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Monday, August 16, 2010

Avastin Meets Death Panel

Avastin is a drug therapy for "advanced" Stage IV breast cancer patients. Approximately 17,500 women in the U.S. are on Avastin.  Being brutally honest here, the FDA believes the drug is too expensive to be dispensed to women who will die anyway, and are considering rescinding it from their drug approval list. The medical community is divided on the effectiveness of the drug. Some believe the toxicity is not worth the results, others see good results in their patients. A look around the InterWeb shows that some insurance companies have already stopped the treatment, and I also see patients who have been on the drug for two years and are doing extremely well. Read a patient's statement below.

Avastin

Before getting to the story, let's revisit Obama's close friend and adviser, Ezekiel Emanuel, the brother of Rahm Emanuel. Ezekiel is an advocate of discontinuing care to patients who will never make a full recovery:
Savings, Emanuel writes, will require changing how doctors think about their patients: Doctors take the Hippocratic Oath too seriously, "as an imperative to do everything for the patient regardless of the cost or effects on others" (Journal of the American Medical Association, June 18, 2008).

ObamaKare is gearing up. Where can the FDA and insurers find savings? By de-certifying drugs for patients considered to be on a terminal list, or soon to be. Who is making these decisions. Well, that's easy, people with "influence," of course, also know as a Death Panel:
The Food and Drug Administration is reviewing the recommendation of influential scientific advisers to revoke authorization of the drug to treat metastatic breast cancer. Contrary to initial research, new studies indicate that the benefits of the drug, which costs $8,000 a month, do not outweigh its risks, the advisory panel concluded.
Avastin is not only prescribed for treating breast cancer. It has proved to be effective for other cancers. Look at this odd statement:

Avastin is approved for use in treating several cancers, including those of the colon, lung, kidney and brain. So doctors could continue to write prescriptions for it for breast cancer, as an "off-label" use
But in addition to prompting insurers including Medicare to stop paying for Avastin, an FDA revocation of approval for its use in breast cancer treatment might mean that breast cancer patients would lose eligibility for a program in which Genentech caps the annual cost of the drug at $57,000 for women with annual incomes of less than $100,000.
Does this mean people suffering from of the other cancer can continue to receive Avastin, and only breast cancer patients would be denied? The answer is 'yes.' Apparently, the toxicity does not affect cancers other than breast cancer. Do we really believe that? This is a death panel issue. Mentioned above is the idea of making Avastin available for breast cancer treatment for "off-label use," meaning you can get have it you can pay for it.
As reported by The Wall Street Journal in July, "an FDA advisory panel voted 12-1 to remove the breast cancer indication from the drug's label. If the FDA follows the advice of its committee - as it often does - the drug could still be marketed to treat colon, lung and other cancers."
Medical sources are divided on the success rendered versus the harm caused. Some believe the drug should have never been approved. Here is one success story, and Susan G. Komen for the Cure and the Dana-Farber Cancer Institute stand behind the drug's good performance:
"I'm very upset," said Leslie Twohig, 48, of Lothian, Md., who has been taking Avastin for eight months and credits the drug with helping her survive. "How long will I be able to stay on Avastin? Are they going to take it away? I know it's working for me. Right now I am able to enjoy my life. Every morning I wake up and wonder how long it's going to go on."
"I am very concerned about people who are receiving the drug and may feel threatened that they may not be able to receive it," said the Dana-Farber Cancer Institute's Winer, who is also chief scientific officer for Susan G. Komen for the Cure, a breast cancer patient advocacy group. "This is not a worthless drug by any means. There is almost certainly a group of women who get a big benefit. "
Some members of Congress have written protest letters to the FDA and the Department of Health and Human Services. Senator David Vitter (R-LA) says he fears this is the beginning of "a slippery slope leading to more and more rationing under the government takeover of health care that is being forced on the American people."

Wealthier patients who can pay the $4000-$10,000 per month for the drug will probably live longer and have far less pain than the patient without an option for Avastin .

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