Thursday, December 18, 2008

Okay kids, squeaky hips are in again - solving an unconsciousable mystery....

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It's always great to hear from an old friend, isn't it? Especially when they produce squeaky sounds as they approach you! In case, you missed my blog from earlier this year (because you were reading random pie charts and "nice" stuff written by bloggers placing ads of the companies they were writing about)...

http://chaaraka.blogspot.com/2008/05/stryker-now-with-squeaky-hipsoh-what.html

Anyway, in May we all found out that Stryker had been providing hip replacements with added functionality - total, unassailable, humiliation to it's customers (no, not the Doctors getting cushy payments, free breakfasts, golf games etc.) - the patients that had to walk around with them.

As you walked with your brand, spanking hips, they would jingle or squeak nicely. Well, around the holidays if you are dressing up as Santa, that must come in handy - or hippy?.

Long story short, thanks to George Bush the Supreme Court Riegel pre-emption, Stryker has walked away, let's say, without having to squeak.

What happened after the news article came out seems to be a total mystery. With a highly ineffective Congress and Judicial System failing to hold companies responsible for grave errors that have put patients through extreme trouble, this doesn't surprise me.

After all, not doing what you are supposed to, or get paid for is the hallmark of...

Oh well.

The Analysis

What is intriguing is, that Stephen B. Murphy, MD is hoping to acquit most hip implants minus one - and which one that is, is anyone's guess.

Back in May, I had alluded to the material properties of the implants and had urged some testing. In fact, I said that the displaced or replaced hips (about 7% of all hip implants had to be replaced thanks to the squeaky joy) and do some fatigue analysis on them.

It turns out the material is probably the culprit.

If you read the rather confusing article on orthosupersite.com, Dr. Murphy points to the specific stem material as the culprit.

If you want a good introductory article on hip replacements, go to:

http://www.orthop.washington.edu/uw/tabID__3376/ItemID__70/mid__10313/Articles/Default.aspx

If you want a good image, go to:

http://www.exac.com/patients-caregivers/images/img_patients_hip_components.jpg

(Thank you guys).

"ceramic components mounted on a beta titanium alloy stem causes the squeaks"

To briefly recap, hip replacements are not new, so please do not accept any feigned innocence on new products. This is a tried and tested product line.

Dr. Murphy's study (which I have not read and vetted yet - I will report back later) claims that when a specific type of alloy, known as the "beta titanium alloys" that contain molybdenum, zirconium and iron are used, alongside ceramic heads, you get this problem.

This should be a slam dunk.

The study looks more like a literature review, but I am sure it is sufficient to indicate probable cause. My theories on the failure still hold:

1. There is a new material. If the FDA where to actually act and examine if the implant material was appropriately tested, I am sure short-falls will be noticed. The very presence of the squeaking in 7% of the products, the apparent attempts to "silence" the patients, not the hips, and a continuing fogging of whatever happened after the news came out in May should be a clear indicator.

When a company endeavors to introduce a new product line with a new material, shouldn't the IDE contain extensive data on material testing and properties, rather than just biocompatability?

2. Take a look at this study:

http://www.ceramtec.com/pdf/8thSymp-5-8.pdf

It points to several factors including "component design and engineering", patient selection and other decisive factors. Like I said, not such a mystery - the science or engineering. I would bet that if you reviewed the squeaky hips, "marketing requirements" would stand out as winner.

Whenever you have "marketing" drive "innovation" and product design, this type of result should not be surprising. After all, ages ago, I almost worked for one, and then did work for another where "marketing" aka MBA jockeys with little to no knowledge or concern for medical device efficacy were driving design. Where those products went, how innovative they have been since that point would be a child's guess.

3. Prove it - A good finite element model can produce enough information on impingement, transcendental friction, long-term wear, fatigue, and so on.

A good motion analysis will produce data on what happens in inaccurate placement. It could also indicate how much error the surgeon is indeed allowed in placement. It's fundamental kinematics that I am sure is well within the analytical prowess of today's software applications.

4. I said this before, and I will say it again - get those replaced, squeaky hips. Study them. It is so easy to do fundamental image comparison and analysis to reproduce the "altered" states of the failing hips thoroughly.

5. Be honest, for heaven's sake. When you print those brochures about saving people's lives - mean it! If you can't stand by one word of your "mission" or "vision" statement, why bother?

