Statins guard against Prostate Cancer

There is a fascinating article that was just posted on Forbes.com. You can read it here.
According to the article:

Several new studies suggest statins help prevent prostate cancer and reduce the risk of erectile dysfunction.

"At this point in time, there seems to be mounting evidence that there may be a future role for statins in prostate cancer treatment or prostate cancer prevention," said Dr. Lionel L. Banez, from the Division of Urologic Surgery and Duke Prostate Center at Duke University Medical Center and lead author of one study.

From a Men's health standpoint, this is great news.

great career advice

Someone just posted this quote on Twitter and I thought it is very sound advice:

"Someone with a job is never secure, someone with a calling is never unemployed."

Medical Devices Face New Scrutiny From FDA

This article appeared in the Wall Street Journal on April 8th.
According to the article:

The Food and Drug Administration asked several medical-device makers to justify their products' safety and effectiveness, as part of a move to require tougher evidence standards before products can be sold.

But here is the kicker:

The agency's request comes in response to a 1990 order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3.

But despite several attempts during the 1990s, the FDA hasn't finished implementing the law. In the past five years, it allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing -- called a 510(k), after a section of federal law -- that they are "substantially equivalent" to combinations of other products marketed before 1976. Such evidence often is collected in a laboratory, not with a clinical trial in patients.

I know the proverbial wheels of Justice and Government grind slowly...but this is ridiculous.
This law has been on the books since 1990 and the FDA still has not fully implemented it.
And now the FDA is going back to the Manufacturers demanding more data on products that are already approved and on the market.....And these companies may actually have to go back and run Clinical Trials on already approved products.....Incredible!

Inspirational 97 yr. old doctor

This post is a little different from my standard subject matter. But I figure anyone who is 97 years old and is still working and productive is definitely worth listening to. Hopefully you find Shigeaki's message as uplifting and inspiring as I did. And you can read the whole article here.

An excerpt from the article is pasted below:
At the age of 97 years and 4 months, Shigeaki Hinohara is one of the world's longest-serving physicians and educators. Hinohara's magic touch is legendary: Since 1941 he has been healing patients at St. Luke's International Hospital in Tokyo and teaching at St. Luke's College of Nursing. After World War II, he envisioned a world-class hospital and college springing from the ruins of Tokyo; thanks to his pioneering spirit and business savvy, the doctor turned these institutions into the nation's top medical facility and nursing school. Today he serves as chairman of the board of trustees at both organizations. Always willing to try new things, he has published around 150 books since his 75th birthday, including one "Living Long, Living Good" that has sold more than 1.2 million copies. As the founder of the New Elderly Movement, Hinohara encourages others to live a long and happy life, a quest in which no role model is better than the doctor himself.

Pharma Innovation in Legal Jeapordy

Lawrence McQuillan writes a fascinating and frightening article regarding recent court rulings that will have a potentially tremendous negative impact on drug innovation. You can read the article here.
The recent Supreme Court ruling in Wyeth v. Levine (which held that even when a drug has been approved by the FDA, the drug manufacturer can still be held liable under state law) has garnered a lot of press.
But an even more frightening decision was rendered in CA in the case of Conte v. Wyeth.
McQuillan writes:

In Conte, a California appellate court ruled that those harmed by a drug don’t have to settle for suing just the manufacturer: now they can sue the inventor as well....The case involved plaintiff Elizabeth Conte, who claims to have suffered severe neurological problems after taking a generic version of the antacid drug Reglan. Conte first sued the generic drug’s manufacturer, alleging that the company was liable for the injuries caused by its product. But then she filed suit in California state court against Wyeth, the inventor of Reglan, though she had never taken Wyeth’s product. Incredibly, the appellate court ruled that Wyeth was legally liable for any adverse effects caused by the generic version of its drug. The makers of the generic product got off scot-free....In January 2009, the California Supreme Court decided not to review the decision, so it’s now Golden State law. Wyeth’s warning labels, and those of other drug inventors, will now apply not just to their own products, but also to those of other companies, which they do not control....The Conte ruling carries extremely harmful implications for drug innovation. The typical pharmaceutical company spends more than $1 billion developing a new drug and bringing it to market through a complicated approval process. Given current patent law, the company has just a few years to recoup its investment before generic drugmakers can enter the marketplace and churn out copies sold at a fraction of the original’s price. Making drug inventors responsible for problems with generics makes drug development that much more expensive—so much so that many companies will likely no longer be able to afford it. They’ll pull out of the market, and pharmaceutical innovation will decline. Conte also guarantees that pharmaceutical-company resources that would have been used for R&D will now be spent on legal defense.

In the long-run, the societal costs of these decisions will be staggering. Innovation will be stifled.
Drugs that could be developed that will save and/or improve people's lives will never leave the lab. It truly amazes me that the courts can arrive at these type of conclusions and that these types of decisions can actually be rendered.

Pharma Business Model Blues

Rick Edmonds has an interesting post here entitled -Newspapers, GM and Big Pharma: Sharing the Business Model Blues.
Edmonds writes:

Pharma seems to be where newspapers were a decade ago, even five years ago -- loaded with cash, still highly profitable, but experiencing marked reduction in revenue growth. Cracks have appeared in the pipeline of developing new medicines and selling them for years as high-priced, proprietary brands.

He does not dispense any specific detailed solutions to the problems that beset Big Pharma....but the post is still an interesting read.