From do scandals disturb you to which scandal disturbs you? - The Pharma Industry comes of age.....

[No external article links on title this time...all links are below.]

Should you choose to accept the mission, your choices are:

1. Avandia - GSK, A Physician and the Senate

2. Lipitor - The Senate, Pfizer and a Doctor who doesn't actually practice

3. Vytorin - Two large Pharmas, The Senate, and ... well some more baggage,

or, here is the bonus

4. The FDA, and the number of centuries it will actually take them to complete inspections, should they choose to follow their own rules for once!!!!

Here are some links to guide you through the sorrow:

Avandia

Vytorin

Lipitor and Jarvik (this one's from yours truly!)

And the FDA

Whatever the heck happened to this industry? Why is there no permanent learning and adoption from old debacles?

It is proudly announced that the very presence of the FDA in the '60s saved many children from cancer and death through suspicious drugs that were sold like aspirin in Europe.

However, the very FDA now seems to be this megalolith that can barely move due its own weight. Among other things, people are now questioning the FDA's role in each of the individual debacles surrounding the pharmaceutical industry. Plus, the FDA's very functioning is now in question....

In the midst of all this the White House and the Solicitor-General actually dared defend FDA's status via federal preemption to be the most effective "overseer" of all things food, drug or device related.

How they can achieve this, suddenly or gradually, I cannot sense! And so cannot most people. Plus, the Congress seems to be the weakest link in the chain...

Without worrying about the completely useless patent "reforms", they should seize the opportunity to find out, among other things,

1. Why, despite Congress and the press raising enough doubts about the Lipitor ads, does Pfizer seem to play them fearlessly anyway..?

2. Do the investigations made by various Senators, Committees and other Capitol Hill-related odds and ends, actually have any meaning, purpose and consequence, given how company after company seems to be steeped in scandal...?

And, we the people, have to sit and wonder, given FDA's stringent regulations in the US, if we see so many failures, what of the "emerging" markets and all the development work that goes on there?

As if this was not enough, here is what UCSF is suggesting for medical devices. "Regulate them seeking more information like you would do for pharmas". Given the FDA's success with pharma, the irony almost makes the article humorous:

UCSF Article

Ironies aside, the article and what UCSF suggests, is accurate by the letter...!!! But is the FDA the right organization to do it?

So what you say? Everybody recognizes problems - what is your contribution? Here is my simple solution:

Make the different divisions in the FDA more entrepreneurial, punish them for their "slips" and provide them with more money and power...oh, before that, throw the existing structure and the dinosaurs in the FDA's office files out....



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Patent Reform Act, H.R. 1908: The [infringer] friendly patent reform

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So, I was thinking of all kinds of titles for this one. Let me first get a few of them out of the way,

"I said we need to 'reform' not 'deform' stupid!"

"Infringing a patent? Now Congress is with you"

"So you think we cannot travel back in time? Just look at where Congress and the USPTO are taking innovation..."

"Surely you jest, Congress!"

"Real men don't innovate"

And then, I saw this by the leader of BIO (short for Biotechnology Industry Organization)

"much more friendly for [patent] infringers"

Seems to be a better title. So, the BIO is opposed to these reforms, big deal you say...wait, even the generics guys are opposed to it. So are several legal beagles (just look online for lawyer blogs), and people from every walk of life, including the Bush administration.

We have all been worried about the need for patent reforms, haven't we? After a long vacation in the summer heat, Congress came back to session and decide to speed things up.

No use in wasting time thinking, strategizing and preventing a downward spiral of capitalism, eh.

After all the USPTO is doing its part (with a flawless final rule that will limit the number of claims and requests for application reviews) to cut down on this maverick innovation, why should other branches of government hold back?

When you are proposing a law, and no one in particular seems to like it , and everyone in general hates it, you may want to take a hint, or two, or three....

Since you may have read some well written articles ridiculing the various badly thought out propositions made by these reforms, I wanted to highlight the one I have the most beef with.

One of the crazy provisions of the new reforms requires that the victim (or the infringee, if you want to be cynical that way) has to prove that the infringer has violated all aspects of a patent to claim compensation.

Also, here is the big laugh, the amounts paid out on the claims will be directly proportional to the impact the infringement has on the product sold through such infringement. If this becomes law, courts will, in future be limited in terms of how much they can hand out by way of judgement.

This is not a reform. This is some Neandarthal attempt at dividing the spoils.

So now there are two motivating energies at work:

Positive - The infringers now have a lot of incentive to go ahead and walk all over your patents. First off, the burden of proof that all of your patent was infringed on, leans a little more heavily on you. Secondly, you will now have to run around with a calculator, trying to work out how much "impact" your patents' infringement had on the infringers' profits....

[If you remember the story of the poor guy who invented and patented wind shield wipers and nearly, literally lost his mind spending the rest of his life trying to get all the big automakers pay, you will understand why this just got a whole lot worse...]

Negative - Well, if you are a small time guy or gal, it is now going to cost more to patent anything, courtesy the new final rule laid down by your friendly neighborhood USPTO. And if you do get one through, it will cost you an arm and leg to defend it. So, you might as well give up...

But see, in the great ying-yang, Congress solved our problems. If patents go away, infringement goes away, ethical issues go away, patent infringement lawsuits go away...so what if innovation also goes away. Innovation is the root cause of all patent evil, anyway.

Some great thinking went into this. And to think, this "reform" was sponsored by someone from California...

Potentially Horrifying Footnote: The above highlighted problems are not the only ones with these reforms....

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