Foster Care

04/26/2010 10:16 AM |

Remember Richard Foster?

 

He’s the CMS official whose report on Part D costs were “suppressed” during the debate over the MMA.  That was in 2003 – when he was a “whistle-blowing darling of Congressional Democrats.

That was then.  This is now.  Robert Pear reports that:

 

A government analysis of the new health care law says it will not slow the overall growth of health spending because the expansion of insurance and services to 34 million people will offset cost reductions in Medicare and other programs. The study, by the chief Medicare actuary, Richard S. Foster, provides a detailed, rigorous analysis of the law.”

 

In signing the measure last month, President Obama said it would “bring down health care costs for families and businesses and governments.” But Mr. Foster said, “Overall national health expenditures under the health reform act would increase by a total of $311 billion,” or nine-tenths of 1 percent, compared with the amounts that would otherwise be spent from 2010 to 2019.

 

In his report, sent to Congress Thursday night, Mr. Foster said that some provisions of the law, including cutbacks in Medicare payments to health care providers and a tax on high-cost employer-sponsored coverage, would slow the growth of health costs. But he said the savings “would be more than offset through 2019 by the higher health expenditures resulting from the coverage expansions.”

 

Mr. Foster says the law will save Medicare more than $500 billion in the coming decade and will postpone exhaustion of the Medicare trust fund by 12 years, so it would run out of money in 2029, rather than 2017. In addition, he said, the reduction in the growth of Medicare will lead to lower premiums and co-payments for Medicare beneficiaries.

 

But, Mr. Foster said, these savings assume that the law will be carried out as written, and that may be an unrealistic assumption. The cuts, he said, “could become unsustainable” because they may drive some hospitals and nursing homes into the red, “possibly jeopardizing access to care for beneficiaries.”

 

Nancy-Ann DeParle, director of the White House Office of Health Reform, said that fear was unfounded.

 

“Unfounded.” That’s the counter-argument? Seems so. The White House is going to have to do better – a lot better.  And remember – this story is from the pages of the New York Times – not the Washington Times.

The complete New York Times Story can be found here.

This will certainly add fuel to the fire of those calling for repeal.

But rather than repeal we should be talking “appeal” – like in appealing to the better angels of our nature. In other  words -- being for something.  And that something is called "the truth."

Let’s start a movement – and let’s call it “Appealism.”  Here’s how it works:  Rather than calling for “repeal” (which is a negative thing) let’s be for “appeal.” That means appealing to common sense and un-fuzzy math.  It means calling a spade a spade and (most importantly) being honest.

I know – how naïve.  But …

Even if the GOP realizes its most optimistic November projections, the likelihood for legislative repeal is still, well, a highly optimistic projection.  And, even all the stars and planets align in an elephant-friendly fashion, there’s no scenario that provides for a two-thirds majority over-ride of a 100% predictable Presidential veto.

Hence, the need for “appeal.” The Foster analysis is a good place to start because the finish line isn’t repeal; it’s controlling the rule-making process.  And that’s where “appeal” comes in.

Appealing to reality.  Appealing to facts and figures rather than rhetoric and double-sided political coin of bribes and threats.

Appealism.  Yes we can.

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Maverick Supplemental

04/26/2010 09:39 AM |

CQ reports:

"Makers of dietary supplements looked to be on a collision course with Sen. John McCain when the Arizona Republican introduced legislation designed to strengthen policing of products marketed to casual and professional athletes." Yet, "the two sides appear to have reached a compromise they say will be part of a manager's amendment to a major food safety bill (S 510) being readied for Senate floor debate." Notably, "the provisions would require the Food and Drug Administration (FDA) to issue long-delayed guidance on acceptable supplement ingredients and report to the Drug Enforcement Administration when it rejects new supplements that contain synthetic anabolic steroids." This "would be a victory for McCain," who wanted the FDA to have more authority over supplements.
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PhRMA giveth and Uncle Sam taketh away

04/23/2010 09:20 AM |

Talk about federal preemption!

