Latest Drugwonks' Blog
Not that I haven't been reflecting about it from time to time..getting aggravated is more like it.
So I was about to write a blistering blog about how the media continually tries to make policy according to a narrative and if the facts aren't there to fit the narrative, well you can always make more.
And then I saw this:
UN 'to appoint space ambassador to greet alien visitors'
A space ambassador could be appointed by the United Nations to act as the first point of contact for aliens trying to communicate with Earth.
Mazlan Othman, a Malaysian astrophysicist, is set to be tasked with co-ordinating humanity’s response if and when extraterrestrials make contact.
Aliens who landed on earth and asked: “Take me to your leader” would be directed to Mrs Othman.
(Could we at least see a resume before making that decision? Coordinating humanity's response? Maybe she and the UN should start with something more pedestrian, like paying it's bills on time. )
She will set out the details of her proposed new role at a Royal Society conference in Buckinghamshire next week.
The 58-year-old is expected to tell delegates that the proposal has been prompted by the recent discovery of hundreds of planets orbiting other starts, which is thought to make the discovery of extraterrestrial life more probable than ever before.
(Let me get this straight: there is an actually a group of scientists who will sit and listen to her? Without laughing? )
Mrs Othman is currently head of the UN’s little known Office for Outer Space Affairs (Unoosa).
(Yes, I am Earth's ambassador to the United Federation of Planets, a little know office in the State Department.)
In a recent talk to fellow scientists, she said: “The continued search for extraterrestrial communication, by several entities, sustains the hope that some day human kind will received signals from extraterrestrials.
“When we do, we should have in place a coordinated response that takes into account all the sensitivities related to the subject. The UN is a ready-made mechanism for such coordination.”
(Of course it is. And you thought UNICEF was the only trick or treat program the UN sponsored.)
Professor Richard Crowther, an expert in space law at the UK space agency who leads delegations to the UN, said: “Othman is absolutely the nearest thing we have to a ‘take me to your leader’ person”.
(Wait a minute. Shouldn't we have a vote? Can't every country nominate one TMTYL type person? I would nominate William Shatner...because he's got the intergalactic experience. Or David Hasselhoff because he can do rehab and host America' Got Talent.)
The plan to make Unoosa the co-ordinating body for dealing with alien encounters will be debated by UN scientific advisory committees and should eventually reach the body’s general assembly.
(when it takes a break from bashing Israel)
Opinion is divided about how future extraterrestrial visitors should be greeted. Under the Outer Space Treaty on 1967, which Unoosa oversees, UN members agreed to protect Earth against contamination by alien species by “sterilising” them.
Mrs Othman is understood to support a more tolerant approach.
(I wonder what that might be: diversity training, a path to citizenship for extraterrestrial aliens ahead of the 12 million illegal aliens, family planning?)
Thank goodness the UN is taking on a challenge it can likely meet and on par with the level of seriousness that organization deserves.
http://www.telegraph.co.uk/science/space/8025832/UN-to-appoint-space-ambassador-to-greet-alien-visitors.html
The National Institutes of Health and the Food & Drug Administration dole out $9.4 million in grants as part of a three-year program to promote "regulatory science"
The National Institutes of Health and the Food & Drug Administration will dole out $9.4 million over three years to support a quartet of research projects in so-called "regulatory science."
The program is aimed at improving data for scientists and regulatory reviewers on medical device safety and at improving the "evaluation and availability of new medical products to the community," according to a press release.
The FDA will put about $950,000 toward the grants, according to the release. It's part of a joint effort announced early this year designed to speed innovative medical technologies to market. When the cooperative effort was announced, the agencies said their total kitty was about $6.75 million over three years.
Regulatory science is the "development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality," according to the February announcement of the program.
