Mixed Signals No one enjoys exposing drug company doubletalk and FDA complicity more than my colleague, HSI researcher/writer Michele Cagan. Some people like a cup of coffee to get them going. Michele? She prefers FDA News, or drug company press releases. One recent morning I found an e-mail from Michele waiting for me. And you could almost feel the heat coming off the computer screen. Michele: "I just saw a new commercial for Evista that focused on its invasive breast cancer preventive feature. Seriously, it says why not take an osteoporosis drug that may also help you avoid invasive breast cancer. But check this out…" And down the rabbit hole we go. Michele sent me a link to an Internet drug index called RxList. On the Evista page, Michele found this comment under the heading "Breast Abnormalities": "Any unexplained breast abnormality occurring during EVISTA therapy should be investigated. EVISTA does not eliminate the risk of breast cancer." Michele: "How is that allowed?!" Only in the "up is down" FDA world. In the e-Alert "Smoke Gets In Your Eyes" (11//8/07) I told you about the FDA announcement that Evista (already approved for osteoporosis) had been granted an additional approval "for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer." That approval came in September 2007, but that was about the ONLY good news for Eli Lilly (the maker of Evista) that summer. In Lilly's "Highlights of Prescribing Information" about Evista (which Michele also sent along) this warning was added in July 2007: "EVISTA should be used with caution in patients with moderate or severe renal impairment" And in September 2007, this prominent black box warning was added: "Increased risk of venous thromboembolism and death from stroke." (In case you don't have a medical dictionary handy, a thromboembolism is the formation of a blood clot that can travel through the blood stream until it blocks a vessel.) As you can see, that black box warning was added the SAME MONTH the FDA gave the green light to use the drug to reduce invasive breast cancer risk. How do FDA officials sleep at night? If you go to the Evista web site (evista.com), the warnings take a very odd turn. A page titled "Bolded Warning and Important Safety Information" carries this note: "In a study of women past menopause who were at high risk for heart attack, EVISTA increased the risk of dying from a stroke. However, EVISTA did not increase the risk of heart attack, stroke, or dying from other causes." How's that again? Evista increased the risk of dying from a stroke, but didn't increase the risk of having a stroke? Meanwhile, that black box warning notes a risk of thromboembolism, which can easily cause a stroke. Are they deliberately TRYING to confuse us? (Come to think of it…) We'll frost the cake with this last word from the FDA, which was included in the 2007 announcement about using Evista to prevent invasive breast cancer: "Other potential side effects include hot flashes, leg cramps, swelling of the legs and feet, flu-like symptoms, joint pain, and sweating." At the beginning of the new Evista TV ad, the announcer asks, "Why not ask your doctor about Evista?" Why not? Here's Michele's response: "I think I've developed pulmonary embolism and non-invasive breast cancer just READING about Evista." Sources:
"Evista" RxList, rxlist.com
"Highlights of Prescribing Information" pi.lilly.com/us/evista-pi.pdf
"Bolded Warning and Important Safety Information" evista.com
"FDA Approves New Uses for Evista" FDA News, 9/14/07, fda.gov | 
