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CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
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Instapundit
Internet Drug News
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Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
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Neuroethics & Law
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11/27/2006 10:24 AM |
Here's a great example of how medicine and the private sector are transitioning to prospective and personalized care...with BG Medicine (called Beyond Genomics in this article) a company that was involved in the FDA task force I chaired when I was at the Manhattan Institute, helping build the foundation with bioinformatics...
Drug and device firms invest in study of plaque to find trigger for heart attacks (11-26-06)
The International Herald Tribune
New York, 11/27/2006 - Most people have a clear image of how atherosclerosis, popularly known as hardening of the arteries, causes a heart attack: fatty deposits called plaque build up in a coronary artery until the day the blood flow that sustains the heart is blocked.
If only they were right. In reality, coronary artery blockages almost always cause chest pain known as angina and other symptoms as they form. But half of the men and two-thirds of the women who suffer heart attacks never experience warning symptoms.
And autopsies of such victims frequently show blood clots jammed into arteries that have been only modestly narrowed.
Standard atherosclerosis therapies include bypass surgery to route blood around blockages, angioplasty and stenting to clear blockages from inside the artery and drugs like statins that reduce cholesterol levels to slow the formation of plaque. But they have not been enough to prevent as many as 500,000 deaths a year in the United States alone from what doctors call coronary artery disease.
As a result, many researchers have turned their attention from atherosclerosis in general to the tendency of some patients to develop a form of plaque prone to inflammation and rupture, which can spill a stew of cells into the bloodstream that can incite rapid clotting.
Such plaques have been called "vulnerable" plaque." But little is known about how such plaques form and even less about how long they last or what makes them rupture.
"Figuring out who is going to have plaque rupture would be the Holy Grail of cardiology," said Deepak Bhatt, a leading research cardiologist at the Cleveland Clinic Foundation.
The broadest effort yet to do that was to be announced Monday by a consortium pledging to invest $30 million over the next four years in an international plaque research program that will be overseen by Valentin Fuster, a cardiologist at Mount Sinai Medical Center in New York.
The initial sponsors include Humana, a leading manager of health plans; AstraZeneca and Merck, from the drug industry; Philips Electronics, which makes diagnostic machines widely used to scan the heart, the arteries that supply it with blood and other parts of the circulatory system; and BG Medicine, a start-up in Waltham, Massachusetts, formerly known as Beyond Genomics.
The centerpiece of the research will be a study of 4,000 to 6,000 Humana patients with at least two known risk factors for heart attacks. As the outcome for the patients becomes clear over the next few years, researchers hope that the profiles that emerge from the study will show patterns pointing to the high-risk patients who actually suffered heart attacks. That in turn could help the companies create therapeutic products.
The payoff could be enormous for health care companies. Coronary stents, which limit the symptoms of atherosclerosis and the damage from heart attacks, but do not reduce the likelihood of future attacks, make up a $6 billion market for device makers and produce some of the biggest profit margins the industry has ever seen.
Drug makers have fared even better with statins, which partially reduce the risk of new attacks and top $20 billion in worldwide sales.
"How we treat the disease is up for grabs," said Andrew Plump, who monitors early-stage research on new cardiovascular medicines at Merck's research center in Rahway, New Jersey.
The initiative spotlights the growing lineup of research projects and technology investments that reflect competition between drug makers and device companies to develop the safest, most effective and cheapest products to combat atherosclerosis. Read More & Comment...
Drug and device firms invest in study of plaque to find trigger for heart attacks (11-26-06)
The International Herald Tribune
New York, 11/27/2006 - Most people have a clear image of how atherosclerosis, popularly known as hardening of the arteries, causes a heart attack: fatty deposits called plaque build up in a coronary artery until the day the blood flow that sustains the heart is blocked.
If only they were right. In reality, coronary artery blockages almost always cause chest pain known as angina and other symptoms as they form. But half of the men and two-thirds of the women who suffer heart attacks never experience warning symptoms.
And autopsies of such victims frequently show blood clots jammed into arteries that have been only modestly narrowed.
Standard atherosclerosis therapies include bypass surgery to route blood around blockages, angioplasty and stenting to clear blockages from inside the artery and drugs like statins that reduce cholesterol levels to slow the formation of plaque. But they have not been enough to prevent as many as 500,000 deaths a year in the United States alone from what doctors call coronary artery disease.
As a result, many researchers have turned their attention from atherosclerosis in general to the tendency of some patients to develop a form of plaque prone to inflammation and rupture, which can spill a stew of cells into the bloodstream that can incite rapid clotting.
Such plaques have been called "vulnerable" plaque." But little is known about how such plaques form and even less about how long they last or what makes them rupture.
"Figuring out who is going to have plaque rupture would be the Holy Grail of cardiology," said Deepak Bhatt, a leading research cardiologist at the Cleveland Clinic Foundation.
The broadest effort yet to do that was to be announced Monday by a consortium pledging to invest $30 million over the next four years in an international plaque research program that will be overseen by Valentin Fuster, a cardiologist at Mount Sinai Medical Center in New York.
The initial sponsors include Humana, a leading manager of health plans; AstraZeneca and Merck, from the drug industry; Philips Electronics, which makes diagnostic machines widely used to scan the heart, the arteries that supply it with blood and other parts of the circulatory system; and BG Medicine, a start-up in Waltham, Massachusetts, formerly known as Beyond Genomics.
The centerpiece of the research will be a study of 4,000 to 6,000 Humana patients with at least two known risk factors for heart attacks. As the outcome for the patients becomes clear over the next few years, researchers hope that the profiles that emerge from the study will show patterns pointing to the high-risk patients who actually suffered heart attacks. That in turn could help the companies create therapeutic products.
