Drugs are tested to show they are safe and effective before being approved by the FDA. But a clinical study is not the real world, and just because a drug leads to a statistically significant improvement doesn’t guarantee that the desired effect will follow.

There are molecular and cellular tests available to weed out those cancer patients that chemotherapy wouldn’t have any benefit, what chemotherapy works the best for those that chemotherapy would benefit, and further monitor treatment success or disease progression.

There is no proof beyond reasonable doubt for any approach to treating advanced cancer today. In life or death situations, one must make judgements based upon preponderance of available evidence as opposed to proof beyond reasonable doubt.

Sorry to discourage you and compare AIDS and cancer(?). Cancers can develop resistance to non-targeted treatments too (eg, upregulate PgP).

It is very discouraging to compare cancer therapies with AIDS drug. On the other hand this is the shortcoming with these targeted cancer drugs. The fact that they do not destroy the cancer causing stem cells means that eventually mutations develop that render these drugs ineffective.

Speaking of stem cells it is appalling that so much money is being wasted on drug therapies while our congress blocks important access to stem cell research. One would have to wonder if pricing could be limited to be pro rated to the actual effectiveness of the drug. Perhaps that would provide the necessary spark to fire up innovation, something that is completely missing at the moment.

The studies showed that patients did not survive any longer either with or without the drug. However, the studies for the Prostate cancer drug did show longer PFS in at least 1/3 of the patients….

B) Many drugs are approved on the basis of a marker, and then subsequently, the proof comes that these drugs do increase survival. Look at all the AIDS meds that get approval for lowering viral load. Subsequent data proves they can increase total lifespan. If you wait for that data many people who could benefit from the drug will not receive it and will die in the meantime.

C) Was there a trend towards increased survival in Avastin-treated patients?

It is becoming a money making rip off.

Shame on the FDA but bigger shame to the drug company - they are playing with patients emotions in order to scam a few bucks from sick and dying patients. How pathetic…

Genetech has announced its projected price for breast cancer treatment- $100,000 per year. The cost to patients will obviously depend on how long they live to take the drug.
1)Patients who cannot afford it and have no insurance to cover this price will not get it.
2) Patients who receive it will either
a) pay for it out of pocket
b) be covered to some degree by their heath insurance carrier, who will pass on the drug cost in the form of increased premiums to all its clients.

Avastin’s anti-cancer mode of action is by anti-angiogenesis, but not in a safe way - reported side effects include bleeding, kidney malfunction, reduced white cell count, gastrointestinal perforation and death. Animal studies in the scientific and medical literature (principally Medline)have documented the safe anti-angiogenic activity of the following, readily available, nutraceuticals(non-inclusive list):

Aged garlic extract(or AGE, non-odorous)from Kyolic
Alkylglycerols (in shark liver oil)
Bupleurum (herb)
EGCG from green tea
Fish oil
Flaxseed lignans (using freshly-ground flaxseeds)
Genistein (from soy protein extract)
Melatonin ~ 10-20 mg/day
Noni(available in juice form)
Pomegranate juice (available at Trader Joe’s)
Resveratrol (in grape seed/grape skin powder)
Reishi (mushroom)
Silymarin (in milk thistle herb powder)
Tocotrienols(in mixed-tocopherol,mixed-tocotrienol NATURAL vitamin E, ~100 mg/day

The eventual development of chemoresistance through genetic mutation is a virtual certainty of all direct-cancer-attacking chemo agents. Anti-angiogenesis is
a potent activity against virtually ALL types of cancer, including breast and prostate cancer. Also, because it represents an indirect attack on the cancer cell, there is rarely the development of cancer-cell resistance to this mode of action.

The Avastin decision was supported and received approval in part because, Richard Pazdur lobbied for it, instead of against it as he did with Provenge. The support of Pazdur for Avastin should be taken by the FDA’s Jesse Goodman to be a slap in his face. Goodman was tricked and bullied by Pazdur into not approving Provenge.

Mr. Goodman, you know CBER did not give Provenge conditional approval only because Pazdur worked so hard to sabotage it. If you did not understand that before please look at his comments before and after Prvovenge including his statements about Avastin. His comments now mirror what the prostate cancer advocacy groups have ben saying about Provenge.

Mr. Goodman now has the opportunity to use Pazdur’s own words agianst him. Goodman has the power to give approval to Provenge if he wants and he can do it now. The FDA Counsel even says so in their appellate brief now available on http://www.caretolive.com lawsuit news page.

Mr. Goodman you have the CTL Petition. Do the right thing. Do not let Pazdur intimidate you any longer.

Further review of the FDA appellate brief will demonstarte how Pazdur speaks from two sides of his mouth. In the brief Pazdurs attorneys trot out the argument that the TTP endpoint was missed even though a survival benefit was seen in Provenge. They also ignore all 17 experts opinion that Provenge is safe and try to trick the Court into thinking there are legitimate safety issues as to Provenge. There are not.

Richard Pazdur likes breasts but could do without a prostate. I don’t think he wants to face the music from the breast cancer advocactes who are admittedly much more powerful then the prostate cancer advocates.

I agree that even if drugs such Avastin are not 100% sure to work, where there are no alternative treatments and are safe, you at least give hope to those dying patients who have access. But why not give hope to AIPC patients as well.

Pazdur has already set immunotherapies back by years by waht he did to Provenge. If Provenge was being used now it would be tried in combination with other treatments and oncologists would be well on their way to determining the most efective way to use Provenge. Sitting on a shelf just means tomorrows treatments will always stay available…tomorrow.

Years from now we will look back and everyone will understand the enormity of the delay in Provnenge.

Dr. Goodman….Do the right thing and do it now!!

Instead, he is resigning America to sit through more of this ongoing farce called ‘science-based decision-making’ at the FDA.

Pazdur’s statement on Avastin—as ‘an effective drug for breast cancer’ is a slap in the face to every prostate cancer patient battling AIPC who hoped they would be able to benefit from Dendreon’s Provenge. And Dr Pazdur knows it.

And unlike Avastin, two major phase-3 trials for HRPC showed that Provenge extended survival more than twice as long as the current standard of care, Taxotere. At 36 months, more than 33% patients treated with Provenge were still alive comparing to about 15% or less on placebo. Many treated patients stayed alive and well after more than five and six years.

Other trials in the earlier disease stage, ADPC or Androgen-Dependent Prostate Cancer, also indicated that Provenge was efficacious, conforming with the general knowledge that a treatment effective in a late stage cancer would often work even better earlier when the disease has not had a chance to ravage the patient’s body.

That Pazdur/FDA went out of their way to block Provenge approval –while embracing Avastin now, is a decision made even more unfathomable now given that it went against the approval recommendation of an Advisory Committee of world-renowned scientists that the FDA, itself, convened.

While Margaret Kirk can celebrate the fact that Avastin will give breast cancer patients hope…it is my hope that organizations like Y-Me Breast Cancer realize that the FDA’s Provenge decision doomed too many desperate prostate cancer patients to die needlessly while waiting for further statistical confirmation of a treatment that has been adequately proven efficacious and known to be safe.

It’s time for the girls and the Margaret Kirk’s to join hands with prostate cancer patients and demand that the FDA start acting like a science based agency and not Richard Pazdur’s hobbyhorse.