Well, this hip story is not over. I am going to try and access the paper, and find out more about the study itself. If you come across this blog and know something about other studies, please let me know.

Saturday, December 13, 2008

Blogging for fun: - The science of Dr. House..."ataxia"

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The premise: I watch way too much House, M.D. - I mean waaaay too much. More than the pills Hugh Laurie scores on the show.

And they keep throwing Kawasaki's Disease, Sarcoidosis, Ataxia, Leukemias, Lymphomas and what not.

And epithets like

"Idiopathic is a term used by idiots who cannot figure out what's going on"

"These procedures would be much simpler if we could perform them on healthy people."

"Relative to its size, the Gorilla has the smallest penis size of any animal."

"Relative to its size, the barnacle has the largest penis size of any animal."

So, I thought why not get something out of it, rather than just watch the show to Kingdom come...

Ataxia

Ataxia is the inability of the Brain to control the patient's muscles during voluntary movement.

Ataxia is usually caused by diseases in the Cerebellum.

The symptoms present themselves as the inability to conduct basic voluntary movements, inability to walk straight, staggering and so on.

So, until the next obsessive House, M.D. Episode...

Thursday, December 11, 2008

China: Now converting no-brainers into "medical mysteries" in an extremely polluted village near you...

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You must think I am such a brazen ass from the title. Except, I am not. I have a lot of sympathy for the poor folk in the Chinese village. Some of what perplexes me includes:

1. I have spoken to many people from China. They all seem to have this weird, controverted line of thought that the complete lack of even strands of democracy is totally "cool". This is in a very small (very, very small compared to China) way, similar to my experiences talking to my friends and neighbors back home in India.

Having been sold on the Kool-Aid of Democracy, I find it quite hard to believe it is possible for a state to not be a democracy and think for the common good of it's people.

I know, I know Singapore has this "Democracy that the Government enforces" - weird, but it is such a microcosm of a heavily progressive society where at least a member of your family is directly or indirectly in Government that it works.

However, when you take China, where protesting affords you a visit to a mental institution, it is not surprising that environmental battles would meet with no victories.

I mean come on, President Bush almost got away with all of our Clean Air Regulations in a supposedly, highly vigilant and proactive society...

2. Why would a country's Government, for whom pride and a public face of ascendance is such a priority, not bother to do anything about it's amazingly dismal environmental and health record?

Mind you, this village is all but a sampling, and we already know about baby food, Heparin, Lead, and the Olympics, the Earth Quake response ( and no, no one is forgetting Katrina. One sad Government failure at a time)....so much just piles up.

In the wake of all this, the lack of even rudiments of a revolution is just flabbergasting!

3. Why does China strongly believe that a positive attitude towards environmental and health concerns would necessarily be a bad thing for it's economy? This is a stupid concept sold solely on shall we say, people grouped with the letter "R" as the first of a word?

Why does everybody have to be sold on it?

I mean, imagine. The economy has slowed down. China is seeing fewer orders. Instead of simply pumping random shards of cash, which has proven highly effective anyway, why can't they jump into modernization?

Wouldn't that re-hash their economy, self-image and dignity without all the contortions, distortions, laughably transparent deceptions and so on?

Why is it that the entire human society is divided into little pockets called "nations" and "economies" - each one of which seem to be missing the blindingly obvious?

4. You know what is the worst part? I have not met a single person from China who would find it hard to understand the urgency or the obviousness of this problem!

And mind you, what is happening in China, is happening in India - and I just don't know what to say. It is probably not at the same level or is poorly reported.

So democracy or communism is not the answer, and I have the sobering feeling that I am leaving this post with fewer answers and more questions....

Do any of you have some answers for me?

Saturday, December 06, 2008

An exciting new vaccination technology to write home about...

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Reading this article took me back to the first time I read about the genius that Louis Pasteur applied to come up with the world's first vaccine. The concepts of vaccination have been building on the same basic principle - create an opportunity for the body to fend off the disease by vaccination and watch the body fight away the disease when it attacks later.

Read about the mechanism in the medicalnewstoday.com brief:

An "incapacitated" version of the flu-virus A is used as the train bearing a string of amino acids attached to a gene of the virus B and inserted into the body. This apparently (and I get it!) sets off an automatic and aggressive response, and what follows is similar to the antibody-antigen mechanism.

Next time the virus attacks, the body is ready!

The Novo Nordisk Foundation and Novo A/S are set to make a fortune I presume, if all of this succeeds!