The payoff could be enormous for health care companies. Coronary stents, which limit the symptoms of atherosclerosis and the damage from heart attacks, but do not reduce the likelihood of future attacks, make up a $6 billion market for device makers and produce some of the biggest profit margins the industry has ever seen.
Drug makers have fared even better with statins, which partially reduce the risk of new attacks and top $20 billion in worldwide sales.
"How we treat the disease is up for grabs," said Andrew Plump, who monitors early-stage research on new cardiovascular medicines at Merck's research center in Rahway, New Jersey.
The initiative spotlights the growing lineup of research projects and technology investments that reflect competition between drug makers and device companies to develop the safest, most effective and cheapest products to combat atherosclerosis. Read More & Comment...
11/27/2006 09:43 AM |
According to a WSJ.com/Harris Interactive health-care poll U.S. adults are divided on whether doctors should be allowed to prescribe drugs to treat diseases or conditions other than those for which they have been approved.
45% of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed.
Frighteningly, nearly two-thirds say they would agree to prohibit off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations. Attention must be paid – this is the slippery slope that the Apostles of Evidence-based Medicine would have us follow – to disastrous consequences.
Fortunately, when put into the appropriate perspective, Americans don't want to hamper innovation. 55% believe that if doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases vs. 35% who disagree.
More than two-thirds believe drug companies shouldn't be “allowed to encourage†off-label use vs. 12% who disagree and 20% who aren't sure. Perhaps a better way to have framed that question would have been to have asked if drug companies should be “allowed to share valid clinical information†about off-label use?
One wonders if the pollsters screened out as respondents patients with cancer, multiple sclerosis, etc. and their family members. And, if not, how that segment answered the questions.
For that we do not need a research project – we need a robust Critical Path program. Read More & Comment...
45% of those surveyed say doctors "should be allowed to decide which prescription drug treatments to use with their patients regardless of what diseases they have or have not been approved for by the FDA," compared with 46% who said this shouldn't be allowed.
Frighteningly, nearly two-thirds say they would agree to prohibit off-label prescribing unless it is part of a clinical trial, while 28% wouldn't support such limitations. Attention must be paid – this is the slippery slope that the Apostles of Evidence-based Medicine would have us follow – to disastrous consequences.
Fortunately, when put into the appropriate perspective, Americans don't want to hamper innovation. 55% believe that if doctors aren't allowed to prescribe freely that it will be much more difficult to find new and innovative ways to treat diseases vs. 35% who disagree.
More than two-thirds believe drug companies shouldn't be “allowed to encourage†off-label use vs. 12% who disagree and 20% who aren't sure. Perhaps a better way to have framed that question would have been to have asked if drug companies should be “allowed to share valid clinical information†about off-label use?
One wonders if the pollsters screened out as respondents patients with cancer, multiple sclerosis, etc. and their family members. And, if not, how that segment answered the questions.
For that we do not need a research project – we need a robust Critical Path program. Read More & Comment...
11/22/2006 08:37 PM |
"The newly empowered Democrats' vow to cut healthcare costs might spell bad news for the brand-name pharmaceutical industry, but could provide new momentum for generic drug rivals, the Wall Street Journal reported on its Web site on Tuesday. "
.How could more competition be bad? Unless of course Dems want to protect generic companies from competition in the process,.,,If the GOP is smart, they will respond with measures to accelerate and encourage development of new drugs too -- as well as protect authorized generics -- since new drugs are the source of generic profits in the final analysis and authorized generics ultimately promote more price competition! Read More & Comment...
.How could more competition be bad? Unless of course Dems want to protect generic companies from competition in the process,.,,If the GOP is smart, they will respond with measures to accelerate and encourage development of new drugs too -- as well as protect authorized generics -- since new drugs are the source of generic profits in the final analysis and authorized generics ultimately promote more price competition! Read More & Comment...
11/22/2006 12:41 PM |
I was in Montreal yesterday giving a lecture on why ideas -- and not just politics -- matter in health care. On my way to the hotel where the conference was being held I saw the headline of the Canada's newspaper of record, The Toronto Globe and Mail. In bold type, across the entire width of Page One was the headline:
Vow Broken on Cancer Wait Times
"It was a bold promise backed by billions of dollars in new government funding: Cancer patients should not have to wait longer than four weeks to obtain critical radiation treatment."
"Four weeks. That's double the maximum waiting time oncologists recommend but still seemingly better than the cancer-care limbo many patients faced when Liberal health minister Ujjal Dosanjh and his provincial counterparts made the announcement last December."
"But figures obtained by The Globe and Mail show a staggering 70% of Canadian hospitals surveyed are unable to meet that standard for prostate cancer patients."
You get the picture?
And yesterday was only the most recent installment of a weeklong series on how the Canadian health care system is failing cancer patients.
Today's headline reads:
Provincial drug disparity a roadblock to cancer research
"For the first time, Canada is unable to participate in a key clinical cancer trial because patients are not getting the best known treatment."
"Since most provinces don't fund Avastin, a crucial drug in the fight against colorectal cancer, Canadian patients could not join a trial run by the National Cancer Institute in the United States, which is studying what drug is most effective with chemotherapy — Avastin or Erbitux — or if they work best given together."
Please pass along this important and devastating series to anyone who recommends that what we need in the US is a system "just like Canada."
Here's a link to the series:
http://www.theglobeandmail.com/cancer
It's a worthwhile, disturbing read. Read More & Comment...
Vow Broken on Cancer Wait Times
"It was a bold promise backed by billions of dollars in new government funding: Cancer patients should not have to wait longer than four weeks to obtain critical radiation treatment."
