From do scandals disturb you to which scandal disturbs you? - The Pharma Industry comes of age.....

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Should you choose to accept the mission, your choices are:

1. Avandia - GSK, A Physician and the Senate

2. Lipitor - The Senate, Pfizer and a Doctor who doesn't actually practice

3. Vytorin - Two large Pharmas, The Senate, and ... well some more baggage,

or, here is the bonus

4. The FDA, and the number of centuries it will actually take them to complete inspections, should they choose to follow their own rules for once!!!!

Here are some links to guide you through the sorrow:

Avandia

Vytorin

Lipitor and Jarvik (this one's from yours truly!)

And the FDA

Whatever the heck happened to this industry? Why is there no permanent learning and adoption from old debacles?

It is proudly announced that the very presence of the FDA in the '60s saved many children from cancer and death through suspicious drugs that were sold like aspirin in Europe.

However, the very FDA now seems to be this megalolith that can barely move due its own weight. Among other things, people are now questioning the FDA's role in each of the individual debacles surrounding the pharmaceutical industry. Plus, the FDA's very functioning is now in question....

In the midst of all this the White House and the Solicitor-General actually dared defend FDA's status via federal preemption to be the most effective "overseer" of all things food, drug or device related.

How they can achieve this, suddenly or gradually, I cannot sense! And so cannot most people. Plus, the Congress seems to be the weakest link in the chain...

Without worrying about the completely useless patent "reforms", they should seize the opportunity to find out, among other things,

1. Why, despite Congress and the press raising enough doubts about the Lipitor ads, does Pfizer seem to play them fearlessly anyway..?

2. Do the investigations made by various Senators, Committees and other Capitol Hill-related odds and ends, actually have any meaning, purpose and consequence, given how company after company seems to be steeped in scandal...?

And, we the people, have to sit and wonder, given FDA's stringent regulations in the US, if we see so many failures, what of the "emerging" markets and all the development work that goes on there?

As if this was not enough, here is what UCSF is suggesting for medical devices. "Regulate them seeking more information like you would do for pharmas". Given the FDA's success with pharma, the irony almost makes the article humorous:

UCSF Article

Ironies aside, the article and what UCSF suggests, is accurate by the letter...!!! But is the FDA the right organization to do it?

So what you say? Everybody recognizes problems - what is your contribution? Here is my simple solution:

Make the different divisions in the FDA more entrepreneurial, punish them for their "slips" and provide them with more money and power...oh, before that, throw the existing structure and the dinosaurs in the FDA's office files out....



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

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

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

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

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

I can probably think of a few good reasons:

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

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

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

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

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

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

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

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

----
The Dubious Hysterectomy Debate:

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

This study in particular makes me very uncomfortable.

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

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

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

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

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




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

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

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

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

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

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

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

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

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

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

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

San Francisco is in the United States! Whopee!

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

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

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

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

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

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Kudos Stanford!



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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


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