– The FDA Approves Provenge, a Prostate Cancer “Vaccine”
Summary: Today, the news broke that the FDA has approved a drug that could extend the lives of some patients suffering from late-stage prostate cancer. For Wall Street, it’s a big story. For cancer researchers, it could represent a break-through. For some of today’s patients, it may be good news—if they can afford the drug.
The headlines are everywhere:
“FDA approves breakthrough cancer therapy Provenge”
“Dendreon (DNDN) is trading at $53.50 after last trading at $45.50 before the halt“
“Dendreon: Provenge boosts survival 40 pct”
What does Provenge actually do? The company calls it a “vaccine,” but it doesn’t prevent prostate cancer. Nor does it cure prostate cancer. Contrary to what you may have read, it doesn’t “save lives.”
It extends the lives of men suffering from late-stage prostate cancer by an average of 4 months. The patients in a trial of 512 men lived a median time of 25.8 months if they received Provenge, compared to 21.7 months if they got the placebo. (I have no idea why Reuters claims that Provenge boosts survival by 40 percent.)
Meanwhile one in four Provenge patients suffered a serious side effect, with 3.5% suffering a stroke, compared to 2.6% of those on placebo, according to the FDA. Patients also can expect minor side effects which include fevers, chills and headaches
Currently, the most common alternative is a chemotherapy drug called docetaxel — the standard treatment for men whose tumors don't respond to hormone therapies. Docetaxel helps patients live about 2.4 months longer, Philip Kantoff of Boston's Dana-Farber Cancer Institute and primary investigator of the study of 512 men told USA Today. But chemo can cause many serious side effects, such as fatigue, loss of appetite and dangerous infections. And Provenge buys the average patient an extra six to seven weeks, for a total of four months.
How much will those 4 months cost? Dendreon plans to charge desperate patients $93,000 for a three-treatment cycle of therapy. Some insured patients won’t be able to afford Provenge because their insurers will ask for a 20% co-pay. Medicare Advantage insurers, in particular, have been demanding hefty co-pays for pricey cancer drugs. (Will regular Medicare pay 100% of the cost? I don’t know. Do you think it should? )
Over at SeekingAlpha.com, Biotech analyst Michael Shulman says that Dendreon is making an enormous mistake by over-pricing its drug. He aruges that "The larger the real world patient population using Provenge, the faster Dendreon will be able to identify what sub-segments of patients respond best." He notes that in the most recent trail, the median increase in life expectancy was only four months, but that "many believe this is due, in part, to the profile of patients in the trial – they were very sick and their immune systems had already been compromised by previous treatments. If the product were priced differently, physicians outside of trials would probably begin to use Provenge off label as an adjunct to other prostate cancer therapies earlier in the treatment cycle and data would more quickly become available on whether patients benefit from earlier treatment. If this can be proven, the market becomes that much bigger that much faster." Granted, this is a drug that is created from a patient's own blood and that makes it expensive to manufacture. But Shulman points out Dendreon's balance sheet shows a cash position of $650 million in cash and marketable securities. The company doesn't need to charge $93,000 per patient.
Right now, the FDA has approved the drug only for a slice of late-stage Prostate cancer patients: men who have castrate resistant metastatic, asymptomatic prostate cancer. This means that the you must have prostate cancer tumors outside of the gland and that you are no longer responding to hormone therapy. Provenge is not approved for patients suffering from early-stage prostate cancer. In many cases, the slow-growing cancer will never catch up with these patient; they will die of something else before experiencing symptoms. Presumably the FDA decided that the one-in-four chance of serious side effects represented too great a risk for such patients. But Shulman is probably right; if the drug were less expensive, doctors might well begin prescirbing it "off-lable" (outside the parameters of FDA approva) for patients who had not yet reached the late stage of the disease.
