There is no drug that has a worse risk profile than some surgeries.
That's my point. When I had surgery, I came within a hair. I had the last sacrament. I made peace with the Lord and basically
asked him to be very tolerant and patient, and said that I would come up and try to explain everything when I got there.
He decided he didn't want to hear it yet.
He didn't want to hear it. I gave him another chance. But the bottom line is that we accept risk/benefits in almost every
phase of our lives. For every million people driving a car, you lose two hundred and eleven in traffic deaths every year.
We spend a ton of money mitigating that risk. But we accept it. We don't pull cars off the highway and shut down highways.
When it comes to drugs that have been approved by the FDA, we have done a miserable job of communicating to the American public
that every drug bears some risk, just like every surgical procedure and every physical event in your life. We have done a
miserable job of explaining that just because a drug is approved by the FDA the risks have not gone away.
PhRMA just finished a survey to find out how much people knew about the approval process. We asked the survey group how many
years it takes to get a drug approved. Most of them said three to five years. When we told them it takes fourteen years, their
confidence in the process rose dramatically.
We asked how many people are involved in clinical trials and how many clinical trials you need to get a drug approved. They
said one successful clinical trial and maybe four hundred or five hundred people. When we explained that it takes three successful
clinical trials involving thousands of people, their confidence in the process went up.
We asked how much of the clinical trial information is shared with the FDA. The majority said fifty to seventy percent. When
we told them that one hundred percent of the clinical trial information—good, bad, and ugly—is supplied to the FDA, their
confidence level soared. When we asked them whether there was any post-marketing surveillance, we generally got a feeling
that no, there was not. When they learned that FD, as a condition of approval, increasingly requires post-marketing surveillance,
their confidence level soared, both in the FDA and the pharmaceutical companies.
What I learned in that survey is that we have done a miserable job of communicating risk/benefit. We have done a miserable
job of communicating the truth about the approval process.
When I went through my own cancer experience, I had a profound moment, as my principal caregiver and my doctor at MD Anderson
Cancer Center had to tell me, "We think you ought to have this drug, but if we put it in your protocol, it might disrupt the
healing process of your surgery." We all sat down together and evaluated the risk of adding Avastin [bevacizumab], this brand
new drug that just came out, to my protocol. I was so pleased that there was not a government official in the room telling
me what I had to do, what I couldn't do. I made the choice to take a chance. I could have been one of those who died, but
I also knew this drug could save my life.
The tragedy is when we pull a drug that is critical to someone because of a misunderstanding about the risk profile. We have
to somehow break through the misunderstanding and fear and talk honestly about risk/benefits to the American public.
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