"Four weeks. That's double the maximum waiting time oncologists recommend but still seemingly better than the cancer-care limbo many patients faced when Liberal health minister Ujjal Dosanjh and his provincial counterparts made the announcement last December."
"But figures obtained by The Globe and Mail show a staggering 70% of Canadian hospitals surveyed are unable to meet that standard for prostate cancer patients."
You get the picture?
And yesterday was only the most recent installment of a weeklong series on how the Canadian health care system is failing cancer patients.
Today's headline reads:
Provincial drug disparity a roadblock to cancer research
"For the first time, Canada is unable to participate in a key clinical cancer trial because patients are not getting the best known treatment."
"Since most provinces don't fund Avastin, a crucial drug in the fight against colorectal cancer, Canadian patients could not join a trial run by the National Cancer Institute in the United States, which is studying what drug is most effective with chemotherapy — Avastin or Erbitux — or if they work best given together."
Please pass along this important and devastating series to anyone who recommends that what we need in the US is a system "just like Canada."
Here's a link to the series:
http://www.theglobeandmail.com/cancer
It's a worthwhile, disturbing read. Read More & Comment...
11/22/2006 08:26 AM |
What can you get for four bucks these days? Cheese in a spray can? Cinnamon dental floss?
How about a month's supply of life-saving prescription drugs?
Have a look at this new op-ed in today's edition of The Baltimore Sun:
http://www.baltimoresun.com/news/opinion/oped/bal-op.walmart22nov22,0,6905737.story?coll=bal-oped-headlines
And have a very happy Thanksgiving. Read More & Comment...
How about a month's supply of life-saving prescription drugs?
Have a look at this new op-ed in today's edition of The Baltimore Sun:
http://www.baltimoresun.com/news/opinion/oped/bal-op.walmart22nov22,0,6905737.story?coll=bal-oped-headlines
And have a very happy Thanksgiving. Read More & Comment...
11/22/2006 08:00 AM |
New Hearing for Suit Against FDA
Associated Press
A federal court agreed yesterday to rehear a case that aims to get terminally ill patients early access to experimental drugs unlikely to be approved before they die.
The full 10-judge U.S. Court of Appeals for the District of Columbia Circuit will probably hear the case next summer, said Richard A. Samp, chief counsel for the Washington Legal Foundation.
The group, with the Abigail Alliance for Better Access to Developmental Drugs, sued the Food and Drug Administration in 2003. It is seeking broader access to drugs that have undergone preliminary safety testing in as few as 20 people and have yet to be approved by the FDA.
In 2004, a district court dismissed the case. In May, a three-judge appeals panel reinstated the lawsuit in a 2 to 1 decision.
The FDA, in turn, appealed and asked for the full court to rehear the case. Read More & Comment...
Associated Press
A federal court agreed yesterday to rehear a case that aims to get terminally ill patients early access to experimental drugs unlikely to be approved before they die.
The full 10-judge U.S. Court of Appeals for the District of Columbia Circuit will probably hear the case next summer, said Richard A. Samp, chief counsel for the Washington Legal Foundation.
The group, with the Abigail Alliance for Better Access to Developmental Drugs, sued the Food and Drug Administration in 2003. It is seeking broader access to drugs that have undergone preliminary safety testing in as few as 20 people and have yet to be approved by the FDA.
In 2004, a district court dismissed the case. In May, a three-judge appeals panel reinstated the lawsuit in a 2 to 1 decision.
The FDA, in turn, appealed and asked for the full court to rehear the case. Read More & Comment...
11/21/2006 07:52 AM |
Yesterday the New York Times published a few letters pertaining to the issue of Medicare reform and specifically the issue of non-interference.
My letter, alas, was not chosen. (My mother-in-law was very upset.)
Here is what I wrote:
To the Editor:
Your editorial (Lowering Medicare Drug Prices, November 14, 2006) suggests that the Veteran’s Administration “negotiates†prices for prescription drugs. Not so, it mandates them – and that’s more than a rhetorical finesse.
Under rules set by Congress, to sell drugs to the VA, companies must offer each drug at a price that “represents the same discount off a drug’s list price that the manufacturer offers its most-favored nonfederal customer under comparable terms and conditions.†The medication must be offered “at a discount of at least 24 percent off [the] nonfederal average manufacturer price (NFAMP). An excess inflation rebate is also required, equal to the percentage by which the price increase for [the] drug has exceeded the consumer price index (CPI) in the prior period.†The manufacturer must make all of its drugs available through the Federal Service Schedule for any of its drugs to be eligible for reimbursement under the VA and Defense Department health systems, the Public Health Service (including the Indian Health Service), the Coast Guard, and the various state Medicaid programs.
A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA formulary’s drugs are more than eight years old and more than 40 percent are 16 years old or more. Just 19 percent of all prescription drugs approved by the FDA since 2000 are available to veterans; only 38 percent approved during the 1990s are.
There’s a big difference between negotiating and mandating – and it’s not a thin line. My fear is that a government negotiated Part D plan is but the first step towards a more strident program of government price controls.
Sincerely,
Peter J. Pitts
Center for Medicine in the Public Interest Read More & Comment...
My letter, alas, was not chosen. (My mother-in-law was very upset.)
Here is what I wrote:
To the Editor:
Your editorial (Lowering Medicare Drug Prices, November 14, 2006) suggests that the Veteran’s Administration “negotiates†prices for prescription drugs. Not so, it mandates them – and that’s more than a rhetorical finesse.
