Avastin and Your Life
The Food and Drug Administration (FDA) is on the verge of taking the highly unusual step of “decertifying” the cancer drug Avastin that it had previously approved. In addition to sparking concerns that this is another step towards medical rationing, the FDA’s proposal will worsen another important but less-frequently recognized danger of government-run health care — namely, the politicization of health benefits. Both problems will accelerate under ObamaCare unless our politicians repudiate the principle of government-run health care.
Avastin is used to help lengthen and improve the quality of life of patients with late-stage cancers of the colon, lung, kidney, and brain. (It cannot cure these terminal cancers.) As the Washington Post recently reported, the FDA had also approved it for late-stage breast cancer, but based on recommendations from its scientific advisory panel it is considering rescinding that approval on the grounds that the risks outweigh the benefits.
Conservative commentators have warned that this could be the beginning of European-style rationing of expensive medical treatments. (Avastin treatments cost $8000 per month.) Liberals counter that the advisory panel’s decision was based on scientific grounds, without consideration of costs. But even if the liberals are technically correct, it is also highly likely that new Medicare administrator Donald Berwick will seize this opportunity to deny coverage for Avastin — especially given his avowed support of British-style cost-effectiveness rationing. Because private insurers often follow Medicare’s lead in determining drug coverage, an FDA decision to decertify Avastin would likely also affect many patients with private insurance — also thus amounting to de facto rationing.
Besides the issue of rationing, the FDA proceedings are also sparking the second great evil of government-run health care — namely, the politicization of health benefits. The FDA usually follows the recommendations of its advisory scientific panel — but not always. Hence, special interest groups are gearing up to pressure the FDA to disregard the panel’s ruling. Several congressmen have already sent letters to the FDA urging them to continue approving Avastin, essentially seeking to use their political power to influence the FDA’s decision.
Such politicization of health benefits is not new. A similar political fight erupted earlier this year with respect to screening mammography coverage under ObamaCare. When the U.S. Preventive Services Task Force (USPSTF) recommended restricting screening mammograms to women over age 50 (despite standard medical practice of having women starting at age 40), it aroused tremendous political controversy — especially because the initial version of ObamaCare legislation gave the USPSTF the authority to determine which screening tests must be (or need not be) offered by insurance companies. Senator Barbara Mikulski then used her political influence to overrule the USPSTF and include mammography coverage for women over age 40 in the final version of ObamaCare.
Politicization of health benefits is already routine in Massachusetts, which since 2006 has had a system of mandatory insurance similar to ObamaCare. Since 2006, special interest groups have successfully lobbied to include 16 new benefits in the mandatory package (including lay midwives, orthotics, and drug abuse treatment) — and the state legislature is considering dozens more. As ObamaCare is phased in, we can expect similar politicization of health benefits at the national level.
To “solve” this problem, some lawmakers want an Independent Payment Advisory Board (IPAB) that would be theoretically insulated from political pressure to make cost-cutting coverage decisions for Medicare (and possibly later for private insurers). But this merely highlights the problem inherent in any form of government-run “universal health care.” Either your medical benefits will be determined by pressure group politics — or rationed by unaccountable bureaucrats. Heads you lose, tails you lose.
The heck with those costly cancer patients who’ll just die anyway, we need to save money so we can increase Section 8 housing to get more Democrat voters! (In case we’re wondering about the issue being debated.)
Here in the UK, decisions about the provision of drugs such as these are taken for England, by the Orwellian “NICE”. Almost invariably, it seems, drugs that reduce cancers are bottom of the list for NICE’s priorities. Frequently, these same medications are routinely supplied in mainland western Europe AND in Wales and Scotland via the “National Health Service” (I don’t know what the situation is in Northern Ireland), when they are simultaneously denied to patients in England. This is probably partly based on politics, since Scotland and Wales generally vote Labour (unlike England) and Labour lost power nationally only last May.
Undoubtedly, though, NICE does very crude calculations of cost. England has about fifty million inhabitants, so can’t have a drug; Scotland, with only a tenth as many people, is permitted the same medication, at the expense of the (English) taxpayer.
Watch out, Americans.
The idea that we can compare the risks to the benefits in a “one size fits all” calculation is also utterly absurd.
For example, consider a patient whose daughter is going to get married in four weeks and the most important thing to him is being there for his daughter. A treatment that has a very high risk of immediate death or even one that decreases his statistically expected lifespan may have benefits that outweigh the costs *for* *him* if they significantly increase the chance he will be at his daughter’s wedding.
