The Cost and Value of Comparative Effectiveness Research

05/04/2009 10:40 PM |

For all the assertions about the value of comparative effectiveness research (and money now being spent on it) there is actually very little theoretical or empirical research on the impact of such studies on things you might want to know about:  Costs for one thing.  There is the small question about whether the research has actually produced conclusions that could be considered clinically reliable or meaningful.  Then there is the question of the impact a quality of life threshold derived from an initial review of a relatively new product that itself reflects a value judgment will shape the rate of  Investment in future technologies.  

A recent paper entitled: Economic Evaluation and Comparative-Effectiveness Thresholds: Signals to Firms and Implications for R&D Investment and Innovation John A. Vernon University of North Carolina at Chapel Hill, Joseph H. Golec University of Connecticut - Department of Finance and me address that last issue. 

Here's the abstract and a link to the article:

Abstract:     
In this article we describe how reimbursement cost-effectiveness thresholds, per unit of health benefit, whether set explicitly or observed implicitly via historical reimbursement decisions, serve as a signal to firms about the commercial viability of their R&D projects (including candidate products for in-licensing). Traditional finance methods for R&D project valuations, such as net present value analyses (NPV), incorporate information from these payer reimbursement signals to help determine which R&D projects should be continued and which projects should be terminated (in the case of the latter because they yield an NPV < 0). Because the influence these signals have for firm R&D investment decisions is so significant, we argue it is important that reimbursement thresholds reflect the economic value of the unit of health benefit being considered for reimbursement. Thresholds set too low (below the economic value of the health benefit) will result in R&D investment levels that too low relative to the economic value of R&D (on the margin). Similarly, thresholds set too high (above the economic value of the health benefit) will result in inefficiently high levels of R&D spending. The U.S. in particular, which represents approximately half of the global pharmaceutical market (based on sales), and which seems poised to begin undertaking cost effectiveness in a systematic way, needs to exert caution in setting polices that explicitly or implicitly establish cost-effectiveness reimbursement thresholds for health care products and technologies, such as pharmaceuticals. In this paper we consider how cost-effectiveness thresholds influence R&D spending because firms react to payer reimbursement signals and guidelines.

Read article here
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Health Care Costs: International Edition

05/04/2009 05:34 PM |

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Nuts!

05/04/2009 12:11 PM |

In a new Harris Interactive/HealthDay online survey (conducted in mid-April, via a nationally representative sample of 2,495 adults aged 18 and over), 47 percent of respondents believe the FDA does a poor job when it comes to monitoring the safety and effectiveness of new prescription drugs. 

The good news is that this is an improvement over the 58 percent disapproval rating noted in a similar poll last year.

Some other interesting findings:

* 49 percent of Americans have a negative view of the job the FDA is doing. 48 percent have a positive assessment.

* 6 percent of respondents say that the FDA's oversight of imported foods is "excellent.” 21 percent say it’s "poor."

* 8 percent of poll respondents feel the agency is doing an "excellent" job of making sure new prescription drugs are safe and effective, or monitoring the safety of prescription drugs after they arrive on the market.

* 11 percent believe the FDA does an "excellent" job of handling recalls of prescription drugs. Overall, 43 percent think the agency's handling of recalls is "good," 28 percent "fair," and 12 percent "poor."

* 56 percent of those surveyed feel positively about how the FDA handles food recalls, while 40 percent feel negatively. Confidence about drug recalls was less robust.

* 59 percent said they feel that food safety should be the FDA's most important priority, followed by ensuring the safety and effectiveness of prescription drugs (37 percent). The safety of imported food came in third at 30 percent.

* 47 percent of respondents felt negative and an equal number positive about how the FDA ensures the safety and effectiveness of new prescription drugs. In 2004, 56 percent were positive and 37 percent were negative.

* More individuals (53 percent) felt positive than negative (40 percent) about how the FDA handles drug recalls in 2009, versus an opposite trend in 2008: 39 percent positive and 53 percent negative.

* Roughly the same percentage of people feel positive and negative about how the FDA monitors drugs after they are approved.

* About one-third (35 percent) of respondents say the FDA approves new drugs too slowly, 19 percent too quickly, and 18 percent think the process is about right.

* Only one-quarter feel "very confident" about the safety of over-the-counter medicines such as cough and cold medicines; 24 percent feel the same about prescription drugs, both brand names and generics. But only 14 percent feel this way about herbal remedies and nutritional supplements.

Obviously, some of these findings are somewhat contradictory – and that’s not surprising considering that many of the questions overlap and the responses are based on what people “think” they know about the FDA.  But, all that aside, it is a snapshot in time of people’s general attitudes about the agency that regulates more than a quarter of the American economy.