The Big Winners: Shareholders . . .Scientists
Looking at the headlines above, you might wonder: is this a financial story or a healthcare story? This is first and foremost, a Wall Street story. Dendreon has “hit the jackpot.” Analysts believe that Provenge has the potential to reap blockbuster sales of $1.5 billion a year. Dendreon’s shares have climbed 200% in the past year, and now shareholders know that their gains are safe. They are ecstatic.
Scientists, too, have reason to celebrate. For decades, they have been dreaming of a treatment that might actively harness the power of the body’s immune system to kill cancer cells like an invading virus or bacteria. Provenge does just that. Dendreon has made history by winning the first FDA approval for this kind of cancer-fighting drug. “This is a huge advance,” Dr. John Corman, a urologist at Virginia Mason Medical Center in Seattle, and an investigator in Provenge clinical trials for eight years told Xconomy Seattle. “It’s a completely new class of therapy that provides remarkable opportunities for R&D.”
For some patients and the doctors who treat them, it’s good news—if patients can afford the drug But four extra months and a 25% risk of serious side effects can’t really be called great news. These late-stage patients still will die of prostate cancer. (There is, of course, the possibility that patients who are not as sick might derive greater benefit. But this hope is based on specualtion and what Shulman calls "anecdotal evidence.")
The Back Story
Long-time HealthBeat readers may remember that I wrote about Provenge back in 2007 here, and here.
My original post began: “Only in America do physicians who evaluate new drugs need bodyguards. You may have read about the brouhaha surrounding Provenge, a vaccine designed to extend the lives of men suffering from late-stage prostate cancer. In March, a Food and Drug Administration (FDA) advisory panel voted 13 to 4 to recommend approval. The next day, shares of Dendreon, the drug’s sponsor, doubled. But shareholders did not celebrate for long. Two of the dissenting votes were cast by the panel’s two prostate cancer specialists: Sloan-Kettering’s Howard Scher and the University of Michigan’s Maha Hussain. And they did not just vote “no”—following the hearing, both wrote to the FDA arguing that Dendreon offered no solid evidence that Provenge works.
“The FDA listened. And in May it told the company it wouldn’t approve the drug until it had more data. That is when the two oncologists began receiving threatening e-mails, phone calls, and letters. Many were anonymous.
“No doubt much of the hate mail came from investors who had watched Dendreon’s shares climb from $5 in early January to $25.25 in late March—before plunging to $3 and change. One Alabama shareholder expressed his feelings on his MySpace page, where he asks “Hey, Hey, FDA, How Many Dads Did You Kill Today?” while images of Hussain and Scher flash across a backdrop of crooked crosses. Mozart’s “Requiem” plays in the background. . . .The e-mails and phone calls were too menacing to be ignored. When Hussain and Scher attended the conference of the American Society of Clinical Oncology both asked for extra security guards. Meanwhile, shareholders continued to accuse Scher of conflict of interest, arguing that he nixed the drug drug because he is the lead investigator for a rival product.”
At the time, I read the transcript of the FDA hearing. As I explained in the post, whether or not Scher was biased against Dendreon, he and Hussain had good scientific reasons for voting against approval at that time. The study had failed to show what it had set out to prove.
Moreover, the evidence that Dendreon presented to the FDA in 2007 involved a trial of only 172 men. I reported that Scher and Hussain believed the FDA should wait for the results from a larger trial.. Hussain has suggested that, in the meantime, Dendreon could make the drug available to dying patients “for compassionate use.” But Dendreon CEO Mitchell Gold has said, “No, the company does not have that kind of resources.”
Ultimately, Dendreon did a better study which offered clearer evidence. Today, shareholders won the victory that they have been waiting for. As for patients—it’s hard to say. Much depends on whether Provenge turns out to be a breakthrough that leads to treatments that will offer cancer patients more than four months. Even if that happens, we will have to find a way to make such drugs affordable. That might mean that the government will have to step in and regulate prices, telling drug-makers that they cannot charge sums that even Wall Street analysts consider piggish. (Shulman is not the first analyst to suggest that Pharma is over-pricing these drugs; other have suggested that drug-makers are –and inviting price caps.)
