What about Kyle and Cartman?

01/05/2009 05:23 PM |

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Hillary TRIPS the Light Fantastic

01/05/2009 12:01 PM |

On December 27th, China passed a new patent law that will allow domestic Chinese pharmaceutical manufacturers to manufacture knock-offs of on-patent medicines – and export them to third countries.  According to Yin Xintian, director the regulations department of China’s State Intellectual Property Office, the new law will “ensure patients can get the drugs they need when they need them.”

It will also be a boon to China’s pharmaceutical manufacturing industry.  Oh well, at least we know that quality won’t be a problem.

The new Chinese law is based on TRIPS – and is the latest example of how international organizations are wrecking havoc with the keystone of medical innovation – intellectual property rights.

It should also serve as a potent reminder that Secretary of State-Designate Hillary Clinton will indeed have an important role in healthcare reform – albeit of an international nature. And the implications for continued U.S. support of intellectual property rights could be profound.

Many in healthcare policy land were pleased that Senator Clinton was tapped by President-Elect Obama to head the State Department because it would (in the words of more than a few) “get her out of the healthcare reform debate.”

Not so fast. 

By moving into the corner office at Foggy Bottom, Mrs. Clinton will be a force majeure in global healthcare issues by dint of her ability to appoint and otherwise influence the United States delegations to the many Geneva-based organizations that address issues such as compulsory licensing (the World Trade Organization) and access to healthcare issues (the World Health Organization).

The U.S. has long been a bulwark in support of global intellectual property rights – and Mrs. Clinton should be questioned about her views on this and related issues during her upcoming Senate confirmation hearing.

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Signal-to-Noise Nuance

01/04/2009 01:12 PM |

By Michael Kahn

LONDON (Reuters) - Many genes linked to various cancers do not appear to raise the risk of getting cancer after all, according to an analysis of hundreds of studies published on Tuesday.

The findings highlight the need to exercise caution over the increasing number of studies associating common genetic variations with a range of diseases, said John Ioannidis of the University of Ioannina School of Medicine in Greece.

"The whole thing about genetic variations and links to diseases like cancer are very exciting, but the general public should be quite cautious about jumping to the conclusion that if they have a change in one gene or another they are doomed," Ioannidis, who led the study, said in a telephone interview.

"Genetic effects are very complex and very subtle and we need to know a lot more before we can make strong recommendations based on genetic profiles."

Ioannidis said his team had looked only at common genetic changes or polymorphisms, not at rare mutations, which in genes such as BRCA1 and BRCA2 significantly raise breast cancer risk. The rare form of these variants, for example, accounts for an estimated 5 to 10 percent of breast cancers.

Since early 2007, variations at more than 100 places on the genome have been linked to diabetes, heart disease and certain cancers.

The problem, researchers say, is that many of these genes typically interact in a complicated manner and their ultimate effects are influenced by the environment -- diet, exercise, smoking and other behavior -- in often poorly understood ways.

Ioannidis and his colleague Paolo Vineis of Imperial College London analyzed hundreds of published studies linking genetic changes to different cancers. They found that, out of 240 associations between a specific mutation and a cancer, only two genes involved in DNA repair and tied to lung cancer -- XRCC1 and ERCC2 -- turned out to be strong candidates for such a link.

"Most of the associations had weak or modest credibility," he said. That included PARP1 for breast cancer and CCND1 for head and neck tumors.

The problem is that on their own, the earlier studies fail to provide a complete picture and run the risk of drawing conclusions from too limited an amount of data, Ioannidis said.

This does not mean studies linking genes to cancer and the risk of other diseases have completely missed the mark, but rather that it takes a mountain of evidence to reach strong conclusions when it comes to the human genome, he added.

"Our study shows that it really takes a lot of research effort and many, many studies to be able to pinpoint a couple of associations," Ioannidis said.

(Reporting by Michael Kahn; editing by Maggie Fox and Tim Pearce)

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Peace In Our Time?

