Latest Drugwonks' Blog
Apparently the NYT thinks that an organization that evaluates medical devices for insurance companies and Medicare is less conflicted than the doctors seeking to help their patients. Does the NYT understand that head to head comparisons of most diagnostics and devices particularly for cancer have no use because of the increasingly personalized nature of treatment and the role such products play in seeking to increase the predictiveness and effectiveness of such technologies. Or that the only way to do so is not through randomized clinical trials but through clinical observation? Certainly insurance companies and ECRI (the comparative effectiveness outfit that works for insurance companies) would benefit from longer reviews before a product is paid for. But what about patients and doctors? Is there any evidence that delaying accessing to innovation for the sake of cost containment is any more efficient in finding the right treatment for the right patient than other patient-centered approaches developing knowledge?
Read New York Times Article here
Read New York Times Article here
In today’s Wall Street Journal, reporter Alicia Mundy begins her article on Wyeth v. Levine as follows:
And here’s former FDA Chief Counsel Dan Troy’s opinion:
“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations. FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.”
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations – so any mention of “the Bush FDA pushing preemption” is just bad reporting.
Recently, the 3rd U.S. Circuit Court of Appeals ruled that federal law bars a suit alleging false-advertising claims under state law because the U.S. Food and Drug Administration has "exclusive authority" to regulate prescription drug advertising.
"To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress' and the FDA's objectives in protecting the nation's prescription drug users," U.S. Circuit Judge D. Brooks Smith of the Western District of Pennsylvania, wrote in his 51-page opinion in Pennsylvania Employees Benefit Trust Fund, et al. v. Zeneca Inc.
Further, U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.
Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted” the law by saying the FDA’s approval of a drug label is only a “first step.” He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.
From the Boston Globe:
Press candidates on electronic medical records
Adopting health information technology will require the knowledge and resources of both the public and private sectors. But health IT will usher in a new era of medicine, improving communication among physicians, helping doctors discover health problems before they grow severe, and allowing medical staff to come up with personalized treatment options. Reforms like this hold enormous potential for reducing healthcare costs and improving the quality of life for millions of Americans without sacrificing valuable programs such as Medicare. Let's hope the candidates give them the attention they deserve.
PETER PITTS
The writer is president of the Center for Medicine in the Public Interest, and a former associate commissioner of the Food and Drug Administration.
http://www.nytimes.com/2008/10/26/opinion/26brooks.html?hp
Some of us hoped that by reforming his party, which has grown so unpopular, McCain could prove that he could reform the country.....
In some sense this whole campaign was a contest to see which party could reach out from its base and occupy that centrist ground. The Democratic Party did that. Senior Democrats like Robert Rubin, Larry Summers and Jason Furman actually created something called The Hamilton Project to lay out a Hamiltonian approach for our day. McCain and Republicans stayed within their lines. There was a lot of talk about earmarks. There was a good health care plan that was never fully explained. And there was Sarah Palin, who represents the old resentments and the narrow appeal of conventional Republicanism.
For those interested, the total number of articles Brooks wrote about the McCain health plan was zero. That's one less than the one he wrote fully explaining Hillary's single payer system...
http://select.nytimes.com/2007/09/18/opinion/18brooks.html
But let's go to the Hamlton project that lays out that Hamiltonian approach Brooks and other pastel Republicans hunger for. Medicare in particular.
Here's what the "centrists" have in mind for the Medicare prescription drug benefit according to
"To encourage price competition and discourage adverse selection, Medicare should allow competition for exclusive contracts to sell the standardized plans in each Part D region. To address the stresses on the federal budget, prices paid for drugs purchased on behalf of beneficiaries previously covered by Medicaid should be reduced to near their former Medicaid levels. To limit the ability of manufacturers to name their prices of therapeutically unique drugs, a standby mechanism for establishing temporary administered prices should be developed."
If you go through the position paper, Frank and Newhouse, two smart people who know better in my opinion, recommend price controls on breakthrough drugs based on the same approach taken by NICE in England. And they would give one drug benefit management firm the right to sell "standardized" plans to by region. That's a backdoor for a national drug formulary and robbing seniors of choice. They argue such a change is needed to encourage price competition, but how will reducing the number of plans increase competition? As for adverse selection, are Frank and Newhouse blind to the emergence of tools to drive patients to the right drug based on clinical and genetic criteria. As Mark McClellan has noted http://www.brookings.edu/papers/2007/04useconomics_frank.aspx
Some of us hoped that by reforming his party, which has grown so unpopular, McCain could prove that he could reform the country.....
In some sense this whole campaign was a contest to see which party could reach out from its base and occupy that centrist ground. The Democratic Party did that. Senior Democrats like Robert Rubin, Larry Summers and Jason Furman actually created something called The Hamilton Project to lay out a Hamiltonian approach for our day. McCain and Republicans stayed within their lines. There was a lot of talk about earmarks. There was a good health care plan that was never fully explained. And there was Sarah Palin, who represents the old resentments and the narrow appeal of conventional Republicanism.
