I assume we don't have a thread on this. Curious to hear people's views on drugs that extend life by 3-6 months but cost $100,000. Should insurance/medicare/public pay for them? Where do we draw the line in how long someone has to live at what cost? We probably have a thread on this already but I really just wanted to post this article that has nothing to do with what I just wrote. Pretty amazing...a $100,000 sugar pill.

Breast Cancer Patients Plead for Avastin Approval

By ANDREW POLLACK

With desperate breast cancer patients imploring the Food and Drug Administration to change its mind, the agency’s staff calmly argued Tuesday that the drug Avastin should lose its approval as a treatment for that disease.

The pleas and presentations came on the first day of a two-day hearing at which Genentech, the manufacturer of Avastin, is getting a chance to try to persuade the F.D.A. to reverse its decision made in December to revoke the drug’s approval for advanced breast cancer.

The proceedings emphasized a conflict that has bedeviled pharmaceutical regulation and other efforts to control the practice of medicine — one between cold statistics from clinical trials about overall populations and the often emotional experiences of individual patients who say a therapy has, or might, work for them.

About a dozen women with breast cancer, some tearful, told the F.D.A. that while Avastin did not show a big benefit over all in clinical trials, the medicine did help some women substantially and should be left available for that reason.

“Despite the potential side effects from Avastin, metastatic breast cancer has only one — death,” Priscilla Howard, who said Avastin had controlled her cancer for 32 months, told the committee presiding over the hearing. “I want every available weapon in my arsenal as I fight this devastating disease.”

Avastin received so-called accelerated approval for metastatic breast cancer in 2008 under a system intended to allow drugs for serious diseases to get to market more rapidly, subject to later studies to confirm they really work.

The F.D.A. said that those subsequent studies had not confirmed that Avastin was safe and effective. With five randomized trials of Avastin now having been completed, the F.D.A. said, no trial had shown that Avastin prolonged life or improved the quality of life. And no trial showed that the drug delayed the progression of tumors to the same extent as the one trial that led to the drug’s approval.

“All we are asking for here is one trial that shows clinical benefit,” said Dr. Richard Pazdur, the head of the agency’s cancer drug division.

F.D.A. officials said that data from trials had not shown even a small subset of women receiving Avastin living substantially longer than those in the control group, raising doubts about whether there are “super responders” who derive great benefit from the drug.

“We’re just not seeing that population,” said Dr. Patricia Keegan, an official in the agency’s cancer drug division.

Even if the approval is revoked, Avastin would remain on the market as a treatment for other types of cancer, so doctors could use it off-label to treat breast cancer. However, insurers would be less likely to pay for the drug, which Genentech says costs a typical breast cancer patient $88,000 a year.

Women with breast cancer testifying at the hearing feared the drug would become out of reach for them and other cancer patients. Husbands, doctors and some patient advocates also spoke in favor. Each speech in favor of retaining Avastin’s approval was met by applause.

“Make no mistake, this hearing is a death trial, not of Avastin but of these women who rely on Avastin to stay alive,” said Terry Kalley, of Troy, Mich., whose wife, Arlene, is being treated with Avastin.

Mr. Kalley also helped organize a demonstration by women and their families that took place just outside the F.D.A. campus in Silver Spring, Md., where the hearing was held.

Representatives of advocacy groups for patients with ovarian, kidney and colon cancer and melanoma also spoke in favor of retaining the breast cancer approval, saying, among other things, that revocation could discourage drug development.

But defying the mood in the room, representatives of four breast cancer advocacy groups testified in favor of the F.D.A.’s proposal to withdraw the approval.

“What use is there for a drug which in this population has more toxicities, some very serious, than the previous standard of care?” said Helen Schiff of Share, a breast and ovarian cancer support group.

Ms. Schiff said that for every woman who testified Tuesday in favor of Avastin, there were others who were not helped by the drug or had even been hurt by side effects like brain hemorrhages.

“Those people don’t come to testify,” she said.

Christine Brunswick, representing the National Breast Cancer Coalition, said: “The F.D.A.’s decision on Avastin must be based on scientific evidence from well-done trials and cannot be based on any one individual story, no matter how compelling.”

These remarks were met by derision. “I am completely disgusted to have to follow somebody like that,” said Kim Jewett, a breast cancer patient and representative of mylifeline.org, a cancer support group, who spoke directly after Ms. Brunswick.

Genentech, which is owned by Roche, will present its case on Wednesday. Later that day, the advisory committee will vote on its recommendations for the F.D.A. commissioner, Dr. Margaret A. Hamburg, who will make the decision at some future time.

I clicked this thread expecting a story about your proctologist.

I miss her. She has a really gentile touch.

Yeah, your opener has nothing to do with the article, because I was just going to argue with something you said which is:


Except in this case, based on the studies so far, the evidence overwhelmingly shows that Avastin does not actually extend life. It's anecdotal, and it is likely that it's a placebo. Cancer, especially stage four seems to advance at a much greater rate depending on the attitude of the patient. If the patient has a ton of fight, and feels like they still want to give it an honest fight - they tend to live longer. Some people die days and weeks after a terminal diagnosis because they simply give up and realize that death is eminent.

Then I read:


So thanks for that.