Here are the details on the recipients of the four grants:
- Dr. Donald Ingber of Harvard University Medical School in Boston — "Heart-Lung Micromachine for Safety and Efficacy Testing"
- Dr. William Barsan, Donald Berry and Roger Lewis of the University of Michigan in Ann Arbor — "Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design"
- Daniel Cerven and George DeGeorge of MB Research Laboratories Inc. in Spinnerstown, Pa. — "Replacement Ocular Battery (ROBatt)"
- Dennis Hourcade of Washington University in St. Louis — "Characterization/Bioinformatics-modeling of Nanoparticle: Complement Interactions"
"These four projects were chosen among many applications because they were the most meritorious proposals for addressing high-priority areas in cutting-edge biomedical research and regulatory science. This partnership marks the beginning of our work with FDA to use new scientific and technological tools to aid/enhance the review of new drugs and devices. It is one facet of our shared commitment to speed the delivery of new medical products to patients," NIH director Dr. Francis Collins said in prepared remarks.
"These projects show the potential breadth of opportunity that comes from advancing regulatory science. The results are likely to have broad application to researchers across scientific disciplines and will result in better-informed regulatory decision-making and faster drug development and approval processes," added FDA commissioner Dr. Margaret Hamburg.
During the initial debate on healthcare reform, those who spoke about “death panels” were called fear mongers. And, to a large degree that’s what they were trying to accomplish. But the issue is a real one. We spend a disproportionate share of our on what is loosely termed “end of life care.” And it’s an issue we have to address. Now. Unless we are willing to surrender to Uncle Sam, MD and the $50,000 QALY and adopt a lowest common denominator of “care we can afford,” we’d better place this issue near the top of our national healthcare conversation.
And so, kudos to Marilynn Marchione of the Associated Press, who asks the question nobody wants to address … what’s a life worth?
BOSTON — Cancer patients, brace yourselves. Many new drug treatments cost nearly $100,000 a year, sparking fresh debate about how much a few months more of life is worth.
The latest is Provenge, a first-of-a-kind therapy approved in April. It costs $93,000 and adds four months' survival, on average, for men with incurable prostate tumors.
For the last decade, new cancer-fighting drugs have been topping $5,000 a month. Only a few of these keep cancer in remission so long that they are, in effect, cures. For most people, the drugs may buy a few months or years. Insurers usually pay if Medicare pays. But some people have lifetime caps and more people are uninsured because of job layoffs in the recession. The nation's new health care law eliminates these lifetime limits for plans that were issued or renewed on Sept. 23 or later.
Unlike drugs that people can try for a month or two and keep using only if they keep responding, Provenge is an all-or-nothing $93,000 gamble. It's a one-time treatment to train the immune system to fight prostate tumors, the first so-called "cancer vaccine."
I'm fearful that this will become a drug for people with more resources and less available for people with less resources," said M.D. Anderson's cancer research chief, Dr. Christopher Logothetis.
When is a drug considered cost-effective?
The most widely quoted figure is $50,000 for a year of life, "though it has been that for decades — never really adjusted — and not written in stone," said Dr. Harlan Krumholz, a Yale University expert on health care costs.
Logothetis said Provenge and other experimental cancer vaccines in development need "a national investment" to sort out their potential, starting with Medicare coverage.
"It's no longer a fringe science. This is working," he said. "We need to get it in the door so we can evolve it."
The complete AP story can be found here.
From the op-ed pages of the Baltimore Sun:
On R&D tax credit, Obama does Reagan one better
President serves up a plan even conservatives can love
President Barack Obama's economic agenda has been controversial, to put it mildly. Tea Partiers are marching on Washington to demand reduced government spending, while meek and mild-mannered Nobel Prize-winning economist Paul Krugman criticizes the administration's stimulus as too small. Nobody seems to agree on what will create jobs and get the economy back on track.Fortunately, the president recently put forward an economic proposal that the whole country should be able to get behind. Its core component is expanding the research and development tax credit.
This move builds on the legacy of Ronald Reagan, who introduced the tax credit in 1982. However, the credit has always been temporary, requiring congressional reauthorization roughly every two years since.
Mr. Obama's proposal would allow companies to take a 17 percent deduction above 50 percent of R&D costs. That's a significant increase over the previous 14 percent rate. And the credit would be made permanent, allowing businesses to make better long-term plans and invest in new research with confidence.
More to the point, the Obama tax credit addresses an urgent economic need. Today, the size of America's Research and Development Tax Credit ranks 17th among the 30 nations measured by the Organization for Economic Co-operation and Development. A decade ago, our credit was the biggest in the world. Even France now has an R&D credit four times larger than ours.
