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The "study" is really a restatement of who will get covered when under Obamacare. It duly notes that certain preventive services will not require a copay or deductible and that all health plans will be required to cover pregnancy and maternal care.
The Commonwealth Fund report fails to consider the added cost of buying coverage for such services and ignores the fact that there out of pocket costs associated with maternal care under every health plan. It also fails to note that obtaining ob-gyn coverage under Medicaid is increasingly difficult. In fact, ob-gyn services are hard to find under any circumstances. Just wait till twice as many patients whose care will be reimbursed as one third private insurance rates flood the system.
The report conveys the impression that all these services will be free and widely available. And it does not account for any increase in insurance premiums or efforts to limits coverage of new services to control costs.
tinyurl.com/26wo4br
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An FDA advisory committee’s 12-1 vote to remove Avastin’s breast cancer indication is unloved - -and misunderstood – by Senator David Vitter (R, LA) who called the decision “essentially government rationing.”
“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a statement. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.” In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee’s vote appeared to be based on cost effectiveness, not safety issues.
Not so.
New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival.
Whether or not you agree with the panel’s viewpoint on the clinical efficacy – they can’t be dinged by making a decision based on cost. That’s just unfair.
While the fear of cost-based care trumping patient-centric medicine is real – the Avastin issue is one of data.
Senator Vitter’s clarion call is accurate – we need to be vigilant to call “comparative effectiveness” what it is – rationing. But this is not the right instance to do so.
Read More & Comment...A women's health advocacy group that hopes to meet with FDA within the next year to explore potentially switching oral contraceptives to OTC may be hard-pressed to find a pharmaceutical company interested in sponsoring such a venture.
The Oral Contraceptives Over-the-Counter Working Group, coordinated by Ibis Reproductive Health, is "interested in moving oral contraceptives over the counter as a way to increase access to" the drugs, "especially for women who now face barriers to access," such as needing a prescription, said Daniel Grossman, leader of the working group and senior associate at Ibis.
"We are currently in the process of talking with a number of potential partners about what would be needed for a switch, and are hoping to meet with FDA in the next few months to discuss the regulatory pathway," said Grossman, an obstetrician-gynecologist.
One aspect the group needs to explore is finding a drug firm as a partner to sponsor a potential switch application.
Grossman said the working group is not interested in sponsoring a switch application or filing a citizen petition to switch the category.
The Pink Sheet reports that pharmacist groups asked FDA to create a few common templates for risk evaluation and mitigation strategies so they can better anticipate and implement the programs into their practices.
FDA and industry groups spoke in favor of REMS templates July 27, the first day of a two-day agency workshop gathering comments on the program. FDA expects to use the comments to help formulate more guidance for REMS on drugs.
Janet Woodcock said an effort will begin in the fall to develop a standard REMS system.
"Each program is proposed by the drug sponsor and then it's negotiated between the sponsor and the FDA and is uniquely tailored to the risks of that particular drug," Woodcock said. "So we don't have the kind of standardization and consistency of the programs that would be ideal."
Additional REMS changes already have been proposed, including allowing medication guides to be developed outside the REMS process.
Poll shows opposition to health care overhaul declining
Washington Post Staff Writer
Thursday, July 29, 2010; 12:02 AM
Opposition to the landmark health care overhaul declined over the past month, to 35 percent from 41 percent, according to the latest results of a tracking poll, reported Thursday.
Support For Health Law Remains Steady While Opposition Drops
The percentage of people who view the new health bill unfavorably dropped 6 points to 35 percent in the past month, but that has not translated into a significant increase of supporters, according to the July tracking poll from the Kaiser Family Foundation. Overall support remained stable since the June survey, with about half the public expressing a favorable view of the overhaul, the poll found.www.kaiserhealthnews.org/Stories/2010/July/29/health-reform-tracking-poll.aspx
If you find the two ledes strikingly, uh, similar, don't worry. It's not plagiarism or even laziness on the part of the WaPo. It's merely a product of the Kaiser Health News effort to "provide new opportunities for health care journalists to produce in-depth work and a new vehicle to distribute it through collaborations with major news organizations and on this Web site." You see, it's really a jobs program first and a pass through mechanism of pro-government run health care reform "news" and surveys second.
Kaiser Health News, which partners with USA Today, NPR, the New Republic along with many fair-minded types who were on the JournoList before it was circumscribed down to the Cabalist, is a venture of the Kaiser Family Foundation. The foundation provides " strategic guidance". That direction consists largely of ignoring original research critical of health care reform in its current iteration and a slavish devotion to recycling the less than balanced or nuanced coverage of the fight over the implementation of the law. Some guidance.
Case in point is the echo chamber KHN creates by paying for polls and writing articles about the polls that are then essentially reprinted by WaPo and then blogged on by the Journolistas like Ezra Klein, Jonathan Cohn, Kate Steadman, etc. It would be sinister if it weren't so banal and boring...