01/02/2009 08:31 PM |

I was in Israel this past summer visiting the National Biotechnology Institute of the Negev (NBIN) which is outside of Beersheva.  The genesis of NBIN was the collection of genetic data from Bedouins as part of a health clinic Ben Gurion University established for that nomadic people.  Now NBIN has a powerful platform for developing genetic markers for diseases, particularly those that afflict the Arab world.    NBIN -- along with school chidren, synagogues, day care centers, hospitals and the very health clinics mentioned above --  is now within the range of rockets being fired by Hamas, rockets acquired during a "cease fire." 

Those who seek to establish a moral equivalence between Israel and it's enemies, particularly journalists, lack both conscience and context. 
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A Post-Nissen World

01/01/2009 05:41 PM |

Steve Nissen believes that drugs should be evaluated strictly in terms of survival ... I guess quality of life means nothing.

See here.

A study published in July showed that diabetics who take insulin plus a diabetes pill have a lower risk of developing Alzheimer's disease than diabetics who take insulin alone.

Oh and that pill?  Avandia or Actos.  How many people are NOT on either thanks to Nissen's cardiovascular fearmongering?
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Personalized Denials?

12/31/2008 03:19 PM |

The Wall Street Journal, reports that,  “Amid studies showing the anti-clotting drug Plavix may not be effective for 30% of cardiac patients, federal regulators are considering updating the drug's label to include data on genetic factors that could interfere with the medicine.”

(Nearly 25 million prescriptions were written in the U.S. in 2007.)

“The issues concerning Plavix show the promise and problems with the new area of "personalized medicine," where drugs are tailored to certain people based on their genetic makeup. In Plavix’s case, the three studies pinpointed a likely genetic factor inhibiting the drug's efficacy -- but that finding has opened up more unanswered questions.”

“Unanswered questions” are a good thing – it means that we’re now being forced to think hard about how to address these new facts.  Nobody said personalized medicine was going to be easy.

Three studies last week -- two in the New England Journal of Medicine and one in the Lancet -- identified a genetic abnormality in some heart patients that could interfere with their liver's ability to completely process Plavix in the bloodstream, but they differed on the number of patients affected.Two of the studies suggested the drug was less effective in about 30% of the population that has the mutated gene from one parent, while one study indicated the drug is less effective in the 5% of the population that has the gene from both parents.

According to Larry Lesko, director of the FDA's office of clinical pharmacology, "What I think we're struggling with is what is the label going to say in light of all the ambiguous data out there."

That’s a key point to remember – that “personalized” labeling is not a black-and-white proposition.  And it’s the FDA’s job to review all of the information (much of it vague and contradictory) and then make the best choice on behalf of the public health.  Larry Lesko’s honesty acknowledges some tough truths about drug regulation – like the nascent nature of the agency’s understanding of pharmacogenomics relative to “safe use” and the dearth of 21st regulatory tools to explore it. 

These new studies mean "life just got very confused and much more complex" for cardiologists and patients, said Dr. James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."

Indeed, not “safety” per se, but “safe use.”

According to Dr. Lesko, the agency is considering amending the Plavix label to recommend that patients get a genetic test to screen them for the gene mutation.  This is similar in concept to the FDA’s change to the Warfarin label – but with one big difference ... at present there aren't any alternatives to Plavix approved for use in the United States. "Once you know the answer, what do you do?" said Douglas Weaver, president of the American College of Cardiology.

Good question – and one that the FDA should acknowledge and take into consideration as it reviews the various safety profiles of new medicines that could fill this gap.

Dr. Paul Gurbel, who authored one of the first studies showing that many heart patients don't process Plavix effectively, said, "Clearly I think just the blind administration of these drugs is rapidly coming to an end."

Dr. Grubel’s comment is a clarion call that the era of “trial-and-error” medicine is over.  One size does not fit all.  Not for anti-clotting drugs, not for cancer medications, not for statins.

