Friday :: Nov 5, 2004

Wearing It On A Worn Out Sleeve

by pessimist

One of the things I detest the most is the general practice of companies charging you for the privelege of wearing their product logos on your clothes as you stroll about providing free advertising for them. But as bad as this is, there IS something worse - being the Guinea pig who tests that product.

Now that the re(s)election of George Warthog Bu$h is done, some Bu$h supporters have been clamoring for Bu$h to abandon some of his most rabid supporters and think about his legacy. It's looking like he's taking that advice to heart.

But it isn't the Christian Fundamentalist evangelicals that he's leaving behind - it's the very drug companies he's been providing protection from foreign competition at the expense of our nation's retired elderly.

This action of protecting the drug companies from competition may be proving to be a total reverse sting. After these companies have raked in big profits from their monopolistic markets, they now have to cover the costs of their drug testing - tests conducted upon Medicare recipients!!!

Medicare Covers New Treatments With a Catch

Medicare has systematically begun to make payments for new and expensive treatments and diagnostic tests conditional on agreement by companies or other groups to pay for studies on whether these new methods actually work on the Medicare patients who get them. The move was decided by the agency's recently appointed director, Dr. Mark McClellan, who said the goal was better and more cost-effective medicine.

Over the past six months, he has been fundamentally transforming Medicare's scope by offering to pay for a number of new and expensive treatments and diagnostic tests - ranging from $30,000-a-dose cancer drugs to brain scans to diagnose Alzheimer's - but with a catch:

Patients can only have them if they enter into studies that evaluate how well they work - And someone other than Medicare will have to pay for those studies.

In the past Medicare just paid the bills or said no to treatments. Now, with a flood of promising but astronomically expensive treatments and little data on how they work in the real world, Medicare has decided to use its 41 million beneficiaries to get some answers. And it is using the threat of refusing to pay unless patients are in a study as a cudgel to get companies or foundations or professional groups to pay for the research.

If I was a drug company executive, I might be feeling a little betrayed right about now. I might be thinking, "We expected to have to shell out big bucks from our windfall profits for the campaign, but we didn't expect that they would stab us in our fat wallets once the election was over!"

But as I've said before, there is no honor among thieves. They tend to demonstrate to each other at the most inopportune times that they aren't to be trusted.

Medicare holds a powerful hand - its beneficiaries are the biggest users of drugs and medical devices, and private insurance companies often follow Medicare's lead on coverage decisions.

While drugs and devices are tested and evaluated by the Food and Drug Administration before they come on the market, those tests often leave huge gaps in doctors' knowledge of how well they work, and for whom. The tests to gain F.D.A. approval "leave an awful lot of ground uncovered," said Dr. Richard Platt, professor and chairman of the department of ambulatory care and prevention at Harvard Medical School. They do not tell doctors or patients whether an older and cheaper drug is as good as or better than a newer one, for example. And they do not reveal whether older people, with many medical conditions, will fare as well as the generally younger and healthier people on whom the drugs or devices were tested. "The best way to learn about practical problems and practical benefits," Dr. McClellan said, "is to evaluate how treatments do in real world settings."

Of course you note as I do that Medicare patients have some say so in this process - NOT! But Medicare isn't the only guy with a black hat:

The system was never questioned until about two years ago, when Zevalin, or Ibritumomab tiuxetan, made by Biogen Idec, was approved for non-Hodgkin's lymphoma, at a cost of about $25,000 a dose, and Medicare started paying the bills. Medicare administrators were taken aback by the price. They also worried that it would be widely used in patients other than those with non-Hodgkin's lymphoma, and that taxpayers would be paying for it without anyone knowing how well it worked in these untested situations.

Considering this information, it is quite understandable that Medicare wants a cost/benefit analysis. It is understandable that patient testing will need to be conducted. But where the hell do they get off requiring that patients be the Guinea pigs while the patients probably have to continue paying the regular fees for the privelege!

If something isn't ready for market, it shouldn't be the patient who has to pay. Remember the recent removal of Vioxx from the market? Remember Bu$h reducing damage awards to a mere $250,000? That's as few as eight doses of some of the following exorbitant drugs!

Hopefully we aren't about to have another Thalidomide! But we will only know once we poison or kill someone with these new drugs!

The agency decided to use its influence to speed up research on off-label uses of four new drugs approved for colorectal cancer - oxaliplatin, irinotecan, bevacizumab and cetusimab. On Monday, Medicare said it would require national contractors to pay for off-label uses of the drugs for patients in any of nine clinical trials being started by the National Cancer Institute. That way, Dr. Tunis said, Medicare hopes to encourage patients to enter the studies, which will determine whether the drugs are effective in the new contexts.

CancerCare, a nonprofit group providing support services to cancer patients and their families, was delighted. "What I most impressed with is to see C.M.S. really focused on this issue of quality and not just as acting as a payer," said Diane Blum, the group's director, referring to the Centers for Medicare and Medicaid Services. "It is an enormous step forward and I hope the patient community pays attention."

They just (s)elected Bu$h! Why should they wake up now???

Medicare does not intend to force studies of everything it pays for. Instead, Dr. Tunis said, "We plan to do this for treatments that are potentially very important to the Medicare population but for which the evidence is not yet definitive."

That could be every drug released while Bu$hCo has been ru(i)nning things! Now comes the fiscal boogie monster to frighten the patients - and the taxpayers - into silent compliance:

While there may be opposition to Medicare's newly aggressive approach, patients, and taxpayers, can only be better off, Dr. Califf said. "We have a huge budget deficit and looming huge costs for health care," he said. "And we know we are spending huge amounts of money on things that don't work. But we don't know what they are." So, he said, the nation has a choice. "Medicare could pay for everything, or we could develop a rational system to pay for the things that matter."

Did you catch the double oxymoron in that last statement? 'Rational system'? Under Bu$h???


And the other oxymoron? 'Pay for the things that matter?'


Stop! You're killing me! And I can no longer afford to pay for the privelege!

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pessimist :: 3:55 PM :: Comments (8) :: Digg It!