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Rationing at the Food and Drug Administration

By: RedState Insider (Diary)  |  August 3rd, 2010 at 07:00 AM  | 

RESIZE: AAA

During the year long ObamaCare debate, there was a spirited debate of the proposition that ObamaCare would cause rationing by the federal government of services and drugs.  Government rationed health care services and drugs have evolved from rhetoric to reality. 

On July 28th, Senator David Vitter (R-Louisiana) raised drug rationing concerns, because of a Food and Drug Administration (FDA) pending decision to take the cancer drug Avastin off the list of approved drugs for breast cancer.   This example of rationing by the FDA of a drug to aid those with cancer is exactly what we should expect under an ObamaCare drug rationing regime.  

According to Ben Evans, an AP reporter, in a ”news article” that is supposed to be an unbiased news source:

Reviving allegations of government death panels, Sen. David Vitter of Louisiana said Wednesday that an FDA advisory panel’s negative recommendation on a contested breast cancer drug amounts to rationing health care.  “I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a press release about the drug Avastin. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.”

Conservatives are seeing a trend by the left to play the “Death Panel” card as a means to disparage reasonable argument about rationing.  The idea that ObamaCare may lead to rationing is close to reality and the Avastin example shows how ObamaCare cost-benefit analysis will hurt the sick.  Senator Vitter never said the words “Death Panel,” yet the AP chose to, in essence, put those words in the mouth of Vitter to make the article more interesting and inflammatory.  The Senator made an excellent point and many will use this example to push for repeal ObamaCare.

Senator Vitter wrote in a letter to Dr. Richard Pazdur, head of the FDA’s Office of Oncology Drug Product, that “based on a review of the FDA Advisory Committee’s report on Avastin no new safety concerns were raised with the drug.  Rather the Committee’s concerns appear to have been based on cost effectiveness.”  The FDA has a criteria to only approve “clinically meaningful” drugs.  Senator Vitter’s concern is that cost is a factor in this ambiguous and vague standard.  Adopting a de facto government run healthcare system will empower federal bureaucrats to make these types of arbitrary decisions on a mass basis for all Americans.  Rationing is a fatal flaw with the intellectual underpinning of ObamaCare.

Vitter further argued:

The decision on whether a patient should use a possible life-extending drug is a decision that should be made solely between a doctor and patient, not a government panel.  I find it outrageous that a government panel would put a price on those precious months for the families that are living through the trauma of a losing a mother, wife, sister, daughter, or aunt.  Taking Avastin off-label for breast cancer treatment is essentially government rationing.

This is a reasonable argument, yet Vitter was hit by the AP for arguing that the Avastin example is evidence of “Death Panels.”  Call it what you will, but either way people will be harmed by government bureaucrats making rationing decisions as individuals or on panels. 

The FDA’s purpose is to protect people from food and drugs that are inherently unsafe or not effective.  The idea that cost can be a factor in an FDA decision is outside of the FDA mission.  Using cost as a means to ration care and drugs is the exact fear that many conservatives raised concerning the means that the government will use to cut corners and save money under ObamaCare.  Avastin should be listed and approved if it lengthens the lives of cancer patients regardless of the drug’s cost.

Rationing is happening in Europe.  Access to life extending drugs under the government run system in the United Kingdom is difficult.  Reports that thousands of cancer patients face an early death because the National for Health and Clinical Excellence (NICE) rejected or only partially endorsed 15 new drugs has caused an uproar in the UK.  Conservatives don’t want to see that flawed system imposed in the United States. 

According to the Daily Mail:

The watchdog totally blocked a quarter of the cancer drugs made available since 2008 and heavily restricted others – despite Government promises to make more treatments available. Medicines rejected include bowel cancer drug Avastin and Nexavar- the only treatment offering any chance of survival for patients with advanced liver cancer.

David Cameron promised to reverse this rationing decisions because of the controversy.  People suffering from cancer in the United States are similarly angered by the pending decision of the FDA about the same drug.  Americans need to study the UK example so we don’t copy a flawed system that bars many lifesaving treatments and drugs for those who are ill because of cost.  At least the Brits reversed a bad decision.  Too bad the FDA has not indicated that they are having second thoughts about the drug.  The Avastin example is of deep concern to those who want cancer patients to get what they need regardless of the cost. 