The Journal article opines that, “The new Plavix studies may give a boost to personalized medicine as a cost-saving measure under President-elect Barack Obama. As an Illinois senator, he introduced a bill in Congress encouraging genomic research and personalized medicine that would "target the delivery of health care." Insurance companies might be able to limit prescriptions for Plavix based on patients' genetic makeup, as they do now with some cancer drugs.”

First of all, news articles shouldn't opine.  Secondly, personalized medicine is not about denying care.  It’s about providing the right care.  The four rights (right medicine at the right time to the right patient in the right dose).  And as far as “cost-savings” are concerned, not providing Plavix to some subset of patients (and particularly one as potentially large as 30%) doesn’t mean these patients don’t need treatment – it means they need alternate treatment, newer therapy, therapy that may cost more than Plavix does today – and considerably more once it goes off-patent.

And as far as former Senator Obama’s “Genomics and Personalized Medicine Act,” goes – I look forward to hearing about its passage during his first State of the Union address.

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Good Golly! Miss QALY?

12/30/2008 02:51 PM |

Earlier we commented on the future path of Britain’s National Health Service as spelled out in the “Darzi Report.”  (“Do you deny it, Mr. Darzi”)
 
One of Lord Darzi's recommendations is that NICE work faster so that the fine and timely work of the MHRA (the FDA’s sister agency in the United Kingdom) isn’t wasted.

According to NICE Chairman Sir Michael Rawlings, "Our ambition is to make sure guidance is available within three to six months.” He said this could be achieved by increasing the number of advisory committees and starting the evaluation process a year before a drug company expects to obtain a license. (Not a bad idea for similar action by CMS right here at home.)

That’s good news.  What’s better news is that Sir Michael seems to be almost, kind of, sort of ready to reconsider NICE’s inflexible devotion to the Holy QALY.

According to the NICE chairman, "People attach a special importance to extending the lives of [those with] mortal illnesses, even for a few months, and we appreciate these extra weeks and months can be very special.”

Further, "We are proposing to provide our advisory bodies with supplementary advice ... which will have the effect of extending the threshold range of what we would normally regard as cost-effective."

Good golly!  Miss QALY?

However, "We are not proposing to extend this to all conditions. Frankly, it would cost the NHS hundreds of millions of pounds."

Well, heaven forbid that the NHS should provide the best care when adequate care is available.  That’s cost-based versus patient-centric care.  That’s NICE.

In other words, when Sir Michael’s political masters feel the heat – NICE sees the light.  This is a case (one not unknown in American politics) of the squeaky wheel getting the oil.  And now that British citizens with “mortal illnesses” will finally be treated like human beings, it’s only a matter of time until every other segment of the British population figures out that where their best chances for best treatment lies – in public activism.

Is this any way to run an airline?

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Son of Diagnostical Materialism

12/30/2008 01:38 PM |

Per yesterday’s blog, “Diagnostical Materialism,” have a look at the latest article in the New York Times’ “Evidence Gap” series, “Patient’s DNA May Be Signal to Tailor Medication.”

Here’s a paragraph to whet your appetite:

“Many policy experts are calling for more studies to compare the effectiveness of different treatments. One drawback is that such studies tend to be one size fits all, with the winning treatment recommended for everybody. Personalized medicine would go beyond that by determining which drug is best for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.”

A worthwhile read.
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I Can Get It For You Retail

12/30/2008 05:04 AM |

Hasn't the New York Times ever heard of retail health clinics?
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Diagnostical Materialism

12/29/2008 02:25 PM |

Molecular diagnostics are what make medicines personal. Diagnostics are how drugs can be made “safer” -- through “safe use.” They make the “four rights” (right medicine for the right patient in the right dose at the right time) possible.  And the four rights lead to lower costs through better outcomes.

Case in point:  Warfarin, the most widely used anti-coagulant medication in the world. Prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes, patients can display markedly different responses to the drug. Doses vary enormously between individuals; so achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, while those who receive too low a dose may remain at risk of life-threatening blood clots. Via molecular diagnostics specifically called out in the amended FDA label, physicians will prevent 85,000 serious bleeding events and 17,000 strokes annually – and that’s just in the United States. And this “safer use” is estimated to save $1.1 billion annually.  And that’s the mid-range.