For those interested, the total number of articles Brooks wrote about the McCain health plan was zero. That's one less than the one he wrote fully explaining Hillary's single payer system...
http://select.nytimes.com/2007/09/18/opinion/18brooks.html
But let's go to the Hamlton project that lays out that Hamiltonian approach Brooks and other pastel Republicans hunger for. Medicare in particular.
Here's what the "centrists" have in mind for the Medicare prescription drug benefit according to
"To encourage price competition and discourage adverse selection, Medicare should allow competition for exclusive contracts to sell the standardized plans in each Part D region. To address the stresses on the federal budget, prices paid for drugs purchased on behalf of beneficiaries previously covered by Medicaid should be reduced to near their former Medicaid levels. To limit the ability of manufacturers to name their prices of therapeutically unique drugs, a standby mechanism for establishing temporary administered prices should be developed."
If you go through the position paper, Frank and Newhouse, two smart people who know better in my opinion, recommend price controls on breakthrough drugs based on the same approach taken by NICE in England. And they would give one drug benefit management firm the right to sell "standardized" plans to by region. That's a backdoor for a national drug formulary and robbing seniors of choice. They argue such a change is needed to encourage price competition, but how will reducing the number of plans increase competition? As for adverse selection, are Frank and Newhouse blind to the emergence of tools to drive patients to the right drug based on clinical and genetic criteria. As Mark McClellan has noted http://www.brookings.edu/papers/2007/04useconomics_frank.aspx
From the educated pen of Matt Herper at Forbes.
Revolutionaries
Merck's Free Radical
Cancer drugs don't help 75% of the people who take them. Stephen Friend says he can use science to end the crapshoot
In the downtrodden drug industry, Merck cancer guru Stephen Friend may be one of the last great dreamers. His latest idea is one that would completely change the secretive and siloed way the pharmaceutical business fights cancer: create a giant, open-to-the-public database that will include every cancer drug and every patient and how that patient is doing. Track everything and over time we might be able to raise the abysmal success rate of treatment.
Friend, 54, has been a doctor who treated kids with cancer, an academic, an entrepreneur and a biotech chief executive. He helped develop a diagnostic test that predicts whether breast cancer will return after surgery. For five years he has been in charge of getting cancer drugs invented at Merck. Now 8 are in clinical trials, up from one, with 15 more preparing to enter trials. Friend is still unsatisfied. Why is it that, on average, three out of every four people who take a cancer medicine get lots of side effects but no benefit?
Researchers have been too willing to bet on hunches, he says, yet the technology to understand the complex biology of cancer is at hand. Spurred by Friend, Merck has spent billions on an arsenal of technologies for understanding how genes work. The resulting data stream is sent through the fastest supercomputer in the drug industry, a beast that consumes 64 kilowatts of power and is capable of 16 trillion calculations a second. Friend thinks he can accurately predict how groups of proteins in tumors work together and use that information to kill the cancer. He's trying to drag the secretive world of drug-discovery chemistry into the computer age.
The Friend way would take all the data collected each year from the thousands of cancer patients entered in trials, make it anonymous and put it into one database, preferably held by the government but definitely accessible to any physician or scientist. Right now those data are lost to the wind once the trial is over. But by keeping track of patients' genes, the genes in their tumors and what drugs they take, scientists will be able to discern patterns. Instead of trying drugs in order, from the ones that work most often to those that work least often, doctors will be able to pick the medicine that is most likely to help a particular patient. New medicines will get to market faster, along with diagnostic tests that will predict what will work. Friend predicts, somewhat optimistically, that prescribing decisions won't be based on "a promotional campaign." The database will decide.
"That future world is coming," says Friend. "And pharmaceutical companies can live in that world. If you develop the best drug and develop it for the right patient, all this does is get it to that right patient."
Merck has not done much so far to open its trial data to the world, nor have its rivals, but Merck has less to lose here and more to gain. It has fewer cancer drugs in human tests than Pfizer or AstraZeneca, and its shares have dropped by half this year. Friend is powering ahead, building a first stab at the big database with the H. Lee Moffitt Cancer Center in Tampa, Fla. Over the next five years every patient who walks through Moffitt's door will be asked to put genes and tumor samples in a database that will number 100,000 patients; 5,000 are already in. The database will provide information to the doctors doing research there and, eventually, to patients. If it turns out you have a gene that tells researchers what drug will work for you, Merck and Moffitt plan to let you know. Experiments that would have required weeks of thawing tumor samples now take a matter of hours.
