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To read this piece in its entirety, click here.
Stop the presses. This just in from the Gray Lady: Genomics is hard.
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 21st 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 20th century comparative effectiveness. And this is why we need a robust critical path for 21st century clinical effectiveness measurements.
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
"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.
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 CareBethesda, 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.
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?
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.
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.
Who’d a thunk it – the pharmaceutical industry recognizing that a well-funded, robust FDA is actually in their best interest? Well, credit AstraZeneca chief executive David Brennan, who also happens to be the new chairman of PhRMA.
According to Brennan, a “strong, well-functioning” Food and Drug Administration is needed “but an understaffed and under-funded FDA is an agency in crisis.” And, further, “we’re working hard for increased appropriations to the FDA so that it is recognized as a watchdog with a full set of teeth.”
Speaking directly to President Obama’s call to “cure cancer,” Brennan said that “contrary to the Hollywood-like scenarios, our battle with cancer isn’t so much about spectacular breakthroughs as it is about steady, incremental progress.” However for that to continue “requires policies that are more conducive to the medical innovation that is the genesis and cornerstone of our industry…we need an environment that includes strong, well-defined intellectual property rights.”
The next target on IMAP's radar screen: patient advocacy groups, many of which receive all or nearly all of their funding from the drug, biotechnology or medical device companies. "We're going to address these patient advocacy groups, some of which are grass roots and some of which are astroturf," Rothman said.
Patient Advocacy groups need to be alerted that this very effective strategy as seen with Academic Medical Centers (Brennan paper 2006, followed by AAMC Taskforce 2008, followed by major reforms 2009), and now Medical Specialty Societies is a model that is working for IMAP. This will be used against them.
They want to cause shame for doing the right thing (working with industry to develop new products that saves lives) even if it costs more in the short run.
This Strategy should be exposed for what it really is, short sighted contempt. Medical Societies, Academic Medical Centers and Patient Groups need to stand up against this bullying tactic; otherwise as a society we will all suffer the consequences of a lost medical research and education base.
Tom Sullivan is too kind. This is intellectual fascist. Rothman represents a point of view that is toxic to the public health, that all "science" must be cleansed of the biases and viewpoints he and his fascist friends regard as the absoute truth. The Jerry Avorns, Marcia Angells, Rothmans, etc inevitably endorse any conclusions that fit their ideology and refuse to subject their assertions to the scientific method. ( It is the very reason that the comparative effectiveness crowd relies on a rigged approach to evaluation: selecting only randomized trials with exclusion criteria that fail to control for variation in treatment effect and using meta-analyses to reach conclusions instead of generating hypothesis so as to reinforce the initial weakness of underpowered randomized trials. All conclusions will show no difference in benefit among competing therapies... )
To assert that patient groups are somehow "fake" because they receive industry funding raises the question of who made Rothman and George Soros the gold standard of probity? The ultimate measure of any individual or organization is the merit of their position, the contribution of their effort. Does receipt of money from a currency wrecker, who has spent money to weaken the state of Israel (Soros), who himself invests billions in biotech and drug companies, qualify for knighthood compared to receiving support from companies that commercialize medical knowledge, invest in scientific research, give away billions in free medicines. Soros -- and by extension -- Rothman and Blumenthal have profited from the profits of drug companies...
If Rothman succeeds in his campaign of intimidation it will not "purify" medicine and thereby improve the quality of care. There is no evidence of this cause and effect. On the contrary there is no scientific evidence to support this assertion. Meanwhile other countries and health systems are increasing the amount of collaboration with direct subsidies, increase patent opportunities, etc in order to promote innovation and retain scientific talent.
Rothman and his ilk are angy elites who should be shunned and attacked by the patient groups. Once the patient groups are silenced then advocacy for faster cures will die. What will happen next is fairly obvious. Soros, who stood by without feeling as Nazis confiscated the property of Jews, has picked his associates well.
A new research study from health-information company Wolters Kluwer Health reports that in the fourth quarter of 2008,
According to a story in today’s Wall Street Journal, “Higher co-payments required under health-insurance plans and other plan features helped boost the number of patients unwilling to pay for their prescriptions, according to the research.”
Why higher co-pays? Because insurance companies don’t want patients to fill prescriptions for on-patent medicines. The Journal writes that “… insurers are flexing their muscle and rejecting coverage for more prescriptions. Health plans denied 10.8% of brand-name prescriptions in the 2008 fourth quarter, a 21% increase from the first quarter in 2007.
Are the majority of Americans with private health insurance spending more for drugs? Yes — because their insurance companies are paying less. In 2000, people under 65 with private health insurance paid 37.2 percent of the cost of their prescription drugs costs out of their own pockets. (Not surprisingly, this leads many Americans to believe that their increased out-of-pocket expenses are because of higher drug costs.) The truth is that the growth in prescription-drug co-payments outpaced the growth rate of prescription drug prices four to one.
Good for payers. Bad for everyone else – including employers.
"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.
As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."
The headline of that New York Times article was, "Health penny wise, medical pound foolish?
Indeed.
Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payers interpose themselves between doctor and patient, when prescribing decisions are made by accountants based on “cost-effectiveness” studies, health outcomes decline for the individual and costs go up for our health care system.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
