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Two independent groups working with advanced-stage cases say the drug extended the period before the disease worsened by more than 3.5 months. Avastin can stabilize tumors in women suffering from advanced-stage ovarian cancer, extending the period before the disease worsens by more than 3.5 months, according to the results of two large, international clinical trials conducted by separate research teams. The findings, published in Thursday's edition of the New England Journal of Medicine, come less than a week after the European Commission approved Avastin for treating women newly diagnosed with advanced ovarian cancer. The drug, known generically as bevacizumab, has...

The Obama administration Friday revoked the approval of the best-selling drug Avastin for treating advanced breast cancer in the United States, despite appeals from distraught women, some patients advocates and the company that makes the drug. FDA Administrator Margaret Hamburg issued a 69-page decision outlining her decision, which was based on the recommendation of a six-member FDA advisory committee that unanimously concluded in June that the drug was harming women more than it was helping them. [Snip] ... Genentech spokesman Charlotte Arnold. “We are disappointed with this outcome. We remain committed to the many women with this incurable disease and...

A Food and Drug Administration panel today voted 6-0 to halt the use of cancer drug Avastin for the treatment of breast cancer, saying studies have failed to show Avastin is effective for that purpose. The recommendation came after two days of testimony from patients, doctors, and advocacy groups. The panel faced several tearful accounts of women, young and old, who believed Avastin saved their lives.

A panel of cancer experts has ruled for a second time that Avastin, the best-selling cancer drug in the world, should no longer be used in breast cancer patients, clearing the way for the U.S. government to remove its endorsement from the drug. The unprecedented vote Wednesday by the Food and Drug Administration advisory panel comes less than a year after the same panel reached the same conclusion. In three unanimous votes, the six members of the FDA oncology drug panel voted that Avastin is ineffective, unsafe and should have its approval for breast cancer withdrawn. "I think we all...

ObamaCare supporters fervently believe that science will prevail in systems that are controlled by politicians. It is usually the unstated assumption behind their arguments defending the Independent Payment Advisory Board. They seem to believe it so blindly that they can’t see evidence to the contrary even when it is right in front of their noses.

Everyone who's ever been on the lookout for a good deal knows that price is one thing, but value is another. Cheaper isn't always better; some things that cost more are worth it. That's especially true when it comes to medical treatment, where "one size fits all" and "cheaper is better" are very bad models. Sure, research studies can effectively answer the question of how the average person will respond to a particular course of treatment. But you can only obtain such an average by measuring individual responses, which vary tremendously. The "best" treatment for a particular patient can't be...

Influenced by the president’s mandate to “bend the health care cost curve,” the Food and Drug Administration (FDA) is preparing to deny late-stage breast cancer patients access to the critical, but expensive, life-extending drug Avastin. The FDA wants to “de-label” the drug, a move that would force patients with insurance or Medicare coverage to pay for the drug out of their own pocket in order to survive. Now patients groups are speaking out. Led by the Susan B. Komen Foundation for a Cure, 15 patient advocacy groups have petitioned the FDA to reverse their effort to ration the drug. In...

ronically, the exact same day the FDA revoked Avastin's approval, its counterpart across the Atlantic did the opposite. The European Union's Committee for Medicinal Products for Human Use had conducted a similar investigation into Avastin in breast cancer treatment... Genentech, Avastin's developer, spent some $2.3 billion creating this treatment. In reaction to this decision, other drug firms will be less likely to make the investments required for research into advanced drugs.

In an unprecedented but unfortunately anticipated move, the Food and Drug Administration has decided to withdraw regulatory approval for the life extending (and sometimes life saving) cancer drug Avastin, solely on the basis of cost. Sarah Palin's death panels have begun their work. The lives of tens of thousands of women will be shorted because of this decision. A few women, whose cancers have actually gone into remission because of Avastin treatment in conjunction with chemotherapy, may well be condemned to die. The decision, based on the recommendation of a 13-member panel, only two of them breast-cancer oncologists, will have...

As the government moves to involve itself in more of our healthcare in the ramp-up to the implementation of Obamacare, the old ways in which it interferes with the doctor-patient relationship serve as a stark reminder of what is come. The Food and Drug Administration (FDA), the regulatory body that basically sets the tone for which drugs patients have access to, is preparing to dramatically shift the drug approval process for the United States. It appears that using the late-stage cancer drug Avastin as a test case, the FDA is using cost as a factor in the drug approval process....

Medicine: After the recess appointment of a Medicare and Medicaid head, an FDA panel drops its endorsement of a widely used cancer drug. Another FDA-approved cancer therapy may not be paid for. It begins. It didn't take long for the health care philosophy of Dr. Donald Berwick, President Obama's choice to head the Centers for Medicaid and Medicare Services, and an appointee we have labeled a "one-man death panel," to have an effect. Berwick is an admirer of Britain's National Health Service and its National Institute for Clinical Excellence, with the Orwellian-acronym NICE. "NICE," Berwick has said, "is extremely effective...

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 and effectiveness that flared during the battle over health-care reform:

Early data for Roche Holding AG's drug Avastin shows enough promise in treating patients with a certain brain cancer to be considered for quick approval, a U.S. advisory panel said on Tuesday. The drugmaker is seeking accelerated approval to market the drug for patients diagnosed with a recurrence of the particularly deadly disease after trying other therapies first. The drug, made by its recently acquired Genentech unit, is already used to treat lung, colon and breast cancers. Data from two early studies showed enough of a response in patients whose disease did not advance and some whose tumors decreased in...

It took only an instant for 58-year-old Gailanne Reeh to go from the picture of health to death's door. By chance, her doctor noticed a lump under her arm during a routine exam. It turned out to be advanced breast cancer... --snip-- What does it mean to say an expensive drug works? Is slowing the growth of tumors enough if life is not significantly prolonged or improved? How much evidence must there be before billions of dollars are spent on a drug? Who decides? When, if ever, should cost come into the equation? --snip-- Mr. Lemieux, who was a sales...

Marion Kleinfeld got up one Sunday morning, picked up the newspaper, settled down to read it, and couldn't see the words. Kleinfeld, 79, of Delray Beach, Fla., already blind in her right eye, lost sight in her other eye because of a condition called wet age-related macular degeneration, AMD, the leading cause of blindness in people over 55. Leaking blood vessels in the back of the eye cause a large black spot in the center of vision. "I could not see at all. It was very frightening," she said. After years of having to tell patients losing their eyesight to...

ASSOCIATED PRESS WASHINGTON -- The first drug shown to significantly improve the vision of patients threatened by a major cause of blindness in the elderly won federal approval Friday. The drug, called Lucentis, treats the wet form of age-related macular degeneration, a disorder where blood vessels behind the retina leak blood and fluid, worsening vision and often causing blindness. An estimated 90 percent of the 1.4 million Americans who have lost their eyesight due to the disorder have the wet form. Lucentis, made by Genentech, Inc., a South San Francisco, Calif., biotechnology company, inhibits the growth of blood vessels when...