The KHN and it's effort to consolidate control coverage of health care reporting and the shaping of public opinion about health care should not be set aside lightly. It should be thrown away with great force...
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Meanwhile, Sanofi is pursuing Genzyme, maybe, instead of or in addition to making an 'authorized' generic version of their product...
To underscore a point Peter made, analysts who think that the approval of generic Lovenox will unleash a flood of follow-on biologics had better readjust their sights and projections. Or at least read the FDA's approvable letter to Novartis and Momenta:
www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220023.htm
Note to analysts: sameness is not interchangeability with all products. It requires testing. And post market monitoring. Reproducing is NOT copying and it is NOT bioavailability. It is equivalence of functionality based on activity. It has to work the same way and be designed in ways that produce such functional equivalence.
There are lots of IP landmines in making a "bio-same-ilar", which explains the Sanofi suit. Meanwhile, the Genzyme play, moving towards targeted, even fractional market, based on narrow therapeutic pathways and complex manufacturing is consistent with what other companies are doing.
The blockbuster model is dead and the era of equivalence is over.
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"Many in the industry have felt that if FDA ultimately approves generic versions of Lovenox and it makes those generics fully 'substitutable' - which it just has - then this might signal what FDA may also ultimately do when it comes to 'true' biologics that generic companies are also pursuing," Tim Anderson, an analyst with Bernstein Research, wrote in a research note on the recent agency action.
Not necessarily.
Remember, the FDA has the authority to use its discretion in asking for new clinical trials for biosimilars and – here’s the sticky question – is Lovenox really a biologic? Sticky question? Not really -- because the answer is, "no."
When it comes to bioequivalence and biosimilars, the FDA will do the right thing.
After all (and with apologies to Senator Kerry), you can’t be for enhanced safety and against it at the same time.
Do not trust all men, but trust men of worth; the former course is silly, the latter a mark of prudence.
-- Democritus
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That Britain’s NHS will undergo an historic change (“Britain Plans to Decentralize National Health Care”) is significant, sobering but not surprising. It’s an experience with valuable lessons for us over here on the other side of the pond.
Lessons about the inefficiencies of centralized government healthcare. There’s no value in calling it “socialist” when you can just say, “see, it doesn’t work.” As the man said, “attention must be paid.”
Lessons about what happens when your system is based on a cost-centric rather than a patient-focused philosophy of healthcare. Yes – we really need to put the 800-pound gorilla on the operating room table. Who needs “death panels” when you have “deny panels.”
And, finally, lessons about money. It really isn’t all about the amount of money you spend – if you don’t spend it in the right places. And that’s Lesson #1.
Britain Plans to Decentralize National Health Care
By SARAH LYALL
LONDON — Perhaps the only consistent thing about Britain’s socialized health care system is that it is in a perpetual state of flux, its structure constantly changing as governments search for the elusive formula that will deliver the best care for the cheapest price while costs and demand escalate.
Even as the new coalition government said it would make enormous cuts in the public sector, it initially promised to leave health care alone. But in one of its most surprising moves so far, it has done the opposite, proposing what would be the most radical reorganization of the National Health Service, as the system is called, since its inception in 1948.
Practical details of the plan are still sketchy. But its aim is clear: to shift control of England’s $160 billion annual health budget from a centralized bureaucracy to doctors at the local level. Under the plan, $100 billion to $125 billion a year would be meted out to general practitioners, who would use the money to buy services from hospitals and other health care providers.
The plan would also shrink the bureaucratic apparatus, in keeping with the government’s goal to effect $30 billion in “efficiency savings” in the health budget by 2014 and to reduce administrative costs by 45 percent. Tens of thousands of jobs would be lost because layers of bureaucracy would be abolished.
In a document, or white paper, outlining the plan, the government admitted that the changes would “cause significant disruption and loss of jobs.” But it said: “The current architecture of the health system has developed piecemeal, involves duplication and is unwieldy. Liberating the N.H.S., and putting power in the hands of patients and clinicians, means we will be able to effect a radical simplification, and remove layers of management.”
The health secretary, Andrew Lansley, also promised to put more power in the hands of patients. Currently, how and where patients are treated, and by whom, is largely determined by decisions made by 150 entities known as primary care trusts — all of which would be abolished under the plan, with some of those choices going to patients. It would also abolish many current government-set targets, like limits on how long patients have to wait for treatment.
The plan, with many elements that need legislative approval to be enacted, applies only to England; other parts of Britain have separate systems.
The government announced the proposals this month. Reactions to them range from pleased to highly skeptical.
Many critics say that the plans are far too ambitious, particularly in the short period of time allotted, and they doubt that general practitioners are the right people to decide how the health care budget should be spent. Currently, the 150 primary care trusts make most of those decisions. Under the proposals, general practitioners would band together in regional consortia to buy services from hospitals and other providers.
