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Subscribe to RSSWhat should someone dying of cancer do when the last-ditch drug that they have relied upon is shown not to work?
And what do insurance companies and government programs do about coverage when bad news arrives showing that the expensive life preserver to which many are clinging does no good -- and may actually accelerate a more miserable death?
These are precisely the horrible dilemmas that many women dying of end-stage breast cancer face with the Food and Drug Administration’s finding that the drug Avastin does not work.
In 2008, the FDA allowed Avastin to be marketed as a treatment for incurable breast cancer. The approval came under a "compassionate access" program that allows very sick patients access to drugs before all the data that drug companies need to gather to show proof of efficacy has been collected. All the data on Avastin is now in. It does not show any real benefit to women in this desperate situation.
Still, many women with no other option will want to give Avastin a try. And they may be right in that the failure of a drug to show any benefit to a big number of women does not mean that no individual woman might benefit a tiny bit. Still, the picture painted by the data is bleak, the drug costs about ten thousand dollars a month, and it is most likely just to make you sicker as you die.
Those now on Avastin should be allowed by their insurers to make the choice to stay on. The cost is large but it would be wrong to deny the drug to those who want to keep taking it even if the most likely result is that these women will provide the final sample of evidence that Avastin is a failure. But, for new patients not on the drug, the only fair option is to let them have access but not to pay for Avastin with government or private insurance money.
The hope that Avastin might extend the lives of those dying from breast cancer is gone. Those who still want to rely on the drug as they die should not be denied that last choice -- as poor as that choice may be.
But there is no ethical argument in favor of paying for a very expensive drug that does not work for new patients, even when there is nothing else to offer.
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I guess $10,000 a month is the price of hope these days.
Dr: are you serious?? Women should take a drug that is shown to do harm and no good (seriously, a "tiny bit" might be worth this risk??), just to be taking something? If that's the case, wouldn't a plecebo do the same, as long as a doctor said, here try this? Women are not children and the whole tone of this essay is condescending. How dare you advocate false hope, just to avoid the reality
Outrageously unprofessional if not immoral.
The logic is flawed , this non doctor, doctor is a an idiot
AP,
The study does not show that no women were helped by the drug.
The study simply shows that when you average all the women who took the drug out, you statistically could not see enough benefit to justify the side effects and the price.
However, when you are talking about women who are going to probably die anyway, side effects may not matter.
Some women want to try every last option and don't want to feel like they've given up. If they can afford the treatment, then more power to them. I don't really agree with this type of philosophy, but it isn't my life, and I don't want to tell dying people how they should spend the rest of theirs.
Some women would prefer to not deal with the side effects when there is not a guarantee of a benefit. Plus, some women are simply more realistic about their chances at survival, and don't see the purpose of spending thousands upon thousands of dollars to extend their life when they know they will die anyway, even if the insurance company pays for it.
The key is educating women so that they know enough to make an informed decision. We don't want women going into a situation where they think Avastin is going to save their lives or greatly extend their lives, especially when the risk-to-benefit ratio doesn't work out in their favour.
For some reason, Avastatin benefits a small number of women. What they need to figure out is which women would benefit and thus the risk would be justified for.
I'm sorry, Art, but you missed the boat on this one. The issue is that money available to pay medical bills is a finite resource. Because of that simple fact it means that $100,000 will not be available to someone else because it was spent so someone or someone's family can cling to false hope. It's called "compensating values" in your little ethics handbook.
There is no moral delimna for the patient since they will die one way or the other. But to give someone a drug with massively bad side effects and no efficacy above that of a placebo is a straw dog. Just give them the pacebo, tell them it is Avastin, and save $99,999.99. The moral demomna lies with the drug companies to put drugs on the market for, or encourage them to be used off label, when they frequently have suppressed trial data that shown almost the same effectiveness of their drug as a sugar pill. But the sugar pill has no side effects. You have to remember that a drug company only has to show two clinical trials that show the drug to be measurably better than a placebo. They can, and usually do, suppress hundreds of trials that show that the pill is only as effective as a placebo. This sort of thing is unconsciounable.
There was a book a while back on the Vioxx thing and the risk of heart attack in trial patients was well-known. The drug company simply ran study after study until they got the two they wanted. And even in those two, several people were shown as "Voluntarily Disenrolled" when, in actuality, the person had had a heart attack.
