Spending $93,000 to extend life four months

[Guest guest]

Louis, we disagree about a lot, and we could go on forever without reaching agreement. This is not the appropriate forum for this debate.

MikeFri, 4/1/11, Louis Carliner wrote:

Subject: Re: Re: Spending $93,000 to extend life four monthsTo: ProstateCancerSupport Date: Friday, April 1, 2011, 1:50 PM

Except for the fraud committed agains Medicare because the Republicans refused to allow resources needed to deter fraud, Medicare's payout ratio is some 95%, compared to less than 70% for the private insurance industry. Social Security is fully solvent for some time and there is time now to plan for the minor adjustments needed later on. The reason that Medicare total costs are rising is the FAILURE to provide universal health care for the early retirees. Most of the chronic conditions that are responsible for the huge costs to Medicare later on start to give rise in the early 50's, when simple medications and mangement by public health clinics which are far less costly to prevent the huge costs later on such as amputations, kidney dialysis, and stroke rehabilitation. It like do we fix the minor leaks in the roof now or have to replace the building later. Remember the visitors center fiasco at the Union Station in Washington, DC, in which fancy and

costly artwork was being done while the roof was leaking? Early intervention and preventive care can clearly prevent unnecessary deaths and illness later on. Maybe, if Cantor comes down with hepatitis B from some "Typhoid " in the back kitchen of his favorite eating and drinking establishment, he will not be so eager to shut down county public health clinics!

Louis. . .

To: ProstateCancerSupport Sent: Fri, April 1, 2011 12:00:44 PMSubject: Re: Re: Spending $93,000 to extend life four months

Sorry, Louis, I just don't agree. Show me a government program that works well. Social Security? Meducare? Medicaid? They're all hugely in debt. The Energy Department which was set up to end our dependence on foreign oil in the Adminstration? I'm much more afraid on the government that I am of any private company.

Mike

Subject: Re: Spending $93,000 to extend life four monthsTo: ProstateCancerSupport Date: Thursday, March 31, 2011, 11:27 PM

Alan:Thank you for your well reasoned reply. Your reply was on target. Many others have missed the point, bellyaching about means vs medians, recommendations vs approvals, or whether the Provenge study was designed properly. All of that was irrelevant to the point I was trying to make.What I was trying to say is "Should we ration healthcare, like other countries do?". Interestingly of those who weighed in on this question, all said that the public (in the form of taxes or insurance premiums) should not pay $93,000 to extend a life by four months. I suspect that a wide poll of Americans would come to that same conclusion.So whatever you want to call it: healthcare rationing, grandma's death panel, etc; some of us (at least those that answered the question) believe in rationing. It is the only way to stop the health care industry from bankrupting our country.I believe that we as a society

need to come to grips with this reality and stop the demagoguery and do something about it. I have as healthy a disrespect for government commitees as the most staunch conservatist.But who can act as the "death panel", fairly and compassionately. We need it. We are spending more for healthcare for less and the problem isn't going away.------------------------------------There are just two rules for this group 1 No Spam 2 Be kind to othersPlease recognise that Prostate Cancerhas different guises and needs different levels of treatment and in some cases no treatment at all. Some men even with all options offered chose radical options that you would not choose. We only ask that people be informed before choice is made, we cannot and should not tell other members what to do, other than look at other options. Try to delete old material that is no longer applying when clicking

replyTry to change the title if the content requires it

[Guest guest]

Who would be the right person to decide what treament you should get. Someone that only looks at numbers (may be a computor). We need to bring down the cost of operations.

Subject: Re: Spending $93,000 to extend life four monthsTo: ProstateCancerSupport Date: Thursday, March 31, 2011, 10:27 PM

Alan:Thank you for your well reasoned reply. Your reply was on target. Many others have missed the point, bellyaching about means vs medians, recommendations vs approvals, or whether the Provenge study was designed properly. All of that was irrelevant to the point I was trying to make.What I was trying to say is "Should we ration healthcare, like other countries do?". Interestingly of those who weighed in on this question, all said that the public (in the form of taxes or insurance premiums) should not pay $93,000 to extend a life by four months. I suspect that a wide poll of Americans would come to that same conclusion.So whatever you want to call it: healthcare rationing, grandma's death panel, etc; some of us (at least those that answered the question) believe in rationing. It is the only way to stop the health care industry from bankrupting our country.I believe that we as a society need to come to grips with this

reality and stop the demagoguery and do something about it. I have as healthy a disrespect for government commitees as the most staunch conservatist.But who can act as the "death panel", fairly and compassionately. We need it. We are spending more for healthcare for less and the problem isn't going away.

