CPTF President Dr. Diana Zuckerman advises women with breast implants not to get too worried about the connection between breast implants and a rare form of lymphoma, but to see their doctors if they have any concern in this ABC news story.
WASHINGTON (AP) – Federal health officials said Wednesday they are investigating a possible link between breast implants and a very rare form of cancer, raising new questions about the safety of devices which have been scrutinized for decades.
The cancer, known as anaplastic large cell lymphoma, attacks lymph nodes and the skin and has been reported in the scar tissue which grows around an implant. The Food and Drug Administration is asking doctors to report all cases of the cancer so the agency can better understand the association.
The agency has learned of just 60 cases of the disease worldwide, among the estimated 5 million to 10 million women with breast implants. The agency reviewed the scientific literature going back to 1997 along with information provided by international governments and manufacturers.
Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site. […]
A handful of researchers have published papers on instances of the lymphoma in breast implant patients over the last three years, prompting FDA’s review. Some research suggests bits of silicone can leak into cells around the implant, triggering the cancer. Even saline implants include trace amounts of silicone to help them maintain their shape.
The lymphoma is an aggressive form of cancer though it is often curable, according to experts. Treatments include radiation, chemotherapy and a bone marrow transplant, if the disease returns. […]
The FDA pulled silicone breast implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.
But in 2006 the agency returned the implants to the market after most studies failed to find a link between silicone breast implants and disease.
The approval came with conditions, including a requirement that the companies complete 10-year studies on women who have already received the implants to study leaks, as well conduct new decade-long studies of the safety of the devices in 40,000 women.
The FDA said the companies have continued to pursue those studies, though several of them have enrolled less than half of the patients needed to make them statistically significant.
Dr. Diana Zuckerman said the studies “will be completely useless unless the FDA can convince the companies to do more to keep women in their studies.” Zuckerman’s group, National Research Center for Women & Families, opposed the FDA’s decision to re-approve silicone implants. […]
The Food and Drug Administration announced Wednesday that it has begun investigating the possible connection between breast implants and an increased risk of a rare form of cancer.
Though the number of women who may develop the disease is small, there is apparently no way to identify those who are likely to develop it — making it a source of potential concern to all women with the implants.
Among women who do not have implants, the cancer — anaplastic large cell lymphoma, or ALCL — develops in the breast tissue of about 3 out of 100 million women nationwide.
But among women who do have implants, FDA investigators say they have identified as many as 60 women who have developed ALCL worldwide, out of an estimated global population of 5 million to 10 million women with implants.
The FDA did not provide an incidence number for women with implants who developed the disease in the United States alone.
The agency said the number of known cases was too few to draw a conclusion that implants were linked to the disease.
FDA officials emphasized the small risk and said that women with implants don’t need to do anything more than be vigilant.
The FDA advised women not to change their routine medical care, but it said they should consult a physician if they notice swelling, pain or lumps around implants after postsurgical healing.
“Women who are not showing any symptoms or problems require only routine follow-up…. FDA is not recommending the routine removal of breast implants,” said William Maisel, chief scientist and a deputy director of the FDA’s medical device office.
ALCL is a treatable cancer of the immune system, and its occurrence in the breast does not equate to breast cancer, Maisel said.
“I think there’s reason to be concerned about this, but there shouldn’t be reason for panic,” said Phil Haeck, president of the American Society of Plastic Surgeons. Signs of ALCL associated with implants “are pretty dramatic. There’s a lot of swelling and pain. They won’t miss it,” Haeck said.
To better understand the development of ALCL, the plastic surgeons group has agreed to report all cases of ALCL to a national registry established by the FDA.
The FDA also will ask the two U.S. manufacturers of implants, Allergan of Irvine and Mentor Worldwide Santa Barbara, to update product labeling to include information about ALCL.
“We fully support FDA’s efforts to gather additional data and study ALCL in patients with breast implants,” Mentor said in a statement.
An Allergan spokeswoman said in a statement that when ALCL has occurred, “most of the patients have responded to a variety of treatments, including simple removal of the implant and surrounding scar capsule.”
“A woman is more likely to be struck by lightning than get this condition,” the statement said.
But the head of a leading women’s health advocacy group said that the risk, while small for individuals, is still alarming.
“It raises a red flag about what other immune disease could be occurring that are not obvious,” said Diana Zuckerman, president of the National Research Center for Women & Families.
Zuckerman noted that there have been reports that Allergan and Mentor have lagged in meeting benchmarks for 10-year safety studies of implant recipients required by the FDA. […]
Read the original article here.
Joshua M. Sharfstein, the second-in-command at the Food and Drug Administration, is leaving that post after less than two years to become Maryland’s top public health official, Gov. Martin O’Malley said Tuesday.
The offer from O’Malley (D) came two weeks ago after John M. Colmers told the governor that he intended to step down after four years as Maryland’s secretary of health and mental hygiene, Sharfstein said.