"Right now most of medicine is based on a bunch of gray-haired guys who say, 'This is the way I do it and it seems to work,'" says Moffitt Director Bill S. Dalton. "We need to determine over time what is useful and what isn't. The only way to do that is to study 100,000 patients."
The database idea is taking root elsewhere. The U.S. government is funding a Cancer Genome Atlas, in order to figure out how a large database would work. The Multiple Myeloma Research Consortium has funded the collection of 1,900 patients' bone marrow samples that are being studied by the mit-Harvard Broad Institute, a genetic research center. New data from that effort will be available within months.
A megadatabase "could save me months or years of trying to collect patient information," says Oregon Health & Science University oncologist Brian Druker, who helped get Novartis' potent tumor-fighter Gleevec to the market. But he questions whether researchers understand cancer biology well enough for Friend's highly computational approach to pay off in the short term. "Over the long term the Merck strategy will be the winning strategy," says Druker. "But right now I don't think we're quite there."
Merck has spent the past few years trying to dig out of one of the toughest periods of its 120-year history. In 2003 several experimental drugs for various diseases failed, all at once. In 2004 the blockbuster painkiller Vioxx was yanked because it caused heart problems. Merck settled its Vioxx liability claims last year for $5 billion.
The stock recovered as eight drugs were approved in two years, but the revival was short-lived. Sales of its Vytorin cholesterol pill, produced with Schering-Plough, have crashed under doubts about its effectiveness at preventing heart attacks. Cervical cancer vaccine Gardasil has hit a growth wall, and the Food & Drug Administration rejected a promising cholesterol drug because Merck had not collected enough safety data.
Merck hopes fighting cancer is one way out of this funk. Friend was put in charge of Merck's cancer research efforts in 2003, two years after Merck bought the company he was running, Rosetta Inpharmatics. Friend had cofounded Rosetta in 1996 with Leland Hartwell, now director of the Fred Hutchinson Cancer Research Center in Seattle, and Leroy Hood, now president of the nearby Institute for Systems Biology. Like rival Affymetrix, Rosetta began selling tiny DNA chips that could be used to figure out how often cells were accessing their genes.
Merck bought Rosetta in 2001 for $620 million. Hood and Hartwell gave their shares to their institutions. Hartwell won the Nobel Prize six months later for other work. Friend made $10 million on the sale and built himself a solar-powered, off-the-grid house on Stuart Island.
The first fruits of Rosetta's technology began to emerge with a 2002 article in the New England Journal of Medicine. Dutch researchers using Rosetta's software found a particular pattern of genetic signals within breast cancer tumors that could predict whether or not the cancer would return after surgery. The test is not a significant product for Merck but was approved by the FDA in 2007. It and a similar test made by a rival, Genomic Health of Redwood City, Calif., are widely used to guide post-op treatment strategy.
Merck has been making big acquisitions to augment Friend's technology. In 2006 Merck spent $1.1 billion in cash to buy tiny Sirna Therapeutics, a leader in a field called RNA silencing, which uses small molecules to shut off genes. These molecules can't be used as drugs because the body destroys them. But they can be used in petri dishes to turn genes on and off to find out which are important.
This technology identified a gene last year called KRAS that predicts whether targeted cancer drugs like ImClone Systems' Erbitux will work in a given cancer patient. Clinical trials confirmed this finding this year, and it turned out that 40% of the patients who were receiving Erbitux were getting no benefit. In the past this would have hurt the chances for a drug like Erbitux, but the new test makes doctors more eager to use the drug when it makes sense. Eli Lilly is now buying ImClone for $6.5 billion.
Friend has identified three families of cancer drugs that he thinks his technology can accurately understand: drugs that destroy DNA; those that mess up cell division; and drugs that block some of the most important signals in cancer cells. Noticeably absent are drugs such as Genentech's $2 billion (annual sales) Avastin, which stanches tumor blood supply. These are too complicated to understand.
He's been buying the rights to drugs that fit his interests. In 2004 Merck bought Aton Pharmaceuticals for its drug Zolinza, used to treat cutaneous T cell lymphoma. In 2007 it pledged up to $1 billion for a cancer pill from Ariad Pharmaceuticals.
All of these bets are based on what Friend's giant computer tells him. "This is going to have to be the path taken by pharma in the future," says Hood of Friend's current work. "It's a gamble, but I think it's one that if Merck sticks with it, they'll win big."
Recently Friend took a detour on his way to a research conference in Chicago. He flew to Florida, rented a 1972 Chevy Chevelle and drove to Cape Canaveral to watch the space shuttle launch. He says it wasn't just that he wanted to recapture the feeling of the space race, when scientists were treated like heroes, but that he wanted to get a sense of a project that massive and complex. Creating a cancer drug is not that different.
"The puzzle's gotten big," he says of the cancer drug hunt. "But I think there is only one way to solve it."