Under rules set by Congress, to sell drugs to the VA, companies must offer each drug at a price that “represents the same discount off a drug’s list price that the manufacturer offers its most-favored nonfederal customer under comparable terms and conditions.†The medication must be offered “at a discount of at least 24 percent off [the] nonfederal average manufacturer price (NFAMP). An excess inflation rebate is also required, equal to the percentage by which the price increase for [the] drug has exceeded the consumer price index (CPI) in the prior period.†The manufacturer must make all of its drugs available through the Federal Service Schedule for any of its drugs to be eligible for reimbursement under the VA and Defense Department health systems, the Public Health Service (including the Indian Health Service), the Coast Guard, and the various state Medicaid programs.
A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA formulary’s drugs are more than eight years old and more than 40 percent are 16 years old or more. Just 19 percent of all prescription drugs approved by the FDA since 2000 are available to veterans; only 38 percent approved during the 1990s are.
There’s a big difference between negotiating and mandating – and it’s not a thin line. My fear is that a government negotiated Part D plan is but the first step towards a more strident program of government price controls.
Sincerely,
Peter J. Pitts
Center for Medicine in the Public Interest Read More & Comment...
11/21/2006 04:52 AM |
Health Affairs is running a study showing that most seniors have a coverage gap...what is left out or unstated or misconstrued is that fact that most seniors have chosen to have a coverage gap....Here is what the study notes but fails to highlight...
“United’s AARP product leverages beneficiaries’ recognition of the AARP ‘brand’,†while “Humana attracted high enrollment in its Standard PDP with an aggressive low-premium strategy.â€
In otherwords, people are choosing coverage based on values that matter to them, not what matters to elites. That was the point of competition. Also unstated is the fact that copays in the plans with most customers have declined as have the price of drugs outside the coverage period. That is also in response to demand.
How soon people forget that consumers, not policy elites, are in the drivers' seat here. Will people like it if the elites rob them of their choce o f plans, deductibles and drugs to satisfy elite concerns about "coverage"?
I don't think so... Read More & Comment...
“United’s AARP product leverages beneficiaries’ recognition of the AARP ‘brand’,†while “Humana attracted high enrollment in its Standard PDP with an aggressive low-premium strategy.â€
In otherwords, people are choosing coverage based on values that matter to them, not what matters to elites. That was the point of competition. Also unstated is the fact that copays in the plans with most customers have declined as have the price of drugs outside the coverage period. That is also in response to demand.
How soon people forget that consumers, not policy elites, are in the drivers' seat here. Will people like it if the elites rob them of their choce o f plans, deductibles and drugs to satisfy elite concerns about "coverage"?
I don't think so... Read More & Comment...
11/21/2006 04:10 AM |
This is my next to last post from Israel....
Since everyone who supports the government getting into the business of compraing the effectiveness of drugs have assured me that the methodological issues are quite easy to address I am announcing a pre-Thanksgiving comparative effectiveness contest to come up a way of establishing the comparative effectiveness of using different cancer drugs with the technological advance described in this article:
Toward Reducing The Toxic Side Effects Of Cancer Chemotherapy
An advance that may speed the use of "prodrug chemotherapy" -- one of the most promising new strategies for reducing the side effects of anti-cancer drugs -- is being reported by scientists from Johns Hopkins University's In Vivo Cellular and
This two-part chemotherapy involves giving patients the inactive form of an anti-cancer drug (the "prodrug") and an enzyme that changes the prodrug into an active, cancer fighting form. Patients first get the enzyme, which is gradually eliminated from normal tissue but builds up and remains in the tumor. Then patients get the prodrug, which changes into its active and toxic form only upon encountering the enzyme in the tumor.
"Determining the optimal time-window for prodrug injection is therefore of utmost importance for success of these strategies," Zaver M. Bhujwalla, lead author Cong Li and their colleagues note in a report scheduled for the Nov. 29 issue of the weekly Journal of the American Chemical Society.
If the prodrug were injected before all the enzyme cleared from normal tissue, it could damage normal tissue and cause body-wide side effects, they say.
The report describes the synthesis and early laboratory testing of the first prodrug-activating enzyme that can be imaged in tissue to time administration of the prodrug. The enzyme produces the active form of the common anti-cancer drug 5-fluorouracil. Its elimination from normal tissue can be monitored with magnetic resonance imaging (MRI) or optical imaging, according to the researchers."
Anyone want to come up with a method of comparing the effectiveness of delivering 5-F with side effects and without that a) does not delay access to new technologie, b) captures individual response to pro-drug injection since that will be key to optimal treatment and c) determine whether alternative drugs delivered in pro-drug or non-pro-drug fashion are the best for a particular cancer at a particular state? And extra credit for figuring out a way to continually add new drugs and new approaches in real time as opposed to when it is convenient for bureaucrats and politiciians
The comparative effectiveness crowd wants to spend a billion a year on this approach as a cure all for drug costs and a filter for setting up drug formularies AND it will be proposed as a way to set government prices for breakthrough drugs.. A Dunkin Donuts coupon for the winner of contest....We promise to post the results and responses...
Bonus question
Come up with a comparative effectiveness method for evaluatng the folowing advance:
Nanoparticle-Arsenic Combination Makes for More Potent Anticancer Agent
Arsenic trioxide, one of most promising drugs for treating acute
promyelocytic leukemia, encapsulated in lipid-based nanoparticles
designed to release their cargo inside tumor cells. Read More & Comment...
