GoozNewsfunction OpenComments (c) { window.open(c, 'comments', 'width=480,height=480,scrollbars=yes,status=yes');}function OpenTrackback (c) { window.open(c, 'trackback', 'width=480,height=480,scrollbars=yes,status=yes');}function onWindowResize(){ var bannerElement = document.getElementById('bannerImage'); if (document.body.clientWidth < 816){ var newWidth = Math.max(700, document.body.clientWidth - 40); var newHeight = newWidth/4.97; bannerElement.style.width = newWidth +"px"; bannerElement.style.height = newHeight +"px"; } else { bannerElement.style.width = "786px"; bannerElement.style.height = "158px"; }}window.onresize = onWindowResize; Home | About | Contact | Archives | Articles | Search January 08, 2009 Health Care for America Now Launches Campaign What do you think? (You can find a list of the organization's supporters here.) Posted by gooznews at 04:19 PM | permanent location | Comments (0) The Public Plan Robert Pear of the New York Times does a good job foreshadowing one of the major controversies in health care reform: establishment of a public Medicare-like plan to compete with private insurers in covering the uninsured. He suggests it will be a major topic at today's confirmation hearing for former Sen. Tom Daschle, slated to be the new Health and Human Services chief.Best quote in the story comes from Pete Stark, the California Democrat who has been a thorn in the side of insurers and providers from his perch on the Ways and Means committee for over two decades. Commenting on a Medicare Payments Advisory Commission report that suggested Medicare pays physicians 19 percent less than private plans, thus forcing those private plans to pick up the tab, Stark said:Medicare is paying the right amounts. To suggest that a heart surgeon has to make $600,000 or $700,000 a year, as opposed to only $400,000 under Medicare fees, does not get much sympathy from me.Coincidentally, the New England Journal of Medicine this morning has a perspective article on physician payment issues by Harvard medical school professors Pamela Hartzband and Jerome Groopman (yes the New Yorker and book writer). They wind around the many ways that fee-for-service medicine -- which they define as applying a dollar value to every element of a physician's time, the relative value units -- undermines quality in health care.They offer an interesting discussion of how money-driven behavior undermines collegiality and consultation, which are the hallmarks of successful medical practices. Yet their discussion about possible solutions is sadly limited.One answer may lie in an experimental new paradigm in primary care termed the "patient-centered medical home." The term itself suggests an emphasis on the social exchange that exists in a family rather than the market exchange of a business. The medical home is envisioned as a "compassionate partnership" of primary care providers and patients, with coordinated care for patients' ongoing problems and increased attention to preventive measures. The insurer would pay a set fee for each patient cared for in the medical home to cover what is now nonreimbursed time. Substantial cost savings are expected to result from coordination of care.Why not use their discussion as an opening wedge into the elephant in the room of the medical home discussion: the best medical practices in the U.S. -- the Mayo Clinic, Kaiser Permanente, Group Health in Seattle -- utilize salaried physicians who don't get paid piecework-style and therefore do not have financial incentives that detract from care coordination or lead physicians to prescribe unnecessary or low-quality care. Patients in these systems don't need a "medical home" physician because they already are home when they walk in the door.Of course, most physicians in these group practices earn less than comparable colleagues in individual or small group private practices. If readers can point me to statistics on this point, I will gladly publish them. Posted by gooznews at 08:39 AM | permanent location | Comments (0) Emory Prof Launches Shadow DSM-V Group Emory University psychiatry professor J. Douglas Bremner has assembled a "shadow team" to follow the deliberations of the American Psychiatric Association as it rewrites the Diagnostic and Statistical Manual for Psychiatry, the desktop reference that defines mental illnesses. Bremner's website, launched, like this one, to help promote a book reports 22 of 28 members of the APA committee have ties to the pharmaceutical industry.Others have received educational grants and other perks from pharma, making pretty much everyone compromised, so it isn't surprising that a lot of people are worried about the potential corrupting influence that the pharmaceutical industry may be having on our beloved "bible" of psychiatry. Not to mention the fact the members of the task force were required to sign confidentiality agreements that they wouldn't talk to anyone until the book was published.Bremner got to see the "corrupting influence" of pharma up close, since Emory is also home to psychiatry prof Charles Nemeroff, who received over $800,000 in consulting fees from GlaxoSmithKline in this decade yet failed to report those payments to his university, according to an investigation by Sen. Charles Grassley (R-IA).Bremner's disclosure, prominently displayed on his website, shows he also has received research support from Glaxo and Eli Lilly. Both are major manufacturers of anti-depressants and other psychiatric drugs. Still, we wish him and the shadow committee, which isn't listed yet on the website, well. The APA, given its long standing entanglements with the pharmaceutical industry, bears close scrutiny as it considers the next version of the DSM. Posted by gooznews at 07:31 AM | permanent location | Comments (0) January 07, 2009 Tom Geoghegan for Congress! (IL-5) The special election to replace Rahm Emanuel in Congress is March 3rd, and Chicago labor lawyer Tom Geoghegan officially threw his hat in the ring today. He's not only dedicated his life to helping working people and a staunch advocate of single-payer health care reform, but he is a gifted writer whose books are always as effortlessly pleasurable to read as they are incisive on the crucial issues of the day.For a perfect example, see the op-ed in today's New York Times on the constitutional questions behind the fight over who will fill President-elect Obama's Illinois Senate seat. To learn more about his campaign and the candidate (and donate, if you're so inspired), go here. Posted by gooznews at 05:47 PM | permanent location | Comments (0) Whoops! Wrong Sanjay Gupta I made a major error this morning in claiming that the Sanjay Gupta on the American Psychiatric Association disclosure website from 2007 was the Sanjay Gupta of CNN. Different people. My apologies to CNN's Sanjay Gupta for making the earlier post, which is now withdrawn.That said, those interested in the Gupta potential appointment as Surgeon General may want to check out this Health News blog item by Gary Schwitzer, a journalism professor at the University of Minnesota, last November 20. It discusses a new show launched by CNN for broadcast in hospital and physician waiting rooms:A powerful contemporary example of entanglement involves a television network called Accent Health (whose logo includes the words "Your target is waiting"), said to be watched monthly by more than 10 million viewers in US medical waiting rooms. The network, which is produced by CNN, overtly offers sponsors, including drug companies, the chance to boost sales of their products, by, for example, putting "your brand in front of the valuable Baby Boomer population just before they discuss their health conditions with their doctor." One of the hosts is Sanjay