FDA Finally Gets Around to Approving New Cancer Vaccine

Yesterday, the Food and Drug Adminstration approved the new prostate cancer vaccine, Provenge, developed by the biotech company Dendreon. The vaccine is created by exposing patients' immune cells outside the body to prostate cancer cells. The exposed immune cells are then injected into patients with the aim of priming the patients' immune systems to attack the cancer. Dendreon first submitted its vaccine to the FDA for approval in 2006, and a FDA advisory panel urged the agency to approve in March, 2007. It's wonderful news that people suffering from prostate cancer now have a new treatment option.

But as Frank Burroughs, founder of the Abigail Alliance for Better Access to Developmental Drugs noted in press release he sent out yesterday:

Today with the prostate vaccine Provenge now finally approved, we have YET another example of why we need lifesaving and life-extending changes at the FDA.  Provenge is the 17th drug or vaccine the Abigail Alliance has pushed for earlier access to and earlier approval of that is now approved by the FDA.

This is yet another reason we need Congress to pass the Compassionate Access Act, H.R. 4732.

There is NOT one drug or vaccine that the Abigail Alliance pushed for earlier access to that did not make it through the clinical trial process.

Burroughs' group wants patients to have access to promising new treatments before they are approved by the FDA.

Back in 1996, the Competitive Enterprise Institute issued this biting video on the "Deadly Effects of FDA Overcaution" portraying an FDA press conference in which the head of the agency announces the approval of a new drug that will save 8,000 lives per year. The video then asks:

If the government approves a drug that will start saving lives tomorrow, then how many died yesterday waiting for the government to act?

For more on the Abigail Alliance's fight for faster access to new drug treatments see my 2007 column, "Whose Life Is It Anyway?"

Comments

[Jordan Elliot]

“Provenge”? Short for prostate revenge I’m guessing.

[Brian Sorgatz]

I was going to guess “proactive revenge.” Or maybe it’s supposed to sound like a French word. Revenge in Provence?

[wylie]

Revenge in Provence

Isn’t that a Jean Claude Van Damme movie?

[Seer]

But if patients can get early access to the drugs would there be any point to the FDA approval process?

[Brian Sorgatz]

That’s the $64,000 question. It practically answers itself.

[Thomas]

The problem is we need studies to make sure drugs are safe and effective. What happens if someone takes an unapproved drug and it turns out to be unsafe and/or ineffective. Speeding up the review process may get some good drugs to market sooner, but with unsafe drugs like vioxx making it through approval, you can make a case for more review and less approvals to keep us safe. I am not sure it is a good idea to be taking unsafe or ineffective unapproved drugs if there is an already approved drug that is safe and effective. Even if a drug saves lives, it needs to be free of side effects if it is to be OK to take.

[Bronwyn]

Even if a drug saves lives, it needs to be free of side effects if it is to be OK to take.

Ummmm…. no. That’s not the goal.

[Contrarian P]

No drug is free of side effects. None. Not one.

[Groovus Maximus]

Vioxx was not a bad drug and a very effective non-opioid pain management option for OA, RA and DJD (off label). I know of patients that would kill to get Vioxx as that drug was the most effective at relieving the pain with minimal side effects.

Where Vioxx went wrong was physicians were prescribing it inappropriately for patients where Cox 2 inhibitor therapy would be contraindicated anyway (which is why Bextra and Celebrex will probably be pulled from the market and Cox 2 inhibitor therapy abandoned; I’m suprised the FDA didn’t pull them at the same time Vioxx was voluntarily pulled from the market).

[robc]

FDA process has killed more people than it has saved. The numbers arent even close.

[Byron]

I am not sure it is a good idea to be taking unsafe or ineffective unapproved drugs if there is an already approved drug that is safe and effective. Even if a drug saves lives, it needs to be free of side effects if it is to be OK to take.

You choose for you; I’ll choose for me.

[J sub D]

If we have to have an FDA –

The drugs and vaccines they approve should be immune from lawsuits if no fraud was committed in the gaining of said approval. Cherry picking studies to gain approval is fraud.

Drugs and vaccines not approved should still be legal to market with the disclosure that they are not FDA approved.

Patients purchasing treatments not approved by the FDA could be required to sign a waiver of responsibilty for the provider of said treatment acknowledging that this is not FDA appoved. Again, absent fraud by the developer/manufacturer, tough luck if your head explodes.

We’d save thousands of lives this way.

[Episiarch]

a new drug that will save 8,000 liver per year

This will be great news for alcoholics!

[Ron Bailey]

Good catch. Fixed.

[wylie]

Dang, i thought i was safe on both the prostate and liver fronts. *shaken fist*

[?]

Maskitte painted landscapes in Provenge.

