Irressistable to post: Hollywood Meets Riegel, Drugmakers and FDA: uninformed and uncompensated lab rats

[Click on Post Title for Link to External Article]

I don't care what you think of me, I don't know who Dennis Quaid is. But, I like his Hollywood style. Though brazen and "filmy", I completely agree. There is a problem with pre-emption. The FDA becomes judge and jury. In any democratic legal system that is a debacle.

We all know the effects of that. One has to only look at how the USPTO "regulates" or until recently tried to "regulate" itself and all of its customers, leaving a very bad taste in the mouths of several lifescience companies.

However, some of them are now trying to hide behind an anologous federal agency pre-emption situation.

Why wouldn't pre-emption benefit all of the industry? Very simple. Let's say your competitor is really selling a terrible product. And, unlike the present times when the FDA is displaying unparalleled levels of leadership, if said leadership were to degrade in quality at a future point in time!, neither you nor said company's unhappy customers have a reprieve.

All that needs to happen is, the FDA can take a look at boiling hearts and squeaking hips and say, "Bah, that was expected. It was not the manufacturer's fault. That is our decision. Of course, the investigation is closed and we won't tell you what happened". While this disastrous drooping of levels in the FDA is next to impossible, this is not just an unhappy customer's headache.

On the other end of the stick, is a problem where this happy state of squeaky hips, burned catheters and other quirks pile up for a while and then an appalled Congress picks up from there and over-regulates the industry. Getting a 510 (k) approval is tough enough, who wants new headaches?

Doubt it will happen? Tell that to the folks trying to end Sarbanes-Oxley.

From these two perspectives it becomes very important that Riegel should not have gone down the way it did. And it did. So now we are in trouble!

It is binding on any society that expects quality in service to create and maintain a system of checks and balances. Otherwise trust, efficiency, creativity and all other elegances will disappear into nothingness...

In face of this, it is important that Congress listen AND understand AND exercise an appropriate system of checks and balances.

Lets see if we succeed or wait till other Hollywood, YouTube, FaceBook and "Can you act stupider and sillier than a 2nd grade child" stars also show up screaming at Capitol Hill....

Off Topic: Customer Relationship, "Jigsaw" and the funnies

[Click on Post Title for Link to External Article]

Well medical device companies have customers as well right? At least not all of us can afford to sell squeaky hips under the guise that they would outlast time itself...

So this may not be so off-topic after all!

Here is a funny thing that happened to me with respect to "Jigsaw" a social networking, online card-exchange, and oh yes, differentiated as "Professional" grade company.

So, I open up my email today morning and Jigsaw sends me a WEBINAR invitation with the title "Take care of your customers or someone else will".

So funny, ha ha.

A few weeks ago, they sent me a survey. Being the oh, so diligent survey filler I am, I filled their survey.

I had some suggestions to make for their survey.

I contacted their support team with regards to it.

My email to the survey-send address bounced.

I duly forwarded that also to their support.

Never heard back!!!

Follow what you preach...or not, eh?!

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:

http://www.fda.gov/foi/warning_letters/s6627c.htm

"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. Hmm..how 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:

http://mrw.interscience.wiley.com/emdi/articles/emd194/frame.html

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....

This just in: Let's lynch..er, sue the messenger - A story of JAMA, the "Hipsaver" and a general threat to the art of scientific quest

[Click on Post Title for Link to External Article]

Alternate Title: Professionals from which field have the best opportunity in pharma/medical device companies?

Hopefully, the title was sensational enough for you to open it. Thanks to Dr Aubrey Blumsohn from the "Scientific Misconduct Blog" for highlighting this one..ironically, maybe there needs to be a new blog, "Blog on Misconduct against Scientists".

( Link to the original article )


Without much further ado or sarcasm, lets jump into what's going on here:

Hip Protectors have been long touted as a means to protect against fractures in the elderly. This is closer to home since my own grand mother is now ridden to a walker because she fell down unconscious following an anemic spell and broke her hip. I used to wonder, maybe, just maybe the Hip Protector could have helped...