But, there is more - there are two key aspects of the technology's effectiveness that the medicalnewstoday.com article refers to that deserve a plagiaristic re-mention:

1. The technology, InVacc proffers a rapid response - and, without expanding we are also informed that the vaccination will be effective even against rapidly evolving and mutating bacteria and viruses. I would like to know what mechanism dictates this second aspect.

2. The technology also instigates the activity of the CD4+ cells (in case you are wondering - CD stands for Cluster of Differentiation, a type of grouping of immune cells) that control the body's immune response. They lead to the active production of CD8+ cells - cells that form the body's defense mechanism.

It appears that the technology has already worked quite well in mice. I wonder how long it will be, before we see the first vaccine to come out of the this technology. More on this as it evolves!

Blog Brief: How to run a company - medical devices or otherwise...

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Two years ago, in the first year of his "professional" career in medical devices, a friend of mine, "not me", came to know that his plant was being shut down to "cut costs" and was being moved from where it was to another state that was offering "tax incentives". (This said state is no longer offering any incentives, its own economy having been..).

In all, a healthy, profit producing part of the organization was shut down. Not only that, it was rumored that the "executive" responsible for this received a healthy "bonus" for all this, to a tune of millions of dollars, not too far south of what this generous family offered up as a bonus to all their employees.

Can you imagine the same amount of money as this family offered to dozens of workers to one guy for firing north of a 100 folks?

Now, I will name no parties and trust that as a reader of this blog you will never try to find out who my friend is, what company he worked for and who this "executive" was by going to LinkedIn or Google or anything.

But why talk about that dumbass "executive" any way?

Immediately after that, my friend happened to work for another medical device company that also laid off 20% off its workforce minus the CEO who is almost singularly responsible for the company's ongoing miserable performance for the last 3 years.

This CEO was also laughably seen giving entrepreneurs advice in Ohio about a month or so ago - himself having never done anything worthwhile in his career, other than of course...

Anyway, let's look past all this.

Do you want to "start-up"? Do you want to "promote the rapid growth of your stellar organization"?

Then stop "seamlessly integrating" anything, or "fitting round holes into square pegs" or "streamline operations" or "initiate a painful, yet necessary set of "cost-cutting" measures" (yes, that was air-quotes in air-quotes)...

Fire your "C" level executives practicing "CYA" management.

Yes, stop the BS. And no, true advice never sounds pretty.

Be honest to your employees. Maybe you don't have to be like the Illinois Family who were caring for their employees even after they sold the company..

Maybe, just maybe, you will treat your own employees - the ones actually producing something other than Excel Spreadsheets and Powerpoint slides - with a little bit more dignity and respect.

Maybe, just maybe.

And, lo! you will have yourself a great organization - whether you are making medical devices, software or bath tissue...

Friday, December 05, 2008

Teach-Yourself Brief: Best practices for part numbering

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I have been quite busy and have found it hard to do any blogging. I was intrigued by a question on LinkedIn about "best part numbering practices" and a brief search on the web brought to attention this excellent link! :

http://www.bpic.co.uk/faq/part_nos.htm

I am sure there is more information out there, but this a good start. The next time I run across this issue again, I will update the page with more information.

I am sure others will be answering the LinkedIn Question. So, if you want to follow the thread:

http://www.linkedin.com/answers/business-operations/project-management/OPS_PRJ/378322-19515337

Friday, November 21, 2008

Well, Joe the plumber, I mean stent maker, I mean emancipated plumber, listen up...

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The Premise
The link up here refers to an article from The Canadian Press telling a grim tale of Angiotech's bleak future stemming from its inability to raise much needed funds.

And no, it has nothing to do with the "financial crisis" caused by banks that tried to make "something out of nothing". This has something to do with "drug eluting stents" which I also believe has a lot to do with the words something and nothing...

I have long lamented the lack of definitive proof that drug eluting stents, or for that matter if stents really work at all. The same question and lament goes to the "pioneers" of "balloon, bell and whistle angioplasty" who are labeling themselves experts and innovators quite generously.

Well, let's comeback to the stents beeswax anyway..

Not only have stents not performed in the market, they have also failed to perform inside the human body. Angiotech is just another proof of organizations that overtly stressed and counted on an unproven "technology", in this case Taxus.

