In an era of personalized medicine we can and must do better than just shoving people into taking the cheapest drug and then seeing if people slip in convulsions. Ultimately many more drugs are going to to go generic so treatment selection will still be an issue and so will the attendant costs.

NOT WHAT THE DOCTOR ORDERED
The Detroit Free Press
By Patricia Anstett 6/5/2009 5:30 AM

Excellent omnibus article on healthcare in the Age of Obama in this month’s edition of PharmaVoice.  It’s titled, “Obamaceuticals” and can be found here.

It covers a myriad of important and timely issues (comparative effectiveness, FDA reform, reimbursement strategies, follow-on biologics, etc.). And one nonsense topic – drug importation.

And since, courtesy of Senator Dorgan and friends, we once again must address this sideshow issue, herewith how I was quoted in this article on this topic:

Mr. Pitts wants to make one thing perfectly clear: “First of all, there is no such thing as drug re-importation.” “The term is a political one that is factually incorrect,” he says. “Re-importation implies that drugs that have already been approved by the FDA are being moved out of the United States and sold back in. In its current use, the term refers to the practice of allowing drugs from other countries that have less regulatory control to be sold to U.S. patients. That is drug importation. “For example, in Great Britain 20% of drugs are parallel traded with Portugal, Greece, Latvia, in other words, countries that don’t have as robust a regulatory regime as the United Kingdom, the United States, or even Canada,” he adds. “The drugs a patient gets from an Internet U.K. pharmacy are not legal in Canada, let alone the United States. Patients are led to believe they are getting the same drug and they are not.” Reports show that drug importation would reduce drug prices over 10 years by less than 0.1%, Mr. Pitts says. “Importation is a great sound bite, but at the end of the day, it has serious safety considerations and doesn’t save a bit of money,” he says. “I don’t think HHS Secretary Sebelius would ever say these drugs are safe and put her signature on a bill that does.”

That last sentence refers specifically to the issue of Secretarial Certification (not in Senator Dorgan’s amendment, but in thoughtful language offered by Senator Cochran and others).

Okay, once more into the abyss -- when it comes to drug importation, there is no there there when it comes to savings – but  there are serious safety implications.

The there that is there is that drug importation is a direct path to price controls.

Should drug safety (not to mention intellectual property rights) be sacrificed at this dubious altar? 

Pfizer tries new uses for failed drugs

By Gail Appleson

ST. LOUIS POST-DISPATCH

When scientists at Pfizer's Sandwich research facility in England began studying a compound called Sildenafil, they thought it showed promise as a treatment for high blood pressure and angina.

However, when early clinical trials were conducted, the results suggested the drug wasn't sufficiently effective for its intended use. But it did work amazingly well for something else. It caused penile erections. So Pfizer decided to market the compound as Viagra and, in 1998, the drug made history as the first oral treatment approved to treat erectile dysfunction in the United States.

The tremendous success of this pharmaceutical recycling effort is far from lost on Pfizer, the world's largest drug maker. About two years ago, it formed a research group to find alternative uses for compounds that don't work as intended. The 50 scientists in the group also try to find other opportunities for drugs in their early development stage.

The Indications Discovery Unit has a new home in the recently opened $200 million research building on the Pfizer Global Research and Development campus in Chesterfield. The new building allowed Pfizer to consolidate its Missouri-based research and development into a single location. About 1,000 Pfizer scientists conduct drug discovery research in Missouri.

Donald Frail, chief scientific officer of the Indications Discovery Unit and director of Pfizer's St. Louis laboratories, said that finding additional uses for pharmaceuticals is important because it can take 10 to 15 years for a drug to get approved, and few in development ever get that far.

Most drugs must go through three phases of human testing. The first round is to make sure the compounds are safe. The second and third test whether the drugs are effective for their intended use. Frail said more than 75 percent of drugs in development never make it past Phase II of testing.

"It's a daunting job," Frail said about being a drug researcher. "It's a minority of scientists that see their drugs get to market."

