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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Can you teach your own doctor? Yes you can, if he or she slipped a little in medical school...

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So what were these guys doing in Medical School? We place medical doctors at a much higher level than fossil-brush doctors (paleantologists) or the other kind of doctors....

And in return, this is what we get!?

Well, bordering on the humorous, this indicates how little doctors seem to know about some of the most basic stuff, while they are overloaded with other stuff, which may be conventionally important.

This news comes this week, following some interesting revelations that most surgeons do not discuss reconstruction with their breast cancer patients:

http://www.ajc.com/health/content/shared-auto/healthnews/-brs/611072.html

Is this a marketing slip on the silicone peddlers? Have they failed in "inducing" patients to get reconstructive surgery because it belongs to another department - plastic surgery, and they won't get reimbursed for it?

Or, are they just plain insensitive? Apparently someone is guessing, it maybe because breast cancer surgeons think it may be a "hassle" to suggest so...

I agree, your patient might walk in the door just wanting to be rid of their cancer. While that may be their biggest bother at that point in time, they are definitely going to regret not thinking of life after cancer. Why? Because there is so much fear surrounding cancer - mostly realistic.

But it is a surgeon's great disservice in not sitting down and painting the whole picture for their patients?

I have heard other stories of how certain "gold standards" arose from a single, unverified opinion of one physician/surgeon!

And yes, before I leave, I am compelled to recollect my cliched rants about questionable dubious "innovations" such as drug eluting stents and rapid - exchange balloon angioplasty...

Are medical practitioners less compelled to initiate, read and follow scientific studies?

All this combined, makes me shudder at the thought of putting my life in the hands of a medico!

How about yourself?

Anyway, do read the article and find out if your doctor has been catching up with his/her reading. After that, double check your prescriptions.. :p



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Want to feel like you are one of the idiots? - Mix it in .... and smoke marijuana?!

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Well, it was hopefully useful for atleast those who did the research - they got to spin the wheels once again.

College students smoke pot. Of course they think it helps them relax, they think it is against the "man" who is trying to stop them from experiment with the limits of their brain, it helps them perform better at..., okay, lets leave it at that.

So why do you need to do research to find that out? You think since Australia was "isolated" from the main land?

People who smoke marijuana - (unless they have cancer or AIDS, because it is a known domain where there is a real pain numbing effect) are just that - idiots!

Yes, you will learn what to do with folks like that - realize that all your efforts to teach them commonsense failed and you will move on.

Wonder whose research money got wasted into this effort in idiocy. I only thank my stars that I don't pay taxes in Australia. Otherwise, I will have to worry about their next research project....hmm, why do college students chug beer?




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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Yes!

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

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

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

So, is an investigation necessary? Yes.

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

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

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

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Update: Stent Startup facing difficulty with IPO..

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Here is my post from yesterday:

http://chaaraka.blogspot.com/2007/12/drug-eluting-stents-what-very-proactive.html

So, I talked about the FDA and their much delayed, yet knee-jerk reaction on DES. I also talked about how stent companies do keep popping up, regardless of several issues with perception. To sum it up, I defined how the major stent players are more worried about litigation on defective products than in actually trying to understand (I am pretty sure - no one has a clue) if stents are actually effective and proving it medically and scientifically.

Referring back to the article on VentureBeat, it is a little bothersome to me that they didn't react quickly. What is it that they were doing from May all the way through December? Yes, and what is with all the secrecy?

Well, it maybe that Devax has other issues to deal with. But they are venture funded. So aren't their investors interested in making sure Devax doesn't raise unwanted suspicions?

Maybe we will hear from them soon....

It is interesting though that Venture Capitalists do continue to fund stent companies. Only time will tell if these "new" stent companies will revive the market or if the whole thing will unravel. One thing we would not expect to see as much is the kind of mania that surrounded DES when they were first introduced.



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Drug Eluting Stents - what a very proactive, caring FDA has decided to do

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It seems like dinosaurs were converted to fuel faster. How long drawn out is the drug eluting stent story going to be? Are DES actually effective? If they are, what is happening with all those deaths and increases in mortality risk?

Is the problem with the drugs? Because stents work don't they? Or do stents work either?

While you may think these don't fall under the gamut of the FDA....they do have a responsibility to patients, companies and stock holders of publicly traded medical device companies.

The essential problem is that the device industry has not always paid a lot of attention to thorough analysis. To date, effective analysis has not been performed on what stents actually do.

Wasn't it one hell of a shocker to find out that angioplasty for all the hue and cry it created and made rich folks out of a handful few is actually not that effective when you compare it to drugs?

So, expert one day, lucky guy another....no one is an expert anymore.