It is a farce to claim that one can determine whether the risks outweigh the benefits for all patients in the world and get a yes or no answer in a scientific way. That’s as absurd as deciding whether a number is greater than or less than five, with one answer for all numbers.
I am not a Democrat, nor am I a liberal. I am 100% absolutely against Obamacare and medical rationing. What I am, however, is a medical scientist (retired, thank goodness). And I have to tell you, you folks that are so aghast at rescinding approval of Avastin are missing a critical piece of information.
Back in the early 90′s Congress & the FDA rewrote the laws and regulations concerning the testing & marketing of new drugs due to pressure from AIDS activists to bring new drugs to market faster. These new laws allowed much of the testing that used to be required before a new drug could be marketed to be done after the drug was made available to the public, particularly for drugs for “critical” or “emergency” use – things like AIDS drugs, new vaccines for “emergency” diseases, cancer drugs and so on. Virtually any new drug in these categories would never have been allowed to see the light of day pre-1992 or so without significant further testing and scientific input. That includes Avastin.
Because many new drugs are coming to market essentially untested, we’ve since seen a large number of class action law suits and more than a couple of drug recalls. Avastin is only the latest in a string of drugs that never would have seen the light of day before changes in the law.
The price of Avastin is not unusual. Virtually all new drugs have horrendous price tags associated with them. We the People pay for a huge chunk of the research for new drug development in the first place and then our laws allow the drug companies to recoup the entire development cost during the period their drug is patented. Since most other nations do not or cannot pay their fair share, we pick up the entire cost of drug development for the entire world – first through grants to develop the drug and then through outrageous pricing that no one in any other country pays.
This is not “medical rationing” by a very long shot. This is the FDA doing the job that it should be doing right along.
Very interesting, well written post… I work as an oncology RN. Avastin has significant risks with it. No surgeries for several weeks pre or post, HTN, and monitoring kidneys are most common issues for me. I would like to see additional studies as well, and would think some are being done presently by the pharmaceuticals, if not by NIH. I need to read more of the clinical trials proceeding presently and get back to you!
Your post incisively describes massive market distortions caused by government meddling, leading to high prices and health dangers … and concludes by promoting the FDA, the most meddling and distortive government agency of them all. Are you unable to imagine that at least *some* self-interested individuals, in consultation with medical professionals and truly free insurance companies, could make informed decisions about their own economic/health/safety tradeoffs? Do you not see the monstrous immorality in using government force to prevent those individuals from doing so? (And, if no such individuals exist, then obviously noone is qualified to work at the FDA in the first place).
Roger – a P.S. to my previous post that wasn’t placed directly under my response. I do believe in individual choice. All clinical trials are not done under the FDA or NIH…many (most?)are sponsored by the pharmaceutical companies themselves and performed by oncologists and willing patients. – “Yet my main response is regardless of whether clinical trials of Avastin were insufficient in number or quality, I am against gov’t controlled health care. Let the individual and their families decide how much treatment they want; thus have to pay for or purchase insurance policies to cover costs.”
You missed the premise of the article. The point is that no government agency should determine what drug should be granted approval. Isn’t this the responsiblity of the patient and doctor? If an indiviudal wants this drug to prolong their life, why should bureaucrats be involved? If I want to take Avastin to prolong my life 2 years, 2 months or 2 days, I should have that right because it IS MY CHOICE!!!
Not only is this rationing, something like this had to happen when government is involved in health care. Dr. Hsieh is right, medicine will politicized, to the detriment of medical care. We’ll soon be seeing this with Avastin since it is primarily used for breast cancer patients. And breast cancer is an enormous lobby. This shameful situation would not have come about if people would stop to think what “universal health care” is when put into practice. The FDA is not some benevolent agency, they are a hindrance with life and limb.
My husband was diagnosed with stage IV colon cancer and although the WSJ article linked was specifically about breast cancer, the drug did wonders for my husband’s tumors and gave him at least a year of extra life. Hard to believe some people wouldn’t think it was worth the cost… maybe if it was their loved one they would be singing a different tune.
Thank you for this! It not only provides another sad but valuable example of the economic principle: controls breed controls, but it also throws into question the idea that government (here via the FDA) should decide what risks we as individuals should be willing to bear, and at what cost. (I hope to have something to contribute to that discussion in a future editorial.)