The FDA simply has to be "re-missioned" as the bureaucrats say, to:
1) Get rid of the MD's (and MD/JD's) that run the place. If there isn't at least an earned MPH, they have no training or skills in designing, conducting, or evaluating clinical trials. Because they do not have the skills, FDA physicians are entirely dependent on the drug companies to do all the design and evaluation of their own drugs. While the law requires that they divulge any financial links to the for-profit medical industry, only 20% have done so, and even within that 20%, about half had impermissible links. These people need to be replace with the bench science skills to be able to tell if the drug company is hiding something and to have designed the clinical trial in the first place. Impermissible links = getting fired.
2) Require drug companies to demonstrate safety with no suppressed trial data or trials. The onus would be on the drug company to prove. Right now a company could easily get arsenic past the FDA as a "safe" drug.
3) Require that drug companies demonstrate that the drug is siginficantly better than a placebo using all trial data. We're not just talking statisticaly significant, but significant enough to make up for the price and side effects. Right now, if you can dredge up two trials that show that it is measurably better than a placebo, you're in.
4) Require that drug companies foot the bill for ongoing monitoring of drugs after they go on the market so as to have a better understanding of any late-developing side effects or drug interactions. This is not being done very much because of the expense.
5) Place all clinical trial data collected (not just that used to get approval) in a database that can be accessed by researchers. This would allow researchers to "mine" the data for correlations that the trials might have overlooked.
6) Limit the profits of drug companies to 12% with the excess profits going to reimburse the American taxpayer for the taxpayer funded research that discovered and developed Avastin and other drugs. After the taxpayers money has been recovered, the drug company would be required to charge no more than a reasonable price. An 8,000% target markup for a drug like Avastin is simply evil. The money recovered could go right back into funding grants to find the next big drug.
7) Bring the dietary supplement insudtry directly under the jurisdiction of the FDA and regulate it properly. Right now more Americans are dieing from the results of vitamins and dietary supplements than are being saved by them. If the vitamins and supplements work and are as good as people think, a true double-blind clinical trial would be nothing to fear, no?
I think that the FDA is badly broken. But I am not one to say that because it is only partially effective that it should be gotten rid of. If it's broke, fix it dammit! And the FDA needs fixing.
How about this: leave it on the market but anyone who wants to buy this ineffective drug can dig into their own pocket to pay for it. Nice, simple free market solution. Who could argue?
norm,
That is exactly what is happening in this situation.
Since Avastin is already approved for use in other forms of cancer, the medication is not in danger of leaving the market.
However, patients who receive a future Breast Cancer diagnosis will eventually start seeing that their insurance company no longer covers the medication for Breast Cancer patients (while continuing to cover it for colon, etc. cancers).
They can still get the medication if their doctors prescribe it, they will simply have to pay the full price for the medication.
This whole story is absolutely idiotic. You can't be serious!
The author of this article is being absurd. There is absolutely no justification for continuing to waste medical resources on providing women with a drug that has been shown not to work. I do not care if they are already taking it or not. To continue to give someone a drug that you know will not help them does nothing but provide false hope and is a huge disservice to the patient. It is also absurd to require an insurance company to continue to pay $10,000/month for a drug that has no benefit to the patient. This does nothing but drive up everyone's insurance premiums. For any doctor to provide a women with a new prescription for this drug as part of breast cancer treatment is basically malpractice and participation in a fraud. They would be prescribing something that is known not to work thereby misleading their patient and providing false hope, not to mention having them waste $10,000/month since insurance will no longer pay for it. All prescriptions for Avastin related to the treatment of breast cancer should be stopped.
Chris -
The five Pharmaceutical companies in the world own and directly/indirectly manufacture 99% of the worlds vitamins/supplements. Most of the ingredients come from China and are derived from coal tar, limestone, etc. Almost all of the research done on vitamins and their inability to provide positive results is based on these vitamins. People should ONLY buy whole food suppliments. The body is only designed to digest and absorb food, not chemicals.
"Whole food" supplements also come from China.
Unless you are eating an actual carrot, almost every supplement you see on the shelves and on-line starts out in China (and if you are eating a Walmart organic carrot, it still comes from China).
Part of what my company does is supplements. You simply cannot buy bulk ingredients that don't come from China.