Our only way to find out whether or not something works is to build it, build a hype around it, bring the FDA into the hype-building exercise and then when patients die...overreact!

Indeed, it is the stone ages of medical devices today. We hit something over the head and if it survives..it works!

Trying out unproven treatments on a whole lot of people based on a slim history to pass judgements is veritably not the right way to device use.

Where lies the solution? Definitely not with the FDA. The FDA has proven itself quite ineffective and gullible to industry pressure.

The solution lies in smart companies and in University laboratories. Instead of "teaching" people how to make devices, some of these schools would benefit from spending research effort and energy on building appropriate models of the human body, with respect to both anatomy and physiology and then study the interaction of the device with the body, and the long term effects of the device. The NIH will also benefit the industry by jumping in with grants..

Of course, data generated from devices should still not be ignored. It is a very critical source for further analysis wherever the models would become inaccurate.

Will it slow down product development? Not really. The current model for developing devices and bringing them to the market is fairly successful. No one is asking for an "overhaul" of the very basics of the industry. (Imagine suggesting that - boy would the bubble burst!)

A sound analytical background should be built around the device development process. That is already being done by the really good companies that spare no expense to ensure that they are actually building effective devices. But two things have to happen:

1. Extend the analysis, way into the post-market process without any slow down.

2. Bring more companies in-line with these efforts and make long-term device and device-body interaction studies an industry standard. After all, this is one heck of an industry where rituals and ritualistic folks make constant hay....

Will it be expensive? I ask you to spend a few seconds imagining your company, the company you built with your very hands on a stock market free fall....now does it sound expensive?

As to the FDA? Instead of restating the obvious, the organization would benefit from learning to act responsibly and instilling a sense of responsibility in device companies.

Didn't we all know that stricter guidelines and more studies were needed for drug eluting stents? Did we ever hear of any efforts by the companies involved to design appropriate research projects to understand drug eluting stents and their effect on the body?

No, instead they are merrily carrying on over a patent tussle on a product that doesn't work!

And more stent companies are popping up...everywhere!

Who do you think is responsible for all this?


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Commonsense and/or a fear of dead patients prevails in China..

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I don't know what ticked off the Chinese initially - that they required a "near 100% inspection of ALL imported medical devices". Maybe it was the fact that they were packing toys with lead...yes it did happen, but enough with it already....

Maybe it was global ex gratias such as Lou Dobbs who have the genius of converting minor issues into apparent major disasters.

Maybe it was the fact that the US and folks around the world in general over-reacted to production quality of Chinese goods.

Well whatever it is, both parties are guilty. If production coming out of China was truly off quality, it was not just the factories that needed to share the blame - atleast not always. Many US and other international organizations have subsidiaries in China. Wouldn't it be a shared responsibility then, to reassure everyone of product quality?

Would it hurt Walmart and other toy stores if they checked products for lead or other mishaps before loading them on stores? Apparently, it would! They are unwilling to play their part - then their yellow smiley cannot keep smiling as the prices would go up. So they blame it on China...and a guy hangs himself...truly nasty!

And, recently China seized toys and products coming into their country from elsewhere that had product defects....it only proves one thing. Many of these companies and countries share a common attitude when dealing with China, "Do as I say and not as I do...."

Would it really work?

No!

Why?

Simple: China is an emerging superpower. Keep ticking them off and lose any percentage of 1.3 billion (and counting) customers. Same would go for China.

The equations and dynamics are changing. The difference between the "old" world and the "new" world is shrinking..helped by a dollar that is on a downward sliding scale. Even when the dollar picks up, if it does, as predicted in 2009, the world would have changed by then....

Companies and countries should realize this, and learn to present a picture of equanimity and commonsense when criticizing...and of course make sure they don't have glass doors before they throw stones at anyone else! So can someone shut up Lou Dobbs already?

But China, how naughty of you?! Did you really think you could do a 100% incoming inspection....And Thank God for the patients who really need those medical devices!


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Forget Genetic Planning and all that - Good, old style self-torture is alive and kicking!

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The big argument that certain religious groups and paranoia-professors is that once genetics and cloning advance enough, people will be able to choose the eye color, height, weight and other characteristics. After placing this argument, they also aptly display shock to try and drive home the message.

I wonder how they would respond to this new surgical technique that helps you grow your limbs - quite painfully. So, orthopedic surgeons took a surgery they only use to perform for people recovering from traumatic injuries or from congenital defects to ... well, anyone who has the money and a story to go with why they would have this surgery done on themselves.

Shouldn't there be a review of ethical issues on braking someone's legs on purpose? Being short is bad now? I am 5'5". Should I go into bouts of depression over this "defect" as opposed to the many other, more easily corrected problems in my life?