According to Big Government:

In September, the Food and Drug Administration will try to take the anti-cancer drug Avastin “off-label.”  Avastin is a Stage 4 drug used to battle breast cancer.  Avastin is not a cure but has been shown to stop the growth of cancer for an average of five months — meaning some late stage breast cancer victims live beyond five months.  But late stage breast cancer patients do not fit into the cost-benefit analysis of the Obama Administration.  We told America rationing would happen if the healthcaretakeover bill passed and in September, women with breast cancer will be its first victims.

The FDA concedes that this drug will extend the lives of many who are afflicted with cancer, yet many are concerned that price may the deciding factor in the FDA’s pending decision to de-list the drug.  If it is de-listed, then Medicare and private insurance companies will not cover the cost of these drugs.  The worry is that this evidence of rationing with regard to those in the most need of these costly drugs.

Americans should be having a dispassionate debate on whether ObamaCare will lead to the mass rationing of care and drugs.  The left loves to raise the term “Death Panels” because it distracts from the real issues with ObamaCare.  Senator Vitter raised an important issue and the Avastin example is evidence of our future under the ObamaCare regime.  A future of arbitrary decisions by federal bureaucrats and health care decisions based on cost.

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  • dt

    Senator Vitter’s letter is grossly inaccurate, and as a result, your article is, unfortunately, misleading. You can read more on the advisory panel’s decision here.

    The advisory panel did not recommend that Avastin be pulled off the market completely. It will still be available on label for patients with other cancers than advanced metastatic breast cancer (e.g. colon). The panel, which voted 12-1 incidentally, based its decision on the drug’s lack of effectiveness compared with other chemotherapeutic agents. The initial data that supported the accelerated approval ended up not being born-out by large-scale studies that showed no statistically significant reduction in mortality. That fact combined with increased side effects for some patients was what caused the panel to recommend yanking the accelerated approval.

    Finally, cost effectiveness is not part of what the FDA evaluates in its approval of drugs. Even if the FDA did use cost effectiveness, which, again, it does not, because Avastin will still be on the market for other cancers, that rationale would not make sense here, because any oncologist that believes that his or her patient would benefit from Avastin can still prescribe it off label.

    • dt

      bad link, sorry: here is the URL in plain text:
      http://www.cancer.org/Cancer/news/News/fda-advisory-panel-votes-against-avastin-for-advanced-breast-cancer

    • taxpayer1234

      the excuse to deny payment for the drug being used off-label. And as expensive as Avastin is, that’s in essence a de-listing based on price.

      If Avastin’s effectiveness is questionable, which drug(s) is doing a better job and should be used instead of Avastin? Please be specific.

      • dt

        I don’t know about Medicare, but private insurers do not need this excuse to deny paying for Avastin for metastatic breast cancer right now. An aggressive insurance company would argue that any drug that has received accelerated approval is still an “experimental” therapy and therefore not covered under its policy. Keep in mind that what treatments are effective and what insurance companies will pay for doesn?t always overlap. Insurance companies only need pay for what is in their contract to cover.

        And it’s very different to argue that an FDA decision rescinding pre-approval has the effect of denying the drug to some people than it is to argue that the FDA used the drug’s cost effectiveness as a basis for its decision. The latter would be an indication of rationing based on price; the former would not.

        The answer to your second question will be highly dependent on the type of breast cancer involved and is best answered on an individual basis by a practitioner after he/she evaluates his/her patient. The way FDA clinical trials evaluate effectiveness is often as follows: The investigators get two populations of people. The first population receives a standard chemotherapeutic agent currently approved for treating the disease in question. The second group gets that same chemotherapeutic agent in addition to the investigational drug. The investigational drug is often considered effective if the second group has a statistically significant improvement in survival (a decrease in mortality). In this case, according to the report in the URL I posted above, these studies did not show any statistically significant decrease in mortality for that second group (i.e. the group that was given Avastin). In addition, this second group experienced an increased level of side effects. Hence, assuming the report is accurate, these studies provide evidence for the conclusion that Avastin is no better than standard chemotherapeutic agents at treating metastatic breast cancer, and, in fact, might be worse due to the increased side effects.

        Keep in mind that Avastin was given accelerated approval, in this case, because initial data appeared to indicate that it halted tumor development in such a way that the committee reasonably believed that it might have a statistically significant impact on mortality rates in the larger study. When that belief was not born out by data, the committee revoked its earlier accelerated approval.

      • mziemann

        In reply to Taxpayer1234:

        By almost any criteria Avastin is an expensive bust that really doesn’t work very well for much of anything. (At least in my opinion, having looked at the research) It is, however, highly profitable for the drug companies Genetech/Roche and for the oncologists who administer it.