Since everyone who supports the government getting into the business of compraing the effectiveness of drugs have assured me that the methodological issues are quite easy to address I am announcing a pre-Thanksgiving comparative effectiveness contest to come up a way of establishing the comparative effectiveness of using different cancer drugs with the technological advance described in this article:
Toward Reducing The Toxic Side Effects Of Cancer Chemotherapy
An advance that may speed the use of "prodrug chemotherapy" -- one of the most promising new strategies for reducing the side effects of anti-cancer drugs -- is being reported by scientists from Johns Hopkins University's In Vivo Cellular and
This two-part chemotherapy involves giving patients the inactive form of an anti-cancer drug (the "prodrug") and an enzyme that changes the prodrug into an active, cancer fighting form. Patients first get the enzyme, which is gradually eliminated from normal tissue but builds up and remains in the tumor. Then patients get the prodrug, which changes into its active and toxic form only upon encountering the enzyme in the tumor.
"Determining the optimal time-window for prodrug injection is therefore of utmost importance for success of these strategies," Zaver M. Bhujwalla, lead author Cong Li and their colleagues note in a report scheduled for the Nov. 29 issue of the weekly Journal of the American Chemical Society.
If the prodrug were injected before all the enzyme cleared from normal tissue, it could damage normal tissue and cause body-wide side effects, they say.
The report describes the synthesis and early laboratory testing of the first prodrug-activating enzyme that can be imaged in tissue to time administration of the prodrug. The enzyme produces the active form of the common anti-cancer drug 5-fluorouracil. Its elimination from normal tissue can be monitored with magnetic resonance imaging (MRI) or optical imaging, according to the researchers."
Anyone want to come up with a method of comparing the effectiveness of delivering 5-F with side effects and without that a) does not delay access to new technologie, b) captures individual response to pro-drug injection since that will be key to optimal treatment and c) determine whether alternative drugs delivered in pro-drug or non-pro-drug fashion are the best for a particular cancer at a particular state? And extra credit for figuring out a way to continually add new drugs and new approaches in real time as opposed to when it is convenient for bureaucrats and politiciians
The comparative effectiveness crowd wants to spend a billion a year on this approach as a cure all for drug costs and a filter for setting up drug formularies AND it will be proposed as a way to set government prices for breakthrough drugs.. A Dunkin Donuts coupon for the winner of contest....We promise to post the results and responses...
Bonus question
Come up with a comparative effectiveness method for evaluatng the folowing advance:
Nanoparticle-Arsenic Combination Makes for More Potent Anticancer Agent
Arsenic trioxide, one of most promising drugs for treating acute
promyelocytic leukemia, encapsulated in lipid-based nanoparticles
designed to release their cargo inside tumor cells. Read More & Comment...
11/20/2006 09:27 AM |
This is not a real news story -- it's from today's edition of The Onion.
But it could be real if we don't address the building momentum towards evidence-based medicine and its cost-centric vs. patient-centric worldview.
End-Life Crisis Marked By Extravagant Spending Spree
The Onion, November 20, 2006
TOLEDO, OH—Ever since his retirement nearly a decade ago, area resident Oscar Subitzky just hasn't been the same. What began as a single, uncharacteristic extravagance—the payment of $15,000 for a coronary angioplasty to expand his narrowing arterial wall—has given way to a growing number of personal luxuries, from the latest brand-name heart medications to the most advanced palliative care. The unusual developments have led concerned family members to suspect that the once prudent and conservative 74-year-old widower is undergoing an acute end-life crisis.
"Sure, the operation seemed a little indulgent at first, but we could tell it was really important to Dad, so we didn't try to stop him from having it," said daughter Martha Welsch, 46, who can still remember when her father didn't need "pricey doodads" like defibrillators and cardiopulmonary-resuscitation devices to be content. "We all thought this was going to be a one-time thing, that it was just something Dad had to get out of his system, and then things would go back to normal," she said.
"Unfortunately, one surgery quickly became two surgeries, which soon turned into three surgeries," Welsch added. "That's when we realized the whole thing was a lot more serious than Dad just wanting to get a clogged artery cleared."
Subitzky's end-life crisis began when he suddenly left a secure job as an accountant at the age of 65. Welsch admitted she didn't quite understand what had come over Subitzky until he announced six months after his retirement that he had started seeing a cardiologist nearly half his age.
"You hear those stories about men in their late 60s all of a sudden coming home with an expensive new pacemaker or deciding to get work done on their kidneys out of the blue, but Dad just never seemed like the type," Welsch said. "If he honestly thinks that spending thousands of dollars on blood transfusions is going to change the way he feels inside, I'm afraid he's got another think coming."
Lately, Welsch said, between "all those fancy new breathing tubes he now wears," and the company of a new live-in nurse only a few years older than some of his grandchildren, she sometimes doesn't recognize her father.
"What's he going to do next, gallivant off to some $10,000-a-day, all-inclusive hospice?" she wondered.
In addition to throwing money around "like there's no tomorrow," as Welsch puts it, Subitzky has also reportedly grown obsessed with his appearance, examining his body for lumps, bruises, or signs of congested veins dozens of times a day. According to son Patrick Subitzky, 39, who admits to being a little embarrassed by his father's newfound vanity, the older man's obsession with his looks has also resulted in a "ridiculous new diet" of only dark-green leafy vegetables, fruits high in citric acid, whole-grain cereals, and absolutely no meat or dairy products.
"I love him and everything, but I don't know who my father thinks he is anymore," said Subitzky, who cringes every time his elderly father speeds around town in that "loud and flashy" ambulance. "He's even talking about a trip to Denver to see some heart specialist there. Whatever happened to the Oscar Subitzky who hated to travel?"
According to psychologist Elizabeth Schulz, who specializes in mortality-identity issues, an end-life crisis is an emotional state of fear and anxiety that often affects men and women between the ages of 65 and 100, and is usually sparked by the uncomfortable realization that one's time on earth is limited.