What explains the improvement of the numbers year-over-year?  Is the “Obama FDA” in April 2009 any different from the “Bush FDA” from January 2008?  The answer, technically, is nothing is different.  But with a new administration (and particularly this one) comes higher expectations.  And the agency’s expeditious approach to pistachios seems to have given the FDA a kick-start to public redemption.

Well, nuts!

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Next Up: Craigslist Killer As Match.com Spokesman?

05/01/2009 09:29 PM |

Because it's Friday and because I am staying at home in a tub filled with Purell under the advice of Joe Biden:

On May 21, Michael Vick will be transferred from a federal prison in Kansas to home confinement in Hampton, Va. (AP)

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Peggy Pandemic

05/01/2009 11:40 AM |

What's it going to take to get the Senate to act on Peggy Hamburg's nomination, a flu pandemic?

While FDA has made all the right moves in dealing with the swine flu issue (specifically by naming Jesse Goodman to oversee the agency’s role in addressing the problem) there’s one more thing that only the United States Senate can do to help – confirm Peggy Hamburg as Commissioner. Now.

After all, she’s only one of the world’s top experts in flu pandemics – serving as vice chair of the IOM’s Forum on Microbial Threats (where she served along side Dr. Goodman and the FDA’s current “Food Czar,” David Acheson.

It’s time for us to use all the weapons at our disposal to combat the swine flu -- and Peggy Hamburg is a powerful one.  Let’s get the confirmation process underway and expedite a Senate vote.

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Ace Ventura, Autism Detective

04/30/2009 01:19 PM |

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The other Stossel and the same old Angell

04/30/2009 11:16 AM |

From the pages of Forbes ...

How To Maintain FDA Standards
Don't follow Marcia Angell's recommendations.
Bruce Gingles and Thomas P. Stossel,

For over 100 years, the U.S. Food and Drug Administration has balanced bringing important new medical products to patients with ensuring their safety. No drug or device is 100% safe, but physicians have steadily obtained ever more effective tools that increase patient longevity and quality of life.

Still, critics we dub "pharma-scolds" depict the FDA as a stooge of medical-products manufacturers and demand that the agency develop a more adversarial relationship with the pharmaceutical industry. One inveterate fault-finder, whose opinion is often sought by credulous audiences, is Marcia Angell, former acting editor in chief of the New England Journal of Medicine and author of The Truth About the Drug Companies. In an April 6 piece in The Boston Globe, Angell made sweeping recommendations that, if enacted, will set back patient care.

First, Angell wants to eliminate the "user fees" drug companies currently pay the FDA to evaluate their products. Such fees, she argues, confer "employee" status on the agency. But these companies have no input into the FDA's final decision to approve or deny new drug applications. Substantial research shows that user fees benefit patients by allowing the agency to hire additional staff to process new drug applications in a timely manner.

And many other federal agencies--even the post office--supplement their budgets with user fees. Taxpayers clawing their way out of an economic recession should appreciate that the industry pays in part for its own regulation.

Next, Angell wants the FDA to exclude industry consultants from advisory committees on new products. But evidence shows that the most productive scholars have industry relationships, and that such relationships have no effect on their recommendations for drug approval. It seems Angell would rather have the FDA get less useful advice than turn to experts who work with companies to develop life-saving products.

Angell also wants direct-to-consumer advertising for new products banned for three years after they're launched, limiting market penetration so that side effects not detected by pre-approval trials will affect fewer patients. But since rare complications emerge only after widespread product use, her recommendation is illogical. Banning this advertising, as Angell suggests, would mainly serve to keep useful products from patients who need them.

This brings us to Angell's worst idea: discouraging "me-too" products--drugs developed as variants of new medicines--based on the incorrect presumption that such products increase costs without adding clinical value. Once a new drug is approved, Angell suggests, no more drugs should be approved for the same general purpose unless it is judged superior to the first product in head-to-head clinical trials.

But Angell fails to understand that most useful innovation is evolutionary, not revolutionary. Tweaking antibiotics, for example, counteracts the penchant of disease-causing microbes to develop resistance to them. Radically curtailing second-generation products makes neither medical nor economic sense and borders on murderous absurdity.

The introduction of "me-too" products by multiple companies facilitates testing of the products in different clinical indications, expanding their versatility and benefit to patient. Competition among brand products reduces prices, and sales of incrementally beneficial products provide the revenues to support the research and development of the occasional breakthrough drug.

