Thursday, August 19, 2010

Wyndham Wilson, Richard Pazdur, Natalie Compagni Portis, and Jean Grem - Bureaucrats who know more than your doctor

You may have heard of Avastin

Last month, an FDA advisory board recommended withdrawing government approval of Avastin as a treatment for advanced breast cancer. The decision betrays a bias that puts costs above treatment, and unless the FDA leadership overrules its own experts, the 40,000 women killed by breast cancer each year will be denied an important clinical option.

From a series of links provided by Instapundit.....

Here's Ann Althouse, quoting the Wall Street Journal:

So here we have government-anointed medical patriarchs substituting their own subjective view of Avastin's risks and costs for the value that doctors and patients recognize. If Avastin is rescinded, thousands of dying women will lose more than proverbial false hope in the time they have left. They will lose a genuinely useful medicine.

And here's Ms. Althouse:

There are death panels. They don't want to be seen as death panels, because to be seen as death panels will undermine their relentless, bureaucratic work. So see them.

Who are they?  Nobody really knows, do they?  They meet in their little rooms, cast their little votes, and then hand down their verdicts predicated on the idea that they know more than your doctor.  Here's Instapundit one last time, on the subject of "naming names":

And name names, which, as I’ve noted before, undercuts the diffusion of responsibility that bureaucrats prefer. In this case, some names are Wyndham Wilson, the chair of the committee, and Richard Pazdur, the FDA’s cancer chief. Also committee members Natalie Compagni Portis, and Jean Grem, both quoted here.

Here's the difficulty, IMAO.....   The government has set up an elaborate series of hurdles that any pharmaceutical company must jump before a new drug is approved for sale in the U.S.     I've read estimates claiming a regulatory cost of one billion dollars per medicine.  Here's one estimate that puts it at 800 million.   Much of this cost is overkill.
Combine this with the elaborate series of hurdles known as Medicare and Medicaid, and you have the perfect storm.  Your health is now in the hands of dueling bureaucracies.   One bureaucracy is charged with ensuring that you are 100% safe, regardless of the cost.  The other is charged with ladling out treatment in an approved, inexpensive manner.  Which side is gonna win?

Back to Avastin.  For the love of God, it is a freakin' cancer medication.  And if you have cancer and your doctor doesn't find a treatment, you are going to die. 
Would it lower the morale of our Bureaucratic Lords And Masters if they simply said "Look, you folks are free to try this medicine.  Hell, you're dying.  The pharmaceutical companies are free to manufacture this medication for the lowest cost possible.  Consider yourselves part of the research.  The medicine can now be produced at a much lower price, as long as it has a red stamp on the lid that says UNREGULATED."

Now, transfer that thinking to all pharmaceutical products.  Transfer that thinking to restaurants, stepladders, florists, beauty salons, and funeral homes
If you trust a cabal of bureaucratic hacks more than you trust your doctor, your neighbors, or word of mouth, then you should be free to pay more for the regulated products. 
If not, you should be free to make your own choices. 


Cedric Katesby said...

Allen, this is just a friendly suggestion but...I really think you should expand your sources of information on this issue.

This is a health issue.
This is a science issue.

If you are going to weigh in on this topic then go ahead but please, please, PLEASE tread carefully.

This is not a subject matter to be decided by a non-expert blog or newspaper article. If you are going to hunt for information on a medical issue then go to those that specialise in this kind of thing.

If you are going to rail against "the system" then go direct to "the system" to find out how it works.
Don't create a caricature of an issue.
Don't risk creating a strawman.
Don't just let someone from your "tribe" tell you second-hand how it works.
That's how myths and misinformation spread.

Perhaps the decision-making process is not as screwy as you believe it is?
There are people out there who would love to sling anything they can at the FDA and government regulation.
If the FDA collapsed tomorrow, certain vested interests would be very happy.

I genuinely admire you desire to shoot some rats.
Go for it!
Shoot 'em dead. Shoot a lot.
But...make double/triple/quadruple sure your aim is straight!

I'm not defending the FDA or attacking it nor do I claim any real knowledge about cancer medications in the U.S. but it seems to me that you have taken a very serious topic and treated it in a superfical manner if your choice of source material is anything to go by.

Who are the "go to" people to find out how the FDA make important decisions on cancer drugs?
Who are the "go to" people that can tell you exactly what Avastin is and is not?

Please dig a little deeper.
Consider the possible biases of those that are saying the things that have got you all riled up.
I'm NOT saying they are actually allowing their biases to colour their judgement.
I'm NOT even saying that they are necessarily wrong.
I just think you can do much better in getting more specialized and accurate and first-hand information.

Not all sources of information are equal.

Harper said...

"It is also approved for colon, lung, kidney and brain cancer, however, the FDA review and recommendation applies only to breast cancer." Great, let the women die.

Obama's health care poster child, the NHS, does not cover Avastin for breast cancer due to cost, though they will make it available to a patient, should they be willing to pay for it.

The Whited Sepulchre said...

And one of the reasons it is so expensive? (Besides making it lawyer-proof)
Because NOBODY has to pay for it themselves. Therefore, a low cost alternative isn't a priority.

Anonymous said...

As a physician I'm rather concerned about the posting. It begins by suggesting that the medical decision on Avastin was made by 'bureaucrats'. Actually, the 'bureaucrats' are scientists, physicians, and experts in the field of oncology, that - last I heard - aren't out to pull something over on people. That isn't to say their decision was necessarily 'right' but there is an attempt to base decisions on science including outcome studies.

The posting suggests that this decision will end up killing people - as if this is some sort of wonder drug that can 'cure' cancer, a drug better than all the rest for patients. And now, the 'cure' has been taken away by evil uncaring people who are merely bumbling bureaucrats. I suppose the argument sounds nice because it so clearly marks good from evil, and it has the ring of a hollywood blockbuster movie.

Science though is a bit more complex, and such a discussion shouldn't be reduced to such simplicity and ignorance. It reduces what could actually be a serious discussion down to a cartoon. And by doing so, postings like this are actually the things doing harm to patients by giving and/or implying falsehood. Having a serious discussion is one thing, making it political is another. Shame on you.