So said said Leonard Saltz, MD, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center in New York.
A piece in MedPage Today (Fauber et al 2014) reveals how the scam works. A big pharma company like Pfizer pays for a study on a drug, like lung cancer drug crizotinib.
With crizotinib, Pfizer established progression free survival with the FDA, thus making their drug available to consumers. Progression free survival means the patient survived without the tumor growing.
The loophole of progression free survival is that you can make the patient so unhealthy the tumor can’t grow bigger. In bad enough conditions, even a weed stops growing and hangs on for life.
Indeed, with crizotinib, an interim analysis showed more deaths among patients taking the drug. This sets off a red flag; the drug increases risk of death. But the tumors didn’t increase in size, the FDA approved the drug, and Pfizer charges $12,000 a month for it.
Why does the market bear such a price? You couldn’t pay me $12,000 a month to increase my chance of death. But the data suggests Americans are paying $12,000 a month for such drugs.
By law, Pfizer is supposed to conduct a follow-up safety trial. But that’s just a law on the books, because the FDA has never imposed a fine on any pharmaceutical company for failure to conduct a follow-up study. A law with no punishment is a fake law, and Pfizer’s lawyers are smart enough to know this. Kindergartners are smart enough to know this.
If the FDA got serious one day, Pfizer would come out and say, “Hey, we did a follow up study and our drug is safe!” Would that bring legitimacy?
Yes, people facing death are desperate and want technology to give them a chance. But they don’t want fraud. And smart, data-driven people see the best technology is benelles.
So fine, let desperate people try any drug they want. But why should the apothecary make $12,000 a month when data shows his poison doesn’t work?
With crizotinib—and 100 other drugs—the market is rewarding risk in a way that doesn’t make sense. Drugs that don’t extend life, or reduce life, should cost little or nothing, and come with warnings such as, “Careful: Research indicates this drug doesn’t work and may kill you.”
Right now, legitimate warnings will never happen because companies review their own drugs. One definition for robbery: a company charging $12,000 a month for a drug approved on self-review.
The government is the gatekeeper. Desperate people are going to pay $12,000 per month for what’s on the market, even if everyone knows the drug does jack shit. The game is simply to get on the market. When you’re on the market, you can’t lose, even if you’re hurting people. Besides, you own doctors who publish in the right journals and who say you’re not causing harm. Hell, you own the FDA, so stop standing around and go make your fucking money.
The result is a predatory medical system. The best place to be is on the inside, where salaries are high, and you have government protections to operate with no skin in the game. But the rest of us—the prey—are transferring our wealth and health to the predator. Call it “progress-free survival” for the middle-class.
Dr. Saltz said it right, we’re paying top dollar for drugs that do very little.