If the first cholesterol-lowering drug (called a statin) for preventing heart attacks had been not Merck's ( MRK - news - people ) Mevacor, but Bayer's ( BAY - news - people ) Baycol--which was later shown to have potentially fatal side effects--and the FDA had delayed the introduction of new statins because it was waiting for evidence from head-to-head trials, patients who needed to cholesterol reduction and had only Baycol available would have been without any alternative. As another example, lanidomide is not materially more effective than thalidomide (from which it is derived) as a treatment for the disease multiple myeloma, but it lacks thalidomide's side effects.

Angell also wants the FDA to exclude surrogate measurements--like cholesterol, which correlates with heart attack risk--as criteria for approval of second-generation products, because such measurements don't always predict clinical outcomes. Instead, Angell thinks companies should conduct expensive trials to document clinical benefits.

However, surrogate values are frequently predictive. Scientists use surrogate markers to make reasonable predictions about actual outcomes in patients--giving patients faster access to new treatments. FDA approved both thalidomide and lanidomide based on surrogate measurements. Abandoning them would make a perfect enemy of the good.

Last but not least, Angell wants to accelerate FDA approval of generic products, alleging that the "FDA takes roughly twice as long to approve them as to approve brand-name drugs." Generics are the ultimate "me-too" products--they're just cheaper copies of older drugs.

Generics are fine, but Angell draws a false comparison. User fees do shorten the time between the filing of a new drug application and an FDA decision; pre-application development time for innovative products is far longer than for generics. A better metric is to compare actual numbers of new drug and generic drug approvals: In 2008, the FDA approved 21 innovator drugs and 90 first-time generics.

In short, Angell's calls for reform would lead to decreased patient access to lifesaving new products, higher drug prices and less competition between pharmaceutical companies. As public policy, that's a prescription for bad health.

Bruce Gingles is vice president of Cook Group, a medical device company. Thomas P. Stossel is a professor of medicine at Harvard University and a senior fellow at the Manhattan Institute for Policy Research.

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Inconsistency on Conflict of Interest

04/29/2009 08:24 PM |

Still trying to get my mind around the IOM conflict of interest document.  I am sure it is because I am not smart enough, as the report implies, to discern if my doctor is a total degenerate because he is unconsciously being manipulated to prescribe a certain product because of the free lunches that were handed out.    Or as the IOM study puts it, it is too bad if I want to judge my doctor or a scientist on the quality of his or her work alone.  Oh no.   You see, " Here again the problem is that many people affected by professional decisions are not in a position to judge the validity of those decisions.  In addition, those who are competent to judge may not be able to do so until after the damage has occurred. "

Note that the IOM report never specifies or demonstrates through research what damage has occured. And note that it presupposes that the great unwashed are too stupid to figure out that it is being duped to able to judge outcomes.  Incredible. So much for evidence based medicine. 

Meanwhile, "policies designed to reduce conflicts of interest and mitigate their impact provide an important foundation for public confidence in medical professionals and institutions."  That should apply to every financial conflict.  To the extent that most of the money and power in the health care system comes from government and involve hospital services that do NOT include devices and rugs. I have only suggested that the focus also be on the abuse of government's role in shaping research and clinical decisions and creating appropriate transparent firewalls between insurers, hospital and physicians so that doctors can be trusted to do what's best for the patient.  

Finally there is the presumption that commercialization is inherently corrupting and that therefore information disseminated with support from commercial sources should be banned or disregarded without regard to scientific or intellectual merit. Perhaps I read too much into the IOM report.  But to the extent that it calls for all measures to limit and eliminate such relationships while failing to disclose similar cozy connections of financing and self-referencing that created the conflict of interest issue, supported the work of the IOM, paid for it's consultants directly and indirectly all while having a media complicit in ignoring these connections, the end result is not objectivity but bias pure and simple.   There may be merit in some recommendation or another in the IOM report.  However the ultimate to goal is to enforce limits on science and medical practice that the authors would not impose on itself or many other interests who would profit from a decline in the rate of the introduction of new products. 
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A Non Partisan Perspective on Pandemic Preparedness

04/29/2009 07:54 PM |

The Obama administration's response -- even absent top HHS and FDA officials -- has been fairly good.  A tribute both to the work of civil servants and sciences in government and to the planning of previous administration.  Tevi Troy, my friend and fellow Yankee fan who had a hand in crafting the game plan that is now being used by Team Obama provided his take in yesterday's WSJ.  If only Tevi could provide two innings of left handed relief for the Yanks.

Swine flu has presented the Obama administration with its first major public-health crisis. Fortunately for the Obama team, the Bush administration developed new tools that will prove critical in meeting this challenge.

Under President Bush, the federal government worked with manufacturers to accelerate vaccine development, stockpiled crucial antivirals like Tamiflu, war-gamed pandemic scenarios with senior officials, and increased the Centers for Disease Control and Prevention's (CDC) sample identification capabilities. These activities are bearing fruit today.