I think this opens a bigger debate though. I absolutely think insurance should cover drugs that are shown to slow progression of extraordinarily painful, debilitating diseases (rheumatoid arthritis comes to mind) - in which there are extremely expensive medications on the market that do slow the progression of the disease. This means that those suffering from it can have many more years of productive life where it doesn't completely debilitate them from work and an active daily life. I know first hand that insurance companies and Medicaid/Medicare coverage is limited to certain medications. I don't think that's acceptable.

However, when you're talking about a terminal illness/disease that is in the end of life stages? I'm actually opposed to medications that prolong bedridden poor quality of life that is known to be terminal. Who benefits there?

The pharmaceutical companies?

Correct. Kam, if a person wants to stay alive for a month or two at the end of a terrible disease, who are you to say that they shouldn't be able to?

The real question is here is the money. There is not unlimited resources for medicine and R&D and where do you draw the line?

I don't think she's saying they shouldn't be able to. I think she's saying that the public funded healthcare system shouldn't cover it.

She is saying that, but I guess my question is where do we draw the line? Clearly everyone would say if a drug extends a life by a week at $100,000 it shouldn't be funded. But what about three months? What about six? Twelve? I think it's such an interesting discussion.

There are a lot of unknowns though. There isn't anyway to definitively guarantee that a medication would extend life by __ time but I can see where you want to go. Take something like HIV/AIDS medication. It doesn't resolve the issue but it's extended the life of the sufferer by decades as medical technology and understanding of HIV/AIDS has increased. Memory tells me that it's extremely expensive and not necessarily publically funded but you'd think it would be considering the benefit.

My memory lies. A quick google search indicates that it is publically funded.

OK, to make it more simple, let's talk just about terminal cancer medications. There are many on the market (I believe) and they extend life anywhere from 6 to 18 months and cost around $100,000. I agree that the HIV/AIDS stuff is way more complicated. I think it's hard to argue that if we keep someone alive for an extra 12 months that has terminal cancer we might find a cure for that cancer in those 12 months. It's possible but it's seem like a stretch. But even so, how do we draw the line with time and money?

We can't so we put it in the too hard basket and bury our head in the sand.

I actually think it's unethical to prolong the life of someone who is terminally ill. Now that seems cold and callous. I'm not talking about someone who got a terminal diagnosis who still has some years ahead of them. I'm talking about giving bed ridden, 1.5 feet in the grave people who sleep all the time and live on pain medication... giving those folks expensive medication to prolong their lives - I find that unethical. When families can't let go, when people want to live and be a burden on the system, their family and friends, I think it's selfish, and I think from a medical point of view it's simply unethical.

It's not about money to me.

I realize that's not the only thing being talked about though. There are plenty of terminal people who while being given a death sentence still have a couple of good years ahead of them. That's obviously different.

haha




There was a great 60 minutes years back about people in hospitals with death sentences being kept alive at the cost of hundreds of thousands because family members wouldn't let go. The chief resident of the hospital was arguing how absurd it all is and how as society we have to draw the line.

The cancer drugs are a bit different. These people aren't suffering in a bed till their death day. It truly prolongs their life 6-18 months or whatever the drug does. But they will also die for certain. And they cost a fortune.

Basically, the $100,000 it costs to R&D/pay for a person to live for 12 months could probably pay for a family of 4 to live for years that is in poverty and can't put food on the table. The easy answer is "well let's do both" but that's not reality. We don't have unlimited resources.

But if you're going to argue this then by the same token shouldn't we look at the accumulation of wealth? My ___ amount of money in the back could feed a family of 4 for years that is in poverty and can't put food on the table. Perhaps I shouldn't be allowed to have that amount? This is clearly deliberately facetious but the whole reason these things aren't discussed more readily is because it basically goes against the fabric of western society. We don't do things for the benefit of society at the cost of the individual. We do things for the benefit of the individual at the cost of society.

Well, that's a much larger/different debate. To me, it really comes down to resources and cost/benefit. I shouldn't have thrown in the "we could spend it on the family of four" but cause it clouds the debate.

Of course but there will never be a cost/benefit answer. It's easier for us to place all of the responsibility on society or all of the responsibility on the individual. We don't acknowledge the shades of grey because it's too difficult to think about.

We all are.

From an ethical standpoint my biggest concern is going to always be quality of life. Cancer patients especially can go downhill rather fast.

Example, lung cancer patient. Often they come with the comorbidity of COPD. In their last year or so of life, breathing is taxing, often on oxygen, losing weight because with lack of oxygen comes lack of apetite, etc. So while the medication may actually prolong their life and extra 12 months beyond the year they have left, it's a miserable life. What responsibility does the medical community have to tell these folks that death is the natural course and they can't in good conscience prescribe them a medication that prolongs their living hell, just because they're scared to die?

Well, that's not really fair. I have no problem with government/community paying for a life saving operation or medicine. It's really how much these specific drugs cost to research and how long (short) they prolong life.

Again, if the drug was free and we had unlimited resources I'd completely agree. To repeat my question though, where is the line drawn? 3 months, 6? 12? $100,000? $250,000?

Lines are currently drawn. The FDA requires a certain amount of prolonged life to even approve a new cancer drug. As far as cost goes, that's a negotiation between medicare and the drug companies. I guess I'm asking what your views would be if you could make up the law. It's harder without consequences for the cost, because that's all this centers around.