Some people argue that you can’t put a pricetag on a life but that simply isn’t true. At some point, those paying for the treatment have to draw the line. Would you (the taxpayer paying the bill) spend a million dollars to save a life? Quite likely. How about $10 million? $100 million? Or maybe a billion dollars to save a single life? The entire federal budget? At some point, you’ll draw the line and say “no more.” At that point, you’ve just put a pricetag on the value of a human life. It’s an economic reality when other people are paying the bills. We as a nation have to face this economic reality or entitlement spending will bankrupt us all.
That’s why it is immoral for the taxpayer to have the bill. The person undergoing treatment and his/her family are the ONLY ONES who should have any deciding power, including the power of choosing what treatments are purchased. There are hordes of charities out there as well who can be applied to for financial assistance, for those who cannot pay, and hordes of wonderful doctors who do pro-bono treatment.
The slippery slope of Obamacare is leading to uninvolved people making those decisions (i.e., “death panels”), government tyranny over medication legalization, and the bankrupting of our country because when medicine is “free,” everyone wants the best for his or her loved ones.
P.S. to my previous post – Yet my main response is regardless of whether clinical trials of Avastin were insufficient in number or quality, I am against gov’t controlled health care. Let the individual and their families decide how much treatment they want; thus have to pay for or purchase insurance policies to cover costs.
The government has no business being involved in medicine at all. Dr. Hsieh is correct that even with the best of intentions, politicization of medical and drug decision is inevitable under Obamacare (and even our current system). The solution is to begin phasing out government involvement in medicine, including medicare, medicaid and the numerous regulations that prevent the freedom to contract freely with doctors, drug companies, and insurance companies.
The free market is a profoundly moral way to make health care decisions. Thank-you Dr. Hsieh.
Arlene, you and I both know better than most that there is a CLEAR and distinct difference between health care and health insurance, which may or may not cover the costs associated with appropriate health care.
FDA approval (or withdrawal of approval as has happened a number of times) is not a matter of individual health care choice, it is a matter of minimal safety standards for public health and one of the foundations that has given us the premier health care system in the world. Under the right circumstances, FDA plays as vital a role in our collective health as does the CDC.
Health care rationing is not going to come to us by rescinding approval for one drug that appears to be pretty iffy and likely should have never been approved in the first place – or even a dozen of them. Newer is not necessarily better.
Health Care rationing is going to come to us through a critical shortage of hospital beds, physicians, scientists and real nursing personnel. Already in many places the nurse that cares for you during your hospital stay may very well wear a name tag that says “nursing staff” rather than RN, to hide the fact this “nurse” is a 6-week CNA. In Massachusetts you might be required by law to buy health insurance, but that does not mean that you can find a doctor taking new patients. In virtually every state it is nearly impossible to find a physician that will accept Medicare or Medicaid. And just try to find an OB if you don’t already have one virtually anywhere in the country . . .
Health Care Rationing is also going to come to us through that “national database” of medical records that your doctor MUST submit your records to – as must your hospital and everyone else. No, you can’t have a new kidney because you have the breast cancer gene. . . . and much, much worse!
That Avastin is being withdrawn is the very least of our worries.
Actually you just highlighted the problem. The FDA’s decisions are based on collective results to the detriment of countless actual individuals. Similar issues have arisen with the diabetes drug Avandia and the birth control patch Ortho Evra. Likewise for Heparin. Guilty until proven innocent are drug-makers and pharma companies.
The FDA is a regulatory agency whose existence is simply unnecessary and detrimental. Drug safety, risks and efficiency are a legitimate concern and can be done by other bodies. Currently, a number of private professional organizations, such as the American Society of Clinical Oncology in cancer and the American Psychiatric Association in mental illness, provide treatment guidelines based on expert evaluation of the available options.
While the examples you mentioned are a good case of rationing, this should not be seen as something irrelevant or trivial. The fact that some individual lives should be sacrificed for the “collective” “health” of the population is troublesome.
Oh no, Mike – that is so far from the truth that it is not funny! The FDA is very, very necessary. The FDA is what stands between you and every quack to dream up some new scam to steal your money and your health. The FDA does NOT provide treatment guidelines. Their sole area of operation is to confirm that the medicines doctors are allowed to prescribe have met standards of saftey and efficacy. The treatment protocols put out by various groups for various diseases are an entirely different matter.
We have three organizations in this country involved in some aspect of public health –
*the FDA, which regulates drugs and food safety, manufacturing standards and efficacy.