The Department of Health and Human Services (HHS) has already deployed 12.5 million courses of antivirals -- out of a total of 50 million -- to states and local agencies. In addition, CDC's new capacities have allowed Mexican officials to send flu samples to CDC for quick identification, a capability that did not exist a few years ago. Collaboration between the government and the private sector on vaccines -- which Mr. Bush and his HHS team actively encouraged -- could potentially allow manufacturers to shepherd a vaccine to market within four months of identifying the strain and getting the go-ahead from CDC or the World Health Organization.

But new tools aside, top health officials must answer difficult questions about response efforts. One is when and where to deploy antivirals.

The Bush administration considered a "forest fire" approach to pandemic outbreaks abroad. This strategy calls for sharing some of our precious supply of antivirals with a foreign country in order to stop a small flame from becoming a forest fire. The risk is that we have only a limited number of courses, and the use of antivirals increases the odds that the flu strain in question will become resistant to that antiviral. With 37.5 million courses remaining in the federal stockpile, the administration needs to think very carefully about how to use them.

Another issue: Under the Public Readiness and Emergency Preparedness (PREP) Act of 2006, the government has the authority to issue "Prep Act Declarations" granting liability protection to manufacturers whose products were used in public-health emergencies. This helps encourage manufacturers to develop countermeasures. The government issued a series of such declarations in 2007 and 2008. They protected the development and use of influenza vaccines and pandemic antivirals, as well as anthrax, smallpox and botulism products. The Obama administration should consider granting more of them -- if appropriate -- in the weeks ahead.

A third policy question has to do with how to stop the spread of the disease both across borders and within countries. The administration has so far initiated "passive surveillance": Border guards are assessing if people entering the U.S. seem sick, but aren't actively stopping anyone. If things get worse, they may have to intensify border security.

The Bush administration examined the question of closing the borders in certain circumstances but determined that it would probably be ineffective. Worse, it could lead other nations to retaliate by closing their own borders, which could hurt Americans traveling abroad.

Another strategy, already in use to some degree in Mexico, is social distancing -- asking citizens to refrain from large social gatherings. During the 1918 influenza pandemic, St. Louis embraced such measures while Philadelphia eschewed them, and Philadelphia suffered a much higher death rate as a result. We are probably not yet at the point where such drastic measures are necessary, but senior officials had better start thinking about how they would address these questions.

Most importantly, the federal government must figure out how to reassure a nervous public. It doesn't help that none of the 20 top officials at HHS has been confirmed. Some of them, like FDA commissioner-designate Dr. Margaret Hamburg, are experts in biopreparedness and could help reassure Americans. Alas, she and her potential future colleagues, including the new secretary of HHS, are still in limbo. They need to be in place and on the job.

Mr. Troy, deputy secretary of Health and Human Services from 2007 to 2009, is a visiting senior fellow at the Hudson Institute.

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Fit to be tied?

04/29/2009 07:00 PM |

From today's edition of the New York Times:

Lowering Drug Prices

To the Editor:

Pegging drug prices to health outcomes is a smart way to lower health care costs (“Drug Deals Tie Prices to How Well Patients Do,” Business Day, April 23). It’s also a patient-centric way of determining which drugs are worth the money.

In Britain, New Zealand and elsewhere, government officials determine which drugs are worth the cost. These officials are under constant pressure to arrive at conclusions that lead to lower government spending, so patients are routinely denied access to expensive, cutting-edge medicine.

Tying drug prices to patient performance is a model worth expanding. Tying drug prices to the whims of budget analysts heartlessly endangers lives.

Peter Pitts
New York, April 23, 2009

The writer is president of the Center for Medicine in the Public Interest and a former associate commissioner of the Food and Drug Administration.

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Bending the Curve on the Swine Flu Outbreak

04/28/2009 09:41 PM |

For all the talk about slowing down the use of marginally effective techologies to "bend the curve" on rising  health care costs I am surprised (not really) that advocates of comparative effectiveness have not brought up the near mothballing of both Relenza and Tamiflu back in 1999 after NICE nixed both as no better than placebo in reducing death in high risk populations.   That year sadly the UK had an outbreak of flu, Relenza and Tamiflu were in short supply and thousands were sent to hospitals where there was no room.  Hundreds died, waiting in freezer trucks because morgues were filled.  Meanwhile Relenza went on life support and Tamiflu did come back to fight another day, but barely...