Gupta, CNN’s chief medical correspondent and host of at least one other CNN health programme that is funded partly through drug company advertising. ...As researchers and writers acting to improve medical journalism, we encourage journalists, educators, and professional associations to scrutinise their own relations with the industry as intensely as they do those between doctors and drug companies and to develop workable solutions. And, if they are to be good watchdogs, journalists need to mark their territory and clearly establish boundaries between themselves and the industry to avoid unhealthy entanglements.Marcia Angell just wrote a scathing condemnation of the corruption of medicine in the latest New York Review of Books. If Dr. Gupta (the one being considered for Surgeon General), has ties to industry, including lucrative fees from making speaking engagement to trade association or company forums, he should make them public immediately so the public can judge that information along with his other qualifications for that high-profile post. Posted by gooznews at 11:55 AM | permanent location | Comments (1) January 06, 2009 That 'Slowdown' in Health Care Spending The rate of increase in health care spending slowed to its lowest pace in a decade, falling to 6.1 percent annual growth in 2007, down from 6.8 percent in 2006. That was just 1.3 percentage points faster than the economy as a whole.In inflation-adjusted dollars, health care spending rose at a 3.3 percent clip compared to 2.0 percent for overall gross domestic product. That differential means 'slower' growth translated into health care's share of the overall economy rising to 16.2 percent of GDP, up from 16 percent in 2006. Given that the overall economy fell into recession in 2008 while health care spending continued on its merry way, this is probably the last good news on health care spending that the rest of the economy will get in a while. "I wouldn't expect the 6.1 percent to stay that low," said Richard Foster, the chief actuary at the Center for Medicare and Medicaid Services (CMS), which compiles the numbers. CMS will release projections for the 2008 to 2017 period in a few weeks.Most of the moderating growth came from slower increases in retail spending on prescription drugs and falling insurance company overhead. Prescription drug spending rose slightly less than 5 percent in 2007, about the same pace as the overall economy. That was down from the more usual 8.6 percent increase the year before.The analysts cited a rise in the number of generic prescriptions as a large number of blockbusters came off patent. There was also an increase in the number of black box warnings issued by the more safety-conscious Food and Drug Administration (68 in 2007 compared to 21 just two years earlier). That may have helped hold down the growth in overall prescription drug use.The net cost of insurance (that includes both profits and overhead), meanwhile, fell to just a 3.6 percent annual growth rate in 2007, which was significantly slower than the economy as a whole. The prior year, it grew 8.4 percent and since the beginning of this decade has grown every year somewhere between 7.6 and 12 percent. The analysts suggested the insurance underwriting cycle, where profits fall as more companies enter the market (think about the explosive growth in drug plans in 2006 and 2007 as the Medicare drug benefit became fully operational), was probably at work and probably wouldn't last long. But the good news on drugs and insurance were offset by faster increases in spending at hospitals and on physician services, which expanded at slightly higher rates than health care spending as a whole. Hospitals increases were due to higher volumes, according to the CMS analysts, while physician increases were triggered by higher prices.Those numbers suggest that efforts to control health care costs have yet to take on the most crucial targets. Hospitals and physicians account for well over half of all health care spending. Drugs and insurance company profits and overhead, on the other hand, account for less than one dollar in five.On the payer side, the shift from private to public spending continued, with all federal, state and local health care expenditures (Medicare, Medicaid, government workers health care, public health activities, etc.) reaching 40.4 percent of the total. This does not include the foregone tax revenues from private spending, which would push it closer to half.Among private payers, private householders have emerged as the largest single financier of our out-of-control health care system, largely due to higher co-pays, deductibles and other out-of-pocket expenses. Individuals and families now finance 31 percent of total health care spending compared to just 25 percent for businesses.Those who wanted consumers to have "more skin in the game" to hold down costs have gotten what they wanted. The effect -- health care spending still growing at a rate over 50 percent faster than the rest of the economy -- was less than advertised. Posted by gooznews at 07:54 AM | permanent location | Comments (1) January 05, 2009 Pharmalot Folds Tent Newhouse (they own The New Yorker) folded the Pharmalot blog over the weekend, putting an end to one of the newspaper industry's more successful forays into online journalism. Ed Silverman was an indefatiguable reporter and writer on all things pharmaceutical, a logical niche market for a newspaper (the Newark Star-Ledger) located in New Jersey, which has long been a center for the U.S. pharmaceutical industry. You can read Ed's last post here. Here's my goodbye comment to a valued colleague:Ed,You set a great example for how journalists can operate in this new medium: you found a niche; you offered fast-hitting news and opinion; and you built a readership. Congrats!While 11,000 unique visitors daily may not seem like much to some, that level of readership is no different than what most reporters get in print. What papers forget is that their daily broadsheet circulation is nothing more than an aggregation of niche audiences, made up of people like me who read only one or two of its many features.I hope the fact that Newhouse allowed you to go does not bode ill for similar efforts in the future. You should be proud of the fact that your experiment was a raging success.Merrill (GoozNews) Posted by gooznews at 02:48 PM | permanent location | Comments (0) Gov't. Science Committees Need Overhaul -- Report Citing numerous cases at the Energy, Interior and Agriculture departments where industry representatives are improperly serving on government scientific advisory panels, the Center for Science in the Public Interest today called on the incoming Obama administration to initiate a complete overhaul of the federal advisory committee system. The report examined appointments at several dozen of the nearly 200 science-based advisory committees that offer advice on issues ranging from food safety and energy production to protection of the environment and public health.The report's findings are based on the 1972 Federal Advisory Committee Act, which states federal appointments to outside panels offering scientific advice should be free from conflicts of interest and reflect balance in points of view. The investigation found numerous examples where government agencies appoint members with industry affiliations and other financial conflicts of interest. The investigation also found the Bush administration made no significant changes in policy despite Government Accountability Office reports in 2004 and 2008 that outlined similar problems at the three agencies.For example, the Department of Energy's Nuclear Energy Advisory Committee, whose charge includes advising on nuclear waste