Revolutionaries
Merck's Free Radical
Cancer drugs don't help 75% of the people who take them. Stephen Friend says he can use science to end the crapshoot
In the downtrodden drug industry, Merck cancer guru Stephen Friend may be one of the last great dreamers. His latest idea is one that would completely change the secretive and siloed way the pharmaceutical business fights cancer: create a giant, open-to-the-public database that will include every cancer drug and every patient and how that patient is doing. Track everything and over time we might be able to raise the abysmal success rate of treatment.
Friend, 54, has been a doctor who treated kids with cancer, an academic, an entrepreneur and a biotech chief executive. He helped develop a diagnostic test that predicts whether breast cancer will return after surgery. For five years he has been in charge of getting cancer drugs invented at Merck. Now 8 are in clinical trials, up from one, with 15 more preparing to enter trials. Friend is still unsatisfied. Why is it that, on average, three out of every four people who take a cancer medicine get lots of side effects but no benefit?
Researchers have been too willing to bet on hunches, he says, yet the technology to understand the complex biology of cancer is at hand. Spurred by Friend, Merck has spent billions on an arsenal of technologies for understanding how genes work. The resulting data stream is sent through the fastest supercomputer in the drug industry, a beast that consumes 64 kilowatts of power and is capable of 16 trillion calculations a second. Friend thinks he can accurately predict how groups of proteins in tumors work together and use that information to kill the cancer. He's trying to drag the secretive world of drug-discovery chemistry into the computer age.
The Friend way would take all the data collected each year from the thousands of cancer patients entered in trials, make it anonymous and put it into one database, preferably held by the government but definitely accessible to any physician or scientist. Right now those data are lost to the wind once the trial is over. But by keeping track of patients' genes, the genes in their tumors and what drugs they take, scientists will be able to discern patterns. Instead of trying drugs in order, from the ones that work most often to those that work least often, doctors will be able to pick the medicine that is most likely to help a particular patient. New medicines will get to market faster, along with diagnostic tests that will predict what will work. Friend predicts, somewhat optimistically, that prescribing decisions won't be based on "a promotional campaign." The database will decide.
"That future world is coming," says Friend. "And pharmaceutical companies can live in that world. If you develop the best drug and develop it for the right patient, all this does is get it to that right patient."
Merck has not done much so far to open its trial data to the world, nor have its rivals, but Merck has less to lose here and more to gain. It has fewer cancer drugs in human tests than Pfizer or AstraZeneca, and its shares have dropped by half this year. Friend is powering ahead, building a first stab at the big database with the H. Lee Moffitt Cancer Center in Tampa, Fla. Over the next five years every patient who walks through Moffitt's door will be asked to put genes and tumor samples in a database that will number 100,000 patients; 5,000 are already in. The database will provide information to the doctors doing research there and, eventually, to patients. If it turns out you have a gene that tells researchers what drug will work for you, Merck and Moffitt plan to let you know. Experiments that would have required weeks of thawing tumor samples now take a matter of hours.
"Right now most of medicine is based on a bunch of gray-haired guys who say, 'This is the way I do it and it seems to work,'" says Moffitt Director Bill S. Dalton. "We need to determine over time what is useful and what isn't. The only way to do that is to study 100,000 patients."
The database idea is taking root elsewhere. The U.S. government is funding a Cancer Genome Atlas, in order to figure out how a large database would work. The Multiple Myeloma Research Consortium has funded the collection of 1,900 patients' bone marrow samples that are being studied by the mit-Harvard Broad Institute, a genetic research center. New data from that effort will be available within months.
A megadatabase "could save me months or years of trying to collect patient information," says Oregon Health & Science University oncologist Brian Druker, who helped get Novartis' potent tumor-fighter Gleevec to the market. But he questions whether researchers understand cancer biology well enough for Friend's highly computational approach to pay off in the short term. "Over the long term the Merck strategy will be the winning strategy," says Druker. "But right now I don't think we're quite there."
Merck has spent the past few years trying to dig out of one of the toughest periods of its 120-year history. In 2003 several experimental drugs for various diseases failed, all at once. In 2004 the blockbuster painkiller Vioxx was yanked because it caused heart problems. Merck settled its Vioxx liability claims last year for $5 billion.
The stock recovered as eight drugs were approved in two years, but the revival was short-lived. Sales of its Vytorin cholesterol pill, produced with Schering-Plough, have crashed under doubts about its effectiveness at preventing heart attacks. Cervical cancer vaccine Gardasil has hit a growth wall, and the Food & Drug Administration rejected a promising cholesterol drug because Merck had not collected enough safety data.
Merck hopes fighting cancer is one way out of this funk. Friend was put in charge of Merck's cancer research efforts in 2003, two years after Merck bought the company he was running, Rosetta Inpharmatics. Friend had cofounded Rosetta in 1996 with Leland Hartwell, now director of the Fred Hutchinson Cancer Research Center in Seattle, and Leroy Hood, now president of the nearby Institute for Systems Biology. Like rival Affymetrix, Rosetta began selling tiny DNA chips that could be used to figure out how often cells were accessing their genes.
