Seniors on Medicare are going to be guinea pigs for new medical methods.

[madfloridian]

This sounds like the elderly are going to be the testing ground for new drugs and diagnostics. They are the very people who might have the hardest time with a range of drugs and tests. Is this our new reality? If you don't help us test our drugs, we won't pay for your care? Could I hear some Democrats on this, please?

http://www.nytimes.com/2004/11/05/health/05medicare.html?pagewanted=print&position=

SNIP..."Medicare Covers New Treatments With a Catch
By GINA KOLATA

For the first time in its history, 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.

The new initiatives began this year when Dr. McClellan, who is both an internist and an economist, decided that evaluating treatments for elderly Americans falls under Medicare's purview to pay for whatever is medically necessary. If the treatment does not work, he argues, then it really is not medically necessary, and Medicare should not be paying.

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.

The goal, Dr. McClellan said, is better and more cost-effective medicine....." END SNIP

I really don't like the sound of this. It makes it sound like the seniors must be the testing ground if they want treatment. Some are not physically able to undergo a new regime of tests under such circumstances. This has a ominous ring to it.

[candy]

1. This is one Medicare lady they wouldn't dare experiment on!

[americanwomanone]

32. They Aren't Testing Anything On Me Either. n/t

[sangh0]

33. Oh yes they are

What do you plan to do about hormone replacement therapy?

Did you know that doctors STILL don't know what the best course of treatment is? If you get ANY treatment for this, then you are being used as a test.

Have you ever taken any birth control pills? They have never been systematically studied to determine the best dosage for the various age groups.

Ever have a mammogram? Doctors are still unsure of whether increasing the frequency of mammograms does more help than harm.

Ever taken a prescription drug? Do you realize that drug was probably NEVER tested on women to see if they react differently to it than men do?

Are you black? Most of the drugs that are tested are tested on white men. We don't know if (and how) these drugs work differently in people of other races.

Only about half of the treatments that doctors engage in have been tested for efficacy. Half of the treatments given are unproven to be effective.

[PROGRESSIVE1]

2. Bush has brought the Third Reich (via Mengles) to America.

:mad:

[sangh0]

3. You are way off base

The truth is, what's going on NOW is the equivalent of using seniors as guinea pigs.

We pay for treatments and we have NO IDEA if they work. We perform surgical procedures on them and we have NO IDEA if they help. We pay for drugs to treat their conditions and we have NO IDEA if they work.

I really don't like the sound of this

Instead of judging things based on "how they sound" why don't you educate yourself about the issue and the relevant facts and then make a decision based on facts, logic, and reason, instead of "how it sounds"?

Some are not physically able to undergo a new regime of tests under such circumstances.

These new studies do NOT require anyone to undergo "a new regime of tests"

[madfloridian]

5. Why do you do this?

:shrug:

I know it is not just me, either. Why?

[sangh0]

6. I was going to ask you the same thing?

Why do you attack one of the most liberal Senators who has been aggresively fighting bush* on his right-wing judges?

Why do you attack studies to find out which medical treatments are effective?

In both cases, it was because something "didn't sound right"

What's your problem?

Don't you care that our seniors are being subjected to all sorts of treatments and WE DON'T KNOW IF THEY WORK?

Don't you care that our tax dollars are paying for expensive new drugs but WE DONT KNOW IF THEY WORK any better than the cheaper older drugs?

Why are you so concerned about how things "sound"? Who does that help?

[KYDEM]

8. Are you volunteering your mother?

n/t

[sangh0]

11. Both my father and my brother participated in medical studies

Give me one good reason why we shouldn't investigate what works and what doesn't. Then you can continue your interrogation about my family

[KYDEM]

15. My mother was diagnosed with lung cancer 1993

The cancer was the type that could not be killed with chemo- therapy would have shrunk it but not cured it other option was an operation to remove tumor and surrounding tissue lower lobe would have been removed if she would have had healthy lungs. She had the operation and it had not spread to her lymph nodes she did not need radiation. She is still living and cancer free and is 85 years old. Now let's say this took place now and the Dr. advises a unknown treatment so they can test it on her? Will she be told of the option of surgery or will Medicare refuse to pay for another option?