That said, it is quite possible, and seems increasingly so that "Hip Protectors" are not effective as they are currently being designed and sold.

So what would you do?

Let me tell you what I would do:

As a mechanical engineer who has worked on medical devices, a small bulb would go off in my head. Disturbing as it may sound, this is an excellent "market opportunity" to build a more reliable, better functioning device that actually protects hips in the elderly..!

How about that?

OR

If I truly thought my device is better than the one the author of the paper used, I would prove it!

How?

I would publish on the JAMA with the proof. In case you haven't noticed, Journals and Publications routinely open themselves up for "Letters to the Editor" and other avenues to "right wrongs"!

Here is what I would not do:

Go on a semi-suicidal mission to "kill the messenger"!

How much below the failing grade in your Public Relations 101 class must you score to NOT realize that suing someone for publishing on the JAMA is a terrible, terrible idea!!!?

From Pfizer to Hipsaver, the biggest opportunity I see for professionals:

1. Please offer them some PR services! Somehow they forgot to staff those departments...

2. Somebody create an "ethics" training program, because many of our friendly, neighborhood healthcare companies are disconnected from their basic missions including:

2.1 Thy primary duty is patient safety.

2.2 Thou duty is to NOT bribe physicians.

2.3 Thou shalt never THREATEN and/or COERCE physicians into USING or ENDORSING or NOT DENYING THE EFFECTIVENESS of your device....

Watch out this blog, the Scientific Misconduct Blog and possibly other blogs as the "fun" starts..

Footnote: From Copernicus to Galileo and to modern times, it is deplorable that constant efforts are made to stifle scientific inquiry. It is a fundamental right of people to question, prove and disprove the current state of medicine. How else are we to know that medical device and pharma companies are at least better than glorified "snake oil" merchants? The Riegel case and this one are just tiny cogs in a giant wheel that tends to want to crush the ability of the "common man" to even question device and drug companies.

With the regulatory agencies' fascinating levels of self-admitted incompetence becoming apparent, who is to guard the gates? Or, maybe we should all succumb to the most terminal, incurable disease: fear and absence of independent thought...

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Guest Post: Cell Phone Camera Becomes Medical Microscope

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Many physicians are finding convenient and cutting-edge uses for their handheld technology these days. This is particularly true for doctors who use various medical applications with their iPhones. However, ABC reports that a recent breakthrough has been made with a simple cell phone camera. There is now a device that can turn that camera into a medical microscope.

This recent invention is courtesy of doctors and biophysicists at the University of California. Known as the "Cellscope," its inventors first intended it to be used in underdeveloped countries where medical equipment is scarce. However, it may have an even broader appeal throughout the world.

By using the Cellscope device on a cell phone with a camera, a magnified picture can be taken. Not only that, but it can be emailed with the assistance of Bluetooth technology and a wi-fi connection. With more cities worldwide being connected to wi-fi, it isn't implausible to imagine a physician taking a picture with the Cellscope and emailing it to a lab or colleague with very little ease.

The researchers who are working on the project have suggested several other uses for the camera. It could be used at home, for example, when a patient would like to send a picture of a skin condition to their doctor. Or, perhaps cancer patients could even monitor their own blood cell counts at home.

If you think the Cellscope is a great idea, you aren't the only fan of the project. Microsoft has just extended $100,000 to the Cellscope project in order to help complete the development. This could be something huge for the medical community in the near future.

About Susan Jacobs:

Susan Jacobs is a part-time teacher, as well as a regular contributor for NOEDb, a site for learning about and selecting an online nursing degree program. Susan invites your comments and freelancing job inquiries at her email address susan.jacobs45@gmail.com .


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Back to Blogging after a long hiatus

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After a rather long, self defined hiatus, I am back to blogging medical devices and especially biotechnology. It is plausible that in the future there will be more from my side on biotechnology.

The first post following this one will be a guest post.