Merck bought Rosetta in 2001 for $620 million. Hood and Hartwell gave their shares to their institutions. Hartwell won the Nobel Prize six months later for other work. Friend made $10 million on the sale and built himself a solar-powered, off-the-grid house on Stuart Island.
The first fruits of Rosetta's technology began to emerge with a 2002 article in the New England Journal of Medicine. Dutch researchers using Rosetta's software found a particular pattern of genetic signals within breast cancer tumors that could predict whether or not the cancer would return after surgery. The test is not a significant product for Merck but was approved by the FDA in 2007. It and a similar test made by a rival, Genomic Health of Redwood City, Calif., are widely used to guide post-op treatment strategy.
Merck has been making big acquisitions to augment Friend's technology. In 2006 Merck spent $1.1 billion in cash to buy tiny Sirna Therapeutics, a leader in a field called RNA silencing, which uses small molecules to shut off genes. These molecules can't be used as drugs because the body destroys them. But they can be used in petri dishes to turn genes on and off to find out which are important.
This technology identified a gene last year called KRAS that predicts whether targeted cancer drugs like ImClone Systems' Erbitux will work in a given cancer patient. Clinical trials confirmed this finding this year, and it turned out that 40% of the patients who were receiving Erbitux were getting no benefit. In the past this would have hurt the chances for a drug like Erbitux, but the new test makes doctors more eager to use the drug when it makes sense. Eli Lilly is now buying ImClone for $6.5 billion.
Friend has identified three families of cancer drugs that he thinks his technology can accurately understand: drugs that destroy DNA; those that mess up cell division; and drugs that block some of the most important signals in cancer cells. Noticeably absent are drugs such as Genentech's $2 billion (annual sales) Avastin, which stanches tumor blood supply. These are too complicated to understand.
He's been buying the rights to drugs that fit his interests. In 2004 Merck bought Aton Pharmaceuticals for its drug Zolinza, used to treat cutaneous T cell lymphoma. In 2007 it pledged up to $1 billion for a cancer pill from Ariad Pharmaceuticals.
All of these bets are based on what Friend's giant computer tells him. "This is going to have to be the path taken by pharma in the future," says Hood of Friend's current work. "It's a gamble, but I think it's one that if Merck sticks with it, they'll win big."
Recently Friend took a detour on his way to a research conference in Chicago. He flew to Florida, rented a 1972 Chevy Chevelle and drove to Cape Canaveral to watch the space shuttle launch. He says it wasn't just that he wanted to recapture the feeling of the space race, when scientists were treated like heroes, but that he wanted to get a sense of a project that massive and complex. Creating a cancer drug is not that different.
"The puzzle's gotten big," he says of the cancer drug hunt. "But I think there is only one way to solve it."
In the drape measuring department there has been a lot of chatter and speculation about who will do what to the FDA if Obama gets elected, which in my mind is still not a given.
However rumor has it that Rosa DeLauro, who has been stonewalling on the funding for the Reagan Udall Critical Path Institute, has been asked to write the transition plan for the Department of HHS by the Obama camp. I can only imagine what that has in store for FDA given her Stone Age view of "Industry involvement = biomarkers = unsafe drugs".
As for names floating around to replace Andy von Eschenbach....How does FDA Commissioner David Graham sound? When I heard this from a contact who told me that Graham was mentioned not once but three times, I nearly choked on my supply of Vioxx. A Graham nomination would trigger mass resignations and protests at FDA and would send a signal that Obama or whoever he appointed at HHS was clearly in the pocket of the trial attorneys and drug safety nuts....
And speaking of suck-ups in pursuit of power...
Airdate: 10/1 - Health care policies
11AM Case Western University Cardiovascular Medicine Chair Dr. Steven Nissen, M.D. for Obama-Biden
Nissen has also given Obama about $3300 in campaign contributions in 2008
However rumor has it that Rosa DeLauro, who has been stonewalling on the funding for the Reagan Udall Critical Path Institute, has been asked to write the transition plan for the Department of HHS by the Obama camp. I can only imagine what that has in store for FDA given her Stone Age view of "Industry involvement = biomarkers = unsafe drugs".
As for names floating around to replace Andy von Eschenbach....How does FDA Commissioner David Graham sound? When I heard this from a contact who told me that Graham was mentioned not once but three times, I nearly choked on my supply of Vioxx. A Graham nomination would trigger mass resignations and protests at FDA and would send a signal that Obama or whoever he appointed at HHS was clearly in the pocket of the trial attorneys and drug safety nuts....
And speaking of suck-ups in pursuit of power...