Wouldn't it be easier to counsel someone on how they would really appear to people if it were to be revealed that they had their legs fractured so that they wouldn't feel bad?

Oh well, for all you "cloning" and "genetic cleansing" naysayers out there, manicure, pedicure and "limb elongation" are all symptoms of a desire to misuse tools that are meant to heal that precede inventions and tools that are supposed to help those suffering through trauma or from congenital defects.

So, please, think twice before you kill the messenger...


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Healthcare: Just what were you thinking?

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In a quest for some justice, Californians have struck gold...again! Las Vegas is not the gambler's haven...California is. You know I read a blog yesterday: they were trying to enlist which CEOs should go back to Business School here:

http://www.bloggingstocks.com/2007/12/04/ceos-who-need-to-go-back-to-business-school/

There seems to be a special B. school that CEOs of all companies doing business in California should go to: The "Don't be stupid enough to fight the State of California" Business School..

Kaiser and Blue Cross should have really spent some time looking at how bad their previous experience has been, and tried to fix things before they blew up so much.

Instead, they gambled with the law in the most populous and, veritably one of the most activist states in the US. Now, all insurance companies that have used dubious insurance schemes will have to deny insurance to Californians will see a spurt in class action lawsuits.

This is another representative example of how poor practices will simply not go down with health insurance and the law will catch up sooner or later

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Update: Its Riegel, Riegel and more Riegel at the Supreme Court, on blogs and everywhere else...

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[According to the WSJ, The Drug And Device Law Blog is the best. I will let you make your own conclusions :), but it is a true blog, in that they posted a written report by a third party and their comments on the proceedings]

So Riegel is everywhere. Everybody who thinks they are some kind of a journalist, a legal expert or a medical devices expert is writing about it, no matter how little they are adding in terms of new information or value. How, but how could I leave myself out of this? I want to feel important to..by way of some n'th association...

Anyway, coming back to reality, it appears that Medtronic, not surprisingly, is set to win this one. Federal pre-emption is set to win anyway. I am guessing this will be my pre-final update on the Riegel case..

All said, I would hope this doesn't open a bleeding wound whereby, jury trials become harder and harder to obtain against drug and device makers, societally speaking.

More or less folklore, it is not uncommon that State Regulations tend to be stricter than Federal Regulations, atleast in some of the "activist" states. This has led to better regulations at the Federal level and the Federal Justice System should not become "a path of least resistance" for the real wrongdoers [Medtronic, not being one of them] to "get away with it".



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OT: For Fellow Bloggers: Know your rights..!

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Thanks to Tim Oey [ http://oeyweb.com/timoey/ ] for the link to the story.

This post is Off-Topic only in one sense. As bloggers, we often tend to write about companies and sometimes if not all times in negative light. I have very little respect for "Professional Bloggers", especially in Medical Devices who just rehash news articles and try to write nice things about everyone - a true betrayal to journalism.

We all have our right to our opinions and our ability to express them. As such, I have not written anything overtly controversial yet, and have not been harmed in any way, but should such a time arise, I would like to see my rights protected. Wouldn't you?!

Anyway, just go to the link and read about how BidZirk tried to harass Philip J. Smith, a blogger and lost.

This should be lasting proof to any of those in doubt. Remember to defend your rights, otherwise they will be taken away from you, one way or the other!

Good Luck Bloggin'!


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Riegel Update, Can States Regulate Medical Devices?, Are Devices and Drugs related? and how "stupid" juries are...

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Typically, struggles in a field ensue because a bubble burst...morbidly, in this case a balloon burst. That is how Medtronic's struggles started with Charles Riegel and his family. Thence followed a series of "interesting" events -

1. Charles Riegel himself did not die from the incident. However, he did manage to sue Medtronic for "alleging design and manufacturing defects and inadequate labeling with the device."

2. He then passed on and his wife continued the lawsuit. At one point in the recent past the case was in the danger of being dismissed based on a technicality - the lawyer acting on behalf of the Riegels displayed the maturity of a 5 year old.
[ http://chaaraka.blogspot.com/2007/09/new-and-ironic-twist-in-riegel-case.html ]

3. Somehow the case seems to have survived, and will be heard by the Supreme Court this month. Against this backdrop, here are some interesting things that have come to view...

a. The basic argument by medical device makers is that they are already regulated by the FDA, a federal agency, which supersedes any state regulation and thus should not have to answer to a state. Fair enough, after all, we do need to invoke the constitution whenever it benefits us. Only, the FDA regulates how a manufacturer makes and labels a device - it does not punish the manufacturer for causing harms to patients by awarding penalties. This is one of the essentials of the legal system.