Today of course both drugs are the last line of defense against every possible pandemic, from avian flu to today's swine flu outbreak.  Those who think economists can predict with certainty what will work and will be effective for all and for all times now and in the future should remember that human lives are in the balance and, as one NIH scientist has said with regard to developing a vaccine conjugant for swine flu, "this is biology, not mathematics."

Read more here

"GSK sued for 'abandoning' Relenza
Friday , May 14, 2004

Biota, the Australian biotech company that discovered Relenza, is taking GlaxoSmithKline to court, alleging that it failed to properly launch and support the influenza treatment.

After the breakdown of two years of talks between the companies, Biota is seeking an unspecified amount in damages for lost royalty revenues to date as well as future losses for the rest of Relenza's patent life.

John Grant, chairman of Biota, said: "Litigation was the only reasonable option left to us to retrieve the substantial value we believe exists in Relenza."

GSK licensed the product from Biota in 1990 and after its launch, captured 50% of the then emerging market for neuraminidase inhibitor (NAI) flu drugs in 1999/2000. But Biota said product sales went into free fall the following year after GSK cut virtually all its promotional efforts for the drug.

Four years later, Relenza held just 3% of the NAI global market, which in 2003 was worth an estimated $330 million.

In the UK, Relenza suffered the effects of a government-backed campaign promoting free flu immunisations for at risk groups and restrictive rulings from NICE.

In its first ever appraisal in 1999, NICE controversially ruled that Relenza was neither cost nor clinical effective, although it did subsequently recommend use of the drug for at risk groups. A further appraisal in 2002 gave a highly restricted recommendation for both Relenza and its main rival, Roche's Tamiflu.

GSK chose not to challenge that guidance, but Roche went on to win an appeal, gaining a new recommendation relating to flu prevention. But NICE stressed that vaccination remained the most cost-effective defence against flu.

Last year Tamiflu increased its global sales by 184% to CHF431 million after a severe influenza outbreak in Japan and an early start to the US flu season.

Biota's agreement with GSK entitles it to a 7% royalty on GSK sales of Relenza, which last year brought it less than $1 million in revenue. If the drug had achieved Tamiflu's market penetration, Biota says its royalty revenue from the drug would have been $35 million.

Chief executive of Biota and former head of Pharmacia Australia Peter Molloy said: "Relenza was a breakthrough influenza drug that had great potential, but it was effectively abandoned at birth."

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Swine Flu Fear

04/27/2009 04:58 PM |

CMPI Senior Fellow Marc Siegel puts the Swine Flu fear in health perspective....

Read Marc Siegel's piece here

"We should also be comforted by the time of the year. This is the end of the flu season, not the beginning. Flu viruses thrive in the low humidity of winter, not summer. It is very likely that this outbreak will die out automatically as the summer comes. It will remain necessary to track it because it could reappear in the fall, but it is very unlikely that it will erupt into a pandemic this summer.

I am glad that this outbreak is a swine rather than a bird flu, not because pig viruses are intrinsically safer than bird viruses, but because the greater lesson to guide us here comes from the 1976 pig hysteria, rather than from the 1918 bird flu plague."

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Cutting Against the Bias

04/27/2009 08:49 AM |

Steve Usdin of BioCentury writes:

“Two recent incidents, one in which a prominent scientist was excluded from an FDA advisory committee because of statements he had made about a product, and another in which a patient representative voted to recommend against approval of a product that she thought had contributed to her son’s death, have led the agency to say it will reassess the way it screens for and responds to intellectual bias among panel members.”

The issue isn’t financial conflict of interest, but rather intellectual bias.

Is “intellectual bias” the same thing as a “Conflict of Interest?” And if it’s different, is it more or less or equally inappropriate?

Here’s what Sid Wolfe has to say, “ “If one has views for or against something based on the data, that is called an intellectual process of trying to grapple with the issue, not bias.”

BioCentury writes, “The issue isn’t a new one for FDA. The agency’s Advisory Committee Policy and Guidance Handbook, released internally in 1994 and still in use, has a two-page section on intellectual bias. The passage notes that “it is important that the FDA minimize the possibility of a member participating in discussions on issues where the member cannot be assured of participating objectively. FDA recently determined that Wolfe’s longstanding calls for a ban on the generic painkiller propoxyphene constituted intellectual bias. Wolfe was not permitted to participate as a member of the advisory committee in February when it met to consider the safety of propoxyphene.”

The complete BioCentury article, “FDA Reviewing Intellectual Bias,” can be found here.

I don’t believe that intellectual bias is a problem unless it rises to the level of conflict of interest. There is no such thing as a non-intellectually biased expert. If you are expert enough to be on a committee, you have strong opinions that others respect. There is a difference between bias and conflict of interest. I think the definition of conflict of interest needs to be somewhat expanded beyond a very narrow focus on dollars and cents.