storage options, is dominated by members with ties to the nuclear power industry. The National Coal Council is similarly dominated by representatives of the coal industry, despite a charter that calls on the panel to evaluate the technical feasibility of clean coal technologies like carbon sequestration. "The new administration should act immediately to address longstanding deficiencies in the advisory committee system, especially since the federal agencies themselves appear reluctant to respond to repeated criticisms of their management," the report concludes.This story first appeared in Integrity in Science Watch, a publication of the Center for Science in the Public Interest. Posted by gooznews at 08:13 AM | permanent location | Comments (0) January 02, 2009 No Uptick in Drug Innovation The Food and Drug Administration approved 26 new drugs and biologics in 2008, a sharp uptick from just 18 new approvals in 2007. That was the most since 2004, the Wall Street Journal reported this morning. The story suggested innovation was finally rising again after a multi-year drought, and slow review times at the agency were once again becoming a bottleneck to new drug approvals.Too bad the paper didn't add up the number of significant new drugs approved by the agency last year. That accounted for just 9 of 26 approvals, as measured by whether the agency gave the drugs a priority review, reserved for those new medications considered an advance over drugs already on the market. That remains sharply below 2004 and 2005, when significant new drugs accounted for most of what got approved by the FDA. Indeed, a closer look at the last decade's performance by the pharmaceutical and biotechnology industries suggests the innovation drought is far from over: Posted by gooznews at 10:26 AM | permanent location | Comments (0) December 30, 2008 DNA-Driven Medicine Here's the one-minute memo on Andrew Pollack's mostly excellent story on "personalized" drug therapy, which made the front page of today's New York Times. It's the latest entry in that paper's "Evidence Gap" series:1. Most drugs only work on a subset of patients who take them.2. Gene variations may determine some of that variable response.3. DNA tests to determine those variations are poorly regulated by the Food and Drug Administration; many may be inaccurate.4. Using knowledge about varying drug responses based on genetic differences will undermine the drug industry's profit model, which usually depends on selling to everyone who has a particular disease.Two minor complaints about the Times' presentation. First, the headline suggesting "patient DNA" is responsible is confusing when discussing cancer drugs, which account for half the drugs discussed in the article. It's usually the tumor's DNA, which are mutations of the patient's DNA, that affects drug performance, such as with the KRAS mutation (or lack thereof) in determining if Erbitux or Vectibix affect colon cancer.Second, and more significantly, Pollack's "nut graf" (for a writer, this paragraph, near the top of a story, reveals the "why" of the story) offers a gratuitous and unnecessary slam on comparative effectiveness research. It said:Many policy experts are calling for more studies to compare the effectiveness of different treatments. One drawback is that such studies tend to be "one size fits all," with the winning treatment recommended for everybody. Personalized medicine would go beyond that by determining which drug is best for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.That's a very narrow definition of comparative effectiveness research (CER). A reasonable part of the charge for a new agency given substantial resources to conduct CER would be to investigate drugs with marginal clinical trial results to determine which patients actually benefit and why. Drug companies often have little or no interest in conducting such research. It's much better to sell a cancer therapy to everyone with a particular cancer, even if it only benefiting a small segment of that population.And it's also important to recognize that not everything boils down to personalized medicine. The individual response to many drugs may have nothing to do with genetic variation. Or, if it does, scientists have no clue as to what the relevant genetic variations might be.In such circumstances, CER can be a powerful tool to determine what the best first approach ought to be to promote overall population health. Lesser alternatives as determined by CER could then be put into a second tier of therapies that should only be tried after the initial therapeutic approach failed.That would be a good use of the sophisticated scientific information derived from well-conducted CER. It would promote the greatest good for the greatest number and at the lowest cost to the health care system.People who slam CER as "one size fits all" or "cookbook" medicine that will undermine physician and patient choice are failing to admit the lack of science behind their own methods. Posted by gooznews at 08:24 AM | permanent location | Comments (1) December 27, 2008 A Yearend Note to Readers GoozNews is entering its fifth year of publication. Readership in 2008 reached new highs. And while we were rated among the top "health care" websites earlier this year, that ranking has fallen in recent months as the marketplace for free information expands.The falloff was also due in part to a reduced number of posts since last autumn. As many regular readers know, this is a part-time effort that generates no revenue and receives no outside financial support, whether from foundations or the private sector. I also receive no consulting fees or other forms of remuneration for this activity.But, while the quantity has declined, its quality, in my humble opinion, has increased. I am trying to spend more time on at least one post each week, and try to feature that in my weekly emails. That involves real reporting -- reading reports, analysing data, talking to sources -- before writing my opinion column. It's not just reading the morning news and springing for the keyboard (although I do that often enough). In that sense, I like to think that my professional journalism training makes my blog read more like a health care-related version of some of the better newspaper-supported op-ed columnists, although some readers may differ with that conclusion. With that thought in mind, it is interesting to review the top health-related websites at yearend 2008. The rankings reflect the growing importance of the Internet to mainstream media outlets, and reveals the new forms of competition they are facing from non-traditional providers.The names of the top-ranked websites today won't surprise you. The New York Times heads the list, according to this ranking, closely followed by the Wall Street Journal's health blog. Many of the other top sites are also supported by newspapers, with the Newark Star-Ledger, Chicago Tribune and Los Angeles Times moving up quickly.Among the sites that have no obvious means of support, on the other hand, many seem to be adjuncts to consulting practices, businesses or professional activities. Others are academic group blogs, such as Health Care Renewal, which does a superb job unmasking conflicts of interest in medicine.Foundations are becoming major players in the health policy quadrant of the blogosphere, with the Health Affairs and the Century Foundation's HealthBeat being leading players in that space. A number of patient advocacy groups -- which are sometimes independent, but more often have corporate support for their activities -- also sponsor leading sites.As I went down the list, here's one thing I didn't find: a single website devoted to health care that, as far as I can tell, generates