Medical Device Innovation! : Arthrocare is now rebranding to Art-no-care!

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Innovations in medical devices have been happening at hitherto unknown magnitudes of time and quality. The time for medical devices to join the banking sector in defrauding the American Public seems to have finally arrived! How, you say?

1. The FDA:

The Bush administration, in well measured tactical moves has rendered the FDA a nearly useless joke (except of course it's the dead Chimpanzee cartoon kinda joke - the kind that no sane person would laugh at). Want to know more?

Read This!

Now, regulations both necessary and otherwise don't exist. You know what happens when there is less regulation?

More "innovation" in medical devices!

2. The Supreme Court:

Give a bunch of extremely old people with outdated ideas and extremely untalented people John Roberts the chance to do what they please and say what they please for life and you have reduced "Democracy" to "Ironic Drivel".

Last year, this was very helpful in creating something so entertaining that Tyler Perry, Stephen Colbert and their like have to kiss it's ass - this was called "Pre-emption".

With this tad bit of innovation, now you the patient cannot sue a company for a medical device that the FDA has already "approved". Yes, you are right, the very same FDA that is totally weak, engages in all kinds of unethical duty dodging...

Yes, you cannot sue if in fact the device malfunctioned, did not do what the labeling suggested it was going to do, or if in fact, the device killed you or a "loved one".

Who else laughed so hard that their stomachs hurt?

Careful there, your stomach ache medication may have side effects including death, permanent disability, loss of self esteem, feelings of suicide...

3. The Slapstick Entertainment Commission, er., SEC:

If you thought the FDA was a joke, wait till the SEC comes to investigate. You know, how in Hollywood movies the cops and the army always show up after the trouble is over (unless they caused it of course!), and the hero has tackled all the thieves, alien monsters and so on....who told you that was fiction?

4. More Tools to help innovation? - Democrat Nominees for HHS, FDA or any government position you can name

Let's see. There is this certain subspecies among humans. They love taxing you. Any excuse is enough. Are you rich? Are you wealthy? Are you a business? Are you none of the above?

Doesn't matter. They will tax you!

Except...they won't pay.

Come on, whoever followed what they preached?

Won't believe me? Go look up "Daschle", "Geithner", "The husband of a labor secretary nominee" on the Googles and see for yourself!

With friends like these in Government, who needs the GOP and their fear of comparative studies? (Yes, they don't like the idea!)

Meanwhile, if you are a medical device company looking to "innovate" alongside the aegis of "Art-No-Care" and others, here are a few tips:

1. Don't worry about the FDA. As long as you fill paper work, you will get a 510(k) - heck you might even get a PMA approval.

2. Tell your sales folks to ignore "approved uses". Tell them to sell the medical device for any use that pleases them. If convicted, only the sales guys go to prison. You can even take your company name out of the mention in court papers!

3. Hire lawyers whose dads work in the federal judiciary system. This way, you can use the son to get the dad to dismiss any cases, pre-emption or otherwise. The dad can always deny even knowing his son had a job!!

(See my previous blog post, if you can't believe your eyes and ears about 2 and 3).

4. When in doubt, be assured that pre-emption will protect you! Do you fear that the Obama administration will ever do something about it? Fear not!

How come you say? Well, for one, they are not very different from the Bush Administration - they just sided with them (and against your right to know) on White House emails. How different do you think they are going to be? Change is only for Washington - not much else.

For another, Obama will never appoint a HHS secretary. Or he may, and it would be too late anyway. Heck he hasn't responded to FDA scientists who lamented about the FDA and later pleaded that they were being persecuted.

5. Ignore audits, the SEC and other regulations. If anything, it will be years before the SEC investigates. By the time the agency would be busy with one of two possibilities - either the administration (and the party that administers said administration) would have changed, or the SEC itself would be re-branding, because the last name did not work out! And you would be far away.

Who cares if you have to re-state revenue figures for a whole decade in the past? As long as you can cook up the numbers for the next 90 days, it's good enough! Be practical.

Meanwhile - Yay! Innovation. Enjoy! There are absolutely no barriers or regulations or rules of law that will stand in your way.

Art-No-Care just proved it.....

Addendum to Provenge Label: Warning! Might expose FDA inefficiences..

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Okay, so the first two Congressmen started expressing their "Provenge" displeasure and I thought, oh well, what is two Congressmen. After all, under President Bush, most federal agencies have weathered an entire Congress!

And then one more added himself to the list and Three's Company of course, so I thought, might as well roll out my cynical red carpet...

The gist of the story is that the panel that reviewed Provenge had atleast one guy working for a competing company, Novacea. How did he get to sit on the panel anyway? Apart from violating fundamental ethics, was he also able to access sensitive data on Provenge? Is the FDA performing the dual function of being unethical and destroying competitiveness?

So, in the future everytime the FDA rejects a drug, are we to spend immense time and energy investigating and/or lamenting over whether or not the rejection was appropriate?

Heck, it atleast gets a few Congressmen to do something..anything!

However, now let's take a step back into this month's favorite cliche: Riegel (with all respect to the deceased).

So, the FDA, the attorney general and anyone who considers themselves an expert (including the lawyer who doesn't believe in juries) went in front of the Supreme Court or blogorama as they saw fit, to argue in favor of federal pre-emption.

But we go back to the age old question that Will Smith asked in that spy movie, "Who watches those who watch us?"

And if we claim that the FDA knows better than the jury because it employs a "panel of experts" who are somehow better than 12 high school educated folks, how would you explain all the hullaboo surrounding Provenge?