For example, “conflict of interest” can certainly mean having a child who is taking the product under discussion, whether that child had a positive or negative relationship with the product. That’s not a wild stretch of the imagination.

Here’s a possible solution – prior to the agency’s final sign off, a designated senior FDA official should hold a final “job interview” (via phone or in person) with all potential advisory committee members. During my tenure at the agency I was the senior official in charge of advisory committees. There were no interviews as part of the process then -- and interviews aren’t part of the process today.  I saw a plethora of multi-page resumes and written remarks and recommendations from various people from the appropriate center divisions.  A decidedly two-dimensional proposition. It’s time for a third dimension. 

More work?  Yes.  More difficult?  Sure.  Worth the effort? Certainly.

Saying anything else would be, well – intellectually biased.

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Plain Manila

04/24/2009 09:14 PM |

From today's edition of the Phillipine Daily Mirror:

Let's Reform Healthcare Without Growing the Government

The nation's preeminent business organization recently released a study showing that the high costs of the American healthcare system puts American businesses at a significant disadvantage. The Business Roundtable, which represents some of the country's biggest corporations, found that for every $100 the U.S. spends on healthcare, our main competitor countries -- the United Kingdom, Canada, Japan, France, and German -- only spend about 63 cents.

This study shows that healthcare reform is integral to the country's economic recovery. President Obama understands this, and has vowed to pass comprehensive reform legislation by the end of the year. Unfortunately, administration officials have indicated that their proposals will likely include raising taxes to finance a massive expansion of the public healthcare system.

But the American people resoundingly disapprove of this approach. The administration should toss it aside, and instead focus on implementing bipartisan measures that reform the system from the inside.

In a recent Rasmussen poll, less than half of respondents supported increasing taxes to pay for additional government-run health insurance.

Those results square with an October survey from my organization, the Center for Medicine in the Public Interest, which found that a majority of "Millennial" voters - the 18-to-28-year-old bloc seen by many as a driving force in American politics - would not support any healthcare reform that could raise theirpersonal tax burden.

Instead of expanding the public healthcare system, here are some steps the administration should take:

Get everyone who already has access to health insurance to sign up. Five million uninsured Americans have employer-sponsored coverage available to them. They just haven't taken advantage of it.

An easy way to remedy this problem is to allow employers to "auto-enroll" employees into the company health insurance plan. People would be allowed to opt-out of this system cost-free, thus retaining personal choice while cutting down on the ranks of the uninsured.

Twelve million people without health insurance are already qualified for public assistance programs like Medicare and the State Children's Health Insurance Program. Educate these people about their options, and then get them insured.

The government should also implement a system of tax credits for low-income Americans to help them afford private insurance coverage.  Private plans are in many ways better suited for the modern workforce. The average person is highly mobile between employers. Business-sponsored insurance tends to be more robust, but people lose it when they leave their jobs.  Private insurance is portable, and ensures that people don't experience any breaks in coverage during job transitions.

The final step the administration should take is to fight chronic disease. Seventy-five percent of the $2.2 trillion this country spends annually on healthcare goes towards treating chronic illnesses like diabetes and cancer. And roughly half of the American population is suffering from one or more chronic illness.

Educating citizens about the benefits of a healthy lifestyle would prevent many instances of chronic illness. Simple behaviors like keeping a good diet and exercising regularly drastically cut down on key risk factors, particularly obesity, which is tightly linked to some of the country's most costly chronic conditions.

Improving healthcare will help dig this country out of this recession. But further expansions of the government health system aren't the way to go. That approach is deeply unpopular, and the administration has much better reform options available.

Peter Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate

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Who Pays More Out of Pocket For Health Care?

04/23/2009 03:50 PM |

Not us in the US.. Or not by much.

Click Here to View Annual Canadian Expeditures

The Canadians spend an average of $1932 dollars out of pocket. We spend about $2600. Most of the burden in Canada falls on the poor and seniors in the form of out of pocket costs for meds.

Click Here to View Annual U.S. Expenditures

Moreover, according the Peterson Institute for International Economics, our out of pocket costs have been dropping... despite all the propaganda flowing these days ...

Household out-of-pocket healthcare expenditures, percent of total, 2006

Source: OECD Healthcare Database, available at www.sourceoecd.org. Data from 2005.

Click Here to View the Full Story

"Empirically, the share of total healthcare expenses that Americans pay out-of-pocket is lower than in the vast majority of European and other OECD countries for which recent comparable data are available. Americans are therefore generally more likely to ask someone else to pay for their health care than people in other OECD countries. In reality America’s healthcare system is already more “socialized” than in most European and other developed countries.