[Guest guest]

We have this in the UK, it is called NICE, some wionder if it is nice

Re: Spending $93,000 to extend life four months

Alan:What you describe sounds a lot like the dreaded "death panels".Actually I am very much in favor of an open panel of experts who will decide which procedure gets reimbursed. So what if it is called by some demagogues a death panel. Only the demagogues and their constituents get any satisfaction from that term.A panel of experts making the tough decision is the only way to control our spiraling health care costs. We can incentivise good behavior to a fare thee well, but hard and fast controls on reimbursement is the only way to control costs.I have no doubt that the medical industry will continue to invent procedures faster than we can pay for them. We as a society must put our foot down and say that we aren't going to pay for those incredibly expensive, but limited health benefit procedures. Then it will stop or at least slow down to a point where the benefit justifies the cost.

[Guest guest]

TD:

That is exactly the point. Faced with a loved one with a debilitatiing disease,

we all would like the best and most care for him/her.

But we as a society can't afford that. Something like half of our country's

medical costs are spent in the last two years of a citizen's life. In many cases

low cost pallitive care would be better than heroic intervention during

someone's last year that does nothing for their quality of life.

I have been there, done that.

:

The UK's NHS/NICE system seems to work well for the majority. If you don't like

NICE's tough limits on expensive procedures, you can buy private insurance to

supplement it. That becomes an individual's choice as to how to spend their

money on health care, not built into the system as in the US.

So those who can afford it can get expensive end of life care and those that

can't get basic care through the NHS.

[Guest guest]

Must admit to being a bit devil's advocate here, they have a difficult job assessing if an expensive drug which on average gives a few weeks extra life is worth the cost. The UK government have indicated that money will be available for this kind of drug if recommended by a consultant.

B

Re: Spending $93,000 to extend life four months

Alan:What you describe sounds a lot like the dreaded "death panels".Actually I am very much in favor of an open panel of experts who will decide which procedure gets reimbursed. So what if it is called by some demagogues a death panel. Only the demagogues and their constituents get any satisfaction from that term.A panel of experts making the tough decision is the only way to control our spiraling health care costs. We can incentivise good behavior to a fare thee well, but hard and fast controls on reimbursement is the only way to control costs.I have no doubt that the medical industry will continue to invent procedures faster than we can pay for them. We as a society must put our foot down and say that we aren't going to pay for those incredibly expensive, but limited health benefit procedures. Then it will stop or at least slow down to a point where the benefit justifies the cost.

[Guest guest]

The cost to the patient , according to the Pharma industry is the expenditure of time and money it takes to develop a drug. Some drugs can take 10 years to develop and squire through clinical trials. I know of one cancer drug that is now in clinical trials 25 years after it's formulation in Academia. According to the company they have have already spent 125 million dollars and this is a small biotech startup. Lupron for example costs only pennies to make when mass produced today but patients pay over 600 dollars a shot when administered. The idea is that the patent exclusivity on the drug over a specific period of time covers the development costs and the chance to make a profit and encouragement for the company to make more drugs. Personally, i disagree with the the concept.

The the protocols for the prevention and cure of stomach ulcers which is responsible for 85 pct of all stomach cancer (a million cases a year world wide up until the cause and cure was known) were discovered by a young Australian doctor/researcher on a 25,000 dollar (Aus. dollars) grant from his government over his summer holiday. Australia has a socialist medical system . During that same time period , the drug firm Glaxokline had reported billions of dollars in revenues from it's various drugs that palliated ulcer symptoms but did not cure stomach ulcers or prevent stomach cancer. In fact, the suggestion up until the time that the Australian discovery was made that ulcers could have been caused by a simple bacterial infection was the equivalent of medical

heresy. Patients were sent to see Psychiatrists when they refused to accept the notion that their mental condition was responsible for their illness. It was also an Australian physician/researcher who proved that the HPV virus was responsible for cervical cancer