For now, this is big story for Wall Street, and a small step forward for cancer patients. Is Provenge worth the time and money that Dendredon and now patients, taxpayers and other payers will invest in it? I'm not in a position to say. But wouldn’t it be nice if cancer researchers at the National Institute of Health—rather than Wall Street investors—set the priorities about where we should invest our time, energy and health care dollars when deciding which drugs to develop?
Maggie,
I had my prostate cancer treated with radiation about 3 years ago, so I have some interest in this. I can say without the slightest hesitation that I would consider this a scam if I were to be offered this drug at even 10% of that cost. There is no situation where I would steal that much money from my wife just to gain about 4 more months.
My brother, a couple of years older, died last year of lung cancer, refusing any form of treatment, knowing he couldn’t defeat the cancer. He used his last couple of weeks, and that was all he had after learning how serious his case was, to visit his many grandchildren and great grandchildren, actually driving about 200 miles a couple of days before dieing, to visit them. I consider him to have been a very wise man.
American Cancer Society’s Dr. Len Lichtenfeld has some interesting perspectives about the Provenge vaccine cancer drug. The point about it being a vaccine and not so much a targeted drug. The treatment will only be available for men whose disease has progressed despite hormone treatments, and the men have to either be free of symptoms or have only minimal symptoms at the time of treatment.
http://www.cancer.org/aspx/blog/Comments.aspx?id=353
Vaughn– Thank you for your comment. I agree: your brother sounds like a wise man. It sounds as if he made extremely good use of his time.
“(Will regular Medicare pay 100% of the cost? I don’t know. Do you think it should? )”
In a word, NO!
At $93,000 for a course of three treatments for four months of extra life expectancy, it works out to $279,000 per quality adjusted life year (QALY) assuming no other medical expenses during that period. Ultra expensive cancer drugs lend themselves especially well to using QALY metrics to guide payment policy. While I would be more generous than the UK is in this area, I think something in the range of $150K per QALY strikes a reasonable balance between the desire of some people to fight to live as long as possible and the reality of finite resources and plenty of other worthwhile but unmet needs from education to infrastructure. Based on a life expectancy of roundly 80 years, $150K per QALY implicitly values a human life at $12 million. For those, whose religious convictions move them to demand all possible treatment no matter how expensive and futile, I say fine if you can self-pay or find a charity to pay on your behalf. You should not, however, have access to taxpayer resources (Medicare / Medicaid) to pay for care that most of the rest of the population would not want or expect for themselves.
At the same time, I think the concept of using the body’s own immune system to fight cancer is a promising area of investigation and Provenge should provide some encouragement to researchers working on treatments for other cancers.
Greg & Barry–
Greg–A very informative and rational response from Dr.Len Lichtenfeld of the American Cancer Society.
I wish more journalists would read it– and spread the message. Like Licthenfeld, I fear that this breakthrough will be used to give false hope to last-stage cancer patients.
He also seems less than hopeful that this is a scientific breakthrough that will lead to further breakthroughs.
Finally, it’s interesting that he believes that Medicare will have no choice but to cover it, and that this will be a major burden for the Medicare budget. See my reply to Barry.
Barry:
I agree that $93,000 is too much to pay for a drug that will give men 4 months of less than higih quality life.
As you now, I’m not keen on using the quality -of-life formula– it’s too cut and dried.
For instance, if I were in a position to make these decisions I would spend far more on children than on people my own age–especially if there was any chance of full remission. Ultimatley, such decisions should be made by medical ethicists who can weight the many variables. . .
But in this case, the big problem, I think, is that the company is gouging. When an analyst points out that there is absolutely no need for them to charge this much, I think that the government should step in and say “We can’t let you decide how much to charge for the drug. As a society, we cannot afford to hand you (and your shareholders) a blank check. Since you have made an unreasonable demand, Medicare will cap how much it will pay, We want you to stay in business and be able to continue to manufacture and distribute the drug, but we also want as many patients as qualify under the FDA approval to receive it so that we can all learn more about it. At the same time, Medicare cannot go broke paying for a half dozen exorbitantly expensive drugs for cancer, MS, etc.