Certainly, it is the case that Americans pay a higher absolute dollar amount in out-of-pocket expenses than almost anywhere else in the OECD (only Switzerland is higher). Yet that is solely because health care in America is so much more expensive than anywhere else and demonstratively not due to Americans being relatively more exposed to the “true costs of healthcare” than people elsewhere, let alone in countries practicing so-called “socialized medicine.”

The simple fact remains that Americans are relatively less exposed to market forces and “the price mechanism” in health care than most people elsewhere, which is certain to be one more reason why Americans end up having to pay so much more for their healthcare."
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Outcomes Baby!

04/23/2009 01:27 PM |

You've certainly heard, "location, location, location." If you follow Microsoft you've heard, "developers, developers, developers."  And now, if you're a believer in patient-centric reimbursement policies, there's a new triad, "outcomes, outcomes, outcomes."

It's about time.

The story in today’s New York Times is headlined, “Drug Deals Tie Prices to How Well Patients Do,” but it could just as easily have been called, “Payers and Phama Focus on Patient-Centric Care.”

The article, by the always excellent Andrew Pollack, begins thus:

“Pressed by insurance companies, some drug makers are beginning to adjust what they charge for their drugs, based on how well the medicines improve patients’ health.”

Outcomes baby!

Pollack writes:

“In a deal expected to be announced Thursday, Merck has agreed to peg what the insurer Cigna pays for the diabetes drugs Januvia and Janumet to how well Type 2 diabetes patients are able to control their blood sugar. And last week, the two companies that jointly sell the osteoporosis drug Actonel agreed to reimburse the insurer Health Alliance for the costs of treating fractures suffered by patients taking that medicine.”

Put up or shut up?  That’s about the size of it. But it cuts both ways.

“We’re standing behind our product,” said Dan Hecht, general manager of the North American pharmaceutical business of Procter & Gamble, which sells Actonel with Sanofi-Aventis. “We’re willing to put our money where our mouth is.”

This outcomes-based strategy was first tried in Great Britain for the Johnson & Johnson drug Velcade and most recently for the Pfizer drug Sutent.

J&J won coverage in 2007 after agreeing to pay back the government for people who didn’t benefit. Patients get the first four doses of the 762.38 pound drug, and then are tested to see if they’ve responded to the treatment. Those who improved continue with the drug. Johnson & Johnson provides a rebate of about 3,000 pounds for those who didn’t respond.

For Sutent, the U.K.’s National Health Service (via NICE) decided the medicine extended the lives of patients enough to justify its cost, as long as the first course of treatment was free.

According to Sir Michael Rawlins, Chairman of NICE, “We’re meeting them partway.”

It's a creative approach based on outcomes -- a giant step towards recognizing the importance of personalized medicine the folly of basing reimbursement decisions on large-scale general population studies.

And such strategies are also being designed to improve compliance.  Pollack continues:

“Some discounts will be granted if more people diligently take the drugs as prescribed. This helps both Cigna, because people who take their pills are likely to have fewer complications from the disease, and Merck, because it sells more pills. The assumption is that Cigna will push for patient-compliance programs that urge people to take their medicine at the right times and in the proper doses.”

Imagine that, an access/reimbursement program that actually helps advance the four rights of 21st century personalized medicine – the right medicine for the right patient in the right dose at the right time.

Sure beats a myopic, QALY-based view that puts cost ahead of care.

Pollack quotes Eric Elliott, the president of Cigna Pharmacy Management:

“We wanted a contract that drives performance,” he said. “Getting this one out will provide more momentum.”

Focusing on outcomes not only means that Pharma will have to put their money where their mouth is – but that payers will have to put patients first.

Now that’s healthcare reform.

The complete New York Times story can be found here.

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Winged Victory

04/22/2009 11:37 AM |

The FDA's Critical Path program must be seeded with more than bird feed.  Here's why:

A team of FDA scientists and colleagues from the National Institute of Allergies and Infectious Diseases the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam; and Switzerland's Institute for Research in Biomedicine say their study of the avian influenza virus might lead to new tests that can detect such infections.

The FDA said in-depth analyses of blood from patients recovering from the H5N1 virus also provided important insights into how to combat the potentially lethal virus and helps define what part of the virus is seen by the immune system.

As one result of the research, the FDA scientists and their collaborators said a protein of the bird flu virus called PB1-F2 was identified as a potentially potent target for attack by immune systems to stop the spread of the virus.

The study appears online in the journal PLoS Medicine.

Now imagine what the FDA could achieve if only Congress would release the designated funding for the Reagan/Udall Foundation.

Collaboration is the key -- and the Critical Path has never been more critical.