Australia has a socialized medical system and it appears that the above proves that money is not always the motivator of innovation. I think that the difference here however, as it has been with many new discoveries and advancements in medicine is that the truly unique and important ones often are the result of efforts and thinking by lone individuals in the field (Jonas Salk, Walter , etc) who do not accept or whom wish to question prevailing standard beliefs and theories. Whereas at the corporate level vast sums of money are expended often in ''group think'' type corp. projects with specific objectives that involve large numbers of doctors, researchers and lab personnel. Whose objectives are defined and decided upon beforehand like just about every other corp. project. And also why we end up with so many ''me too'' type drugs. Because

if one drug is a blockbuster, then another one almost like it with a few more bells and whistles is likely to be as well and it's a very safe well worn path to profits to follow. If the formula for success works once, then it's likely to work again. While straying from the proven course might end up in failure and be very costly. Recently Clariton, the allergy drug went off patent. You can now get that drug without a prescription over the counter with no doctor approval and pay out of pocket. But now there is a ''New and improved Clariton'', which will be paid for by your insurance and which you do need to see a doctor to get and a prescription.

I do not know how much the development costs were for Denreon's Provenge. It would of course be interesting to know. What I find most interesting however regarding this drug is that Dr. Strum devoted an entire issue of PCRI to the recruitment of patients for the Phase III trial, and, in that issue, he did not make a single reference to PSA testing with connection to the trial. One would expect that PSA testing would have been a cornerstone and standard hallmark testing procedure at every stage of the trial and featured prominently in the PCRI article. But, it was not. I called Strums people and asked but did not receive an answer to my question. I do however recall that the FDA did not accept the original results of the Phase III trial and one of the reasons given was that the company was unable to explain in any logical or coherent manner how and why the

drug Provenge worked and achieved it's results. The FDA then required them to conduct a second Phase III trial in which they pretty much reported the same results. However, not once has either Dendreon or the FDA made any mention of PSA testing or PSA levels achieved at any state of any clinical trial conducted with reference to Provenge as far as I have been able to find. Which is suggestive is that the treatment works on an entirely different premise than effecting or controlling PSA levels. Also suggestive as to why the FDA was unable to corrolate the results of the Provenge trial with the standard PSA testing that they had come to expect with any recent drug trial that has to do with PCa.

If any of you have any information with regards to reported PSA levels by the company or the FDA of patients in any of the clinical trials on Provenge I would appreciate you posting them here. As, I would prefer to be wrong on this issue. My suspicion is/was that the reason the FDA was unable to evaluate Provenge based on PSA testing is that PSA levels (either up or down) , were not a consideration in judging the effectiveness of Provenge and that Provenge has little if any effect on PSA levels.

Dr. Strum is probably one of the most ardent advocates of PSA testing I know of and I found it terribly confusing when he devoted an entire issue of PCRI to the Provenge Phase III trial and never discussed or mentioned even once PSA levels of the men who were in that trial or any of the previous trials. I also found it confusing when no one at the publication could give me an explanation and why no one to this day, either at the FDA or at any Internet support group has broached the subject of PSA testing and the use of Provenge.

Have no doubt that I'm very much in favour of the approval of Provenge and I'm very happy that the FDA has approved it. Yet, I'm also very much in favor of knowing if the mechanism by which it performs it's magic has anything at all to do with effecting PSA. If it does, there has mysteriously been no mention of it in the public record. If it does not, then that is of major importance and consequence for all PCa patients. Something the public should know about and something Dendreon should be required to explain. PSA testing is obviously very useful in evaluating where any patient at any stage of his treatment lies on the treatment curve. However, if there are mechanisms by which PCa can be treated that do not effect PSA directly or have much if any effect on PSA, then we need to know about it as well and it is incumbent

upon Dendreon to explain. After all, men taking Provenge are going to pony up to 93,000 dollars (so they say) to Dendreon for the privilege. They should at the very least know how it works and how it effects ,or does not effect, an important cancer marker which we have all been taught to rely on and is the Holy Grail for the testing for PCa.

Why? Because we have been taught since our Dx to rely on PSA as the standard measure of the effectiveness of any treatment protocol for PCa that we agree to. If this turns out to be incorrect, then in my opinion we should be fully aware of those circumstances and occasions when PSA is not relevant , and more importantly, why it is not relevant. .

