Monday, February 2, 2009

Forewarned is to be forearmed

with the latest in the medical circles, which is not helping the people as it supposing should be doing. Be aware of the treatments available in the market today.

Medicare has broadened its payment for new anticancer drugs, according to a recent article in the New York Times (1/26/09). At first sight, this might seem like a good development for cancer patients. Medicare will now pay for more drugs! But, as the story makes clear, the change actually raises serious questions about the overuse and promotion of dubious drug combinations that have become popular in recent years.

As background, the Food and Drug Administration (FDA) has approved a variety of new drugs over the past few years that, at best, are minimally effective. Sometimes, they confer a few months of extra survival; oftentimes there is no proof that they do even that. They also may carry an increased risk of serious side effects, and in almost every case they are very expensive.

According to the Times authors, "for many such uses there is scant clinical evidence that the drugs are effective, despite costing as much as $10,000 a month." Medicare approval may therefore waste money and needlessly expose patients to the adverse effect of drugs that might hurt them, and make their final months more miserable.

New drugs are approved by FDA only for specific indications, and they cannot be assumed to work in other circumstances. For a dozen or so years, however, industry has succeeded in chipping away at these FDA barriers. Now the dam has broken. Medicare has in effect over-ridden the carefully constructed FDA barriers and agreed to pay for a much wider degree of "off-label" use. These uses are sanctified by various guidelines, called compendia, that are often written - according to the Times - with the eager input of drug company representatives.

"We have very little faith that those indications that make it into the compendia are safe, let alone effective," said Dr. Allan M. Korn, the chief medical officer for the Blue Cross and Blue Shield Association. Medicare is now providing "carte blanche in treatment for cancers," according to Steven Findlay, a health policy analyst for Consumers Union. He also said that such coverage encourages doctors to use patients as guinea pigs for unproved therapies. But skeptical views like this are overwhelmed by a chorus of cheers coming from Big Pharma and its many friends in the oncology community.

Political Implications

What will this change mean in practice? For example, Avastin (bevacizumab) - at $100,000 per year one of the most expensive of the newer drugs - will now be covered by Medicare for ovarian cancer. But does Avastin actually work for ovarian cancer, i.e., does it increase the patient’s overall survival? No one can say, since randomized controlled trials (RCT), formally required for FDA approval, have never been done. But the new Medicare ruling "makes it easier to give drug after drug," said Andrew Berchuck, MD, director of gynecologic oncology at Duke University, "and keep the fantasy alive." Keeps the fantasy alive! The "fantasy" in this case is the idea that oncologists actually have effective pharmaceutical solutions to intractable ovarian cancer, when they do not.

Implications for CAM

Oncologists have hailed the change as a way of generating new knowledge about what works and what doesn’t. But I suspect that, on the contrary, these new rules will further reduce the motivation to do rigorous research. Who now will bother if you can get compensation based just on a drug industry-influenced compendium?

This also has serious implications for complementary and alternative medicine (CAM). On the one hand, I realize it may make it easier for the few CAM practitioners, who utilize these drugs in off-label ways, to get compensated for doing so. But, on the other hand, the rules will further decrease the attractiveness of alternative treatments, since now patients will perceive their conventional doctors as the source of a wider array of potential treatments (without evidence that they can actually increase survival).

What I find particularly disturbing is that the double standard has just gotten much wider. CAM treatments that have a considerable amount of data behind them still have little chance of being accepted by FDA or paid for by Medicare. They are expected to jump through all the hoops of a lengthy testing process, including prohibitively expensive randomized clinical trials. This is virtually impossible for them to do, but Big Pharma - which has the money to do such trials - now gets a free pass.

At the same time, the combined forces of FDA, Medicare, ASCO, and their friends, continue to prevent accurate information on these competitive treatments from reaching the ears of oncologists. Take, for example, ASCO’s guidelines on exhibiting at their massive annual meeting:

"Dietary supplements that (i) make any claim to diagnose, mitigate, treat, cure, or prevent any disease, specific class of disease, disease symptom, or abnormal medical condition; or (ii) claim an effect similar to that of an approved drug, biological product, or medical device must not be exhibited" (emphasis added).

Is it any wonder, then, that rank-and-file oncologists remain ignorant or scornful of the effects of less toxic or botanical compounds, and eagerly turn to the products of Big Pharma. In addition, although not mentioned in the current Times article, readers should be aware of several excellent articles by the same authors on the so-called "chemotherapy concession." This means, essentially, that oncologists are allowed to sell chemotherapy in their offices at a profit, a privilege granted to few other medical doctors. They may also receive rebates from these same companies when they prescribe a high volume of their products.

CAM treatments are not paid for by Medicare, even when they have extensive testing behind them or have been approved as legal treatments in other countries. The high regulatory barrier remains in place for nutritional, non-toxic or unconventional approaches. But the products of Big Pharma, once they have gained a foothold in a single indication (often in the absence of proof of life-prolongation) are now eligible for compensation for many other indications. This is a move that primarily benefits Big Pharma and profit-oriented oncologists, and not cancer patients in search of more effective treatments.

There is a medical breakthrough that is not reaching the public through our medical schools or public health-maintenance organizations : the discovery that chronic unintentional dehydration of the body is the primary cause of pain and disease in the human body, including cancer. The reason these traditionally trusted institutions do not celebrate and spread this scientific discovery and refuse to use it to help the sick and the uninsured poor citizens in our society is obvious. There would be no money in it for them.

Imagine, more than one hundred years of serious scientific research has been conducted on the solid composition of the human body - obviously and totally oblivious to the vast complications that ensue when the human body is dehydrated ; when its plum-like and juicy fluid cells become transformed into prune-like and drying cells because of insufficient water, or due to the additionally dehydrating beverages and medication pill that are on the market now.

What we in medicine did not realize until very recently is the fact that the human body can become short of water inside its cells even when water is available, plentiful, and virtually free.

When the gradually dehydrating body begins to malfunction and manifest its water shortage, we label thee symptoms and signs of the human body's regional and local drought as disease or syndromes of unknown origin (diseases of unknown etiology).

And since the discovery of DNA structure, we now blame genes for a patient's health problems - obviously not realizing that when any cell begins to dry up and get damaged from inside, the nucleus in that cell, and its DNA structure, are not exempt from the process.

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