Latest Drugwonks' Blog
Rumor has it that the WH is fed up with the Republican holds on Andy's nomination and will seek to pressure Senators Demint and Vitter to drop their craven and politically motivated opposition during the lameduck session. Demint will never get the GAO study he wants looking RU-486 and Vitter will get his importation vote anyways because the Dems are interested in spending billions to turn the FDA into a parcel inspection service for European wholesalers while letting the agency infrastructure for evaluating new medicines fall apart....
Businessweek's John Carey has a nice article describing the hell awaiting drug companies come January when the Democrats take control of both ends of Congress...the question is, do the companies have what it takes to use meet this challenge and actually exploit the inherent weaknesses and contradictions in the Democrat proposals...
USA, 11/9/2006 - For drugmakers, the Democratic congressional election triumph means a return to the political crosshairs.
Nancy Pelosi (D-Calif.), widely expected to be the new Speaker of the House, has vowed to give the government the power to negotiate—and thus, she hopes, drive down—drug prices for Medicare patients. Henry Waxman (D-Calif.) and John Dingell (D-Mich.), now that they are back in power, "are licking their chops at the prospect of having hearings" on topics such as the sky-high price of some cancer drugs, says analyst Ira S. Loss of Washington Analysis, which assesses the impact of public policy on investors. The industry also may face a higher bar for drug approvals at the Food & Drug Administration.
So it's no surprise that, on the day after the Nov. 7 election, pharmaceutical stocks went down. The AMEX pharma index sank nearly 2%. Losers included everyone from Pfizer and Schering-Plough to Eli Lilly and Merck.
The scrutiny could be intense. In the next Congress, expect hearings—and well-publicized outrage—over the price of drugs like Genentech's cancer treatment Avastin, which can cost more than $50,000 per year. Expect the Pelosi-led House to quickly act on her promise by passing a measure aimed at driving down the cost of drugs in the Medicare program. Expect more talk about importing cheaper drugs from Canada, and more rhetoric about how the FDA may have moved too fast in the past, allowing risky drugs like Merck's Vioxx on the market. "
Well, we will see. The word is that the D's know the vaunted savings can't be had unless you rob seniors of the choice of drugs they do have. And the "third way" Democrats are likely to propose, requiring comparative effectiveness studies and driving prescribing to the drugs of most "value" will be caught up in methodological, biological and clinical disputes and leave them open to charges that they want to government to practice medicine.
I can see a funny ad around seniors trying to get their medicines from the government supply depot or a costco type place where you have to buy your one drug by the caseload...
"In the meantime, the pharmaceutical industry is raking in the profits that are coming from the Medicare drug benefit. One big winner: Lilly, whose third-quarter sales rose 7%, with profits up 10%, in part on the strength of Medicare prescriptions for its mental illness drug Zyprexa. "
"Raking in?" More seniors are using more medicines. Meanwhile the actual price of Zyprexa (not the retail or manufacturer price) has fallen as a result of price competition. Why shouldn't Lilly prosper? If you sell more, you make more. Check the profit margins of genetic drug firms since Medicare came online, particularly Teva and Mylan, generic drug manufacturers that have had about a 50 percent jump in earnings as a result of patent expirations and a switch away from brand drugs.
Why not make a big stink about those margins or the big profits PBMs and pharmacists will make by selling generic drugs at markup?
If the Democrats want eliminate profit from the prospect of increasing sales volume (sell more, don't increase profits) then the road ahead will be rocky indeed.
If I were "Big Pharma" I would run ads pairing patients with Parkinson's, juvenile diabetes and spinal cord injury with scientists from their companies and with scientists from the small money losing biotech firms they are now investing billions with that are doing work in stem cells and Parkinsons. The scientists would disappear one by one as a narrator talks about how Medicare price controls will make future cures disappear.
Drug companies have a lot at stake. If they don't have the backbone to defend their mission, we will all suffer.