Note– Dr. Licthenfeld, of the American Cancer Society who Greg links to above says that almost all of the patients will be on Medicare. So Medicare will be footing the lion’s share of the bill–i.e. virtually all of it.
Finally, Medicare should tell the company and patients: Medicare is pledging to pay for this drug for a period of two years only. Then we’ll revisit what we have learned and whether we think the benefits justify continuing to pay for it.
And any doctor who prescribes it for off-lable use and attempts to bill Medicare or any other insurance company will be charged with insurance fraud. The penalty should include jail time.
In other words, this should be treated as a controlled scientific experiment–not as a matter of a company hitting “the jackpot.”
Ultiimately, the story highlights the problem with having for-profit drug companies that are presented to investors as potentially high growth stocks where you might double or triple your money.
The casino mentality is not a good fit with health care. Medicare cannot afford the pay-out that shareholders expect in these situtions.
Perhaps drugs of this type should be developed exclusively at NIH and not in the for-profit marketplace.
I suppose you will only post comments that agree with your stand on Provenge, so I doubt that others will ever read this.
4.5 months was the “median” survival benefit for Provenge. One suggestion would be for you to look up the definition of the word “median”. It does NOT mean the “average”. It refers to the exact mid-point of deaths. For example, if half the men lived 1 month and the other half lived 10 YEARS, the “median would be one month. BUT, the “average” would be about 5 years. Why is it sooo difficult for “journalists” to understand the difference between the 2? Please take the time to research this all too important distinction. What you are spreading to your readers is false information. Many patients lived full lives for 5, 6, even 7 years after receiving Provenge.
If you go to Dendreon’s website, you might read about Eduardo Garcia…who lived about 8 YEARS after receiving Provenge…with no side effects and a wonderful quality of life. Why do you suppose so many men simply refuse chemo and just let themselves die??
You seem more worried about the price than the patients or the true facts about Provenge.
Bill–
I post all comments–unless they are abusive. (OR clearly trolls ranting about something that has nothing to do with the post.)
I was senior editor at Barron’s for 10 years. Also wrote a book about the bull market that Warren Buffet recommended in Berkshire Hathaway’s annual report.
At Barron’s I covered Genentech and many pharmaceuticals.
So, yes, I know what median is. This is why I wrote: “It extends the lives of men suffering from late-stage prostate cancer by an average of 4 months. The patients in a trial of 512 men lived a median time of 25.8 months if they received Provenge, compared to 21.7 months if they got the placebo.”
In my first draft of the post, there was a sentence in between those two sentences which said “Half of teh men lived longer than 4 months; half lived less than 4 months.”
Then I decided this was redundant. (My readers are pretty smart; I think all of them probably know what “median” means. )
That one person lived 8 years is not a reason to say that Medicare should pay $93,000 to provide the drug to thousands of patients.
Given that the median was 4 months, that person was clearly outlier.
And in terms of quality of life — one out of 4 patients on PRovenge suffered severe reactions–stroke, reactions to the infusion etc.
That’s why the FDA (and all scientists) look at the median benefit.
Secondly, note that the men who received a placebo lived nearly two years (21.7 months vs. 25.8 months.)
Prostate cancer is a very slow-growing cancer so it’s not suprising that a number of men lived well more than two years–both on placebo and on PRovenge.
(I serached the company’s website but couldnt’ find any reference to how many patients lived 3 or 4 or 5 or 6 years and how many of them were on Provenge and how many on the placebo. Given that you want to get the facts out there, I’m surprised that you didn’t provide the exact numbers.)
The problem, as the American Cancer Society’s Dr. Len Lechtenfield points out,(see my most recent post)it that there is no evidence that Provenge slows the growth of the cancer.
We don’t quite understand why the average man lives a few months longer. But, as Dr. Lechtenfield stresses, it would be wrong to give patients and their families false hopes.
