Latest Drugwonks' Blog
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.
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
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?"
For the rest of the story, see here.
Comparative effectiveness research might lead to people being denied life saving care but at least they would get to choose the music they die to...free of charge I hope....
Hallelujah or Highway to Hell? Songs to die for
AFP/File – US entertainer Frank Sinatra sings in Washington, 1992. Sinatra's "My Way" is the most …
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
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.
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.
