Latest Drugwonks' Blog
But the views offered on the inside were equally stimulating.
A few examples:
Elizabeth Teisberg (Professor, Darden School of Business, University of Virginia):
"Today pay-for-performance" means "pay-for-process-compliance."
Dr. J. Edward Hill (Past President, American Medical Association):
"If we believe in evidence-based medicine, then we should consider the evidence of what government run healthcare provides."
Dr. Hill also posed this interesting question, "Can we really have personalized care provided by the government?"
Dr. Michael McGinnis (Senior Scholar, Institute of Medicine):
"40% of deaths in the US are caused by the behavioral choices we make," led by lack of diet, not enough exercise -- and tobacco.
He also pointed out that "what happens at the intersections of the domains of influence" is what drives both health and care. McGinnis defined the relevant "domains of influence" as Behavioral, Genetic, Social, Environmental, and Healthcare.
There was much heated debate and audience participation -- but the most memorable comment was also one of the pithiest and it came from Dr. Hill who said, "People need to quit being complacent."
And included on that list of people needs to be doctors.
(Yes, doctors are people too.)
I asked Dr. Hill why we only hear from doctors when it's about their payment schedules. His reply was honest -- "I was afraid someone was going to ask me that question."
And that's when he offered the remark about complacency.
GERMAN BRAIN DRAIN
Sick of Bad Pay, Doctors Flee Germany
By Udo Ludwig
German doctors are packing their scalpels and seeking their fortunes abroad, lured by the prospect of far higher pay and driven away by stifling bureaucracy in their country's health service.http://www.spiegel.de/international/0,1518,399537,00.html
Where are they going? Take one guess...
"The NHS is flying in doctors from Germany to provide out of hours cover for GPs, at a cost of up to £650 a day.
The news comes a week after it was revealed that a health board hired a doctor from Italy to cover a remote practice over Christmas.
Such doctors are being used to work shifts, including holidays and weekends, that British GPs no longer have to cover following contracts introduced in 2005.
A Scottish health board is using GPs from Germany to provide out of hours care, sourced through a foreign recruitment agency.
NHS Grampian has used at least two doctors from Germany through the agency, which charges between £60 and £65 an hour for shifts that can last for up to 10 hours. Over Christmas, another Scottish health board, NHS Highland, flew Dr Annibale Bertollo from Venice to provide cover for a practice in Wester Ross for five days."
Here's wondering if Obama will praise the German health care system as a model for reforming our own....
The FDA said Thursday it will launch a two-year fellowship program for physicians, chemists, statisticians and other science professionals interested in food and drug regulation. About 30 to 40 fellows will be accepted for the first program, which begins in October. Some of those accepted are expected to stay on as full-time employees after completing the program, which includes course work and seminars.
This is crucial since the average age of the FDA's work force is 54, and about 30 percent of general staffers already are eligible to retire.
That’s why “a strong FDA” is part of the agency’s five year strategic plan.
FDA’s most proprietary and valuable resource comes through the door each morning. There are almost 1,500 people with PhDs at FDA and well over 400 with medical degrees – and that’s without double counting.
An organization that can keep up with the rapid changes in the industries that it regulates, and that is capable of developing and implementing effective and innovative public health measures, requires a very special workforce. The FDA’s mission depends more than ever on a solid cadre of experienced physicians, toxicologists, chemists, statisticians, mathematicians and other highly qualified and dedicated professionals. Their expertise is essential for making regulatory decisions that are balanced and fair and timely -- and for keeping the agency on the cutting edge of the technology and sciences used by industry.
Agency leadership must make it a priority to encourage creativity, efficiency, and superior performance - an environment that attracts and retains top-quality scientists, and enables them to do top-quality work as part of an effective team.
"Over the last decade or so, access to scientific literature has changed radically. Reading a research paper no longer requires a trip to the library, as the research journals are only a web browser away. A paper in the current edition of Science looks into whether this transformation has triggered a corresponding change in how that literature is used. Its author's statistical analysis suggests that the ready availability of scientific information has a counterintuitive result: a smaller pool of articles are referenced in the scientific literature."
Using Thompson's citation index (CI), which indexes articles and references from the 6000 most highly cited journals, and Information Today's Fulltext Sources Online (FSO), sociologist James Evans has examined what effect the availability of online articles has had on how researchers cite previous work. The combined data from CI and FSO hold over 26 million articles and an additional 8 million distinct articles that referenced them through 2006.
His conclusion?
"Fewer and fewer distinct articles were cited even as more publications could be accessed online... "
"The conclusion of all this statistical work was that, as more and more articles are readily available online, researchers, on average, cite fewer articles. The articles that are cited are newer, and fewer distinct articles receive attention. The results of the explosion of easily available articles, according to Evans, is that "researchers can more easily find prevailing opinion, they are more likely to follow it, leading to more citations referencing fewer articles." As a side effect of this, a scientific consensus will typically form more rapidly. The other side of this is that papers containing ideas that don't catch quickly will be forgotten by the scientific world much faster. "
Which stifles debate, discussion, error correction. Someone who is not careful or wishes to unduly influence medical opinion would merely have to publish a handful of articles -- bereft of previous research so as to reduce the chances for comparison -- in a handful of journals to change thinking and consolidate consensus quickly all the while evading serious scientific scrutiny. And once a rash conclusion reaches the public it is quickly disseminated -- online again-- where it whirls into common use. Meanwhile minority opinions -- even those with more solid scientific support -- can be ignored or attacked.