Frail said Pfizer now focuses on six principal areas: oncology, inflammation, neuroscience, diabetes, cardiovascular and pain. Scientists in the Indications Discovery Unit look for other applications both within and outside those areas.

"The hunt is pretty fascinating," he said. "We let the compounds lead us to the patient. Our playing field is preset by the molecules."

An example of a drug being examined for other uses is Pfizer's Sutent, which is on the market for use against kidney and stomach cancer.

Pfizer has been testing it for other uses as well, and in March the company said Sutent showed "significant benefit" in patients with a form of pancreatic tumor.

But the research on the drug doesn't stop there.

"We're looking at it now for a different, totally nononcology application," Frail said.

Although most drugs never get regulatory approval, the possibility of finding a successful treatment or cure continues to drive researchers in their quest, Frail said.

"It's easy to be motivated when there are patients in need out there," he said.

Advisories led to 'unintended consequences,' researchers say

By Karen Pallarito
HealthDay Reporter

MONDAY, June 1 (HealthDay News) -- Newly diagnosed cases of depression in America have dropped sharply since the government's warning of an increased risk of suicidal behavior among children and teens taking antidepressants, a new analysis finds.

"AMERICANS HAVE, at best, a love-hate relationship with the life-sciences industry—the term for the sector of the economy that produces pharmaceuticals, biologics (like vaccines), and medical devices. These days, the mere mention of a pharmaceutical manufacturer seems to elicit gut-level hostility. Journalists, operating from a bias against industry that goes as far back as the work of Upton Sinclair in the early years of the 20th century, treat companies from AstraZeneca to Wyeth as rapacious factories billowing forth nothing but profit. At the same time, Americans are adamant about the need for access to the newest cures and therapies and expect new cures and therapies to emerge for their every ailment—all of which result from work done primarily by these very same companies whose profits make possible the research that allows for such breakthroughs."

During the course of his article, Troy discusses the issues that threaten to derail medical progress (litigation, an overly cautious FDA and, of course, legislation to put Uncle Sam in charge of our healthcare).  Troy concludes:

"Just as there is potential danger from the way in which Americans take the power of the antibiotic for granted, so, too, one of the greatest threats to our health and continued welfare is that Americans in the present day, and particularly their leaders, are taking for granted the power, potency, and progress flowing from life-saving medical innovations. And in so doing, they may unknowingly prevent the kind of advance that could contribute as vitally to the welfare of the 21st century as the discovery of the antibiotic altered the course of human history for the better in the century just concluded."

Tevi's complete article can be found here.

All the rest is, well, commentary.

• Start with high power predictive tools for big time clinical decions with short term impact on major diseases
• Create model clinical settings where clinical data and genetic information can be collected and combined
  
• Use clinical setting to establish predictive reliability of clinical decision tools and measure clinical outcomes
  
• Measure value of such tools to employers, individuals and health plans
  

Somehow, I don't think Adam Smith had this in mind.....

I bought my daughter Botox jabs for her 18th birthday...says mother who has spent £45,000 on plastic surgery
By Tamara Cohen
May 26th 2009

Most mothers would aspire to pass on something of themselves to a teenage daughter.

But for Margaret King, that didn't mean offering young Jodie advice on the opposite sex or even guiding her on her wardrobe choices.

For her 18th birthday, she bought her Botox injections to get rid of the 'wrinkles' on the teenager's forehead.

Jodie King and mother Margaret, who bought her daughter Botox injections for her 18th birthday

Mrs King, who has spent £45,000 on cosmetic surgery procedures for herself, said: 'Jodie's forehead is like mine - she gets pronounced lines when she makes a facial expression. I knew Botox would solve the problem.'

Many surgeons do not recommend using Botox under the age of 30 because the skin has not sufficiently wrinkled and it could lead to an unnecessary loss of facial expression.

But Jodie, who had been worried about her complexion, is now addicted to the jabs and has spent £1,000 on them. "