First off, let me introduce Susan Jacobs:

Susan Jacobs is a part-time teacher, as well as a regular contributor for NOEDb, a site for learning about and selecting an online nursing degree program. Susan invites your comments and freelancing job inquiries at her email address susan.jacobs45@gmail.com .

Please be sure to read her post and send her your thoughts and comments.

I am also very open to having other guest bloggers post on the blog.





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Weekend Cap: Heard across the medical devices and pharma world today..

Here are a few things that I found intriguing today...

Following up on several different letters that Congress has been sending off to the FDA, here is a nice summary on the FDA Law Blog:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/01/hot-bothered--.html

Seems like a nice little letter writing competition between the various people at Congress, doesn't it?

Here is a blog on lawsuits against drug experimenters and some huffing and puffing about torts and informed consent:

http://blogs.wsj.com/health/2008/01/31/when-drug-trials-go-wrong/

How does the HIV hide in the body?

http://www.washingtonpost.com/wp-dyn/content/article/2008/01/31/AR2008013101938.html

and, before we bid adieu, on the unnecessary patent "reforms"

http://www.patenthawk.com/blog/2008/01/justification_please_1.html

And the latest authority on Drug Eluting Stents? Boston Globe...who would have thought, all you needed was pretty charts!

http://www.boston.com/business/healthcare/articles/2008/02/01/crucial_studies_turn_in_stent_makers_favor/

Enjoy your weekend, and come back Monday. Who knows what study will try to cloud what mystic hill..?!

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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Women's Health, Fibroids and Liver Cancer: Embolization gets a new breather..marketwise speaking..Any other indications?

[Click on Post Title for Link to External Article]

Champagne bottles must be popping at BioSphere today. They have dipped into the Chinese market, thus proving what an advantage it could be for companies if they started selling in India or China.

They also saw an immediate spike on their stock price..

Moving on to Fibroid Embolization, I have always been curious about why this procedure did not take off more in the US. Of the 600,000 odd hysterectomies a year, about 40% are related to Fibroids directly or indirectly. That is about 240,000 procedures.

Comparitively speaking, there have been only a total of 50,000 (as of 2005) to about 75,000 (just my stretchy guess. don't quote me) UFE procedures worldwide!

I can probably think of a few good reasons:

* Would gynecologists be willing to place their patients in the hands of Interventional Radiologists?

* Gyn-Surgeons prefer to do hysterectomy, and there are some dubious studies that claim that hysterectomy is actually a good option. [Refer to the bottom of this post for an "interesting" example]

* Embolization of Uterine Fibroid Arteries has been around for about 10+ years now, and has festered in the absence of strong scientific publications or long term studies backing it. A few studies have taken place, but are by no means large enough to justify a shift in treatment standards.

* Embolization cannot be the best solution always, since fibroids occur in multiples usually and it is not possible to accurately pinpoint or embolize arteries feeding all fibroids.

* Arterial embolization requires, among other things, good visualization, and in cases where the Uterine Artery or one of its main branches has been harvested by the fibroid to vascularize, embolization cannot be an option.

Among my other worries, something I wish to find out is, what are the risks of the microspheres, bioresorbable or not, in terms of their ability to cause thrombus related cardiovascular problems elsewhere in the body? Though this is sparsely discussed, again, for the want of long term follow up, no statistical data is available.

Well anyway, it still seems like, outside the US, where the lines between the practice of Interventional Radiology and Gynecology may be thin, or owing to the fact that hysterectomies tend to be expensive, it is possible that the availability of microspheres could help increase the number of UFEs performed worldwide, thus allowing us to see some long term data emerge, painting a clear picture...

As to primary liver cancers and Embolization, a similar lack of data seems to be the basic problem, although very honestly, I have not spent a lot of time looking at the problem area. Comments are welcome!

----
The Dubious Hysterectomy Debate:

http://pub.ucsf.edu/newsservices/releases/200704091/

This study in particular makes me very uncomfortable.

We don't have effective therapies for fibroids or pelvic pain - reasons for which include the inability to accurately pinpoint etiology and origin of pain. There are several options for menorrhagia, the leading product being NovaSure.