“It was not that I was looking to leave or was burned out,” Sharfstein said in an interview Tuesday. “I was committed to the FDA. But opportunities like this don’t come along very often. It’s a really great job at a really important moment in time, and with terrific leadership in the state.
“It was impossible to turn it down.”
The new job, which Sharfstein will start next week, touches a broad array of public health issues, including infant mortality, HIV/AIDS, substance abuse, mental health and implementation of health-care reform.
The FDA had no comment on Sharfstein’s departure, according to spokeswoman Karen Riley.
Sharfstein, 41, led the FDA transition team for the Obama administration and aimed to restore the agency’s public health mission. Critics had complained that the FDA grew too cozy with the industries it regulates during the George W. Bush administration.
Once Obama tapped him to help lead the agency, Sharfstein reviewed the FDA’s approval process for medical devices and drugs. He led an investigation into the controversial approval of a knee surgery device, which resulted in the unusual finding that the FDA had incorrectly approved the device because of political pressure.
Under Sharfstein and FDA Commissioner Margaret A. Hamburg, the FDA has stepped up enforcement, cracking down on deceptive claims by foodmakers, quality problems with over-the-counter pediatric medicines, and producers of caffeinated alcoholic beverages.
Sharfstein also tried to get the agency to do a better job of explaining its actions to the public.
Diana Zuckerman, president of the National Research Center for Women & Families, said Sharfstein “inherited a dysfunctional agency, and he made substantial progress on many fronts. His efforts have saved lives, but there’s a lot more work to be done.” […]
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FDA made the right decision in starting the process to remove the breast cancer indication for Avastin. We commend the FDA for carefully considering the concerns of patients currently on Avastin who believe that Avastin has helped them, but ultimately, FDA’s decision needs to be based on science. Scientific research results are clear: Avastin doesn’t prolong survival — the data show it often reduces survival. And, Avastin has potentially terrible side effects that harm patients’ quality of life. Painful and potentially deadly perforations in the nose, stomach, and elsewhere are clearly a result of the Avastin, for example.
We hope that the FDA will move quickly to ensure that breast cancer patients are not harmed by Avastin. We urge the agency to stick to the science and not be intimidated by the company or by those who don’t understand the need for scientific decision-making. The company has made a lot of money selling Avastin to breast cancer patients, and they will fight the FDA’s decision with well-paid lobbyists and multi-million dollar public relations efforts. Breast cancer advocates need to see through those lobbying and PR efforts, and help the FDA finalize their decision and thus safeguard patients’ lives and the quality of their lives.
We agree with the FDA that research is needed to figure out if there are breast cancer patients who can be identified as most likely to benefit from the drug. If Genentech can identify a subgroup of patients who have a high likelihood of success and low risk of harm, FDA can consider an approval decision just for those types of patients.
The Aug. 16 front-page article “Breast cancer drug in dispute” was a balanced look at Avastin, but the dueling claims were confusing. Here’s the most important issue: Research shows that breast cancer patients taking Avastin don’t live as long and they have more serious side effects than patients taking placebo. That is why Avastin should not be used for breast cancer, even if it were free. Its cost is not the main point, and politicians need to understand that just because a drug is expensive doesn’t mean it improves health.
The manufacturer is correct that Avastin can delay the progression of breast cancer. So why aren’t Avastin patients living longer? Data indicate that it’s because women taking Avastin are more likely to die from side effects such as stroke and heart disease. If a breast cancer patient takes Avastin, it will not improve her chances of living longer, but her quality of life is more likely to be harmed because of the debilitating conditions linked to the drug.
Avastin may help some breast cancer patients, but it appears that nobody can predict which ones it will help and which ones it will hurt. The research indicates that it harms more breast cancer patients than it helps, which is why its approval for breast cancer should be rescinded. If the manufacturer wants to help breast cancer patients, it should do the research necessary to show who is helped by Avastin and seek approval just for those types of patients.
Diana Zuckerman, Washington
The writer is president of the Cancer Prevention and Treatment Fund of the National Research Center for Women & Families.
There’s been a major setback for blockbuster cancer drug Avastin. A panel of experts says it should no longer be recommended for women with advanced breast cancer. Avastin aimed to starve tumors by choking off their blood supply. When it was approved in 2008, it seemed to be working. Giving women with advanced breast cancers an extra five months before their disease worsened. But the new studies reveal it wasn’t so.
Diana Zuckerman from the National Research Center for Women said, “It is not saving lives, and in fact women taking this drug seem to die a little sooner than women taking other drugs.”
Avastin will still be used for other cancers. Even if the FDA pulls the plug on it for breast cancer, doctors could offer the drug off-label. But the price-tag, 50-to 90,000 dollars a year, is one few women could afford.
A panel of Federal health advisors say the cancer drug Avastin should no longer be recommended for women with advanced breast cancer. The panel says the risks outweigh the benefits.
