[Click on Post Title for Link to External Article]
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/
A blog on medical devices, biotechnology, bioengineering, healthcare, etc. Join me on discussions about devices, regulations, the FDA, policies, law, and what not! Chaaraka is take on Charaka, an ancient Indian Physician of lore...
Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts
Friday, July 04, 2008
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....
Add to Onlywire
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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