enough revenue to support working journalists who weren't already on the payrolls of an existing media outlet. How long can that go on?Did you know that the editorial side of the journalism business lost 20,000 jobs or nearly 1 in 12 slots in the past 21 months? My former company, the Chicago Tribune, is in bankruptcy. The New York Times is on the verge of auctioning off its building. The Detroit News has reduced its home delivery to three days a week. Non-profits like the Kaiser Family Foundation, Pro-Publica and the Center for Public Integrity are attempting to fill the gap, but their efforts pale besides the magnitude of the layoffs.Meanwhile, the Internet is filled with comments based, for the most part, on those outlets' original reporting. Or it contains comments based an ever-growing supply of barely digested press releases from organizations like Reuters Health News or synopses of medical journal articles like Health Behavior News Service. Indeed, click on the latest posts from many websites (including on my own on many days) and what you'll find is a personal opinion or observation based on something read in the press, in the medical journals, or elsewhere online. It's an endless hall of mirrors reflecting a shrinking supply of original images.I know from watching agencies like the Food and Drug Administration, the Center for Medicare and Medicaid Services, the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Centers for Disease Control and Prevention that a tremendous number of stories are going uncovered in the nation's capital. At least two or three go by each week that I wish I had time to report on and rarely see covered in the press, or even by the wire services.But they are getting covered -- by expensive newsletters and trade journals read by corporate executives, lawyers, and lobbyists who pay top dollar for this highly specialized information. The information available in those outlets is tailored to meet their needs.The conventional wisdom suggests consumers won't pay for information on the Internet. But that's not entirely true. Most newspapers screwed up by first dismissing the Internet and then giving away their product for free. The Wall Street Journal didn't make that mistake, and it has a large subscriber base. Ditto for Consumer Reports. Meanwhile, high-end newsletters, specialty publications like trade, medical and scientific journals and a handful of consumer-oriented publications are thriving by keeping their content locked behind pay-first firewalls. Look for GoozNews to launch something similar in the new year. It will contain value-added content aimed at health care professionals, policy makers, and informed consumers. It will be timely. Will people pay for well-reported point-of-view journalism? Write me at merrill@gooznews.com and let me know what you think. Posted by gooznews at 01:13 PM | permanent location | Comments (0) December 26, 2008 Who Will Have the Right to Say No? Health care pundit Ezra Klein over at The American Prospect blog has an interesting post that generated a very intelligent discussion among readers (I'm envious) that, for this reader at least, poses a crucial question: Who under any insurance system should get the ultimate right to say no to paying for any particular treatment? Should it be the patient? The doctor? The insurance company? The government? Until we have a public discussion and resolution of that question, achieving both universal health care coverage AND a health care system that the nation can afford will be impossible. Some will call it rationing. Others will call it evidence-based medicine. Others will suggest anything less than Lexus-care-for-all will create a two-tier health care system because the rich will always be able to buy the latest therapeutic "advance," even if it is still unproven.Whatever you call it, the bottom line is that someone has to make the decision. And who you think that someone should be probably says a lot about where you stand on the issue of health care reform. Posted by gooznews at 02:24 PM | permanent location | Comments (6) December 24, 2008 CBO's Conventional Wisdom For months, Peter Orszag of the Congressional Budget Office traveled the health policy circuit in the nation's capital with a bracing message: the upward arc of spending on Medicare and Medicaid was unsustainable. The only way to reduce annual health care spending growth to something approaching the rate of inflation was to embrace the idea that 30 percent of health care expenditures are wasted, and figure out ways of eliminating some, if not all, of that waste.Orszag promised that his agency would put a price tag on all promising proposals to hold down rising health care costs, thus providing a financial roadmap for lawmakers who wish to expand coverage for the uninsured without breaking the bank. It was an enticing vision. For the first time, a government economist with the power to influence the debate -- Orszag will soon take over President-elect Obama's Office of Management and Budget -- had embraced the pioneering work of Eliot Fisher, John Wennberg and their Dartmouth colleagues. For over three decades, the Dartmouth Atlas of Health had documented regional variations in Medicare spending and its lack of correlation with either health care quality or patient outcomes. The clear implication of that work was that high spending areas could be cut sharply without affecting quality.But how? Reformers have lots of ideas. Cut some of the payments to high-spending areas (as recommended in a report last week from Dartmouth and reported here on GoozNews). Establish a comparative effectiveness agency to evaluate technologies and gear payment to what works best. Create medical homes that can do a better job of managing people with multiple chronic conditions. Reward hospitals and physicians that get it right the first time, or begin penalizing errors. Build the health information technology highway to dramatically improve efficiency and eliminate errors.But after giving each of these and dozens more reform initiatives the once-over, last week's CBO health care "Budget Options" report delivered a devastating conclusion: yes, these reforms will save money. But not much, not soon, and not enough to cover the uninsured or even save Medicare from its looming confrontation with insolvency, slated for 2019 in the latest trustees report.The report laid out 115 separate options, and while its authors cautioned that adopting some would affect others, each were considered in isolation for budgetary purposes (this matters for lawmakers; when they change laws, CBO's word on what any proposal will either cost or generate is the final say for projecting future budgets). Here's what it had to say about some leading reform proposals and what impact they would have on the Medicare budget (a combined federal outlay of $431 billion in 2007).* Slash Medicare reimbursement rates across-the-board in high-spending areas and impose higher cost-sharing on beneficiaries (so they feel the pain of excessive spending): $7.4 billion a year in savings by 2014 and about that on average over the next ten years. That's not even 2 percent of Medicare spending.* Requiring Medicare docs and hospitals to embrace interoperable, computerized medical recordkeeping? Savings: $3.3 billion a year. Again, that's not even 1 percent of spending.* Establish a medical home for the chronically ill? A scant $530 million a year by 2014.* Beef up primary care using a partial capitation system instead of fee-for-service? Just $700 million in savings a year.* Pay hospitals with high readmission rates less? $1.1 billion a year.