510 Kay doesn't play in the WNBA

10/08/2010 10:33 AM |

Who "lost" medical technology? 

At an FDA-sponsored public meeting in Irvine, California, CDRH Director Jeff Shuren shared that new regulations for approving medical devices may include a new category for medium-risk products.  Products in this category would require more studies on safety to win agency clearance. According to Shuren, changes will be phased in and that changing the rules may not result in more studies being required of device makers initially. “We are still addressing that on a case-by-case basis where it’s appropriate and necessary, he said.

 

Is more data always better?  Sometimes.  But how does this weigh against the growing “device gap” between the US and the EU?  It seems that what’s old is new again – and not necessarily for the better.

 

When the agency determines it needs more data for an approval or that a device application should fall under a new designation, consideration must also be given to what’s going on “over there.”  We cannot and must not create a regulatory environment for medical technology (or, for that matter, pharmaceuticals) that exists in isolation from the rest of the world.  Harmonization mustn’t mean “do it our way,’ but rather, “let’s talk.”

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Expletive Deleted

10/07/2010 08:31 AM |

The FDA's new framework for "Advancing Regulatory Science for Public Health" has it's heart in the right place.

It even discusses the need for collaboration:

Support for mission-critical applied research, both at FDA and collaboratively

Support within the FDA is critical to expanding the field of regulatory science. An active research program, directly connected to the FDA review process, will not only bring needed advances in regulatory science straight to FDA review, product development, and evaluation but will also add value to guidance and policy development.

In addition, the discipline of regulatory science must be developed though support from both partnerships and external research and collaboration. There are substantial opportunities to enhance and expand current FDA programs and to develop new ones that support effective, more robust, external and collaborative efforts to advance regulatory science. Some projects are already under way:

• A Joint Leadership Council recently created by FDA and NIH to promote the expansion of regulatory science through enhanced scientific collaboration and jointly supported and administered extramural research grants in regulatory science.

• Creation and support of academic Centers of Excellence in Regulatory Science to carry out applied regulatory science research both independently and in collaboration with the FDA and as a locus for scientific exchange and training opportunities for both FDA and academic scientists

• Enhanced strategic collaboration and coordination with other governmental agencies to develop new programs to advance regulatory science and innovation

• Enhanced support and focus for the Critical Path Initiative to catalyze and enable partnerships and consortia that advance regulatory science and public health through innovation and modernization of the medical product development and evaluation process

• Partnership with the Reagan-Udall Foundation on projects in support of regulatory science

Good words.  But two important words are missing ... "with industry."

Obviously, the one-line reference to the Reagan/Udall Foundation means "with industry" and it's possible that these words which must not be spoken also reside within "partnerships and consortia."  But why the strange silence about such a valuable partner?  Advancing regulatory science without regular and robust collaboration from the regulated?  Not likely.

Fortunately, Peggy Hamburg often speaks about working with industry on Critical Path issues.  Enquiring minds want to know if any references to "industry" were blue-penciled out prior to publication -- and if so, by whom.

The white paper intelligently comments that:

There is no single discovery — no magic bullet — to address our unique set of modern scientific regulatory challenges. But one thing is clear: if we are to solve the most pressing public health problems we face today, we need new approaches, new collaborations and new ways to take advantage
of 21st century technologies. And we need them now.

All said, this paper is a step in the right direction and people who work in (expletive deleted) should read it.
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A (Minor) League of Their Own

10/06/2010 09:30 AM |

There’s no crying in healthcare reform.

In today’s New York Times, David Leonhardt (discussing the Presidential rhetoric used to assuage citizen uncertainty) writes, “Mr. Obama went so far as to suggest there would be no disruptions, saying that people could keep their current plan if they liked it. But that’s not quite right. It is not possible to change a system as huge, and as hugely flawed, as ours without some disruptions.”

 Now that the legislation has passed, it seems as though the new talking point is, “It’s gonna get worse before it gets better.”  And whether or not it’s going to get better is still very much theory (at best) and hoping (at worst).

