The Avastin Travesty
Avastin is a cancer-fighting drug that works by starving tumors of vital nutrients and oxygen. Although Avastin doesn’t cure cancer, it can improve quality of life by slowing the disease’s spread. The Food and Drug Administration approved its use for colon cancer (2004), lung cancer (2006), and advanced breast cancer (2008).
But now the FDA is on the brink of rescinding that last approval, relegating breast cancer to the category of an “off-label” use. In our semi-socialized health care system, that’s significant because government-funded insurance plans (such as Medicare, Medicaid, and Tricare, which serves the military) refuse to reimburse off-label prescriptions, and private insurers generally follow their lead.
Since an Avastin breast cancer regimen costs as much as $88,000 annually, withdrawal of FDA approval would, in effect, lock the medicine cabinet and throw the key onto a high shelf, unreachable by many desperately sick patients.
The FDA is slated to decide whether to follow the advice of its own Oncologic Drugs Advisory Committee, which back in July voted 12-1 that Avastin does not “represent a favorable risk/benefit analysis.” Does that mean the drug fails to help any woman more than it hurts her? Not at all — many individual women benefit from the drug. But the FDA regards such facts as sentimental distractions, to be deliberately ignored when deciding the fate of a drug like Avastin. The FDA’s idea of a risk/benefit analysis deals with health in the aggregate, as revealed in statistics involving large populations, not with the health of individuals.
But can risks and benefits really be weighed at the level of society as a whole? A society is only a collection of individuals. A society doesn’t enjoy life, or suffer — only individuals do. Metaphors aside, a society doesn’t get sick and die — only individuals do. To appreciate the difference, consider how a rational patient with breast cancer decides whether to undergo drug treatment.
Such a patient weighs (among other things) the statistical likelihood of a favorable result against the statistical likelihood of painful side effects. At all times, her judgment is individual and personal: How will my life improve if these tumors temporarily stop growing? How might side-effects interfere with my enjoyment of life? How much better will I feel if the results are above average — or how much worse, if the results are below average? How much is an additional year, month, or week of relatively normal life worth to me?
Hi Thomas:
This decision will definitely represent the Obama administration’s first salvo into rationed care and death panels.
I wrote an article on the subject yesterday and included an amusing video that describes and extremely serious subject. If you are interested the link is:
http://politicsandfinance.blogspot.com/2010/12/avastin-fda-death-panels-and-rationed.html
Here is another difference between conservatives and liberals. Conservatives, indeed this country, are pretty much based on the idea that we are individuals with individual rights and aspirations whereas the liberals think of everyone in groups or as parts of a group, never as individuals with their own self worth.
This one is a tough one . While I agree with the authors general stance on the subject, when faced with this drugs particular circumstance it gives me pause. The drugs cost of $60,000 per treatment for an effect of an up to a 14 week life extention seems a terrible bargain for an already stressed health care financial system. It is nowhere close to being a cure for anyone. At some point we will have to accept that death is as natural as birth and that there is a time for both.
But that “natural death” may be prevented or retarded and it should be our choice, and not government fiat that is the determining factor. As the article indicates, it is only the socialization of medicine that takes the choice out of the realm of the individual and allos for the question you asked about the cost of the medication vs value of 14 weeks of someone else’s life.
Well said. Thank you.
There is another point here that will become increasingly important. It is being understood that tumors are not like bacteria, which are all essentially identical and thus all treatable by the same antibiotic. Tumors are different in different people — and even in the same person. The future of treating cancer will include concocting specific mixes and doses of medicines for specific patients after analyzing individual tumors. Individual choice for medications will be crucial. Collective cost decisions will be ludicrous.
This sounds like rationing without calling it rationing. I suspect we will see more of this.
“Reform should start by targeting the FDA’s power to substitute collectivized decisions for individual choice.”
I couldn’t agree more. What must be challenged is the social theory of medicine. It requires the sacrifice of individuals’ right to life to a non-existent collective, society. People need to understand that when they give a government the power to control their health, that government will eventually control the end points, birth and death.
Government run health care is the cancer that afflicts us all.
The FDA is a big bully of a bureaucracy. That is really evident when one sees how it brings down the weight of Leviathan on a small food producer.
