Last week, the Food and Drug Administration (FDA) revoked its regulatory approval of the drug Avastin to treat late stage, metastatic breast cancer. Each year, the practicing oncologists chosen by 17,500 American women to save them from their life-threatening, heavily progressed cancer prescribe Avastin to treat them.
The FDA explained that it was revoking approval of the drug for that use because it decided that the drug does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Risk? The drug is prescribed for women who are otherwise going to die from cancer unless the drug saves them at least for a time. The far greater risk to these women is from the FDA, not the drug.
As The Wall Street Journal said last Friday in response to the FDA's explanation:
Ponder that [word] "sufficient." The agency is substituting its own judgment about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.
That FDA judgment was determined last summer by an internal agency panel of 13 experts, only two of whom were breast cancer oncologists, and none of whom were breast cancer patients.
Death Sentence for Mrs. Turnage?
Contrast the FDA's elitist, authoritarian, Ruling Class explanation for its bureaucratic dictat with the real world experience of Mrs. Turnage, whose story was told in a New York Post commentary on December 15 entitled "Don't Kill the Drug That Saved My Mom," by her son Josh Turnage. Josh explained:
In June 2006, my mom was diagnosed with Stage II breast cancer. She underwent a double mastectomy, reconstruction and six months of chemo…. Then just 44, she had "triple negative breast cancer," a rare and particularly lethal form of the disease.
As Josh observed, traditional therapies typically do not work against the disease that threatened to kill his mother at that early age. As a result,
A year after the initial diagnosis, the doctor told our family that the cancer had gone metastatic, or Stage IV, and had spread to her right lung. Such news is typically a death sentence.
But her doctor urged her to try a new experimental drug called Avastin, just approved by the FDA for breast cancer. Josh explained the results:
We got a miracle. After four months of Avastin treatment in combination with chemo, the cancer effectively vanished -- the doctors literally couldn't find any trace of the disease in her body.
In January, 2009, Mrs. Turnage's chosen doctors decided she could terminate her chemotherapy treatments and just continue with exclusive use of Avastin. Today, nearly two years later, she's still cancer-free.
Mrs. Turnage is a "super responder" to Avastin, one of a minority of patients receiving the treatment for whom the drug is powerfully effective. Tumors shrink for about half of patients receiving Avastin. On average, patients taking the drug with chemotherapy experience twice as many days or months with no progression of their tumors as those not taking the drug. That means they live longer, on average a few months longer, with their families and friends. Whether that and the chance for much greater success as for Mrs. Turnage is worth it is for patients to decide, with the advice of their doctors, not government bureaucrats.
As Josh rightly says, "We're talking about Stage IV cancer; the FDA should let patients and doctors decide if a medicine's benefits are worth the risks." That has been the tradition of freedom in America.
Josh explains the message from the FDA's decision to his mother, and to the American people:
By denying approval for this drug, the FDA is basically telling my mother and my family that her life just isn't worth the price. They're robbing her of a chance to celebrate her 30th wedding anniversary with my dad, or to see my little sister who is in kindergarten graduate from high school…. Avastin has given my mom priceless time -- time to spend with me, my siblings, my father and all her other family and friends. No woman should ever be denied that opportunity by our government."
The Susan G. Komen Foundation opposed the FDA's action. So did the Ovarian Cancer National Alliance, a cancer patients' advocacy organization. The U.S. National Comprehensive Cancer Network, an alliance of 21 top cancer centers that issues medical guidelines based clinical evidence, also supports the continued availability of Avastin for breast cancer. Even in Europe, where health care rationing is prevalent, the European Medicines Agency, which is the FDA for the European Union, ruled last week that Avastin would continue to be available for breast cancer treatment there.
To no avail. In America, the FDA has spoken. Those super responders to Avastin like Mrs. Turnage, if not Mrs. Turnage herself, must die, the sooner the better.
As Sally Pipes wrote at Forbes.com last week, "Government drug rationing isn't going to stop at Avastin." The FDA decision is a straw in the wind, indicating an ominous turn in American medicine, if doctors, patients, and the American people do not fight back. What is needed is not a stop gap solution applying only to Avastin. The FDA must be fundamentally reformed, as specified below.
Avastin works by cutting off the blood supply to tumors, causing them to wither and die. It is still in use for the treatment of kidney, colon, lung, and brain cancers. Because of that, doctors can still legally prescribe Avastin even for breast cancer "off label," which means for a use not approved by the FDA. But the treatment costs $88,000 a year. The FDA didn't say so, but that cost is the real reason for its action.
The FDA's decision means that Medicare and Medicaid will likely refuse to pay for the drug for breast cancer. These government programs do not pay for costly medicines where not FDA approved. This in turn provides the legal foundation for private insurance companies to now refuse payment for the treatment as well. They are not legally obligated to pay for costly therapies denied FDA approval and rejected by Medicare and Medicaid. Otherwise, they could be forced to pay for dances by Indian Medicine Men to cure cancer.
Ignorant liberals running your mouths about insurance company rationing, take note of how this works. No insurance company has the power to weigh costs against benefits, and tell you that your health if not your life is not worth the money. But the government has now arrogated to itself the power to do precisely that. That is the meaning of the Avastin decision.
When a third party, not the patient with his doctor's advice, weighs your health and life in the balance like this, I call it Fascism. It is a perfect analogue to Nazi practices, and we are not going to accept that in America. The American people need to go to war now against the FDA.