But diagnostics are in trouble.  And that trouble comes in the form of skittish reimbursement and ambiguous regulation.

On the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial.

Case in point:  Herceptin. Studies show that Her2 testing for breast cancer delivers savings that are 65x its cost.  For a very powerful presentation on the economics of the Her2 test and molecular diagnostics in general see here.

In short, reimbursement should be based on value rather than activity.  This is an essential (you should excuse the expression) paradigm shift. 

On the regulatory front clarity and predictability are required. FDA approved the molecular diagnostic for warfarin based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples.  But guidance on diagnostic approvals are vague as is the pathway.  To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review.  This should be a top priority of the agency’s Critical Path program.

Unless and until the reimbursement and regulatory issues are addressed, investment in developing these tools will languish, patients will needlessly suffer and our healthcare system will continue to be burdened by unnecessary costs.

If the popular culture clarion call is for “safer drugs,” then the path forward shouldn’t include beating up Big Pharma or reversing FDA preemption authority – it’s via molecular diagnostics. 

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Medical Home or Potemkin Village?

12/26/2008 01:52 PM |

“President Bush leaves office with a health care legacy in bricks and mortar: he has doubled federal financing for community health centers, enabling the creation or expansion of 1,297 clinics in medically underserved areas.”

Says who?  The New York Times.  (Ergo, it must be true.)  The article, “Expansion of Clinics Shapes a Bush Legacy.” All the news that’s fit to print?  Well almost.  It’s pretty amazing that the Gray Lady opted to leave out any mention of Part D in the President's legacy.  But maybe that article’s on the way.

But to give credit where credit is do, it’s a good article that raises some important questions -- one of the most important raised by House majority whip Representative James E. Clyburn (D, SC).  Mr. Clyburn makes the very important point that reducing the number of uninsured will be meaningless if the newly insured cannot find medical homes.

This is a key policy point for many reasons, not the least of which is the successful management of chronic disease.  Minus a warm and welcoming (and e-tized) medical home, we cannot seriously advance prevention initiatives (i.e., early detection) or improve our abysmal compliance/adherence rates. Minus a medical home we remain an acute care culture.  Minus a medical home, even community health centers are but Potemkin villages.

Last year over 80,000 Americans had a foot amputated because of undiagnosed and untreated diabetes. Hundreds of thousands of heart attacks and strokes, caused by undiagnosed or untreated high blood pressure and high cholesterol, cost the American health care system billions of dollars a year while the cost in terms of human suffering cannot even begin to be measured.

Lack of early detection?  Sure.  Lack of compliance/adherence?  Definitely. Lack of a medical home?  Shameful. 

When it comes to healthcare reform, we cannot leave patients home alone.

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FDA Reform by the Numbers

12/24/2008 03:40 PM |

When it comes to FDA reform, if you don't ask the right questions, you won't get the right answers.

It’s been widely reported this week that the FDA approved more “first-of-a-kind” drugs in 2008 (21) than it did in 2007 (18).  During that same period fewer “black box” warnings (both new and updated) were awarded in 2008 (46) than in 2007 (62).  What do these numbers mean?

To some (and you know who you are) they signal an agency that isn’t as concerned with safety as it was only twelve months earlier.  More drugs approved?  Fewer black boxes? And why, these same FDA watchers wonder, isn’t DDMAC sending out more warning and untitled letters to curb the abuses of pharmaceutical marketing – particularly of the off-label variety?

These are some of the questions they would ask.  The media-friendly questions.  The staff-prepared hearing questions.  The trial lawyer questions. The politics before public health questions.  The "tabloid medicine" questions. And they are the wrong questions.

For those who actually understand what’s going on there is a different set of queries altogether:  Why did the FDA miss review deadlines for at least 15 drugs?  Why are a growing number of complete response letters sounding more and more like the old-style not-approvable variety?  And why are more and more complete response letters requesting information that was never discussed during the review process or at advisory committee meetings?  Savvy pharmacenti also want to know what in Hell’s Bells is going on with “early safety” communications and signal-to-noise ratio issues.