[sangh0]

16. You've misunderstood the article

This is not the result of doctors trying to get subjects to test new treatments on. This about putting ALREADY EXISTING treatments to the test. These are treatments that Medicare currently DOES NOT pay for now.

Right now, doctors are advising patients to undergo treatments EVEN THOUGH these treatments have never been shown to be effective at treating the condition the patient actually has.

Will she be told of the option of surgery or will Medicare refuse to pay for another option?

This new Medicare policy has NOTHING to do with what a doctor can tell their patients. And right now, Medicare DOES REFUSE TO PAY for treatments that haven't been proven effective. With this policy, Medicare will pay for things it previously did not, but it will require that the patients be MONITORED (not subjected to medical tests) to see if the treatment actually helps.

What's wrong with this?

[madfloridian]

10. You do not have a clue what the article is saying.

You did not have a clue that I was not attacking Schumer the other night. I wonder if your greatest joy is.....oh, never mind. The pleasure of saying it is not worth being banned. :shrug:

[sangh0]

12. Yeah, right

I noticed you haven't corrected any of my statements. All you've done is make personal attacks. You say you're concerned about the seniors, but all you do is talk about me.

[KYDEM]

7. can you explain then ?

Do you have an elderly sick mother or father?

[sangh0]

9. Yes and more

What makes you think health issues are something that only affects some people? Even if I didn't have any elderly parents, I have an 88-year old friend down the block who is dying slowly. The woman who lives next door, my friend, is dying of breast cancer, probably before this day is over.

I'm like everyone else. I have a mommy and a daddy, and neither are getting younger. I'm not getting younger either. Neither are my friends.

[FlaGranny]

13. Please tell me

what you mean. "We pay for treatments and we have NO IDEA if they work. We perform surgical procedures on them and we have NO IDEA if they help. We pay for drugs to treat their conditions and we have NO IDEA if they work." Which treatments do we not know work? Are you saying that we are using experimental treatments now? Confusing - I don't know of any insurance, Medicare included, that will pay for experimental treatment.

[sangh0]

14. Read the article

It goes into it a bit.

In order to get FDA approval, a procedure/drug/machine/etc, has to shown to be safe and effective at treating something. Once that's done, it's approved and once approved, doctors can use that procedure/drug/machine/etc for ANY purpose EVEN IF it hadn't been tested or approved for that particular purpose. It's called "off-label"

The use of these treatments have NOT BEEN TESTED to see if they effectively treat the condition. They have only BEEN TESTED to see if the effectively treat SOME OTHER CONDITION.

From the article:

The problem arises because 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."

Dr. Platt and other academic experts, as well as patient advocacy groups like the Center for Medical Consumers in New York, agree, and applaud the new Medicare initiative.

It is so compelling, said Dr. Robert Califf, director of the Clinical Research Institute at Duke University, that "almost regardless of your political philosophy, this makes sense."

"We have an increasingly powerful array of drugs and devices and a bewildering array of choices," he said. "And there is a broad agreement among people who make these choices that we don't have the information we need."

The dearth of information reached a crisis with cancer drugs, Dr. Tunis said, when new drugs, so-called biologics, began reaching the market.

With cancer drugs, he said, the tradition is to test new medications in situations that their makers think are most likely to show benefit. That leads to approval by the F.D.A. Then the drugs often come into widespread use off-label - doctors give them to patients with different cancers or in combination with other drugs, trying them out in new contexts. Medicare is required to pay for the original approved use and for uses listed in certain drug compendia. Other than that, Medicare payments for off-label uses are up to the discretion of local contractors to the agency. Some pay; others do not.

[FlaGranny]

19. I see what you're getting at.

I still don't totally agree, though. Just focusing on drugs and off- label uses of drugs, these are historically the way the human race has discovered treatments and cures. Physicians "practice." When they, for example, give a diabetic patient a certain drug and patients report it has improved some other problem, physicians report it to each other and other physicians try it. That is a good thing. How many discoveries are serendipitous? We already test new procedures and new drugs more than any other country. It takes a decade to get any new drug on the market. I don't know how much longer we can or should test them. If dangerous drugs turn up after all this testing, perhaps the pharmaceutical industry is being dishonest with their testing results and the FDA is colluding with them.

