Tuesday, July 29, 2008

eV3/FoxHollow: Why does old wine in a new bottle not taste like new wine?

[Click on Post Title for Link to External Article]

Okay, it may not be so bad you say. But this was predicted a long time ago. The entire product line of eV3 that also swallowed the erstwhile FoxHollow last year is all old wine.

Artherectomy has now been around for what, a couple of decades? From the rotablade to now, how much has changed really? This is why, last year when I looked at this industry, I saw no stand-alone breakthroughs.

There's stents, balloons and the rake (or Hawk or whatever). If you think about it (or look at the statistics instead), you will find that the three types of intervention to treat atherosclerosis have nearly the same efficacies.

Granted, in some fields you will see the "n'th" in class device (now becoming a cliched excuse for why your device doesn't work as effectively as expected) suddenly blaze past the rest in the market.

However, I always doubted this would happen here. When I asked certain sagely leaders about this, I was brushed off as an intemperate "nin" whose "com" was quite "poop" (nincompoop for easy reading).

Oh well!

As of now, eV3, the unlikely suitor for FoxHollow has lost a patent battle to Boston Scientific and is closing down the Redwood City plant.

It has also terminated its research agreement with Papa Merck (which is actually good news given the latter's "reputation", read Vytorin). This wasn't exactly a cash-cow, but of course, they must have thought it was innovative at the time.

To assess atherosclerosis, one probably didn't need tons of tissue worked out with bad science. One probably needed fewer samples with good scientific principles implemented to study the issue.

Of course, understandably, if studies didn't go Merck's way, they would just cook it up. You think not? If they just put in physicians' names as placeholders (and nobody is talking about the geniuses that acquiesced to this), why wouldn't they fake data as the next incarnation?

Well, we will discuss Papa Merck in other blogs.

For now, I wonder what holds in eV3's future. I still see it as a major acquisition target (No Boston Scientific, first sell of all your assets and hopefully you will remember not to be naughty enough to bite off more than you can chew, especially with a whole lot of teeth missing).

Who will take a stab? Medtronic? Edwards? Our friendly, neighborhood J&J ?

Independently, eV3 stands no chance for growth. Embolic Protection is more a ruse than a market, as Boston has learned painfully. Atherectomy is a crowded market with no foreseeable clear winner. Its not like eV3 is breaking new ground with other endovascular products either.

Yes, sales are increasing, but at what cost?

It is to be seen where this goes. Of course, some other options include the possibility of eV3 acquiring a smaller player, combining the "Hawks" with a stenting solution, or something of that effect, which can at least improve success rates.
Will the Jedi defeat the Sith? Will there be peace and quiet in the republic? Wait for the next edition. Meanwhile, read my blog from July 2007 on FoxHollow before you leave:

FoxHollow: Now unveiling, new tricks to please a stock market near you...
[ http://www.wkbt.com/Global/story.asp?S=6823871 ]

After sales languished for quite a while once it reached a peak of $200mn., this Redwood City company was dangerously close to being a sweet acquisition. In an attempt to stave this off, it went off on its own to try and appear larger than itself. This obviously hadn't paid off - if you observe their stagnant sales and stock.

So now, they seem to have finally given up the hopes of going it alone. They already have a partnership with ev3, so this marriage should not be so unfamiliar.

But will it pay off?

There have been quite a few ups and downs - the previous CEO left all too suddenly and quietly one day, the VP of sales left unable to push sales upwards, the strategy for NightHawk, one of their next generation products changed all of a sudden. Their other R&D efforts are yet to pay off..And then there is the somewhat questionable acquisition of Kerberos.... this is definitely one medical device company to watch and see if it can pick itself up...!

Wednesday, July 09, 2008

Who said you can't take it all with you? Medicare doesn't think so...

[Click on Post Title for Link to External Article]

Ever wonder why the CMS is in so much trouble? Why there is forever little money to support your claims? Why there is always a threat that CMS might just implode on its own?

Well, it has mostly to do with a weird religion that CMS practices - it's called "honoring dead doctor's billing requests"

Its a strange religion, but a very serene one. Following this religion means you look past material needs - such as safeguarding the public money you are using to write checks. After all, I am being taxed out of my very existence so that some fraud in Miami can bill CMS to Kingdom come (and beyond, for the dead Doctors). That's how it has always been, and that's how it should always be.

This CMS religion also chafes at the modern society for its demand that intelligence be used in the practice of day to day business activities. After all, we need some society or organization to remind us that human evolution is a necessary condition for progress.

By demonstrating absolute lack of intelligence in any and all aspects of conducting their business, CMS is actually helping us appreciate evolution.

Or, if creationism was your thing, then CMS does a double pronged roadshow - it helps you understand God's other creatures that display even rudimentary forms of intelligence (like the Jelly Fish, for example) and also helps you believe in life after death.

This is a topic of mild controversy however, especially on the evolution side.

Some evolution experts tend to believe that CMS is living proof that evolution does not always "progress". Many a time it can "regress". Wait till these "experts" send in their requests for wheelchairs, and glucose monitoring strips....

$92 million. And no one is taking the blame. Congress is playing some weird investigationary musical chairs game, requesting information on billing from randomly selected doctors while CMS continues, with absolutely no remorse and regard for what they have done.

Are you worried about your future and the future of your health care?

You should be. For very good reasons.

"Fraud and abuse in the context of Medicare-covered durable medical equipment has been a focal point of ours in recent years," said CMS spokesman Jeff Nelligan.

Yes, we understand. And CMS has done a very good job focusing.

Now, all we need is for someone else to take charge and have CMS focus on something other than patronizing fraud and abuse....

Friday, July 04, 2008

Introducing Drug3k: A European answer to consumer understanding on prescription drugs

[Click on Post Title for Link to External Article]

Also look at: http://www.drug3k.com/

True, we live in an age of conflict in the pharmaceutical industry:

- Slower approvals (not slow enough)
- Blatant, unpunished, unscientific fraud (read Avandia, Vioxx, Celebrex and don't stop there...)
- Spiraling costs of innovation
- Lack of blockbusters
- A failed system of patent protection, combined with generic manufacturers

However, the main problem to the consumer is:

- Lack of clarity on drugs and their effects (not "side" effects as many sad users of Avandia and Vioxx would note if they could), further complicated by a distinct attempt by pharmaceutical companies to hide them and a readiness from Governments across the world to let go with a slap on the wrist following discovery

- Well meaning physicians are also clueless in the face of sparse and fraudulent publications (Do you know what Merck did last summer?)

- A dearth of public resources that are neutral in their objective to educate the Physician and the consumer.

It is this third gap, the "dearth" that the drug3k project aims to fill. It is a project of the European Organization of Family Health Research. The idea is to provide neutral, evidence based support to physicians and consumers, exactly what is missing.

The project pages are quite effusive detail and one would hope that it gains strength in patronage and wealth of information. I also hope that this is seen more as a central resource and is adapted by Consumer Health Non-profits all over the world.

Here's to wishing them good luck... http://www.drug3k.com/