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New state-by-state fact sheets are now available at the Medicare Rx Education Network website.
Here’s the link:
http://www.medicarerxeducation.org/statefacts.htm
According to Canadian law enforcement authorities, the Hell’s Angels used their Canada-wide connections to supply a major drug trafficking network that operated in the lower Laurentians. Police seized 49 kilograms of cocaine and smaller quantities of hashish and marijuana. They also found more than 136,000 Viagra pills. Other people are still being sought on warrants in the on-going investigation, dubbed Project Piranha.
I’m blogging to you from the Arizona State University conference, “Transforming American Healthcare Over the Next Decade.” Organized by ASU, the C-Path Institute (led by CMPI board member Dr. Ray Woosley) and CMPI — this event brings together many of the leading thinkers on 21st century medicine.
Here are a few snippets:
The Second Hundred Years
“When you compare what’s available today versus 100 years ago you have to wonder whether we’re not spending enough on health care.” (Senator Jon Kyl, R, AZ)
T.S. Eliot and the Critical Path
“We must transcend mindless empiricism. Today medicine is still an empirical science. We still approach it as a one-size-fits-all situation. T.S. Eliot wrote that ‘Hell is the place where nothing connects.’ We must confront the unacceptable cost of an unconnected healthcare system.” (George Poste, MD, The Biodesign Institute, ASU)
Do not take this medication if you operate heavy machinery or are African-American
“The Critical Path will lead to advances such as gene or haplotype specific labeling as well as ethnopharmacology.” (George Poste, MD)
The Problem in a Snapshot
“Are today’s pharmaceuticals the Kodak film of the Digital Age?” (Ray Woosley, MD)
An Alliterative Illustration
“21st century medicine must be patient-centric, proactive, preventive, and predictive.” (Caroline Kovac, IBM)
And in case you don’t think regulators have a sense of humor
“Relative to polymorphic metabolism, slow metabolizers are cheap dates for their healthcare providers.” (Janet Woodcock, MD, FDA Deputy Commissioner and COO)
Well, so much for me-tooism. The ineffable LA Times, which actually does get things right occasionally, reports today the finding of a major government study “that at least a quarter of clinically depressed patients who failed to achieve a complete remission with one antidepressant succeeded by adding a drug or by switching drugs.”
Whoda thunk it? After all, did the Great Marcia Angell—-physician, economist, courageous siren with respect to The Truth About the Drug Companies—-not solemnly inform us awhile back that only two or three drugs in any given class are needed, and that further research and development investment in given classes is a social waste? And that the evil pharmaceutical producers are interested in profits and little else? And that advertising—-the provision of information—-is wasteful, and the the drug market simply does not work in some sense, ad infinitum? Well, yes, indeed she did. And indeed did she get virtually everything wrong in her silly book. Such are the fruits of economic analysis conducted by noneconomists with an ax to grind.
The LA Times published this latest report in the Science and Medicine section; Marcia’s “findings” were trumpeted on the front page, above the fold. But progress is to be welcomed.
Read More & Comment...I will be writing about this issue in far greater depth soon, but there seems to be a view in Beltwayland, among the suburbs of which are the NY Times and the LA Times, that drug prices ought in some sense to reflect “costs,” however defined, and that efforts by the pharmaceutical producers to establish prices for new drugs in accordance with their higher economic (or medical) value is illegitimate.
Well. Let us recognize that politics by its very nature is the art of wealth redistribution, always and everywhere, and so discussions of drug prices must proceed with that context firmly in mind. Drug development is a process of iterative investment, research, and testing; that process must appeal to the capital market (investors) in order to be viable, that is, expected returns (adjusted for risk) must justify the prospective costs of the development process for any given project. If prices reflect only costs and not value, investment streams will be reduced from levels that would prevail otherwise; and that means automatically that the future supply of new and improved medicines will be lower than in the alternative.
And so the preference for cost-based drug pricing on the part of those utterly compassionate with other people’s money in the end boils down to the argument that future patients ought to subsidize current ones. It is only a coincidence, of course, that it is the current patients who vote; thus does the wealth redistribution dynamic emerge yet again. And yet again the highminded compassion of the elites proves as phony as it is in so very many other contexts, except that a reduction in the supply of drugs means more future suffering and higher medical costs overall. Such are the outcomes yielded by the nostrums of the unthinking.
