Biotechnology Nature — Pressure is mounting on the US Food and Drug Administration (FDA) to explain its decision to ignore an advisory committee’s positive recommendation for the cancer vaccine Provenge. (click this link for full article) Below is an excerpt.

In the coming weeks, it looks increasingly likely that the US Congress will launch an investigation into the circumstances behind the FDA’s decision last May to delay approval of Provenge, a recombinant therapeutic vaccine developed by Dendreon for use in terminally ill patients with androgen-independent prostate cancer. Cancer patients have been exasperated by the agency’s decision to ignore an advisory committee recommendation made in March, which gave the green light for full approval. The flip-flop came following the panel meeting, after FDA received three letters sharply critical of Provenge’s safety and efficacy, which were subsequently leaked to the press. With allegations of ‘dirty tricks’ by agency officials and undisclosed, potentially damaging corporate ties associated with at least one of the letter writers, the onus is now on the FDA to affirm the legitimacy and impartiality of its regulatory process.

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Congressmen Mike Michaud (D-Maine), Dan Burton (R-Ind.) and Tim Ryan (D-Ohio) are calling for a congressional hearing into what happened. We must continue to be vigilant and to contact our representatives in the Congress to keep the pressure on, and to demand a congressional hearing. Please fax your own Congressional Representative the letter and the Biotechnology Nature article, etc. and ask them to send a letter to Congress saying that they want to join in this action. Do not take no for an answer. It may require several phone calls, emails etc to your Representative. Ask to speak with the health staffer. Do not give up. Tens of thousands of lives hang in the balance each year until Provenge is approved.

Please contact us if you need further assistance, rk@CareToLive.com . We would like to see immunotherapy, whereby the immune system is strengthened to fight off the cancer cells, rather than the current system of killing our healthy cells along with our cancer cells indiscriminately, sometimes killing us during the process, one day be made available for breast, colon, lung cancer etc. We are tired of the chemo cartel’s stronghold on our cancer treatments. We want immunotherapy choices like Provenge, which has gone through extensive trials, and proved to be safe and effective and as well as prolonging life along with improving the quality of our lives, when there are no viable options. The FDA delay was unprecedented. CareToLive attorney Kerry Donahue is currently suing the dysfunctional FDA on our behalf to try to make this treatment available to the men who need it now.

CONGRESSIONAL LETTER ASKING FOR A HEARING (click here to download) Please fax this letter to your own congressional representatives and ask them to join this action.

An Easy Way To Contact Your Elected Officials - (click here) EVERY VOICE COUNTS!

Contact Your Elected Officials - Click Here

This link will take you right to a page to send a form to the committee

Here are the members of the subcommittee that would take up the investigation.
Please use this link to email them.
You may also fax them at 202-225-2525.

Please fax the Congressional Hearing letter to your own Congressional Representatives along with the Biotechnology Nature article (use link at top of blog) and ask them to join the action to call for a hearing into what went wrong with the safe and effective immunotherapy Provenge approval process at the FDA. Over 20,000 men have died without the benefit of Provenge since the delay. Tell them you want a full inquiry into the undisclosed conflicts of interest of the 2 panelists that “leaked” letters used to derail Provenge. How did these two “doctors” offset the 17 to 0 vote on safety and the 13 to 4 substantial evidence of efficacy vote. The FDA works for us and not the other way around. We Want Provenge approved and We Want It NOW! WE WANT ANSWERS! Here is the letter in full. Continue Reading FDA Under Pressure From Congress To Explain Provenge Delay »

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