"Individuals in the middle of an end-life crisis are usually easy to spot, as they tend to foolishly acquire big-ticket items such as liver transplants to compensate for feelings of growing inadequacy," said Schulz, who in the past several years has observed increasing numbers of clients suffering from the common disorder wheeling themselves into her office. "While these shortsighted material purchases will often work at first, leaving the individual feeling rejuvenated and even energized, in the long term they have very little effect."
In the meantime, Welsch is hopeful that her father will eventually move beyond his present situation into a better place.
"I'm praying this is just a phase that will pass," Welsch said. "Hopefully in a couple of months this will all be over." Read More & Comment...
But it could be real if we don't address the building momentum towards evidence-based medicine and its cost-centric vs. patient-centric worldview.
End-Life Crisis Marked By Extravagant Spending Spree
The Onion, November 20, 2006
TOLEDO, OH—Ever since his retirement nearly a decade ago, area resident Oscar Subitzky just hasn't been the same. What began as a single, uncharacteristic extravagance—the payment of $15,000 for a coronary angioplasty to expand his narrowing arterial wall—has given way to a growing number of personal luxuries, from the latest brand-name heart medications to the most advanced palliative care. The unusual developments have led concerned family members to suspect that the once prudent and conservative 74-year-old widower is undergoing an acute end-life crisis.
"Sure, the operation seemed a little indulgent at first, but we could tell it was really important to Dad, so we didn't try to stop him from having it," said daughter Martha Welsch, 46, who can still remember when her father didn't need "pricey doodads" like defibrillators and cardiopulmonary-resuscitation devices to be content. "We all thought this was going to be a one-time thing, that it was just something Dad had to get out of his system, and then things would go back to normal," she said.
"Unfortunately, one surgery quickly became two surgeries, which soon turned into three surgeries," Welsch added. "That's when we realized the whole thing was a lot more serious than Dad just wanting to get a clogged artery cleared."
Subitzky's end-life crisis began when he suddenly left a secure job as an accountant at the age of 65. Welsch admitted she didn't quite understand what had come over Subitzky until he announced six months after his retirement that he had started seeing a cardiologist nearly half his age.
"You hear those stories about men in their late 60s all of a sudden coming home with an expensive new pacemaker or deciding to get work done on their kidneys out of the blue, but Dad just never seemed like the type," Welsch said. "If he honestly thinks that spending thousands of dollars on blood transfusions is going to change the way he feels inside, I'm afraid he's got another think coming."
Lately, Welsch said, between "all those fancy new breathing tubes he now wears," and the company of a new live-in nurse only a few years older than some of his grandchildren, she sometimes doesn't recognize her father.
"What's he going to do next, gallivant off to some $10,000-a-day, all-inclusive hospice?" she wondered.
In addition to throwing money around "like there's no tomorrow," as Welsch puts it, Subitzky has also reportedly grown obsessed with his appearance, examining his body for lumps, bruises, or signs of congested veins dozens of times a day. According to son Patrick Subitzky, 39, who admits to being a little embarrassed by his father's newfound vanity, the older man's obsession with his looks has also resulted in a "ridiculous new diet" of only dark-green leafy vegetables, fruits high in citric acid, whole-grain cereals, and absolutely no meat or dairy products.
"I love him and everything, but I don't know who my father thinks he is anymore," said Subitzky, who cringes every time his elderly father speeds around town in that "loud and flashy" ambulance. "He's even talking about a trip to Denver to see some heart specialist there. Whatever happened to the Oscar Subitzky who hated to travel?"
According to psychologist Elizabeth Schulz, who specializes in mortality-identity issues, an end-life crisis is an emotional state of fear and anxiety that often affects men and women between the ages of 65 and 100, and is usually sparked by the uncomfortable realization that one's time on earth is limited.
"Individuals in the middle of an end-life crisis are usually easy to spot, as they tend to foolishly acquire big-ticket items such as liver transplants to compensate for feelings of growing inadequacy," said Schulz, who in the past several years has observed increasing numbers of clients suffering from the common disorder wheeling themselves into her office. "While these shortsighted material purchases will often work at first, leaving the individual feeling rejuvenated and even energized, in the long term they have very little effect."
In the meantime, Welsch is hopeful that her father will eventually move beyond his present situation into a better place.
"I'm praying this is just a phase that will pass," Welsch said. "Hopefully in a couple of months this will all be over." Read More & Comment...
11/20/2006 07:37 AM |
What a difference a day (or two) makes.
On 11/15 Senator Grassley wrote to Senator Enzi and Senator Kennedy that the FDA “needs and deserves a strong permanent Commissioner.â€
On 11/17 he placed a “hold†on the nomination of Dr. von Eschenbach.
Maybe he’ll change his mind again tomorrow.
Maybe. Maybe not.
Maybe he needs to stop playing politics with the public health.
Maybe isn't good for the public health or the future of the FDA. Read More & Comment...
On 11/15 Senator Grassley wrote to Senator Enzi and Senator Kennedy that the FDA “needs and deserves a strong permanent Commissioner.â€
On 11/17 he placed a “hold†on the nomination of Dr. von Eschenbach.
Maybe he’ll change his mind again tomorrow.
Maybe. Maybe not.
Maybe he needs to stop playing politics with the public health.
Maybe isn't good for the public health or the future of the FDA. Read More & Comment...
11/17/2006 01:49 PM |
Some new and crucial statistics from the WHO:
* Medicines purchased over the Internet from sites that conceal their actual physical address are counterfeit in over 50% of cases.
This should be cause for pause and reflection for those in the US who are calling for various and sundry importation schemes.
* Counterfeiters exploit weaknesses in border control whenever governments try to promote world commerce by reducing border inspections.
And yet we've passed a law that prohibits US customs and border control agents from opening packages of foreign prescription drugs coming into the US.