Since Lictehnfield devotes his life ot cancer and cancer patients, I think it’s fair to say that he care about them. I’m not sure that the same can be said of Dendreon’s CEO: two years ago he refused to make the drug available to patients for “compassionate use.” With this CEO, money seems to come first.
Finally, the drug is approved for only a small slice of late-stage cancer patients. So it’s usefulness is limited.
Price matters because $93,000 is far more than the company needs to charge. (See company balance sheet. If the company charged significantly less, it could stay in business, keep on manufacturing the drug, and probably sell more products– so that we could learn more about Provenge. But company and its sharehodlers want to “get rich quickly.”
If Medicare pays $93,000 per patient for this and six or 7 similarly over-priced cancer and MS drugs, Medicare will need an infusion of money from taxpayers–or it will need to stop paying for some other drugs or services.
What would you be willing to give up to make sure that this company enjoys a “Jackpot” pay-off? Maybe Medicare shouldn’t do knee and hip transplants for people over 75? Or maybe you woudl be willing to pay more in Medicare payroll taxes? How much more?
Finally, I’m guessing that you own shares of Dendreon. (Or are in some way involved with the company). If so, you should say so–as a matter of full disclosure.
I think I recall reading either in the NYT or WSJ that Dendreon will only have the manufacturing capacity to supply a course of treatment for 2,000 patients per year, at least at first. It’s a complex process apparently and each dose must be custom manufactured for a specific patient. Even at $93K per course of treatment, which we both think is too much, 2,000 patients would generate $186 million of revenue which is not large in the context of Medicare’s $500 billion plus of annual spending. Over a two year period, if 4,000 patients are treated, we should be able to learn quite a lot about Provenge’s efficacy.
Regarding the use of QALY metrics to guide payment policy, I agree that the UK approach is rather cut and dried. However, there is no reason why QALY metrics can’t vary by age – say, $250K – $300K for 0-34, $150K-$200K for 35-64, and $100K-$150K for 65 and older. The point is we have to draw the line somewhere. Genzyme charges over $200K per year for Cerezyme to treat Gaucher’s Disease, and patients must take it indefinitely.
As you probably know, I’m not a fan of having NIH or some other non-profit body doing all of the important research though I have no problem if they do some of it. Without a profit motive, how does NIH or other non-profit entity determine which projects get funded? I suspect politics would play an important role. Also, for projects that are not panning out or meeting benchmarks, who determines when and under what circumstances to pull the plug and redirect limited capital to more promising projects? All for profit companies that do research, no matter what the product, have well established mechanisms for allocating capital and managing the portfolio of projects intelligently.
I have no idea what the right price is for Provenge or what it would cost Dendreon to scale up its manufacturing capacity to meet potential demand. I do believe that if drug companies knew ahead of time that there were specific limits as measured by QALY metrics or some other approach to what payers would pay, both drug research programs and the ultimate pricing of products that are successfully commercialized will adjust appropriately. If we set the prices we are willing to pay too low, it could have an adverse effect on innovation over the intermediate to longer term, but we need to try to find an appropriate balance which is admittedly not easy.
Could there be some “lead time bias” in this case? The efficacy of a particular therapeutic maneuver (Provenge) shows the maneuver was effective, when in fact patients survive longer because the disease was diagnosed earlier.
The FDA advisory committee on Thursday was asked if
Meanwhile one in four Provenge patients suffered a serious side effect.
ONE IN FOUR. Are you serious ? Shame on you.
Do you remember the 17-0 FDA panel vote ??????
Meanwhile one in four Provenge patients suffered a serious side effect.
ONE IN FOUR. Are you serious ? Shame on you.
Do you remember the 17-0 FDA panel vote ??????