We can't afford to lose our advantage in innovation. Research and development are at the heart of America's most vibrant industries. Case in point: The biopharmaceutical sector.
Biopharma innovation is usually noteworthy for saving lives. Three years after introducing the first antiretroviral treatments, AIDS deaths dropped 70 percent, and new pharmaceuticals are largely responsible for cutting cancer death rates in half.
Less well known are the tremendous economic benefits of the industry. Biopharma directly employs some 700,000 Americans and indirectly supports 3.2 million more jobs. The average biopharma salary in 2008 was $77,595. That's $32,000 more than the average private-sector job.
From 1996 to 2006, the rate of job growth in biopharma was twice the national average. Even through the first year of the current recession, when overall private sector unemployment fell, the biopharmaceutical sector grew by 1.4 percent.
Globally, America dominates this rapidly expanding, high-wage industry. In 2007, America had 2,700 new drugs under development, compared with 1,700 being developed by all other countries combined.
But with other countries offering huge tax credits for research and development, America can't count on biopharmaceutical dominance forever.
On average, a new biotech drug costs more than a billion dollars to develop. And for every new drug that gets FDA approval and makes it to market, 5,000 to 10,000 unsuccessful drugs get tested. America's R&D tax credit provides significant support for this industry.
A bigger and permanent credit would boost the biopharmaceutical industry, help create new, life-enhancing drugs, and drastically cut down on overall medical expenses. It's estimated that each additional dollar spent on new pharmaceuticals saves $7 elsewhere in the economy.
At first glance, a bigger R&D tax credit might seem like just more government spending. But the evidence suggests the credit would create jobs and pay for itself.
According to a 2010 study by the Milken Institute, increasing this credit by 25 percent and making it permanent would add $206.3 billion to real GDP and raise total employment by 510,000 jobs within a decade.
By comparison, the Research and Development Tax Credit is currently estimated to cost just $7 billion a year.
At a time when there's a lot of partisan rancor over economic policy, Mr. Obama's proposal is the expansion of an existing policy that has had bipartisan support for decades. There are precious few points of agreement on the economy these days. A bipartisan solution with almost no economic downside rarely comes along. We shouldn't miss the opportunity to expand and make permanent the Research and Development Tax Credit.
The Wall Street Journal reports:
WASHINGTON—The Food and Drug Administration decided to allow the diabetes drug Avandia to remain on the U.S. market with new restrictions, while the European Medicines Agency suspended use of the product Thursday.
The FDA said the restrictions are aimed at reducing use of Avandia and other medications that contain the same ingredient. GlaxoSmithKline will be required to develop a restricted access program for Avandia, which would make it available only if other types of drugs fail to properly control high blood sugar levels seen with diabetes and they areunable to take a similar drug, Actos.
Patients currently taking Avandia can continue on the medication if they choose to. FDA Commissioner Margaret Hamburg said the FDA and EMA made their own decisions based on the same data. However, she said the EMA doesn't have a similar mechanism that FDA has to restrict access to a drug, explaining the divergent decisions.
The restricted access program applies to Avandia and as well as two other drugs that combine the active ingredient in Avandia with other diabetes medications. Those medications are sold by Glaxo under the brand names Avandamet and Avandaryl.
"These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia," the FDA said in a statement.
The FDA said doctors will have to attest to and document their patients' eligibility to receive Avandia and patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks.
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.
Congrats to former CDER Director, Acting Surgeon General and all-around decent guy Steve Galson on his appointment as Global Regulatory VP for Amgen.
In August 2009, a study (conducted by research firms LegitScript.com and KnujOn.com) found that over 80% of on-line advertisements for Internet pharmacies accepted by the search engine Yahoo were in violation of US federal and state laws. The researchers were able to buy prescription drugs without a prescription from Yahoo Internet pharmacy advertisements, and in one case the drugs were imported from India, which is prohibited by US law, says the survey, which was.”
In September 2010, Google filed a federal lawsuit seeking to block groups it called "rogue online pharmacies" from advertising on its search engine and websites.