Read More & Comment...Apparently Consumers Union thinks that we should pay higher, not lower, hospital and doctor bills to prop up failing hospitals and subsidize charity care. At least that’s the rationale for the so-called consumer group which publishes price and quality ratings stereos and cars and supports price controls on prescription drugs for opposing the trend towards publishing the prices of doctor and hospital services. See healthgrades.com for examples. Bill Vaughn who publishes Consumer Reports, the ratings guides said that ” if enough patients choose less expensive hospitals, other facilities could have trouble caring for patients who cannot pay for services, which “would further break up the social safety net.” Or the more competitive hospitals would be able to care for more patients. Or perhaps the entire system would respond to consumer demand and begin to actuallly prevent disease before it starts rather than treat it after it happens using the newer medicines whose prices Consumer Union wants government to lower. In otherwords, Consumer Union wants government to limit the freedom of people to choose the best price for hospital and physician care and to drive down the price of new medicines artificially through price controls.
Read More & Comment...Ten years ago, few people predicted the impact of the Internet or the cell phone. Today the digital revolution has transformed the way we work, live and learn. Information is being turned into knowledge literally at the speed of light. Today, we are on the verge of another revolution that will dramatically change the way we live and how well we live.
So why aren’t people paying attention?
Over the next decade, researchers will use genomics to develop many more disease-specific drugs and diagnostics to predict who will respond best and who needs a medicine most than ever before. And medical information will be used to discover the best way to care for people based upon their unique genetic and individual circumstances.
So why doesn’t the media write about it more (or more enthusiastically)?
Drug, biotech and diagnostic firms are already gathering genetic information on patients taking part in clinical trials. New technological tools are currently available or under development that will help achieve this vision. The real concern, for industry and society alike, is not that technology will not advance, but that the technology itself will not be fully used.
So why isn’t government doing something to help FDA facilitate and advance the public health?
Last week the FDA announced the next phase of the Critical Path project — and in great detail. Unfortunately the announcement was largely ignored by the media, assorted thought-leaders, and our elected representatives.
We here at drugwonks.com will do our best to fill in the blanks, but we’d certainly appreciate some assistance from the MSM
Well, not really. But I did enjoy my 12 minute live segment on last night’s NewsHour with Jim Lehrer. Ray Suarez interviewed me and Dr. Alistair Wood on the future of the FDA. We talked about Andy von Eschenbach and Critical Path, and personalized medicine, and the fact that if we want the FDA to do more we need to make sure the agency is properly funded. And, yes, we also touched on Plan B.
Here’s a link to the audio archive: http://www.pbs.org/newshour/newshour_index.html
And here’s the video clip (“FDA Under Fire”): http://www.pbs.org/newshour/video/
Read More & Comment...Interesting article by Anna Mathews in today’s edition of the Wall Street Journal on how the FDA approaches the regulation of prescription drug product names.
Here’s a sample …
“The FDA’s scrutiny, an odd corner of the federal bureaucracy where language meets safety, is a growing problem for drug companies. They spend as much as $1 million per product making up, checking and registering words like Lipitor, Prozac and Zyprexa. In the 2004 fiscal year, the agency’s name-safety reviewers turned down 123, or 36%, of the proposed names they received. That was up from 90, or 29%, the year before, and 86, or 31%, in 2002. The rejection rate now may be even higher. The FDA recently toughened its procedure by requiring that possible names be checked against overseas brands because of concerns about U.S. drugs that have names identical to some used abroad, but very different uses.”
“To find out whether a drug works, a manufacturer runs studies, with the guidance of the FDA. The agency then decides whether the product merits approval. With a proposed name, the agency does its own internal tests to see whether the name is likely to be confused with that of an existing drug. The tests involve writing the names on mock prescriptions to check how they would look in real-world conditions, conducting Web searches and using a proprietary software program that the agency has never released.”
The full story (and it is worth reading) can be found at: http://online.wsj.com/article/SB114255589999700763.html
Yesterday I spent a lot of time talking to reporters about why I believe Andy von Eschenbach will make a terrific FDA Commissioner. Today all the news is about Plan B. And while that’s certainly relevant, what about some background on AvE? Isn’t that important information for the public to know? Doesn’t the media have a responsibility to report it?
Guess not. Too bad. We will.
Read More & Comment...It’s official. President Bush nominates Andy.
It’s news today — even though DrugWonks reported it last week.
But whatever — it’s the right choice.
Read More & Comment...Bob Goldberg calls it like he sees it …
Last week, according to Fox News, South Carolina Senator Lindsay Graham urged GOP activists to make sure the party returns to its roots before Election Day. “We’re not going to win by being Democrats,” he said “Conservatism sells.”