This study claims that since people with fibroids, pelvic pain and (wrongfully so) abnormal (typically heavy) menstrual bleeding do not have many treatment options, and hence will undergo hysterectomies anyway - one should now consider undergoing a hysterectomy to avoid "years of pain".

This strategy is very dubious, and fails to account for emerging treatment strategies as they relate to menorrhagia and fibroids. I am not very clear on chronic pelvic pain, but I am hoping someone out there is trying something.

So, instead of shying away from hysterectomy and encouraging other treatment options, the study snidely suggests that women should just be offered hysterectomy as a preventive measure.

Somehow it is a very disconcerting point of view....




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MRSA, UCSF, Homophobia and General Idiocy - how they destroyed one school's credibility

[Click on Post Title for Link to External Article]

Here is how they linked MRSA to gay men in San Francisco.

They had a suspicion that MRSA and MSM had a link, so...

They took a look at a few charts in San Francisco.

They took a look at a few charts in Boston, because gay men don't (or maybe can't?) live there (another stereotype - hey, when you are dealing with one, why not throw in a few more..).

And they said, well yes, people in San Francisco have MRSA infections. San Francisco has the Castro Area. Another stereotype of the Castro? Gay Men having anal sex in abandon.

Now, lets put two and two together and publish a "scientific" paper.

Why do they "regret" the fact that they were trying to stress "general population" and "Mommy, no one gets what I am trying to say, boohoo?!!"?

What, do you think we are all just a bunch of idiots?

You work at the University of California, "SAN FRANCISCO"

In case you need more help, the University of California where you work, is in San Francisco.

San Francisco is in the United States! Whopee!

And in the US, there are people who don't like gay men.

So, how is it that you did not realize that your irresponsible "scientific" publication will be misused?

See here is my gripe. Commonsense and Scientific Prowess cannot be independent of each other.

It may very well be true that MSM may have higher incidences of MRSA and that may be linked back to unsafe sex practices. It is not just your responsibility to point, laugh and then leave. As scientists and Doctors, it is your primary responsibility to make sure messages come across in the right way.

Here are some hints for your next publication, "There may be a link. Further reports are needed. While we continue our research, we are asking people to practice safer sex. There is some indication that MSM may be at higher risk, and so our message reaches out to them as well".

This way you wont hand out a bunch of homophobes some premium quality PR material.

Or, here is another hint. Now that your irresponsibility has become so self-evident, please, just don't publish anymore...


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Why are the Lipitor ads still on? (Or) Does the Congress matter anymore?

[Click on Post Title for Link to External Article]

Trust me, I am not on an anti-Pfizer streak or anything. But, I had just posted this in passing in one of my other blog...and I thought Pfizer would be quick to react and actually take Dr. Jarvik off the air...

See, it was a lesson in deception I had to learn again. When the dude Jarvik first started showing up, I really thought this guy used to practice at some point of time...even if he was not practicing as of the time the ad was up.

However, when the Congressional investigation first started, I thought, "Hey, that must be a mistake". And then reality kicked in..

Here I am, arrogant enough to think I am a "healthcare professional" and assuming that I know a thing or two about how things work...but look what just happened!

Okay, where is the FDA now? Why is Congress the only party concerned?

Boy, regardless of the answers to all those questions, one thing is for sure - Pfizer has a sucky PR department...

Their claim to fame in the whole game is that Dr. Jarvik asks "patients to consult their physicians".

I see, so this is the "barely legal" version of the generics world.

So does Congress not matter anymore? Yeah, it doesn't - unless they rope Pfizer, the Boniva guys and the FDA for its now infamous inaction on such matters.

Rewind back to 2004 when the friendly, neighborhood FDA was supposed to rope in on all Direct To Customer Ads such as Paxil, Wellbutrin and so on? Whatever happened to all that?

Does the FDA actually tell us what they plan to do or what they are supposed to be doing but won't do?

Its good that the T.Rex has woken, now it must take action on all parties concerned....wonder how many innocent people thought Dr. Jarvik was giving them free medical advice..