The "national standards" argument is very weak - given how several states have time and again demonstrated the ability to exceed politically motivated federal standards that are generally lower.

b. Here is the Soliciter General's Office expressing their "expert" opinion:
"Subjecting a manufacturer to liability for not departing from an FDA-approved design or label would interfere with FDA's ability to protect public health by balancing the risks and benefits of a particular design or label," the brief states.

- Call me naive, but doesn't the statement sound like "Bring it on"? It is almost asking the people to sue the FDA instead. Exactly how does a lawsuit in a state interfere with the public's duty? The suit will follow the approval usually, not precede it. They seem to be claiming an extraordinary amount of defense, almost as if saying they are infallible.

c. Here is the clincher:

"I think you should put this in the hands of an expert federal agency, which sets up one set of standards that applies nationally," said Mark Herrmann, a partner at the law firm Jones Day, who has followed the Riegel case closely. "Having a jury of 12 people, with an average of a high school education and in the presence of an injured person in the courtroom, decide whether or not the medical device company did things that were right or wrong is a bad situation for society," he said.

- If you are thinking, "Geez, are they handing out law degrees at the county fair?", you are not alone. Sometimes, they suggest, if you cannot say something nice, just say nothing. This guy could have done himself the favor.

Let's extend his argument. What do a bunch of lawyers who read books for three years to get a degree know about medical devices? All they do is argue, "He says, she says".

Juries of 12 people have gone on for a few hundred years around the world, making judgement calls on hundreds of thousands of cases. Yes, they do make mistakes, but so do the "experts". And that is what is being argued out in the Riegel case, that is if it gets past the point of State Vs. Federal statutes.

Who would have known insulting the intelligence of juries, high school education and the general practice of law is considered a cogent argument by some? I am thanking my stars I am not a lawyer. To believe this guy would be a peer just makes me shudder...

Believe me I have nothing against Medtronic or other device makers. The Riegel case makes an important judgement call on the volume of legal troubles device makers will see in the future. It is a very serious situation, and what happens to Medtronic will reflect on the entire industry.

So, for their own good, and for the rest of the device makers, lets hope Medtronic has a better argument (they seem to have a good lawyer, who won a case based on thin air) than that of the Solicitor General and the genius lawyer who didn't believe in juries.

On a slightly different note, here is something Howard Brody raises, "Are devices different from drugs?". Read the blog here:

http://brodyhooked.blogspot.com/2007/12/are-devices-different-from-drugs.html

Now, visualize if the Riegel case is part of a rather larger, more troublesome issue of coercion than basic legality and ethics. Because, if device makers are indeed dodging the law in Minnesota and elsewhere based on influence, it is bound to run out one day and bring what would seem like a house of cards down. One would hope, they decide to take the high road... so that the rest of us in the devices industry stay safe and employed!




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It is World AIDS Day Today. How can you contribute?

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This is not a question I am trying to answer for you. This is a question I am trying to answer for myself. On the outside, it would seem that the biggest benefit we can derive for AIDS is by going out and finding some cure.

However, if you have paid the slightest amount of attention on the problem of AIDS and the HIV virus, you know that a cure is not very forthcoming any time soon, and that even the most successful therapies, resemble a finger placed on a dam wall to save Holland..

So what is it that I as a single unit do to contribute to the cause of fighting HIV/AIDS?

For starters: Remove I. Think Team. Yes, as the cliche goes, there is no I in team. And, this is one more of those situations where cliches don't hurt.

There are several small and large steps that have been identified and recommended for people in the fight against AIDS. I did a quick brainstorm and came up with these:

1. Advocate the practice of safe sex, and where possible abstinence.

2. The article on the link [Click on the title of this post] recommends proper nutrition for HIV+ individuals, especially in those that have the onset of AIDS already. If you know someone who has AIDS, make sure they are on a proper diet. If you don't know someone personally, donate to the cause.

3. Donate whatever you can to the cause for a cure for AIDS

4. Be responsible. Always demand that blood gets checked before any transfusion.

5. Do not under any circumstances share needles with another person.

6. Do not reuse your needles, if you are taking medicines for legitimate purposes. While this has nothing to do with HIV, it is important to follow good hygenic practices.

7. Ensure that you dispose of any needles you may personally use appropriately, so that no one will be able to retrieve and reuse them. This is a major problem in several regions around the world.

8. Educate yourself. Educate those around you. Join HIV advocacy groups when and where possible and volunteer your time, energy and, if you have the luxury to do so, your money.

Are there other things a person can do? I am sure there are. If so, do write in. I would like to hear them, and so would several people, I am sure!

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