[TrickyVic]

If this is the same one I heard on the radio the other day, treament is 100K a year. I’m not sure why they said a year.

[Lou Binion]

Oh wow, imagine that. The FDA Finally got around to actually doing anything! Its about time. I think the FDA is about as useless as the TSA.

Lou
http://www.anon-vpn.se.tc

[Bee Tagger]

Can anon bots be placed on a watch list? Surely a question only Phil K. Dick can answer.

[Ken Shultz]

I appreciate the arguments for speeding up the regulatory process, but even more important, doesn’t this demonstrate how market driven research increases quality of care and helps cut healthcare costs?

How much better is it to never develop full blown prostate cancer? Didn’t the quality of life for a whole slew of people just make a big jump?

How much will insurers and patients save getting a vaccine and never needing expensive treatments for cancer?

And we’re killin’ the goose that laid this golden egg?!

They should definitely cut regulatory hurdles for such things, …but sadly there may not be as many things submitted for regulatory approval in the near future as there might have been too.

[Ron Bailey]

Ken Schultz: Actually this vaccine is used to treat men after they’ve been diagnosed with prostate cancer.

Fortunately, there is a drug, dutasteride, a.k.a., Avodart, which lowers the risk of prostate cancer.

[wylie]

vac?cine
? ?/v?k?sin or, especially Brit., ?v?ksin, -s?n/ Show Spelled[vak-seen or, especially Brit., vak-seen, -sin] Show IPA
?noun
1.
any preparation used as a preventive inoculation to confer immunity against a specific disease, usually employing an innocuous form of the disease agent, as killed or weakened bacteria or viruses, to stimulate antibody production.

Huh?

[Groovus Maximus]

The elevated Prostatic Antigen (PSA) is the marker of DX of prostate cancer Wylie (confirmed by biopsy of PET scan). The immune system does not recognize that the potent cancer cells are dividing at an acclerated and uncontrolled rate. The “Vaccine” is essentially telling the immune system to recognize the altered potent cells as a an invading pathogen and destroy them.

Oh and Ron, fuck the SPAM filter as I have reservations about Avodart and other 5-alpha reductase inhibitors, most notably their side effects and drug interactions. I can’t seem to post my concerns and I tried twice.

[Joe]

Although the press is referring to Provenge as a prostate cancer vaccine, it would be more accurately described as immunotherapy for prostate cancer. The concept is similar to vaccination in that it trains the immune system to recognize and attack a specific molecule, but there are differences.

The typical vaccine uses injection of either a weakened form of the pathogen (eg the Sabin polio vaccine), a related microorganism (eg smallpox vaccine), or a protein derived from the pathogen (eg the tetanus, diphtheria, acellular pertussis [Tdap] vaccine). When these are injected, the body’s natural response to infection is activated to create a specific immune response to the disease.

Provenge works by direct modification off immune cells outside the body. Immature immune cells are isolated from the blood and a molecule specific to prostate cancer is inserted, along with a molecule which can activate the immune system.

When these cells (dendritic cells) are reintroduced to the body, they present the prostate cancer-specific molecule to other immune cells, training them to attack the prostate cancer.

[Groovus Maximus]

I’m not a urologist Ron, but Avodart is a rather nasty drug with a plethora of drug interactions and contra-indications requiring very careful prescribing considerations. I’m not a huge fan of the drug personally, as men with High PSA’s also tend to be cardiac patients with renal concerns, as a concurrent condition with Benign Prostatic Hypertrophy (BPH).

[Groovus Maximus]

Ron, I can’t seem to post anything regarding this subject as I keep getting “marked as spam”. Even though I’m not a urologist, I have a number of concerns re: 5-Alpha-reductase inhibitors and the layman’s etiology of PSA’s and why this Provenge TX fits the definition of a vaccine. And I’m not using HTML when I provide links. All I’m trying to do is answer Wylie’s question.

[robc]

GM,

I think there is a max links per post filter. So split the links across many a post.

[Groovus Maximus]

I did robc. I even tried to post one without links and trade names, using only generic drug names and very little jargon. The post @ 3:15 pm is Occam’ed as it gets.

[robc]

Heh, and I got away with posting an entire poem in Welsh.

[Groovus Maximus]

I remember that you POS! (shakes fist) Heh! I’ll get you robc if it’s the last thing I ever do!!!!

/end Gargamel

[Ken Shultz]

I appreciate the correction.

Thank you.

[Xeones]

Oh wow, imagine that. The FDA Finally got around to actually doing anything! Its about time. I think the FDA is about as useless as the TSA.

If anonymity guy really is the first stirrings of the Singularity, at least we’ve trained him to a libertarian outlook.

[wylie]

Highfive! Skynet wont be so bad…for us at least. Statist/Nannyists/Collectivists might be in for a shock.