CMS Medicaid confirmed Thursday that some money states receive as rebates from drugmakers will now be redirected to the federal government to help pay for the new health overhaul.  

State officials had hoped the federal government would interpret the law in a way that left their discounts untouched. But in a letter Thursday to state Medicaid officials, CMS Services explained, "The amount of the savings resulting from the increases in the rebate percentages … will be remitted to the Federal government."

Cindy Mann, CMS director for the Center for Medicaid and State Operations , confirmed in an interview that meant states that already received drugmaker rebates between 15.1 and 23.1 percent would no longer be able to keep that portion of their savings. States and the federal government would continue to share in savings for the portion of the rebates both below and above that range. Many states already have average rebates well above 23 percent.

Mann suggested that state officials could negotiate deeper discounts with drugmakers to try to "recapture that dollar."

Thanks Cindy.  Very helpful.

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The Changing "Nature" of GPhA

04/23/2010 09:10 AM |

Teva is resigning from the Generic Pharmaceutical Association effective June 30th. (Apotex and Hospira resigned from GPhA last year.)

Does this make GPhA the healthcare equivalent of the Not Ready for Primetime Players?

Because Teva (Hebrew for "nature") most certainly is.

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The New Republic's Unquestioned New Collaboration

04/22/2010 10:29 AM |

Jon Cohn has written long and well on behalf of single payer health care for The New Republic.  For over a decade he posted his analysis and observations through The Treatment, a column that grew in influence once Obama took office.  I rarely agreed wth Cohn's observations but always admired his persistence and willingness to wade at least a little bit into the clininal literature. 

He has "retired" The Treatment but now reappears in TNR -- and elsewhere -- as a, hired hand or observer at large courtesy of the Kaiser Foundation which is now spending tens of millions to support Kaiser Health News.  Or as the byline in Cohn's most recent TNR piece puts it:  "This column is a collaboration between TNR and Kaiser Health News. KHN is an editorially independent news service and is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization, which is not affiliated with Kaiser Permanente."

Read Cohn's piece here

A collaboration?  Does that mean KHN paid for Cohn to write the piece and TRN ran it?  Did it split the costs?  Did TNR pay for lunch?  Is this something KHN will continue to do with other news outlets and magazines?  Given the Kaiser Family Foundation's advocacy role and support of Obamacare, does this raise questions about media objectivity or should this be considered a novel way of funding reporting?

I have no problem with the Kaiser Foundation setting up KHN or engaging in a collaboration witn TNR  or any other publication to run pieces by Cohn.  I do have a problem when those who support Obamacare then turn around and attack those who have reservations about reform who use similar approaches to disseminate their views. 

Kudos to Cohn and TNR for finding creative ways to carry on the health care discussion.  Let's see if they and their followers are intellectually honest and consistent when folks like me follow suit. 
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Rank Incompetence

04/22/2010 09:13 AM |

From the New England Journal of Medicine:

To the Editor: In their Perspective article (Jan. 14 issue), Murray and Frenk review a number of indicators of the relatively poor state of the population's health in the United States. Most, if not all, of this information is well known to readers of the Journal, and the authors' use of it is not objectionable. However, Murray and Frenk begin their discussion by referring to the World Health Report 2000, Health Systems: Improving Performance, from the World Health Organization (WHO), which ranked the U.S. health care system 37th in the world, and this is objectionable. (I was editor-in-chief of the World Health Report 2000 but had no control over the rankings of health systems.) Fully 61% of the numbers that went into that ranking exercise were not observed but simply imputed from regressions based on as few as 30 actual estimates from among the 191 WHO member countries. Where the United States is concerned, data were available only for life expectancy and child survival, which together account for only 50% of the attainment measure. Moreover, the "responsiveness" component of attainment cannot be compared across countries, and the estimates of responsiveness for some countries were manipulated. This is not simply a problem of incomplete, inaccurate, or noncomparable data; there are also sound reasons to mistrust the conceptual framework behind the estimates, since it presupposes a production function for health system outcomes that depends only on a country's expenditure on health and its level of schooling, ignoring all cultural, geographic, and historical factors.