According to the Wall Street Journal, “The move comes as Internet companies continue efforts to prevent fraudsters from preying on their customers, potentially keeping them from doing business with legitimate online operators.”
"Rogue pharmacies are bad for our users, for legitimate online pharmacies and for the entire e-commerce industry—so we are going to keep investing time and money to stop these kinds of harmful practices," said Google lawyer Michael Zwibelman.
That’s all well and good—but it’s not new. In December 2003, Google said they would stop accepting advertising from unlicensed pharmacies that have used the Internet to sell millions of doses of narcotics and prescription drugs without medical supervision.
As the Washington Post reported at the time, “Illegal Internet pharmacies have become a virtually unregulated pipeline for highly addictive painkillers, tranquilizers and anti-depressants that have resulted in overdoses and deaths.”
Back in 2003, the FDA was aware of the problem and trying to work with the search engine community. As the Post reported, "We're literally placing calls to the search engines trying to get a meeting going," said Peter J. Pitts, the FDA's associate commissioner for external affairs. "You can't blame them for accepting commerce. But they really haven't understood the consequences."
Plus ça change …
Much discussion at the Business of Biosimilars conference today about the evils of evergreening. Purity, potency and safety? Feh.
Other topics of heated debate centered around whether or not “biobetters” would always precede biosimilars (most thought so) and whether or not that was a good thing. (Different points of view depending on whether you’re looking at it from a developer, payer or provider standpoint. (Hint – there weren’t any providers in the room.)
And there seemed to be general consensus that, with a clear FDA pathway still off in the future, BLAs are the way to go. Hence a redefinition of BLA as “Beat Legislative Ambiguity.” No aBLA biosimilar.
Badges? We don’t need no stinking badges.
Two interesting comments from Leigh Purvis (Senior Strategic Policy Advisor, AARP). The first was that the folks at AARP are concerned that “biologics will soon be used to treat paper cuts.” (Nice to reconfirm where they stand on the issue.) And the second that, while it’s important to educate AARP members about both generics and biosimilars –“there isn’t any money available in the budget.”
Draw your own conclusions.
A funny thing happened on my way to the Business of Biosimilars conference in Boston -- a draft document about a two-day FDA public hearing on FOBs began making the rounds.
According to the draft, the hearing will take place on November 2nd and 3rd and, potential changes notwithstanding, provides insight into the future of FDA-regulated biosimilars.
"The purpose of this public hearing," the document states, "is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute concerning the following issues, among others:
* Scientific and technical factors related to a determination of biosimilarity or interchangeability;
* The type of information that may be used to support a determination of biosimilarity or interchangeability;
* Development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products;
* Scope of the revised definition of a “biological product”;
* Priorities for guidance development;
* Scientific and technical factors related to reference product exclusivity;
* Scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and
* The establishment of a user fee program for biosimilar and interchangeable biological products."
An ambitious agenda for two-weeks or two months – let alone two days. But, you’ve got to start somewhere.
And none too soon if the frustration, confusion, angst and agita (pardon the mixed ethnography) at the Boston confab is any indication of the larger issues in play.
And from the “Use That Gavel While You’ve Got It” department, draft legislation unveiled Monday (courtesy of Representatives Henry Waxman, Frank Pallone, John Dingell, and Bart Stupak) aimed at boosting the FDA's authority to monitor the sale of prescription drugs, which increasingly occurs on a global scale.
"Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how," Dingell said in a statement.
The draft legislation would require "parity" between inspections of foreign and domestic drug manufacturing plants. Now, overseas production sites are inspected much less often than U.S.-based facilities. It also would require that manufacturers "ensure the safety of their supply chain" and would give the FDA power to mandate recalls of unsafe medicines.
Dingell stated, "Americans have been alarmed in recent years over some very concerning issues related to the quality and safety of certain drug products. We know we need to address this. The only question now is how."
“How,” it seems, is the order of the day.
This goal, though not fleshed out in a detailed legislative proposal, is much more than a campaign slogan. That conclusion emerged from interviews with a wide range of Republican lawmakers, who said they were determined to chip away at the law if they could not dismantle it.
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.
