Friday, November 30, 2007

Update: Disgrace of Indian Medicine breaches new heights...

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Rarely do I get the opportunity to update my displeasure with more displeasure, but now would be a good time to do so. Thanks to comments by a "Lone Crusader", I now know that the President of India, a women who guilelessly accepted a cosmetic position handed to her to prove that the Government could put a woman "up there", has signed a veritably unconstitutional but definitely unethical modification to an act that has ousted the troubled director of AIIMS.

Not withstanding the fact that the move by the Government is illegal in the face of the fact that a lower court had specifically ordered the Government to seek its permission before getting rid of Dr. Venugopal, this case is now going to court soon, with the Supreme Court gunning to examine the act on Monday.

So, this wont be the final update on this issue. But, I reiterate that this demonstrates how weak India's position is in the world of medicine, biotechnology and medical devices. The industry has very little independence from the Government, the chances of India's Government being populated by people with base levels of commonsense are quite low and the Indian populace barely wants to pay attention.

To sum it up, this is a lingering (a bit too long) moment of disgrace to India, and the practice of medicine in this great country of mine....

[For the original post, read the blog immediately below this one..]

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Thursday, November 22, 2007

Dr. Anbumani Ramadoss's contribution to Indian medicine: Eternal Shame

[Click on Post Title for Link to External Article]

For all those people blindly tolling the bells of progress in my country, Ramadoss serves as the "duh" reminder.

A very inept man, he represents everything that is a political stumbling block that hinders rapid progress of India. Not only does his existence have nothing positive to contribute to the nation, but he has also taken on a personal enmity with the Director of AIIMS, one of India's premier institutions to prove how low, demeaning and cheap his existence can be, and how much damage he could continually cause in a "democracy".

He has the full backing of Manmohan Singh, a man who, surprisingly enough, continues to fall in stature. Singh is only interested in keeping his party in power, which has naturally translated into an unabated freedom for Ramadoss to act like the veritable Bull in a China Shop.

This incident that appears more like a long drawn out battle in idiocy is a good example that highlights the weaknesses in India's democracy:

1. Just like the US Constitution, the Indian Constitution is weak in that parties in power can pass legislation that is fundamentally wrong - ethically, morally and legally. In India, the situation is worse, and continues to unravel despite an active Judiciary.

2. The caste systems that the British took advantage of have now become a weapon in the Indian Government's hands. This is something that can only contribute to some of the darkest pages of contemporary Indian History.

3. The Indian Press, and the force of public opinion is more or less a joke. While AIIMS continues to suffer through multiple strikes and government interventions, patients continue to suffer. The public has not taken a stand and has not represented its grievances against the situation.

4. Healthcare continues to be a very low priority issue in India.

5. Autonomy of institutions is also of very little concern to the Indian Government, the opposition, the press and the general public.

Given all these facts, and the very untenable situation created by parasitic ministers like Ramadoss, progress has a dim outlook in the Healthcare education and administration in India.

These facts are not factored in multiple assessments of the Indian Healthcare, Pharmaceutical and Medical Devices Industries.

It is indeed easy to fix a dollar amount X to any product/service unit, multiply it by a billion or a fraction thereof to come up with juicy numbers. This, however, does not represent the true market size of any industry in India.

Here are some very damaging scenarios that could play out in the presence of someone with as minimal intellectual capabilities as Ramadoss:

1. The quality of medical education can be diluted to the extent that Indian Doctors and Medical Institutions will lose their credibility and competitiveness in the world. This will severely hamper the future ability of India to fight off China and other emerging nations in terms of clinical trials, clinical research and related industries.

2. Irresponsible Healthcare Ministers can suspend or permanently stop clinical trials and research without logical reasons or explanations. It is very obvious where this will lead to.

3. Both 1 and 2, individually or collectively will also affect patient healthcare, both local and those coming in through medical tourism.

What India needs is responsible, educated ministers who need to be qualified for their portfolios. In the absence of such leadership, and in the presence of cretins like Ramadoss, all new and existing companies doing business in India within the healthcare or other frameworks will have to be very cautious and conservative in their approach and outlook.

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Professional Stupid: Do not attempt at home or airports

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Why does the practice of medicine have to be more like "Grey's Anatomy" and less like "Scrubs"?

We have all watched Scrubs, and besides the promiscuity, we are apalled by some of the activities "J.D." and the rest of the Archies-Scrubs gang get involved in.

But Dr. Chiu here has proven that Scrubs is not that far from reality.

Please read the rest of the article posted as the Link for details on how crazy this "Doctor" is. Hope he has his licensed taken away from him...

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Monday, November 19, 2007

Of Eyelashes and how the overgrown eye brows blinded the organization to commonsense...

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The hottest market for drug or device development is : brain growth for governments worldwide.

Unfortunately this largely untapped market looks like it will remain so...forever!