The number 37 is meaningless, but it continues to be cited, for four reasons. First, people would like to trust the WHO and presume that the organization must know what it is talking about. Second, very few people are aware of the reason why in this case that trust is misplaced, partly because the explanation was published 3 years after the report containing the ranking. Third, numbers confer a spurious precision, appealing even to people who have no idea where the numbers came from. Finally, those persons responsible for the number continue to peddle it anyway. To quote Wolfgang Pauli's dismissal of a theory opposed to quantum mechanics, "Not only is it not right, it's not even wrong!" Analyzing the failings of health systems can be valuable; making up rankings among them is not. It is long past time for this zombie number to disappear from circulation.

Philip Musgrove, Ph.D.
Health Affairs
Bethesda, MD

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Ode to COI

04/22/2010 08:28 AM |

Much conversation about the FDA’s revised guidance on advisory committee conflict of interest waivers.  Commissioner Hamburg wants a “stricter” policy.

Transparency?  Certainly.  But what exactly is the problem that requires stricter guidance?  It’s not COI – its empty seats. 218 positions of the 600-plus on FDA's 49 advisory committees have yet to be filled.

According to the Pink Sheet, The general perception has been that the conflict-of-interest policy has made it more difficult to properly recruit for advisory committees. "There have been places where we felt we didn't have the right experts and we cancelled the meetings," John Jenkins, director of the Office of New Drugs, told attendees at the FDA/CMS Summit in December 2009 "We may have gone too far."

During my tenure at the FDA I was the senior official in charge of advisory committee oversight and the final decision-maker on who got a COI waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical.

And we should all pay attention to the nomenclature.  It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.”  And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.

If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is a significant disservice.

The revised FDA guidance can be found  here.

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Live Long and Prosper...

04/21/2010 10:06 PM |

Leonard Nimoy is retiring... and so is his incarnation of Mr. Spock

http://www.space.com/entertainment/leonard-nimoy-retires-star-trek-100421.html


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"Step" Lively -- and Mind the Gap

04/21/2010 09:49 AM |

“Fail First” or “Succeed First?”  It’s a pretty good proxy for the larger health care debate that pits short-term cost savings over long-term patient benefit.
 
Sound familiar?

A new bill in the California Assembly (AB 1826) addresses the issue of “fail first” policies (aka: “step therapy) and cuts right to the chase.

The bill “Requires a health plan or health insurer that covers prescription drug benefits to provide coverage for a drug that has been prescribed by a participating licensed health care provider for the treatment of pain without first requiring the enrollee or insured to use an alternative prescription drug or over-the-counter product.”

And it uses chronic pain as a specific example:

“Due to the variety of causal conditions and types of pain (acute and chronic), there is no standard treatment for pain.  Pain treatment varies according to type, severity, and duration of pain, as well as the causal condition (if known), patient co-morbidities, and other factors (e.g., medication intolerance or patient compliance).  Health care providers use clinical judgment to select among various pain medications and treatments in efforts to resolve or control pain for individual patients …For some enrollees, no pain medications are subject to fail-first protocols.  Other enrollees, depending on the provisions of their plan contracts or insurance policies, have outpatient pharmacy benefits that make coverage for between one and 38 pain medications subject to fail-first protocols …Of more than 200 prescription medications used to treat pain, 54 are subject to fail-first protocols for at least some portion of enrollees with health insurance subject to this bill whose health insurance includes an outpatient pharmacy benefit.”  

(The complete bill can be found here.)

One example of a group supporting this legislation is the California Medical Association. Opposed?  The Association of California Life and Health Insurance Companies.

The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, of “fail first” policies over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.

In California -- indeed across the entire United States -- access to care must be matched with quality of care.