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Sure, why not?

04/21/2009 12:46 PM |

Posting off-label trials on clinicaltrials.gov is a nefarious marketing technique?  Give me a break.
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Regulatory Rapporteur

04/21/2009 12:26 PM |

Regulatory Rapporteur is the name of a journal (www.topra.org) as well as as an apt moniker for Center for Medicine in the Public Interest Visiting Fellow Dr. Rick Turner.

Apt because of his excellent new article, "Drug Safety, medication, safety, patient safety:  An overview of recent FDA guidences and initiatives."

Rick's article can he found here.

His abstract sets the stage:

"Drug development and pharmacotherapy are components ofintegrated pharmaceutical medicine. The term ‘drug safety’ canbe used when evaluating adverse events during clinical trials, andwhen evaluating adverse drug reactions to a correctly prescribed, dispensed and administered drug. The term ‘medication safety’ refers to the evaluation of medication errors that occur at the prescribing, dispensing and/or administration level; endeavours to educate clinicians and patients about the correct use of a particular drug; and the design and implementation of safety systems and educational programmes to minimise these errors. Drug safety and medication safety are subsets of patient safety.Recent guidance documents and initiatives at the US FDA indicate the agency’s awareness of the paramount importance of safety considerations throughout drug development and pharmacotherapy, its commitment to expand and enhance its governance role in lifecycle drug development, and its commitment to play an infl uential role in the safe use of medicines."

Turner's discussion of REMS, safe use, FDAAA, the Sentinel initiative, and other important items makes this article a must read.

They don't call him "Page" Turner for nothing.


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Holocaust Remembrance Day in Israel

04/21/2009 10:33 AM |

Yom HaShoa fell on Hitler's birthday.  Two groups of people were mindful of this dark coincidence.  All Israelis -- or at least everyone I talked to -- knew about the overlap.  They thought it was both poetic justice and divine intervention.    Hitler didn't just want to destroy the Jewish people, he wanted the world to remember us.  He envisioned creating a museum to house our corpses and conquered religious treasures -- torahs, talmuds, menorahs, tallit (prayer shawls), etc. to make eternal mockery of a people who believed in a G-d and way of life in which the absolute worth of each individual was the eternal foundation of society, behavior and technological progress.   And of course the opposite has happened.  Hitler is now a re-run on the History Channel and the Jewish people thrive and remember and are a reminder of both the mindless hatred of our enemies as well as our determination to fight and thrive as a nation.

The other group of people were of course not the clueless in the mainstream media.  They were the audience the President of Iran played to by speaking -- on Hitler's birthday at a UN sponsored conference on racism rigged to engender more hate and promote the destruction of the Jewish state.   As Ahmadinejad spoke European delegates to this conference on racism walked out in protest.  Yet many of their own countries were party to cancelling Holocaust Remembrance ceremonies in various cities to "protest"  Israel's military operation in Gaza in response to both rocket attacks and it's continuing project of establishing medium and long range missle capacity against major cities in Israel, courtesy of Iran.    The irony of siding with those who eliminate the Jewish state as a form of protest was lost on these nation states.  Similarly, the willingness to abet militant Islam in meaningless international conferences and expect to be congratulated for walking out on the speech of a monster...well now that I think about it, that's something the students at Columbia University didn't do!

Once again history and the future of the Jewish people appear to be on a collision course.   Throughout the world lip service is paid to our "right to exist", as if this is some sort of special gift from the family of nations and not something Jews -- mostly Israelis in the past 60  years -- have had to defend with their lives almost  yearly.   The promise of "Never Again" is uttered but in Europe and in the the halls of Congress and the mainstream media, attacks on the Jewish lobby are now part of the conversation. Modern day blood libel (the Gaza operation) is now the grist for playwrights  who explore the Jewish soul and conclude it is dark, violent and racist to the core.  England has become a cesspool of anti-Semitism and many in the American left are following suit.    Sometimes I fear the world is slouching from indifference back to eon-old habits.

Yet I believe Israel will prevail and the Jewish people will thrive precisely because of day's such as this one.  In Israel at 10 am sirens wailed, traffic stopped, people stood still.  For a minute the entire nation as one remembered, not just as a collective reminder of what preceded the establishment of Israel, but to show that one nation carved out of national tragedy will eternally bear witness to both the evil that nearly consumed the world and to our capacity not only rouse the conscience of others but to defend our existence the next time such evil rises again.  We pause in silence.  Not just to remember, but to underscore our willingness to set aside "normal" life and do what is required to survive, thrive and contribute to the world.

It is 10:01 am.  Life in Israel goes on.  Am Yisroel Chai. 
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