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."

  Read More & Comment...

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.

  Read More & Comment...

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

  Read More & Comment...

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."
  Read More & Comment...

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.

  Read More & Comment...

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.

  Read More & Comment...

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.
  Read More & Comment...

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.


  Read More & Comment...

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. 
  Read More & Comment...

No Pain, No Gain

04/20/2009 01:16 PM |

The issue at hand is opiods –but there’s a larger issue – how can the FDA, industry, physicians, pharmacists and patients work together to enhance the safe use of medicines.

The theory is that the way to make drugs “safer” is to ensure they are used appropriately. 

And communications is the weak link in the chain.  Hence REMS as a tool for safe use.  Seems to make sense.

Presented for your consideration -- questions posed by the FDA in advance of a two-day public meeting set for May 27-28 on whether class-wide opioid REMS should include a certification process for prescribers, pharmacists and other heath care providers, a strong patient education component, and prescriber-patient agreements.

According to a report in the Pink Sheet, “Since FDA's announcement that it intended to seek the class-wide REMS in February, pharmaceutical companies have been charting new territory as they try to work together to develop a REMS framework for the whole class.”

Working together to advance safe use.  Good idea.  The Pink Sheet continues, “The evolution of the opioid class-wide REMS will set an important precedent for trying to get competitors to work together on post-marketing programs in the future.”

In short, competitors must also be allies in pursuit of the public health.  And that means both innovator and generic companies.

Not easy.  But important advances rarely are.

  Read More & Comment...

The Acute Nature of Chronic Disease

04/17/2009 01:02 PM |

The President has recently reaffirmed his conviction that "we must have quality, affordable health care for every American.”  This is an important goal. In the health care debate, though, misconceptions abound — and this hurts reform efforts. As lawmakers move forward, they must be aware of the facts. And they must be clear on the precise causes of America’s health care woes.

The American health care system is broken in important respects. American health care is designed to provide acute care, but too often neglects the urgent imperative of chronic conditions. This disconnect will become even more problematic as Baby Boomers continue to age and the fastest growing demographic segment in America is the over-75 population. The argument that health care is "too expensive" is too broad. A better argument is that waiting until Americans become seriously ill to intervene is too expensive. Earlier diagnosis and earlier, continuing care is crucial to the future health of both Americans and the American health care system.

Prevention must be our first line of defense. Our health care system often works miracles when people become very ill, but it needs to do a better job at keeping people healthy before disease attacks. Although proper diet and nutrition are misunderstood and undervalued, better health care habits will not prevent the diseases that all Americans (and Baby Boomers in particular) will develop as we age. There are effective treatments, including medicines, which stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives rather than undergoing surgery, emergency care, hospitalizations, disabilities, and nursing home care.

We cannot afford, in terms of either dollars or lives, to continue playing the health care "blame game," tending to focus on health care prices - for hospitals, insurance, drugs, and doctors. Disease is the enemy and the cost of disease is staggering. Rather than looking for a villain, it's time to start asking the hard questions and finding the right answers - focusing on how to reduce the price of a diabetic amputation is the wrong approach. We need to focus on prevention because that's the best way to save money and improve lives. Now is the time to do this, so that we can invest in and afford better treatments for other conditions such as cancer and Parkinson's disease, which are so desperately needed and that hold so much promise.

All Americans deserve access to quality health care, but how can Americans get broader access to health care without diluting the quality of health care and compromising the future of health care? If miracles have become expectations - "What's a miracle worth?"

The first step in this process is an honest, broad-based dialogue. In order to revitalize our health care system we must refocus the debate about health care on the prevention of disease before it becomes expensive and deadly. In order to save lives, reduce costs, enhance quality, and deliver on the promise of robust health to all groups of Americans, all of the players in the health care debate - including government - must work together as a team, as a unit, as a public health defense force armed and ready to advance the public health

For the rest of the story, see here.

  Read More & Comment...

Or May As The New Theme Song For Comparative Effectiveness Decisions?

04/16/2009 06:04 PM |

LONDON (AFP) – Frank Sinatra's "My Way" is the most popular song played at funeral services, but other more arresting death-bed choices were revealed in a poll published in Britain Thursday.

Australian rockers AC/DC's "Highway to Hell" has stormed into the funereal charts along with Queen's "Another One Bites The Dust," while Leonard Cohen's "Hallelujah" has a new lease of life after its recent success on a talent show.

More traditionally, hymns including "The Lord Is My Shepherd" and "All Things Bright And Beautiful" are among music chosen by people to accompany their final journey.