What intrigues me is that the FDA has failed to question any of the drug eluting stents and their effectiveness. Our darling, the beautiful baby called "preemption" that the lovely Supreme Court handed us, allows us to theoretically assume that an FDA approval precludes "high levels of performance strictly in accordance with product labeling and marketing for which the device has been approved", how come reality seems to differ?

(Well, we all know accepting preemption is like stepping on horse do and continuing to stand on it, pretending the odor will just go away...well, if the device was put inside you and someone claimed preemption, how will you feel? Ever thought of that amigos?)

This is the last call for passengers of the "reality express" to dismount from the plumbing, er, stenting train.

Here are somethings to think about:

1. A nexus proof, large scale study on drug eluting stents. NIH should be dumping money on this, if at all to stop the money bleeding and waste on health care costs.

2. Companies, especially startups, (you know the ones that don't have too much money to throw away on full page ads, sponsorship of TCT and so on...) should really, really ask themselves if they want to go down the elusive, I mean eluting stent business?

3. VCs should really question further investment in stent companies. Let's see - where did Taxus get BSC and now Angiotech? What has Endavor done to Medtronic? And Xience, well its just Taxus (in case you don't know the whole Guidant story - which means a large portion of this rant makes no sense to you).

And no, I am not buying the bio-resorbable theory either..till I see scientific proof.

4. There seem to be so many companies with the -stent suffix, ThisStent, ThatStent and the NewNewStent..that soon we won't have "-stent" name combinations left...at least somebody stop it for that sake please!

5. Somebody should ask the FDA if it remembers what "post market followup" means. And they should also ask the FDA if they remember having something to do with enforcing something called "post market approvals and follow up".

People who advocate drug eluting stents to me right now look like people propounding all those "weight loss" drugs on TV.

Don't believe me? - I will give you a list of companies. Go look at their current status with reference to stents - BSC, Medtronic, Xtent, Angiotech...

A few random FEA runs on stent designs do not make for fundamental, analytical, scientific proof, without which we should rather be advocating healthier lifestyles and medical treatment.

Thursday, November 06, 2008

So, is there one thing that is not wrong with the FDA? Maybe Grassley should start checking off things that are right...

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Okay, so the FDA cannot get one thing right:

1. They have a very, very poor record on approvals - Avandia, Celebrex, Vioxx, Drug Eluting Stents (being continually approved despite the fact that EVERY single one of them has performance issues, fatalities and demonstrated weakness compared to medical treatment)

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!).

3. 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! :

http://www.pharmalot.com/2008/09/fda-tapped-pharma-consultant-for-dtc-web-site/

And oh well, now this!

4. The FDA mismanaged and harassed its own employees - overpaying them and then threatening them with collection letters and such...

It makes you wonder if the FDA is deliberately harassing its employees to make sure it helps filter any possible talent that may even accidentally enter the FDA so that it can, in the words of someone we are all trying to forget "pall around with the pharma and medical device companies"!

This at a time when the FDA has brazenly sought more money to hire 1,300 hapless souls so that they can underpay them or overpay them only to shower them with collection letters and insult and humiliate them as much as possible.

In times of steeped economic strife, they must be getting special kicks out of this.

It makes one wonder, how "change" can be brought to the FDA!

Will it be Grassley who effects this? Or will we be just adding more bullets to describe the miracle that the FDA is as years pass....

Monday, August 04, 2008

Navilyst: The newest new old thing

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Alternate Titles:

1. Clueless in Seattle (don't ask me why, I don't know :p )
2. Tutorials in branding, marketing and reading between lines
3. 10 things you cannot learn from THIS press release
4. Press Release for Dummies (the readers)

Alright, so August has me being a tad bit more cynical than usual (and you thought that it was impossible...). Now, I have nothing against the good people at Navilyst, but when Google Alerts started rolling in the press release through multiple websites, I clicked (or took the bait) hoping to see something new, some new competitor in some branch of medical devices and so on.

"A press release is a very useful tool..." - how many times did you read that in your "Tips for Small Business Success" or "Textbook for really expensive yet completely pointless MBA (expands to Much Bigger...) and so on.?

Yet, the press release is a useful tool, when generated appropriately. The key point to note, would be that the press release should also be of eventual use to the journalist, blogger and Google Alert fanatic, not just Navilyst and marketwatch.com .