* In 2004 over 60 tons of stolen, expired, and counterfeit pharmaceuticals were seized by federal agents in Mexico.
And it's been shown time and time again that many of the drugs being sent from the Great White North into the US begin their journey in sunny Mexico.
The complete WHO report can be found at:
Counterfeit Medicines: an update on estimates
We here at Drugwonks respectfully suggest that, when it comes to trying to legalize drugs "from Canada" ("In Canada," as always, in quotes), Speaker-Presumptive Pelosi stop asking "how" and start asking "WHO." Read More & Comment...
* Medicines purchased over the Internet from sites that conceal their actual physical address are counterfeit in over 50% of cases.
This should be cause for pause and reflection for those in the US who are calling for various and sundry importation schemes.
* Counterfeiters exploit weaknesses in border control whenever governments try to promote world commerce by reducing border inspections.
And yet we've passed a law that prohibits US customs and border control agents from opening packages of foreign prescription drugs coming into the US.
* In 2004 over 60 tons of stolen, expired, and counterfeit pharmaceuticals were seized by federal agents in Mexico.
And it's been shown time and time again that many of the drugs being sent from the Great White North into the US begin their journey in sunny Mexico.
The complete WHO report can be found at:
Counterfeit Medicines: an update on estimates
We here at Drugwonks respectfully suggest that, when it comes to trying to legalize drugs "from Canada" ("In Canada," as always, in quotes), Speaker-Presumptive Pelosi stop asking "how" and start asking "WHO." Read More & Comment...
11/17/2006 11:48 AM |
Further thoughts on "banning" pharmaceutical sales representatives from Stanford University Medical Center ...
Click on the link below. The article is on page 8:
http://rxcompliancereport.com/issues/2006/RxComp1116.pdf Read More & Comment...
Click on the link below. The article is on page 8:
http://rxcompliancereport.com/issues/2006/RxComp1116.pdf Read More & Comment...
11/17/2006 11:04 AM |
To read the testimony of all of but one (and a half) of the witnesses who presented before the Senate HELP committee, you can't help wonder whether the object was to pay homage to the dreadful IOM report or ignore the connection between science and FDA reform. Witnesses -- with the exception of Greg Simon's Faster Cures and the head of Benefit and Risk analysis at J and J were literally tripping over themselves talking about how important it was to spend all this money on making sure each and every drug was equally safe. Only Greg and the J and J guy managed to point out that embedding bean counters and epidemiologists from the Office of Drug Safety and giving them authority over drug appovals and study designs might add to the cost and time of new drug approvals without regard to the relative benefits of medicines. And the entire discussion was disconnected from ongoing efforts by the FDA to make pre-approval a more targered path that actually focused on eliminating safety problems.
Only Greg pointed out that the real value of a cliniical ttrials registry was to help avoid potential safety flaws and develop more targeted medicines and treatment regimens on a real time basis. (I think the industry is inching towards acceptance ... as it should)
And only Greg made the point, diplomatically, that the real crisis is not a lack of safe drugs but a lack of effective CURES being developed for patients being killed and crippled by horrible illnesses. As Garret Fitzgerald cogently observed and was cogently quoted (kudos to those reporters who did their job in this regard) with respect to studies about Arcoxia, Merck's latest COX-2, the use of many drugs for broadly shared problems (pain) will have to be tailored by metabolic response, age, co-morbidity, instead of banned and panned outright.
There is an unhealthy relationship between the HELP committee and the IOM panel ... There is no speaking truth to power. Instead, it is an effort on the part of the IOM committee to pass legislation it likes. I hope the committee ignores IOM and listens to Greg Simon.
Better use of medicines in a targeted fashion require a total feedback loop and not a balance of cultures or a massive purcahse of claims databases or the FDA's equivalents of a quasi-kosher certification as the IOM proposes. It would have been nice if the IOM had some really scientists on the panel...but that would have meant having a chair who wasn't threatend byy such expertise.... Read More & Comment...
Only Greg pointed out that the real value of a cliniical ttrials registry was to help avoid potential safety flaws and develop more targeted medicines and treatment regimens on a real time basis. (I think the industry is inching towards acceptance ... as it should)
And only Greg made the point, diplomatically, that the real crisis is not a lack of safe drugs but a lack of effective CURES being developed for patients being killed and crippled by horrible illnesses. As Garret Fitzgerald cogently observed and was cogently quoted (kudos to those reporters who did their job in this regard) with respect to studies about Arcoxia, Merck's latest COX-2, the use of many drugs for broadly shared problems (pain) will have to be tailored by metabolic response, age, co-morbidity, instead of banned and panned outright.
There is an unhealthy relationship between the HELP committee and the IOM panel ... There is no speaking truth to power. Instead, it is an effort on the part of the IOM committee to pass legislation it likes. I hope the committee ignores IOM and listens to Greg Simon.
Better use of medicines in a targeted fashion require a total feedback loop and not a balance of cultures or a massive purcahse of claims databases or the FDA's equivalents of a quasi-kosher certification as the IOM proposes. It would have been nice if the IOM had some really scientists on the panel...but that would have meant having a chair who wasn't threatend byy such expertise.... Read More & Comment...
11/17/2006 07:27 AM |
Merck, Lilly and Celgene have all invested heavily in technologies or companies that enable or are directly engaged in stem cell research. None of the projects are turning a profit or will likely do so for years. If Pelosi's Part D plan is implemented....slashing prices and profits of today's drugs by 40 percent with more of the same for stem cell cures in the future along with
new hurdles including comparative effectiveneess studies that take years to compelte and mandatory delays of at least a year (that's the VA anyway) in even allowing something to be used off formulary...what will happen?
Oh, and let's not forget the safety requirements that add at least two years to the time it takes to get such cures to dying patients.
