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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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“Effectively, this drug is gone.”
U.S. sales of the drug have plunged from $2.2 billion in 2006 to $520 million last year because of fears generated largely by Nissen. Meanwhile Actos, made by Takeda, the company Nissen has consulted for, has seen sales of it's product soar from $1. 9 billion in 2006 to $3.4 billion last year.
I think they got their money's worth.
Whether patients did is another matter. During the same time, the combined number of scrips for TZDs declined overall by 40 percent and scrips for oral diabetes agents fell by 20 percent. (I am going to double check this figure..) Did cardiovascular events among diabetics decline by 25 to 43 percent as might be predicted? No.
While there was an effort to depict Avandia's problems as a matter of deadly risks purposely hidden by GSK the issue was really two-fold. First, the fact that the FDA had to react to the risks of Avanda as framed by Nissen rather than the overall risk and benefits of each drug in the class in the context of treating diabetes and all it's complications. It had to focus on heart risks and whether surrogate endpoints were reliable, etc. all of which were issues framed to undermine confidence in the FDA and shift power to Nissen and outside or rogue forces. Second, and only after wading through this thicket, was the FDA able even to carry out it's public health responsibility and provide the advisory committee with that task. To that end, Commissioner Hamburg's leadership on this issue, along with the stewardship of Drs. Woodcock, Temple, Jenkins and DelPan should be applauded. And once again David Graham demonstrated why he is best suited for getting coffee in the FDA's division of psychopharmacology..
The big question is whether the treatment and management of diabetes is better off after the fearmongering.
More people have diabetes and fewer people are taking drugs. Is that a good thing?
Maybe Nissen should worry more about patients instead of his publicity and his bank account.
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The vote ended up not even being that close. Ten panel members voted to keep Avandia on the market but with serious revisions to its label as well as possible restrictions on its sale. Seven voted to simply add further warnings to the drug’s label. Three voted to allow further sales without change. Twelve members voted for market withdrawal.
To most Americans it means that it’s almost time for lunch.
Robust internal debate.
Reading the coverage of yesterday's Avandia adcomm, you'd think the FDA professsional staff never disagreed with each other and lived in perfect regulatory harmony. Nothing could be further from the truth. Also, statements like "Avandia has split the agency in two" is just laughable -- considering the issue exists in one division of one center. But, hey, hyperbole sells.
Robust internal debate. It's healthy and it's the rule rather than the exception -- media reports to the contrary.
Kudos to Peggy Hamburg who, once again, reminds everyone that the science is the only thing that counts.
And science, as those who know understand, is plenty contentious enough.
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It’s got to be more than just “sign here.” And it’s about time.
The IOM report on ethical and scientific issues in post-marketing drug safety studies could very easily get lost in the frenzy over you-know-what. That would be a shame because its real value lies in an intelligent and thoughtful outline of how to restructure informed consent. And in our age of the digitally empowered healthcare consumer, this is welcome news
"When a substantial amount of information indicating that a drug to be studied may involve serious safety risks has already accumulated, there are heightened obligations to ensure that potential participants understand the risks posed by study enrollment," the IOM Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs says in a letter report.
The IOM says the emphasis given to risk information in the informed consent process should increase with the severity of risk and the level of certainty about the causal connection between a drug and the adverse outcome. "At a minimum, risks that should be disclosed should include any black box warnings, the 'major statement' currently listed in television advertisements, any adverse event findings of an FDA advisory committee, and a summary of evidence from published peer-reviewed studies."
The committee notes that in addition to verbal disclosures and written consent documents, there is a growing set of additional tools, such as videos and interactive electronic presentations that can enhance potential study participants' understanding of risks they may face.
Bravo.
"Whatever efforts are employed to communicate with potential participants, it is key that they include information that is useful to participants about where the weight of the evidence falls with regard to serious risks and the level of confidence that experts have in drawing conclusions about the risks," IOM says.
Potential study subjects should understand how treatment they will receive in the study differs from the current standard of care. "This is particularly crucial in cases in which medical practice has shifted away from prescribing the study drug because accumulating evidence from passive surveillance, observational studies and small trials or meta-analyses suggests that another therapy is as effective and has a more favorable safety profile," IOM says.