Here is the latest proof that determines this urgent clinical need:

>FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."<

Why does this seemingly innocent policy bother me? Well for starters, apart from being an engineer in the field that FDA breathes down, I am, fundamentally a consumer. I am glad they went ahead and "siezed" a product that they had already "banned" from sales before I could dunk it by the pound to grow giant eyelashes, a lifelong wierd dream of mine.

But, what seems like a cliched protest from a hithero unknown Jan Marini Skin Research, Inc, did raise a few red flags(lifted verbatim from the Reuters Article):

1. Jan Marini, the company's president and chief executive, said the product at issue had been in its warehouse since September 2006, when California public health authorities "embargoed" it at FDA request.

2. The company added in a statement it had offered to destroy the product, "but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizure."

3. "We have been unfairly singled out," Marini said in a telephone interview. "Other companies use the same ingredient and we're not aware of any action that has been taken against them."

And, going back to the very beginning of this post,

4. FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."

Here is why all these 4 statements mother me....

1. Okay, September 2006 subtracted from October (I am sure it took the FDA two weeks to prepare for a one page, cryptic, zero value press release) 2007 equals 1 year and a month. Why on Earth did it take the FDA 13 months to make some sort of a final decision, however small its incremental value was? Is this the average, lower end or higher end of the timeline for the (in)activity of FDA? Will we ever be blessed with the opportunity to find out what happens in Wonderland that takes them soo long to arrive at simple endpoints?

2. "so that it could issue a press release announcing the seizure." In all fairness, I don't know if this is true, but this is what got quoted on the company's behalf on the Reuter's Article, and I didn't see the FDA protest this statement anywhere. So have we been treated to a classic dog and pony show? Moreover, what irks me is why do they need to "seize" these products? How much money was spent into this "seizure"? Why would it be harder to let the company destroy the product on its own?

3. This is what ticks me off the most. Maybe the company was wrong in making and marketing this product, but not only did the FDA hold them in a state of limbo for over a year, they won't even reveal if other companies do make products with the same chemical "bimatoprost" or similar eyelash products are under investigation. Why is that so? It almost makes one think that JMSR is being singled out! This may very well not be the case, but 4, the statement by an FDA spokesman makes one very suspicious...

4. This is a "company friendly" policy that just seems to be wrong in every possible way, except that it probably thrills the companies under investigation. While we all would love for the stock prices of healthcare companies to perform as well as all other companies, we love living and not getting killed by devices and pharmaceuticals even more. This seems to be one of the worst policies a government agencies could have.

It also means the FDA is uncomfortable with the appropriateness of its own investigations. It seems to indicate they don't trust themselves. And, it is definitely not a good starting point. If at all Congress is interested in changing the way devices and drugs are developed and delivered to customers, this little "policy" needs to be wringed out of the FDA's day to day activities....

In effect, points 1 - 4 and my doubts relating to this issue seem to leave open some holes that would challenge the ozone layer's own holes in terms of graveness, urgency and the ability of the FDA to act as an effective policing agency..

If you have it in you, you may choose to shock yourself more, relating to the regulation of devices here:

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Thursday, November 15, 2007

Autodesk: Not just engineering, now bringing new suicidal techniques to a courtroom near you...

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Okay, what is the connection between a medical devices blog and Autodesk? Well not much, but to be fair, AutoCAD was the first modeling package I used as an engineering student. Suffice it to say there is no love lost here. And then, they do this to bring joy and happiness....

The premise of copyright is to protect your work, not to further your illegal plans to build huge corporate empires based on CAD package sales. It is almost shameful to honest engineering that companies would lose sight of fundamental ethics and go off on the left field to commit what could veritably be proved a crime in court.

Exactly where commonsense disappears and insanity begins seems to be a greying deadline. You know, I was always wondering, with the advent of Pro/Engineer and later, SolidWorks, what AutoCAD's marketing and sales strategies where...well now we know!

It is hard as it is, for engineering students, small firms and entrepreneurial individuals to afford software, but AutoCAD has done grave injustice to all these classes of people for years, as it now becomes apparent.

I wonder what this one person achieves by earning $10 million from AutoCAD, but one would hope that if the court sees this activity as purely illegal, it should set an example for other large companies trying to "cut corners".

And, as to the California Bar Association's investigation of the lawyer, one would hope this is quick and effective. My cliched suggestion to them is "put legal back into the practice of law".

Hopefully this case results in more of a lesson to companies donning the fraud coat than, say, what a very large, two letter-name bearing IT firm got for its "creative listening" activities...

My advice to young engineers?

- Based on my understanding of the "best practices" at Autodesk, gain skills in modeling packages that you may afford.

My advice to other modeling companies?

- Before you plan to mire your future customers with "network licensing" and other dubious "lock ins" .... watch out. The customer is not for yours to imprison, but win over.

How is it that I repeatedly see companies missing out on the "Duh" facts of life? Why do I find myself repeatedly asking these questions?

