Avastin is hailed for treating colon cancer and certain other malignancies. But the Food and Drug Administration said it appeared to be a false hope for breast cancer: Studies haven’t found that it helps those patients live longer or brings enough other benefit to outweigh its dangerous side effects. “I did not come to this decision lightly,” said the FDA’s commissioner, Dr. Margaret Hamburg. But she said, “Sometimes despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing.”

Avastin remains on the market to treat certain colon, lung, kidney and brain cancers. Doctors are free to prescribe any marketed drug as they see fit. So even though the FDA formally revoked Avastin’s approval as a breast cancer treatment, women could still receive it — but their insurers may not pay for it. Some insurers already have quit in anticipation of FDA’s long-expected ruling.

However, “Medicare will continue to cover Avastin,” said Brian Cook, spokesman for the Centers for Medicare & Medicaid Services. The agency “will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies.” Including infusion fees, a year’s treatment with Avastin can reach $100,000.

The ruling disappointed patients who believe Avastin is helping to curb their incurable cancer.

“It’s saved my life,” said a tearful Sue Boyce, 54, of Chicago. She’s taken Avastin in addition to chemotherapy since joining a research study in 2003. Her breast cancer eventually spread to her lungs, liver and brain, but Boyce says she is stable and faring well. “So I’m hoping the insurance company will grandfather me in to continue taking it,” she said.

The Avastin saga began in 2008, when an initial study suggested the drug could delay tumor growth for a few months in women whose breast cancer had spread to other parts of the body. Over the objection of its own advisers and to the surprise of cancer groups, FDA gave Avastin conditional approval — it could be sold for such women while manufacturer Genentech tried to prove it really worked.

The problem: Ultimately, the tumor effect was even smaller than first thought. Across repeated studies, Avastin patients didn’t live longer or have a higher quality of life. Yet the drug causes some life-threatening risks, including severe high blood pressure, massive bleeding, heart attack or heart failure and tears in the stomach and intestines, the FDA concluded. In two public hearings — one last year and one this summer — FDA advisers urged the agency to revoke that approval.

“The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin,” said Diana Zuckerman of the National Research Center for Women and Families in Washington. Genentech had argued the drug should remain available while it conducted more research to see if certain subsets of breast cancer patients might benefit, and some patients and their doctors had argued passionately for the drug.

“There certainly are patients who benefit tremendously,” said Boyce’s oncologist, Dr. Melody Cobleigh of Rush University Medical Center. “We’ll just be battling with the insurance companies.”

“For those not fortunate enough to be on Medicare or an insurance plan that covers it, it’s a death sentence,” Christi Turnage of Madison, Miss., said of the FDA’s decision. Her breast cancer had moved into her lungs before she began Avastin three years ago and the spreading stopped, but Turnage said her insurer is ending coverage and she will seek financial help from Genentech’s access program.

Hamburg said that she considered those arguments but that scientifically there are no clues yet to identify who those rare Avastin responders would be — putting a lot of people at risk in order for a few to get some as-yet-unknowable benefit. She urged Genentech to do that research, saying the FDA “absolutely” would reconsider if the company could find the right evidence.

Genentech, part of Swiss drugmaker Roche Group, pledged to begin that research.

“We are disappointed with the outcome,” said company chief medical officer Dr. Hal Barron. “We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States.”

The breast cancer organization Susan G. Komen for the Cure said that it respected the FDA’s decision and that it was time for researchers to concentrate on finding so-called biomarkers that would tell which drug is right for which patient.

“Each type of cancer is very different from another in important ways, and in the end it’s no surprise that Avastin’s effectiveness may not be equivalent against all types of cancer,” said Dr. Neal Meropol of University Hospitals Case Medical Center in Cleveland, who has long used Avastin for colon cancer.

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“This is a big concern among the physician community because we all know that not every hospital has the capacity to treat those patients on the weekend,” said Dr. Ying Xian, who studies stroke care at the Duke Clinical Research Institute in Durham, North Carolina and wasn’t involved in the new study. “What is most amazing in this study is that they show that comprehensive stroke centers have the capacity to (eliminate) those disparities in terms of weekend status,” he told Reuters Health.

