FDA Approves Vaccine For Prostate Cancer

reverseengineer writes "The US Food and Drug Administration has given its first first approval for a therapeutic cancer vaccine. In a clinical trial 'involving 512 men, those who got Provenge (sipuleucel-T) had a median survival of 25.8 months after treatment, while those who got a placebo lived a median of 21.7 months. After three years, 32 percent of those who got Provenge were alive, compared with 23 percent of those who got the placebo. ... "The big story here is that this is the first proof of principle and proof that immunotherapy works in general in cancer, which I think is a huge observation," said Dr. Philip Kantoff, chief of solid tumor oncology at the Dana-Farber Cancer Institute in Boston and the lead investigator in Dendreon's largest clinical trial for the drug. "I think this is a very big thing and will lead to a lot more enthusiasm for the approach."'"

Comments

Statistically significant?

[Rene S. Hollan]

Is it just me or do those numbers look too close to be statistically significant?

For that kind of (small) difference to be statistically significant, I'd thing rather large sample sizes would be required.

Re:Statistically significant?

[aurispector]

Bright indeed. The immune system has an amazing ability for specificity. Once we master the art of training the immune system to recognize and kill cancer cells the fight will be over. Interestingly, there was a cancer treatment in the late 1800's that relied on injecting cancer tumors with an infectious serum designed to elicit an immune response. The treatment had some success but was dangerous as the patient ran the risk of death from infection. I really think immuno therapy is the future of cancer therapy.

Re:Statistically significant?

[TheMeuge]

2. View the #2 in your post. They have to struggle in a market that's immediately artificially saturated by Company A's wonder drug. This is like Pepsi trying to show up and claim "we can quench your thirst", but regulations say that, for the first n number of years, people have to drink a full coke before they can drink a Pepsi. Hope you're still thirsty after that coke, and if you're not, then hopefully the pepsi will quench your thirst when the coke did not!

And there, spelled out in soda, we have the well-meaning recipe for disaster in American healthcare -- the one that isn't fixed by the government plan, but needs to be before the government plan sends us headlong into a depression because of this unresolved bug.

That's not at all a good understanding of the market or of biomedical research.

Anyone else is free to come up with a treatment that works better using the same principles. It just can't be the same exact protocol.

Similarly, to spell it out in soda for you, Pepsi can't produce soda using Coke's recipe and charge less for it.

Drug patents are woefully short-lived in the US, and only give the company a few years (unlikely to reach a decade, even under the fastest FDA review) to make their research money back, make a profit, and finance further research. For all the negative press patents get, the are still essential for stimulating development by rewarding innovation.

Unlike other IP, however, drug patent periods haven't been climbing up in duration, and as a result we can all enjoy levostatin, ezomeprazole, and the rest of the drugs that used to be sought-after prescription drugs, and are now cheap generics.

Re:Statistically significant?

[Anonymous Coward]

You don't understand. The costs the previous poster refers to are not drug costs, but extremely expensive lab costs during treatment, for example doing gene sequencing or custom drug synthesis as part of a single patient's treatment. These things may eventually get economy of scale as they are automated with gene-sequencing machines and better chemical processes.

The main idea is that this difference of 32% and 25% survivor rates may not indicate a "slight extension" due to a universal treatment, but rather a treatment that is very effective for one segment of the patient population and worthless for the rest. This is where evidence-based medicine and personalized medicine is meant to go in the end: focus the scientific process on the powerset of all possible experimental and control populations, so we can learn where our previously known disease conditions are actually an over generalization of several different disease conditions with different biochemical causes but nearly indistinguishable symptoms. Each sub-condition may need a different treatment which can potentially have much higher success rates than any one-size-fits-all treatment protocol.

Re:Statistically significant?

[nanoakron]

It was the treatment of tonsillar squamous cell carcinoma but I can't find the reference at present. Read about it in med school.

However, may I draw your attention to a couple of other cancers that seem to benefit from localised immune activation due to injected bacteria:

Stomach: http://www.nature.com/bjc/journal/v84/n4/abs/6691599a.html
Mouth: http://www.springerlink.com/content/rw3kk056t4014t5j/
Bladder: http://www.ncbi.nlm.nih.gov/pubmed/20205607

Re:Statistically significant?

[Bengie]

I other OLD news, men who ejaculate 5 times per week had a 66% less chance of prostate cancer EVER in their life than men who only did once or less per week. They has to be started young and you must continue this into your 50s. 3 different studies on this from 3 different universities in 3 different countries and all 3 go roughly(damn near the same) the same results even though they went about different ways of testing. They one test alone was a periodic questioner that followed over 30,000 men. Is that a good sample size? There seems to be a semi linear link, so each day you clean the pipes per week gives you and ~X% reduced chance of getting this dreaded disease.

I say an orgasm of prevention is worth more than a pound of cancer.

The current theory is that the prostate is great at concentrating carcinogens because of how it excretes and re-absorbs fluids which essentially filters and captures bad crap. Gotta flush it out.

Remember, a 66% reduction of the chance of cancer is like saying "you have a 200% INCREASED chance of caner if you don't".

P.S. remember to tell your wife to put out or close the door, because you're busy curing cancer.

Re:4 months?

[drjoe1e6]

Propecia on the other hand (the stuff for baldness) has been shown to help the prostate.

Not surprising at all. Proscar, a prostate medication, had the side effect of making people grow extra hair. So Merck marketed a lower dose of the same substance, and called it Propecia.

Re:This is good news.

[TheLink]

But smokers dying earlier helps reduce the "aging population" problem. It reduces the costs on average - since everyone is going to die anyway, and many nonsmokers still eventually get expensive to treat diseases (live long enough and you'll get something :) ).

Plus if the tobacco taxes are high enough, you can get smokers to pay for other stuff as well[1]

As a nonsmoker, I think smoking is good economics. Drug money and all that :). All these smoking bans (in restaurants, pubs etc) seem rather stupid to me. Just tax places that allow smoking higher compared to those that don't, then you won't lose another revenue opportunity ;).

[1] I saw some stats in the UK where the smokers cost the UK healthcare system 3 to 5 billion every year. But the tobacco tax revenue is 10 billion a year!

http://news.bbc.co.uk/2/hi/health/8086142.stm

http://www.the-tma.org.uk/tobacco-tax-revenue.aspx

http://www.ecancermedicalscience.com/news-insider-news.asp?itemId=311