Thread by markomalley.
December 16, 2010 will forever be the day that changed my life. I had just received a news flash across my monitor that the FDA had confirmed its advisory panel’s decision to ”de-label” the drug Avastin for breast cancer patients. The practical implication of this was that my wife Arlene was now at mortal risk.
My wife has stage IV or metastatic breast cancer. This is an incurable disease that claims the life of a woman every 14 minutes. A reported 17,500 women take Avastin for metastatic breast cancer and my wife is one of them. As Avastin is a unique drug that works by cutting off blood flow to tumors, we believe that the drug is saving my wife’s life and taking Avastin away is tantamount to a death sentence.
I picked up the phone to call my wife and tell her the news. When she answered, I was too choked-up to speak. The next five minutes were some of the worst moments of my life as I told my wife that bureaucrats in Washington were deciding to take away a drug that was keeping her alive.
I read a mountain of reports about the FDA’s Avastin decision and it become clear that it was corrupted with procedural problems (the Wall St. Journal referred to it as “rigged”), rendered almost meaningless by poor science and tainted by the bad faith of the FDA, which had moved the goalposts for approval of Avastin, almost after the game had been played.
The drug’s manufacturer, Genentech, said that it would file an appeal and the FDA granted a hearing for June 28 and 29 in Silver Spring, Maryland.
(Excerpt) Read more at foxnews.com ...
Thread by me.
Annie Farlow was just short of three months old when she died in an Ontario hospital of what her parents believe might have been a treatable respiratory condition.
Born with the chromosome disorder Trisomy 13, Annie had little chance of surviving to her teens, but her parents, Barbara and Tim Farlow, had taken comfort in the hospital’s assurance that their daughter’s genetic disorder, also known as Patau syndrome, wouldn’t preclude her from receiving the same level of care as any other child suffering from a medical condition.
But months after Annie’s death, the Farlows discovered that physicians at the hospital had not initiated emergency resuscitation measures in their daughter's case with the same alacrity as they would in others. They also found out that a physician had placed a “do not resuscitate” order on Annie’s chart before obtaining their consent, and subsequently their daughter had been administered an undisclosed quantity of narcotics that, in the Farlows' opinion, could have caused her "unexplained, rapid" decline.
The circumstances surrounding Annie’s death have left the Farlows asking age-old questions that plague Canadian patient advocates, health care professionals, ethicists and policy makers in the face of growing health care resource scarcity: When is it appropriate to limit or withdraw potentially beneficial treatment? Who should make those decisions? How should decisions be made?
“I never took the position that my daughter had a right to any and all treatments, but the unilateral decisions we believe the doctors made should have been made transparently. We have a right to know and appeal the limits of the system, and be provided with whatever care is possible within its confines. Not only do I believe my daughter was denied a chance to prolong her life, the secrecy in which decisions seem to have been made also meant she was denied timely palliative care, and she suffered greatly at the end.”
Health expenditures consume more than 50% of revenues in six of Canada’s 10 provinces, not including federal transfers, and are on pace to consume some 75% of revenues in five provinces by the year 2019, according to the Fraser Institute (www.fraserinstitute.org/WorkArea/DownloadAsset.aspx?id=3411).
Canada’s aging population and the ongoing development of expensive therapies for life-threatening illnesses are further escalating pressures on the health care system, particularly intensive care units. Surveys estimate that Ontario, among other provinces, will need 80%–93% more intensive beds over the next 20 years, while about 87% of intensive care physicians indicated they had provided “futile” care at least once in the previous year (http://www.cmaj.ca/cgi/content/abstract/177/10/1201?ijkey=90110ebfb38e9dc79c26cfd0ffc266868702b7d4&keytype2=tf_ipsecsha).
“It’s evidenced in things like the exclusion criteria built into new provincial pandemic planning protocols. In the case of a flu pandemic, for example, having a developmental disability now excludes you from access to a ventilator.”
Such protocols set a precedent for withholding and withdrawing beneficial treatment from vulnerable groups, she argues.
Under Canadian law, doctors do not have to provide treatment that they deem “futile." However, without clear consensus about what constitutes futility, clinicians have no clear standard for weighing medical versus nonmedical criteria in their decision making.
“the use of considerable resources without a reasonable hope that the patient would recover to a state of relative independence or be interactive with their environment.”
“These are really existential questions about judging quality of life. I worry we’ll get to a place where we’re the sum of our illnesses. I know that if there’s one respirator and two people, one who will need it for 12 hours and the other who will need it for the rest of their life, there’s a split second allocation decision that’s going to be made, and likely in the favour of the healthier person.”
Some 80% of resource allocation decisions are currently made by physicians at the bedside, effectively putting physicians in the role of “double agents,”
“There’s a clear ethical rule that a doctor has a primary obligation of personal care for each patient, meaning a doctor cannot put the interests of a group, society or another patient in front of the best interests of the patient he or she is treating.”
“At an institutional level, hospitals and health authorities have an obligation to take into account other people’s requirements, rights and needs, and can put efficiency ahead of any one patient in ways a doctor cannot.”
“No one wants to be seen as the person that started the conversation on who we exclude from universal health care. But we’re already excluding people like my daughter in other subtle ways, so the time to talk is now.”