And they may be right in that the failure of a drug to show any benefit to a big number of women does not mean that no individual woman might benefit a tiny bit
Might as well give them heroin, oxycontin, or marijuana for the pain.
Cassivella -
Actually, a company called Standard Process, which has been around since 1936 produces all of it's own whole food ingredients in Wisconsin from seed to supplement. They have one of the biggest organic farms in Wisconsin and grow, harvest, and produce their own natural supplements. None of its ingredients come from China. And on a side note, if you buy any food from Walmart (not saying you do), that person really needs help.
No, I don't buy food at Walmart.
I just find it rather humourous that people go to Walmart to buy organic produce (Walmart is the #1 seller of organic products now), and the produce is from China with absolutely no oversight of what is considered organic.
Norm, read some history. That is EXACTLY what existed BEFORE the passage of the Pure Food and Drug Act in 1906, and the market was mostly "patent" medicines - snake oil crap consisting of opiates, alcohol and turpentine. "Free" markets give you snake oil, and I have THE FACTS of history to prove it. What do you have besisdes magical think and a naive belief in the magic of "free" markets?
My Dad died of Transitional Cell Carcinoma. He was diagnosed at stage 4, yet we had hope because the Avastin / Carboplatin / Taxol regimen he was on was working wonders, the tumor was shrinking, and he was feeling better.
At least that was until he suffered a perforated ulcer, which is a risk factor with Avastin, but it was also attributed to the fact that my Dad had long since been dealing with H. Pylori and ulcers, because he constantly took his anti-inflamtories and opioid pain killers, etc., on an empty stomach. I always told him to at least drink a full glass of water, but he didn't even really due that most of the time.
After the perforated ulcer, he was taken off of Avastin and any and all progress that he had been making on shrinking the tumor stopped. Then eventually he reached the maximum dose of Carboplatin and that was pretty much it.
Avastin worked for my Dad's TCC without a doubt. And had he been more careful to not take his NSAIDS and other pills on an empty stomach for so long, and treated his H. Pylori properly (broccoli sprouts do wonders, but he wouldn't really eat anything like that), he could have continued the Avastin treatment, and it very well could have saved his life.
It's a terrible dilemma. I know. I have untreatable stage IV kidney cancer and made a conscious decision NOT to chase after every unproven treatment out there. I participated in one clinical trial which quit providing any benefit (in the lingo - progression-free survivial time) after four months. Beyond infusions to help with the bone metastasis, I have been left the hell alone. I have some fatigue and other minor issues but otherwise someone would never know I have cancer. I still work full-time. I credit this at least in part to not being halfway poisoned to death with drugs. Quality vs quantity means a lot. At least to me.
Coffe: So sorry you are having to deal with this. Your independence and strength are truly admirable.
Thank you for sharing this. So sorry for your illness, and best wishes to you.
It's an illogical statement from a Doctor who is not supposed to do harm.
Sounds like "I don't want to be in the middle of the problem in stopping the drug"!
Not a big ethical issue, just a matter of courage.
Dear CoffePlease, I am so sorry for the circumstance that you are in. I myself was diagnosed with a brain tumor 1 year ago. I stayed away from all conventional treatments (because they could offer me no benefit) and pursued holistic help. Some things I would recommend if you are so inclined, visit cancerfightingstrategies.com, buy Knockout written by Suzanne Somers (crazy, I know) but it is interviews with doctors curing stage IV cancers naturally in the US, and look into Young Living Essential Oils. My blood work has been cancer free for 1 year and this is with a confirmed cancer diagnosis through biopsy and MRI scans at Brigham and Womens hospital in Boston. I agree with you that you are doing so well because you avoided the poisons. Maybe with some alternative therapies you might recover. Best wishes.
What a bull@!$%# article . . . if it doesn't do any good then by all means it shouldn't be used anymore and there is no reason for someone to keep taking it. It doesn't pass FDA scrutiny and no way should insurance companies have to pay for it. This probably comes from the drug manufacturer who puts an 75% mark-up on it.
@fedotter,
Sorry to be the one to tell you. This pertains only to the use of Avastin in late-stage breast cancer. It is not being taken off the market, its just that an off-label prescription for it has shown to be ineffective. It can still be used for other cancers, such as colon cancer.