USA, 11/9/2006 - For drugmakers, the Democratic congressional election triumph means a return to the political crosshairs.
Nancy Pelosi (D-Calif.), widely expected to be the new Speaker of the House, has vowed to give the government the power to negotiate—and thus, she hopes, drive down—drug prices for Medicare patients. Henry Waxman (D-Calif.) and John Dingell (D-Mich.), now that they are back in power, "are licking their chops at the prospect of having hearings" on topics such as the sky-high price of some cancer drugs, says analyst Ira S. Loss of Washington Analysis, which assesses the impact of public policy on investors. The industry also may face a higher bar for drug approvals at the Food & Drug Administration.
So it's no surprise that, on the day after the Nov. 7 election, pharmaceutical stocks went down. The AMEX pharma index sank nearly 2%. Losers included everyone from Pfizer and Schering-Plough to Eli Lilly and Merck.
The scrutiny could be intense. In the next Congress, expect hearings—and well-publicized outrage—over the price of drugs like Genentech's cancer treatment Avastin, which can cost more than $50,000 per year. Expect the Pelosi-led House to quickly act on her promise by passing a measure aimed at driving down the cost of drugs in the Medicare program. Expect more talk about importing cheaper drugs from Canada, and more rhetoric about how the FDA may have moved too fast in the past, allowing risky drugs like Merck's Vioxx on the market. "
Well, we will see. The word is that the D's know the vaunted savings can't be had unless you rob seniors of the choice of drugs they do have. And the "third way" Democrats are likely to propose, requiring comparative effectiveness studies and driving prescribing to the drugs of most "value" will be caught up in methodological, biological and clinical disputes and leave them open to charges that they want to government to practice medicine.
I can see a funny ad around seniors trying to get their medicines from the government supply depot or a costco type place where you have to buy your one drug by the caseload...
"In the meantime, the pharmaceutical industry is raking in the profits that are coming from the Medicare drug benefit. One big winner: Lilly, whose third-quarter sales rose 7%, with profits up 10%, in part on the strength of Medicare prescriptions for its mental illness drug Zyprexa. "
"Raking in?" More seniors are using more medicines. Meanwhile the actual price of Zyprexa (not the retail or manufacturer price) has fallen as a result of price competition. Why shouldn't Lilly prosper? If you sell more, you make more. Check the profit margins of genetic drug firms since Medicare came online, particularly Teva and Mylan, generic drug manufacturers that have had about a 50 percent jump in earnings as a result of patent expirations and a switch away from brand drugs.
Why not make a big stink about those margins or the big profits PBMs and pharmacists will make by selling generic drugs at markup?
If the Democrats want eliminate profit from the prospect of increasing sales volume (sell more, don't increase profits) then the road ahead will be rocky indeed.
If I were "Big Pharma" I would run ads pairing patients with Parkinson's, juvenile diabetes and spinal cord injury with scientists from their companies and with scientists from the small money losing biotech firms they are now investing billions with that are doing work in stem cells and Parkinsons. The scientists would disappear one by one as a narrator talks about how Medicare price controls will make future cures disappear.
Drug companies have a lot at stake. If they don't have the backbone to defend their mission, we will all suffer.
How is the French government cutting national health care costs? Why by asking doctors to prescribe fewer medicines of course. In other words, deny patients the medicines they need in order to save the State a few euros in the short-term.
Don’t you love socialized medicine?
Time for a revival of Le Medecin malgre lui.
The full story can be found at:
http://www.reuters.com
Don’t you love socialized medicine?
Time for a revival of Le Medecin malgre lui.
The full story can be found at:
http://www.reuters.com
So now what happens?
Post-election it’s all about the letter “P.â€
I am concerned that, as far as FDA is concerned, we will lose whatever momentum there was towards an agency that was focusing on (as Andy von Eschenbach phrased it) “the three P's of prevention, predictive tools, and the participatory Critical Path†...
