(Prostate) Cancer therapy delay attacked (FDA, threats)

msnbc ^ | 7-5-07 | Rob Stein

[Tired of Taxes]

Oncologists do not usually need bodyguards when they present scientific data at a medical symposium.

But when Howard I. Scher of the Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan spoke at the recent meeting of the American Society of Clinical Oncology, they were in fear for their safety.

The two doctors have been at the center of an unusually bitter debate over an experimental therapy for prostate cancer, ever since they helped persuade the Food and Drug Administration to delay approving it, enraging both patients and investors. The first-of-its-kind therapy, called Provenge, is a "vaccine" designed to extend the lives of patients with advanced prostate cancer by stimulating their immune systems.

The debate over Provenge illustrates the highly charged atmosphere that often surrounds new treatments as the desperation of deathly ill patients increasingly converges with the high-stakes intensity of biotech investing in the anything-goes forum of the Internet. The result in this case has been anonymous threats, accusations of conflicts of interest, Capitol Hill protests, congressional lobbying and vitriolic postings on blogs, Web sites and MySpace pages.

[Tired of Taxes]

(SNIP)

"The prostate-cancer community has probably been awakened for the first time. We're clearly upset about what has happened," said Thomas A. Farrington of the Prostate Health Education Network, which created the ProvengeNow.org Web site. "The true victims are the prostate-cancer patients whose lives could be saved. We're talking about terminally ill men, many of whom have no other options."

(/SNIP)

Patients should be free to choose to take the risk, especially when they have no other options.

[SteveMcKing]

But when Howard I. Scher of the Memorial Sloan-Kettering Cancer Center and Maha Hussain of the University of Michigan spoke at the recent meeting of the American Society of Clinical Oncology, they were in fear for their safety.

Now that's pathetic. More likely they are both lifelong nerds who feel threatened and victimized by everything they perceive. No sense of proportion between them.

[therut]

Tell that to the next lawyer you see.

[AnotherUnixGeek]

Patients should be free to choose to take the risk, especially when they have no other options.

Exactly - this is so bleeding obvious to those of us not in the FDA. If prostate cancer is killing me, let me sign waivers indemnifying everyone on the planet and give me the damn experimental drug.

[Tired of Taxes]

ping

[dcwusmc]

In before the PINGGGGGGGGGG!!

[Cacique]

BFL

[tinamina]

YES, let patients choose....I am a widow of 10 months. Husband had prostate cancer and knew in his heart Provenge was going to save him, but no doctor or clinic would let him have it,,,dying patient, doctors would rather prescribe hospice than try to save a life...my husband is gone from my sight and I am devastated. Let advanced patients choose their treatment. My husband had just turned 60 and was very healthy except for the chemo they killed him with. Sorry, prejudiced on this issue.

[Finalapproach29er]

The FDA kills more people than any other cause. IMO

I’m waiting for a lung device that could help those with lung distress.

Sorry for your loss.

[Major_Risktaker]

Now that's pathetic. More likely they are both lifelong nerds who feel threatened and victimized by everything they perceive. No sense of proportion between them.

Steve your speculating. Looks like corruption.

Dr. Howard Isidor Scher has Ten Reasons to Worry about Provenge's Approval

[USMCVet]

I am very sorry for your loss and my prayers are with you.

Semper Fi

[Diogenesis]

FDA's goal #1: Make sure no disease is CURED, that way drugs will be used for the patients life.

FDA's goal #2: If it can be made in China, it is WONDERFUL.

FDA's goal #3: Vitamins, bad. Choice, bad.

[traviskicks]

Libertarian ping! To be added or removed from my ping list freepmail me or post a message here.

[trisham]

YES, let patients choose....I am a widow of 10 months. Husband had prostate cancer and knew in his heart Provenge was going to save him, but no doctor or clinic would let him have it,,,dying patient, doctors would rather prescribe hospice than try to save a life...my husband is gone from my sight and I am devastated. Let advanced patients choose their treatment.

***********

I'm so sorry.

I agree with you regarding this patient's choice issue. If someone is considered "terminal", it only makes sense to allow them to make the decision.

[Old_Mil]

I haven't seen the study, but the article goes on to state:

Scher and Hussain told the FDA that Dendreon Corp., the small Seattle biotech company that developed Provenge, submitted a study to win approval for the drug that was so small that the apparent benefit it showed could have been the result of chance...

...After the price of Dendreon's stock quadrupled and then plummeted, irate investors wrote hundreds of letters to the FDA and Congress, posted blistering critiques in Internet chat rooms, and created Web sites and MySpace pages denouncing the FDA, Hussain and Scher.

Remember the last time something like this happened? It was called Celebrex. Sounds to me like the doctors are acting appropriately - after all, you don't want to bring a non-helpful therapy to market and have patients turn their backs on something that has some benefit in order to try something that has none. It would appear that it's the biotech investors that are behind this - follow the money.

[Paul_B]

My sincere sympathies for your loss. The FDA’s and cancer establishment’s professional arrogance and avarice is literally killing people.

Please see Howard Scher’s conflicts of interest posted in this thread. And to keep up with this issue tune into the investor message board at http://www1.investorvillage.com/smbd.asp?mb=971&clear=1&pt=m

God bless,
Paul

[traviskicks]

heh heh...

[Old_Mil]

I agree with you regarding this patient's choice issue. If someone is considered "terminal", it only makes sense to allow them to make the decision.

While patients should be free to chose between different treatments that have different associated benefits/risks, it's a doctor's responsibility to make sure that the treatments he offers are more than sugar pills.

[trisham]

While patients should be free to chose between different treatments that have different associated benefits/risks, it's a doctor's responsibility to make sure that the treatments he offers are more than sugar pills.

**************

I'm not sure I would feel that way if I were the patient.

[Paul_B]

They’re not. Even the FDA’s statistician admitted the chance was one in forty that the results were not statistically significant. The problem is the trial designs were antiquated. Due to the cancer establishment’s traditional focus on chemotherapy, time to disease progression has been accepted as a surrogate marker for survival. But Provenge, being a vaccine therapy, trains the body to do its own cancer fight, and that takes time.

Thus, time to progression is not Provenge’s strong point. Survival, the gold standard for which TTP is only a surrogate, is however.

But there’s a lot of money and prestige invested in the chemotherapy regime. Provenge would quickly become the front line therapy and upset a lot of people’s apple carts.

And as Dick Pazdur and the FDA fiddle, 27,000 men will die of prostate cancer each year in this country alone.