About fifteen years ago the owner of a family sausage company had been pushed to the brink by FDA inspectors and he killed four of them. He was punished for his transgression and most people may have viewed him as the villain in that story, but I saw him as a victim of official oppression and someone worthy of sympathy.
The FDA causes many pernicious outcomes. Another one is that, since it costs roughly 10 years and 500 million dollars to get a new drug through FDA screening, many aspects of our vibrant new biology industry are moving off shore to make things easier to advance. Of course, new biology is one of the few remaining cards we have to play here after our industry was hollowed out by outsourcing and offshoring. Yet another example of how overzealous regulation savages economic vitality.
“The FDA causes many pernicious outcomes. Another one is that, since it costs roughly 10 years and 500 million dollars to get a new drug through FDA screening, many aspects of our vibrant new biology industry are moving off shore to make things easier to advance.”
This is what they portray as the truth but it is not so. They move offshore to pursue even more obscene profits for their poisons and even less oversight on what they produce. If we got all government tentacles out of the health picture and people had to pay for their OWN health care, we’d see people scrambling to re-examine their diets, their habits, a their level of movement (exercise). The drug cartels would then realize that the cash cow of obscene amounts of taxpayer money would no longer be lavished upon them. For god’s sake, we taxpayers even subsidize THESE parasites. The drug cartel has overhead expenses that are huge because they pay vast amounts of lobbyists, bribe MDs to no end, and pretty much own the medical schools. Their so-called clinical trials are cherry-picked for positive outcomes and disregard the numerous negative outcomes. It’s all based on fraud and deception. Even the medical journals have documented this.
We are NOT deficient in drugs. We ARE deficient in real nourishing foods, clean and unadulterated water, clean air–free from the continual spraying of aluminum, barium and other poisons. The sooner we understand this, the sooner we will begin to take back control that is rightly OURS to choose how we will sustain ourselves. Bureaucratic parasites produce nothing and know absolutely nothing about how best that we care for ourselves.
Another good point about a truly free-market health insurance industry (as opposed to the overly regulated mess we have now): In a free market, a person can shop around and find an insurance plan that will pay for these sorts of treatments, as opposed to those that won’t.
“But,” the critic might say, “you don’t know if you’ll get one of those cancers until it’s too late, and then the eeeeeeeeeeeevil insurance companies will deny coverage to you!”
This is, actually, a fair point. However, there are many indicators that someone might be prone to certain cancers long before they actually show symptoms. A family history of these cancers is the first red flag; after that, there are genetic tests (like those offered by a company called Myriad… and no, I have no connection whatsoever with Myriad) that can determine a patient’s risk of getting various types of cancer.
So, we come back to a truly conservative principle: personal responsibility. If a person has a family history of cancer, they should get tested to see if they are a high risk… and if (God forbid) they are, then it is their own responsibility to find medical insurance that will cover the medications, if/when it’s needed.
Unfortunately, the way the system is set up now, it’s practically impossible to do that last step–find their own medical insurance–without prohibitive costs. And ObamaCare does absolutely nothing to address that… in fact, in many ways, it makes the situation worse.
The solution is to either remove the tax break given to medical insurance purchased by employers, or give the same break to individuals purchasing medical insurance on their own. Either one would make it much easier for people to get the insurance that matches their needs and desires.
Of course, we also need to dismantle onerous regulations both at the federal and state levels on medical insurance, but that’s a whole ‘nother topic.
Bowden is absolutely right — these sorts of coverage decisions should not be made by the government but rather by individual patients and physicians operating in a free market. The current debates over costs to “society” only arises in a collectivized system. After all, no one debates whether “society” is spending too much on iPads and personal computers.
In a truly free market for health insurance (which we don’t currently have), some people might prefer to pay higher premiums for a “gold plated” insurance plan that will cover expensive drugs in the event they developed a terminal illness — even if it might only extend their life by a few months. In contrast, others might not wish to spend extra for that small marginal benefit. They might prefer more modest insurance which didn’t cover such treatments — and instead use the money they saved for more important personal priorities such as buying a new home, starting a business, or saving for their children’s college fund.
