Thursday, March 26, 2009

Sparky, Phaky and Trooper, the medical device manufacturer!!!

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Conducting sting operations can be boring sometimes, apparently! So, some of the following names were used (I made up Sparky, but how would you know?)

1. Device Med-Systems (okay, that's for warm up)
2. Adhesiablog (apparently, titled to be a surgical adhesive. So, the blog did not raise any eyebrows?)
3. April Phuls
4. Timothy Witless
5. Alan Ruse, and to top it off,
6. Chetesville, Ariz

It is not like Grassley was suffering from want of material, you know. Or we. No one was going to miss this, but now that we have it, it is time to frolic on the floor..unless of course, you forget the fact that these people are supposed to examine and approve trials on humans...

The IRB and its function

Amidst the laughter that April Fool's Day was subsumed with March Madness, we may have forgotten what IRBs are supposed to do. IRBs can be part of large institutions, such as teaching hospitals, University hospitals, etc. or they can be independent.

They ensure that studies performed on humans meet the medical and ethical standards and are within reason - simply put, Frankenstein doesn't get to build his/her monster in the name of research.

Want to dig deeper than the primary school level mention here?

Knock yourself out on this link!

One bad apples = IRB dead?

No, not really. There are several IRBs across this country. Many of them would have caught this, maybe..Many actually function just to satisfy the local needs of the communities they serve.

Remember, most countries don't have the faintest notion of an ethics review board that goes beyond what can be termed as "eye wash". (This, based on the personal experience of yours truly!)

Then, do we just stand by and defend this?

No! Obviously, the FDA, the HHS and Congress have failed again. And so has our friendly, neighborhood administration (by failing to split the FDA in a timely manner). The FDA itself has existed for too many years in a very brazen, devil may care environment. The organization, and its guidances have become toothless (and now we are on a pistachio scare, for nuts' sakes...).

Whither Grassley?

Yes, he loves to hit the roof. However, where was he all these years? And why is Grassley the only contestant in a letter-writing contest to the FDA, IRBs and the biotech companies in Congress? Is everyone else already bought out, or do they not care enough?

What we really need:

What we really need is a thorough washing, rinsing and drying (saw that with a nice regional drawl..).

A thorough examination of "trust" based systems that also includes a plan on how to manifest and maintain this trust, while ensuring that they system has checks, balances and inspections that allow people to scrutinize and perform their functions well. Systems need to be modernized as well - with electronic record keeping and sleuthing tools, IRBs may just be able to catch Chetesville, Az. off the map.

Monday, March 23, 2009

Where should you go for choosing the materials for your device?

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I am not one for rehashing press releases by publishers of expensive documents. There is always time to make exceptions (if not hay in sunshine), however. In any case, I need to disclose that I did go to the MPMD Conference in 2007 and took classes for two days. It was quite an educative experience. In that context, you may judge the objectivity of my posting about the ASM Materials Database here.

But all that egotistical legal mumbo-jumbo aside, what I found extremely fascinating was not actually the materials database - it was the classification of devices. Don't get me wrong. Having a list of materials, with data sheets and everything is very important.

What I liked was how they split up the devices by category. Some day I hope to lay my hands on the catalog myself, but for now, I am glad that device designers have some possibly excellent reference material on their hands...

Friday, March 13, 2009

Abbott the innocent fires Harrison the unrepentent? ...And some very disappointingly minimal actions by Obama

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If I were the lion from Narnia, I would name Abbott, "Abbott the innocent", that is, if my taxonomy went solely on the basis of companies' ostensible acts. Of course, I am not the lion of Narnia, and no one else should be buying this load of Humira either...

One classic political strategy used in many situations is - assuming the one to yell out loud and clear first is the one to blame.

Except, ahem, we understand politics. And it is "classic" which means old. How many Lucille Ball show endings surprise you anymore?

Here are some questions someone might have to put to the innocents here:

1. Do you review the ads that get put out for $70 million on your behalf?

If not, you are either too rich or, well you are you.

2. If you did review the ads, did you not check for the most fundamental aspect of what approval conditions the ad hints at? Examine this - you don't really get people with science education working for ad companies much. I would imagine not...

So, how did the decision to leave the final proofing for an ad to be displayed in a medical journal get left in the hands of an ad agency? Was the expectation that the ad agency would go hire some outside consultant that would clarify the language on FDA approvals?

If so, who thought that this was a great idea?

3. So, are we to assume, the ad agency, acting on its own poorly conceived cognizance decided to make the fine print, so fine that it is a blur at best, that even if, as suggested by, you were to zoom in to 100% or more, the pink vs. white would nearly blind you?

May the cat-belling ceremonies begin

Alright, as another cliche goes, enough beating around the proverbial bush. What responsibility, if any is Abbott going to presume? What punishment if any, is the FDA going to dole out? I mean, the damage is done - right? People have already viewed the ad right? (This presuming those who read journals are incredibly stupid and will trust everything at face value - just ask those who invested in Wall Street).

An analysis

1. The Politics

So, for the last 8 years or so, we can argue, for certain inexplicable reasons (The Bush Presidency if that's what you want to call it), the FDA has been "Deadbeat Central". And now, we have hope and change.

Except it is coming at such a deliberate pace that our hoping and changing seems to need some "extreme enema". The FDA is headless (as of Saturday morning, it has a prospective head and a deputy, provided they have managed to pay taxes, something that Obama nominees have a chronic problem dealing with). Only the God (and not evolution because every alternate opinion, however incredible needs support) knows how much tax-paying and withdrawing drama the nominees will finally bring before they start at the FDA.