Perhaps Skynet will allow them to participate in whatever form of craziness they want to voluntarily follow.

[Pope Jimbo]

You know Arnold was pretty self-reliant in The Terminator.

He performed his own health care procedures (no leaching off of Medicare for him)

He wasn’t constrained by social norms and felt free to curse when he wanted to.

Wasn’t deferential to LEO’s at all. In fact he felt free to park his car right in the middle of their squadroom despite their strenuous objections.

And for the clincher… What did he wear the entire movie? Yup. A Leather Jacket!

[zoltan]

Can you imagine a world where an anti-statist, omniscient supercomputer watches over everything and whenever some tool wants to interfere with other people’s lives it gently nudges them away…somehow…must work this out for my future sci-fi short story collection.

[Groovus Maximus]

Burroughs’ group wants patients to have access to promising new treatments before they are approved by the FDA.

Fine. However, I propose three caveats to this:

1) The company that does so is NOT subject to class action suits in the event side effects occur in the patient population.

2) Doctors are off the liability hook for prescribing them, especially for off label use.

3) Eliminate patents for Pharma.*

*If this is unfeasible, then eliminate blatant patent extensions just because an indication has been added, the dosage amount had been altered, i.e. the dispensed dosage is 5/500 of X drug; patent extension has been granted because X drug is now available in 2.5/500, or changes in inactive ingredients, forms (elixir v. pill) or route of delivery (IV v. PO).

Informed decision making regarding pharmacological/biotherapy includes understanding risks in allopathic TX regimens, and good medicine offers a high likelihood of successful outcome, but no guarantees. As a physician, one of the areas that inflates the cost of medicine higher than any others is the government subsidy protectionism of Big Pharma, the biggest backer of OBAMACARE.

It should also be noted that Provenge is currently indicated for patients with late stage prostate cancer and the average increase in life expectancy is four months and the average cost of this therapy is $30,000 to $50,000 and may be as high as $75,000 per TX dose. Now that “Health Care is a Right(tm)”, how will CMS determine who gets TX and who doesn’t (yes, I know that lack of reimbursement by CMS and third party does not equal denial of care, but if the cost of care is not going to be reimbursed by these actors, why should I prescribe it?)

[Xeones]

Perhaps Skynet will allow them to participate in whatever form of craziness they want to voluntarily follow.

Skynet’s a panarchist? I can get behind that.

[johnl]

The FDA does a competent job of vetting drugs, similar to what Underwriters Labs does with electronic gizmos. Except the UL doesn’t have regulatory power and apparently doesn’t need it. Neither does the FDA.

However the story would not change a lot even if the FDA had no regulatory power. If the UL wants more data for a test, they can ask the manufacturer to send over another box and then they can test more. For the FDA, if they need more data, it takes years. It’s the nature of the problem. Privatizing the FDA is not going to make an insurance company pay for a 100k treatment that hasn’t been tested. And it’s not going to make tests happen faster.

But it will stop jerks in the FDA from interdicting vet meds from dog owners.

[Captain Obviousness]

This is the final chapter in the sordid history of Dendreon and the abuse it’s suffered at the hands of a captured Wall Street media and SEC. The rabbit hole goes so deep no one will believe it. Here is a 30,000 word article about the assholes who kept Provenge off the market for a few extra years. It starts like this:

This story, like too many others, begins with Jim Cramer, the CNBC personality, making “a mistake.”

On September 26, 2005, Cramer announced to his television audience the sad news (punctuated by funny sound effects ? a clown horn, a crashing airplane) that Provenge, an experimental treatment for prostate cancer, had flopped. Thousands of end-stage patients had been pinning their hopes on Provenge, but according to Cramer the treatment had just been rejected by the Food & Drug Administration. It would never go to market.

This seemed odd, because Dendreon (NASDAQ: DNDN), the company developing Provenge, had not yet submitted an application for FDA approval…

Full article here:

http://www.deepcapture.com/mic…..-dendreon/

[Hacha Cha]

I wish the FDA would have its powers scaled way back or that the FDA would just be dismantled. people that want cutting edge medicine either have to apply to the FDA for a compassionate exemption or try and buy the chemical from a company selling it “not for human consumption”. its bullshit.

[Hacha Cha]

I wish the FDA would have its powers scaled way back or that the FDA would just be dismantled. people that want cutting edge medicine either have to apply to the FDA for a compassionate exemption or try and buy the chemical from a company selling it “not for human consumption”. its bullshit.

[dmoynihan]

God bless the Angel Alliance and you, Mr. Bailey.

Or, Cthulu, he can bless too.

/Don’t get me started on FDA…

[angie]

Helloooo? Anybody see I am Legend?