Latest Drugwonks' Blog
The former is interesting and unquestionably telegenic -- but the latter is highly qualified and, as it happens, the current Acting Surgeon General and a career United States Public Health Service officer.
Prior to his appointment as Acting Surgeon General, Steve Galson served as the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). As the director, RADM Galson oversaw CDER’s broad national and international programs in pharmaceutical regulation and provided leadership for 2300 physicians, statisticians, chemists, pharmacologists and other scientists, as well as administrators whose work promoted and protected public health by ensuring that safe and effective drugs are available to the American public.
RADM Galson began his Public Health Service career as an epidemiological investigator at the Centers for Disease Control after completing a residency in internal medicine at the Hospitals of the Medical College of Pennsylvania. He has held senior-level positions at the Environmental Protection Agency, the Department of Energy where he was the Chief Medical Officer, and the Department of Health and Human Services.
RADM Galson received his Baccalaureate Degree from Stony Brook University in 1978, an M.D. from the Mt. Sinai School of Medicine in 1983, and a M.P.H. from the Harvard School of Public Health in 1990. He is Board Certified in General Preventive Medicine and Public Health as well as in Occupational Medicine.
RADM Galson is the recipient of numerous PHS awards, the Robert Brutsche Award from the Commissioned Officers Association of the USPHS and the Founders Award from the Association of Military Surgeons of the US. He is also the recipient of three Secretary of Energy Gold Awards.SG for SG. And make that Steve Galson.
Late last year we interviewed Representative Tom Price (R, GA) on his vision for 21st century healthcare reform. The full video interview can be found be clicking here and then (in the "Newsmakers" section) on the bespeckled gentleman in shirtsleeves and red tie. Price's opinions are all the more germane since he is both the new chairman of the Republican Study Committee and one of the few MDs serving in Congress.
Here’s what Dr. Price had to say in today’s Wall Street Journal:
The GOP Should Fight Health-Care Rationing:
Perhaps the greatest missed opportunity of the past eight years was the chance for Republicans to fundamentally reform the terribly broken American health-care system. Access to quality health care has long been a professed priority, yet Republicans have been reluctant to tackle the issue.
As a physician, this is deeply disappointing to me because patient-centered health care is, at its core, conservative. Health care is fundamentally a personal relationship between patients and doctors. To honor this relationship -- consistent with Republican ideals -- our goal should be to provide a system that allows access to affordable, quality health care for all Americans, in a way that ensures medical decisions are made in doctors' offices, not
Republican unwillingness to address the issue, however, has left us facing an emboldened Democratic Party well equipped to push a government-centered health-care agenda. While Democrats are still dangerously misguided in their policies, this time they are prepared to avoid the political mistakes of the
For a preview, look no further than "What We Can Do About the Health-Care Crisis," a book published this year by former Sen. Tom Daschle, President-elect Barack Obama's choice for secretary of Health and Human Services. Atop the list of worrisome ideas proposed by Mr. Daschle is the creation of an innocently termed "Federal Health Advisory Board."
This board would offer recommendations to private insurers and create a single standard of care for all public programs, including which procedures doctors may perform, which drugs patients may take, and how many diagnostic machines hospitals really need. As with Medicare, for any care provided outside the board's guidelines, patients and physicians would not be reimbursed.
Mr. Daschle is quick to note the board's standards would serve only as a suggestion to the private market. Yet to ensure that there are no rogue private insurers, he has proposed making the employer tax deduction for providing health insurance dependent on compliance with the board's standards. In an overtly political ruse, Democrats will claim they are dictating nothing to private providers, while whipping noncompliant insurers in place through the tax code.
To be sure, this strategy seeks to eliminate private providers completely. Forced into accepting rigid
If we fail to recognize the scope and scale of Democratic ambition on this issue, we will find ourselves with a permanent
First, we must fundamentally reform the tax code so that it makes sense for all people to have health insurance. This may be readily accomplished through the adoption of tax equity for the purchase of insurance, active pooling mechanisms for increased purchasing power, and focused use of tax deductions and credits. Through positive changes in the tax code we can make health-care cost effective and create incentives so there is no reason to be uninsured. This way, care is purchased without government interference between you and your doctor.
Secondly, we must transform our health-care model to one that is owned and controlled by patients. Currently, most Americans receive coverage through a third party, leaving health-care decisions to an employer or the government. By creating a new system in which Americans are provided the opportunity to purchase whichever health-coverage product fits their personal needs, insurers would be forced to focus on patients. Not until patients truly own their own health plans will we see the accountability and flexibility needed to ensure quality care and necessary cost-lowering efficiencies.
A historic debate about American health care is ast approaching. We are not doomed to a Washington-run bureaucratic health-care system, so long as Republicans push for the right remedy for health care and return to being the party of solutions.