And, of course, FDA must assure that the post-marketing study is appropriately designed to answer the public health questions at issue and minimize risk to participants. Risks should be judged acceptable by FDA, data safety monitoring boards and institutional review boards and the study and subjects should be continuously monitored. As always – but it’s certainly worth repeating.
“Ignorance is never better than knowledge”
-- Enrico Fermi
As a commentary in this week's Biocentury suggests, the FDA's public hearing on Avandia being held this week is stacked in favor of Steve Nissen and David Graham, the two most public and vociferous critics of the drug. Something tells me that forces within and outside the FDA are seeking to force FDA commissioner's Peggy Hamburg's hand.
If the advisory committee votes to pull Avandia it will be hard for the FDA not to concur. And that will be the beginning of the end of the FDA's science-based regulatory authority, at least under this administration. It will mean that that marauders who react to any safety signal can run to the media and members of Congress to slow down or delay a product's approval or kill it's sales. It's means that meta-analysis, which has become a powerful data dredging tool for generating risks and diverting attention from benefits by producing spurious statistical association will triumph over biologically based outcomes.
Fearmongering requires new and unexpected risks. It must eliminate efforts to individualize treatment based on risks and benefits.
Nissen and Graham along with their fellow travelers on the one side. Dr. Hamburg and the FDA's future is on the other.
The decision on Avandia will decision which way regulatory science and the FDA will go for years to come.
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One of the more interesting subtexts surrounding King James’ move to Miami is the negative economic impact it will have on the economy of Cleveland specifically and the Ohio in general.
A similar subtext (albeit one that has been entirely ignored) is the negative economic impact the State of Michigan will experience following the University of Michigan’s recent announcement that it will ban any industry-sponsored CME.
The Fighting Wolverines currently receive about $1,000,000 in such services. And in cash-strapped Michigan that ain’t chump change when libraries are being shuttered and teachers are losing their jobs.
And for what larger purpose? The U-M's intent in banning industry funding for CME is "to dispel the risk or appearance of conflict of interest.”
It will also result in less CME for the university systems physicians. The school expects the number of CME courses to decline "somewhat" as a result of the new policy.
(According to the ACCME, the university produced 499 separate CME activities last year, reaching more than 130,000 physicians.)
"Somewhat less" CME is not acceptable. Does the university system expect the taxpayes of Michigan to make up the difference -- so that they can exult in their political correctness?
Since an important aspect of healthcare reform is about lowering costs, how will similar moves by other large public universities (motivated not by public health but by "perceived conflicts") be justified?
Speaking of Cleveland, in the January 2010 issue of Academic Medicine (Adad. med. 2010; 85:80-84), four researchers from the Cleveland Clinic published a paper entitled, "The Effect of Industry Support on Participants of Bias in Continuing Medical Education." The purpose of the study: "To obtain prospective evidence of whether industry support of continuing medical education affects perceptions of commercial bias in CME."
The method: "The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multi-specialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support."
The study's conclusion? "This large prospective analysis found no evidence that commercial support results in perceived bias in CME activities. Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present."
The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have adopted a new policy regarding the disclosure of conflicts of interest. Here's the key paragraph:
"There is no inherent conflict of interest in the working relationships of physicians with industry and government. Rather, there is a commonality of interest that is healthy, desirable, and beneficial. The collaborative relationship among physicians, government, and industry has resulted in many medical advances and improved health outcomes."
What a unique perspective -- a "commonality" rather than a "conflict" of interest.
We should all pay attention to our nomenclature. It's not about "conflict of interest" -- it's about (as Secretary Sebelius correctly says) "interest." And having an "interest" is not necessarily a bad thing -- as long as you're transparent about it.
When it comes to CME and "interest," we need to weigh it against benefit. And, as with drugs and devices, we must consider the "safe use" of industry-sponsored CME.
"The best interest of the patient is the only interest to be considered."
William Mayo, MD
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