* More promising is paying hospitals a bundled rate that includes post-hospitalization acute care, which would put them in the business of managing patients after their release. While that would save just $500 million a year by 2014, it is projected to escalate in later years and would save $18.6 billion over the ten-year period covered in the report (to 2019).The biggest areas for lowering costs had nothing to do with eliminating waste. They involved lower prices, and getting rid of subsidies. So, the best way to lower hospital costs would be to turn the extra money hospitals get for treating poor patients and the uninsured into a block grant, and then letting states distribute the money to where it is most needed. Savings? $7.8 billion a year by 2014. Ditto for lowering the extra payment teaching hospitals get for training the next generation of physicians. That could save $5.6 billion a year.That latter reform would lower the number of new physicians, and the number of new specialists entering practice. If you agree with the Dartmouth analysis that says there is a close relationship between the supply of medical technology and practitioners and the amount of health care services consumed (without a noticeable impact on outcomes), this should reduce other costs, but the report did not go that extra mile and make an assumption.The report was no more hopeful about comparative effectiveness research, which gets lots of attention from the policy community because of its potential to provide better information for practitioners and thereby save money by getting them to prescribe the best care, which isn't always or even often the most expensive care. If Medicare invested $400 million a year in such research, it would actually cost the system money over the next ten years since it would take years for such research to get done, get disseminated and impact medical practice.One is tempted to point out that most advocates for a robust comparative effectiveness agency talk in terms of investing $4 to $5 billion a year in such an enterprise. I'm glad CBO didn't use these more ambitious assumptions, since, given the tenor of the report, it would have only multiplied the losses.So where will legislators find the big money in the report to close the Medicare funding gap and/or come up with cash to expand Medicare to take in more of the uninsured? (One proposal included in many reform proposals is expanding Medicare to people age 55 and older if they have no other source of insurance.) Here are the big ticket items:* Decrease fee-for-service payments in line with anticipated increases in productivity ($15.9 billion a year by 2014);* Reduce hospital payments by 1 percent a year ($7 billion);* Eliminate inflation adjustments for home health care ($5 billion):* Reduce update factor for home health care ($3.9 billion).In other words, cut, cut, cut across-the-board -- not pare away at waste.Of course, legislators could go the other way and raise taxes (fat chance in a recession). Increasing the Medicare payroll tax rate by 1 percentage point raises $67.5 billion a year. Now we're talking real money. Another option for raising taxes -- included in the skimpy prevention section -- would be to raise tobacco and alcohol excise taxes and impose a federal tax on sugar-laden drinks for the first time. There's $20 billion a year there if legislators want to take on those powerful lobbies.Even the idea that prevention will save money got short shrift from Orszag's CBO army of analysts. Most prevention measures weren't analyzed, and one of the few that was -- encouraging more flu vaccines for the elderly by penalizing doctors who don't give them to their regular patients -- saved only $160 million a year by reducing hospitalizations and other forms of acute care. And even there the CBO couldn't stop itself from turning the knife by adding that "over the long run, CBO expects that the savings from fee reductions and avoided hospitalizations would be more than offset by the combination of the direct costs of additional vaccinations and the increase in the number of Medicare beneficiaries surviving to older ages."In other words, prolonging lives will cost Medicare more money in the long run because people will be living longer and getting other diseases. You got to love the way economists think. Sadly, none of the assumptions behind the report are elucidated. There are no footnotes. I have real questions about some of the conclusions, not the least of which is the impact of comparative effectiveness analysis. Did they look at including comparative cost-effectiveness analysis? Did they consider what impact that might have if used by Medicare?As it stands, anyone spending serious time with this report can only draw one conclusion. There's not much money to be saved by reorganizing how health care gets delivered and is reimbursed. Nor is there much money in prevention. To save Medicare, it's either cut across the board or raise taxes.That's not bold new thinking. Peter Orszag's CBO has given us the conventional wisdom. Posted by gooznews at 06:10 PM | permanent location | Comments (2) Pete Stark Says to Harry and Louise: "Bring It On!" Pete Stark, the California Democrat who chairs the House Ways and Means health subcomittee, dropped by the Wall Street Journal editorial office to send a message to the health insurance industry: We're ready for you this time. “I think their intention is to see the Democrats fail, regardless of what it does for health care in this country,” he said. He wouldn't even negotiate with the industry, he told the Journal.I thought this comment from one "Bill Shea" made sense:Public relations professionals know that he or she who names an issue controls that issue. I’m convinced to this day that if in 1994 the Clintons had labeled their initiative “Insurance Company Reform” instead of “Health Care Reform,” it would have been successful. People were and are generally satisfied with the healthcare delivered by physicians and other health professionals. But insurance companies? No one really likes them, their bureaucracy and their attempts to limit/ration health care. I hope Obama and Daschle understand this and don’t make the same mistake.If Stark is a leading indicator, it looks like the main debate next year will be about insurance reform to get everyone covered. Let's hope that this long-time advocate of holding down unnecessary payments to providers will take on those special interests, too. Posted by gooznews at 12:25 PM | permanent location | Comments (0) Ezetimibe Flunks Inflammation Tests Atherosclerosis is a chronic inflammatory process, and some of the benefits of statins are thought to be related to their ability to reduce inflammation. A study by James K. Liao and colleagues published online December 15 in Circulation raises questions as to whether ezetimibe lacks these antiinflammatory effects. Statins reduce production of cholesterol in the liver by inhibiting an enzyme called HMG-CoA reductase (see figure 1 in this paper), and inhibiting this enzyme also reduces production of rho kinase, a substance that increases vascular inflammation. By contrast, ezetimibe works by reducing cholesterol absorption in the intestines. Although ezetimibe lowers LDL ("bad") cholesterol, it does not reduce production of rho kinase (and in fact may increase it). One way of measuring inflammation is by testing the brachial (upper arm) artery's ability to relax in response to increased blood flow through a test called flow mediated dilation (FMD). Low FMD is a marker for increased cardiovascular risk and an early sign of atherosclerosis. The study compared the effects of a moderate dose of a statin (40 mg. simvastatin) with a lower dose of the statin combined with ezetimibe (10 mg simvastatin/10 mg ezetimibe) on FMD and rho kinase in patients with high cholesterol. Another