2. The Supreme Court

Meanwhile in a far, far galaxy, unkown to Obama and Pelosi (because they are too busy organizing Healthcare summits - because talking rather than doing your job is indeed the best way to get the job done!), the Supreme Court and other agents of spontaneous change will continue to constrict us. How did they figure that pre-emption works only for devices and not drugs?

Is the intention to demonstrate the FDA is good enough only for devices and not drugs? Or did they decided to demonstrate that they are so far removed from the lofty quanta of intellect and depth of understanding required for being at a minimum, a district court judge? Don't they have the responsibility to explain this mess they are leaving us in?

Or did I miss the memo that they don't have to? Looks Cheney-istic, n'est pas?

3. The joke FDA

To pre-empt or not pre-empt - is not the question. In every single way possible, the FDA has demonstrated its incapability at administering anything.

Wait, didn't they just yell at Yaz and Abbott?

Heard of too little, too late?

If no one remembers (and given our short term memory, no one does), here are a few things that the FDA has done to win accolades in the recent past, read my previous post here:

1. The website that the FDA put together on DTC ads to "inform" consumers was designed by a "non-profit" (which of course helps put all the good non-profits to shame) that is a front for the mob, er, pharmaceutical companies. This just makes me sound like one of those Area 51 conspiracy freaks, but this is real! :

2. They have been so ineffective that companies openly disrespect them - before warning Bayer, the FDA did indicate to them that there was trouble brewing. Bayer didn't care. Take a look at the DTC ads by "Dr." Jarvik and how much pain even Congress had to go through to take him off air (yes, I was one of the folks duped by the ads with him as well, and I am still smarting!).

This is new:

3. Bayer misled customers on Yaz and it's capabilities. The FDA entered into an "agreement" with Bayer asking for a minor correction in the ad - something that appeared fleetingly and is nowhere to be seen. Of course, after the initial celebration of a watered down, ineffective response, no one is talking about it anymore:

So, where does this all lead? It goes back to the same topic - the FDA, it's inherent weakness and the unwillingness of lawmakers to do anything about it.

Should we simply complain or come up with a strategy?

Yes, there are several strategies that can be employed - the least effective of which is the one President Obama wishes to employ: blindly continue the same course for the FDA and simply hope that dumping cash and new leadership on a dead mechanism will somehow fix things. Which, is exactly what he has done today. Given the level of promise for change, disappointment and frustration are on the rise.

Here are a few things Obama and Congress can do, at least in the future:

1. Stop thinking linearly as far as the FDA goes. In today's speech, Obama's primary focus was on food, probably motivated by the salmonella outbreaks. However, the FDA regulates much more - drugs, devices, food and a whole array of things. Today's speech confirms that even the President has a poor grasp of the FDA's reach and the necessity to stem it.

One single organization cannot regulate so many aspects of health anymore. Yes, yes, we all know they have subdivisions, but we also know that has basically done nothing. Food administration has to be separated from drug and device administration.

Given the fact that drugs and devices have to be regulated together, one organization should do it. However, they should be distinguished by separate administrations with distinct leadership and separate teams.

2. "Warning letters" and "agreements"

The FDA's business is regulation, not officious groveling to businesses. This is the key point missing in how the FDA is run and how it acts today. In the case of Dr. Jarvik, the Bayer Aspirin ads or even in the case of Yaz, there should have been stricter punishments handed out.

The FDA has failed to act appropriately on all counts. They did not identify the issues at all in some cases - Dr. Jarvik was a fall out of Congress begging and groveling in front of Pfizer for information. The ads kept running for a whole while before Pfizer removed them, almost as an act of condescension, not repentance. The same goes for Bayer with their "dietary supplement nonsense".

This is why the FDA has absolutely no standing anymore. Organizations continually paint outside the boxes and sometimes the paper itself, and they have very, very little to answer for.

How is simply appointing a new head of the FDA actually going to change this? A simple change in leadership is not going to eliminate the regulatory cancer we suffer from.

The solution exists. The strategy exists. However, a lot more action is needed for implementation, bold and quick and unfortunately the President does not seem to be up to it...

Sunday, March 01, 2009

Form 483s - With surprisingly meaningful advice, is the FDA on a path of self-correction

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So, the cat's out of the bag. A form-483 is not for your entertainment only. The FDA does want you to pay attention to the 483s if you got them.

I still think it is a little backwards for the FDA to make observations, but not necessarily enforce. The only logical alternative would be that the FDA does not want to penalize you for shortcomings that may be inadvertent and can be overcome voluntarily.

If you receive a 483, here is what the FDA wants you to do (there is some value in repeating somethings straight from the horse's mouth):

1. Not sit on it (okay, that was mine).

2. Assess each of the FDA observations and let the FDA know through a response whether or not you agree with each of them individually.

3. Consider the root causes of all the FDA's observations that you consider as valid.

4. Try corrective action, and if you are able to achieve corrective actions, mention this to the FDA.

5. In cases where corrective action is not promptly forthcoming, send a well-devised action plan to the FDA.

To quote from the article directly: In summary the FDA believes that “a well-reasoned, complete, and timely 483 response is in your best interest”.

And, here is a link to the FDA Presentation on this matter:

Keeping your plant in self-check is probably the first step to avoiding 483s and warning letters. Your "strategy" should not be, "let's wait till something goes wrong". Would you rather have an excellent record or a 'corrected' excellent record?

Yes, perfection is not possible, however, aiming for it most definitely is.

Remember, the FDA itself, in its current state is an organization with veritably very poor standards (peanuts, syringes and Avandias give you any ideas?) on every front.

If you can't even meet the FDA standards for your manufacturing plant, then....