… and we will move to a House of Representatives that is focused on payback and partisan politics. And that means hearings. Lots and lots of hearings couched in the word “oversight.†And that’s deleterious and particularly dangerous right now because of PDUFA.
On the broader health care front the Big P is certainly going to be a debate over whether or not Part D should be redesigned, specifically whether the non-interference clause should be revoked. Our new Speaker, Nancy Pelosi has this on her “First 100 Hours†to-do list. And that’s just a preliminary peroration towards a more frightening parley over price controls and intellectual property (aka: patents).
You can also bet we’ll see more rhetoric over plans for phony importation schemes.
It's very important to remember that this election wasn't fought on health care. And don't let anybody tell you different.
Which means we must redouble our efforts to advance the public health by being peppy, potent, proactive, persuasive, puissant – and most importantly – positive.
America's health is too important to be about partisanship or about profits. It must be about progress, about patients.
We must keep our eyes on the prize and persevere.
Post-election it’s all about the letter “P.â€
I am concerned that, as far as FDA is concerned, we will lose whatever momentum there was towards an agency that was focusing on (as Andy von Eschenbach phrased it) “the three P's of prevention, predictive tools, and the participatory Critical Path†...
… and we will move to a House of Representatives that is focused on payback and partisan politics. And that means hearings. Lots and lots of hearings couched in the word “oversight.†And that’s deleterious and particularly dangerous right now because of PDUFA.
On the broader health care front the Big P is certainly going to be a debate over whether or not Part D should be redesigned, specifically whether the non-interference clause should be revoked. Our new Speaker, Nancy Pelosi has this on her “First 100 Hours†to-do list. And that’s just a preliminary peroration towards a more frightening parley over price controls and intellectual property (aka: patents).
You can also bet we’ll see more rhetoric over plans for phony importation schemes.
It's very important to remember that this election wasn't fought on health care. And don't let anybody tell you different.
Which means we must redouble our efforts to advance the public health by being peppy, potent, proactive, persuasive, puissant – and most importantly – positive.
America's health is too important to be about partisanship or about profits. It must be about progress, about patients.
We must keep our eyes on the prize and persevere.
If the D's take control of both the House and Senate expect legislation to rollback Medicare reforms enacted in 2003 to pass with Republican support. If they do, they will find that such proposals will require robbing seniors of the choice of essential medicines now and in the future and starve biotech firms that are already losing money of markets. If the pharma and biotech industry were politically smart they would link the Democrat support of embryonic stem cell research with the fact funding for the enabling technologies comes from private firms that would be bled to death by Democrat part D proposals. That's a big if....
Gail Wilensky, who ran the Health Care Finance Administration under Bush I (that's CMS now) has an article today calling for a new public-private agency to evaluate the comparative-effectiveness of medical technologies.
Gail is smart and thoughful on health care matter so I can't figure out what she was thinking here. Maybe she thought she could tame the CE crowd which has an agenda.
http://
As the ALLHAT and CATIE studies show, even well funded comparative effectiveness studies will fall into dis-use for every good reasons. They are poorly designed, they are superceded by studies or personalized medicines that are based on a better mechanistic understanding of disease pathways. Applying ALLHAT recommendations to African Americans will kill them for example. And notice that people who promote C-E never talk about genetic testing to determine which medicine works best? That would be like Tower records talking about Itunes...
Indeed, since most C-E are underpowered they do not capture the genetic variations that explain and cause differences in response to medicines or other intereventions so of course "they all look alike" and regress to cheaper is better. Meta analysis only reinforces this one size fits all conclusion. Which is why for example, NICE has never caught an increased survival benefit from any new cancer drug since 1970. Then again, if you post your QALY at 50K survival doesn't mean very much either.
All of which translates into reimbursement decisions and the comparative effectiveness crowd knows it.