In 11 years of stroke data from New Jersey hospitals, 37,000 patients who were admitted on a weekend or holiday were slightly less likely to survive the next few months than 97,000 who arrived on a weekday. After 90 days, 17.2 percent of weekend patients had died, compared to 16.5 percent of weekday patients. Weekend admission meant people who had suffered a stroke were about five percent less likely to survive that long, when other factors were also considered.

But when researchers focused on the 12 out of 88 hospitals that had been deemed comprehensive stroke centers, weekend arrival did not mean a higher risk of death, according to findings published in Stroke. Hospitals that qualified as primary stroke centers — meaning they provided care in between non-centers and comprehensive centers — still didn’t do as well on the weekend.

One caveat is that New Jersey didn’t begin certifying stroke centers until 2007. (An organization called The Joint Commission started accrediting hospitals nationwide in 2003.) So for the most part, the data comes from before “stroke center” designations were made.

Still, the researchers said, those hospitals were probably providing the best stroke care before that was made official. In general, “there’s a decrease in the quantity and spectrum of care that’s provided on the weekend,” said Dr. James McKinney, the study’s lead author from the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School in New Brunswick.

But at stroke centers, “it’s kind of a 24-hour, seven-day-a-week operation,” he told Reuters Health. “There’s really not a fall off regardless of the time of day or day of the week.” Stroke centers, Xian explained, always need to have a stroke specialist on call, and brain imaging services available.

“We are seeing increasing evidence that the designation of primary stroke centers (and) comprehensive stroke centers is having an impact on care,” said Mat Reeves, an epidemiologist from Michigan State University in East Lansing who wasn’t involved in the research. That supports a recent push in the healthcare field to recognize “centers of excellence” that specialize in treating certain conditions.

In some states, ambulances are required to take patients with stroke symptoms to the nearest stroke center.

But because that’s not always the case, “be an advocate for yourself or your family member to go to a specialty center for stroke if there’s one close by,” Reeves told Reuters Health. “It’s not worth driving four hours for… (but) when that’s an option, I would want my family members and myself to go to those centers.” Researchers emphasized that the most important thing to do when someone is having a stroke is still to call 911.

Most of the rare medications are for hospital use, including sterile injections, intravenous treatments, anesthetics and antibiotics. The products include both name-brand and generic drugs. “FDA hears from patients and also from healthcare professionals and organizations about the terrible impact the shortages have had,” spokeswoman Shelly Burgess said.

“We continue to do all we can under our current authority to address shortages when they occur.”

The FDA’s efforts are hindered, however, because it cannot force private pharmaceutical companies to produce certain drugs or even require them to notify the agency when they plan to discontinue one, Burgess said.

In 2010 it was able to avert 38 shortages, mainly by persuading other manufacturers to produce the drugs or helping to resolve production issues. But a survey of 820 hospitals carried out in June by the American Hospital Association found that almost all had run out of an important drug over the past six months. Eighty-percent said they had to delay patient treatments because of drug scarcity, and 70 percent said they administered less effective treatments.

“We really need to take a very careful look at what is going on. I have never seen anything like this and I have been a pharmacist for over 40 years,” says Mike Cohen, a pharmacist at the non-profit Safe Medical Practices.

The group recently surveyed 1,800 health professionals and found that a third of doctors and a fifth of pharmacists were aware of adverse reactions in their patients — including deaths — because of drug shortages. Cynthia Reilly of the American Society of Health System Pharmacists says the “dramatic increase” in shortages is in part due to “quality issues.”

“In a lot of instances the manufacturer is either having problems with the production lines or perhaps they found particular products in vials so they have to do a recall,” she said. Reilly fears the shortages will worsen as the pharmaceutical industry continues to consolidate, and as more companies stop producing generic drugs because they are less profitable.

“A few years ago five companies were making a similar product. Now there is only one or two… There are not a lot of companies to fill the gap,” she said.

She and other advocates believe new legislation to allow the FDA to force companies to alert it six months in advance of closing a production line would be helpful, as it would give the agency more time to find a substitute. Two bills with broad support are currently under discussion in Congress.

Another problem is the so-called “gray market,” whereby distributors scoop up rare drugs and then charge hospitals exorbitant rates for them. Some drugs can fetch up to 1,000 times the normal price. “We tell our members to contact their state attorney general. Unfortunately there is opportunity for unscrupulous behavior,” Reilly said.