Airdate: 10/1 - Health care policies
11AM Case Western University Cardiovascular Medicine Chair Dr. Steven Nissen, M.D. for Obama-Biden
Nissen has also given Obama about $3300 in campaign contributions in 2008
From Factcheck.org
In a TV ad and in speeches, Obama is making bogus claims that McCain plans to cut $880 billion from Medicare spending and to reduce benefits.
- A TV spot says McCain's plan requires "cuts in benefits, eligibility or both."
- Obama said in a speech that McCain plans "cuts" that would force seniors to "pay more for your drugs, receive fewer services, and get lower quality care."
- Update, Oct. 21: A second Obama ad claims that McCain’s plan would bring about a 22 percent cut in benefits, “higher premiums and co-pays," and more expensive prescription drugs.
http://www.factcheck.org/elections-2008/obamas_false_medicare_claim.html
The media continues -- with help from "watchdog" groups -- continues to characterize drugs as dangerous by confusing association with cause:
Prescription drug injuries and deaths reach record levels
A watchdog group reports that 4,825 deaths and nearly 21,000 injuries occurred in the first three months of 2008. The drugs heparin and varenicline are cited as the most dangerous.
The number of deaths and serious injuries associated with prescription drug use rose to record levels in the first quarter of this year, with 4,825 deaths and nearly 21,000 injuries, a watchdog group said Wednesday.
Those numbers represent a nearly threefold increase in deaths from the previous quarter and a 38% increase in injuries from last year's quarterly average, according to the Horsham, Pa.-based Institute for Safe Medication Practices.
Those numbers represent a nearly threefold increase in deaths from the previous quarter and a 38% increase in injuries from last year's quarterly average, according to the Horsham, Pa.-based Institute for Safe Medication Practices.
http://www.latimes.com/news/nationworld/nation/la-sci-drugs23-2008oct23,0,3729962.story
Are drugs three times more dangerous? Are we picking up more danger and death that is being attributed to other causes?
None of the above.
Here's a more likely answer provided by the authors of the ISMP study who happen to be well known industry and FDA critics.
"Most drugs in medical use produced only a small number of reports of serious
injury or death. One-half the 773 identifiable drugs tracked in the most recent
quarter had six or fewer serious adverse events reported. Only 50 drugs accounted
for 100 or more reported serious injuries."
http://www.ismp.org/
The newest drugs, the one's that are most likely reported in the media in other words or to be likely targets of lawsuits.
At the same it would appear prudent for companies who are launching new products or new uses to proactively seek out the response of consumers and integrate those responses into other pharmacovigilance activities as soon as possible. Studies show that doing so allow companies to identify and test signals earlier than would otherwise be the case.
- Expert Opin Drug Saf. 2007 Nov;6(6):705-12.Effect of consumer reporting on signal detection: using disproportionality analysis
One such consumer-centered source of information is http://iguard.org/
Better to go right to the source rather than to be "sourced" by sources that don't have your interest or the consumer's real interest in mind. That goes for health care policy and drug safety.
Next Tuesday and Wednesday (in collaboration with FDA News and United BioSource), the Center for Medicine in the Public Interest is sponsoring the "Risk Management and Drug Safety Summit." Topic A: REMS.
Here's a link to the agenda.
A few thoughts in advance.
Many have looked at the FDAAA language on REMS and seen it as an ill-advised green light for the FDA to inject itself into the practice of medicine.
While I agree that REMS does indeed represent an expansion of the FDA's mission, I do not agree that it is ill advised. REMS is the responsible extension of the FDA's mission of safety and efficacy into the new realm of safe use. As previously discussed in this space ("A Potent FDA Double Feature") the FDA's role in educating both patients and providers on the safe use of approved therapies is a logical and approprite third leg of the agency's mission.
The first real move into this space was the FDA's change in the warfarin label. As Dr. Caroline Wright (Foundation for Genomics and Population Health) wrote:
“Just a month after the label for the blood-thinning drug warfarin was updated to explain that genetic variation in specific genes influences how patients respond to the drug, the US Food and Drug Agency (FDA) has approved the first genetic test for warfarin sensitivity.
Warfarin is the most widely used anti-coagulant medication in the world, prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes. Patients can display markedly different responses to the drug, so doses vary enormously between individuals. Achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, whilst those who receive too low a dose may remain at risk of life-threatening blood clots.
The Nanosphere Verigene Metabolism Nucleic Acids Test detects particular variations in two genes, CYP2C9 and VKORC1, which are involved in the metabolism and mechanism of action of warfarin respectively. Specific variants of these genes are identified from a patient sample by hybridization to sequence specific probes (oligonucleotides) attached to a microarray. These are subsequently detected using the Verigene System which measures light scattering from gold nanospheres tethered to another complementary oligonucleotide. Depending upon the genotype, patients can then divided into slow, fast or normal warfarin metabolisers and their doses adjusted accordingly.