Even 12 year olds know thats not the right thing to do!

IMO, by taking up the Riegel case, the Supreme Court has snatched itself a nice little commonsense vacuum. With low funding, low morale and definitely lower ethics, the FDA is now an aging dinosaur - just refer back to my post on the "new" DES rules..

All our friendly, neighborhood Supreme Court Justices run the risk of stepping on some 'caca' for suggesting that the FDA is above "torts" and has its own "experts" who will keep us all safe....a very dubious and unbelievable statement indeed.

Meanwhile, do you have any hope for some good to come out of the potential Provenge investigation? Do Congressional investigations actually result in any good?

I have a suggestion: Try to make the panel immaculate (not religiously, and this is the season when Discovery Channel tries to show through reruns that nothing can happen immaculately! - sorry for the spoiler!!!). That is, there should not be folks with conflicts in the panel. If you had a prostate cancer panel of 14 guys, none of them should be working on ANY prostate cancer drugs, maybe even cancer drugs.

Am I suggesting that 14 such folks can be found among a population of 300 million (and counting)?

Yes!

Whenever that's not possible: Pick rotating panels of experts from the FDA. Let them keep serving their commercial masters. But come time for applications (which the FDA can set starting from 3 - 6 months prior to the actual review date), the FDA should set a period where it decrees that the panelists should stop any conflicting work which might include accruing current benefits (like salary, bonuses etc). They can pick up conflicting businesses once the decision is made. Given the potential "upping" to the resume that serving on FDA panels brings, I doubt if many will protest this with vigor.

Then again, don't blame it entirely on the panel. This is where the irony of the FDA's argument in Riegel sets in. The Provenge panel did recommend an approval. The panel is support to be the expert..and a 13-4 vote is not contentious. So, who then got to decide to screw Provenge over?

What would be the point of arguing that panels know better than juries and then not listening to panels? We might as well do a TV program where out-of-work parttime bartenders could review drug applications...

So, is an investigation necessary? Yes.

Is there a better way for the FDA to function? Yes

Transparency somehow appears to be a potential keyword in this business...so does commonsense!

But hey, why listen to me..after all the FDA has its own experts!!!

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Of Eyelashes and how the overgrown eye brows blinded the organization to commonsense...

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The hottest market for drug or device development is : brain growth for governments worldwide.

Unfortunately this largely untapped market looks like it will remain so...forever!

Here is the latest proof that determines this urgent clinical need:

>FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."<

Why does this seemingly innocent policy bother me? Well for starters, apart from being an engineer in the field that FDA breathes down, I am, fundamentally a consumer. I am glad they went ahead and "siezed" a product that they had already "banned" from sales before I could dunk it by the pound to grow giant eyelashes, a lifelong wierd dream of mine.

But, what seems like a cliched protest from a hithero unknown Jan Marini Skin Research, Inc, did raise a few red flags(lifted verbatim from the Reuters Article):

1. Jan Marini, the company's president and chief executive, said the product at issue had been in its warehouse since September 2006, when California public health authorities "embargoed" it at FDA request.

2. The company added in a statement it had offered to destroy the product, "but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizure."

3. "We have been unfairly singled out," Marini said in a telephone interview. "Other companies use the same ingredient and we're not aware of any action that has been taken against them."

And, going back to the very beginning of this post,

4. FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."

Here is why all these 4 statements mother me....

1. Okay, September 2006 subtracted from October (I am sure it took the FDA two weeks to prepare for a one page, cryptic, zero value press release) 2007 equals 1 year and a month. Why on Earth did it take the FDA 13 months to make some sort of a final decision, however small its incremental value was? Is this the average, lower end or higher end of the timeline for the (in)activity of FDA? Will we ever be blessed with the opportunity to find out what happens in Wonderland that takes them soo long to arrive at simple endpoints?

2. "so that it could issue a press release announcing the seizure." In all fairness, I don't know if this is true, but this is what got quoted on the company's behalf on the Reuter's Article, and I didn't see the FDA protest this statement anywhere. So have we been treated to a classic dog and pony show? Moreover, what irks me is why do they need to "seize" these products? How much money was spent into this "seizure"? Why would it be harder to let the company destroy the product on its own?

3. This is what ticks me off the most. Maybe the company was wrong in making and marketing this product, but not only did the FDA hold them in a state of limbo for over a year, they won't even reveal if other companies do make products with the same chemical "bimatoprost" or similar eyelash products are under investigation. Why is that so? It almost makes one think that JMSR is being singled out! This may very well not be the case, but 4, the statement by an FDA spokesman makes one very suspicious...

4. This is a "company friendly" policy that just seems to be wrong in every possible way, except that it probably thrills the companies under investigation. While we all would love for the stock prices of healthcare companies to perform as well as all other companies, we love living and not getting killed by devices and pharmaceuticals even more. This seems to be one of the worst policies a government agencies could have.

It also means the FDA is uncomfortable with the appropriateness of its own investigations. It seems to indicate they don't trust themselves. And, it is definitely not a good starting point. If at all Congress is interested in changing the way devices and drugs are developed and delivered to customers, this little "policy" needs to be wringed out of the FDA's day to day activities....

In effect, points 1 - 4 and my doubts relating to this issue seem to leave open some holes that would challenge the ozone layer's own holes in terms of graveness, urgency and the ability of the FDA to act as an effective policing agency..

If you have it in you, you may choose to shock yourself more, relating to the regulation of devices here:

http://seattletimes.nwsource.com/html/localnews/2004020583_miracle18m2.html?syndication=rss

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