 

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Prescription for Change

04/20/2010 01:29 PM |

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Israel's Independence Day

04/20/2010 09:41 AM |

On the 62nd anniversary of the founding of the Jewish state, a reminder of what David ben Gurion said regarding Israel's ability to thrive -- "to be a realist, one must believe in miracles."  ( CMPI has been a proud partner of  program based at the Tel Aviv University School of Management to support life science entrepreneurship in Israel for the past three years.  “Health Care Technological Innovation - From Idea to Commercialization.” )   Israel's robust contribution to biomedical innovation -- despite the threat of terrorism and annihilation -- is truly miraculous:

According to the WEF 2007-2008 Competitiveness Report, Israel has the 5th highest number of patents pending in the world and ranks 3rd in technological readiness. Israel is ranked in 1st in the world for Medical Device Patents per capita, and ranks third in Europe for the number of clinical trials in progress.

Fourth in the world in biotechnology patents per capita, Israel not only has the talent to innovate, but the skills to transform technology into successful enterprise. A generous government incentives program is a major factor for pushing progress forward.

Entrepreneurship in Israel

Israel has the largest number of startups in the world per capita. In absolute numbers, Israel is only second to the US. Israeli startup companies are known for their creativity, innovation, and originality. Israeli ingenuity can be found in some of the world's leading products and technologies: voice mail, billing systems, internet security, instant messaging, ingestible video cameras, and generic pharmaceuticals.

Investments in Israel

Israel has the largest number of companies listed on the NASDAQ outside of the United States and approximately 70 Israeli companies are traded on various European exchanges.
According to the Israel Venture Capital Research Centre, Israel requires approximately $1.5 Billion of new investment annually to support its developing companies. Israel continues to attract capital both locally and from abroad. However, there continues to be a strong need to fuel the capital requirements of early-stage companies

Many major multi-nationals have chosen to run core activities in Israel including: HP, Microsoft, Intel, IBM, Siemens, GE, SAP, Philips, Time Warner, Sony, Cisco, Google, eBay, Analog Devices, Computer Associates, Berkshire-Hathaway, Applied Materials, Sun Microsystems, 3Com, Motorola, Pfizer, J&J and more.

Israel’s high tech industry in particular is extremely profitable and attractive to foreign multinationals.
2007 witnessed over 40 international Mergers & Acquisitions.

Mergers and Acquisitions in Israel

Major foreign firms have stepped up their local M&A activities, and direct foreign investment in Israel has exceeded $2 Billion annually.

2006 saw a record number of Mergers & Acquisitions - a total of 76 Israeli companies were acquired. Warren Buffet's Berkshire-Hathaway made its first international investment when the company made its monumental acquisition of Israeli ISCAR for $4 billion, HP acquired Mercury for $4.5 billion and SanDisk acquired M-Systems for $1.5 billion.  Other examples of multinational companies that have acquired Israeli companies include: Microsoft, Motorola, Intel, HP, Siemens, Samsung, IBM, GE, Phillips, Lucent, AOL, J&J, Applied Materials, Sun Microsystems, EMC, Boston Scientific, eBay, HP, Kodak, Cisco and Xerox.

M&A activity involving Israeli companies that were either acquired or merged totaled $3.2 billion in 2007 in 75 deals – the second highest number of M&A deals in any one year to date.
Mergers and acquisitions of VC-backed Israeli companies in 2007 totaled $1.9 billion and consisted of 32 deals.

Israeli companies were also on the acquiring side in some 60 deals in 2007, including about 20 where one Israeli company acquired another Israeli company, and nearly 40 acquisitions of foreign companies. Israeli companies spent $2.15 billion on mergers and acquisitions in 2007, of which $1.96 billion was for acquisitions of foreign companies (IVC Online)

Venture Capital in Israel

With 100 active funds and over $10 billion under management, Israel’s venture capital industry thrives like in no other country. In 2004, foreign funds committed over 50% of the total dollars invested, demonstrating that Israel is an internationally sought after and sound investment (Israel ’s Ministry of Industry, Trade and Labor).

