FDA Red Tape: Bureaucracy Harms Cancer Patients

In theory, the Food and Drug Administration is supposed to protect patients from unsafe drugs. Unfortunately, the reality is more complicated.

Over the course of the last few years, stringent rules, red tape and an unyielding maze of protocols has done as much harm for cancer patients as good.

The New York Times, despite being a proponent of rationing has introduced us to Thomas McLaughlin and Brandon Ryan -- two cousins who were diagnosed with a lethal form of skin cancer called melanoma.  A new drug was available to each of the cousins -- a drug that showed incredible promise in slowing the same cancer McLaughlin and Ryan had and doctors were certain their tumors would respond to the drug.

The Times notes:

And major cancer centers, including the University of California, Los Angeles, were enrolling patients for the last, crucial test that regulators required to consider approving it for sale.

“Dude, you have to get on these superpills,” Thomas McLaughlin, then 24, whose melanoma was diagnosed first, urged his cousin, Brandon Ryan. Mr. McLaughlin’s tumors had stopped growing after two months of taking the pills.

But when Mr. Ryan, 22, was admitted to the trial in May, he was assigned by a computer lottery to what is known as the control arm. Instead of the pills, he was to get infusions of the chemotherapy drug that has been the notoriously ineffective recourse in treating melanoma for 30 years.

Even if it became clear that the chemotherapy could not hold back the tumors advancing into his lungs, liver and, most painfully, his spine, he would not be allowed to switch, lest it muddy the trial’s results. “I’m very sorry,” Dr. Bartosz Chmielowski, the U.C.L.A. oncologist treating both cousins, told Mr. Ryan’s mother, Jan. 

At times beseeching and belligerent, Mr. McLaughlin argued his cousin’s case to get the new drug with anyone he could find at U.C.L.A. “Hey, put him on it, he needs it,” he pleaded. And then: “Who the hell is making these decisions?”...

He believed he should trade places on the trial with Mr. Ryan, who was pursuing his contractor’s license and had just bought a four-bedroom home in Bakersfield. “Brandon has everything going for him,” he told his Aunt Jan.

But Mr. Ryan told his mother he was glad that Mr. McLaughlin, who has a young son and daughter, was the one getting the promising drug. “Tommy has the kids,” he said. “They need him around.”

Brandon Ryan is dead -- his pills rationed from him by a government protocol that prevented him from getting the pills he needed to save his life.  Thomas McLaughlin was the lucky one -- the protocols allowed him to use the drug that could have saved his cousin.

Evidence clearly points to the fact that the breakthrough drug, known as PLX4038 that saved Mr. McLaughlin is, in fact, a breakthrough.  The standard chemotherapy used in melanoma, dacarbazine, slowed tumor growth in 15 percent of patients for an average of two months. By contrast, PLX4032 had halted tumor growth in 81 percent of patients for an average of eight.  Doctors working with the drug have seen patients weeks or days from death get out of bed and off oxygen, sometimes for months calling this the "Lazarus effect."

Rather than allowing patients to get the drug now, the government mandates extensive and expensive trials that could take two years to complete, essentially denying the drug to thousands who could benefit from it today

The stringent bureaucratic rules that cost Mr. Ryan his life will quickly accelerate thanks to the passage of the President’s health care plan.  The president promised that his health care plan would never ration care but professionals and FDA watchers believe a pending decision on the cancer drug Avastin may open the door to rationing of drugs – not based on protocols – but based on cost. 

Avastin is a late-stage cancer drug that has shown promise in extending life.  The average breast cancer patient who takes the drug lives six month longer than without the drug.  That is an average.  To some the drug does not have an impact.  To others, they respond positively and there are cases where patients with stage four-breast cancer live for years. 

An FDA subcommittee voted 12-1 to create a different standard when evaluating the drug for breast cancer patients – a standard where the cost of the drug plays a role. 

The full FDA postponed a final decision until after Election Day leaving the specter that the new standard that factors cost into the equation will be implemented after the voters have spoken.

The American people clearly reject the idea of drugs being approved or covered by insurance based upon their cost.  The seniors rights group The 60 Plus Association recently polled the issue and found by huge margins Americans reject this new standard.

If the FDA creates these new standards that include the cost of the drug in the evaluation process, Americans will be denied treatment and they will be denied access to life extending drugs in order to meet budget goals. The sick and elderly will be sacrificed because of budgetary constraints, as the effort to reduce health care costs will impose rationing on the American people.

Cost based rationing most certainly will become more prevalent as government seeks to “bend the cost curve”. But it is not the only form of rationing that will lead to harm. Rigid protocols as highlighted in the Ryan case are just as onerous. Any time government bureaucrats whose mission is something other than individual patient care trumps the judgments of doctors, patients will pay the price.


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