But the big question those who know are asking is, Why is ambiguity trumping predictability in the regulatory process? This is the key issue that must be addressed by the new FDA Commissioner.  That’s the question.  The fear is Precautionary Principle creep.  If the FDA adopts the position of doing nothing until it knows everything -- that will send a chilling message to the pharmaceutical industry to dial back R&D unless the program looks like a sure thing.

And there are no “sure things” in pharmaceutical discovery and development.

Industry seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple and fair, but inside the FDA it has proven to be a fractious bureaucratic kulturkampf.  “Change is not required,” as management guru W. Edwards Deming once said. “Survival is not mandatory.”  And that doesn’t mean change for show, for politics – it  means thoughtful, timely, strategic change that enhances the public health.  And that kind of change requires not walking on egg shells – but breaking them.  Andy von Eschenbach learned that the hard way.

Changing the minds of regulators to embrace bright lines rather than broad definitions is a challenging proposition -- because changed minds must begin with change agents. The new Commissioner must seek out and work with those career officials within the FDA who are smart, confident and gutsy enough to embrace new ways of doing business, who support bright lines over draft guidances, pragmatism over dogmatic doctrine.  And those people are there and are excited about the possibilities of an FDA that will lead rather than an agency that buffets from side-to-side based on gusting political winds.

FDA’s Critical Path initiative is a promising example of the agency’s desire to embrace change. Going forward, the agency’s stakeholders will be looking for other “surrogate markers” to gauge FDA’s willingness to continue the McClellan era’s aggressive determination to both protect and advance the public health.

Despite new draft guidances that attempt to draw bright lines, what is and is not “in compliance” remains more art than science. Industry is confused, and the public health is not served.  Predictability is power in pursuit of the public health. Predictability is the result of creative, forward-thinking leadership that rises above bureaucratic ambiguity.  Driving this philosophy won’t be easy for the new Commissioner -- because swimming against the tide of an entrenched bureaucracy never is. But if the Commissioner communicates this philosophy, leads by doing and empowers change agents within the FDA career staff, the tide will turn.

As Winston Churchill said, “Ease is relative to the experience of the doer.”

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Talk is Cheap..So Are Lives

12/24/2008 02:47 PM |

Another study showing that certain drugs used in combination when we are old don't always mix well. 

This on the heels of a NEJM study showing high and low responders among Plavix users based on genetics.

How long will it take HMOs to connect the dots, save lives and practice patient-centered medicine by using genetic testing on high risk populations?
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Healthcare Reform and Two Boxes of Thin Mints

12/23/2008 01:34 PM |

Interesting story in today’s New York Times on Tom Daschle’s call for “Healthcare House Parties.”

In typical New York Times fashion, the event they chose as an example was peopled mostly by Obama campaign volunteers (including one person who works at the NIH and another who is “active in women’s health advocacy”).  So not your typical slice of America. 

Nevertheless, some interesting tidbits.

For example, here’s what one party member had to say about a government-sponsored plan, “similar to Medicare,” that would compete with private insurance companies -- “A public insurance plan would not take anything away. It just adds another option.”

Options are good. But would a government plan compete fairly?  Or would it ultimately drive private plans out of business by adopting, what in the free market world would be referred to as, a loss-leader strategy?  And we all know what happens once that happens.  A government run one-payer system that puts cost before care.  Options are good.  Naïvité is not.

And what might such a system cost?  According to the Times story, “The Obama transition team did not ask people how a new health care system should be financed, but several people here said that individuals and businesses should have to pay a small health care tax — some preferred to call it a ‘contribution’ — so that everyone could be covered.”

That’s nice.  A contribution.  Like buying Girl Scout cookies.  Well, not quite.  Consider the facts:

In the United Kingdom, British citizens pay 11 to 12 percent of their weekly income to finance the country’s healthcare system. And in Canada about a fifth of taxes collected in Canada go toward funding the country’s health system.  That's a lot of Thin Mints -- more than many Americans are willing to swallow.