In the past 10 years, Israeli VC's attracted a total of $10.6 Billion. According to IVC, $2 Billion in capital is currently available for investment by Israeli VC's, of which $1.2 billion is intended for First investments in high-tech companies and the remainder reserved for Follow-on investments. $800 Million is expected to be raised in 2008 by Israeli VC's for investment in Israeli high technology over the next few years. (IVC Online)

In 2007, 462 Israeli high-tech companies raised $1.76 Billion from local and foreign venture investors, 8.5 percent above the $1.62 billion raised in 2006 and 31.5 percent above 2005 levels.
In the fourth quarter, 115 Israeli high-tech companies raised $503 million, a 21 percent increase from the $414 million raised by 108 companies in the third quarter and a 5 percent increase from Q4 2006. (IVC Online)
In 2007, Israeli VC's invested $678 million in Israeli high-tech companies. The Israeli VC share of the total amount invested in Israeli high-tech companies was 39 percent.

Israeli VC's invested $50 million in foreign companies during 2007 (in addition to their investments in Israeli high-tech companies), compared to $60 million in 2006 and $95 million in 2005. Three of the 39 investments were first investments and the remainders were follow-on.

In 2007, 78 Seed companies attracted $151 million, the highest amount raised since 2001.

http://www.novuscom.net/~allon.m/isratech/fund.html
 

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Quote of the Month

04/20/2010 01:59 AM |

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PDUFA Follies

04/19/2010 09:12 AM |

Important reporting from today’s edition of the Wall Street Journal:

“An unusual clinical trial involving four different drugs offered promise that guiding treatment based on the molecular traits of a tumor can improve survival from lung cancer. Researchers said the study amounted to "proof of concept" for a new approach to clinical trials that could improve the efficiency of cancer-drug development and eventually shorten the time it takes to get new treatments to market.”

The “Battle” study involved 255 patients with advanced lung cancer.

According to Edward S. Kim, a cancer researcher at M.D. Anderson and principal investigator of the Battle study, "This is a first step to find biomarkers that may help supplant existing toxic therapies and to find the right population for a particular drug," said.

The WSJ writes, “The adaptive design is gaining interest among researchers and drug companies because it could help identify drugs that don't work sooner, and identify biomarkers that would be used to enroll patients in late-stage studies required for market approval.”

Currently large clinical trials typically take all comers without evaluating their biomarker status. "The problem is that when you take a drug that has a specific target, but you treat everybody, you dilute the effect" of the drug, said Dr. Kim.

Researchers say that is why many targeted cancer drugs fail in late-stage or Phase III studies.

"This is the future," Tyler Jacks, a cancer researcher at Massachusetts Institute of Technology and president of the AACR, said of the Battle trial. "This is how drugs will be developed and clinical trials organized."

Important news.  Good news. Potentially life-saving news.  And interesting news considering that some are using the current PDUFA reauthorization debate to suggest the FDA demand comparative effectiveness studies as part of the agency’s drug approval process – something that no other drug licensing agency in the world does.

If the Battle study proves nothing else – it’s that we don’t know enough about how new medicines work once approved ("in the real world"). And that’s particularly true for cancer drugs. So what does “comparative effectiveness” really mean?  And should it be applied to the global gold standard of safety/efficacy or, if you prefer, risk/benefit.  Lung cancer is a good example, considering that average survival on chemotherapy is about eight months. What’s the value in asking about pre-approval “comparative effectiveness? Compared to what? "Best practice" treatment? And compared how?

Those who call for such a third leg are on a price jihad (cost effectiveness). That’s their privilege – but they had better understand the consequences such a move inside the FDA process would have on pharmaceutical  innovation.

But first, there are some things they should understand, more generally about innovation itself:

Innovation is slow.  As any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time. Companies more often profit by improving existing chemicals and making processes more efficient than by revolutionizing the whole field with new products.

Innovation is hard.  Today it takes about 10,000 new molecules to produce 1 FDA-approved medicine. And if that's not frightening enough, only 3 out of 10 new medicines earn back their research and development costs. And here's the kicker -- unlike other R&D-intensive industries, pharmaceutical investments generally must be sustained for over two decades before the few that make it can generate any profit.