Does being a conservative include voting to place the pharmaceutical and biotechnology industry under the the same government controls that exist in Canada and the United Kingdom? The same controls that have destroyed innovation and delayed access to new medicines in Germany? How does Graham’s flirtation with command and control health care square with his desire to ensure the party returns to its roots? Or does he mean pushing conservative principles six feet under?
Bob Goldberg has his mind in the toilet as well …
The last time I checked Costco did not control 60 percent of the toilet paper market and therefore did not, as a matter of course tell people to use the Kirkland (that’s the Costco house brand for you outsiders) before stepping up to the Charmin two-ply plush. And by the way, if you don’t like Costco’s limited selection of items for each type of good, you can go to Walmart or Target or Kohl’s or any number of department stores, etc.
This is not about price. This is all about choice and value. And the fact is there is not one example, not one, of a government system “negotiating” drug prices where access to medicines are not delayed or denied and where the total cost of treating disease does not balloon as a result and where people do not die waiting for important drugs. THEY are the ones making this about saving money. Let’s make this a battle about saving lives now and in the future.
According to a story running on the AP wire today, “Spending on brand advertising is flat while disease awareness campaigns are flourishing. The look of the ads are more straightforward; doctors bluntly describing products is becoming de rigueur.”
Read that out loud. That’s the sound of voluntary guidelines working.
The AP continues, “The possibility of more government regulation looms. Late last year, the Food and Drug Administration held two days of public hearings on drug advertising and is now reviewing comments on the subject. The FDA said it is too early to say whether any new rules will be instituted, but some say it is likely.”
Well, I was there (in fact, I testified) and the message from the senior management of the FDA who sat on the panel was NOT that new rules would be instituted, but rather that the agency and industry need to work together to make direct-to-consumer communications better.
And that’s a good thing.
For the growing chorus of politicians who think that Medicare Part D should look more like the benefits offered by the VA, consider the following …
(1) A study by Professor Frank Lichtenberg of Columbia University found that the majority of the VA National Formulary’s drugs are more than 8 years old, with just 19% of its prescription drugs approved since 2000 and 38% of prescription drugs approved between 1990-2000.
(2) The VA imposes an automatic one-year hold on most new medicines while it “studies” the effects.” For many important medicines such as Gleevec for stomach cancer or drugs for mental illness, patients must “fail first” on a cheaper drug before they get a breakthrough.
(3) Lichtenberg found that veterans’ life expectancy increased significantly before the National Formulary was introduced (between 1991-1997)) but did not increase and may have declined after the National Formulary was introduced (between 1997-2002). Yet, the life expectancy of all U.S. males increased both before and after 1997.
Remember the character-assasination job that Alicia Munday did awhile back in the Seattle Times? Well here’s what one of their own editorial writers had to say about it. And all I can add is “well done!”
Our Man at the F.D.A.
The Times’ page one story on Scott Gottlieb, the Wall Street analyst hired by the Food and Drug Administration is an editorializing story — a story with a message. We can tell the story straight — and our reporter, Alicia Mundy, tells it pretty straight, but the premise of it, the definition of it as a story, carries a message of the fox guarding the henhouse or “regulatory capture,” meaning an industry influencing its regulator.
Our reporter has put in a resume of Mr. Gottlieb, and so we can have a rough measure of his attachments to Wall Street. He ran a Forbes investment newsletter for about half a year, also participating as a policy guy at the American Enterprise Institute, a right-of-center policy shop. He has previously worked for the FDA in medical policy under the Bush administration. He has worked for George Gilder, who writes about investments and policy from a pro-technology view. He has been a medical internist at a hospital. In the Clinton years he wrote for the Journal of the American Medical Association and worked in the investment firm Alex. Brown. His degree is in economics.
My question is: For a policy job, would it have been preferable to hire a person who had been in the bureaucracy for an entire career? Certainly there are people like that, and probably lots at the FDA. Probably the lifetime regulators are more pro-regulation than Mr. Gottlieb will be. The unspoken assumption of this story is that that’s what the public should want.
It’s not what I want. I want innovation, I want information, and I want choice. I want new drugs to be tested and reviewed, but I don’t want the system to be so safety-conscious that I can’t get the drugs I need. The fact is, people are suffering and dying now. New medicines may be able to help them. If you insist on a drug-approval system of near-zero risk, you delay the new medicines and more people suffer and die. You can die from taking a drug that should have been studied longer and you can die from not getting a drug that should have been approved earlier.