And a 75% markup??? Where have you been. The target profitability for a 'blockbuster" drug like Anastin is 8,000% Yep, take the costs associated with a drug to the point that the first pill is sold and multiply it by 8,000.
And yet, to this very day the FDA still continues to deride Dr. Burzynski’s, “antineoplastons” cancer treatment; based on over 40 years of clinical experience and research.
"Dr." Burzynski is a quack.
His studies have been called "scientific nonsense".
He has never published a peer reviewed article.
His only clinical trial, in Japan, was not renewed for Phase II (meaning that no benefit was shown).
He charges over $100,000 a year for treatment, none of which is covered by insurance.
Considering what he is selling is actually urine (otherwise known as pee, piss), I think that is pretty expensive.
Cassivella
"Dr." Burzynski is a quack.
And who are you to call someone a quack? Are you an oncological pharmacologist?
His studies have been called "scientific nonsense".
I'm sure the only negative critiques were published by his pharmacological competitors.
He has never published a peer reviewed article.
In all certainty, he doesn't want any his work plagiarized while he "patents" his findings.
His only clinical trial, in Japan, was not renewed for Phase II (meaning that no benefit was shown).
Wrong: "Currently, there are 5 open clinical trials on Antineoplastons (as of January 2011). All of the clinical trials are registered with the FDA and results of the trials are reported to the FDA on an annual basis. "
He charges over $100,000 a year for treatment, none of which is covered by insurance.
His fees appear to be less than the present annual cost of conventional cancer treatments. Unfortunately, his treatment is being derided by the FDA and his pharmacological competitors and until final approval is granted insurance companies will probably continue to deny payment.
Considering what he is selling is actually urine (otherwise known as pee, piss), I think that is pretty expensive.
Just as an aside Pfizer Pharmaceuticals manufactures "Premarin", a hormone therapy drug used for post-menopausal symptoms in femals; this drug is derived from horse urine (pee, piss). Furthermore, antineoplastons are actually peptides ,complex molecules built from amino acids, found in blood.
Premarin is DERIVED from mare urine.
This quack is injecting urine.
Little difference there.
Who am I?
I hold a PharmD. I spent 4 years in cancer research. So, yes I am.
Cassivella
"I spent 4 years in cancer research"; past tense, so in other-words, you're a has been looking for recognition.
Having fun voting up your own comments, Mal?
I no longer work in cancer research because I moved on to a better paying job at a university.
You simply do not understand that posts such as yours KILL people. Steve Jobs himself, once a member of your cult, admitted that he killed himself because he thought he knew better than modern medicine and tried alternative therapies first, to the exception of modern medicine.
You would be laughable if you didn't prey on the poor, ignorant, and desperate. Disgusting.
People like you have bought into the cult so much you can no longer see the world rationally.
Whether you are worshiping Jesus, Santa Claus, or "Dr. Burzynski", you would allow facts to sway you from your brain washing.
There is no sense in trying to debate you, as debate requires logic, and you aren't capable of using that.
Cassivella
So you moved on to a "better paying job at a university".
Your comment is "laughable"; I think there are many more readers that would rather worship Jesus than follow your pecuniary ideology. It’s all about the bottom line to you, money; right?
Wrong, that only makes you a “high priced has been.”
That's it, keep voting up your own comments. It's probably the only vote you will be getting.
Even most of the Jesus worshipers look to modern medicine. Most aren't as blind as the urine cult.
I'm not sure why you insist upon calling me a has been. I've never wanted "to be" whatever it is to which you are referring.
If I wanted to get my name well-known, I certainly wouldn't have chosen a scientific field. I would have stuck with my Bachelor's degree in Theatre if I was craving attention.
Even with your "high priced" college position the cognitive invention of your comments are creatively lacking. Are you a janitor at one of our major universities?
With that said, I do concede to one of your statements; the one about how you should have stuck with your Bachelor's degree in Theatre. It's obvious you yearn for recognition. Allegorically speaking, you're beating a dead horse (pee) to death.
It's still cute how you vote up your own comments.
But, your comments really aren't making sense anymore.
Are you a native English speaker? Or are you just ignorant and functionally illiterate?
And you certainly are rude. Do you know what using bold means on the internet?
Do you feel the need to try to make yourself feel better by trying to out-argue people who are smarter than you? You will be disappointed. It's obvious you can't, and then you simply degrade into making personal slurs.