Innovation is expensive.  In 2003, researchers at TuftsCenter for the Study of Drug Development estimated the costs to bring a new medicine to market to be $802 million, and others suggest that the total cost is closer to $1.7 billion

Innovation is under attack.  From accusations of the “me-too” variety, to crackpot schemes to replace pharmaceutical patents with a “prize” system, life for innovator pharmaceutical companies is rough and tough.  Israel Makov (formerly the Big Abba of generics giant Teva) once told me that he wasn’t really in the pharmaceutical business, but rather “in the litigation business.”

But innovation is important – and not just for pharmaceutical industry profits. Increases in life expectancy resulting from better treatment of cardiovascular disease from 1970 to 1990 have been conservatively estimated as bringing benefits worth more than $500 billion a year. In 1974, cardiovascular disease was the cause of 39 percent of all deaths. Today it is about 25 percent. Cerebrovascular diseases were responsible for 11 percent of deaths back then. In 2004 they caused 6.3 percent of deaths. Kidney diseases were linked to 10.4 percent of deaths and now they are associated with 1.8 percent. And that’s just for the United States.

As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "The average person aged 45 will live three years longer than he used to solely because medical care for cardiovascular disease has improved. Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."

Comparative effectiveness is an interesting health policy issue -- but the PDUFA reauthorization process is the wrong place for the conversation.

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Congressman Bob Franks

04/16/2010 10:29 AM |

Bob Franks was my congressman and my friend.  As a public servant, candidate and leader of the Healthcare Institute of New Jersey he brought enthusiasm, humor and decency to his every endeavor.  His untimely death from an aggressive form of cancer this past week reminds us not only how too short life is but how we should never take for granted indiviudals of Bob's caliber.  

Memorial Service In Tribute of The Life of Rep. Bob Franks

A memorial service will be held in tribute of the late Former U.S. Representative Bob Franks. Below is information on the service:

Rep. Bob Franks Memorial Service

 

Saturday, April 17, 2010, 11:00AM

 

Cathedral Basilica of the Sacred Heart

89 Ridge Street

Newark, NJ 07104

 

(973) 484-4600

 

Speakers:

Governor Chris Christie

 

Former Governor Jon Corzine

 

Former Governor Tom Kean

 

Former Governor Christine Todd Whitman

 

Roger Bodman, Godfather to Abigail Franks

 

Alfred Fasola, Godfather to Sara Franks

 

Former Congressman John Kasich, Godfather to Kelly Franks

 

Donations:

The Franks family asks that in lieu of flowers, donations should be directed to the New Jersey National Guard State Family Readiness Council, http://www.nationalguardsfrc.org/.

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Not so APpy together

04/16/2010 08:07 AM |

Oddly -- not covered widely (at all?) by the MSM:

WASHINGTON (AP) -- Opposition to President Barack Obama's health care law jumped after he signed it - a warning to Democrats running for re-election this fall that his victory could become their liability.

A new Associated Press-GfK poll finds Americans oppose the health care remake 50 percent to 39 percent. Before a divided Congress finally passed the bill and Obama signed it at a jubilant White House ceremony last month, public opinion was about evenly split. Another 10 percent of Americans say they are neutral.

Disapproval for Obama's handling of health care also increased from 46 percent before the bill passed to 52 percent currently - a level not seen since last summer's angry town hall meetings.

Nonetheless, the bleak numbers may not represent a final judgment for the president and his Democratic allies in Congress. That's because only 28 percent of those polled said they understand the overhaul extremely or very well, and a big chunk of those remain neutral.

Democrats hope to change public opinion by calling attention to benefits available this year for seniors, families with children transitioning to work and people shut out of coverage because of medical problems.

"There are some things I like, because I think that there are some people who need health care," said Jim Fall, 73, a retired computer consultant from Wrightwood, Calif.

But "I don't like the idea of the government dictating what health care should be like," added Fall. "Nor do I like them taking money out of Medicare. They are going to create more waste and they are going to take away benefits."

Seniors - reliable voters in midterm congressional races - were far more likely to oppose the law. Forty-nine percent were strongly opposed, compared with 37 percent of those 64 and younger. Seniors' worries that Medicare cuts to insurers, hospitals and other providers will undermine their care are a formidable challenge for Democratic congressional candidates this fall.