It is likely that many such groups would have to spend money to hire outside managers to manage their budgets and negotiate with the providers, thus canceling out some of the savings.
David Furness, head of strategic development at the Social Market Foundation, a study group, said that under the plan, every general practitioner in London would, in effect, be responsible for a $3.4 million budget.
“It’s like getting your waiter to manage a restaurant,” Mr. Furness said. “The government is saying that G.P.’s know what the patient wants, just the way a waiter knows what you want to eat. But a waiter isn’t necessarily any good at ordering stock, managing the premises, talking to the chef — why would they be? They’re waiters.”
But advocacy groups for general practitioners welcomed the proposals.
“One of the great attractions of this is that it will be able to focus on what local people need,” said Prof. Steve Field, chairman of the Royal College of General Practitioners, which represents about 40,000 of the 50,000 general practitioners in the country. “This is about clinicians taking responsibility for making these decisions.”
Dr. Richard Vautrey, deputy chairman of the general practitioner committee at the British Medical Association, said general practitioners had long felt there were “far too many bureaucratic hurdles to leap” in the system, impeding communication. “In many places, the communication between G.P.’s and consultants in hospitals has become fragmented and distant,” he said.
The plan would also require all National Health Service hospitals to become “foundation trusts,” enterprises that are independent of health service control and accountable to an independent regulator (some hospitals currently operate in this fashion). This would result in a further loss of jobs, health care unions say, and also open the door to further privatization of the service.
The government has promised that the new plan will not affect patient care and that the health care budget will not be cut. But some experts say those assertions are misleading. The previous government, controlled by the Labour Party, poured money into the health service — the budget is now about three times what it was when Labour took over, in 1997 — but the increases have stopped. The government has said the budget will continue to rise in real terms for the next five years, but it is unlikely that the increases will keep up with the rising costs of care and the demands of an aging population.
“The real mistake that is being made by the health secretary is to drive through an ideologically determined program of reorganization which is motivated by the principle of efficiency savings,” said Robin Durie, a senior lecturer in politics at the University of Exeter. “History shows clearly that quality will suffer as a consequence.”
Dr. Durie added, “The gulf between the rhetoric of the white paper and the technicalities of what is involved in the various elements of the overall reorganization being proposed is just extraordinary.”
For example, he asked, how will the government make good on its promise to give patients more choice — a promise that seems to require a degree of administrative oversight — while cutting so many managers from the system?
“How will the delivery of all this choice be funded?” Dr. Durie asked. “And how will the management of the delivery of choice be funded?”
Dr. Vautrey said the country needed to have a “mature debate about what the N.H.S. can and cannot afford.”
He said: “It is a sign of the mixed messages that government sends out. They talk about choice and competition and increased patient expectations at the same time as they tell the service they need to cut costs and refer less and prescribe less. People need to understand that while the needs of everyone may be met, their wants will be limited.”
As they prepare for the change, many doctors are wondering whether it will be permanent this time around.
“Many of our colleagues have seen this cycle of change repeatedly,” Dr. Vautrey said. “Many would look at previous reorganizations and compare it to this one and wonder how long the current change will last before the next one comes along.”
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WASHINGTON—The Food and Drug Administration approved the first generic version of the big-selling blood thinner Lovenox, in a victory for a unit of Novartis AG.
The Novartis unit, Sandoz, and partner Momenta Pharmaceuticals Inc. have been in a tug of war for years with a California-based company, Amphastar Pharmaceuticals Inc., to win FDA approval for generic versions of Lovenox.
Amphastar has accused the FDA and its drug-division leaders of favoritism in the past year, noting that Momenta worked closely with the FDA on safety issues and investigations in recent years. Momenta has said its relationship with the FDA is appropriate.
Sanofi has fought to protect Lovenox from generic competition, saying that the drug is too complex to be completely copied safely. Researchers with ties to Sanofi recently filed citizens' petitions to the FDA asking the agency not to approve any company's enoxaparin.
Read More & Comment...The good news: FDA Social Media Guidance. The bad news: FDA Social Media Guidance.
Here’s how my interview with emarketer begins:
eMarketer: The FDA is expected to issue guidance on the use of social media this year. What do you think it will look like?
Peter Pitts:
There are a lot of ifs. The first if is, is this really a good thing? A lot of times when you ask for regulation and you get it, you may not be happy with it. If marketers are waiting for FDA guidance with the assumption that it’s going to make their jobs easier, that’s very much open to question.
And here’s how it ends:
Peter Pitts:
The concept of being incomplaunce vs. doing the right thig for the
For everything in the middle, see here.
Congressman John Boozman (R,AR) from CMPI on Vimeo.