*the CDC – involved mostly in patterns of disease outbreaks & accumulation of statistical data regarding various diseases along with dissemination of case studies of general interest to the medical community
*the NIH – these guys do lots of research into various health issues
Decision by the FDA have nothing whatever to do with collective results. They are based on long term scientific studies and data analysis.
Is anyone getting that the one has nothing to do with the other and this is a straw argument?
I am a centrist, articles using fear tactics come from both sides.
Once the word “Obabcare” was used this writer lost credibility.
Isn’t this article “the politicization of health benefits”?
Aren’t you using this opportunity to say hooray for your side, damn those other guys?
The gaping hole in our society is the divide created by the wealthy to distract the great people of this nation.
Wealthy corporate interest started this resistance against health care and you took the bate and found a chance to spout hate.
“Conservative commentators have warned that this could be the beginning of European-style rationing of expensive medical treatments. (Avastin treatments cost $8000 per month.)”
This statement is factually incorrect. The term “European” encompasses a large area, an entire continent in fact. The UK system is true socialized medicine for sure. The Affordable Care act is NOT socialized medicine, even though “conservative commentators” would like us to believe that.
Health care delivery in Germany and France does not include rationing, especially for cancer patients. But here in the states, once you start costing too much rationing is all too common. In other words, we already have death panels, they’re called private insurance companies.
In France, the sicker you are, the more coverage you get. There is NO rationing. For people with one of 30 long-term and expensive illnesses — such as diabetes, mental illness and cancer — the government picks up 100 percent of their health care costs, including surgeries, therapies and drugs. Do we have something comparable to that in the states? Thought so.
France has also made an unusual guarantee that every cancer patient can get any drug, including the most expensive and even experimental ones that are still being tested. Sound like rationing. This kind of access is why the French — unlike Americans — say they are highly satisfied with their health care system. Moreover, the French spend about half as much as we do in the states per person on health care and are far healthier for it. Why is that?
What is most astonishing is that conservatives continue to defend a system that is clearly too expensive and doesn’t work. Why? Sounds like someone might be losing some money with the new changes.
http://www.npr.org/templates/story/story.php?storyId=92419273
so you’re asking us to embrace another unsustainable government run healthcare system as the solution to our problems? And yes they do ration and restrict healthcare just like any other government-run healthcare system.
The article infers that rationing occurs across the board all over Europe. It does not. I pointed that out. If you disagree, then back it up. Just saying that “yes, they do ration” isn’t good enough. What is it they ration in terms of care and medicine? And who does the rationing impact? Certainly not cancer patients in France. They get whatever they want no matter how much it costs. And if you have cancer I bet that is pretty reassuring. Here in the states the private insurance crime syndicate would just let you fade away and die because providing you with the care and medicine you need would impact the shareholders bottom line and their ability to take spa vacations. Europe has many different health care delivery systems under the umbrella of Europe. They are not all the same. Only ignorant teabagging lemmings believe that.
That said, France does have it problems in term of funding the best health care system in the world. But that was not the topic of this article. The article says that European health care is rationed. Some places it is and others I’m not sure you would even call it that, certainly not in France. Bottom line: If I had cancer, I’d rather get care under the French system that the crappy archaic system in the U.S. The private health insurance crime syndicate only cares about one thing: to take in more money in premiums than they pay out in claims. You can sacrifice your body and life on the altar of free market health care delivery. Many of us have decided we want a better approach for us and our families.
The Affordable Care Act will be repealed just like Social Security and Medicare were repealed. But I don’t blame the GOP trying to score a few political points with their useful idiots in trying to make them believe they will do just that. Not!.
One other thing. You mention that the systems I mentioned are “unsustainable.” The French spend half of what we do per person and are healthier for it. Why is that? Got an answer. Hows that for unsustainability! If you are a real conservative you have to at least be curious as to why that is. What are they doing right and what are we doing wrong?
You also seem to imply that only government healthcare is prone to rationing. This is an ignorant statement. Whether it is the government or private entities there are price controls. The question is in the details. What are the price controls and who do they impact. Are they reasonable or unreasonable. Bumper sticker one liners are really not enough to address the complexity of the situation.
Praetorian, I notice you like to say things that are entirely false as if they are true – in your knee jerk support for all the really bad Progressive ideas. Just some alternate opinions about the French health care system from casual searches:
“It’s true we really have good access, but what if the system is not sustainable anymore? It’s going to break. It’s going to blow. And then no more accessibility for anybody.”