Analysts said such wariness on a major piece of social legislation is unusual.

"The surprise of this poll is that you would expect people to be more supportive of the bill now that it's the law of the land - and that's not the case," said Robert Blendon, a Harvard public health professor who follows opinion trends on health care. "The election for the House is going to be competitive, and health care is clearly going to be an issue."

The nearly $1 trillion, 10-year health care remake would provide coverage to nearly all Americans while also attempting to improve quality and slow the ruinous pace of rising medical costs.

Nonpartisan congressional budget analysts say the law is fully paid for. Its mix of Medicare cuts and tax increases, falling mainly on upper-income earners, would actually reduce the federal deficit. And people covered by large employers may even see a dip in their premiums.

The public doesn't seem to be buying it.

Fifty-seven percent said they expect to pay more for their own health care, contrasted with 7 percent who expect to pay less. And 47 percent said they expect their own medical care to get worse, compared with 14 percent looking forward to an improvement.

"Based on the little information we know, somebody's going to have to pay for it, so it makes sense that taxes would go up," said Lang Fu, 48, an oil and gas engineer from Houston.

Politically, Americans are polarized. Democrats support the overhaul by 68 percent to 18 percent, while Republicans oppose it 85 percent to 9 percent. Whites oppose it by 57 percent to 32 percent, while minorities support it 61-27.

Political independents are roughly even, with 44 percent opposed and 40 percent in favor - within the poll's margin of error. Some may be swayed by appeals from Obama and the law's supporters.

Donna Christian of Kingsport, Tenn., is an independent leaning in favor of the law. A bad heart forced Christian, 45, to leave her job as a supervisor at a wireless phone company a few years ago. She and her 10-year-old daughter make do on a limited income, and have coverage through Medicaid.

"I think Americans are going to be better off in the long run even if they don't see that now," Christian said. "More will have coverage, and they'll be able to go to the hospital when they need to."

Ron Pollack, head of Families USA, a liberal advocacy group that supports the overhaul, said it will be "a real task" to turn public opinion around, but he's confident.

"When you dig deeper, individual provisions of the law have enormous support," he said. Pollack believes current polls reflect public disgust with a "very lengthy and messy process."

But Rep. Dave Camp, R-Mich., says Democrats already lost their chance to persuade the public.

"They have had 16 months to explain this bill," Camp said. "Good luck trying to explain it in the next six."

The AP-GfK Poll was conducted April 7-12, 2010, by GfK Roper Public Affairs and Media. It involved interviews with 1,001 adults nationwide on landline and cellular telephones. It had a margin of sampling error of plus or minus 4.3 percentage points.

PS/ The Associated Press is not owned by Fox News.

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But not too narrow

04/15/2010 10:35 AM |

From the Pink Sheet:

While narrower bioequivalence margins might be necessary for certain categories of generic drugs, FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee has determined that the specifications should not be tightened across the board for all generic drug approvals.

On April 13, the panel voted that current bioequivalence standards are not sufficient for generic versions of "critical dose" drugs, drugs where there is a narrow therapeutic index and deviations can result in therapeutic failure or adverse drug reaction. But on April 14, the committee pulled back from FDA's proposal to revise the bioequivalence margins for all generics, rejecting that idea in a 12-2 vote.

FDA officials presenting at the meeting signaled strong agency support for the move.

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What's Old is Neu(tral)

04/15/2010 09:47 AM |

"Net Neutrality?" Really?

Here are the four component parts:

1. Information is presented in language that is readily understandable by consumers;

2. Audio information is understandable in terms of volume, articulation, and pacing used;

3. Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and

4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.

Subjective. Subjective. Subjective. Subjective.

Nothing new -- just more of the same old ambiguity.  And more excuses to write warning letters that serve no purpose other than to satiate the hunger of those on the Hill who see volume of letters as equaling more robust oversight. 

Really?

For a good overview of the issue and some top notch opinions, see this article from the RPM Report.

