Agree or disagree, the FierceHealthcare/pharma/biotech dailies and their editors do the some of the best reporting and analysis anywhere. I love their editorials and commentary -- especially when I don't agree or am introduced to a new trend -- because they force a careful rethinking and readjusting based on facts, events and insights on health care and science. I learn a lot.

Case in point, Anne Zeiger's commentary on Wal-Mart's movement into health care. Zieger called this trend months ahead of everyone and her coverage is the most comprehensive insightful of anyone writing about this stuff.

"About a year ago I suggested, half tongue-in-cheek, that Wal-Mart might want to go into the business of providing healthcare services. The idea remains intriguing to me, particularly as Wal-Mart ramps up its retail clinics and cheap meds initiative.

As you probably know (if you haven't been under a rock for a year or two), Wal-Mart has rolled out a program under which it offers hundreds of commonly-used generic drugs for a flat $4 per prescription. The program has sparked copycat programs from rival retailers, generated a lot of talk and probably saved some patients some bucks. This week, it's extending the program to cover new types of drugs (such as an ADHD med), and what's more, has established a $9 tier which will allow it to broaden its offerings.

To me, this has implications well beyond the retail pharmacy sector. Not only will such moves continue to push business into the Wal-Mart pharmacies, they could indirectly support the retail clinic businesses emerging in its stores over the next few years. With price-conscious consumers already hitting the stores for retail healthcare, getting cheap medication makes a lot of sense.

What I'm getting at, here, is that offering cheap meds is likely to be followed by other strategies that cement Wal-Mart's position as an outpatient healthcare destination, such as clinical testing. Future enhancements could even include non-retail activities--probably, in partnership with local hospitals--such as community healthcare education programs or blood pressure screenings.

I admit I could be reading this all wrong, and that all Wal-Mart cares about is to generate more transactions for its core retail businesses. But when you consider that it's planning to launch 2,000 retail clinics in coming years, maybe the idea of Wal-Mart as provider isn't such a wacky notion. Sure, Wal-Mart has no experience offering healthcare services today, but somehow, I doubt that will stop 'em."

(Thanks Anne. And think transfusions too.)

http://www.fiercehealthcare.com

President Bush signed the FDA reform bill into law today. Now we'll see who gains control of the future of drug regulation: those who support personalized medicine and develop tools to make medicines safer and more effective by tailoring treatments to those best suited for them. Or the plaintiffs priesthood, the Grahams, the Avorns, the Nissens, the Furbergs who will cherry pick clinical trial data on the trial attorney/Soros/Public Citizen/ dime. The choice is between those who want to really reduce risk through better science and those who want to distort data to make us more afraid.

From today's edition of the Wall Street Journal ...

Consortium to Study Genetics, Drug Safety
By JENNIFER CORBETT DOOREN


WASHINGTON -- A group of seven pharmaceutical companies and academic institutions today will announce an alliance designed to look for genetic links to safety problems associated with medicines.

The group, known as the International Serious Adverse Events Consortium, will launch two studies to look for genetic markers that researchers hope will predict which people are at risk for serious drug-related adverse events.

The first study, with results tentatively slated for release about a year from now, will look at whether variations in a person's DNA are responsible for the development of a rare drug-related skin condition known as Stevens-Johnson Syndrome. Stevens-Johnson is typically marked by a painful, blistering skin rash that causes the top layer of the skin to die. It can be fatal if a person is exposed to the drug that initially caused Stevens-Johnson again.

The second study will look at genetic variations behind serious drug-induced liver injury. Arthur Holden, a former Baxter International Inc. executive who is chairman of the consortium, said he hoped results from that study would be available in two years.

"Everyone's talking about drug safety, and this is what we need to do to improve drug safety," Mr. Holden said in an interview. The seven companies, Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson, Pfizer Inc., Roche Holding AG, Sanofi-Aventis SA and Wyeth are providing "millions" of dollars for the research effort, he said.

The consortium will collect and combine already existing data on serious liver side effects, tissue samples housed in two Britain-based academic institutions, and information and DNA samples from at least one pharmaceutical firm on Stevens-Johnson Syndrome and a related skin condition known as toxic epidermal necrolysis. The DNA from the individuals with side effects will be compared with DNA from "control" subjects who didn't have drug side effects to see if there are genetic variations among the two groups.

Mr. Holden said that if the first two studies are successful, the consortium would then move to other serious side effects like heart trouble and kidney damage that are linked to several different types of drugs as well as drugs in the same class.

The data from the consortium will be made public and could be used by government regulators such as the Food and Drug Administration.

Janet Woodcock, the FDA's chief medical officer, will work with the consortium, although the agency isn't formally a member. "We want this kind of information," she said of the genetic studies, so the agency can find ways to prevent drug side effects or to better manage them. Dr. Woodcock said it is possible that FDA regulations and guidelines on drug development and approval could change if the studies yield clear results.

