Wall Street Journal Attacks FDA's Decision To Limit Approval For Avastin

Wall Street Journal: FDA Decision “Is Merely Another Way Of Imposing A Blanket Government Abstraction” Over Patients And Doctors. In a November 19 op-ed titled “The Avastin Denial,” The Wall Street Journal attacked the Food and Drug Administration for revoking approval of the drug Avastin in the treatment of metastatic breast cancer. From the op-ed:

The extraordinary Avastin saga has become a kind of randomized controlled trial, pitting the Food and Drug Administration's power against potentially life-saving drugs for terminally ill patients. The results are proving that the former is far stronger, with FDA Commissioner Margaret Hamburg's decision yesterday to withdraw the biologic medicine as a treatment option for women with metastatic breast cancer.

In a 69-page decision, Dr. Hamburg quashed the drug maker Genentech's last appeal, claiming (in the first person throughout) that FDA approval requires “credible, objective evidence.” But there is no credible or objective definition for that term of art other than what the FDA claims it means at any given time for any given drug, as she goes on to detail. It is merely another way of imposing a blanket government abstraction over the individual choices of a patient and her physicians. [The Wall Street Journal, 11/19/11]

But Multiple Studies Have Concluded Avastin Does Not Provide Benefit To Patients With Breast Cancer ...

FDA: Out Of Five Studies Involving More Than 3,500 Patients, None Have “Demonstrated An Overall Survival Benefit Or An Improvement In Quality Of Life.” In her 69 page report, FDA commissioner Margaret Hamburg noted that multiple studies involving thousands of patients have yielded no evidence that Avastin “has demonstrated an overall survival benefit or an improvement in quality of life.” From Hamburg's report:

Including RIBBON2, there have been five studies of Avastin submitted to FDA in support of the indication for metastatic breast cancer, involving more than 3,500 patients. None of these studies has demonstrated an overall survival benefit or an improvement in quality of life. [FDA, 11/18/11]

NY Times: FDA Panel Found That “Studies Did Not Confirm” That Avastin Could Prolong Women's Lives. The New York Times reported on July 20, 2010 that “use of Avastin did not prolong the women's lives by a statistically significant amount” and that 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. [The New York Times, 7/20/10]

... And Comes With Potentially Serious Side Effects

FDA: Addition Of Avastin To Chemotherapy “Leads To An Increase In Serious Adverse Events.” From FDA commissioner Margaret Hamburg's November 18 decision:

As discussed above, CDER and Genentech agree that the safety profile of Avastin is accurately described by its prescribing information. This information includes a boxed warning, the most serious warning for prescription medication under FDA regulations, and Avastin's labeling warns of toxicities that include gastrointestinal perforations, would healing complications, and hemorrhage. Avastin's prescribing information also warns that it is associated with more common, serious toxicities, such as hypertension, proteinuria, and increased incidence of chemotherapy-related toxicities such as neutropenia, febrile neutropenia, sensory neuropathy, diarrhea, and hand-foot syndrome. The clinical trials that Genentech has submitted to FDA show that the addition of Avastin to chemotherapy leads to an increase in serious adverse events and grade 3-5 adverse events. [FDA, 11/18/11]

Hamburg's decision included the below chart detailing increases in adverse events with inclusion of Avastin in chemotherapy treatments:

Wash. Post: FDA Advisory Committee Concluded That Avastin “Was Not Doing Very Much” And Was “More Than Offset By The Negative,” Which Included Hemorrhaging, Blood Clots, And Heart Failure. An August 16 Washington Post article reported:

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 Washington Post, 8/16/10]

Decision To Revoke Approval Is Supported By Cancer Advocacy Groups ...

National Breast Cancer Coalition Applauds FDA Decision. In an official statement, the National Breast Cancer Coalition applauded the FDA and commissioner Margaret Hamburg for revoking the approval of Avastin in treating metastatic breast cancer. From the statement:

The National Breast Cancer Coalition (NBCC) applauds the FDA and Commissioner Margaret Hamburg, MD, for the decision to revoke the approval of Avastin^® (bevacizumab) in the first-line treatment of metastatic breast cancer. We understand the devastation of metastatic breast cancer and the fact that we do not know how to prevent or cure it. We remain committed to and focused on finding those answers.

Since 2008, NBCC has taken the position that accelerated approval for Avastin was lowering the bar on drug approval. Based on the results of randomized clinical trials, there is no evidence the drug extends the lives of breast cancer patients; evidence indicates it does increase the risk of harm.

We are gratified that the FDA has continued to support science and put what is best for patients above political, public and industry pressures. The FDA's mission is to protect and promote the public's health. The goal of drug approval is to make available drugs that save lives, that significantly extend survival while maintaining a good quality of life. If meaningful benefit for patients cannot be established, approval must not be granted. If evidence shows an approved drug has little or no benefit and harms patients, approval must be revoked [National Breast Cancer Coalition, 11/18/11]

National Research Center For Women And Families: “The Science Is Clear: Breast Cancer Patients Are More Likely To Be Harmed Than Helped by Avastin” A November 18 Associated Press article reported that Diana Zuckerman of the National Research Center for Women and Families responded to the FDA decision by saying: “The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin” [Associated Press, 11/18/11]

National Cancer Institute Official Served On FDA Advisory Committee That Recommended Revoking Approval Of Avastin For Breast Cancer. From The New York Times:

[T]he Avastin studies were conducted promptly by Roche and evaluated by the F.D.A. “This is a good example of the system working,” said Dr. Wyndham Wilson of the National Cancer Institute, who served as chairman of the [advisory] committee. [The New York Times, 7/20/10]

... But Right-Wing Media Have Repeatedly Gone To Bat For Avastin

The Wall Street Journal Has Used Avastin To Fearmonger Over Health Care Rationing. A June 29 Wall Street Journal editorial argued in favor of the FDA approving the use of the drug Avastin for end-stage breast cancer without noting studies concluding the drug was ineffective and had serious side-effects. On the July 2 edition of Fox News' Journal Editorial Report, Journal deputy editorial page director Daniel Henninger tied the FDA's Avastin decision to the Affordable Care Act and said that under that law, drugs like Avastin “would be pushed to the side.” [Media Matters, 6/29/11, 7/2/11]

Other Right-Wing Media Have Also Used Avastin To Push “Rationing” And “Death Panel” Lies. Numerous right-wing outlets have claimed that the FDA's actions regarding Avastin were a sign of coming rationing or death panels. [Media Matters, 2/22/11, 3/22/11, 6/22/11]

For more about the false claim that the FDA's decision regarding Avastin is an example of rationing or death panels, click here.