Fox & Friends' Peter Johnson Jr. continued Fox's campaign against health care reform, this time by claiming the FDA approval process for the cancer drug Avastin was a sign of "Obamacare rationing" and by falsely suggested that the decision is being made based on cost. However, the FDA does not consider cost in its decisions, and studies have shown that Avastin -- which was given "accelerated approval" in 2008 with the requirement that further studies confirm its benefits -- has serious side effects without significantly prolonging life.
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Peter Johnson Jr. Uses Avastin To Continue Fox's Anti-health Care Campaign
Johnson Jr.: "Don't Play Cost-Benefit Analysis, Don't Play Politics, Don't Play Obamacare Rationing" With Avastin Approval. On the December 16 edition of Fox News' Fox & Friends, Fox News Legal Analyst Peter Johnson Jr. falsely suggested that the FDA ruling on whether Avastin was approved to treat advanced breast cancer would be related to the cost of the drug. He further falsely suggested that if the FDA did not give final approval to the drug, the decision would be an example of "Obamacare rationing." From Fox & Friends:
DOOCY: The FDA is deciding the fate of nearly 20,000 women who are battling breast cancer right now. The government is considering revoking approval of the drug Avastin for the treatment of late stage breast cancer. But is this because of cost? Fox News Legal Analyst Peter Johnson Jr. has a prescription for truth. Peter, a couple years ago, it sounded like this was on the fast track to be approved and now we're hearing not so fast.
JOHNSON JR.: There was a fast track approval. And when you look at the story, at least I do, I kind of say to you and I say to the people at home, have you ever gotten a call from someone, a friend, a family member who says, the cancer has stopped growing? And that's because of a drug that they're taking.
JOHNSON Jr.: And is there any happier moment in that person's life or yours when you hear that? Even if you know that cancer may not be cured, but it stopped growing and their lives are going to be longer--
JOHNSON JR.: -- and better and stronger and they're going to spend time with their husbands and wives and children and grandchildren, that's what people who are taking Avastin are saying. About 17,000 a year it costs about $80,000 a year. They're saying, listen FDA, don't play cost-benefit analysis, don't play politics, don't play Obamacare rationing. Say, this has benefit to some people, especially in late stage breast cancer.
JOHNSON JR.: Not all people, but some people. So they're saying to the federal government, 'don't take it away from me, don't impose a death sentence on me because if I live too long, you may have to spend federal government, $80,000 - $100,000 a year.'
DOOCY: You know, Peter, when you hear these stories about how those stimulus jobs cost $400,000 a copy, and then you hear that for $80 or $90,000 a year, you can have somebody live longer, I think that's a good investment!
JOHNSON JR.: You're absolutely right, Steve. We have to make a decision in this country. I understand the burdens of the deficit. I understand all the burdens we have in this country.
DOOCY: Sure, we all do.
JOHNSON JR.: But is the goal of our medical care in this country to affirm life--
DOOCY: Yes, I hope.
JOHNSON JR: --or to say, listen, you will not live forever as a result of this drug and since it will not cure you, we will not provide this drug to you and the FDA will say, this is not approved for this. And you know what happens once the FDA says it's not approved? Medicaid and Medicare--
JOHNSON JR: --is not going to allow it and private insurance is not going to allow it. So, what happens to those 17,000 people a year, some of whom it has benefit for--
JOHNSON JR.: --some of who it extends their lives, some of whom it improves their lives? We need to make a decision in this country, whether politics is going to trump medicine, whether the bureaucracy is going to win over people's lives and the extension of their lives. [Fox & Friends, 12/16/10]
FACT: The FDA Does Not Consider Monetary Cost, Only The Drug's Health Risks And Benefits
AP: "FDA And Its Advisory Panels Don't Consider Cost Effectiveness When Reviewing Drugs For Approval." A July 28 Associated Press article reported:
But the FDA and its advisory panels don't consider cost effectiveness when reviewing drugs for approval; the agency is charged only with reviewing a product's health risks and benefits. An independent panel of cancer experts convened by FDA voted 12-1 last week to recommend dropping the agency's endorsement of Avastin's use against breast cancer. The panel cited recent studies finding that the drug did not extend patients' life spans and also increased the incidence of side effects and other complications. [Associated Press, 07/28/10]
The Wall Street Journal similarly reported, "Advisory panels do not discuss monetary costs of the drugs they consider." [Wall Street Journal, 07/29/10]
NY Times: FDA Panel Found That "The Studies Did Not Confirm" The Benefit Used For Initial Approval Of Avastin. The New York Times reported on July 20 that "use of Avastin did not prolong the women's lives by a statistically significant amount" and the new studies "showed even fewer signs that it could prolong lives." From the Times:
Avastin was given so-called accelerated approval in early 2008, a way for the FDA to approve drugs for life-threatening diseases based on less than complete evidence of effectiveness. Manufacturers must then do further studies to confirm the benefit of the drug.
The two new trials sponsored by Roche for this purpose showed a much smaller effect of the drug, so small, that the committee voted 13-0 that the studies did not confirm the initial benefit.
In the initial study, use of Avastin delayed the worsening of patients' disease by about 5.5 months. Those who received Avastin plus the chemotherapy drug paclitaxel went a median of 11.3 months before their tumors worsened, or progressed, compared to 5.8 months for those who got paclitaxel alone.
But use of Avastin did not prolong the women's lives by a statistically significant amount, the gold standard for cancer drugs. And the drug had serious side effects for some patients.
The two new studies, in which different chemotherapy drugs were used with Avastin, showed even fewer signs that it could prolong lives. And the delay in a tumor worsening was much smaller. In one trial, it was just under a month and in the other about one to three months. [New York Times, 07/20/10]
Wash. Post: Advisory Panel Found Low Effectiveness, Significant Side Effects, Including Hemorrhaging, Blood Clots, and Heart Failure. An August 16 Washington Post article noted:
An FDA advisory committee voted 12 to 1 on July 20 to withdraw Avastin's authorization for advanced breast cancer based on two new studies that the advisers concluded had not shown that the drug extends life. Not only that, the committee concluded that the studies indicated the drug slowed tumor growth for even less time -- perhaps as little as about a month. "The vast majority opinion of the committee was that the drug was not doing very much, and what it was doing was more than offset by the negative," said Wyndham Wilson of the National Cancer Institute, who chaired the committee. Avastin can cause a variety of potentially serious side effects, including blood clots, bleeding and heart failure. "In our best judgment, we did not feel this drug was safe to give relative to its benefits," Wilson said.
The recommendation has been praised by many cancer experts and by advocates for breast cancer patients.
"The FDA should never have approved Avastin for breast cancer to begin with," said Fran Visco of the National Breast Cancer Coalition. "We don't see evidence of benefit, but we do see evidence of harm." [Washington Post, 08/16/10]