There is also the question of whether people who are sick should be allowed to make these choices themselves. If you have cancer, and it’s going to take five years to review a new drug to a zero-risk standard, maybe you don’t want to wait five years. Maybe you want the drug now. I think the system should allow that — and (judging from one newspaper article) Mr. Gottlieb is more likely to consider that point of view than someone who has been a regulator all his adult life.
Bruce Ramsey, Editorial Writer, The Seattle Times
I’ll be speaking in Brussels on how Europe can begin to embrace and then help to educate the empowered 21st century health care consumer. Here’s more information …
The Amigo Society invites you to discuss:
“Consumers and Health Information: Is knowledge really power?”
Featuring:
Peter J. Pitts
Former Associate Commissioner
Food and Drug Administration (USA)
Commentators:
James Copping,
European Commission
(High Level Pharmaceutical Forum)
Colin Webb
Vice-President, European Patients’ Forum
A recent consumer survey in Europe asked people in eight old and new EU member countries what reforms would most likely increase their quality of care. In every nation, by a large margin, “giving patients more information about their illness” was the preferred solution.
Health care education is the consumer’s Rosetta Stone. Public policy institutes, pharmaceutical companies, health care professionals and patient advocates, along with government must be allied in the drive to deliver information to patients, for it is, ultimately, about saving lives and saving our health care systems. Moreover, increasing information to patients will improve disease awareness and aid in defeating patient non-compliance estimated to cost billions of euros a year in increased emergency room visits, unnecessary surgeries, expensive hospital stays, and lost productivity.
To debate and discuss the value of these arguments, please join us on:
Tuesday 21 March 2006
7-8:30 pm (cocktails to follow)
Hotel Amigo, Rue de l’Amigo 1-3, Brussels
To RSVP visit
http://www.stockholm-network.org/conferences/events/signup.php
Bob Goldberg asks a tough question …
Is it suprising that the return of the MS drug Tysabri was scarcely covered by the mainstream media or that Senator Charles Grassley — who just a week ago was red-faced about the dangers of ADHD drugs — did not hail the fact that a drug demonstrably effective for so many patients was once again available? Media coverage of the withdrawal of Tysabri outweighed the coverage of it’s return by 6-1… and while the articles about the horrors of the drug ran on and on and were on the front page of major papers, those about the FDA advisory panel recommending that it be brought back to market were under a paragraph and tucked into the back of the business section. The New York Times and the Boston Globe were notable and laudatory exceptions to this trend. Shame on the Wall Street Journal for sensationalizing the withdrawal and then consigning its return to a few sentences a year later. “Hate the drug companies” bias persists.
This bias harms patient health and amounts to fear mongering on the part of the media. When editors decide that the return of life enhancing drug is less important than it’s removal from the market — that a public has less of a right to know about the former than the latter — then the legitimacy of the media as an arbiter of what is in the public interest should be openly and vociferously debated. And so should the judgement of the politicians that see the media as their platform.
On February 23, Bob Goldberg blogged on the half-truths Liberally sprinkled throughout a report issued by the Democrat minority staff of the House Government Reform Committee. Dr. Goldberg’s argument was based 100% on fact. The report by the minority staff was based on politics, sound bites, and fuzzy math. As my grandmother used to say, a half truth is a whole lie.
Now it seems that Democrats in Congress are taking the same half-truth strategy, customizing its fallacies to fit local constituencies and taking it on the road. Consider the case of Northern California.
Here’s how the San Francisco Chronicle reported it …
Bay Area Democrats in Congress released a survey earlier this week concluding that prices for 10 top-selling drugs purchased through Medicare were higher than those paid by Canadian consumers or Costco customers … For its part, the study by Bay Area Democrats found the average costs of 10 common brand-name drugs offered by 10 plans in the Bay Area were 75 percent higher than prices negotiated by the federal government for agencies such as the Veterans’ Administration, 60 percent higher than prices in Canada, nearly 5 percent higher than prices available online through Drugstore.com and almost 2 percent higher than those at warehouse club retailer Costco.
Yep — it’s the exact same story that ran in the national press in late February. How soon the media forgets. And I fear it is selective memory loss.
So let me repeat what Bob said only a few short weeks ago — the Bay Area Dems deliberately omitted drug plans that allow patients to pay a fixed low price for all the drugs they survey. There are many drug plans that allow consumers to pay $30 for a month’s supply of each drug (or $25 a month if purchased through mail order). All these prices are substantially lower than any of the average prices cited by the Democrat staff. Not decimal dust.
Maybe we should call these representatives the new Bay City Rollers.
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