Once I landed on the press release things got boring pretty fast:

Yes yes, it would have been terrible for the company to be called "Boston Scientific's old Fluid Management Unit sold to try and save company from a stock market debacle, Inc." (for one thing it would have been too long and too truthism-y), but one would hope for something beyond that:

"By 2011 the company should look very different than we do today--and that's exciting," - sorry Ron Sparks, being different from what you are in 2008 is below any bottomline expectation for 2011!

This is a sad case of people giving themselves stickers for just existing...or just a very weakly thought out statement for a press release.

After this, we come to our real world meanings of the several paragraphs in the press-release:

"We maintain the singular focus of a small, eager organization striving to improve patient care while collaborating with clinicians in the global marketplace"

equals "We are smaller than we used to be, in case you are completely incapable of surmising that yourself."

"Navilyst Medical combines the best attributes of an established medical device company--market-leading technology, superior clinical data, experienced leadership and proven worldwide sales and distribution capabilities"

equals, "We assume you dont know what it means to be an established medical device company because you might be out there presuming that you think one of these is not necessary"

Oh come on, yes we agree, you are projecting yourself as a full entity rather than a broken limb (no sales, marketing, etc). Well, no investor is going to be interested in broken limb companies anyway...

"We maintain the singular focus of a small, eager organization striving to improve patient care while collaborating with clinicians in the global marketplace"

equals space filler,padding, icing, pepper dumped on pizza to 'spice' it up or as the elderly sage said, "Hmmm..."

"Navilyst Medical manufactures and markets a portfolio of fluid management and vascular access products used during some of the most frequent hospital procedures including angiography and angioplasty. Navilyst Medical's Fluid Management business, including the proprietary NAMIC(R) line of products enjoys a leading global market share. Navilyst Medical's vascular access products include devices designed to provide access to the blood stream for patients requiring intravenous antibiotics, nutrition, chemotherapy, blood sampling and hemodialysis. The company's PASV(R) Technology, with strong clinical data, is uniquely designed to automatically close after infusion, disconnection or aspiration, and remain closed during normal pressure fluctuations, reducing the risk of complications including catheter-related bloodstream infections. "

does not equal Press Release. May equal "About Navilyst" in press release or website.

A very good example of what you could put in your $1,500 case study on "10 things to NOT publish in a press release with only 10 things" that you can sell to future company executives.

Barely existing or surviving is not an achievement. We cannot hand each other stickers for this.

Yes, I repeat myself here (about the stickers, of course). Hey, if press releases can do this, why can't a blog do it? And this blog doesn't digest and spit out full article tests (without miserably trying to 'entertain' you first!)


Once upon a time you thought a press release talked about something significant, so that you could spend your time reading 20 - 25 press releases and glean some information that you could use. Nowadays, what with all the "Optimize your SEO" guides out there, the "press release" has become a sad victim of the "Restating the blindingly obvious and/or mundane, Inc." movement...

Tuesday, July 29, 2008

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

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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...

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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

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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/

Sunday, June 22, 2008

Under pressure to publish? Publish a coffee study!!!

[Click on Post Title for Link to External Article]

Honestly! Trust me. You can never go wrong with coffee. Many people drink it, sell it, swear by it and some also swear at it. This should be enough to confound anyone and anything. And, to publish and see your name in the "scientific" press, you don't have to spend much. Just make a few guzillion pots of coffee!!!

Many moons ago, in 2004 to be precise, I was interning for a blood glucose monitoring startup and it was also the time when "Google Alerts" became the "in-thing". As a result, I had an alert set up for diabetes. And that's where the saga began.

I soon started seeing so many of these coffee studies pop up in relation to diabetes:

1. Coffee causes Type II Diabetes

2. If you drank more than x, y or z cups of coffee a day, you will not get Type II Diabetes

3. Coffee causes Type I Diabetes

4. Coffee does not cause Type I Diabetes (and in fact it doesnt, and there may never have been a study of this sort, but there were so many coffee studies, who can tell anymore?)

5. Coffee "may" cause Diabetes

6. Coffee "may" not cause Diabetes

7. Coffee and Diabetes "may not" cause Diabetes

8. Coffee messes with your testicular production quotas! (We haven't seen one dismissing this yet. But to date, this is my most favorite study ever. They had a bunch of men drink coffee and, er, counted 'em soldiers!? I suppose...)

Coffee studies have become the mainstay of pointless and needless publications. This one takes the "cream" I suppose.

You follow people for years and years and have them fill up a survey. What method could generate better results? What other scientific form of study could be superior to this?

