of politicians that is fighting Bush on the importation issue. He and U.S. Rep. Rahm Emanuel, D-Ill., contend that increasing drug imports will create competitive pressures that will force pharmaceutical companies to lower their prices in the United States. The two have even organized a program, so far lightly used, in which residents in Illinois and a few other states can purchase drugs through the Internet from Canada and Europe."
Canada considers plan to stop Internet, mail-order drug sales to Americans.
Source: 
Chicago Tribune (Chicago, IL)
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.