The FDA approved Avastin for breast cancer in 2008 based on a trial showing it significantly lengthened the time until the disease worsened. However, two subsequent studies failed to show the same outcome.
“It is not saving lives and in fact women taking this drug seem to die a little sooner than women taking other drugs,” said Diana Zuckerman.
An estimated 90,000 women have used Avastin for breast cancer.
WASHINGTON, March 31 (Reuters) – Tobacco companies defended menthol cigarettes to a U.S. advisory panel on Wednesday as health advocates called for a government ban on the popular flavoring.
About 19 million Americans smoke menthol cigarettes. Health advocates say the flavor masks the harshness of tobacco, making it easier to start smoking and harder to quit.
Manufacturers told a Food and Drug Administration panel that adding menthol did not make a cigarette more harmful or addictive.
“Overall the weight of scientific evidence indicates menthol does not change the inherent health risks of cigarette smoking,” said James Dillard, a senior vice president at Altria <MO.N>, which sells menthol versions of its Marlboro brand cigarettes.
The panel of outside experts is studying the health effects of menthol and is due to submit a report by March 2011. The FDA eventually could ban menthol, although some activists and industry analysts doubt that will happen. Stronger warnings or advertising limits are other possibilities.
Any government action against menthol could be a blow to Lorillard, the nation’s third-largest cigarette company and maker of the top-selling menthol brand Newport.
A 2009 law that gave the FDA oversight of tobacco products banned other cigarette flavors such as chocolate, clove and fruit that could lure children. But Congress exempted menthol, the most popular flavoring with about 27 percent of the cigarette market, and instead called for an FDA review.
The issue is racially sensitive as blacks overwhelmingly favor menthol and suffer more from smoking-related illnesses and deaths than whites. A government survey showed 83 percent of adult black smokers chose menthol cigarettes.
The American Academy of Pediatrics and others urged a ban on menthol flavoring, telling the FDA panel that it appealed to young people.
“Menthol has become the industry’s last holdout and last hope for disguising the taste of tobacco… we should not allow companies to sweeten the poison,” said Brandel France de Bravo of the National Research Center for Women & Families, a consumer group. […]
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GAITHERSBURG, Md. (Dow Jones)–U.S. Food and Drug Administration officials Thursday told industry experts and the public that it lacks certain powers over the medical-device industry and may go to Congress to ask for more authority.
FDA officials who oversee the agency’s medical-device approval system said the regulatory body has limited powers to recall devices that are already on the market and can’t adequately oversee how device makers label their products. They said the agency also has limited power over products once they are on the market.
The FDA comments came as part of a meeting where government officials and mostly industry representatives from companies such as Medtronic Inc. (MDT) discussed ways to possibly alter and strengthen its medical-device approval process. The focus was on an FDA approval system for moderate-risk devices such as orthopedic knee and hip replacements. The agency has said that this system is open to abuse and wants to revamp it. The approval process, called 510k, is used when a company wants to sell a new device that is based on a product already on the market. The FDA’s main process for approving high-risk medical devices such as heart implants isn’t under an intense review.
Device-manufacturer representatives said they feared changes to the 510k system would dry up investment in the industry and keep novel devices away from patients. They said they worry the FDA is erecting hurdles that are too high to clear.
“There is fear in the industry that the FDA may be moving in a direction that isn’t rational,” Jon Kahan, director of the medical device practice at the Washington law firm Hogan & Hartson. Others who work in the industry also cautioned the FDA from changing the entire process, saying they haven’t seen anything beyond anecdotal reports to suggest there are major problems with the 510k program.
Dr. Jeff Shuren, head of the FDA’s device division, said concerns about the 510k program have been around for several years. So the best thing the agency can do is “look under the hood…and see what the root causes are,” he said.
The FDA officials aired concerns about several problem areas in the system, including that the FDA often doesn’t know when one company has sold the ownership of a medical device to another company. “You can imagine how hard it is to investigate” problems and take enforcement actions when the FDA doesn’t know who owns the device, said Heather Rosecrans, who runs the 510k program at the agency.
In one example, Rosecrans said one unidentified company bought the rights to more than a dozen different medical devices from another manufacturer. In reviewing the product information that the original owner had submitted prior to receiving FDA approval, the purchasing company found that “all of it was fraudulent” and subsequently told the FDA about it. Rosecrans said the FDA then was able to pull those products from the market because they had been approved based on false information.
FDA officials and industry representatives also highlighted the success of the 510k process, saying it has fostered innovation and helped make the U.S. a leader in device technology.
Dr. Diana Zuckerman, president of the National Research Center for Women & Families, a Washington-based patient advocacy group, offered one of the few non-industry perspectives at the meeting. She said more information and testing is needed for many of the devices approved through the 510k system.
Many industry representatives and even a few FDA officials said devices that go through the 510k program do include a lot of information. Still, Shuren said only about 8% to 10% include the clinical data that are generally required for high-risk devices approved through the FDA’s other major device-approval system.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207; jared.favole@dowjones.com