Take UK, Germany, Australia and Canada. All take their sweet time reviewing studies. All deny and limit access to new medicines and have fail first policies based on C-E. Have you read any of the VA off-formulary guidances? Take someone who has non-hodgkins's lymphoma. In the private sector, Rituxan is standard therapy. But not in the countries you cite and not in the VA.. Why? According to the comparative effectiveness studies, the reimbursing agencies want you to go through more painful and more toxic treatments first.
Finally, the entire field of medicine is moving toward the molecular and the personalized. Comparative effectiveness in the 21st century boils down to the right treatment for the right person at the right time. The agency Gail proposes is totally unsuited for arriving at that answer. I have read everyone of the AHQR comparative effectiveness studies...They are not usable in the clinical setting for docs because they are one size fits all and retrospective.
We need to invest in developing personalized treatment strategies that are preventive and prospective in nature. All this C-E will make the foundations and liberals that hate drug companies -- who by the way -- are not developing the next generation of new medicines (biotech firms that make no money are, ) happy. But it will hurt patients by delaying access and giving bureaucrats who know nothing about the practice or science of medicine control over care.
Gail is smart and thoughful on health care matter so I can't figure out what she was thinking here. Maybe she thought she could tame the CE crowd which has an agenda.
http://
As the ALLHAT and CATIE studies show, even well funded comparative effectiveness studies will fall into dis-use for every good reasons. They are poorly designed, they are superceded by studies or personalized medicines that are based on a better mechanistic understanding of disease pathways. Applying ALLHAT recommendations to African Americans will kill them for example. And notice that people who promote C-E never talk about genetic testing to determine which medicine works best? That would be like Tower records talking about Itunes...
Indeed, since most C-E are underpowered they do not capture the genetic variations that explain and cause differences in response to medicines or other intereventions so of course "they all look alike" and regress to cheaper is better. Meta analysis only reinforces this one size fits all conclusion. Which is why for example, NICE has never caught an increased survival benefit from any new cancer drug since 1970. Then again, if you post your QALY at 50K survival doesn't mean very much either.
All of which translates into reimbursement decisions and the comparative effectiveness crowd knows it.
Take UK, Germany, Australia and Canada. All take their sweet time reviewing studies. All deny and limit access to new medicines and have fail first policies based on C-E. Have you read any of the VA off-formulary guidances? Take someone who has non-hodgkins's lymphoma. In the private sector, Rituxan is standard therapy. But not in the countries you cite and not in the VA.. Why? According to the comparative effectiveness studies, the reimbursing agencies want you to go through more painful and more toxic treatments first.
Finally, the entire field of medicine is moving toward the molecular and the personalized. Comparative effectiveness in the 21st century boils down to the right treatment for the right person at the right time. The agency Gail proposes is totally unsuited for arriving at that answer. I have read everyone of the AHQR comparative effectiveness studies...They are not usable in the clinical setting for docs because they are one size fits all and retrospective.
We need to invest in developing personalized treatment strategies that are preventive and prospective in nature. All this C-E will make the foundations and liberals that hate drug companies -- who by the way -- are not developing the next generation of new medicines (biotech firms that make no money are, ) happy. But it will hurt patients by delaying access and giving bureaucrats who know nothing about the practice or science of medicine control over care.
Today the New York Times invokes the myth that drug prices went up an average of 6 percent last year. I think that number comes from an AARP study conducted by the PRIME Institute which used manufacturer prices posted from July 2005 and June 2006.
Well, a little research goes a long way. Going to plans in my home state of NJ, If you look at some of the changes in Medicare part D prices for the Top 25 Brand Name Prescription Products over the same time period, you find that the retail prices have actually gone up slower (4.5 percent) under the AARP than manufacturer prices reported by its own study and out out of pocket share during the initial coverage level has declined by 12 percent! That suggests actual price concessions were deep and that therefore the 6 percent manufacturer price increase (the sticker price) was wishful thinking at best. Prices during the gap under the Humana plan decreased by 4 percent a year and the out of pocket costs during coverage have dropped as well.
And in all cases the retail price of the drug is cheaper than what seniors could get a drugstore.com.