Remember all that money that healthcare reform was going to save us?  Well, since a swiftly deprogrammed Peter Orszag put that shibboleth to bed (again, in the pages of the New York Times), the debate seems to be about how insurance is going to be made more affordable.  One way we’re supposed to achieve this, according to Leonhardt, is that “people will be required to buy insurance, to spread costs among the sick and the healthy.”

Sure – except that this mandate (if it doesn’t turn out to be unconstitutional) (1) doesn’t even kick in until 2014 (the same time the theoretical state exchanges come in to play) and (2) will likely penalize offenders less than even a low-cost health insurance premium.  Oops.

Specific to the state exchanges that are the foundation of the theory, Leonhardt writes, “the new markets for health insurance, known as exchanges, won’t be up and running until 2014. This timetable has its problems, and the Obama administration will probably need to grant some more temporary exemptions.”

Call me when the revolution starts.

Not to say that it’s at all about politics!  No penalties until 2014?  If we’re in such dire straits – why not, say, right now.  “It’s coming and it’s going to be great,” as a rallying cry is, plainly speaking, tanking since the reform plan is already leaking like a sieve. And it’s not going to cut it before the November elections. The truth is that it’s likely to get worse.  Whether or not it gets “better” (whatever that means) depends largely on “fixes” that will necessarily be made in the next Congress.

Just what we need, healthcare sausage.

 All this to say that we’d better all stop crying and start trying to think about what needs to be done beyond the talking points.  After all, if it was easy, anyone could do it.

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Payback?

10/04/2010 12:27 PM |

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The Peter (Orzsag) Principle

10/04/2010 12:11 PM |

Both the left and the right hew to narratives about healthcare that comport with their worldview rather than mechanism-based analysis of treatment outcomes or evaluation of the impact of technological innovation on such interventions.  Both make the assumption, badly mistaken, that quality reduces cost.   Both base this mistaken assumption on the flawed Dartmouth Study that has peddled the falsehood that less care is actually better.  

Peter Orszag was the peddler in chief of this notion, stating that the Dartmouth research demonstrates that at least $700 billion in health care spending is wasted each year.   CMS commissar Berwick, with usual hyperbole, says that Dartmouth research shows that HALF of all health care could be eliminated and that doing do would improve outcomes. 

Such statements are made in the face of research that both cite.  And when they encounter a finding that conflicts with their narrative, they simply ignore it, even when citing the literature.

The most recent example is Orszag's oped in the NY Times today (Health Care’s Lost Weekend) tinyurl.com/27sfn7v

"The Dartmouth data also indicate that the N.Y.U. patients received no clear benefit for the higher cost. They saw, on average, more than 14 different doctors, compared with fewer than 10 for patients at the most efficient hospitals. But the extra visits did not seem to produce better outcomes. In fact, seeing more doctors may have caused harm, as patients ran the risk of side effects and complications from additional tests, treatments and medicines."

But Orszag cites an article in the NEJM that proves the opposite, en route to making his point. 

First, weekends. It’s never good to be hospitalized, but you really don’t want to be hospitalized on a weekend. There are fewer doctors around, and people admitted on Saturdays and Sundays fare relatively poorly.

One study in 2007 found, for example, that for every 1,000 patients suffering heart attacks who were admitted to a hospital on a weekend, there were 9 to 10 more deaths than in a comparable group of patients admitted on a weekday. The weekend patients were less likely to quickly receive the invasive procedures they needed — like coronary artery bypass grafts or cardiac catheterization.

Except that the study concludes the more care leads to better outome not that more people receiving care quickly:

Overall, mortality 30 days after admission was significantly higher for patients admitted on weekends than for those admitted on weekdays...Patients admitted on weekends were less likely to undergo invasive cardiac procedures than were those admitted on weekdays....the worse outcome of weekend admissions may be due in part to a lower rate of invasive intervention.

www.nejm.org/doi/full/10.1056/NEJMoa063355#t=articleTop

This article is consistent with other studies , including those by PCORI governor Dr. Harlan Krumholz, showing that the rate of invasive intervention, once severity of illness is adjusted for, saves lives and improved outcomes

The key variable shaping re-admissions:  intensity of interventional care.   The shorter the stay and the fewer the procedures, the more readmissions there were.  

jama.ama-assn.org/cgi/content/short/303/21/2141

When it comes to invoking quality, both the right and the left should be more circumspect about clalming it can save money.   And Orszag, who perpetuated this myth, ought to lead the charge.