Sound familar? How about the vaccine-autism controversy or the Avandia or SSRI scare? I would like to see what percentage of articles are now actually original research as opposed to meta-analysis or combing through of databases which is easier and quicker to publish and which "leading publications" are more eager to run with to generate attention.
The internet can rapidly distribute new information. But not all information is new knowledge, which is information that advances understanding.
Insta-think can lead and does lead to Tabloid Medicine.
Science, 2008. DOI: 10.1126/science.1150473
Reps. John Dingell and Bart Stupak on Thursday questioned whether FDA officials knew about the potentially fraudulent information but approved Ranbaxy's products anyway.
Stupak said the Ranbaxy case "may be another example in which FDA found it inconvenient to assure the safety and effectiveness of drugs before approving them."
The Rambaxy situation is very unsettling and certainly worthy of investigation. Casting such snide unfair aspersions on the hard working career staff of the FDA is not.Mr. Stupak -- apologize now!
Take a look at the response to the allegations that Ranbaxy was hiding data from the FDA about the safety and integrity of their products. Large company is accused of willingly conspiring to evade and avoid FDA scrutiny even as it submits the "right" data and who is hauled before Congress?
FDA, the same FDA that has been lambasted for being short of staff. It is now being all but accused of conspiring with Ranbaxy.
If importation becomes a free trade zone for counterfeiters, you will see more evasion as the opportunities for profit and piracy pile up.
Don't expect Congress to take the blame for poisoning our medicine supply.
Read more here
Ron Paul videocast
Not surprisingly, he has a lot to say -- but we tried to keep him focused on healthcare.
And we were almost successful. You be the judge.
It’s surprising how much ink is being spilled over the revised PhRMA code – considering it bans free pens.
Commission’s rigorous testing helps ensure interoperability of technology
As Congress takes up the subject of health information technology, it must take great care to enable accelerated progress rather than sending the process back to the starting line.
My vision of health information technology in the
Getting health information systems in various parts of the healthcare system to work together requires the adoption of common technical standards. I’ve often compared the problem to the building of railroads. Before the railroads of the East, West, North and South could be interoperable, they all had to agree on one standard track size. A similar process is required with health IT, except that the degree of difficulty is much harder than just agreeing on a track size.
There are more than 200 developers of electronic medical record systems in the
Until three years ago, there was no process for harmonizing and coordinating the standards they used. To remedy this problem, we formed the American Health Information Community (AHIC). It has succeeded, and as time passes we are seeing an accelerating stream of solid and widely accepted health IT standards emerge.
People who buy systems need to know they are making an investment that will connect them with the rest of the medical world. Today, they can buy with confidence.
The Certification Commission for Healthcare Information Technology gives systems a rigorous testing to demonstrate interoperability. Those systems that pass the test are given CCHIT certification. When doctors buy systems with that seal, they know that they are on a pathway to interoperability. This has given many doctors the confidence to buy who were waiting before.
We have seen more progress toward interoperability in the past three years than in the previous two decades. This is because government agencies, the medical family, the insurance industry and the health IT sector are all working together collaboratively. This type of collaboration is hard and requires great effort, but it is working, and its momentum is increasing.
As Congress begins to write a health IT bill, it is critical that it be crafted in a way that does not interrupt this success by imposing government controls. Government has to be at the table as a full participant, but if the bill prescribes the way these standards are to be set, or puts in place a politically controlled process that picks winners and losers, it will devastate a healthy but fragile process and lose three years of maturity and momentum.
I would offer three principles to members of Congress in dealing with legislation:
First, let’s protect the flexibility of those who are working to invent new tools, and let’s not undermine the work on AHIC that is already underway. Writing legislation to bias the process in one direction or another will constrict innovation and slow the process.
Second, let’s not try to solve all the privacy challenges of the 21st century in a health IT bill. We have to be careful to avoid penalizing early adoption.
Third, let’s respect the need for legitimate healthcare communications. We have to find the balance here. It is in the patient’s best interest for doctors and the patient to have information.
The most important thing government can do is adopt the standards ourselves. The adoption of standards by Medicare, the Veterans Administration, the Department of Defense, and Indian Health, is critical.
We’re making progress on health information technology. Let’s make sure that any legislation accelerates the progress already under way, rather than chilling it with requirements that the government dictate one-size-fits-all answers.
Now here's a healthcare story that deserves to be on Page One.
Hepatitis C, investigators report that they have developed the first tissue culture of regular human liver cells that can imitate infections with the hepatitis C virus (HCV).
"This is the first efficient and consistent model system for HCV to be developed," Martina Buck, assistant professor of medicine at the University of California, San Diego, School of Medicine, who developed the culture, said in a university news release. "There is a need for new treatments, and for development of a possible vaccine for HCV. Now we have a model system to support work by investigators in this area."
Some 170 million people worldwide are infected with hepatitis C, which affects the liver. In the
The virus is usually transmitted by sharing intravenous drug needles and through sexual contact.
Right now, there is no animal model to test different therapies, according to background information in a paper published in the July 16 issue of PLoS ONE.
The therapy can also cause severe flu-like symptoms.
Researchers have so far been hampered in their efforts to understand HCV, because it hasn't been possible to infect normal human liver cells in a laboratory setting.
The new culture allows scientists to directly infect cells with virus from the blood of HCV-infected patients.
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.