What a company charges and what Medicare is willing to pay are two entirely different issues. When Medicare approves a drug, CMS also approves how much they are willing to pay. Generally , private insurers follow CMS's lead . As you know, prices are negotiated with each individual insurer as to what the drug company will accept for payment. The 93,000 dollar figure applies to an individual paying for the treatment themselves, a very rare occurance these days. What an insurance company will negotiate for their group members can be quite something else and usually, less than half. Medicare negotiates it's own prices via CMS. As you probably know, most, if not all European countries have their drug prices negotiated for them by their Ministry of health directly with the drug comany in question. In the U.S., by act of congress, it is illegal for the government to negotiate drug prices for

anyone who is not on Medicare, the government run health insurance program for people over 65 years of age.

If you are paying for a drug out of pocket, you have to negotiate the price for yourself. Which is why the prices being bandied about in the media are so high . Because as an individual, you have absolutely no leverage with which to negotiate anything with a drug company , let alone attempt to make that negotiation when under the duress of a terminal illness. In any other circumstance there is a legal principle that governs any legal contract entered into under duress which relegates all such contracts Void and unenforcable on their face. Only when it comes to individuals obtaining health insurance and access to medical treatment does this principle seem not to apply. It was in fact the Pharma lobby that got that law barring the government to negotiate drug prices for all citizens through Congress. They claimed that having nationally negotiated

drug prices would be an impediment to research and development. Most non-U.S. drug companies that do business in the U.S. make the bulk of their profits in the U.S. where the price of drugs are not controlled or negotiated with the government.

Thank you all,

_7@...> wrote:

Subject: Re: Re: Spending $93,000 to extend life four monthsTo: ProstateCancerSupport Date: Monday, April 11, 2011, 1:13 PM

I would question why this drug costs $93,000. These medicine costs are out of control, much like the drug now sold to help prevent premature births. Established drug went from $20 to $1600 a dose when a major drug co. became the sole supplier. Knowing medicaid pays the freight.

[Guest guest]

On 4/11/11, Nowak wrote, in pertinent part:

> I have yet to hear anyone complain about the cost of Taxotere

> and Jevtana (chemotherapy). For 2 months life extension the

> real cost of taxotere is higher then the cost of Provenge.

Um, , it might be well to inform folks about the medical

status of the patients who participated in the early trials. They

were far-advanced with hormone-resistant metastatic PCa. My med

onc says that " they were on their last legs. " This is the class

of patients that trial management especially desires in trials

such as this.

Seems to me that men who are not " on their last legs " might

reasonably expect (hope) to do better.

From PCRI: " The average survival for patients following

treatment with chemotherapy was nearly 19 months for those

treated with Taxotere®/prednisone (every 3 weeks), compared to

16.5 months for those treated with mitoxantrone/prednisone. " And

the author used the term, " average " when he *might* have meant

*median*. (sigh) -- See, Tannock I, de Wit R, Berry W, et

al. Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for

Advanced Prostate Cancer. New England Journal of Medicine. 2004;

351:1502-1512. See also, http://www.ncbi.nlm.nih.gov/pubmed/15470213

A 2008 updated study reported that, " Median survival time was

19.2 months (95% CI, 17.5 to 21.3 months) in the D3P (docetaxel +

prednisone 3 weeks cycle) arm, (and) 17.8 months....in the

D1P(docetaxel + prednisone 1 week cycle) arm.... " Well, they used

" median " this time....

: What is your source for the two-month survival you cite?

Regards,

Steve J

[Guest guest]

Steve,OK, I lied there is a 2.4 month survival increase, not a 2.0 month increase as I stated. I apologize that I missed the .4 month difference,but all my statements stay the same, the cost for each median increase of survival for taxotere remains higher than the per month cost of Provenge. 

>

> I have yet to hear anyone complain about the cost of Taxotere and Jevtana

> (chemotherapy). For 2 months life extension the real cost of taxotere is

> higher then the cost of Provenge.

>

> At the recent CME hearings an advanced prostate cancer patient testified as

> to the real cost of his treatments with taxotere which exceeded $106,000 for

> the year 2010.

>

> I refer you to the advanced prostate cancer blog (

> www.advancedprostatecancer.net) where I wrote about the comparative costs:

>

>

> Provenge, It Isn't Over Priced, Its Actually A Bargain Basement

> Product<http://advancedprostatecancer.net/?p=1574>A

> Survival Advantage – Is It Worth It and What Does It Mean? When Economics

> Interface with Survival <http://advancedprostatecancer.net/?p=2171>

> What our society really needs is a frank and open discussion about the value

> of a human life.