If you spend a few minutes past the cynicism, here are a list of reasons why I have a problem with this "coffee" study:

1. "Coffee consumption has been linked to various beneficial and detrimental health effects, but data on its relation with death were lacking,"

- Yes, because, not many people pop after they drink coffee. Maybe the guy in the photo on Science Daily is going to, one of these days...

2. Coffee consumption was not associated with a higher risk of mortality in middle-aged men and women.

- Dissociation is not causation either. Coffee consumption was not associated with higher mortality, because you could not, based on your own assertion in 1 above.

3. The possibility of a modest benefit of coffee consumption on heart disease, cancer, and other causes of death needs to be further investigated.

- Insert the "Are you kidding me" cliche here! Heart Disease, Cancer and other causes of death? What is this, MOAS (Mother of All Studies)?

I don't understand what the thought process for this was. Cardiovascular risk is associated with any number of problems from congenital defects to a sedentary life-style, diabetes, alzheimer's, side effects from drugs?! and so on.

Cancer causes death through complex biological mechanisms.

And other causes of death? Hmm...let's see kidney failure, influenza, the hit-by-a-bus-while-reading-stupid-coffee-study-reports syndrome....

How is it that they could casually send out a bunch of questionnaires over a 20 year period and expect this to be a study with conclusions of any positive value?

Why is such drivel getting past "peer" review? Maybe the reviewers weren't drinking enough coffee?

And yes, if your head aches, get a little coffee...the caffeine helps get rid of a headache. That much we know. About hot flashes, alien landings and death....I am sorry, we haven't had a good study yet.

But, if you want to publish, you know what to do...whip out those survey monkey questionnaires, now that we have "modern" technology to bungle the same scientific reasoning principles...

Saturday, June 21, 2008

Follow Up: How 23andme is getting some free spin doctorism...who's buying?

[Click on Post Title for Link to External Article]

I also want you to read this one from the same blog:

http://mndoci.com/blog/2008/06/17/the-right-to-get-yourself-genotyped/

And my original post here:

http://chaaraka.blogspot.com/2008/06/my-husband-had-all-this-money-lying.html

Here is my problem:

Most things are actually not your decision. This viewpoint that because it is your body you can do anything with it sounds like something you hear from irascible teenagers and pot smokers.

This is not about you at all!

This is also not about whether or not WebMD is organizing information the way you would appreciate it and how 23andme is better organized at rehashing the same information.

This is about vulnerability.

Of course they are not "telling" you that you should get yourself tested. But heck, they are implying it.

And if the Doctors know less than you about genetics (from the second blog I believe) - however believable that statement might be - it doesn't solve the basic problem.

The practice of medicine is mired by its own puff-able concept "Gold Standards". And even then, genetics hasn't gotten to the stage where insurance will pay enough and Doctors will pay attention. It will get there soon, not just yet.

But, we need to get back to the context.

Here is the problem with 23andme and its Redwood City look-alike:

1. We understand very little about how genetics actually work, even less about why SNPs occur, how they are triggered to start up or shut themselves and so on. Yeah, we know something...we have no clue about most other things.

2. In case this is news to you, people are gullible. The guy who's dad just died from Colon Cancer, the lady who's mom died of breast cancer. 23andme, believe it or not is a lovely, expensive trap for such people.

3. Let's go back to your Doctor thing. Let us say that family X did get their genes profiled. You admit yourself that based on your extensive survey and unfathomable depths of prescience, most Doctors have no clue what A,T,C,G and U do other than serving as alphabets. Given this situation, knowing that no insurance company wants to pay for the information, what is family X to do with the junky printouts 23andme sells them.

4. This may also be news to you. There is this group of people called hypochondriacs...

Oh my God! The things people say and imply. California sent those C&Ds at the appropriate time. Before we understand genetics, trying to randomly decode information at a perky price of $1000 or higher is as good as offering people to clone their dogs for them! (Apparently there is a huge market for them, and yeah, yeah, they are your dogs. God, someone call the SPCA - it's after all the dog's own genes...)

(Note: If 23andme were to do it for free at this point, I would have no problems! That would be a true contribution to science. Otherwise its like trying to get 1000 monkeys to come up with Shakespeare's plays, and asking the monkeys to pay for it as well)

And come on! Who are you fooling? If you walk down the street and described 23andme to random individuals on the street, how many would actually realize, admit or agree to your view that this is NOT about healthcare and that the Department of Public Health should just wait and watch.