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Thursday, November 08, 2007

Of PFO Closures and the MIST Trial: Troubling times for Alice in Wonderland

[Click below for link to external article]

[Another update has been added at the bottom]

In case, you have a problem with blogs, here is the "original" article that reported it:

It is your choice to read either article or the blog. Both read like the Oh-la-la of a Hollywood movie, er..the Fugitive. Okay, maybe it is not so dramatic, but our main characters are Dr. Wilmshurst and Dr. Dowson. The playground was TCT 2007 and the (you thought I was going to use the e-prefix, huh?) Corporation is NMT.

Several not-so-mysterious mysteries surround the issue:

Now if everything is both hunky and dory in PFO land, why not show Dr. Wilmshurst the data and shut him up? What is wrong with letting him see the data?

Or what is wrong with proving to him that the echocardiogram data was independently verified?

In fact, why not publicize the entire data set?

Why not conclusively prove and delineate the purported "protocol" violations of Dr. Wilmshurst?

What about Dr. Dowson's seemingly troubled past?

It seems cliched enough, but the silence of NMT (on these questions only) is deafening. See, not answering these questions, to the simple mind, seems to be very troubling.

Essentially, it seems like the MIST Trial seems to be well on its way to becoming a prime example for the "10 Things to avoid", "How to turn your device Trials into publicity nightmares", "It is fun to try and fool all of the people some, most and all of the times" case studies that business schools and a variety of other graduate schools could hand over to avid students worldwide...

I am constantly surprised at how companies with so many "experts" fail to take the easy, simple, honest way out with things. Who knows if the MIST Trial was even wrong in the first place? But things have escalated to a level where that is not even the issue anymore...

Remember, this is only ONE of the several foul-smelling issues raking up in the "increasingly, well-funded, rapidly growing" medical devices industry. For hints look up defibrillators (going back to more than a year, if you please) and Orthopedic devices for other "issues".

Well, if this trend continues, our entire industry is going to look like a bunch of quacks trying to sell sham wands in the place of sham potions..

What this industry needs is people with strong, actually very strong ethics, not blind "several years of experience conceiving, designing, redesigning, launching, manufacturing and hand deliverying devices to patients and surgeons for very, very low pay". Effective leadership in the medical devices industry seems to be its very own holy grail...

By the way, coming back to our friendly, neighborhood PFO-closure mania, this is not the first time I have posted on the subject either. Here is another archive:


Bad coincidence. Just after I published this post, another of my Google Alerts turned this one up:

If that doesn't send a chill down your spine, I wonder what will..

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A cryptic one: They call it "money talking". I call it "Dinosaurs Rising"...

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(I feel like the Oracle today. You are going to have to visit the link and some of my archives to get the full purport of what I am trying to post here)

It has taken them so long. This letter, that has come up with the alacrity of a brontosaur from the Triassic Period, very much reminds me of the cow like portrayal that Spielberg did in Jurassic Park.

I am still not happy. Is this letter going to do anything? Where did the number 31 VCs come from? Does it take them SO LONG to come up with one measly letter? And the end-result of their co-operation is a letter? Is that the show of the strength? I seem to have more respect for the TV show writers..! Is anyone paying attention anymore...?

Oh well, one would hope so! If I am wrong, and if this is indeed "money talking" and not "Dinosaur Rising", then it might help us to get rid of H.R. 1908, the maniacal child of a miscarried intellect...

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Thursday, November 01, 2007

The Cliched Post: Patent Rules blocked in cinematic fashion....

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Okay, this is becoming all too familiar. Why am I commenting on these things so late, after everyone? Look at the Exubra thing, and now this..

Well, first I thought, regardless of the last minute courtroom drama typification, it was bound to happen anyway, so where is the surprise. And then I read another law blog. And another, and yet another.

At one point my only thoughts where, "God, I wish Nancy Grace was covering this..."

And then, slow as I am, I got to thinking...

Here are some of the salient features of the whole brouhaha:

1. The pharma industry is the largest user of continuations. Only one of them filed against the new rules. What were the other companies smok doing?

2. Why did it take so long to get a district court to block the final rules?

3. Why was there not much effort put into the public commenting period?

Now, comes my most important worry:

4. The USPTO spent over a year to get to the rules. They were announced in August 2007 and this mania went into November, scintillated by webinars and other gala activities arranged for the public benefit (or the opposite effect thereof) by the USPTO.

Who, other than me is worried about holding someone accountable for all the public money and time spent in framing and trying to implement illegal rules, the illegality being as clear as it would be in broad daylight?

If government agencies are using public money, which is what they are using every minute they are functioning, shouldn't they be held accountable to spending the money in a sensible manner? Can they just act like irresponsible kids blowing away their grandpa's inheritance? How is it that the USPTO thought that this very anti-competitive, anti-inventive, anti-public-service measure would actually survive? How low has their ethical nature stooped that regardless of the answer to the previous question, they went ahead and tried to impose these measures anyway?

Given the amount of "public" interest in bringing the USPTO to its heels on the rules themselves, I don't think point 4 will be addressed...ever!

Atleast, as an inventor, the injunction makes me happy. Thank You, random Judge in Virginia...

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