For classical music fans, Schubert's "Ave Maria," Puccini's "Nessun Dorma" and Bach's "Air On A G String" are among the most chosen pieces to comfort their loved ones as they pay final farewells.

Television and radio music also features on the burial playlist: theme tunes from popular programmes like "Top Gear", "The Benny Hill Show" and even the Radio Four Shipping Forecast music, which many fall asleep to at night.


 Click Here to Read the Full Article

  Read More & Comment...

MD? We Don't Need No Stinking Medical Degree!

04/16/2009 04:12 PM |

  Read More & Comment...

Putting Health Care Reform Into Perspective

04/16/2009 03:23 PM |

  Read More & Comment...

Hype is Easy. Genomics is Hard.

04/16/2009 01:11 PM |

Stop the presses.  This just in from the Gray Lady:  Genomics is hard.

According to an article in today’s New York Times, “The era of personal genomic medicine may have to wait. The genetic analysis of common disease is turning out to be a lot more complex than expected.”

Really?  More complex than expected?

The Times continues, “One issue of debate among researchers is whether, despite the prospect of diminishing returns, to continue with the genomewide studies, which cost many millions of dollars apiece, or switch to a new approach like decoding the entire genomes of individual patients.”

Specifically, “A set of commentaries in this week’s issue of The New England Journal of Medicine appears to be the first public attempt by scientists to make sense of this puzzling result.

But the Times story is somewhat misleading. The NEJM articles aren’t about molecular diagnostics (Herception, Warfarin, etc.) but rather the attempt by some companies “to offer personal genomic information” that would offer customers specific genetic risk for common diseases.

That’s something else entirely.  In fact, it's what confuses people (meaning "people" but also "journalists" and "politicians") about what “personalized medicine” is all about.

The unintended (one hopes) consequences of articles such as the one in the New York Times and the commentaries in NEJM are that the important momentum behind pharmacogenomic research gets slowed – along with all-important funding for same.  Case in point:  how will this article play in the battle to fund the FDA's Reagan/Udall Foundation?

Alas, there is no magic bullet.  Frustrating?  Sure.  But anyone who thought it was going to be easy wasn't paying attention.  But hype is like that -- you want to believe it. Just because alluring promises of a personalized genomic map aren’t panning out doesn’t mean that genomics aren’t the most crucial pathway forward for 21^st century medicine and the roadmap in achieving the four rights (the right medicine for the right patient at the right time in the right dose).

The complete New York Times article can be found here.

Such misunderstandings also play into the hands of those who believe that the only way forward is through 20^th century comparative effectiveness.  And this is why we need a robust critical path for 21^st century clinical effectiveness measurements.

  Read More & Comment...

Medical Innovation: Burden or Solution?

04/15/2009 01:12 PM |

At 9:30AM on May 14 at the National Press Club, the Center for Medicine in the Public Interest will launch the Odyssey Project -- conceived out of a concern that even as technology-sustained growth is offered as the hope for solving environmental problems, there are broad political and cultural forces that could undermine the development of biomedical technologies that offer the same promise for health care problems of a growing and aging population.

Please join the Honorable Anna Eshoo, (D-CA.) Vice Chair, 21st Century Health Care Caucus former Congressman Mike Ferguson (current Senior Fellow, CMPI), former NFL linebacker Elijah Alexander, President, Tackle Myeloma Foundation, and other special guests at the inauguration of this timely and important project

CMPI created the Odyssey Project because we believe that medical technology is a not a costly burden to be contained, but the solution to humanity’s greater challenges. The Odyssey Project will provide a forum to discuss how medical progress has added to the health and wealth of families over the past half century, create a roadmap to insure it generates tremendous near and long-term prosperity and offers patient-centered prescriptions for America’s health care crisis.

Please RSVP to Meryl Reichbach:  mreichbach@cmpi.org or 212.417.9169

  Read More & Comment...

FDA: HELP is on the way

04/14/2009 01:51 PM |

David Dorsey, who left the FDA on detail in January 2001 to the Senate Health, Education, Labor, and Pensions (HELP) Committee, is returning to the agency as a senior advisor to Principal Deputy and Acting FDA Commissioner Joshua Sharfstein. Dorsey’s portfolio includes the Office of Legislative Affairs.

"One of his major tasks will be to bridge the development of policy in the Centers and the Office of Policy and our legislative work through the Office of Legislative Affairs," Sharfstein wrote in an April 13 memo to senior staff.