MADRID, Spain - Actor Tom Cruise said Scientology teachings helped him overcome childhood dyslexia, a Spanish magazine reported.
"Cruise was quoted by Spanish magazine XL Semanal as saying he was diagnosed with the learning disability when he was 7 years old.
Cruise said he was often anxious, frustrated and bored as a youth and couldn't concentrate in class, the magazine reported on its Web site Sunday.
The magazine quoted Cruise as saying he was functionally illiterate when he graduated from school in 1980, but learned to read perfectly as an adult through Scientology technology.
XL Semanal said the interview was conducted in Los Angeles, but did not say when. A transcript of Cruise's original comments in English was not available.
The Church of Scientology was established in 1945 by science-fiction writer L. Ron Hubbard, and claims 10 million members around the world. Cruise and fellow actor John Travolta among its more famed followers."
A functional illiterate joins "religion" that believes aliens inhabit our bodies that can cure most brain diseases.
Meanwhile, diet tips from Gwyneth Paltrow. Do NOT try this at home or on Yom Kippur:
Gwyneth Paltrow: How I'm Losing Those Holiday Pounds
By Us Magazine January 5, 2009"I need to lose a few pounds of holiday excess. Anyone else?" she says. "I like to do fasts and detoxes a couple of times during the year, the most hardcore one being the Master Cleanse I did last spring. It was not what you would characterize as pretty. Or easy."
See how Gwyneth Paltrow's style has changed over the years.
So she is not stuck subsisting solely on lemon water this winter, she has asked her doctor, a detox diet specialist, for the guidelines he uses to achieve a good detox that is not as hallucinogenic.
"What it came down to was this: you can detox easily and effectively while you continue to eat as long as you are cutting out the foods and other substances that interfere with the detoxification process," Paltrow writes.
See photos of famous weight winners.
She is cutting out dairy, grains with gluten, meat, shellfish, anything processed (including all soy products), fatty nuts, nightshades (potatoes, tomatoes, peppers and eggplant), condiments, sugar and alcohol, caffeine or soda.
Instead, her diet will consist of salads, fruit smoothies, chicken, soups and lots of water.
Sounds non-hallucinogenic to me. I am sure the doctor is following the DeTox Doc Society practice guidelines.
Here's Sir Alan's most recent contribution:
Time for NICE to lower its cut-off price?
A leading health economist has suggested that NICE’s new year’s resolutions should include lowering the cut-off threshold for new drugs from £30,000 per quality adjusted life year gained to £20,000.
Professor Alan Maynard’s suggestion comes in the wake of the recent re-announcement of the Government’s response to the Richards Review on drug top-ups, which has suggested that for end-of-life rarer conditions such as cancer, the cut-off threshold should be raised to £70,000 / QALY.
Professor Maynard, whose OBE was announced in the New Year Honours list, also points to findings from a House of Comons Health Select Committee report that the Scottish Medicines Consortium, which reviews new technologies within six months, has reached “remarkably similar conclusions” to those on NICE, and proposes that this duplication is wasteful.
Discriminating against those not near the end of life
Maynard also argues that the £70,000 threshold for people with rarer end-of-life illnesses represents “an arbitrary equity value judgment (which) is inherently unfair for those not in the last two years of life”.
He also emphasises that NICE has much work to do in removing from use existing technologies already adopted in the NHS that are not demonstrably cost-effective. Writing on Health Policy Insight, Maynard suggests that the current recession’s inevitable effect on NHS funding “requires NICE to pay much more attention to marginal technologies already being used in the NHS, as their elimination will free resources to provide better patient care”.
Maynard also suggests that NICE should work “much harder to acquire a price setting role” – a radical proposal, given the existing barrage of negative publicity NICE has faced over its refusals to approve products for NHS use.
Hmm. If 70,000 pounds is arbitrary, then so is 20,000. And so is the judgment that the recession's inevitable effect on NHS should lead NICE to use even older and cheaper technologies and ration new ones further. Sir Alan as a hospital administrator? I'd bring my own food if I had to go inpatient at York Hospital. Come to think of it, what are the mortality rates there?
The fact is, NHS has a 3 million pound surplus attained in the same way NICE and NHS have rationed technologies. At the same time rates of chronic illness are rising and death rates from cancer are the highest in the Western world.
And here in America, comparative effectiveness is being offered as a tool to solving the innovation "problem." In reality, comparative effectiveness is just an arbitrary judgment made by government about who should get what and when.
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No, really.
Susan Dentzer (editor-in-chief of Health Affairs and an on-air analyst on health policy for the NewsHour with Jim Lehrer) has an excellent and timely Perspective piece in the January 1 edition of the New England Journal of Medicine, “Communicating Medical News — Pitfalls of Health Care Journalism.”