Great assurances of safety in the Post-Pelosi/Waxman world means more and longer clinical trials instead of personalized medicine.
Well, the D's said they didn't want the status quo. Read More & Comment...
new hurdles including comparative effectiveneess studies that take years to compelte and mandatory delays of at least a year (that's the VA anyway) in even allowing something to be used off formulary...what will happen?
Oh, and let's not forget the safety requirements that add at least two years to the time it takes to get such cures to dying patients.
Great assurances of safety in the Post-Pelosi/Waxman world means more and longer clinical trials instead of personalized medicine.
Well, the D's said they didn't want the status quo. Read More & Comment...
11/16/2006 07:00 AM |
Last month Rep. Henry Waxman requested an investigation of the effects of US trade policy on public health from the Government Accountability Office and called for the US to drop pressure on WHO to bury a report on trade and health critical of US policies.
Rep. Waxman said, “Administration trade agreements have numerous provisions that threaten access to affordable medicine. We have to recognise that the Bush administration’s single-minded pursuit of intellectual property protections for drug companies can have potentially devastating consequences for the public health in developing countries.â€
Last month he was just wacky. Soon he'll be wacky with a gavel.
Don't you just love oversight! Read More & Comment...
Rep. Waxman said, “Administration trade agreements have numerous provisions that threaten access to affordable medicine. We have to recognise that the Bush administration’s single-minded pursuit of intellectual property protections for drug companies can have potentially devastating consequences for the public health in developing countries.â€
Last month he was just wacky. Soon he'll be wacky with a gavel.
Don't you just love oversight! Read More & Comment...
11/16/2006 06:39 AM |
Sometimes when you put a stake in the ground and stand up for what’s right, good things happen.
From today’s edition of the Wall Street Journal …
“In a case that adds momentum to Merck & Co.'s Vioxx defense strategy, the drug maker prevailed in the 11th trial over the painkiller after a New Orleans jury cleared the company of responsibility in a man's heart attack.â€
“Merck's win, which came after the jury deliberated just 90 minutes, gives the company a slight edge on the trial scorecard with six victories and four losses. (Another Merck victory was tossed out and will be retried in January.) It still faces some 24,000 lawsuits, however, and the pendulum could swing back in the plaintiffs' direction. Both sides are eager to notch as many early victories as possible before judges overseeing the litigation start corralling them into a settlement.â€
“Merck's strategy of fighting each lawsuit one by one, and its recent winning streak in the courtroom, have helped to restore confidence in the prospects of the Whitehouse Station, N.J., company. After being preoccupied with Merck's Vioxx liability for much of the past two years, investors lately have become much less worried about the litigation.†Read More & Comment...
From today’s edition of the Wall Street Journal …
“In a case that adds momentum to Merck & Co.'s Vioxx defense strategy, the drug maker prevailed in the 11th trial over the painkiller after a New Orleans jury cleared the company of responsibility in a man's heart attack.â€
“Merck's win, which came after the jury deliberated just 90 minutes, gives the company a slight edge on the trial scorecard with six victories and four losses. (Another Merck victory was tossed out and will be retried in January.) It still faces some 24,000 lawsuits, however, and the pendulum could swing back in the plaintiffs' direction. Both sides are eager to notch as many early victories as possible before judges overseeing the litigation start corralling them into a settlement.â€
“Merck's strategy of fighting each lawsuit one by one, and its recent winning streak in the courtroom, have helped to restore confidence in the prospects of the Whitehouse Station, N.J., company. After being preoccupied with Merck's Vioxx liability for much of the past two years, investors lately have become much less worried about the litigation.†Read More & Comment...
11/15/2006 05:04 PM |
Talking about making the auto industry competitive, Senator Carl Levin and John Dingell maintained yesterday that the problem isn't the other car companies but the anti-competitive practices of other countries that allow imports to be brought in at artificially low prices that include labor costs that are lower because of subsizied health care (a factual inaccuracy but whose counting).
Let's remember that the next time Dingell and Levin and Stabenow argue for drug importation which of course a function, not of companies but of countries.... Read More & Comment...
Let's remember that the next time Dingell and Levin and Stabenow argue for drug importation which of course a function, not of companies but of countries.... Read More & Comment...
11/15/2006 04:55 PM |
In am in Israel for the week visiting my son. Interesting article in the Jerusalem Post amidst the items about Hezbollah rearming, Hamas attacking and Iran building up its nuclear weaponry as it hopes the election of Democrats is the beginning of the end of American support for Israel..
Seems as though Israel's pharmaceutical industry is being hammered by counterfeits and patent theft. For those who think this is just an fiction fabricated to screw the Third World -- an idea that can get you a GENIUS AWARD.
It turns out that Israel's pharma and biotech industry has lost about $331 million a year from such practices.
The Jerusalem Post article can be found here:
Intellectual property fraud an 'epidemic' Read More & Comment...
Seems as though Israel's pharmaceutical industry is being hammered by counterfeits and patent theft. For those who think this is just an fiction fabricated to screw the Third World -- an idea that can get you a GENIUS AWARD.
It turns out that Israel's pharma and biotech industry has lost about $331 million a year from such practices.
The Jerusalem Post article can be found here:
Intellectual property fraud an 'epidemic' Read More & Comment...
11/15/2006 07:32 AM |
The title says it all.
Click on the link below and have a look at this new op-ed from the Orange County Register:
All prescription drugs not created equal
Those in agreement stand up and shout "Me too!" Read More & Comment...
Click on the link below and have a look at this new op-ed from the Orange County Register:
All prescription drugs not created equal
Those in agreement stand up and shout "Me too!" Read More & Comment...
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