group of patients received a placebo. The higher dose of simvastatin and the combination of simvastatin and ezetimibe lowered LDL to a similar extent. No change in rho kinase activity or FMD was found in the placebo group or the simvastatin/ezetimibe group, but in the group that received simvastatin alone rho kinase activity was reduced and FMD increased, indicating decreased inflammation. In addition, a strong statistical association was found between changes in FMD and changes in rho kinase activity. The inhibition of rho kinase activity was statistically significant even after controlling for changes in LDL, supporting the idea that inhibition of rho kinase by statins is independent of cholesterol lowering. The authors conclude that the findings of their study may help explain the disappointing results of the ENHANCE study, in which ezetimibe did not alter the progression of atherosclerosis when added to a statin. -- Marilyn Mann Posted by gooznews at 09:03 AM | permanent location | Comments (3) December 23, 2008 Nemeroff Steps Down -- With the Money Charles Nemeroff, the Emory Universisty psychiatrist who took $800,000 in speaking fees from GlaxoSmithKline between 2000 and 2006, stepped down from his post as chairman of the psychiatry department. He will keep his job as a professor; and he will keep the money. His sin? He didn't disclose the payments to the university.According to this morning's Wall Street Journal, a university investigation into his presentations showed that his lectures were not product specific, but focused on the conditions that required drug therapy.The dean of the Emory medical school, Ron Sauder, refused to sanction Nemeroff beyond losing his chairmanship. "It was money that he rightfully earned," he told the paper.In September, David Rothman and Susan Chimonas of Columbia University's Institute on Medicine as a Profession (IMAP), reviewed the latest calls for better policing of medical ethics from groups like the American Board of Internal Medicine Foundation (ABIM) - IMAP and the American Association of Medical Colleges (AAMC). "Both (guidelines) prohibit ghostwriting and differ only on speaker's bureaus," they wrote. "The ABIM-IMAP task force prohibits these activities; the AAMC proposals 'strongly discourage' them."Emory, apparently, didn't get the memo. Posted by gooznews at 07:29 AM | permanent location | Comments (0) December 18, 2008 Report: Expand Coverage without Increasing Health Care Spending The Dartmouth Institute for Health Policy & Clinical Practice released a White Paper yesterday outlining a strategy for providing health insurance for all while curbing health care spending. Based on decades of work at Dartmouth documenting variations in the amount of care people in different parts of the U.S. get without noticeable differences in outcomes, the paper's most radical reform calls for setting premiums for any new insurance plan that covers the uninsured based on the actual cost of care in a region.Why should those living in low-cost, more efficient health care markets subsidize providers in high-cost markets, when the reasons for high costs isn't illness but inefficient care?They would include the cost of Medicare and private coverage in establishing the payment rates in a region, thus setting the stage for extending differential pricing to all health care purchasers. This reform implies taxpayers in Minnesota and upstate New York (home to the Geisinger and Mayo clinics, two of the most efficient and best health care systems in the country) would pay a lower Medicare taxes and insurance premiums than payers in New York City, Los Angeles and Miami, where seniors spend their days going from specialist to specialist in a daisy-chain of costly care that gets no better results.Why set off the firestorm of opposition sure to greet such a proposal?If the cost of medical coverage reflected differences in local and region market spending, then the problems of disorganized care, underuse, misuse, and overuse would become more transparent to local opinion leaders and decision makers . . . It would become apparent that decisions to increase capacity of acute care hospitals by building beds, buying new imaging equipment, or hiring new surgeons or other specialists would have a direct impact on local utilization, and thus the local price of insurance.Not surprisingly, the press release accompanying the report did not mention this proposal. In other recommendations that take aim at physician practice and physician education, the report called for:* Reorganizing physicians into salaried group practices like the Geisinger and Mayo clinics and Kaiser Permanente;* Requiring physicians educate patients about their choices and reward physicians through Medicare and Medicaid who engage their patients in shared decision-making;* Stop training more specialists and give current slots in graduate training programs to students who want to become primary care physicians."The U.S. does not need more physicians," the report said in a direct slap at efforts by schools trying to raise the cap on graduate medical training posts funded by Medicare. "We have enough to care for America's needs well into the future."The authors, led by John Wennberg of Dartmouth, get high marks for highlighting some of the thorniest questions in U.S. medicine, even if their more radical solutions stand about as much chance on Capitol Hill as a Hanover snowball in Miami. Their reported foreshadows a Congressional Budget Office report on the same subject that is due out today. Posted by gooznews at 09:00 AM | permanent location | Comments (0) Weighing in on the New FDA Commissioner Patient advocacy groups, most of them drug industry-funded, have asked President-elect Barack Obama to appoint a Food and Drug Administration commissioner who won't cave in to pressure from lawmakers or the news media, according to this morning's Wall Street Journal.It is news to me that the news media has much say about decisions at FDA. There are reporters who highlight problems, especially safety problems, in the nation's food and drug supply. And there are reporters who highlight every study suggesting the next miracle cure is just around the corner. Large news organizations like the New York Times have both. For every Gardiner Harris, there is a Gina Kolata. The news media are megaphones. They are not, to use someone else's phrase, the decider.Vioxx and Avandia didn't come to light because of the press or angry legislators on Capitol Hill. What consumers and patients, legislators and the press learned about the lethal side effects of those drugs was due to diligent researchers like Steve Nissen and Eric Topol and courageous whistleblowers inside the FDA like David Graham. Ditto for most of the other safety scandals that have plagued the agency in this decade.That said, patient advocates who are worried that the agency under a more safety-conscious commissioner will somehow abandon the search for faster cures should know that their views are well represented inside the transition team. Josh Sharfstein, the Baltimore health commissioner, formerly on Rep. Henry Waxman's staff, who took up cause of making pediatric cold medicines safer, may be leading the effort. But his co-conveners include Greg Simon, who heads a group called . . . da da . . . Faster Cures (not industry-funded, according to Simon). The other team leader is attorney Alta Charo from the University of Wisconsin, whose expertise is primarily in bioethics, not drug safety.I don't think I'm talking out of school by confirming that I was one of a dozen or so consumer advocates who met with the transition team last week. A memo I prepared on behalf of the Center for Science in the Public Interest will be