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Drafters had hoped the provision would generate $17 billion to help pay for reform. But James Gelfand, director of health policy at the U.S. Chamber of Commerce, says he's rarely seen an issue on which members are so strongly united in opposition, calling them "apoplectic" over the provision. An administration source tells Pulse that the comments from the business community are "obviously something we take seriously" and that there's been significant outreach to them. Treasury has already made one change: Transactions on credit and debit cards won't have to reported on a 1099.
James Gelfand Director of Health Policy, US Chamber of Commerce from CMPI on Vimeo.
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According to Craig Kessler, professor of medicine and pathology at Georgetown/Lombardi, the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness.
He said that the difference in manufacturing processes between companies can alter the drugs "in ways that technology can't detect.”
The healthcare reform law outlined a pathway for FDA to approve next-generation biopharmaceuticals modeled on original breakthrough drugs. But the legislation leaves the agency with a great deal of leeway -- including the flexibility to decide whether clinical trials are necessary at all.
"If you don't have clinical trials to take a look at all of these other off-label uses," Kessler said during a Capitol Hill discussion hosted by the Congressional Health Care Caucus, "then you don't really know what the equivalency in dosing is going to be like, and what the safety — the long-term safety — [issues] will be."
We need to proceed with biosimilars – but with care and caution.
No profit grows where is no pleasure ta’en;
In brief sir, study what you must affect
Close the FDA Approval Gap
The extensive review by a panel assembled by the Food and Drug Administration of the diabetes drug Avandia highlights the critical importance of government regulation and oversight of the drug industry.
Questions have been raised about the safety of Avandia since 2007, and a process to assess these risks versus patient benefits was undertaken by the objective professionals at FDA. But one important question underscores all such inquiry: What happens when the drug safety cop is taken off the beat?
Even though our system of pharmaceutical review and approval is regarded as the most effective in the world, there exists an incredible -- and potentially deadly -- loophole: unapproved drugs.
Recent news stories regarding the recall of 1,500 lots of Johnson & Johnson's children's and infants' Tylenol, Motrin, Zyrtec and Benadryl due to bacterial contamination, and the subsequent suspension of the their manufacture, reinforce the importance of the US Food and Drug Administration's (FDA) regulatory oversight over drug products--even years after they have been approved for sale. But due in large part to grandfather provisions going back 50 years, unapproved drugs - those that have been marketed prior to the establishment of today's FDA - are actively promoted, prescribed and taken by millions of patients in the U.S. These drugs escape FDA scrutiny otherwise imposed for all approved prescription and over-the-counter medications.
Most alarming is the fact that unapproved drugs account for nearly 72 million prescriptions per year. Unapproved drugs lack the specific quality controls of an FDA-approved drug, including manufacturing oversight that ensures the appropriate amount of active drug in each tablet, the purity of ingredients and consistency from dose-to-dose. And perhaps equally troubling is the fact that - unlike every other medication available for human consumption in the United States - unapproved drugs are not required to be accompanied by dosing information supported by human clinical studies.
The consequences of this approval gap can be tragic. Hundreds of deaths have been linked to the more than 500 unapproved drugs that FDA eventually banned. Yet to this day dozens of unapproved drugs are marketed under the regulatory radar. As recently as this past March, FDA took action against manufacturers of unapproved sublingual nitroglycerin tablets for treating certain heart conditions. FDA stated that it had seen "significant quality and efficacy problems" with unapproved nitroglycerin products and, as a result, recalled them from the market. Meanwhile, an FDA approved version had been available for years right alongside the unapproved, unregulated, and we now know, unsafe versions.
And the front-line gatekeepers of the nation's prescription drug delivery system--America's pharmacists--are themselves largely unaware of this dual standard for safety among the products on their shelves. A 2006 nationwide study of 500 pharmacists found that 91% of them incorrectly assumed that all of the products they dispense are FDA-approved.
They should be approved, of course. That's why in June of 2006, when I was head of the FDA's Center for Drug Evaluation and Research, we launched an initiative to finally address unapproved drugs. The Agency issued a Compliance Policy Guide (CPG) to review the safety and efficacy of unapproved drugs that continue to be available, in an attempt to bring these products into the modern world of drug safety with clinical, regulatory and manufacturing oversight.
Certain medications that have never undergone FDA evaluation should continue to be available for patients--when no substitute exists--so long as there are no known safety concerns. Many patients simply have no alternative treatment. But as soon as an approved version becomes available, FDA needs to act immediately and enforce its policies by withdrawing all unapproved formulations from the market. Regulatory oversight alerted us all to the risks associated with certain products manufactured by J&J. If no one is watching, how can we be sure it will never happen again?
"Patients should continue taking all currently prescribed medications unless instructed otherwise by their healthcare provider," said Dr. Robert A. Vigersky, immediate past president of the Endocrine Society. "Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short-term health problems and could increase the risk of diabetes-related complications in the long term."
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