As for Pfizer, are they testing someone's patience with such PR disasters: Nektar, Nigeria, Dr. Jarvik...what next?

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My Medical Devices Blog: Noticed by the alma mater...

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If you have paid enough attention to my profile, you will realize my alma mater is Stanford University. I am very proud of having been a student of a University that represents a clear and ambitious vision for education and progress.

On a more mundane note, Stanford is trying to list the blogs being published its students, faculties, employees, alumni and other stakeholders alike - a truly vast undertaking indeed!

I submitted my blog and got listed! I do hope I get some traffic from this reliable back link to foster discussions and education on medical devices, biotechnology and related industries.

If you are from Stanford, you might want to pay a visit to http://blog.stanford.edu to either get listed or to take a look at the dozens of amazing blogs being posted there.

If you are not from Stanford, You should also check back with your alma mater to see if they offer similar services.

Kudos Stanford!



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Nigeria: An example of risks of global business or risks of stupid business?

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With a little bit of help from places like FiercePharma, Pfizer may try to make itself look like the victim of "doing business globally". Well, I disagree, without any due respect whatsoever.

I come from a country, India, where you would be doing business "globally". Yes, we have an idiot for a health minister and what not, but more often than not, companies have been shoving business across the world to avoid regulations in "developed" nations.

And then, the rude awakening happens when the "developing" or "third world nations" "dare" to create a rule of law situation!!!!

While it might be true that meningitis can cause disease and disability in and of itself, here are a few things Pfizer needs to answer:

1. Did they do appropriate patient education or did they just let it slip? I am not talking about shoving oodles of legalese under patients' noses and forcing them to sign, but I am talking about encouraging doctors to use the utmost sensitivity to educate and warn their patients before allowing them to become subjects of any form of experimental studies?

2. Why wasn't (or Was) Pfizer proactive in suspending the trials as soon as things went wrong?

3. Pfizer does seem to promote aggressive abrasiveness when it comes to dealing with disgruntled patients. Yes, yes, we all know how expensive drug development is, and how torts are, but people "died" - as in, they went dead. Finito. Do you really think insensitive aggressiveness and playing a blame game with the Nigerian government is what the patients' families need?

Just take a look at how they are strong arming torts in the Celebrex case. Just today a NY Judge followed a SF judge in saying that the folks suing Pfizer do not have enough scientific proof that Celebrex caused heart attacks. While this may very well be true, this seems to be a problem for the FDA and Pfizer, not for relatives of folks who died. There seems to be something very disingenuous about the whole thing.

I don't understand how these highly paid individuals who lead large companies believe that brutal show of money force can solve problems that people deal with at an emotional level. It may be possible in the United States, but get used to it not working where Capitalism hasn't succeeded...yet.

Don't blame it on the "globe". Its not like people in Nigeria have no brains. They know that aggressiveness is what Pfizer uses and that is the only thing they will probably respond to. You should get used to the taste of your own medicine...sounds ironic for a drug company!

End the "holier than thou" attitude, Pfizer. You too FiercePharma - stop referring to Nigeria and the techniques of its people as "infamous".

Just try repeating this in China or India and see what happens. It does bother me now that the US seems to be the only country where such bothersome aggressiveness is tolerated.

And no, don't come back trying to educate me about the need to stumble in the drug discovery process. Its not like Pfizer's executives are out of their shirts. All they do every time something goes wrong, is fire a bunch of scientists. The company is doing just fine.

Big Pharma is mostly in trouble because it has grown too big too fast. The lesson of "global" business in the "21st century" might be that, you might actually have to look past mere cliches and actually pay attention to people's sensitivities around the world. Doing business across the globe will actually involve more than flying around in company jets on company credit...put those MBAs to good use!

Go back to Nigeria, apologize for your attempts to blink and make it go away. Take responsibility, and promise to act responsible. Both parties need each other and prevent companies from saying, "Pfizer ruined it for all of us".

Man, someone should invent the commonsense pill....

