Dr. Weeks’ Comment: the wise doctors know to be skeptical of the promises of drug companies and I was taught by dr. Wolf in medical school “Remember Brad, when a new drug hits the market, use as much of it as you can while it is still available.” reminding me that tragically , many drugs are let loose upon the unsuspecting and trusting public without sufficient scientific or clinical merit and are subsequently withdrawn within a year. Now Avastin is pulled as regards treatment of breast cancer.
FDA Withdraws Bevacizumab’s Approval For Treating Breast Cancer.
The FDA’s withdrawing its approval of Avastin (bevacizumab) to treat breast cancer received major media coverage, including front-page articles in major papers and a lead story on a network newscast.ABC World News (11/18, story 5, 0:35, Muir) reported, “The FDA revoked its approval” of Avastin “as a treatment for breast cancer saying there’s no evidence it helps patients live longer or better and citing dangerous side effect, despite the pleas of some patients who say the drug saved their lives.”
The Los Angeles Times (11/19, Roan) reported that the FDA ruled that “the cancer drug Avastin should not be used to treat breast cancer that has spread to other organs because it doesn’t help patients enough to justify its risky side effects.” For years “clinical trial results have fueled doubts” about its value in treating breast cancer, but “many women and their doctors have put their faith in the drug and lobbied hard on its behalf.” Dr. Neal Meropol, chairman of the American Society of Clinical Oncology’s comparative effectiveness research task force, “said that he agreed with the FDA’s decision and applauded the time and diligence the agency gave in weighing the matter,” but added, “It’s quite likely there is a subset of patients who benefit from Avastin to a major degree,” with the challenge being identifying them.
In a front-page article, the Washington Post (11/19, A1, Stein) reported, “The decision leaves few last-ditch options for many of those fighting the most advanced form of” breast cancer, so it “sparked one of the more emotional and acrimonious debates in years over a medical treatment among patients, oncologists, women’s health advocates, health-care policymakers, politicians and the pharmaceutical industry.” While some “likened the FDA decision to a death sentence” and “advocates of quicker access to new treatments and critics fearing health-care rationing called it a prime example of government overstepping,” others ,such as “leading researchers, public health analysts and even prominent breast cancer doctors and advocates” say this is “a crucial demonstration that careful examination of the scientific evidence trumped emotion and intense public pressure.”
The New York Times (11/19, B1, Pollack, Subscription Publication) reported the revocation is “an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.” FDA Commissioner Margaret A. Hamburg “said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects.” The Administration’s vow “to make decisions on the basis of science” made it difficult to reject the recommendations by FDA staff and outside experts to revoke the approval, as did criticism the FDA failed “to make sure the follow-up studies are done” for accelerated approvals, “or to remove approvals if those studies did not confirm the expected benefit.”
The AP (11/19, Neergaard) reported, “Avastin remains on the market to treat certain colon, lung, kidney and brain cancers,” so it could be prescribed for breast cancer off-label. However, insurers may not pay for it and a year’s treatment with Avastin can cost $100,000. Brian Cook, spokesman for the Centers for Medicare & Medicaid Services, said, “Medicare will continue to cover Avastin,” although it “will monitor the issue and evaluate coverage options.”
The National Journal (11/19, MaCarthy, Fox, Subscription Publication) reported, “The battle illustrates the fine line that Washington regulators must walk as they seek to balance patient pressures with the medical evidence.” While “advocates and some breast-cancer patients complained — and even demonstrated outside the FDA — arguing that the decision would take away what they believe to be a life-saving drug,” CMS’ continued coverage “suggests that such fears are unfounded,” as “private insurers often follow CMS’s lead in deciding what drugs to cover.”
In an article on the front of its “Business & Finance” section, the Wall Street Journal (11/19, B1, Buront, Dooren) reported Aetna Inc. and UnitedHealth Group Inc. plan to continue covering Avastin for breast cancer, as they follow the the National Comprehensive Cancer Network’s cancer treatment recommendations. Blue Shield of California already plans to stop covering it, and Cigna Corp. is reviewing its policies. The Journal suggested that Congress may react to the FDA’s decision. The legislature has increased leverage as it is considering legislation to reauthorize medical device and pharmaceutical user fee payment levels
In a front-page article, the Boston Globe (11/19, A1, Kotz, Subscription Publication) reported, “Oncologists had already begun to curtail use of Avastin in newly diagnosed breast cancer patients with metastatic disease after clinical trials demonstrated that the drug did not prolong their lives and led to potentially life threatening side effects.”
The CBS Evening News (11/18, lead story, 3:50, Pelley) reported, “Avastin is big business, with sales of three billion dollars a year, and it’s estimated that as many as 5,800 Americans are taking it for breast cancer.” Dr. Jon Lapook said that “a small group of women…may well benefit from Avastin,” but others died due to its side effects, “and that’s what the FDA has to consider as its refereeing this tension between evidence-based medicine on the one hand and patient belief on the other hand.”
Bloomberg News (11/19, Edney) reported Hamburg said, “This was a difficult decision,” adding, “FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments.” However she explained that “patients must have confidence that drugs they take are both safe and effective for their intended use.”
NBC Nightly News (11/18, story 2, 2:40, Williams) reported, “There is a big decision to report tonight about a drug for breast cancer that some women contend saved their lives. Tonight, though, the government says the science tells a different story.” NBC (Bazell) added, “FDA Commissioner Margaret Hamburg said her decision to follow the advisory panel’s recommendation was a difficult one.” Bazell continued, “This decision is getting a lot of attention because it pits such powerful emotions against the best science available.”
CQ (11/19, Norman, Subscription Publication) reported Hal Barron, chief medical officer and head of global product development at Avastin manufacturer Genentech, “said that the company will begin a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer,” as well as “review a potential biomarker that might help identify particular groups of patients who could benefit from Avastin.”
This story was also covered by the Financial Times (11/19, Rappeport, Subscription Publication), the Philadelphia Inquirer (11/19, Sell), the Pittsburgh Tribune-Review (11/19, Togneri), the “Chart” blog of CNN (11/18), the Washington Times (11/19, Cunningham), theJackson (MS) Clarion Ledger (11/19, Crisp,) Reuters (11/19), HealthDay (11/19, Reinberg), MedPage Today (11/19, Walker), andMedscape (11/19, Lowes, Subscription Publication).
WSJournal Critical Of FDA Move. The Wall Street Journal (11/19, Subscription Publication) argued that the FDA’s requiring credible, objective evidence is a subjective standard and criticized the government for interfering with patients’ choices. The Journal argued that the FDA and medical journals dislike the accelerated approval process for medicines and that its decision isn’t based on Avastin’s side effects but an effort to convey a message that the agency is in charge of pharmaceutical development. The Journal asserted that the FDA was ignoring the real world and should have allowed Avastin to remain on the market while more was learned about it.
FDA Decision Applauded. On a blog in Forbes (11/19), Matthew Harper wrote, “the FDA’ decision is the right one, and, more than that, it’s actually good for the drug industry.” According to Harper, the opposite decision “would have made scientists who work at the regulator or who advise it on expert advisory committees more reluctant to give accelerated approvals at all.” Furthermore, “we’re not going to beat cancer by lowering the bar.” Harper notes, “that Avastin costs $80,000 for the average breast cancer patient, and Roche pockets the money whether it works or not,” adding, “we can’t afford to fight cancer with weapons that don’t both shrink tumors and prolong patients’ lives.”