posted on the transition team's website in short order (as per the president-elect's instructions; he wants the process totally transparent). I raised a number of concerns well beyond the narrow topic of drug safety, including several familiar to regular readers of this blog like rejoining the Helsinki Declaration on protecting human subjects in clinical trials, comparative effectiveness and biogeneric legislation. Our group didn't get special treatment. As we entered for our one-hour session, a group of patient advocates, including representatives from the National Organization on Rare Diseases (NORD) and several cancer advocacy groups, was leaving. As we departed, a phalanx of lawyers and lobbyists for Advamed, the medical device industry trade association, entered.When President Clinton took office, he left the sitting FDA commissioner -- David Kessler -- in place. He went on to become a fervent advocate of reining in the tobacco industry, even as he allowed the drug division to drift toward closer collaboration with industry. The current commissioner Andrew von Eschenbach, a faithful servant of the Bush administration with close ties to the cancer research establishment, signaled this week he will resign on inauguration day. I suspect the appointment of a new commissioner will come quickly. There's much work to be done in implementing last year's safety amendments.But the new commissioner will not have the option of being anti-industry. The drug and biotechnology industries recognize they are at a crossroads. Their blockbusters are coming off patent. The era of personalized medicine based on validated biomarkers is at hand. But as we learn more about these drugs (this week's hearing on EGFr inhibitors like Erbitux and Vectibix and how they don't work on colorectal cancer patients who have the K-RAS mutation is a case in point) means new drugs in the pipeline will be useful to ever smaller segments of the patient population.Getting the science right, so that the right drugs get to the right patients and only the right patients so that they will be affordable to the health care system as a whole, is the challenge that now confronts agency scientists and whoever becomes the next commissioner. That's not faster cures. That's smarter cures, even as the new commissioner insists that they still meet the agency's statutory hurdles for safety and efficacy.The above article was corrected from an earlier version to accurately report Alta Charo's primary area of expertise (see the comments). Posted by gooznews at 06:01 AM | permanent location | Comments (3) December 16, 2008 IOM on HHS Reform: The Drug Industry Dissents There's an intriguing sidebar to the Institute of Medicine report released last week describing how to revamp the Health and Human Services department for the 21st century (must reading for Secretary-designee Tom Daschle and White House health czar Jeanne Lambrew). Three of its key members issued a blistering dissent from its most far-reaching finding. The report said:The secretary should work with Congress to establish a capability for assessing the comparative value—including clinical and cost effectiveness—of medical interventions and procedures, preventive and treatment technologies, and methods of organizing and delivering care. The assessment of comparative value should begin by leveraging department-wide data sources in conjunction with supportive evidence from providers, payers, and health researchers.Let's underline the key elements of that paragraph:1. It calls for establishing an agency that can conduct not just comparative effectiveness studies, but cost effectiveness studies; and2. The department should use Medicare, Medicaid, and insurance industry patient outcomes data to help make those determinations, i.e., not just rely on clinical trials. Guess who took exception to those recommendations. While the committee included former HHS chiefs Donna Shalala (President Clinton), Louis Sullivan (first President Bush) and former Center for Medicare and Medicaid Services chief Mark McClellan (under the second President Bush), its roster also included attorney David Beier, chief lobbyist for Amgen; Kathleen Buto, a health policy v.p. at Johnson & Johnson; and Myrl Weinberg, president of the National Health Council, which is a large consortium of patient advocacy groups, many of whom have close ties to the pharmaceutical industry.Beier's angry dissent suggests the hyperventilating rhetoric we can expect when comparative effectiveness gets discussed in the next Congress. For instance:Foreign models of centralized government decision making should not be applied to the U.S. health care system without full consideration of the implications and associated risks.And what are those risks? In a footnote, Beier complains that cancer physicians in England, because of its comparative effectiveness agency, the National Institute for Clinical Excellence, have been slow to use some of the newer, less effective and pricier anti-cancer drugs. The result, according to Beier, is that "the UK ranked 9th out of 28 in European male cancer mortality . . . and twenty-second out of 28 in female mortality." He's some data he forgot to mention. A few years ago, a group of Japanese physicians wanted to know how their country stacked up in cancer mortality between 1960 and 2000 compared to the U.S. and three European countries: the UK, France and Italy. In leukemia, the U.S. had the highest mortality rate both at the beginning and the end of the period, even as everyone's rates -- except Japan, which increased -- stayed about the same or declined slightly.Prostate cancer? Italy held the dubious distinction of having the highest mortality rate with the U.S. in third place among the five, slightly behind the UK. The UK rate had, in fact, crept up over the four decades under study while the other nations' mortality rates stayed relatively constant (again, Japan was the outlier; its mortality rate, which still well below westerners, more than doubled over the period, which seemed to be the point of these comparison studies).Okay, how about breast cancer. The UK did have the highest rate at both the beginning and the end of the 40-year period. But its rate, as seen in this study, was only marginally higher than the other four western nations and, like the U.S., was trending down at the beginning of the 21st century. As numerous studies have pointed out, survival has been increasing all over the world through early detection programs, which increase incidence and survival in part through early identification of lumps that might not have emerged as full blown tumors in earlier eras.After complaining about cost-effectiveness payment standards as low as $50,000 per quality-adjusted year of additional life (it ought to be raised to $120,000, Beier said), the industry lobbyist ended his dissent with the warning that "rationing" is not "consistent with prevalent social values" in the U.S. The dissents from J&J and the patient advocacy front group carried similar messages.The IOM report was requested in mid-2007 by Rep. Henry Waxman and Rep. Tom Davis, the majority and minority leaders, respectively, of the House Government Oversight committee. It's not surprising that the industry representatives on the committee used their perch to assert their own interests.What I don't understand is how the IOM allowed them to serve on the committee in the first place. Doesn't it have conflict of interest rules?Be that as it may, while the committee came out with a strong call for both comparative and cost-effectiveness studies, it didn't suggest that HHS use the latter. It said only that reimbursement policy should be evidence-based, with the evidence generated by comparative analysis.At