In a recent poll  of over a thousand 18 to 24 year-old Americans – the so-called “millennial” generation -- conducted by the Center for Medicine in the Public Interest (the public policy home of drugwonks.com), 62% said they would not support any reforms that could increase physician wait times or restrict access to new medical treatments. Nearly two-thirds said they would not support additional government interference in the doctor-patient decision-making process.

Precisely the result of government healthcare. 

Oh, and a majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden.

The Times reports that, The Obama transition team asked for ‘particularly poignant stories to highlight the need for health care reform,’ and such stories were abundant at the round table here.”

But can we afford healthcare reform by anecdote?

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How About Rating Health Plans?

12/23/2008 01:59 AM |

Ok to rate doctors and hospitals, but why are HMOs so reluctant to be rated in terms of how patient-centered they are? 

Blue Cross, Zagat to rank doctors
But the ratings will be based on nonmedical factors, and some question insurance link

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Integration Now!

12/22/2008 10:29 PM |

Could you invent better timing for a new book on integrated cardiac safety?

Our friend Rick Turner (along with Todd Durham) has co-authored an important new study of new, more effective approaches for screening drugs for adverse cardiac effects, "Integrated Cardiac Safety."

This timely tome deals with drugs that are not indicated for cardiac diseases or conditions. It begins with an introduction to cardiac safety assessment and the biology of adverse drug interactions. Following sections on cardiac function and cardiac pathophysiology and disease, the authors guide readers through the assessment process during discovery, pre-approval (including QT/QTc trials), and postmarketing surveillance. The book concludes with chapters on medication errors and an examination of future trends in drug safety.

For more information on this publication and how to order your own copy, see here.

The perfect holiday gift for the pharmacovigilance geek in your family!
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NY Can't Fail Its Way to Budgetary Salvation

12/19/2008 02:57 PM |

Desperate times call for desperate measures -- and nowhere is this more evident than in Governor Patterson's proposed budget for New York.

But pennywise and pound-foolish doesn't help. And nowhere is this more true than when it comes to healthcare.

Specifically, the Governor's budget calls for the required use of step therapy for many medications. This means patients must "fail" their way to more expensive (generally on-patent) drugs. So, even if a physician wants her patient on (what in her expert medical judgment is) the best, most effective therapy -- the state demands multiple therapeutic failures via less expensive options first. This is a short-term fix with very expensive long-term repercussions when you consider that (nationally) 7% of our healthcare spend is on brand-name pharmaceuticals while in excess of 30% is on hospital care. When patients are forced to fail -- hospitalization often ensures. The budget wizards in Albany calculate this program would save the state $18.9 million in the next budget year. But the unintended consequence of increased hospitalization rates could be staggering. Step therapy? Bad idea.

Another codicil calls for required disclosure of payments by manufacturers to prescribers of over $50. There is no listed budgetary saving to the state. So why is it in the budget? We know why -- because too many of our elected representatives have a serious jones out for the pharmaceutical industry. So be it. But if disclosure is the order of the day than it should also be required of insurance companies that offer monetary spiffs to physicians for switching their patients to lower cost medicines and to lawyers who pay doctors to be "expert" witnesses. What's good for the goose is good for the gander -- but it doesn't save the state a nickel.

Along these same lines is another line item that requires the presenters of continuing medical education to disclose financial relationships with manufacturers. This is a contentious public policy issue -- but not a budgetary one. (For more on the CME issue, see "Battling the COI Polloi" here.) Savings to the citizens of New York State -- zero.

If the order of the day is austerity (and it is) then Albany needs to stay on point.
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FDA Transition Talk

12/18/2008 11:48 AM |

Playing FDA parlor games may be fun for some -- but reform of the U.S. Food and Drug Administration must be about serving the public health—not partisan political interests. That’s why I was honored when the Obama FDA transition team called and asked for my advice on how the incoming administration could make the agency a more robust and forward-looking regulatory instrument.