A free market for health insurance would allow insurers to offer both types of plans (or anything in-between) — and would allow customers to freely join insurance risk pools with others sharing their same preferences and priorities. Those who wished future access to expensive drugs that might lengthen their lives by a few weeks or months would be free to pay for that option. Conversely, those who didn’t would not be compelled to pay for those who did.
Only a free market avoids the rationing of health benefits inherent in government-run health care.
Dr. Hsieh:
Looks like you and I are thinking along similar lines… see my comment immediately above yours.
I’m honored to be in such intelligent company.
Dr. Hsieh is a outstanding spokesman for market-based health insurance and health care.
I support the federal government no longer paying for this drug. Of Course, I support the ending of all government spending on health care with exceptions for Military Veterans.
Denying patients Avastin is already being done in the UK. There’s no reason to think it won’t also become widespread here.
Avastin denied in UK: http://www.dailymail.co.uk/news/article-1230349/Bowel-cancer-victims-UK-denied-life-prolonging-drug-thats-free-Europe.html
NHS threatened to stop paying for patient’s cancer care if she spends her own money to buy Avastin: http://www.dailymail.co.uk/news/article-502664/NHS-tells-cancer-patient-care-stop-buys-extra-drugs.html
Paul et al,
I don’t disagree with you in principle, that this should be between doctor and patient, but IT ISN’T! I like Avastin but it is ludicrously expensive for a marginal benefit, and I don’t want my child picking up the bill for my father’s Avastin. IF they want to pay for it themselves or buy boutique coverage, be my guest. This is a ridiculous use of taxpayer money and as long as Medicare/Medicaid/Tricare/VA etc are the bellwhether for coverage limits, I don’t think it is acceptable.
Let’s hope we can change the system but when this is coming out of tax revenue, I don’t think it can be justified.
Retired radiation oncologist here. Count me out re your argument for Avastin despite unfavorable “cost/benefit” analysis. From my own familiarity with the literature I know that much of accepted medical practice would fail such analysis. And actually its not just cost/benefit; in many cases interventions fail to offer any benefit at all when examined in large scale clinical trials. Examples: screening mammography, most cardiac bypass surgery, prostate cancer screening, routine post lumpectomy radiation therapy…I could go on and on. Much of the crisis in medical care can be traced to care given that will produce little benefit. But we want the best care that money can buy as long as somebody else pays for it! And that is why that none of the so-called health care solutions on offer will work.
Thank you “noahp”. As a doctor your opinion carries a lot of weight in this particular discussion. I lost my first wife to brain cancer when she was only 33 years old and am all too familar with the lack of efficacy and tradeoffs that come with grabbing for “hope” in a new drug. It is comments from experienced and unbiased professionals like yourself which make it possible for average citizens to be able to understand what is happening to their healthcare.
For all the advances in cancer care, we are still many miles away from anything resembling a cure. The problem with chemotherapies like Avastin is that the results are wildly different, depending on the individual, the cancer, the chemo cocktail Avastin is mixed with, and likely other factors we may not yet be aware of. But does this mean we should throw in the towel? Do we wait until we find the “magic bullet” that will cure everyone’s cancer for $0.95 a dose (available at your local Wal-Mart) before anyone can have a chance at a prolonged life?
Unfortunately, my family is way too well acquainted with cancer; my father, his 4 brothers, and two nieces endured brain cancer (x3), lung cancer, stomach cancer, esophageal cancer, and blood cancer (not leukemia but related). In some instances, the treatment not only prolonged life but gave quality life. My uncle, nearly 80, has lived many good, quality years with chemotherapy. My father got 3 good quality years, where he could travel and enjoy his expanding brood of grandchildren. Two of the three brain cancer victims died before any kind of chemotherapy was available for their illness, which was really too bad because they were children (age 9 and 12). Better treatment was available when my cousin contracted brain cancer at age 4, and she survived.
My point is, regardless of how well or how poorly we declare our health care system, it’s the best thing we’ve got right now, and why we should deny our loved ones their chance at life (if they choose such)? My family struggled with this dilemma numerous times. We were grateful when there were choices to be made because at least there was a possibility to consider.
When there is no choice, there is no hope.
Has the FDA already incorporated a Death Panel? By another name of course!
WHO population control already has its tentacles in every continent. You won’t be able to recognize them until it’s too late. See Bill Gates admissions on you tube. They have to work through the only other heartless big money portals that they can trust..
