By Henry I. Miller and Jeff Stier, The recent high-profile case involving Avastin shouldn’t be a black mark against the entire system. An important but obscure aspect of the Food and Drug Administration’s regulation of drugs has been in the news in recent months. Called “accelerated approval,” this “quick-on, quick-off” mechanism for medicines to reach…
By Rob Stein Federal regulators are considering taking the highly unusual step of rescinding approval of a drug that patients with advanced breast cancer turn to as a last-ditch hope. The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending…
The health care system in America has been set up, thanks to decades of government and private sector incentives, to be all about treatment, not prevention. Now, Merck (MRK, Fortune 500) is feeling the effects of that mindset on preventative care with one of its drugs called Proscar, which has been proven to reduce the…
By NICHOLAS WADE, A new generation of DNA tests for colon cancer seems likely to improve the detection both of cancers and of the precancerous polyps that precede them. The tests, if validated, could reduce the burden of disease substantially by detecting tumors at an early stage, including those not picked up by a colonoscopy.…
Tom Murphy, Health care reform hits another milestone next month , with new provisions that include a coverage expansion for young adults and restrictions on an insurer’s ability to impose annual coverage limits or to reject children with pre-existing medical conditions. Insurance coverage that starts on or after Sept. 23 will have to comply with…
A U.S. panel dealt a blow to Roche Holding AG’s multibillion-dollar cancer drug Avastin on Tuesday , urging U.S. officials to revoke the medicine’s approval for breast cancer after concluding studies showed insufficient benefit for patients. If regulators follow that advice, the Swiss drugmaker could no longer promote Avastin for that use in the United…
By Lisa Richwine, GlaxoSmithKline Plc’s diabetes drug Avandia should be allowed to stay on the market but with additional warnings, U.S. health advisers recommended on Wednesday, easing a threat of further costly litigation that could have followed a ban. A majority of the 33-member panel of outside experts found data raised concerns about heart…
by Jocelyn Kaiser, Harold Varmus, the new but familiar leader of the National Cancer Institute, spent part of his first day yesterday describing some of the ideas “percolating through my cerebrum” before an auditorium full of NCI staffers. Varmus said he plans to review all NCI programs, address “dysfunction,” and come up with a list…
By SCOTT CANON , Bioscience “holds promise like no other area of human endeavor,” Kathleen Sebelius, Health and Human Services secretary, told Tuesday’s town hall-style meeting on cancer drug research at the Kauffman Conference Center in Kansas City. Time and again, the scientists, doctors, drug makers and regulators who gathered Tuesday in Kansas City to talk…
By Christine Metz, U.S. Health and Human Services Secretary Kathleen Sebelius thinks it’s taking too long to bring life-saving drugs to patients who need them. The former Kansas governor returned to the region Tuesday morning to address a crowd of more than 200 at the Ewing Marion Kauffman Foundation in Kansas City, Mo. Accompanying her…