 
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The Rational Pessimist

10/01/2010 06:44 PM |

I couldn't sleep on the way back from Israel.  So I read Matt Ridley's new book, The Rational Optimist.  www.rationaloptimist.com/   Ridley's thesis is that innovation -- broadly defined as technological advances that reduce the time required to develop goods and services that enrich life --  is the process of human evolution and uniquely so.  The huge gains in life expectancy, declines in infant mortality, growth in income are the product of innovation and the rational optimist bases his or her hope for a better world on these advances, not faith.  To him, innovation is always worth the time and investment precisely because the decisions and actions leading to specific innovations reflect a collective exchange of ideas, interests and needs across continents, civilizations and time.  By contrast, Ridley derides the efforts of government to substitute it's "wisdom' in favor of this collective and iterative process.

But one also has reasons to be a rational pessimist about innovation in large part because our society is hamstrung by free lance regulators who are able to use the government to impose the precautionary principle or their own biases on the public as a whole.  We have become a nation of tattle-tales, whiners and instant experts who confuse a foot-noted declarative statement with wisdom. 

Take this most recent example:

"Impressionable utes weren't the only ones watching when Cincinnati Reds owner Bob Castellini (right) passed out victory cigars and then lit up after his team clinched the NL Central title at Great American Ball Park on Tuesday.

Also watching at home on television were at least five whistle-blowers who noted that the Reds were violating Ohio's indoor-smoking ban. They called Cincinnati's health department to report the team and now the Cincinnati Enquirer reports the club is under investigation. 

In case you're wondering, the answer is yes — I'm extremely sorry to report that there are people living among us who would actually do this."

Me too.   Here is a list of the people and organizations among us who are now enriching themselves or making themsevles famous by using government to impose their views on the rest of us, crippling innovation in the process.

1.   The anti-Avandia axis of Gardiner Harris, Steve Nissen and David Graham who have use innuendo and meta-analysis to drive Avandia into near extinction.  Perhaps the FDA's decision to keep the drug on the market can be considered a victory of sort, but as someone said, another victory like this and we are done for.

2.  The comparative effectivness crowd that will be telling us how much a life or product is really worth.   Imagine if the same experts who now raise questions about whether a cancer drug is worth it because, on average, it adds a few months of life and costs $100k a year made the same determination about HIV drugs in 1987.  In today's dollars AZT would cost $21000 a year and based on initial studes added on average about 6 months of life to patients who still suffered horribly.  Today of course the cost of AZT is much lower and as Tom Philipson and co-authors found "ex-post value of hope associated with treatments for HIV patients to be as much as four times as high as standard per-capita estimates of treatment effects and as many as two and a half times as high as aggregate values across all cohorts."  (Meaning across time and society.)

www.nber.org/papers/w15649.pdf

3.  The board of governors of the so-called patient centered outcomes research institute which has as a member a chiropractor who lead the American Chiropractor Association and who believes that immunization should be "voluntary."  

4.  Those at the NIH and FDA who have hijacked The Critical Path to fund basic research that has nothing to do with creating tools that contribute to accelerating product development.   You see, 'regulatory science' now means anything that could be used down the road in the development process.   Basic research is much sexier and easier to get money for and avoid being attacked as providing aid and comfort to industy.

Lots of other countries provide generous R and D tax credits.  They provide struggling companies with cash flow in the short term.  But they are no substitute for a culture that embraces innovation.  And start ups rarely become engines of commercialization and innovation.  

So I am pessimistic because unlike Ridley so many people take innovation for granted and confuse.  Worse, unlike Ridley, as AEI's Alex Pollock writes:
"there is a danger with intellectual brightness. It is to overemphasize and develop a bias for cleverness, quickness, facility with data, and the ability to persuade."   There is a danger we all face in underestimating the pernicious influence ideas have when armed with the power of the media or government.  