On that note, there are many non-practicing Doctors like Dr. Jarvis who are now "experts" in Lipitor or Biomedical Innovation who need to be weeded out:

http://www.cardiovascularbusiness.com/index.php?option=com_content&task=view&Itemid=89&id=403

Hippocrates must be spinning at the speed of light in his grave....


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Medical Device Myth Busters: Can Linux meet the cut with FDA?

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Disclaimer: I am not a Linux hater. However, like Will Smith in iRobot, I am allergic to "BS".

The credit goes to slashdot for showing me where the original link is:

http://knightvision.calvin.edu/bbcswebdav/orgs/ENGR/senior-projects/2007-08/Team06/

[This is an interesting project. Nothing against them either. Ah, to enter the magical world of incessant disclaimers..]

Linux users usually piss me off with something or the other. This time, it is by spreading this vague notion that the FDA would like to side with devices based on Microsoft (who else?) For all the brouhaha, Linux adoption has been slower than that of handicapped snails....not because Bill Gates and Steve Balmer double up as "thugs of the night" going around slashing electrical wires and smashing monitors wherever Linux is used....

It is mostly because people who work with Linux have this ad obnoxium problem with using Linux for what it is. Instead, they always have to somehow make it a Windows problem...always fighting the "man".

A very simple "Google" search produced "Merlin"

http://linuxdevices.com/articles/AT2024685245.html

-a device that is used in CRM.

(That's a real medical device by the way. I am constantly nagged by people posting monitors as "medical devices just because they will be used in hospitals. I don't have a problem with someone marketing their product as strong and ready for use in hospital environments - but equipments and devices that directly aid a person's treatment are different...a helmet helps you keep your head working(class I device), a monitor helps the doctor(usually does not require approval). A doctor who drops a monitor is... here is a link to this ignominous monitor: http://www.linuxdevices.com/news/NS4916097677.html )

'Tis the season to rant, but Merlin seems to have done fine with FDA approvals. And I am sure if I dug deeper, I would find enough software and OS based on Linux that are probably being routinely used in medical devices.

Validated Software and Operating Systems

It is not that there will be a witch-hunt when devices fail, but medical devices need to be "validated" to be "approved". So, a disciplined development approach is needed. While it may be great to think of downloading an entire operating system and making whatever the heck we want of it, a disciplined approach is needed for use in medical devices.

Imagine lying on the OR table while the OS or software springs a little "surprise". No one would like that now, would they?

Validated Linux OS, Software, and Unix Software are commonly used in medical devices. Here is another reinforcing link:

http://public.kitware.com/pipermail/vtkusers/2006-October/087594.html

Here is a paragraph stolen directly from that link:

"In short terms, medical device manufacturers can usesoftware from third parties as long as they validatethat the software behave as intended in the medicaldevice. The degree of validation required for a packageis relative to the confidence that such package mayhave developed in the industry."

What will it take, anyway?

In short here are the ways in which Linux can see increased adoption in the medical devices industry:

1. No negative, Windows is the all consuming evil - marketing, please (and that's not just for medical devices). Thing is, it always feels great to think all corporations are out to get your goat, but so is every honest-to-salt business man. You have to compete. It's not Microsoft's fault that at some point they were really good at it. Linux developers, for the most part still haven't left their teenage rage behind..

Practicing physicians and surgeons do not care about your phantom wars.

2. Adoption breeds on adoption. There are Linux based devices out there. Use these as examples when you plan to design software for your medical devices and definitely reinforce these when seeking approvals from the FDA. Learn and understand how medical device validation works. It is not unlike software validation in general, its just more procedural. (After all, you don't want your CEO in prison for your coding or commenting shortcomings, now do you?)

That's it! Get set go! And don't blame the FDA for poor Linux adoption. (That note is for our anonymous friend at Slashdot who tries to peg the wrong reason for the "extremely rare" adoption of Linux for medical devices). There are several hundred other real problems among which you can pick and choose - to blame the FDA :).

Happy Developing!


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