Moving over to the VA model is to see that drugs such as Aricept, Abilify, Evista, Fosamax, Lipitor and Xalatan are not on the VA formulary while they are on the Medicare Part D formulary.
That's just for starters. Which explains why nearly 35 percent of VA seniors tried to join Medicare part D.
Well, a little research goes a long way. Going to plans in my home state of NJ, If you look at some of the changes in Medicare part D prices for the Top 25 Brand Name Prescription Products over the same time period, you find that the retail prices have actually gone up slower (4.5 percent) under the AARP than manufacturer prices reported by its own study and out out of pocket share during the initial coverage level has declined by 12 percent! That suggests actual price concessions were deep and that therefore the 6 percent manufacturer price increase (the sticker price) was wishful thinking at best. Prices during the gap under the Humana plan decreased by 4 percent a year and the out of pocket costs during coverage have dropped as well.
And in all cases the retail price of the drug is cheaper than what seniors could get a drugstore.com.
Moving over to the VA model is to see that drugs such as Aricept, Abilify, Evista, Fosamax, Lipitor and Xalatan are not on the VA formulary while they are on the Medicare Part D formulary.
That's just for starters. Which explains why nearly 35 percent of VA seniors tried to join Medicare part D.
Good morning class and I hope you had a relaxing and refreshing weekend.
To welcome you back, Professor Drugwonk has decided on a pop quiz. Please do not turn over your paper until I say "go!"
Question: Which article appeared in today's New York Times?
As drug prices climb, Democrats find fault with Medicare plan
For big drug companies, the new Medicare prescription benefit is proving to be a financial windfall larger than even the most optimistic Wall Street analysts had predicted. But those gains may come back to haunt drug makers if Democrats take control of Congress this week.
or ...
Antidepressants tied to lower suicide rates in kids
In US counties with the highest rates of prescriptions for selective serotonin reuptake inhibitors (SSRI), a type of antidepressant, the rate of suicide among children ages 5 to 14 is lower than that observed in counties with lower rates, according to a new report.
First person to get the answer correct wins the new edition of Sid Wolfe's "Worst Pills, Best Pills."
Second person to get the correct answer wins two copies.
To welcome you back, Professor Drugwonk has decided on a pop quiz. Please do not turn over your paper until I say "go!"
Question: Which article appeared in today's New York Times?
As drug prices climb, Democrats find fault with Medicare plan
For big drug companies, the new Medicare prescription benefit is proving to be a financial windfall larger than even the most optimistic Wall Street analysts had predicted. But those gains may come back to haunt drug makers if Democrats take control of Congress this week.
or ...
Antidepressants tied to lower suicide rates in kids
In US counties with the highest rates of prescriptions for selective serotonin reuptake inhibitors (SSRI), a type of antidepressant, the rate of suicide among children ages 5 to 14 is lower than that observed in counties with lower rates, according to a new report.
First person to get the answer correct wins the new edition of Sid Wolfe's "Worst Pills, Best Pills."
Second person to get the correct answer wins two copies.
Yawn?
According to today's edition of the Wall Street Journal, The U.S. Centers for Disease Control and Prevention is aiming to boost awareness of chronic fatigue syndrome.
Chronic fatigue syndrome "is a terrible illness that prevents many people from taking part in everyday activities and participating in the things they enjoy," CDC Director Dr. Julie Gerberding said at a news conference Friday. Early diagnosis and treatment of the disease are important for recovery -- even though it isn't clear what the best treatments are, CDC officials said.
Currently, there is no cure for the syndrome, which is estimated to affect around one million Americans.
Symptoms of the illness, including fatigue, short-term memory impairment, joint and muscle pain, are treated with medications that target the pain or fatigue. Antidepressants are also used.
Although the syndrome was officially recognized by the government in the late 1980s as a medical condition, many people still question whether the condition is a true physical illness.