If you're wondering why "net impressions" has become "net neutrality" -- it's because the FDA doesn't do impressions.

(And don't call me Shirley.)


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The 100-Yard Daschle

04/15/2010 09:28 AM |

Former Senator (and almost HHS Secretary) Tom Daschle keynoted the opening of the 19th Annual Partnerships in Clinical Trials conference.

He spoke at length (and in very laudatory terms) about the recent healthcare reform legislation.  Pretty much party-line material, but three things to share:

(1) Senator Daschle made the point that the US has a “healthcare market” while the rest of the developed world has a “healthcare system.” He prefers the latter. No surprise there.  But …

(2) “This reform legislation only puts us “on the 30-yard line.” I found this peculiar since he had initially referred to the new law as “comprehensive.” But then I realized that he was being honest. Draw your own conclusions, but remember -- the healthcare debate isn’t over. It’s only the beginning. And the scary thing is that the component that’s over is the transparent part.

(3) Daschle suggested, as one of the things that need to happen to advance America’s health, “a less risk-averse FDA.”  Hm.

Smart guy.  Savvy remarks.  Attention must be paid.

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Navigating the therapeutic narrows

04/14/2010 09:12 AM |

Okay, once more with feeling – “generic” does not equal “identical.” That’s why the FDA wants to tighten the bioequivalence standards for generic drugs. Bravo!

The Pharmaceutical Science and Clinical Pharmacology Advisory Committee voted unanimously, with one abstention, that critical dose drugs do constitute a distinct group and voted unanimously that FDA should develop a formal list of those drugs - although the terminology of "narrow therapeutic index" may be more appropriate. And in an 11-2 vote, the committee concluded that current bioequivalence standards are not sufficient for drugs in the narrow therapeutic index group.

Critical dose drugs have a narrow therapeutic index, meaning that "small changes in blood concentration have the potential to result in serious therapeutic failures and/or serious adverse drug reactions." FDA is consulting the committee on the need to establish separate bioequivalence criteria for these drugs given continuing debate about whether critical-dose drugs require special consideration, the agency explained.

Currently, the "sameness" of a brand product and a generic version is evaluated based on two-treatment crossover study to prove bioequivalence, the aim being to show that the 90 percent confidence intervals of the geometric mean test/reference ratios for both maximum plasma concentration and the area under the plasma concentration-time curve fall within a range of 80 percent to 125 percent.

According to the agency, although that methodology is "statistically rigorous" and accepted as a valid way to establish bioequivalence in most of the world, "many consumers and health professionals do not understand these statistical methods and the approval standards based on confidence intervals … Many wrongly assume that the FDA places the standards ... on the mean or average of the study data rather than the confidence intervals."

"Since the public seems to have a basic understanding of averages, the proposal to be discussed is for an additional criterion to be placed on the geometric mean (average or point-estimate) of the data limiting it to 90-111 percent." The agency surveyed 12 years of generic approvals and found that only approximately 2 percent to 3 percent of approved generic drugs would not have passed with the additional criteria.

According to a report in the Pink Sheet, “There is regulatory precedent in the definition of narrow therapeutic ratio, where drugs that meet certain parameters of median lethal dose and median effective dose are required to have careful titration and patient monitoring. But that definition is not necessarily clinically practical, FDA states, because the relevant parameters are not always available during drug development. Thus, the agency is asking the advisory committee whether it should consider CD drugs to be a distinct class, and how it should be defined. The agency also wants to know whether if the current bioequivalence standards are appropriate for CD drugs.”

The agency has already set up specific requirements for one drug product, asking manufacturers of generic versions of Sanofi-Aventis's insomnia drug Ambien CR (zolpidem) to compare partial AUCs over clinically relevant time intervals. An appendix considers the role of partial AUC for generics of modified-release methylphenidate products as well.

Its good news that the FDA is taking a strong stance in favor of the public health – because there will be many who seek to undermine this important initiative.

In the words of John Stuart Mill,

“One person with a belief is equal to a force of 99 who have only interests.”

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New CMS Director Loves NHS

04/13/2010 05:40 PM |

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