Yes, 23andme and Navigenics are just that - snake oil merchants with deep pockets!

And if you are mad, maybe 23andme can figure out and help you remove the "mad" gene. I am sure they have good, well organized notes on why people get mad....

Monday, June 16, 2008

My husband had all this money lying around, so I thought I could do something medically useless in the field of medicine...how can that be

[Click on Post Title for Link to External Article]


wrong?

To quote: "Requiring that such tests demonstrate clinical "utility" could pose a particular problem if applied to 23andMe: The company has admitted its tests are not medically useful, as they represent preliminary findings, and so are merely for educational purposes."

Well, what have we here! So much money and they did not get their lawyers to do a simple fact check?

Demonstrating clinical utility could be a problem for a genetics test company?

Of course, all that really needs to happen is for Sergei to take a plane to Sacramento and convince people that demanding utilities in products is an absurdity:

"Our family has a tradition of creating half-functional products that we like to then display as the 'next best thing'.

Demanding fully functional or otherwise useful products interferes with our ideals to do business with no meaning, purpose or use and severely inhibits our ability to charge people for it!

If you don't stop making such demands immediately, we will buy California and sell it to someone else."

And so the story goes...

In reality though, if you look past the silliness, I do not have any sympathies for 23andme or Navigenics. Sailing on funds available through randomness or gullible Venture Capitalists, these firms set off to "create genetic profiles" that are "preliminary results only" and what not.

I am also not ga-ga over Navigenics "going through a doctor".

Its not like everyone with a Medical Degree has been sifted through the sieves of ethical practice.

We have barely understood that we have about 30,000 odd (or 40,000 odd was it?) genes in the human body.

We still theorize and struggle to explain why, our genetic scheme is only 1 - 2% different from that of the chimpanzee and that somehow fabulously makes us superior ( a very subjective opinion) as animals.

We have just finished realizing that our mitochondrial DNA - in statistical summary all of ours, meaning the 6 billion of us, almost shared the same mother once - meaning our entire race was nearly destroyed.

All this means one thing: we need to understand a lot more of the nuances of genetic interactions and how they are turned on and off before running around with a CD of our genetic code. Of course, whenever SNPs lead to disease, we can start working on those in the near future, but for most other complex genetic interactions, data provided by companies like 23andme would be useless.

Yes, indeed, it would be a great idea to cull genetic data from thousands of human beings. It would allow for statistical correlations (if we believe in statistics, that is) and eventually solid proof.

However, I have some serious problems with companies that want to charge people for things even they consider to be useless.

It is also an important lesson for entrepreneurs.

Sometimes funding is not enough.

Sometimes funding itself can make you shortsighted and lead you down the wrong path.

What 23andme or Navigenics have failed in doing will be a great stepping stone for the next company that comes in:

1. Research, research, research. Clearly understand what you are selling, understand who is buying and what they want and why the want it. Are they buying something because they want it, need it, or think they need it (like the practically useless ipods and iphones)?

2. Understand national, international and rather more importantly local regulations - especially if "local" happens to be California.

But don't stop there. Just because something is not being regulated right now does not mean you can run away with anything (or precisely, that something). States and Nations often start regulating an industry in the wake of new practices. Of course, most of this is driven by fear, sometimes unfounded, but you need to spend at least a little time thinking about this, especially when you are doing something "groundbreaking".

3. Be wary of where your funding comes from. While it is often harked that you need supportive investors, you also need independent investors who need to judge if your idea makes for an actual sale-able product or service.

4. Don't name something "educational" (refer back to the quote about 23andme) unless it is actually educational. Yes, genetic testing can be educational. But how can it be educational to potentially gullible customers who paid for something useless?

Friday, May 16, 2008

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....

Wednesday, May 14, 2008

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?!

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:

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....

Sunday, March 23, 2008

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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Saturday, March 22, 2008

Guest Post: Cell Phone Camera Becomes Medical Microscope

[No Link to External Article]

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

[Click on Post Title for Link to External Article]

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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Friday, February 01, 2008

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..?!

Thursday, January 31, 2008

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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Monday, January 28, 2008

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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Tuesday, January 22, 2008

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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Saturday, January 12, 2008

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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Thursday, January 10, 2008

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

[Click on Post Title for Link to External Article]

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?

[Click on Post Title for Link to External Article]

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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