Pollock adds:  Max Planck, the great physicist, made this provocative observation: “A new scientific truth does not triumph by convincing its opponents and making them see the light, but rather because its opponents eventually die, and a new generation grows up that is familiar with it.”

www.american.com/archive/2010/september/it2019s-easier-to-be-brilliant-than-right

Will we waste a generation ignoring the constants that enrich civilization in favor of shorr term policies, sound bits and cleverness with wisdom?

 

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UN phone home

09/29/2010 06:53 PM |

Between the Jewish holidays, traveling to Israel (where I am now) and the Yankees stinking up September it has been hard to focus on healthcare. Or at least blog about it.

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


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Just don't tell Rosa!

09/28/2010 09:01 AM |

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.

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Tough Luck? Tough Love? Or Tough Problem?

09/27/2010 09:08 AM |

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.

See you on November 3^rd.

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Credit where Credit is Due

09/24/2010 08:17 AM |

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.  Read More & Comment...

Avandia: Who won?

09/23/2010 12:22 PM |

If you're keeping score, notch up a victory for science, patients and physicians.

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.

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The Amgen Admiral

09/23/2010 09:08 AM |

Congrats to former CDER Director, Acting Surgeon General and all-around decent guy Steve Galson on his appointment as Global Regulatory VP for Amgen.

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The song remains the same

09/23/2010 08:49 AM |

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 …

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No aBLA Biosimilar

09/22/2010 04:39 PM |

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.

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A funny thing happened on the way to the forum (on biosimilars)

09/21/2010 04:22 PM |

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 2^nd and 3^rd 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.

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And the hits keep on coming

09/21/2010 10:39 AM |

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Of stimulus and stimulants

09/20/2010 12:20 PM |

As seen in the Atlanta Journal Constitution:
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Avastin Avowal

09/17/2010 01:45 PM |

From today's edition of Reuters' "Great Debate" series:

Let cancer patients have this pill

By:  Peter J. Pitts

One more day — or week, or month, or perhaps even a year. It may not seem like much time, but patients with incurable cancer know better. For Christi Turnage of Mississippi, who lives with stage IV breast cancer, it means seeing her daughter start kindergarten, celebrating her 27th wedding anniversary, and watching her sons graduate from college.

Her family and her oncologist credit her quality of life for the past two years to the drug Avastin, a biologic that combats cancer by cutting off the blood supply to tumors. But advanced breast cancer patients like Turnage have been forced to spend precious time battling something else: the possibility that federal regulators will vote today to remove approval of Avastin for their treatment.

If officials with the U.S. Food and Drug Administration are wise, they will overrule the agency’s cancer-drug advisory panel, which voted 12-to-1 last month to recommend denying a valuable clinical option to advanced breast cancer patients. According to the Department of Health and Human Services, an estimated 40,000 women die from breast cancer each year.

The panel concluded that the costly drug doesn’t eke out enough extra lifetime among breast cancer patients to justify its use and risks. This ignores all the “super responders” — the patients who reap significant benefits from Avastin. Scientists have no way of identifying these people in advance, and they could be devastated if they are denied the medicine.

“This is not a worthless drug by any means,” Eric Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston. “There is almost certainly a group of women who get a big benefit.”

Indeed, the Susan G. Komen for the Cure and Ovarian Cancer National Alliance – recently sent a joint letter to the FDA urging the government to keep it as a choice best made by a woman and her doctor.

The groups also warned that if the FDA de-lists Avastin for breast cancer, it would only discourage future drug development.

Two years ago, the FDA fast-tracked approval of Avastin for metastatic breast cancer two years ago, and since then it has been prescribed to about 17,500 women a year with the disease. The drug, which earned FDA approval for the treatment of colon, lung, kidney and brain cancer, is the world’s best-selling cancer drug.

A clinical trial that took place from December 2001 and May 2004 found that Avastin boosted the amount of time that breast cancer patients lived without the disease spreading or worsening. The drug in combination with chemotherapy delayed tumor growth for about 11 months, which was more than five months longer than chemo alone. Follow-up studies indicated a less robust response, yet still found an average delay in tumor growth to between one and three months.