Socialized medicine has always failed for the same reasons wherever practiced. Bureaucratic greed is a contagious malady that runs downhill like its sewer twin leaving practicing systems with only two choices. (1) Increased taxes effecting a taxpayers choice at the polls or (2) decreased services effecting those on a waiting list or deemed as hospice turnips on a deathbed . Does one need any help to recognize the politically correct choice?
Search hydrogen peroxide therapy for fast eight hour cures for illness caused by a virus or bacterium using non FDA controlled vitamins and amino acids. Look here: to get an idea what a physician trained in Europe to cure disease has to face when upsetting the most prominent cancer clinic in the US by curing patients they sent home to die with simple amino acids. His analysis of autopsies performed on deceased victims of inoperable brain tumors all proved to exhibit a deficiency of the particularly cheap amino acid he used in treatment and cure of the living. Needless to say his patients followed him to court where every possible angle was used by boards of barristers retained by the FDA and their bed partners in the AMA to discredit his success including the first ever seizure of patient records by the IRS. Thirty four years have passed and they still maintain a stranglehold on his practice.. Wiki this: http://en.wikipedia.org/wiki/Burzynski_Clinic. One would assume that clinical trials could be finished in 17 years with hospice patients waiting in line. See 2 movie trailers at website on you tube
Alternative therapy has been an exposing crack in the armor of BIGPHARMA’s bottom line for 80 years. Maybe the unfiltered information on the www will help you to see the efficiency of a healthy immune system and to understand the necessity of forced health care to insure continued support of the greatest fraud ever perpetrated on the US having previously failed in the UK and Canada.
The real travesty of our “poor-health-care system” is that we get to the point of diabetes/obesity/congestive-heart-failure/arthritis/taxed-immune-systems/etc. in the first place.
There are natural ways to heal our bodies and PREVENT disease without the need of man-made pharmaceuticals. We come to physicians when we are already ill. We are going about this all wrong. We need to take better care of ourselves and learn how to strengthen our bones/brains/immunity. Studies on turmeric and many holistic herbs are very promising for reducing inflammation which is a leading factor in many chronic illnesses and diseases.
Doctors prescribe more than they ‘cure’.
We need to empower ourselves and not poison ourselves with drugs.
When I had two broken ribs my doctor prescribed me pain meds and that was it. PAIN MEDS which damage the liver. Great!
This is why I’ve gone to the doctor only 7 times in 23 years and I’m healthy.
MORE time with doctors is NOT going to help people get ‘healthier’.
Knowledge of how to treat ourselves WILL.
During flu season I take vitamin C and zinc and vitamin D and never get sick now. Blacks should take vitamin D supplements forever if they live in colder climates because their body can’t manufacture enough vitamin D from the sun as white folks do (and they can get it from tanning booths surprisingly).
We put our faith and our very lives into someone else’s hands that really should be a last resort when all else fails.
Doctors aren’t failing us. WE are failing ourselves by not taking the reigns of control over our own health more seriously.
How many times a day do you pray at your little ‘holistic’ alter in the corner.
I bet your front door is blue and inside you have a mirror facing the door.
The UK Gov Medical Institution studied this sort of crap and they have now stopped paying subsidies for holistic medicine in general.
It’s a whacko belief and you had better start putting the bear gallbladders over your doorway to keep the spirits out. Too many people in the UK died from holistic medicine instead of going to a real doctor, that’s why they had to act.75% of people take Vitamins when their body already has the vitamin in them. It just colours their Urine, What an expensive party trick.
I suspect you’ll be astonished to discover that I wholeheartedly agree with you.
Me. A bleeding-heart liberal. How about that?
*hug*
WHO population control already has its tentacles in every continent. You won’t be able to recognize them until it’s too late. See Bill Gates admissions on you tube. They have to work through the only other heartless big money portals that they can trust..
Socialized medicine has always failed for the same reasons wherever practiced. Bureaucratic greed is a contagious malady that runs downhill like its sewer twin leaving practicing systems with only two choices. (1) Increased taxes effecting a taxpayers choice at the polls or (2) decreased services effecting those on a waiting list or deemed as hospice turnips on a deathbed . Does one need any help to recognize the politically correct choice?