The transition team’s initial request was a memo, of no more than two pages, outlining key issues and offering general recommendations. Never have two pages seemed so inadequate. But I did my best.

My suggested areas of focus are

(1) A strong, science-based FDA

(2) The Reagan/Udall Foundation -- a Partnership of Unequals

(3) Clarity vs. Ambiguity

(4) Information Management

(5) Food Safety and Security

(6) Risk Communications

(7) The Drug Label and the "Safe Use" of Drugs

My complete memo to the transition team can be found here.

There are, obviously, many, many other important issues (a more thoughtful position on expanded access, United States-European Union regulatory harmonization, etc.) andI look forward to working with the transition team to ensure that the new commissioner can hit the ground running—in the right direction—with some early and important wins that will set the tone for a newly confident FDA. And kudos to the Obama transition team for reaching out to a wide variety of groups. That's the right way to get things done -- despite what some politicians and pundits may think.

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Spreading the Pain With Comparative Effectiveness

12/17/2008 08:30 PM |

Steve Pearson is quoted in today's New York Times as filling in the evidence gap prostate cancer care... Wow.

“Most policy makers think that, in general, we would want to do more national coverage decisions, partly because there’s a concern that the evidence review in most local regions isn’t very good,” said Dr. Steven D. Pearson. He is president of the Institute for Clinical and Economic Review, an organization partly financed by the insurance industry that is pushing for the use of evidence in medical decisions.

But that concern reflects an impatience with the views of others, particularly patients and physicians who would disagree with comparative effectiveness decisions that Pearson and his group would be entitled to produce under proposed comparative effectiveness legislation. His response to to a piece by Tom Philipson in health affairs about how comparative effectiveness analysis is, in fact, price controls is revealing:

"Surely an innovation that creates a near-cure for HIV should be valued more than a new combination pill of previously established drugs. It seems nonsensical that society would want to lavish rewards on innovators who produce equivocal or marginal gains and charge a steep price. The key is not to control prices but to incentivize investment in interventions that yield significant gains in effectiveness. When used rigorously and transparently, cost-effec-tiveness criteria can send the signal that the bestway to succeed as an innovator is to create interventions that are much more effective than previous alternatives. This is the signal that is missing from much of the U.S. healthcare system, where low-risk and marginally superior interventions are marketed to price insensitive physicians and patients.

I would completely reframe the authors’ argument by advocating that linking insurance coverage to cost-effectiveness might make patients feel a little worse off today but would
greatly benefit future patientswho will inherit a less bloated and wasteful health care system. That way, future patients will find a health care market dominated by focused, skilled innovators
who know that their greatest reward will come from producing interventions of greatly enhanced effectiveness at a reasonable cost. If, as a result, some of today’s venture capital chooses to flee elsewhere to seek easier returns, so be it. Let’s get the innovation we want."

Note how he concludes that government set criteria or criteria provided by the institute via government contracts can replace "price insensitive physicians and patients." Then and only then my friends will be the innovation "we" want. And if we make patients a little worse off in the process, oh well.
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Scherer's Case for Price Controls

12/17/2008 03:01 PM |

Here's how Fred Scherer explains how price controls won't discourage innovation:

In criticizing a paper, one of only dozens showing that price controls do discourage innovation (and he only has to look at the reality in Europe, UK, and elswhere, but ok, just pretend your Harvard generated model is the real world ) Scherer claims "that the drugs chosen for the authors' analysis are neither the most therapeutically innovative candidates nor those whose development is most likely to be discouraged by price controls."

Really. So Prof. Scherer knows which drugs -- years before they will be approved and used and then subsequently evaluated with tomorrow's genomic and epigenetic techniques, which drugs will be the most therapeutically innovative or discouraged.

Has he run a drug or biotech company? How about a venture capital fund? Last time I checked, the most therapeutically innovative candidates were also the most challenging to develop and required a higher burn rate and a higher rate of return. And where is that money going to come from? Did he factor comparative effectiveness delays and market restrictions into his model?

See the Health Affairs article here.


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