FDA states that it cleared the test based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. ‘In a three site study, the test was accurate in all cases where the test yielded a result, although 8% of the tests could not identify which genetic variants were present.’ Although the Nanosphere test is not intended as a stand-alone tool to determine optimum drug dosage but to be used alongside clinical evaluation and other tools to determine the best treatment for patients, this approval underlines the FDA’s ongoing commitment to personalised medicine."
It's important to note that when the FDA announced the warfarin label change the agency (and Larry Lesko in particular) came under attack from critics who asserted that this was the FDA, inappropriately, telling doctors how to practice medicine.
What some see as mission creep, others see as responsibility in our new age of more precise diagnostics.
The concept of "safe use" as an integral part of the FDA's 21st century mission and the REMS concept (as refined via FDAAA) as one of many tactics to achieve better patient care is contentious.
And crucial.
Here's a link to the agenda.
A few thoughts in advance.
Many have looked at the FDAAA language on REMS and seen it as an ill-advised green light for the FDA to inject itself into the practice of medicine.
While I agree that REMS does indeed represent an expansion of the FDA's mission, I do not agree that it is ill advised. REMS is the responsible extension of the FDA's mission of safety and efficacy into the new realm of safe use. As previously discussed in this space ("A Potent FDA Double Feature") the FDA's role in educating both patients and providers on the safe use of approved therapies is a logical and approprite third leg of the agency's mission.
The first real move into this space was the FDA's change in the warfarin label. As Dr. Caroline Wright (Foundation for Genomics and Population Health) wrote:
“Just a month after the label for the blood-thinning drug warfarin was updated to explain that genetic variation in specific genes influences how patients respond to the drug, the US Food and Drug Agency (FDA) has approved the first genetic test for warfarin sensitivity.
Warfarin is the most widely used anti-coagulant medication in the world, prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes. Patients can display markedly different responses to the drug, so doses vary enormously between individuals. Achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, whilst those who receive too low a dose may remain at risk of life-threatening blood clots.
The Nanosphere Verigene Metabolism Nucleic Acids Test detects particular variations in two genes, CYP2C9 and VKORC1, which are involved in the metabolism and mechanism of action of warfarin respectively. Specific variants of these genes are identified from a patient sample by hybridization to sequence specific probes (oligonucleotides) attached to a microarray. These are subsequently detected using the Verigene System which measures light scattering from gold nanospheres tethered to another complementary oligonucleotide. Depending upon the genotype, patients can then divided into slow, fast or normal warfarin metabolisers and their doses adjusted accordingly.
FDA states that it cleared the test based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. ‘In a three site study, the test was accurate in all cases where the test yielded a result, although 8% of the tests could not identify which genetic variants were present.’ Although the Nanosphere test is not intended as a stand-alone tool to determine optimum drug dosage but to be used alongside clinical evaluation and other tools to determine the best treatment for patients, this approval underlines the FDA’s ongoing commitment to personalised medicine."
It's important to note that when the FDA announced the warfarin label change the agency (and Larry Lesko in particular) came under attack from critics who asserted that this was the FDA, inappropriately, telling doctors how to practice medicine.
What some see as mission creep, others see as responsibility in our new age of more precise diagnostics.
The concept of "safe use" as an integral part of the FDA's 21st century mission and the REMS concept (as refined via FDAAA) as one of many tactics to achieve better patient care is contentious.
And crucial.
Three percent of all children under the age of 19 lack insurance at some point during the year according to a study release in JAMA this week.
But what do the numbers really say?
"However, the Rochester team found that kids from families with annual incomes at 200 percent to 400 percent of the poverty level ($38,000 to $76,000) are now just as likely to be uninsured as children from poorer families. "
76K and you can't or won't add your kid to your health plan? In NJ, the cost of adding two kids to your individual HMO health plan (and this is the most expensive place in the nation to do so) is $400 a month. Not cheap but still....
Moreover, why can't we provide middle class Americans, single parents, kids starting out, with less expensive health care coverage. Am I missing something? Why not a monthly fee of $100 to cover primary care, prescription drugs and catastrophic health care costs?
Read article here
But what do the numbers really say?
"However, the Rochester team found that kids from families with annual incomes at 200 percent to 400 percent of the poverty level ($38,000 to $76,000) are now just as likely to be uninsured as children from poorer families. "
76K and you can't or won't add your kid to your health plan? In NJ, the cost of adding two kids to your individual HMO health plan (and this is the most expensive place in the nation to do so) is $400 a month. Not cheap but still....
Moreover, why can't we provide middle class Americans, single parents, kids starting out, with less expensive health care coverage. Am I missing something? Why not a monthly fee of $100 to cover primary care, prescription drugs and catastrophic health care costs?