Barry, Greg, small_farmer
small_farmer I’m not sure what you are objecting to. Here is a direct quote from the FDA: “About 25 percent of recipients suffered more serious side effects, including stroke or a serious reaction to the injection, the agency said.” (You’ll find this statement in virtually every news report on Provenge. Just Google Provenge, 25 percent, stroke FDA and it will turn up. )
Greg– I imagine they corrected for lead time bias. It does seem that Provenge gives patients some extra time (4 month is the median amount of time) though we don’t know why. (Since it doesn’t slow down growth of the disease. See my newest post quoting Len Fedlstein from the American Cancer Society.)
Barry–
Yes, the first year and even the second year their won’t be that much product available, though I’m sure they will ramp up as quickly as possible. (We really need more than one company involved, but Dendreon has refused to partner with anyone.)
The problem is that once Medicare says it will cover Provenge (which it seems it will) then they can’t stop covering it after two years. (This is what I would do if I were czarina–I’d like to see the results when 5,000 or 6,000 people take it, but if it still gives patients an average of only 4 months and a 1 in 4 chance of serious side effects, I wouldn’t be willing to continue to pay $93,000.)
But in the real world (where I’m not czarina) once Medicare agrees to pay $93,000, they will be stuck, indefinitely, and the cost will quickly add up.
On the NIH–You may find this hard to believe but when NIH decides what drugs to develop it focuses on a) public need and b)where it seems likely that they can acheive real benefit.
NIH ultimatley did a good job in develping AIDS drugs-it didn’t move as quickly as the UK, but ultimately AIDS activists overcame the Reagan admnistration’s initial reaction. I covered AIDS for Barron’s in the late 1980s and early 1990s and came to know many of the people involved.
Patient advcacy groups will alway have an influence on the NIH– you could call that politics, but I think that NIH should be responsive to the public.
A for-profit company is going to focus on developing drugs that will be highly profitable either because they can be sold in large volume (allergy medications) or becuase they feel there is no limit to what price the market will bear (drugs that extend the lives of dying patients.)
But I’m not sure that it makes sense to pour resources into trying to develp drugs that give people a few extra months unless scientists have reason to believe that what they learn from developing the drug could ultimately lead to a drug that puts the cancer into remission. (That could conceivably be the chance with Provenge, though the American Cancer Society’s Len Feldstein is pretty sketpical, and he has as much reason as anyone to want to be hopeful.)
You talk about “stifling innovation” but when it comes to the war on cancer we have made so little progress in the past two or three decades that many oncologists are increasingly skeptical (as Feldstein is). For-profit companies continuet to develop drugs that give the average patient a few extra months. (A couple of years ago the FDA approved a drug that gave the average patient 13 days.)
It’s easy to hype these drugs on Wall Street. There are always a few outlier patients who get more than a few months, and people begin talking about how maybe, maybe, some patients will be cured. (what the Wall Street analyst I quote refers to as “anecdotal evidence of remisssion.”)
But it never happens.
I’m not saying that we should give up. But I do think we should pour more resources into improving the quality of life for people ages 50 to say 85 (or whatever life expectancy is today) rather than trying to eke out 4 ot 6 or 8 extra months at the very end of life. Usually those extra months are not high quality–the patient is dying of cancer.
(I believe it’s simply our fear of death–our refusal to accept death as a natural part of life– that causes us to put so much emphasis on extending life rather than improving quality of life. . . )
Given finite resources, I would rather see NIH pull out the stops in reseraching AMD (acute macular degeneration)– a disease that is going to blind a great many baby-boomers. From what I understand we are making progress on this front- so it seems doable–and if we could head off AMD before the boomers retire, tens of thousands of baby-boomers would be able to enjoy their retirement years– able to see the world.
Finally, you ask: “Also, for projects that are not panning out or meeting benchmarks, who determines when and under what circumstances to pull the plug and redirect limited capital to more promising projects? All for profit companies that do research, no matter what the product, have well established mechanisms for allocating capital and managing the portfolio of projects intelligently.”
A couple of years ago, I heard an executive from a major Pharma company talk about how for-profit companies don’t pull the plug when they should. Once they have invested a certain amount of money, exeuctives have their jobs on the line, and are relucatant to admit that the investment isn’t going to pay off. That’s why so many drugs fail in phase 3 trials. He said that they never should have gone into phase 3, or in many cases, phase 2.