The good news is the Dorsey (who previously serviced in the Office of the Chief Counsel) has significant expertise in the often-neglected areas of food labeling and dietary supplements.  He also has worked on medical devices and tobacco. 

One big difference Mr. Dorsey will find is that, today, there is no one remaining at FDA with any knowledge or expertise in the area of tobacco regulation.  If the agency receives Congressional authority to deal with tobacco (which now seems likely) it seems plausible that Dorsey could find himself leading the team.

Inquiring minds what to know -- What was the role of FDA Commissioner-designate Peggy Hamburg in the Dorsey appointment?  Considering the importance of position, one hopes she signed off on it.

Welcome back, David Dorsey.  
  Read More & Comment...

The Incredible Shrinking Healthcare System

04/14/2009 01:48 PM |

Maybe it's being in Israel and reading too much from right to left but I get the sense that the infatuation with health IT will not make up for what appears to be an erosion in the actual treatment of real people...

For instance...

Minnesotans to receive access to a virtual clinic
April 13, 2009 | Molly Merrill, Associate Editor

ST. PAUL, MN – Minnesotans will soon have access to a virtual clinic, thanks to a partnership between Blue Cross and Blue Shield of Minnesota and American Well.

America Well's Online Care will provide Minnesotans with live interactions with physicians and other medical care providers. The virtual clinics at the worksite will emphasize treatment for common illnesses, monitor care for patients with chronic illnesses and offer preventive and wellness care.

Meanwhile....

Plan to close Northeastern Hospital stirs anger
By Josh Goldstein
Philadephia Inquirer Staff Writer

After 37 years at Northeastern Hospital, mostly in its bustling emergency room, Beverly Soska jokes that she knows many patients so well, she can diagnose them without asking a question.

Now the 67-year-old nurse who grew up near the hospital is worried about how her patients will fare if the Temple University Health System sticks to its plan to close the hospital in the city's Port Richmond section by July 1.

Northeastern is the dominant community hospital between Frankford to the north and Temple University Hospital to the west. It delivers 1,800 babies and treats about 50,000 patients in its emergency room each year, making it the ninth-busiest adult ER in the five-county area, state records show."

Oh well... If they are sick or pregnant or critically ill, they can just log in or visit a chat room....

Then there is this...

'Health Informatics Specialists' Play Key Role in Health IT Ramp-Up
Monday, April 13, 2009

Demand for "health informatics specialists" who have expertise in medical records, insurance claims, clinical care and computer programming is rapidly increasing as health care providers look to utilize the $19 billion in stimulus funding directed at implementing and expanding electronic health records, the New York Times reports.

These specialists usually start their career or education in computer programming or as health care professionals, and later earn a degree in health informatics and take midlevel or senior jobs at a hospital, doctor's office, insurance company, drug firm or other organization working with health care data.

William Hersh, chair of the Department of Medical Informatics and Clinical Epidemiology at Oregon Health and Science University, said, "The health IT people run the servers and install software, but the informatics people are the leaders, who interpret and analyze information and work with the clinical staff."

All of which is great if you are an Oracle server down for a day... But if you are a cancer survivor...well, at least you will have an electronic medical record, but not much else...

"In the United States, about 6.5 million cancer survivors are 65 years or older. Approximately 43% of these seniors survive more than 10 years, and approximately 17% survive more than 20 years from the time of their initial diagnosis, as reported in a December 2008 supplement to Cancer, "Aging in the Context of Cancer Prevention and Control."

Additionally, a shortage of oncologists creates the classic example of demand exceeding supply.

The American Society of Clinical Oncology (ASCO) predicts that by 2020, demand for oncology services will significantly outpace the supply of oncologists available to provide patient care. Driven principally by the aging population and an increasing number of cancer survivors, demand for oncology services will increase by 48% by 2020. The number of oncologists is expected to grow by only 14% in that same per-iod. This translates into a shortage of as many as 4,080 oncologists—roughly one-third of the 2005 supply."

Of the course the response is to dump more of the responsibility on primary care docs... but does anyone remember what is happening to the ranks of these medical foot soldiers ...

But those docs who try to practice quality medicine outside guidelines designed to keep care within deeply discounted limits wind up quitting or going elsewhere... And there is already a shortage of physicians to meet an aging population who are also chronically "ill" with cancer ...

And as for the lofty goal of providing integrated and preventive disease management at the primary care level there is this ...