But even if Avastin does not, “on average,” extend life for breast cancer patients, that  “average” is composed of patients who respond in dramatically different ways –including some like Christi Turnage who gain years.

Another is retired California art teacher Patricia Howard, who reports that infusions of Avastin every three weeks over the past two years have shrunk tumors in the lining of her lung and eliminated fluid that hampered her breathing. Now she enjoys shopping and golf, and describes her life as “beyond fabulous.”

Serving as a patient representative at the FDA’s last session, Howard recalled, “One doctor got up during the meeting and said ‘This drug gets women only to first base and we want a home run.’ I felt like jumping up and saying I don’t mind just being in the ballgame.”

If the FDA does remove approval of Avastin for breast cancer, doctors conceivably could write prescriptions for it anyway, going “off label.” But it’s likely that Medicare and private insurers would not cover the cost of what is one of the world’s most expensive drugs. Patients could continue Avastin only if they could afford $8,000 a month out of pocket.

Avastin is a better alternative than the status quo for breast cancer patients, and can be truly transformative for some. No wonder Avastin-users are desperately writing letters, circulating petitions and, like Turnage’s 19-year-old son Josh, posting videos on  YouTube pleading their case.

Avastin is their last hope. The FDA should make sure it is not their lost hope.

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Joint Relief?

09/17/2010 08:08 AM |

(Reuters) - A new process to review medical products at the U.S. Food and Drug Administration in tandem with the nation's Medicare insurance program could help speed up coverage decisions, the FDA said in announcing the move on Thursday.

Under the proposal, the FDA would review and make approval decisions alongside the Centers for Medicare and Medicaid Services, which decides whether and how to pay for new medical products for its elderly and disabled patients once they are approved for the U.S. market.

To start, the agencies proposed a pilot project for devices after both FDA and CMS had time to review public comments on the proposal.

More than 45 million people are covered under the Medicare program. Private insurers often weigh CMS's coverage decisions when setting their own reimbursement policies, and a decision by Medicare to cover a new product can speed its adoption in the wider marketplace.

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Decomposing Obamacare

09/16/2010 01:58 PM |

The diehard supporters of Obamacare consist of the bloggers and wonks who said ramming the bill down the throats of the American people would pay dividends because people would fall in love with the legislation after it was passed.

This litte group of elites guessed wrong.  Poll and after poll shows that not is Obamacare wildly unpopular but it remains a principal reason for voters to toss out Democrats in November.

Yet, the elites still insist that the law is popular:

"A new CBS/New York Times poll has found that 49 percent of Americans oppose the health care law, compared with just 37 percent who support it.
ObamaCare booster Jonathan Cohn, while acknowledging that recent polls have been discouraging, sees some silver lining in the CBS/NYT poll. He notes that "While 40 percent of respondents said they supported repealing the Affordable Care Act, more than half changed their minds (leaving just 19 percent in favor of repeal) when pollsters mentioned that it'd mean letting insurance companies exclude people with pre-existing conditions."


What a hypocrite.   As Phil Klein of the American Spectator points out:

"Yet this is the same argument that proponents of the legislation have used all along to explain poor poll results -- that it's more popular when you ask separately about its component parts. The problem is that the popular parts are linked to other less popular parts to make up the whole."

spectator.org/blog/2010/09/16/opposition-to-obamacare-rises

Moreover, Cohn and others have always insisted that you can't provide such exemptions without forcing everyone to buy into government approved plans and using price controls and rationing to control use of services.  You can't have it both ways: point to support of changes people are in favor of yet insist that the entire law in its current form must be implemented.     If pollsters mentioned other aspects of the bill -- as an earlier CMPI poll showed --  support evaporates.

The fact is, repealing the worst features of Obamacare and replacing it with something that gives people coverage, choice and control over health care decisions is something a vast majority of Americans favor.

pajamasmedia.com/files/2010/03/CMPIA.PJM-raw-data.pdf

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