Pharmaceutical Industry Is Unappreciated By Society

Bayer’s chief executive, Marijn Dekkers really underscores a major problem that the Pharmaceutical industry faces - they are unappreciated by society.
The article in Clinical Professionals goes on to say (quoting Dekkers):

"...one of the fundamental problems is society’s 'general lack of appreciation for innovations.' If a patient has a serious illness and is doing better following treatment with a drug, 'he will obviously thank his doctor and maybe praise the hospital too.' However, 'it rarely occurs to anyone to thank the inventor and manufacturer of the medicine'."

The lack of appreciation for the effort of the Pharma industry is a major issue.
And this is a problem that the Pharma industry needs to seriously address.

More on the FDA's problem with Innovation

I posted earlier this evening about the problems many industry experts - and even people within the FDA - feel the Agency will continue to have with regards to dealing with the ongoing innovation within the Drug and Medical Device industries.
After posting to my blog - I came across this quote which I think sums up what ultimately may be the biggest problem the agency faces.

“I always remind people, the easiest way to lose a civil service job at the FDA is to push the approval of something that is later found out to have a problem.”
- Carl Weissman, CEO of Accelerator

To a certain extent - that sort of "risk-averse" attitude is probably the biggest stumbling block the FDA faces.

FDA and Medical Innovation

Andrew Von Eschenbach wrote an interesting article in the Wall Street Journal last Tuesday.
You can view the article here. (Subscription required)
The article addresses the issue that the FDA is, unfortunately, woefully unprepared for the new world of Drug Development.
As Mr. Von Eschenbach writes, even FDA Commissioner Margaret Hamburg:

conceded to Congress in 2010 that 'the FDA is relying on 20th century regulatory science to evaluate 21st century medical products.'

And one of the major problems is that the FDA's inefficiency in evaluating new drugs, devices etc. ultimately leads to significantly higher costs for new drug and device development.

Von Eschenbach goes on to say:

The Tufts Center for the Study of Drug Development has reported that clinical trials from 2003-2006 were nearly 70% longer than those from 1999-2002. Longer (and more complicated) trials have led to skyrocketing drug-development costs. High costs discourage investment in much-needed new therapies for conditions like obesity, diabetes and heart disease.

This is not a critique of the FDA itself.
They are doing what they can with the tools they have.
But the bottom line is that Congress and the Obama Administration need to make modernization of the Agency a priority because not only the health of our economy - but our very own health - is at stake.

Roche warns of counterfeit vials of best-selling cancer drug Avastin

Roche has issued warnings about counterfeit vials of Avastin. You can read the article here.
A major concern of a number of people I speak with in Pharma is that this sort of issue with counterfeit drugs will only get worse.
According to the article:
"Recent legislation introduced in the House would give the FDA greater resources and authority to inspect foreign drug imports. Separate legislation would create a mandatory barcode system to monitor the authenticity of all prescription drugs moving through the U.S. supply chain."
But the question is - Are these measures going to be enough?

Pharma's Fear of Innovation

Bill Drummy wrote an interesting article in this month's Pharmaceutical Executive magazine entitled: "Innovation: Why is Pharma Scared to Death?"
Drummy discusses the irony of how an industry that is supposed to by nature be innovative, instead appears to be afraid of the risk inherent in innovation.
Drummy believes that this lack of innovation is hurting the health of the industry.
He writes that:

"According to a new report published by Deloitte, the 12 largest pharma companies saw their ROI drop by 29 percent in the last year. The average internal rate of return for R&D dropped to 8.4 percent from 11.8 percent a year ago."

Drummy opines that the reason for Big Pharma's lack of innovation is that Executive Management at these companies are fostering a risk-averse culture. And he believes that unless there are changes in attitude at the top, Big Pharma companies will continue to eschew risk, and with that, continue to stifle innovation.

I think Drummy has a point. I was speaking a couple of years ago with a mid-level executive at one of the major Pharma companies. I asked him why his company's pipeline was so barren.
He laughed and replied that, "People here are less interested in making drugs, and more interested in 'covering their asses' ".

Reasons for Optimism

Great article in the Wall Street Journal entitled "The Coming Tech-led Boom".
You can read it here.
The article highlights some coming Technological Transformations that bode well for the U.S.
While I don't necessarily agree with every point in the article - it is nice to read something positive about the United States' long term prospects for a change.

Big Pharma's new business model

The Wall Street Journal had an excellent article on 12/27 about Big Pharma's new business model.

In the article Scott Gottleib discusses an event last November that marked the end of an era for Big Pharma - Lipitor went off patent. Lipitor was the last of the big blockbusters for the industry.

While the industry has hit a bit of a rough patch - Gottleib says things are improving for the industry overall.

In his article, Gottleib details how Big Pharma is changing the way it discovers and develops new drugs. No longer are companies simply "screening millions of random compounds against a molecular target".

Instead Companies are embracing a model where, "Drugs are designed around the individual biological receptor they're targeting rather than being screened out of a library of random compounds"

Gottleib highlights other changes in the industry. He writes:

"...pharmaceutical companies started to carve up their sprawling research enterprises into smaller, more focused teams. The right size of a research team is now said to be 20-40 people. To get at new science early, drug makers rely on collaborations with academic research teams and licensing deals with smaller biotech outfits."

Again - while the industry still has challenges to face - it nevertheless appears better days lie ahead.