        Having said that, I will defend your right to petition your disease insurance provider for it and if they decline, your right to seek it elsewhere – even if you have to buy it yourself – if you believe that it will benefit you.

        I also respect the right of the insurer, private or public, to limit it’s costs so long as it meets it’s established obligations – even if that means saying ‘no’ to something that they feel does not provide an appropriate cost/benefit ratio. They are, after all, in the business of making money not health and we should never allow ourselves to be deceived otherwise.

        You asked: “If Avastin?s effectiveness is questionable, which drug(s) is doing a better job and should be used instead of Avastin? Please be specific.”

        My answer: A “better job” for what? There are many varieties of cancers – which are you interested in? Please be specific. There is no one ‘magic bullet’ that will cure cancer, no matter what the pharmaceutical companies would have us believe. What should be used instead of Avastin? The flippant answer is ‘almost anything’.

        The more reasoned and respectful answer to the question of what might be an alternative to Avastin, and indeed to many of our so-called chemo-therapies might be found here: http://www.drmyattswellnessclub.com/DietaryKetosisSolidTissueMalignancy.htm

        Unfortunately, since this strategy does not involve expensive drugs you are unlikely to ever hear of it from your conventional oncologist.

        Here is a very detailed paper with yet more possibilities for the treatment of solid tissue cancers: http://www.drmyattswellnessclub.com/cancer2006update.htm

        Both these papers are fully scientifically referenced – for those who wish to dig deeper into this subject.

        With a very few exceptions, the conventional modalities of “Cut, Burn, and Poison” are a cruel waste of both money and quality of life. A drug like Avastin “promises” to extend life for those with colorectal cancer by 4.7 months (20.3 months vs. 15.6 months) but at a cost of $42,800 to $55,000 and who-knows-what additional suffering with side effects. Are we living longer with treatment, or does it just feel that way?

        I hope this gives you some food for thought.

        Good luck.

        • taxpayer1234

          Yes, I know more than I’d like to about the various cancer drugs and their frustratingly inconsistent results–having watched cancer take the lives of my father, his 3 brothers, my stepmom, my aunt, my grandmother, and my cousin. On the bright side, I have a cousin, nephew, and grandfather who all survived cancer.

          When my dad was diagnosed with esophageal cancer, his docs told him that without treatment, he would die in 6 months; but with treatment, he could live longer than that, and have some good quality time. So he opted for treatment and lived another 3 years. They were good, quality years, too–he got to enjoy being the retired granddad of 15, travel, and host parties.

          The journey he chose wasn’t easy, but without the available treatments–as nasty as they are–he’d have had no choice at all. Yes, we checked out all the alternatives, but none were shown to have any effect whatsoever on esophageal cancer. He never regretted his choice, and I treasure every second of extra time I got with him.

          My husband is a pharmaceutical chemist who is currently working on cancer treatments. He and his colleagues do not sit around and plot to keep the world from learning about treatments that don’t come from big bad pharma. They’re too busy trying to solve humanity’s biggest puzzle.

          I’ll continue to cheer on all efforts to treat cancer, even those that produce frustratingly inconsistent results. And I’ll continue to insist that all of us have the right to make whatever choices we wish when it comes to our own medical care.

          • tara2009

            thats the reason so many were aganist it. I hope and pray that this monster bill gers nullified.mehpensacola,fl

          • dt

            I heartily agree with your point about the right to make whatever choices we wish when it comes to health care (not that the State should necessarily pay for it but that we should have the option). The FDA’s policy with respect to “expanded access”, though slightly improved in 2009 is still very paternalistic and onerous for seriously ill patients. If you’d like to read more about what, in my view, is a truly critical fight in this area, see here:
            http://en.wikipedia.org/wiki/Abigail_Alliance_v._von_Eschenbach

          • taxpayer1234

            was originally created to address the need for new AIDS treatments, but is also used to get drugs to those who have cancer and other life-threatening illnesses.

            The Abigail Alliance is a group with its heart in the right place. But insisting that experimental drug access is a constitutional right is a flawed argument. If it had prevailed in court, that would have laid the foundation to eliminate not just the FDA’s regulatory authority but the property rights of those who develop and own the drugs. That would have a chilling effect on all kinds of drug development efforts in this country. We don’t need any more of that, as Obamacare is already freezing the domestic drug development industry.