“the cost of France’s socialized health care is growing faster than its economy. Workers pay about fifty percent of their paycheck each month into healthcare, retirement and unemployment and more companies are outsourcing jobs to avoid those costs. Quality of care also suffers in France because hospitals and doctors resist government requirements to report their success and failures.”
“Contrary to the media standard portrayal, the system of “free” unlimited care requires high taxes, and with unlimited care, including costly sex-change operations, in vitro fertilization and alternative medicine, it is a dying system that should look to America (pre-Obamacare)for a fix, especially now that the French have protested the rationing of benefits and the government has stopped bailing out over-budget public hospitals.”
“As far as Democrats and advocates of “free” health care are concerned, it’s a good thing that the media ignored a story about the sorry state of the “best” health care system in the world.”
Granny, again I’m impressed with your well-stated, wise response. The medical field misses you. Stay vocal.
I don’t know whether Avastin was tested sufficiently or not. I DO know if it cost $20/month, NOBODY would be giving it a second look. It would be same situation as it was with AIDS: “if you’re dying & you want this drug, you take your chances.”
The FDA and CDC would probably still exist in a free market but they would be private corporations making tons of money (rather than costing taxpayers money) testing drugs for pharma and insurance companies. The media would be informing the public which would become more knowledgeable. People would be free to make choices between doctors and hospitals and insurance companies.
It is not up to the government do decide what is healthy or unhealthy for citizens. Government run medicine means that some people get to decide health care for others and enforce their decisions at the point of a regulatory gun.
To paraphrase you, “privately run medicine means that some people get to decide health care for others and enforce their decisions at the point of a regulatory gun.”
And we know this for a fact because it is happening right now.
Speaking from experience here, this drug is already in the middle of an FDA/Medicare fiasco, and has been for years. Even though it is made primarily for colon cancers, it is an extremely inexpensive way to treat macular degeneration due to the way it interacts with vascular tissue (and only costs $250 per injection due to the dosing). However, the company that makes it also make’s something they market specifically for macular degeneration called Lucentis which costs $2000 per injection, and apparently doesn’t even work as well! And guess which one Medicare approves? (which of course causes private health insurers to follow suit with….)
The problem here Eric, is with the way drug approval is now done. First, the FDA is not and never has been in this business of picking one drug over another. Their entire focus is supposed to be “safe & effective.” Thus, if a drug proves through scientific study to not actually do what it is supposed to or to carry significant risk of unintended consequences or to actually be harmful in some way rather than beneficial, it is the business of the FDA to say “You can’t sell that here” – even if a drug has been on the market for a number of years. Scientific studies take time. Evidence can take years to accumulate.
It used to be that much of the study involved in testing a new drug for FDA approval had to be done before the drug was approved by the FDA. Now, because of the demand for drugs to treat AIDS, drugs under development for “critical” things like AIDS and cancer are fast tracked – put out for general consumption after only limited testing. In the past, those new drugs were still available in a more limited way as part of ongoing medical studies. The participants knew from the get go that they were participating in a study for a drug that might or might not work (and that they might or might not get – some people always get a placebo.) Under these new rules, those studies are done AFTER the drug goes to market. Essentially, if you take a new drug these days you are a human guinea pig.
Because of the way the pharmaceutical regulations are now written, it is not the least uncommon for a company to come up with something new (and thus still under the fast-track regs) and much more expensive to replace something that is either proving to be a drug that is going to be pulled by the FDA or one that is approaching the end of the gravy train. Drug companies achieve huge, HUGE profits the first few years a drug is on the market because no generics are allowed. As that time comes to an end the drug is no longer profitable, so something new is developed.
The problem is that the Government employees benefit from people dying at ever earlier ages. They can shorten pensions and seize estates when the owners die, this gives them every reason to oppose progress in medicine. They want death panels for the wealth and power they bring.
After all we have the cure for cancer. In April 2003 people doing product testing found a cancer proof mouse. Technicians have spliced and diced the genetics of that family of mice. The have identified the gene and what it does which is to kick the immune system in to high gear. They have put the gene into test animals at that works. They created immune system ‘T’ cells for a man with last stage skin cancer in 2008 and he was completely cured. At the beginning of 2010 large vats of yeast with the gene were being produced. The last hurdle is a cure with no danger of autoimmune disease. If cancer were a disease of homosexuals it would be in the final human trials stage right now. The FDA will delay the human trials at least five years and probably ten years.
Some Canadian researchers trying to treat MS and working with used mice produced a cure for diabetes, “Cell” magazine Dec. 2008.