> Can Our Society Find Its Way To An Honest Dialogue About The Price Of A

> Human Life? <http://advancedprostatecancer.net/?p=1808> What is the Value of

> One Human Life <http://advancedprostatecancer.net/?p=2106>

> er

[Guest guest]

Tax and Jevtana have the option of following psa and tumor markers and scans to determine if the treatment is effective and when to move on to another option. This can limit the costs and side effects when response is not worth the treatment costs (of all kinds). Provenge does not offer this option. With Provenge you must go on faith, never knowing if it has any effect, or how much effect. One pays the 100k$, passes through and moves on. What other medicine or treatment has no effect on the symptoms, progression, or pain and the patient and doctor know this at the beginning. It is quite easy for me to understand why some men would question the usefulness of the treatment. Because this is a unique type of treatment, no comparison with other modalities is possible.It is possible that Provenge at an earlier stage will show real results, measurable while on treatment, and with powers of synergy with other compounds. Dendreon should look seriously in this direction. Steve,OK, I lied there is a 2.4 month survival increase, not a 2.0 month increase as I stated. I apologize that I missed the .4 month difference,but all my statements stay the same, the cost for each median increase of survival for taxotere remains higher than the per month cost of Provenge. > > I have yet to hear anyone complain about the cost of Taxotere and Jevtana > (chemotherapy). For 2 months life extension the real cost of taxotere is > higher then the cost of Provenge. > > At the recent CME hearings an advanced prostate cancer patient testified as > to the real cost of his treatments with taxotere which exceeded $106,000 for > the year 2010. > > I refer you to the advanced prostate cancer blog ( > www.advancedprostatecancer.net) where I wrote about the comparative costs: > > > Provenge, It Isn't Over Priced, Its Actually A Bargain Basement > Product<http://advancedprostatecancer.net/?p=1574>A > Survival Advantage – Is It Worth It and What Does It Mean? When Economics > Interface with Survival <http://advancedprostatecancer.net/?p=2171> > What our society really needs is a frank and open discussion about the value > of a human life. > Can Our Society Find Its Way To An Honest Dialogue About The Price Of A > Human Life? <http://advancedprostatecancer.net/?p=1808> What is the Value of > One Human Life <http://advancedprostatecancer.net/?p=2106> > er

[Guest guest]

> Steve,

> OK, I lied there is a 2.4 month survival increase, not a 2.0

> month increase as I stated. I apologize that I missed the .4

> month difference,but all my statements stay the same, the cost

> for each median increase of survival for taxotere remains higher

> than the per month cost of Provenge.

I'm sorry to see that has not replied to my message of April 11.

Steve J

[Guest guest]

I ran across this old post while deleting e-mails, but if I were in the position you describe below, I would give any amount of money to have an extra four SECONDS with my husband.

You know I suspect that the time is skewed to less months because of the sample for the study. I also suspect the more they use this approach the better they will able to target and the more life it will give. I also suspect given this in combination the other drugs may also extend life. Yes 93,000 is a lot and also the future of medical science. How much does taxotore cost with everything for the same length of time and the side effects. If they get better at this with practice and cobine these cells with a bit of nano....

I often get impatient with the cost analysis when we just threw 500,000,000 or more in three days. I do not disagree with the action but just how are we breaking the government when we are paying for three wars. Sorry will stop now.

Tom W.

Subject: Spending $93,000 to extend life four months

To: ProstateCancerSupport

Date: Thursday, March 31, 2011, 11:52 AM

Medicare has just approved reimbursement of $93,000 for a course of treatment with Provenge which has been shown to extend the lives of HT resistant PCa patients by an average of four months.

Now if I was one of those patients, I would want the drug if it were provided free by Medicare. But as an American who pays for that treatment with taxes and insurance premiums I don't think it is worth it. This treatment wouldn't meet the criterion of Great Britain's NHS and I suspect that it doesn't qualify in other Eurpean countries (anyone know?), so why pay for it in America?

And twisting my decision another way, if I had HT resistant PCa and given my current financial resources, I wouldn't pay for it out of my own pocket, which I could. I would want my wife and kids to get that money, not waste it on an extra four months of my life. Tough call but that is how I feel now (but with PCa a distant memory).

We are going to have to make some tough choices to reign in our country's health care cost and this is one of them. The medical industry can and will develop more expensive treatments than we as a society can afford to pay for.

What do you guys think?