Two-Thirds Of Primary Care Physicians Can't Get Mental Health Services For Patients

Shortages Of Mental Health Providers, Health Plan Barriers, And Lack Of Or Inadequate Coverage Cited As RoadblocksTo Mental Health Care

Bethesda, MD -- About two-thirds of U.S. primary care physicians reported in 2004-05 that they couldn't get outpatient mental health services for their patients -- a rate that was at least twice as high as for other services, according to a national study funded by the Commonwealth Fund published today as a Web Exclusive in the journal Health Affairs. Click Here to Read the Article

Conducted by Peter J. Cunningham, Ph.D., a senior fellow at the Center for Studying Health System Change (HSC), the study found that more than half of the primary care physicians reporting problems getting mental health services for their patients cited lack of or inadequate insurance coverage, health plan barriers, and shortages of mental health providers as "very important" reasons their patients couldn't get care.

Meanwhile the $700 billion "reserved" by Obama is to pay for people who already have access to health care and assumes that doctors and hospitals will take a 25 percent cut in reimbursement. It also assumes a decline in the introduction of new technologies and a more selective use of "high" cost services. Like psychiatric and cancer care.

In any event, there are fewer doctors across the board and more new technologies waiting in the wings. Investing in health IT will allow us to, perhaps, monitor the steady decline in health status and the cost of lost lives and prosperity as medical innovation is squandered. In the virtual world we are creating we all simply email our illness in. The doctor will "see" you but never touch or treat you in the new medical order. That's prevention for you.
  Read More & Comment...

The New SILK Road

04/13/2009 11:29 AM |

One in 10 people over 65 – or 5.6 million Americans – will have Alzheimer’s Disease by 2010. Without interventional therapy, the number of cases is expected to rise to 13.5 million by 2050. As a recent CMPI study found, if we delay onset of Alzheimer's by 5 years it would be worth nearly $2 trillion to the United States.

For this sobering American pharmaco-economic data, have a look at the CMPI report, “Alzheimer’s Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money? 

Click Here to Read the Report on Alzheimer's

Currently one of the biggest hurdles providers and payers face when deciding which treatment for Alzheimer’s disease to prescribe and pay for is efficacy.  Now the public health community may have a new tool. Scientists at Washington University have developed a test to quickly assess how effective a drug is at treating Alzheimer's disease.

Until now, determining whether a drug is working has meant measuring a patient's mental functioning over a long period of time. The new measurement tool -- called stable isotope-lined kinetics (SILK) -- takes just 36 hours.

Researchers recently developed the test to find whether an Alzheimer's drug given to healthy volunteers could reduce production of a substance known as amyloid beta. Called A-beta for short, the substance is a normal byproduct of human metabolism that builds up to unhealthy levels and forms plaques in the brains of Alzheimer's patients. Scientists believe it is this buildup of plaque tangles that causes the disease's characteristic mental deterioration.

The drug currently being tested is made by Eli Lilly and is in the third phase of clinical trials. Using SILK, researchers found the drug reduced the production of the troublesome A-beta.

Smooth as SILK?  Perhaps.  But certainly an important step forward in personalized, 21st century comparative effectiveness.  A step towards achieving the four rights – the right medicine for the right patient in the right dose at the right time.

The study was released today in the online version of Annals of Neurology. The study was funded through an Eli Lilly grant.
  Read More & Comment...

What Would Hubert Say?

04/10/2009 12:29 PM |

A presidential executive order will establish a Department of Health and Human Services Office of Health Reform that will coordinate "closely" with the White House health reform office led by Nancy-Ann DeParle,

The executive order doesn’t not name the head of the new office, but cognoscenti point to Jeanne Lambrew who was originally recruited to serve as Daschle's deputy in the White House.  Since Tom’s tax troubles, she has been parked at HHS in an undefined role.

It is likely that Ms. Lambrew will act coordinator between the White House and HHS on healthcare reform-related issues.

The order also officially establishes the White House reform office. According to the executive order, the principle functions of the White House Office of Health Reform are to lead and coordinate development of the administration's policy development across executive departments and agencies, including the Domestic Policy Council, National Economic Council, Council of Economic Advisors, Office of Management and Budget, HHS and Office of Personnel Management.

The office will integrate the White House policy agenda across the federal government and coordinate public outreach to gather input from the public, from demonstration and pilot projects, and from public-private partnerships on priorities for policy measures.

We anxiously await the manner and methods this office will use to “gather input from the public” and how they chose who those publics are.

  Read More & Comment...