I'm sorry I'm smarter, better educated, and less likely to be brainwashed than you.
You can get help. There is medication for paranoia.
Cassivella
I’ve already wasted too much time on your theatrical fantasies and psychotic self-indulgence. You’re statement: “I'm sorry I'm smarter, better educated, and less likely to be brainwashed than you”; says it all.
I've always said that the pen is mightier than the sword; but the internet is mightier than the two combined.
If I wanted; I could verbally castrate you; however, having full awareness of your obvious condition, I’ll just say, good-bye and leave you to your own pandering.
Uh yeah. I'm sure you are so busy saving the world that chatting online is taking up your precious time.
I did notice you haven't voted your own comment up yet, so perhaps there is help for you yet.
The yelling thing is getting rather old.
If you insist upon being ignorant, brainwashed, and psychotic, the least you could do is be polite.
BTW - I programmed lighting equipment for my theatre degree.
Unlike you, I don't have a narcissistic fantasy life.
Bye bye now. Your mommy is calling you to come take your meds.
Cassi I was with you until ... "I'm sorry I'm smarter, better educated, and less likely to be brainwashed than you." Not that Mal'achi was/is winning but they did manage to bait you and get you to stoop to their level.
Mal'achi, you are nothing but a hack job. Go drink more of that urine, er koolaid.
Sorry if the truth hurts.
The fact is that some people are smarter, better educated, and less likely to be brainwashed than others.
My mother has ovarian cancer and is currently being treated with Avastin. After trying 7 other chemotherapies, Avastin is the only drug that has helped. Since ovarian cancer is considered "off-label" for Avastin, you can assume how devastating news like this can be, especially since ovarian and breast cancer are closely linked. How will this affect my mother?? Will she be denied coverage of the only drug that works for her?? Sometimes one must consider ALL of the collateral impacts that rulings like this can entail.
In my experience as a PharmD, when a drug goes off-formulary, any patients currently taking the drug are "grandfathered" in so they are still covered.
Additionally, with any drug, if you can show that you tried the drugs the insurance company wants you to take, those drugs didn't work, but you found a drug that did work, then the insurance company will approve an exemption for you (called prior authorization). This is sometimes handled, or requires contact with, the insurance holder's benefits department at work (or union, or from wherever the insurance is purchased). This depends on whether your company is considered self-insured or not.
The drug may cost a higher copay (non-formulary), but it will be covered by the insurance company.
Of course, this does require your doctor's office to send in significant documentation attesting to these facts, but I have never seen a patient get denied when these criteria are actually met.
Most people, however, never fill out the proper paperwork, or follow up with their doctors' office, or don't meet a requirement - such as trying another drug - and therefore decide to blame the insurance company instead of their lack of commitment.
Good luck to your mother!
Wow. You just reversed my freak-out. Thank you so much :)
My pleasure! :)
This is why health care costs too much ... expensive treatments that don't work but approved by doctors for no good reason. Give them a sugar pill for Pete's sake and save us all tens of thousands of wasted dollars per patient. Let them have the drug if they pay for it themselves, but don't put it on the public's tab! ... Oh gee, I bet they just changed their mind...
Yeah thats right.... let woman stay on this drug with all the FACTS (not some teary eye personal opinions) say doesn't work and is more likely to make you sicker, at the cost of tens of thousands of dollars to their insurance companies? Screw that. I have no love for insurance companies, but allowing people to milk insurance companies for $10,000 a month for a treatment that has zero chance of helping them does nothing but helps drive up the price of insurence for everyone else.
I'm sorry to anyone who has, or will have end stage cancer. I can't imagine what it much be like, and the desire to cling to anything that might work must be over powering... however false hope, is no hope at all.
Is it ethical to sell a placebo to women with end-stage breast cancer? No. Is it more ethical to sell them a drug at $100,000/year that could kill them, but only provides a placebo's false hope? No. It should be illegal.
Would it not perhaps be better if the woman has small children to put that $100,000 into a fund for the kids rather than spending it on a drug that has no proven value in a cure?
Prescription medications never fix the problem. It's up to the body to do it itself. Fix the body and fix the cancer. We need to address natural alternatives as a solution in our health care system instead of trying to find the next "wonder drug" that will fix cancer. I've seen safe, natural solutions work time and time again after medicine has given the patient a death sentence. We just cant say anything or the the FDA (who are run by the Pharmiceutical companies) will bust down the doors with guns drawn (not joking) and say we are making claims we cant prove or we're praticing outside our scope of practice. Cancer is from malnutrition, not a drug shortage in the body.
