Monday, May 12, 2008

Stryker - Now, with squeaky hips....oh what a mess

[Click on Post Title for Link to External Article]

While the hip jokes roll on, I apologize to anyone that may be offended.

I am sure you awoke yesterday morning to squeaky hips. From NY Times to thousands of bloggers, including yours truly (who could not but give in to coming out of his cave for this) have been waxing eloquent about the squeaky hips issue.

The problem is, this is not just about squeaky hips. Its about:

1. Stryker (and we will revisit this, I am certain)
2. The FDA
3. Preemption!
4. Post Market Follow Up (a surprisingly new concept for medical device companies with large market caps)
5. General Company Goodwill to customers, the lack thereof, idi...wasn't I supposed to revisit something? :)

Well, so where do we begin?

I think I will go for the letter writing contests called "warning letters" and the hard won "preemption" guilt-relief that the FDA afforded for medical device businesses everywhere.

So, hmmm...let's see. Avandia, Vytorin, Dr. Jarvik with his very helpfully misleading qualifications, medical practice (the lack thereof, rather) and ads, catheters burning inside people, the dude selling medical devices from Hungary in case anyone recognizes him, the fake-heparin touting, mysterious, unnameable (well, go find out! Its true. The FDA won't name them!) Chinese salesmen of lore and now this...

Apparently, Stryker was sent a "Warning Letter" (which itself is now under review after a company pointed to a rather surprised FDA that the letters were so detatched from their purpose as to be 100% gobbledygock) last year.

True, they sent out a letter, but the funny thing is it doesn't actually allude to the real number of patients who have complained of the squeaking.

Plus, who will trust a letter with impertinent references to the Finnish. What? Do I not make sense? Well, here goes:

"However, your finn has not prevented the recurrence of poor fixation of the hip implant component or prevented the failure to function which has resulted in revision surgeries"

Unless the FDA has been secretly requiring all medical device companies (or just Stryker) to employ a finn (Finn, more respectfully) to solve their problems, this demonstrates the level of competence these letters bear.

Of all the people writing about the Squeaky Hip Phenomenon (and that is not a reincarnation of the Flower Children's (carefully sidestepping the childrens joke created by the super-chief of all Federal Organizations)endavors of 1969), the most silent one is the FDA.

It is now clear through several examples that another 1300 or 13000 employees will fail to make a difference, if the FDA does not reign in some of these fundamental issues.

While semantically federal preemption sounds great, a letter and an NY Times Article is not going to push some of our friendly, neighborhood device manufacturers into post-market follow ups and complaint handling.

The orthopedic industry, previously famous for its chivalrous bribery and other favorable forms of nepotism, now dragged this to its own house.

Anyway, I digress (you say, "You think!?")...

Why is the squeaky ceramic hip replacement a "mystery"?

It is really not a mystery. Its either a fixable problem, or Stryker should have stopped selling those.

"Defects in the product's performance arise due to improper usage by surgeons and patiens" - is not the answer. The only point where I agree with the FDA's "letter".

The very premise in cGMP is and if not, should be, that the product should not be prey to the whims and fancies of those fast and loose surgeons that seem to never learn how to use any of the FDA approved products. I wish we could do something so that companies are required to train surgeons...wait a minute, aren't they supposed to do that anyway? Oh well...

If this were a smaller firm, they wouldn't try to push the blame that way, boosted by the paucity of grandeur and a need for good publicity.

Also, it is a warning to people wanting to walk around with Stryker's hip replacements that their surgeons and they alone (also fondly described as "patient variables") should currently face the blame for all the unintended Herman Munster impersonations...

"failure to achieve initial biological fixation" (from the letter)

Here is a somewhat non-fundamental definition of fixation:

Well, really, how much does patient variability come into this?

Alright, if it does, how so?

Then, why weren't new instructions created so that the surgeons would then contact their patients and let them know of ways to reduce their own variability in this? (Well, its impossible, so let's move on..)

What did the surgeons receive in terms of new instructions to modify their surgical techniues so that a desirable initial fixation can be achieved?

The rest of it is garbled in the letter, but you don't need invaluable degrees in engineering to realize under what circumstances two bodies rub against each other so as to squeak. Lets do a little bit of Engineering 101 brainstorming:

1. Two bodies rub against one another in unexpected manners when the interluminal lubricant is missing, or is lost due to other causes.