[sangh0]

25. I guess I wasn't clear

Just focusing on drugs and off- label uses of drugs...

I'm not sure if you misunderstood me, but I wasn't saying that this is limited to off label usage of drugs. There are medical procedures (angioplasty) and devices (coronary stents) that have not been tested to see if they are truly effective when used how they're actuall being used.

When they, for example, give a diabetic patient a certain drug and patients report it has improved some other problem, physicians report it to each other and other physicians try it. That is a good thing. How many discoveries are serendipitous?

I have nothing against serendipity. However, I don't see that as a reason to ignore the benefits of focused studies on the efficacy of various medical treatments. Right now, they're not being done.

We already test new procedures and new drugs more than any other country.

That's true, but the only testing that gets done is to see if the drug/treatment/etc works for the ONE condition it's being tested for. The off-label usages are never tested for their efficacy. Isn't a good idea to see if these off-label usages do any good or any harm?

If dangerous drugs turn up after all this testing, perhaps the pharmaceutical industry is being dishonest with their testing results and the FDA is colluding with them.

You should look into the Vioxx recall. That's EXACTLY what was happening.

[MatrixEscape]

4. Well, at least they are not threatening to

turn them into Soylent Green ... yet.

I don't think I am going to be surprised by any of the crazy things that will be coming down the pipes. Everything BUT the People has a green light to do whatever it wants to.

[madfloridian]

17. In effect this is turning treatment over to private companies.

Medicare will not pay unless the seniors submit to evaluation under the auspices of a private company.

"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."

What happened to the right to have your own doctors?

[sangh0]

20. You are wrong again

"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."

Medicare patients are ALREADY being treated by private physicians or privately owned medical corporations. This is about the TESTING, not the treatment.

What happened to the right to have your own doctors?

Medicare allows beneficiaries to choose their own doctors. That hasn't changed just because you don't like "the sound" of it.

[madfloridian]

24. They won't pay for new treatments unless you join a test group.

If you join a test group, the research will be paid for by private foundations and private companies.

Now, think in your mind.....how do they do testing? Think...placebo.

Think what could happen if you are given the placebo.....you could die?

[sangh0]

27. If you don't get the treatment, you can also die

and under the old rules, YOU DON'T GET THE TREATMENT.

Under the new rules, you have good chance of getting the treatment.

[amazona]

18. what if you're in the control group?

Studies have control group. Doesn't this mean that half the people who think they are getting medicine are not getting medicine? Guinea pigs often die for science.

[madfloridian]

21. Aha,....and turned over to private companies as well.

You get it. Guinea pigs in control groups.

[sangh0]

23. Medicare is ALREADY provided by private physicians and companies

That's what people want. That's A GOOD THING

[madfloridian]

26. NOT under the new law.

I am not going to argue this with you anymore. Read the new law which will end so much. It will nearly be like an HMO for poor folks and no choice of doctor.

[sangh0]

28. Wrong again

Under the new rules, treatment is still provided by private doctors.

Read the new law which will end so much

This isn't new legislation. It's a new regulation. From the article:

"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."

The Director of Medicare has no power to pass legislation.

[madfloridian]

29. That statement shows you are just arguing.

It shows you do not have a clue what this is about. Those who can choose physicians now are in for a big surprise. And what do you mean provided by "companies". It may be dispersed by companies, but right now the government still has oversight.

Never mind.

[sangh0]

30. Where does the article say that?

Where does the article say that Medicare will no longer allow seniors to choose their physicians?

[sangh0]

31. And look who agrees with you

from the article:

But the defibrillator makers are not enthusiastic about starting a registry.

"The first option is that C.M.S. should pay for it," said Peter Gove, a spokesman for St. Jude Medical, a defibrillator maker, referring to the Centers for Medicare and Medicaid Services.

The medical CORPS are not happy at being forced to pay for studies that show their devices are effective. Why are you on the side of for-profit health corporations that donate to repukes?

[sangh0]

22. Now THERE'S a valid concern

Yes, some of the people who want these treatments will NOT be getting the treatment they've requested. On the other hand, under the new rules, they have a chance of having Medicare pay for the treatment. Under the new rules, there was NO CHANCE Medicare would pay, and therefor NO CHANCE they would get the treatment.