Well said Ben.
Thanks. I just wish more people knew about alternative solutions instead of only relying on allopathic medicine.
The more we talk about it in a calm, rational way the better. I am proof of what it can do. Things will change one person at a time. It came in time for me to save myself, but it was only after watching my wonderful dad succumb to lung cancer after following conventional treatments. I figure I am paying it forward now.
What if a woman wants a witch doctor to come in twice a day to chant and do whatever it is they do at a cost of a few thousand a day?
Or if she wants a Monk flown in from Tibet to do some magical ceremony that will cost thousands every month?
Should insurance pay for these also?
After all I bet you could find some people who do get better after almost anything but that of course does not mean that the action or drug and the remission is correlated.
It is a very unfortunate fact of life - but if we are ever going to get insurance costs under control we can't expect insurance companies to pay for everything even if what they are paying for have not been proven to work.
I know that is harsh and I hope that I am never in that situation but it is what it is. If we want to give everyone, every chance - that simply costs a LOT of money and if we want that - ok - but then we better be willing to pay for it and not complain down the road.
High times had an article of a man who used cannabis oil to treat cancer. He said he was very successful, but of course the 1%'s will shut anything down to keep it incureable, you can't make money with a natural cure, whether weed or anything else. A lot of money will be lost.
Maybe it's easy for me to say, but I think we need to learn how to die. It's something that we'll all get a shot at, and we can't beat the odds. When our chances of dying are so much greater than our chances of living, why bankrupt the living to maybe add a few more minutes to what is really misery? Compassionate hospice care and a death that is a painless as possible while surrounded by those who care about us is what makes the most sense.
Unfortunately, there is still the misconception that choosing hospice means you are giving up.
I've seen patients' families try to talk them out of hospice, even though our local hospice providers will still continue with chemotherapy and other "cancer fighting" treatments along with palliative care.
Sadly this is a major problem with the healthcare in our country. We have too many expensive potential fixes for all the problems the human body might have. It is both a blessing and a curse.
here it is! Gay is right and Monogamy is wrong. Which side of the fence are you on...for family, for life, or for rolling around eating each other...there is no difference. One is to raise a family, future lifetimes given strength and heart to go out and thrive. The other, is to just eat, and eat, and eat, and eat and turns its ever increasing hunger to the more weirder and darker aspects of the human psyche gone wild in a self-deteriorating way, where there literally is no self only appetites to be filled needing greater and greater, uglier and more disgusting ways to get off, children, animals, gerbils...Everyone knows in their hearts what is right and wrong. Everyone. Even the most 'evil' are the most ignorant not listening to their inner spirit, soul which is love - they hate and refuse to look at their actions and how they bring a karma of negativity. God bless even them, for someday they will grow up.
Wow, Roberta, you might want to see a psychologist about those issues you got... on second thought, maybe see 2 or 3.
Are you kidding me?
So we keep people on a $10k a month drug that has been proven to do nothing, and we wonder why health insurance costs just keep going up and up...
Ridiculous. This is such a no-brainer it's absurd. Stuff doesn't work, let people continue to use it, but they pay out of pocket if they want it.
End of story.
Hmm i dont want anyone to lose hope but if the drug does in fact not work why waste money on it?
Its always a drug when it comes to treating a disease. Breast cancer is preventable and in most cases reversible. Check out this non commercial, science based website on the topic of breast cancer reversal through diet.
Is anyone even reading the article?
And they may be right in that the failure of a drug to show any benefit to a big number of women does not mean that no individual woman might benefit a tiny bit.
He also suggested that the drug be available, not paid for by the insurance company.
Lost my precious baby in June of this year. Had her since she was 8 wks old. She just turned 10 yrs old. She died of a myisterious illness with liver enzymes elivated. I had been giving these Waggan Train Checken "Jerky Tenders" to her. I was devistated just having her checked out the moth before as being very healthy. When are we going to put a stop to this, when China starts killing people with there less then standard food supply. Even though Waggan Train is a USA company, the treats are only packaged here. Shame on you Waggan Train, I had trusted them for many, many years.