The lack of knowledge on the causes and treatment of the disease has caused drug companies to stay away from research in the area. Information on the disease can be found at the CDC's Web site, www.cdc.gov/cfs/.
Philadelphia-based Hemispherx Biopharma Inc. plans to seek Food and Drug Administration approval to market Ampligen as a chronic fatigue treatment by the end of the year. If approved, it would be the first drug directly targeted to treat the syndrome.
According to today's edition of the Wall Street Journal, The U.S. Centers for Disease Control and Prevention is aiming to boost awareness of chronic fatigue syndrome.
Chronic fatigue syndrome "is a terrible illness that prevents many people from taking part in everyday activities and participating in the things they enjoy," CDC Director Dr. Julie Gerberding said at a news conference Friday. Early diagnosis and treatment of the disease are important for recovery -- even though it isn't clear what the best treatments are, CDC officials said.
Currently, there is no cure for the syndrome, which is estimated to affect around one million Americans.
Symptoms of the illness, including fatigue, short-term memory impairment, joint and muscle pain, are treated with medications that target the pain or fatigue. Antidepressants are also used.
Although the syndrome was officially recognized by the government in the late 1980s as a medical condition, many people still question whether the condition is a true physical illness.
The lack of knowledge on the causes and treatment of the disease has caused drug companies to stay away from research in the area. Information on the disease can be found at the CDC's Web site, www.cdc.gov/cfs/.
Philadelphia-based Hemispherx Biopharma Inc. plans to seek Food and Drug Administration approval to market Ampligen as a chronic fatigue treatment by the end of the year. If approved, it would be the first drug directly targeted to treat the syndrome.
Important new paper by, among others, my friend and former colleague, Randy Lutter, FDA's Associate Commissioner for Policy & Planning, on why personalized medicine saves lives and saves money.
Here's the executive summary:
Progress towards realizing a vision of personalized medicine—drugs and drug doses that are safer and more effective because they are chosen based on an individual’s genetic makeup—has been slower than once forecast. The Food and Drug Administration has a key role to play in facilitating the use of genetic information in drug therapies because it approves labels, and labels influence how doctors use drugs. Here we evaluate one example of how using genetic information in drug therapy may improve public health and lower health care costs.
Warfarin, an anticoagulant commonly used to prevent and control blood clots, is complicated to use because the optimal dose varies greatly among patients. If the dose is too strong the risk of serious bleeding increases and if the dose is too weak, the risk of stroke increases. We estimate the health benefits and the resulting savings in health care costs by using personalized warfarin dosing decisions based on appropriate genetic testing. We estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually. We estimate the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually, with a range of about $100 million to $2 billion.
Did that last bit get your attention? Good! Here's a link to the entire paper:
http://www.aei-brookings.org/admin/authorpdfs/page.php?id=1337&PHPSESSIS=2b0284fa8e8d5t08bd4e1515ac971482
Here's the executive summary:
Progress towards realizing a vision of personalized medicine—drugs and drug doses that are safer and more effective because they are chosen based on an individual’s genetic makeup—has been slower than once forecast. The Food and Drug Administration has a key role to play in facilitating the use of genetic information in drug therapies because it approves labels, and labels influence how doctors use drugs. Here we evaluate one example of how using genetic information in drug therapy may improve public health and lower health care costs.
Warfarin, an anticoagulant commonly used to prevent and control blood clots, is complicated to use because the optimal dose varies greatly among patients. If the dose is too strong the risk of serious bleeding increases and if the dose is too weak, the risk of stroke increases. We estimate the health benefits and the resulting savings in health care costs by using personalized warfarin dosing decisions based on appropriate genetic testing. We estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually. We estimate the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually, with a range of about $100 million to $2 billion.
Did that last bit get your attention? Good! Here's a link to the entire paper:
http://www.aei-brookings.org/admin/authorpdfs/page.php?id=1337&PHPSESSIS=2b0284fa8e8d5t08bd4e1515ac971482
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.