“Whether they realize it or not, journalists reporting on health care developments deliver public health messages that can influence the behavior of clinicians and patients. Often these messages are delivered effectively by seasoned reporters who perform thoughtfully even in the face of breaking news and tight deadlines. But all too frequently, what is conveyed about health by many other journalists is wrong or misleading.”
“Consider news reports on the findings of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, reported in March 2006. The STAR*D study was a complicated trial designed to test treatment approaches for seriously depressed patients who weren't helped by taking one antidepressant. The results showed that 50% of patients had improvement after pursuing additional treatment steps, such as switching or adding medications, taking a higher dose, undergoing cognitive therapy, or some combination of these. Arguably, for people with serious long-term depression, this was hopeful news. Yet on March 23, 2006, the Washington Post ran a story whose lead paragraph framed the study as a failure because half the patients had no improvement: ‘Antidepressants fail to cure the symptoms of major depression in half of all patients with the disease even if they receive the best possible care, according to a definitive government study released yesterday.’ Apparently, simply noting that half got better and half did not was not deemed sufficiently new or interesting.”
The full article can be found here.
It will also be a boon to China’s pharmaceutical manufacturing industry. Oh well, at least we know that quality won’t be a problem.
The new Chinese law is based on TRIPS – and is the latest example of how international organizations are wrecking havoc with the keystone of medical innovation – intellectual property rights.
It should also serve as a potent reminder that Secretary of State-Designate Hillary Clinton will indeed have an important role in healthcare reform – albeit of an international nature. And the implications for continued U.S. support of intellectual property rights could be profound.
Many in healthcare policy land were pleased that Senator Clinton was tapped by President-Elect Obama to head the State Department because it would (in the words of more than a few) “get her out of the healthcare reform debate.”
Not so fast.
By moving into the corner office at Foggy Bottom, Mrs. Clinton will be a force majeure in global healthcare issues by dint of her ability to appoint and otherwise influence the United States delegations to the many Geneva-based organizations that address issues such as compulsory licensing (the World Trade Organization) and access to healthcare issues (the World Health Organization).
The U.S. has long been a bulwark in support of global intellectual property rights – and Mrs. Clinton should be questioned about her views on this and related issues during her upcoming Senate confirmation hearing.
By Michael Kahn
LONDON (Reuters) - Many genes linked to various cancers do not appear to raise the risk of getting cancer after all, according to an analysis of hundreds of studies published on Tuesday.
The findings highlight the need to exercise caution over the increasing number of studies associating common genetic variations with a range of diseases, said John Ioannidis of the University of Ioannina School of Medicine in Greece.
"The whole thing about genetic variations and links to diseases like cancer are very exciting, but the general public should be quite cautious about jumping to the conclusion that if they have a change in one gene or another they are doomed," Ioannidis, who led the study, said in a telephone interview.
"Genetic effects are very complex and very subtle and we need to know a lot more before we can make strong recommendations based on genetic profiles."
Ioannidis said his team had looked only at common genetic changes or polymorphisms, not at rare mutations, which in genes such as BRCA1 and BRCA2 significantly raise breast cancer risk. The rare form of these variants, for example, accounts for an estimated 5 to 10 percent of breast cancers.
Since early 2007, variations at more than 100 places on the genome have been linked to diabetes, heart disease and certain cancers.
The problem, researchers say, is that many of these genes typically interact in a complicated manner and their ultimate effects are influenced by the environment -- diet, exercise, smoking and other behavior -- in often poorly understood ways.
Ioannidis and his colleague Paolo Vineis of Imperial College London analyzed hundreds of published studies linking genetic changes to different cancers. They found that, out of 240 associations between a specific mutation and a cancer, only two genes involved in DNA repair and tied to lung cancer -- XRCC1 and ERCC2 -- turned out to be strong candidates for such a link.
"Most of the associations had weak or modest credibility," he said. That included PARP1 for breast cancer and CCND1 for head and neck tumors.
The problem is that on their own, the earlier studies fail to provide a complete picture and run the risk of drawing conclusions from too limited an amount of data, Ioannidis said.
This does not mean studies linking genes to cancer and the risk of other diseases have completely missed the mark, but rather that it takes a mountain of evidence to reach strong conclusions when it comes to the human genome, he added.
"Our study shows that it really takes a lot of research effort and many, many studies to be able to pinpoint a couple of associations," Ioannidis said.
(Reporting by Michael Kahn; editing by Maggie Fox and Tim Pearce)
Those who seek to establish a moral equivalence between Israel and it's enemies, particularly journalists, lack both conscience and context.