Read article here
When it comes to making the tax system more progressive, truth be told, no one does more in one fell swoop in that regard than John McCain.
At least that was the point I made at a debate I participated in at Columbia University Medical Center on which health care proposal was better for America: McCain's or Obama's?
According to a report by the Lewin Group, the Obama plan -- which seeks to preserve employer based insurance -- does so by shoving about 52 million Americans into publicly funded health plans. It pays for that transition by cutting the reimbursement of doctors by at least 25 percent compared to what they get from private insurers, raising about $300 billion in taxes and cutting insurance premiums through price controls. I ignore the estimated savings from health IT and disease management because it's all based on articles published by people like me.
In essence, the Obama plan is preserving the tax exclusion for employer based insurance, which favors the rich. As the Center for Health Transformation's Jim Frogue noted several years ago: "Under the current tax code, workers whose employers contribute to their health coverage have that amount excluded from income and payroll taxes. Most employees are not aware of this (which is why Obama is able to portray the McCain health plan as a tax increase). Yet it amounts to a significant and, incidentally, highly regressive tax break--the higher one's tax bracket, the bigger the subsidy. According to the Lewin Group, a leading econometrics consulting firm, families earning $100,000 per year average $2,638 in tax subsides, but those under $15,000 get an average subsidy of only $79."
http://www.heritage.org/research/healthcare/EM740.cfm
26 million Americans will get private coverage under the McCain plan and 12 million of those will be able to shop for health insurance that is cheaper than the $12000 a year policy Obama and Biden believes is the "right" amount of coverage. And that coverage will be available with guaranteed issue conditions but shorn of expensive mandates that many people who are indifferent to risk but price sensitive do not want.
Under the McCain plan, as I noted, the amount employers contribute will be counted as wages and will be taxed at the marginal tax rate as Obama notes. But it will also, as the Lewin study notes, lead to an increase in wages and overall greater tax subsidies overall at every tax bracket with most of the tax subsidies going to Americans in the lowest income brackets. Of course, those in the higher brackets will be able to bank increased wages in tax free HSAs, IRAs ,etc. to offset tax liability.
And under the Obama plan Dan the Doctor will get paid less, pay more taxes and get sued more often and more successfully. Under McCain, doctors will be able to compete and serve patients directly outside of government controls.
I think there is considerable openness to other approaches to making health care convenient and affordable in both camps. At least I hope so. Because the effort to herd people into a glorified version of SCHIP or Medicaid -- or simply giving everyone an HSA -- will fail.
At least that was the point I made at a debate I participated in at Columbia University Medical Center on which health care proposal was better for America: McCain's or Obama's?
According to a report by the Lewin Group, the Obama plan -- which seeks to preserve employer based insurance -- does so by shoving about 52 million Americans into publicly funded health plans. It pays for that transition by cutting the reimbursement of doctors by at least 25 percent compared to what they get from private insurers, raising about $300 billion in taxes and cutting insurance premiums through price controls. I ignore the estimated savings from health IT and disease management because it's all based on articles published by people like me.
In essence, the Obama plan is preserving the tax exclusion for employer based insurance, which favors the rich. As the Center for Health Transformation's Jim Frogue noted several years ago: "Under the current tax code, workers whose employers contribute to their health coverage have that amount excluded from income and payroll taxes. Most employees are not aware of this (which is why Obama is able to portray the McCain health plan as a tax increase). Yet it amounts to a significant and, incidentally, highly regressive tax break--the higher one's tax bracket, the bigger the subsidy. According to the Lewin Group, a leading econometrics consulting firm, families earning $100,000 per year average $2,638 in tax subsides, but those under $15,000 get an average subsidy of only $79."
http://www.heritage.org/research/healthcare/EM740.cfm
26 million Americans will get private coverage under the McCain plan and 12 million of those will be able to shop for health insurance that is cheaper than the $12000 a year policy Obama and Biden believes is the "right" amount of coverage. And that coverage will be available with guaranteed issue conditions but shorn of expensive mandates that many people who are indifferent to risk but price sensitive do not want.
Under the McCain plan, as I noted, the amount employers contribute will be counted as wages and will be taxed at the marginal tax rate as Obama notes. But it will also, as the Lewin study notes, lead to an increase in wages and overall greater tax subsidies overall at every tax bracket with most of the tax subsidies going to Americans in the lowest income brackets. Of course, those in the higher brackets will be able to bank increased wages in tax free HSAs, IRAs ,etc. to offset tax liability.
And under the Obama plan Dan the Doctor will get paid less, pay more taxes and get sued more often and more successfully. Under McCain, doctors will be able to compete and serve patients directly outside of government controls.
I think there is considerable openness to other approaches to making health care convenient and affordable in both camps. At least I hope so. Because the effort to herd people into a glorified version of SCHIP or Medicaid -- or simply giving everyone an HSA -- will fail.
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.
