Lymphoma Vaccines Must Be Immediately Approved sign now

From The Washington Post May 31:
On May 30th the FDA, responding to the threat of bioterrorismand of criticism heading their way over the utter failure to develop defensive vaccinesadopted a new rule that would allow approval of vaccines based upon animal studies alone.

Progress in biodefense has been impossible, we are told, because it is simply be unethical to design a randomized trial of an anthrax or plague vaccine that would expose human subjects to the diseaseafter giving only half of them the vaccine.

The Washington Post had much to say that will strike a chord with each and every one of us who has been touched by LYMPHOMA: The new standard will only be allowed when tests of a drug's effectiveness on humans would be unethical, adding: It is considered unethical to expose a test subject to a potentially lethal or permanently disabling agent.

This is a topic weve been commenting on for some time--most recently in our op-ed piece in the journal Cancer Biotherapy & Radiopharmaceuticals. We questioned in particular the ethics of randomizing the NCI vaccine, an outgrowth of Dr. Ron Levys breakthrough lymphoma vaccine, which has shown benefit as far back as 1986.

Lymphoma vaccines offer the chance of a cure. In its 1999 phase II study, the NCI vaccine delivered long remissions to 90\% of trial subjects. As of January 2001, 77\% were still in remission for up to 74 months.

But this vaccine and others are now stuck in lengthy randomized trials that force those in the placebo part of the trial to take chemotherapy given alonea therapy widely recognized to be outmoded. The therapy of choice for numerous oncologists is Rituxan-CHOP, which delivers large response rates, durable remissions, even molecular remissions.

If it is unethical to expose a test subject to a potentially lethal or permanently disabling agent, it follows that it is unethical to expose hundreds of people who get placebo in these randomized trials to the heart-damaging potential of Adriamycin just to establish a scientific principle. It is also unethical to give these HUMAN trial subjects less than the best therapy available. The best therapies today are unquestionably Rituxan-CHOP--or the vaccines themselves.

But, with this new rule the FDA has revealed, for all to see, that they do NOT have to conduct lengthy and unfair randomized trials while thousands die, that they CAN act swiftly when forced to, that they DO know what is ethical and what is not.

Lest any of us doubt that the new rule pertains not only to bioterrorism, but also to life-threatening illnesses, the Washington Post adds:

The new rule, which was first proposed in 1999 and took on a new urgency last fall, was likened yesterday to the FDA's landmark decision a decade ago to approve new HIV and AIDS drugs that had not been fully tested by previous standards. At that time, the FDA concluded that its standard review process was standing in the way of making potentially lifesaving drugs available to infected people.

That paragraph reveals the new rule had languished since 1999 on someones desk at the FDA, just as the NCI vaccine languishes now in an unnecessary randomized trial, and has languished since 1999--the year that vaccine brought long remissions to 90\% of subjects in the foregoing phase II trial.

The paragraph also reveals that everybody knows the FDAs review process was keeping hopeful drugs from people with AIDS, that the FDA woke up (after ACT UP street protests) and made changes.

From then on, AIDS had a priority that has never been afforded to cancer. This is obvious because cancer is NOT EVEN MENTIONED.

FDA can be taught that cancer--LYMPHOMA in particular--is just as important. We must publicly speak up, NOW.

There has, in fact, been far more testing of all the lymphoma vaccines than is proposed for the not-yet-developed bioterrorism vaccines. Remember: FDA intends to give newly developed vaccines to HUNDREDS OF MILLIONS OF AMERICANS after testing on monkeys. If they can do that, they can give us these vaccines, a number of which have shown efficacy in HUMANS.

This PETITION demands that the FDA apply to lymphoma the same common sense they are finally applying to the bioterrorism problem. We demand that lymphoma vaccines which have shown efficacy be immediately approved by the FDA.

When we get the maximum number of signatures, this PETITION will be delivered--with appropriate publicity--to the FDA commissioner in Washington.

For further info: http://groups.yahoo.com/group/LymphomaPatients/

-- Lymphoma Patients United for The Cure

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Tamra HaneyBy:
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The Commissioner of the FDA

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