Search hydrogen peroxide therapy and far fast eight hour cures for illness caused by a virus or bacterium using non FDA controlled vitamins and amino acids. Look here: to get an idea what a physician trained in Europe to cure disease has to face when upsetting the most prominent cancer clinic in the US by curing patients they sent home to die with simple amino acids. His analysis of autopsies performed on deceased victims of inoperable brain tumors all proved to exhibit a deficiency of the particularly cheap amino acid he used in treatment and cure of the living. Needless to say his patients followed him to court where every possible angle was used by boards of barristers retained by the FDA and their bed partners in the AMA to discredit his success including the first ever seizure of patient records by the IRS Thirty four years have passed and they still maintain a stranglehold on his practice.. Wiki this: http://en.wikipedia.org/wiki/Burzynski_Clinic. One would assume that clinical trials could be finished in 17 years with hospice patients waiting in line. See 2 movie trailers at website.
Alternative therapy has been an exposing crack in the armor of BIGPHARMA’s bottom line for 80 years. Maybe the unfiltered information on the www will help you to see the efficiency of a healthy immune system and to understand the necessity of forced health care to insure continued support of the greatest fraud ever perpetrated on the US having previously failed in the UK and Canada.
@captaingrumpy,
Research how many people die in hospitals and how many deaths happen because of over-prescribed antibiotics which create super-bugs. Relying on doctors is a last resort and not a first resort. Self-reliance and self-empowerment means taking care of yourself and being a responsible citizen.
Women don’t need pap-smears and radiation on their breasts and men don’t need non-spreading cancer removed from their prostates which can then spread and kill them.
Why not learn a little and empower yourself? There are plenty of studies on the benefits of turmeric from the ‘regular medical community’. Look it up, fool.
This is just one more example of the fact that since coming into power the only industries Obama has actually stimulated is funeral homes and mortician schools that will surely see an increase in demand thanks to his policies.
The FDA regulates on the basis of risk. This isn’t a question of “shoving everyone’s wealth into one big pot and spreading it among those in need”. This is a question about the overall safety and effectiveness of a very expensive product. The FDA is doing what it always has – checking that drugs are safe and the manufacturer’s claims are reasonable.
On a completely unrelated note: Thomas, do you or the Ayn Rand Center for Individual Rights receive any money from Hoffmann–La Roche, or Genentech?
Hello?
Thomas, you may be interested to hear that the FDA approved a new drug called Provenge, which is a treatment for men with advanced stages of Prostate Cancer.
Normally when the FDA approves the drug, it is covered by Medicare. With Provenge, however, Dr. Donald Berwick’s Medicare and Medical Council insisted on reviewing the findings of the FDA and it’s own panel of Oncologists.
Provenge does not yet promise a cure; however, it does prolong life (and at a high quality) by as much as six months in men with advanced PROSTATE CANCER. I suspect, rather strongly that Dr. Berwick will not approve coverage by Medicare or Medicaid, not because it’s expensive (and as is true with virtually every new cancer medication in the line, it is expensive) but because most men who have prostate cancer are “elderly” and on Medicare. Dr. Berwick is simply redistributing health care to those who are young enough to still contribute to society. Those of us who’ve worked hard all of our lives, have provided strength (and taxes) to this nation, who may have served our nation in time of war, and who are over 65 years of age, will – I wager – be denied that precious additional 6 months of life.
So by the FDA pulling approval for breast cancer it means it wont be covered by Medicare, but the drug will still be available on the market. Doesnt that support the idea of individual choice? Isnt it contrary to the idea of socialized medicine? The drug isnt being denied to anyone, the FDA is merely saying, if you want it, you pay for it yourself.
Or am I missing something?
@Confused,
It isn’t quite that simple, an FDA approval for an indication provides impetus for insurers to cover a drug, and in the absence of some other medication for the same indication this leads generally to coverage of the medication by the big boys.
It also provides decreased liability if someone uses a medication for that indication.
As a practical matter there are lots of off-labelled drugs being used and lots of insurances that cover them off-label (especially in psychiatry it seems). Having FDA approval for an indication, however is massive because it allows the drug pimps to really sell it.
n=1, take for what it’s worth…