But the FDA decision is just one symptom of that more ominous, fundamental turn in American medicine mentioned above. The decision reflects a new fashion rising among America's Ruling Class, the imperious "judgment" that the latest, most advanced medical care for America's most seriously ill is too costly and not worth it.
The great virtue of American medicine is that it provides to the broad public, rather than just to the rich as in some enclaves around the world, the latest, most technologically and scientifically advanced health care on the planet for the most sick. Those suffering from cancer and heart disease, seniors suffering from the infirmities of advancing age, premature babies born smaller than your hand, are consequently rescued from premature death and incapacitating suffering far more than anywhere else on earth.
It should be no surprise that most health care spending is actually spent on the sick. That is what health care is for. But that is a big revelation to bloodthirsty progressives in the Ruling Class. In their emerging view, so much could be saved if we would just cut off the costly health care for the sickest and most vulnerable, and they would just fulfill their social responsibility by dying a cheap natural death that would not so burden the glorious Welfare State.
But what else could we better spend our money on but our health and our very lives and those of our loved ones? The progressives in the Ruling Class have their own dark answer to that question.
The rising anti-health care fashion is fueled by the realization of those in the know with access to the levers of power that they can buy far more votes spending all that money elsewhere than on health care for the sickest and most vulnerable. Those suffering from cancer and heart disease are too weak and sick to be relentless, effective political advocates. They may well be dead before they can even vote in the next election. Far more votes can be bought spending that money on younger, healthy voters who will be around a long time to work on, contribute to, and support campaigns and the progressives' Ruling Class political machine. Maybe spend it on more welfare for young families, or on more corporate subsidies for the endless "Green Energy" funding drain.
I call it the political logic of socialized medicine. This is why we see rationing in every other country where the government and politics have taken over the health care system. Of course, there are many "useful idiots" just caught up in the latest fashion swirl who have no clue as to the deeper political logic. But it is that political logic that is driving the suicide train that will deprive America of the central health care component of its high standard of living, unless we derail it.
Do Not Ask for Whom the Bell Tolls
The rising, anti-health care fashion of the Progressives and the Ruling Class is at the heart of Obamacare, which otherwise seems so perverse in relentlessly attacking the ability of the health care system to serve the sickest and most vulnerable. That is reflected most obviously in the legislation's insufficiently heralded, draconian cuts to Medicare.
When I compared the year by year data from the 2010 Annual Medicare Report with the 2009 Annual Medicare Report, even I was shocked by the draconian effect of Obamacare policies. For the first 20 years of full implementation of Obamacare, 2014 to 2033, Medicare is cut by $5 trillion! This involves mostly cuts in the payments to doctors and hospitals providing health care to seniors under Medicare. The Administration has already claimed political credit for the positive financial effects of these cuts. But if these Obamacare policies are not reversed, no doubt seniors will no longer be getting the health care under Medicare that has been so effective in extending their lives and functional capabilities. Even before these cuts, two thirds of hospitals were already losing money on Medicare patients,
The Wall Street Journal indicated in last week's Avastin editorial what is coming,
In September, the FDA and Medicare proposed a "parallel review" process that will allow the two agencies to coordinate market and reimbursement approval. Medicare is also increasingly opening "national coverage determination" reviews that allow a government board to decide if a therapy is "reasonable and necessary."
In other words, still more death panels for seniors.
Conservatives have been far too reluctant to criticize the unworkable Medicare cuts because they know that fundamental reform of Medicare is necessary to sharply reduce the program's dramatic runaway costs. But denying payment to doctors and hospitals for the health care they provide to seniors is no way to reform Medicare. That would not only suddenly leave seniors without the health care they have been promised, and have come to rely on as a result. It would suddenly leave doctors, clinics, specialists, and hospitals with uneconomic practices for seniors that they entered in good faith on the promise of payment from the government. This is like trying to balance the family budget by deciding not to pay the bills, for services the family expects to continue to consume. Or trying to achieve budget savings in national defense by not paying the manufacturers of the Air Force's planes, the Navy's ships, the Army's tanks and artillery, and the bullets, bombs and guns.
Far more responsible and carefully crafted are the Medicare reforms of newly minted House Budget Committee Chairman Paul Ryan in his Ryan Roadmap, which conservatives should be supporting and advocating even more ardently. Those reforms would turn all of Medicare into Medicare Advantage, granting seniors vouchers they could use to purchase the private health insurance of their choice. As the above discussion shows, those private insurers would not have the power to ration and deny health care for seniors on the grounds that their health and their lives are not worth the money, which is what is now developing in Medicare.
The growth in payments for these health insurance vouchers is slowed so that seniors may have to pay some more for their coverage over time than under the current bankrupt Medicare system. But funds are provided to protect lower income seniors from these added costs. CBO scores these reforms as achieving full solvency for Medicare, without rationing and denying health care for seniors. This is a big winner politically as well as economically as compared to the Obamacare fiasco. This is what more conservatives need to realize.
Further, fundamental, FDA reform is also now essential, to protect all Americans from the Ruling Class bureaucrats. The FDA's legal mandate must be changed so that it determines only whether a drug is safe in considering approval, not whether it is effective as well, as required by current law. Whether it is effective can and should be determined by the patient's chosen doctors, not government bureaucrats. This should become a major cause among conservatives, to blow back the Ruling Class.
Finally, I can't tell for sure from Josh Turnage's article whether his mother is still receiving Avastin treatments to keep her cancer from returning. But if it does return, and she is denied the treatment, and she dies from the disease, then I would expect the Attorney General of her state to open an inquest into her death.
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