Secondly, NIH would make the decision looking at social need first. (A for-profit comapny can’t do that-as you know, it would be violating its fiduciary responsibility to its sharehodlers.)
But NIH will put money into developing “orphan drugs”- drugs for a disease that relatively few people have–say a disease that kills or cripples 3,000 children each year, because we as a society consider the death of young children unacceptable, and so it’s worth spending more money to develop the drug –even if we’re spending more than one can hope to recoup by selling it anytime soon.
It’s a different standard–not how much money can be make on this drug but how much good would it do, and is it worth it?
We spent a fortune reseraching AIDS, but ultimately, it was worth it– for a huge number of people it is now a manageable chronic disease.
In the late 1980s, it began to seem that it was going to be an unstoppable plague, like the plagues of the Middle Ages. Not only young men, but babies and women were infected, and there was no cure in sight. But clearly something had to be done, and we did it.
The best defense we have against cancer are our own regulatory systems and immune system. Medicine is starting to realize that now and that is why you see all these immunocooperative treatments.
I many cases prostate cancer is not a death sentence because it can grow so slowly that something else will kill your first.
http://www.tracx.net/adtrack/go.php?c=makemebig&s=WannaPleaseHer?
Very negative response to a pretty amazing event. Yes it is expensive – yes 4.1 months increase in overall survival doesn’t seem like a lot – but it’s a lot more tolerable than chemo. The FDA is currently investigating commonly used drugs for prostate cancer for their risk of heart-related side effects, including death, so perhaps we should not be so quick to damn Provenge for the small increase in cerebrovascular events seen in trials. Regarding Reuters’ statement about survival, it was the 3-year survival that was boosted by 40%. If you’re faced with a life expectancy of 1.5 years, the chance of living a few extra months, without chemo, might seem very precious. The price is a major issue, true, as is the fact that it is hard to see how a cheap generic version of this would ever be developed, but personally I can’t see this as anything but a great day for drug development in cancer – it is what lies ahead of this, the possibility of countering cancer with the immune system, rather than the expense of Provenge itself that we should be looking at.
Tekkie–
I am sorry to seem negative.
When I first read about this drug, I had hope that it would lead to other drugs that would use the body’s immune system.
Then I read what The American Cancer Society’s Dr. Len Lichtenfield had to say “I think it is fair to say that some of us—me included—have been forced over the years to mute our enthusiasm and develop some healthy skepticism that “vaccine” or immunotherapy treatments like Provenge would ever prove helpful in cancer treatment.
“It’s not because we wanted to be skeptics,” he continues. “No, in fact some of us over the years were excited by the possibilities of working with the immune systems of cancer patients to help the body’s own natural defense mechanisms fight cancer cells that for uncertain reasons escaped from those defenses in the first place.”
But he is not hopeful:
“We have seen decades of effort and many professional careers invested in proving the ‘vaccine hypothesis’ without seeing successful, broadly applicable treatments. Our own hopes have been dashed too many times. The reality is that many studies with similar approaches have failed to produce consistent results or effective treatments.”
See my post right after this one : https://healthbeatblog.com/2010/05/the-american-cancer-societys-dr-len-lichtenfield-on-provenge-prostate-cancer.html
As a nurse practitioner, my focus is prevention of disease. The recommendation has been made not to screen for prostate cancers as soon or as often as we currently do. This logic is stemmed from the idea that providers may be aggressively treating false positives on what is seen as a “slow growing cancer and that you will most likely die of something else first.” I screen based on symptoms, family history, and then age in that order. If it were me, I wouldn’t want to let a slow growing cancer get “out of the box” to begin with. The cost of the vaccine is horrifically overpriced in proportion to the adverse effects in my opinion. I think quality rather than quantity is more important to patients. This is illustrated by Vaughn Hokins’ comment.