the end of the day, the committee steered clear of calling for using cost-effectiveness studies, which would empower payers like Medicare to deny coverage for high-cost, marginally useful care. Memo to lobbyists: Methinks thou doth protest too much. Posted by gooznews at 06:02 AM | permanent location | Comments (1) December 14, 2008 Biogenerics, Not Just Biosimilars The debate over a regulatory pathway for biotechnology generic drugs is shaping up and it doesn’t look good for cost-conscious patients or anyone pulling their hair out over rising health care costs.Last week, both Merck and Eli Lilly announced plans to expand their biotechnology divisions. While they are taking aim at proteins already on the market, both companies told the press that their new biotech drugs would not be generics in the traditional sense. They will be slightly modified versions of existing drugs that will be run through the full panoply of clinical effectiveness testing and sold at prices much closer to the original drug. In essence, both companies are banking that the “biosimilar” legislation that now seems destined to pass Congress next year will bring into existence a biotechnology me-too industry. That’s very different than a true generic industry, which was created by the Hatch-Waxman Act of 1984 for small-molecule drugs. Continue reading "Biogenerics, Not Just Biosimilars" Posted by gooznews at 02:39 PM | permanent location | Comments (4) December 12, 2008 Med Journals: Where Seldom Is Heard A Discouraging Word Fellow bloggers (Alison Bass, Howard Brody, Brandon Keim, and Andrew Hyde) have discussed a new study on publication bias published November 25 in PLoS Medicine. Publication bias is the tendency for some types of clinical trial results to be published more frequently or more quickly than others. Recently, Erick Turner and colleagues studied publication bias in trials of antidepressants submitted to the FDA and found that 31 percent were not published, with studies having a positive result much more likely to be published. (Merrill Goozner of the Center for Science in the Public Interest -- and proprietor of this blog site -- published a similar analysis in February 2004 on the eve of the FDA advisory committee that discussed the issue of SSRI use and suicidality in children.) According to the published literature, it appeared that 94 percent of the antidepressant trials were positive, but only 51 percent of the trials submitted to the FDA were positive.The anonymous blogger on Clinical Psychology and Psychiatry Blog discussed that study here. Publication bias can lead doctors to prescribe treatments that are less effective or less safe than indicated in the medical literature. Frequently, these treatments are also newer and more expensive than established treatments, driving up costs. In the new study, Lisa Bero and colleagues examined all efficacy trials of New Molecular Entities (NMEs) submitted to the FDA from 2001 to 2002 (NMEs are drugs containing new active ingredients not previously approved by the FDA). They found that 22 percent of the trials were still not published five years after FDA approval of the drug. Trials with favorable outcomes were 4.7 times more likely to be published, and some publications selectively omitted outcomes that had been submitted to the FDA or added other outcomes, in each case presenting the drug in a more positive light. The statistical significance of some outcomes changed, in each case in a way that favored the drug. In an accompanying editorial, An-Wen Chan states that "[i]t is clear that the trial literature is biased," and calls for public access to full clinical trial protocols and regulatory agency submissions. -- Marilyn Mann Posted by gooznews at 07:35 AM | permanent location | Comments (3) December 11, 2008 PSA Test on Trial Last August, the U.S. Preventive Services Task Force definitively declared that men over 75 should not submit to PSA prostate cancer screening. USPSTF stated the tests "provided few health benefits but led to substantial physical harms and some psychological harms in men age 75 and older."Yesterday's issue of the New England Journal of Medicine endorsed that recommendation. But how about slightly younger men? The editorial hinted that men approaching that age also might want to reconsider the wisdom of taking this test. While 6 percent of men in their 60s wind up getting biopsies because of a positive PSA test, that rises to 21 percent in their 70s.Whereas the benefits of screening attenuate with age, the harms increase. . . PSA screening roughly doubles the risk that men will have to face a diagnosis of prostate cancer over the next 10 years, but many of these cancers would never present clinically.I'm reminded of a friend who was diagnosed at 70 with prostate cancer. He ignored it, fearing impotence far more than death from cancer. A decade later, he was still going strong. Posted by gooznews at 11:50 PM | permanent location | Comments (3) Health Wonk Review Check out the best of the health care blogosphere by clicking on the e-CareManagement blog. Some very good posts this week. Posted by gooznews at 07:41 AM | permanent location | Comments (0) December 10, 2008 Nobody Told Him Who To Send The story is told about the first year of old man Richard Daley's reign on the fifth floor of Chicago City Hall. A young job aspirant had been ushered into "Da Mare's" office. Daley asked him who had suggested he come in for a job."Nobody," the jobseeker said."Nobody?" asked an incredulous Daley. He gave the kid a pat on the back, and sent him out the door. He then called in his patronage chief and gave him a tongue-lashing. "Don't send me nobody dat nobody sent," he bellowed.In an odd way, President-elect Barack Obama is partially responsible for Gov. Rod Blagoyevich becoming the next Illinois ex-governor to spend time in Joliet. Oh, he was already under investigation, and probably would have wound up there anyway.But when Obama refused to intervene in naming his successor to the vacant Senate seat, he left the decision entirely in the hands of Blagojevich, whose history as a creature of Chicago machine politics is well-known. A mere nod, a mention of a few names that would have been acceptable, and Blagojevich would have known who was the new boss in town. Ah, but these Hyde Parkers. They believe in due process and separation of powers and all that fancy stuff. So Rod was on his own. Obama could have left a loaded pistol in Blagojevich's family den. Or he could have thrown a fifth of whiskey and the car keys to his teenage son. Instead, he left a machine pol get the final call on a valuable plum. And as they say, the rest is history. Posted by gooznews at 04:37 PM | permanent location | Comments (1) Do FDA Regs Preempt Lawsuits? The following article by GoozNews contributor Marilyn Mann is reprinted from the American Bar Association health law section online newsletter:The Supreme Court will soon determine whether FDA approval of a drug’s label preempts failure-to-warn claims under state law. Because the Federal Food, Drug, and Cosmetic Act, which provides the statutory framework for the regulation of drugs by the FDA, does not contain a preemption clause, in Wyeth v. Levine the Court will decide whether preemption of state tort litigation is implied by the statute, even though it is not explicitly stated.Below I argue that state tort litigation supports, rather than impedes, effective FDA regulation of drugs and medical devices. Because the public policy arguments against preemption of state tort law are similar in the case of drugs and devices, I address both of them together below. . . Continue reading "Do FDA Regs Preempt Lawsuits?" 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