          • dt

            I disagree with your legal analysis. The right articulated by the alliance in its briefing makes explicit that it does not seek free access to drugs or a right to force companies to supply critically ill patients with drugs. Instead, the way the group articulated its right as follows: in a situation where a company was willing to sell its drug and where a terminally ill patient, in consultation with her/her physician, wished to try it, the FDA could not interfere with that relationship through its expanded access program. The group even conceded that the government had a substantial interest in preventing potentially unsafe drugs from reaching the public as described above and was willing to curtail the right until drugs reached stage 2.

            Interestingly, the objection of some of the doctors’ organizations, namely the oncology society, that filed amicus briefs against the Alliance, was that such a right would interfere with the supply of people willing to partake in stage 1 trials. These trials are potentially even more dangerous than drugs that are in stage 2 because stage 1 is the first time that the drugs safety has been tried in larger scale human trials. This justification is particularly paternalistic because it forces the ill patient to subvert his/her welfare in favor of the remainder of people in society who might end up benefiting from these drugs 5-10 years down the road. I even had a doctor tell me that terminally ill patients need to sacrifice themselves so that progress can be made against the disease later on. To me, a horrifying sentiment.

          • taxpayer1234

            to ignore the FDA, who would monitor what the end-runners are doing–the FDA? And would the FDA view the clinical outcomes for or against the drug company if the drug makes it to an NDA?

            Also, the drug company would be exposing itself to litigation for NOT making it available to all who want it. When some patients get the drug and others don’t, you can bet there will be litigation. And it won’t be the FDA the lawyers will be coming after.

            Most terminally ill patients will jump at ANY chance to get well, so they don’t give a darn what stage trial it is. And even with a large population of ill patients, getting a sufficient group that meets the narrow trial criteria is extremely difficult. Without a sufficient Stage 1 trial, there will be no Stage 2, Stage 3, NDA, drug on market.

          • dt

            I think it’s apparent that we won’t convince each other of the soundness of our respective positions. I’m happy enough to leave it there. But to respond to the points you raise, the way the right was articulated in briefing by the alliance, the only drugs that would be available were those that had filed a NDA and passed stage 1. As to how the FDA would evalute the clinical outcomes, that’would not be a new issue. Insofar as anyone gets a pre-approval drug under and expanded access program, the FDA confronts that same issue today.

            On your second, point about drug firms exposing themselves to litigation, I think that there is no greater likelihood than exists today under the FDA’s expanded access program. Again, the right as articulated is about freedom from government interference.

            I’m not sure what point you’re trying to make in your third paragraph, but if you are suggesting that the right articulated by the alliance might somehow upend our clinical trials process, the alliance specifically accepted that preservation of that process was a substantial government interest. The only people that would qualify under the alliance’s articulation fo the right is those people that were ineligible for any other clinical trial.

          • taxpayer1234

            until a drug passes Stage 3. Someone got their briefs wrinkled.

            So, this “right” would provide patients “freedom from government interference,” but the FDA would still be regulating the use of the drug by the selfsame patients. Interesting.

          • dt

            On your first, point, I meant INDA, apologies for the error, though I suspect you knew what I meant, and it doesn’t really change the argument I was making. On your second point, essentially the answer is yes. The right as articulated by the alliance in its briefing does not attempt to end the clinical trial process or curtail the FDA’s role in the review of drugs. All it seeks to do is to challenge the onerous and burdensome process that is the FDA’s expanded access program. To participate in the expanded access program, as it currently exists, doctors must fill out significant paperwork and the FDA gets to make the decision about whether to allow the patient expanded access to the investigational drug in question. The right articulated by the alliance challenged that process and the FDA?s role in it for terminally ill patients who were ineligible for other clinical trials. It really is a very limited right.

          • taxpayer1234

            especially when challenged by herds of lawyers. I don’t begrudge terminally ill patients their shot at a cure. But if the drugmakers’ property rights and the FDA’s regulatory role are eroded because of an expansion of this “right,” then we’ve hurt the many by trying to help the few.

          • dt

            I would also encourage you to read the briefing filed by the alliance in the D.C. Circuit en banc case. It goes into far more detail than I can do here and presents the arguments made by the alliance much more precisely than is possible in this forum.

  • wayneepalmer

    These Obamians do not operate in a vacuum. If you want to know what this is all about, start with Daschle’s book. Then Read Thomas Malthus and Paul Ehrlich.

    Eugenics, population control, Utopianist ideals – all of the same garbage that we went thru that lead to the rise Roosevelts “benevolent Socialism” and of Hitler and Stalin and the horrors that followed.

    Here we go again.

  • ihateliberals

    that conservatives have to take over both the House and the Senate and repeal ObamaCare as a first priority. Everything else Obama has done does not match the devastation that will be caused by ObamaCare.