Print Edition
TT On-The-Go
TT Feed
| Decision by FDA on drug 'very sad' |
|
 |
 |
 |
Font Size 
 Madison resident Christi Turnage was told in 2008 that she probably only had a couple of years to live.Despite the return of an aggressive, incurable form of breast cancer, she is still kicking, and she credits Avastin - a medication the Federal Drug Administration revoked its approval for on Friday. "It's just devastating," Turnage, 49, said of the FDA's decision. "It's very sad." FDA Commissioner Dr. Margaret Hamburg explained the decision, saying that the drug has not been shown to be safe and effective for the treatment of breast cancer. "After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life," she said in a statement. The National Breast Cancer Coalition also does not support use of the drug as a metastatic breast cancer treatment. But Turnage and others who suffer from the disease say Avastin has been a "miracle drug" for them. "(The FDA's decision) is a death sentence for some," Turnage said. Turnage, who worked as a nurse before retiring because of her illness, has triple-negative breast cancer - a rare but highly aggressive form of the disease. "We don't have as many treatment options," she said. Turnage first was diagnosed in June 2006. She had a double mastectomy and other treatments, but found out in 2008 that the cancer had spread to her lung. Just a few months earlier, the FDA granted the use of the drug for metastatic breast cancer patients under an accelerated approval process, which allows a drug to be approved based on data that would not normally be sufficient. A devout Christian, Turnage credits God and Avastin as the reason she's been able to return to work part-time and why she has not had to continue chemotherapy. "I don't look like I have a terminal illness," she said. Avastin will remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer. Medicare will continue to cover Avastin, said Brian Cook, spokesman for the Centers for Medicare & Medicaid Services. Including infusion fees, a year's treatment with Avastin can reach $100,000. But, as of today, Turnage's insurance no longer covers it because of the FDA's decision. She's due for another dose on Nov. 28. "I'm hoping one way or the other I'll be able to get it," she said. Genentech, the company that makes the drug, offers an uninsured program that she may be able to use. Turnage and others pleaded for the FDA to approve the drug , even if only for triple-negative cases. But Hamburg said the FDA is trying to protect people. According to the FDA's studies, some of the greatest risks include heart attacks or heart failure, severe high blood pressure and "development of perforations in different parts of the body such as the nose, stomach and intestines." In a statement about the FDA's decision, the National Breast Cancer Coalition said, "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.The decision on Avastin supports patients' trust that the drugs they are given have been proven to give them benefit and not expose them to greater harm." Turnage said she's aware of the risks. "You know what's worse than (the side effects)? Stage four breast cancer," she said. "That's a no-brainer for me - I'm willing to take the risk." Turnage presented a petition with 11,500 signatures to FDA officials. She and others in her situation also testified at hearings. "(The FDA) just ignored us all," she said. Several members of Mississippi's Congressional delegation said they are disappointed with the decision. "While drug safety is an important consideration, women taking Avastin have run out of options," said 3rd District U.S. Rep. Gregg Harper. "Until a cure is developed or a greater number of successful treatment alternatives are available, women with metastatic breast cancer should be allowed the option of taking Avastin." Sen. Roger Wicker said: "For some battling this deadly disease, Avastin is the only option." Wicker sent a letter to Hamburg in July asking the FDA to think of patients who rely on Avastin as their last option. Four of his Senate colleagues also signed it. Harper and 1st District U.S. Rep. Alan Nunnelee also sent a letter to the commissioner, and it was signed by 15 of their House colleagues. (Source: ClarionLedger.com)   Socialize this Subscribe to our RSS feed to stay in touch and receive all of TT updates right in your feed reader
|