BURNET, Texas (April 13) – Stopping all war is not just something we need to do in the Middle East. It is something we need just as badly here at home. When I say “stop all war,” I’m not just talking about the bombing and fighting overseas; I’m talking about the wars that the U.S. government wages against its very own citizens. I am talking about how bureaucrats kill Americans, not with guns and bombs, but with laws and regulations.
Perhaps the best example of this is the war against the terminally ill. Did you know that if you are dying and want to take a promising new drug that could save your life you can’t legally do it unless the Food and Drug Administration says you can? A coalition of cancer patients recently sued the FDA for permission to buy promising new drugs that had been tested for safety in people, but had not yet undergone the lengthy and rigorous effectiveness studies. The Supreme Court refused to hear the case, so the lower court ruling of 2007 still stands. The ruling says that you have no constitutional right to buy a drug – even one that might save your life – without FDA approval.
This suit was spearheaded by the Abigail Alliance [http://www.abigail-alliance.org], founded by Frank Burroughs, Abigail’s father. Abigail and her family tried to get FDA permission to try the drug Erbitux, which was in human trials for her type of cancer and was eventually shown to be a breakthrough treatment for it. Time and time again federal bureaucrats refused to help her.
The FDA finally relented a couple weeks before Abigail died at the age of 21. Mr. Burroughs decided that no other person should ever have to endure the heartbreak of losing a loved one while a life-saving treatment might have been given. He formed the Abigail Alliance shortly after his daughter’s death to stop this war on dying patients. The Alliance has fought a largely losing battle for better access to 17 new drugs, all of which were eventually approved by the FDA and saved many lives thereafter. Unfortunately, terminally ill people who might have been saved could not – and still cannot – buy promising new drugs until they go through an FDA-mandated 12 to 15 year development process.
When AIDS patients started being diagnosed in the 1980s, it was a death sentence. These desperate people didn’t have 12 to 15 years to wait for the drug companies to jump through the FDA’s regulatory hoops. They hired underground chemists and distributed the promising new drugs throughout the AIDS community themselves. By the time the FDA gave drug companies permission to test their anti-AIDS drugs in people, every AIDS patient in the U.S. who wanted them had already gotten them.
This is what the war on the terminally ill does – it drives dying people into the underground if they want a chance at life. What a cruel and senseless war against our own people! Instead of actually helping the people that need them the most, the FDA makes criminals of these dying people who are only trying to save their own lives.
What happens to desperate people when the FDA withholds a potential cure? They die! What happens to the bureaucrats who withhold a potential cure? Nothing! FDA employees, like most government bureaucrats, have sovereign immunity as they decide whether you and your loved ones get a chance to fight for your lives. If a thug held a physician back from treating an accident victim, that thug could be charged with murder. If an FDA bureaucrat holds a drug company back from selling you a potentially life-saving drug, it’s just business as usual.
Right now, metastatic melanoma patients, who usually have less than a year to live after diagnosis, are fighting for access to Plexxikon’s new drug, PLX4032. PLX4032 targets a genetic Achilles’ heel that occurs in about half of the melanomas. In June of 2009, Plexxikon announced that PLX4032 shrunk tumors in 13 of 16 patients with this type of melanoma, whereas those without this mutation showed no response.
The standard treatment for melanoma, dacarbazine, does very little for melanoma patients. Consequently, when the updated results with PLX4032 in 32 patients were published August 26, 2010 in the prestigious New England Journal of Medicine, the accompanying editorial called PLX4032 “the poster child” of personalized medicine and a “major breakthrough” in melanoma treatment. What is so unusual about these results is that they happened in early safety testing where small benefits are rarely observable. However, because PLX4032 is so effective in melanomas with the genetic “Achilles’ heel,” its impact was obvious. Melanoma is no longer a death sentence! It wouldn’t be, that is, except for the Food and Drug Administration.
Unfortunately, the FDA is requiring the manufacturer to go through the same testing that less potent drugs must do to demonstrate their effectiveness. This testing is projected to take until spring of 2014. By the time the manufacturer writes up the data for the FDA and the FDA reviews it, another year or two is likely to pass. In the meantime, over 8,000 people each year will die from melanoma, about half of which could have their lives extended by PLX4032. Will you or your loved ones become a cancer statistic because the FDA demands that manufacturers jump through its regulatory hoops no matter how many people die as a result?
Even the doctors involved in the new studies are beginning to question the ethics of treating half of the dying subjects with dacarbazine instead of PLX4032 simply to let the FDA check off its regulatory boxes. I wonder how many of them can sleep at night knowing that they are sentencing half of their patients to almost certain death instead of giving them the best chance of survival.
In a Wrights’ administration, no bureaucrat could withhold potentially life-saving treatment from a dying person. The war on the terminally ill will end. Please join me in ending all war, including the war at home against the terminally ill. The life you save may be your own.