2. The body is not strong, is corrosive and otherwise subject to loss of material, that changes its interaction with surrounding objects, in this case, a counterpart composed of the same material.

3. The material has non-linear properties such as fatigue, creep and other behaviors that were not realized through veritably appropriate, but accelerated (and thus, eventually inaccurate and unnatural) aging studies.

4. The material, composition, design, tolerances and lubricants all accounted for, there may be defective manufacturing and/or quality processes in play, leading to a loss of properties.

Alright, how many more can we grab if we go down the brainstorm. You are right - we could be here, all day long.

But is this really a problem?

Most likely, yes. First, it is psychologically demeaning. If I were wearing one and it squeaked merry, I don't give a damn as to whether or not this outlasts the supposedly inferior plastic and metal ones. Who the hell wants to drive around a rattling Bimmer?

What is the solution?

1. Well, some if not many of the 7% of defectively squeaky replaced hips have been replaced, I am certain. If not, I am sure at least a few more are on the verge of being surgically replaced. Stryker should get their hands around some of these. Grab 'em, and test them.

2. These patients must also have had extensive radioloical exams during the post-operative process. Get them and test them. I am sure you have to wade through HIPAA and other issues but the summary un-squeaking of replacement hips is a much more urgent desire than any other...

3. Even for the patients in whom, the culprits still reside, it is possible to perform appropriate radiological exams to examine what's going on.

4. Play with ones that have never been implanted, accelerate them, age them, but try to find out what's wrong with them.

And yes, we could play this game till the moon sets as well.

What is the main message anyway - the real root causes?

1. Post-Market Follow Up. It is almost criminal that such low quantity of follow up exists in our industry. If the company that makes them cares less for them, fine. But what about the competitors? The FDA? Someone should be looking at Old Squeaky Sarah and find out what's up!

2. It is clear that the preemption is acting as an inducement for certain companies in the industry to do as less as they please about the problems that crop up in their devices. It is not that anyone wants to welcome a slew of lawsuits based on misplaced commonsense. However, it is important to realize that in some cases, unnecessary delays, careless designs and such can be reigned in by juries.

3. It is clear that the lengthy approval processes (which hurt the good devices from being approved rather than improve upon bad designs) and very un-threatening warning letters are not working. Some device and drug companies exhibit an unabated degree of insolence and irreverence to the FDA and the US Congress. The regulatory environment, to the detriment of the innovative many, feeds to the whims of the careless few. I do not fail to recognize that the FDA has the world's best regulatory process. However, it is still not enough and absent the FDA this world would be a chilly place for patients...

"Overblown" (see the NYT article)

“It is important to keep this in perspective,” said Aaron R. Kwittken, a spokesman for Stryker. “Published research shows squeaking is rare compared with other total-hip-related risks like infection, dislocation and leaving patients with uneven leg length.”

Overblown you say?

Here is something NYT would like to share with the rest of us:

One study in the Journal of Arthroplasty found that 10 patients of 143 who received ceramic hips from 2003 to 2005, or 7 percent, developed squeaking. Meanwhile, no squeaks occurred among a control group of 48 patients who received hips made of metal and plastic.

So, what he is really saying is:

"Come on...(with a Peter Griffin accent). What's sheven percent eh, Louis? A little squeak in the legs should scare the kids into eating their breakfast cereal and never done no one no harm..."

Well, I am sure, apart from the 143 lucky hip recipients examined, in an aim to achieve and sustain profitability, these ceramic jingles were sold to several more. Amidst laughing wives and mocking colleagues, they might not have yet mustered the courage to reveal that the original hips that they came packaged with have been replaced with noisy toys.

Really, it never ceases to amaze me, the source of PR messages of these companies...

A Note

These enchantingly rare squeaks are not serving the hip-bearers and their wives anymore. These squeaks can be heard on NYT, thousands of blogs, this blog, YouTube, other tubes and in several other places. The squeak is now shrill! It may come as a surprise, but this might actually be classified as a problem now.

Next Edition: D'Antonio Vs. Orozco (see NYT, page 2)

Which one is the better surgeon? Who is telling the truth?

Conclusion - Opportunities

As I have lamented in the past, it is the mistake of the few that cause harm to all, in this case other medical device designers and patients in general. This is a great opportunity for young, innovative companies to learn to perform extensive pre-design and post-design analyses, testing and some more testing.

Keep a watch on what happens once the product gets released in the market and never, I pray and repeat, never, say "It's overblown" because that, is how, you blow it....

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