Many serious drug side effects, such as an increased risk for heart attacks and strokes seen with Merck & Co.'s withdrawn painkiller Vioxx, don't become apparent until after drugs hit the market and thousands or millions more people are exposed. Most clinical studies used to gain approval for a drug involve several hundred to a few thousand patients.

Already, the FDA is highlighting genetic information to help doctors and patients manage drug side effects. Last month alone, the agency said as many as one-third of people on the blood-thinning drug warfarin metabolize the drug differently than expected and warned that breast-feeding women on painkillers with codeine could expose the infant to too much codeine if they are "ultra-rapid" metabolizers of the drug. However, the FDA stopped short of recommending that patients undergo genetic testing to see how they might process the drugs

“If you want to save money and save lives, the "switching" we need in the United States is a one from a focus on acute care to one on chronic care.”

So begins a new op-ed in The Journal of Life Sciences.

The complete article can be found at:

http://www.tjols.com/article-289.html

To cut healthcare costs, we need to focus on early treatment of chronic conditions, rather than force patients to switch to generic alternatives that may not be equivalent to the medicines they are using.

The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too” medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.

Let's restrict access out of cost considerations and use safety as the excuse!!!

http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/09/19/ncancer219.xml

Additional thoughts on warfarin, genetic testing and personalized medicine courtesy of Dr Caroline Wright of the Foundation for Genomics and Population Health (a charitable company registered in England and Wales) …

“Just a month after the label for the blood-thinning drug warfarin was updated to explain that genetic variation in specific genes influences how patients respond to the drug (see previous news article), the US Food and Drug Agency (FDA) has approved the first genetic test for warfarin sensitivity.

Warfarin is the most widely used anti-coagulant medication in the world, prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes. Patients can display markedly different responses to the drug, so doses vary enormously between individuals. Achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, whilst those who receive too low a dose may remain at risk of life-threatening blood clots.

The Nanosphere Verigene Metabolism Nucleic Acids Test detects particular variations in two genes, CYP2C9 and VKORC1, which are involved in the metabolism and mechanism of action of warfarin respectively. Specific variants of these genes are identified from a patient sample by hybridization to sequence specific probes (oligonucleotides) attached to a microarray. These are subsequently detected using the Verigene System which measures light scattering from gold nanospheres tethered to another complementary oligonucleotide. Depending upon the genotype, patients can then divided into slow, fast or normal warfarin metabolisers and their doses adjusted accordingly.

FDA states that it cleared the test based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. ‘In a three site study, the test was accurate in all cases where the test yielded a result, although 8% of the tests could not identify which genetic variants were present.’ Although the Nanosphere test is not intended as a stand-alone tool to determine optimum drug dosage but to be used alongside clinical evaluation and other tools to determine the best treatment for patients, this approval underlines the FDA’s ongoing commitment to personalised medicine”

Remember – PDUFA page 182. Working together we can accomplish great things for the public health.

In PDUFA, that is. Page 182. That's where the language creating the Reagan/Udall Foundation begins. And if you want to talk about real FDA reform -- its really the most important part of the whole package.

But what's been written about it can be summed up in two words -- almost nothing.

All the more reason to watch this space.

Steve Galson is a man of honor, integrity, passion, and intelligence -- and he's a terrific choice for Acting U.S. Surgeon General.

We don't want people living too long now, do we? Not cost-effective. Thank goodness we have the know it alls at CMS who can quickly come up with the optimal lifespan. Once you have the optimal dose for ESAs down pat why stop there? Something for Herb Kuhn and co to think about as they defend their decision and peddle their brilliance to congressional staff in the weeks ahead....

http://home.businesswire.com/portal/site/google/index.jsp?ndmViewId=news_view&newsId=20070920005089&newsLang=en

MarkMonitor that is.

Congress may soon consider legislation that would allow Americans to buy prescription drugs from foreign countries. Lawmakers who plan to vote for it should first read a new report on online pharmacies published by the respected Internet fraud expert MarkMonitor.

Published in August while Congress was on vacation, it found that of the 3,160 online pharmacies it studied, almost all of them were likely selling fake medicine.

This shocking finding should cause the congressional supporters of drug importation to change their minds, as many of their constituents will be turning to such websites for their prescriptions if the bill becomes law.

Here's a taste:

"The FDA has caught a number of pharmacies that claimed to be based in Canada -- but were operated out of China and sold medicine that was manufactured there. It's not clear how many online pharmacies are doing this, but anecdotal evidence suggests that the number is large. MarkMonitor found that 18 percent of the Web sites it evaluated were based in China, and that 12 percent were in the former Soviet Union."

And here's a link to an op-ed from today's Detroit News ...

http://www.detnews.com/apps/pbcs.dll/article?AID=/20070920/OPINION01/709200323/1008

Unsafe online pharmacies would be among the first to capitalize on legalized importation. If Americans care about their safety, they ought to log off online pharmacies. And lawmakers ought to shut down their push for drug importation.