An excellent article in today’s edition of the Chicago Sun-Times on the strides we are making towards making acute diseases chronic conditions. Here’s a sample:

In the last 25 years, the death rate from heart disease has been cut in half. On another front, the number of cancer deaths recently dropped for the first time in more than 70 years. Yet heart disease and cancer together still kill more Americans than all other causes of deaths combined. Researchers are developing high-tech new treatments such as targeted cancer drugs and stem cell heart therapies.

But the best way to fight the Big Killers is to not get sick in the first place. If we all simply took better care of ourselves, experts say, we could cut the death toll from cancer and heart disease by at least 50 percent.

It’s worth a read. Here’s the link: http://www.suntimes.com/output/health/cst-nws-kill261.htm

Caroline Kovac (IBM’s Princess of Prescience) on what Big Pharma can learn from Big Blue:

“Replace the word blockbuster with mainframe and then we can talk.”

Nope, not a mixed metaphor. I just returned from Brussels where I spoke on what the Europeans call “information to patients” or “ItP” (what we heathens on this side of the Atlantic refer to as “direct to patient communications”). The event was at the Amigo Hotel. (For you trivia buffs, this hotel used to be a prison — and one of its most famous guests was Karl Marx.)

I spoke on the American experience with DTC advertising (both the pros and the problems) and my fellow panelist, James Copping, talked about how the EU is trying to figure out what to do next, since “not American-style drug advertising” is not a go-forward policy. Jim’s a player. He’s the Principal Administrator for the EU’s Enterprise and Industry Directorate-General, the body drafting the EU’s go-forward recommendations.

One interchange between Jim and me that is worth sharing:

COPPING: “We must find new ways to regulate health care information to patients.”

PITTS: “Jim, I think a better way to frame the question is to say that you need to find new ways to facilitate health care information to patients.”

COPPING: “Yes, that’s right.”

God’s speed Mr. Copping.

Here’s an exciting timely and important new paper on what antihypertensives have accomplished and what more could be accomplished if people were treated to guideline. It’s a clarion call to address our nation’s (indeed the globe’s) chronic health care problem — ignoring the urgency of focusing on chronic care.

The Impact of Antihypertensive Drugs on the Number and Risk of Death,
Stroke and Myocardial Infarction in the United States by Genia Long,
David Cutler, Ernst R. Berndt, Jimmy Royer, Andree-Anne Fournier, Alicia
Sasser, Pierre Cremieux #12096 (AG HC)

Abstract:

Estimating the value of medical innovation is a continual challenge.

In this research, we quantify the impact of antihypertensive therapy on U.S. blood pressures, risk and number of heart attacks, strokes, and deaths. We also consider the potential for further improvements.

We estimate the value of innovation using equations relating blood pressure to adverse outcomes from the Framingham Heart Study. Our results show that without antihypertensive therapy, 1999-2000 average blood pressure for the U.S. population age 40 plus would have been 10-13 percent higher. 86,000 excess premature deaths from cardiovascular disease (2001), and 833,000 hospital discharges for stroke and heart attacks (2002) would have occurred. Life expectancy would be 0.5 (men) and 0.4 (women) years lower. At guideline care, there would have been 89,000 fewer premature deaths (2001) and 420,000 fewer hospital discharges for stroke and heart attack (2002) than observed. Our analysis suggests that antihypertensive therapy has had a significant impact on cardiovascular health outcomes but that mortality gains would have been approximately twice as high if guideline care had been achieved for all.

Here’s the link:

http://papers.nber.org/papers/W12096

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.

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.

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.

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/

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

Here’s a link the the FDA’s Critical Path Opportunities Report.

Download file

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.

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.

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.