Andrew Zajac, Los Angeles Times: January 26, 2011

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. […]

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Lyndsey Layton and John Wagner, Washington Post, January 5, 2011

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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Diana Zuckerman, PhD, The Washington Post: August 22, 2010

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.

KTNV, July 21, 2010

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.

Jared A. Favole, Wall Street Journal: February 18, 2010

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

Susan Heavey, Reuters, February 18, 2010

WASHINGTON, Feb 18 (Reuters) – U.S. Food and Drug Administration staff said they face difficulties in reviewing certain medical devices, hurdles that may call for additional regulations and authorities, even as the industry defended the current approval process.

At a public meeting Thursday, held to discuss possible changes to the FDA’s device program, agency staff said it is difficult to weigh new products under the accelerated review process used for products similar to those already approved.

It can be hard to tell if a new device is truly similar to an approved product or if there are enough differences to classify it as an entirely new product, they said. Difficulty inspecting devicemakers and a high number of proposed new products are also an issue.

“Developing clear definitions, guidance and additional authorities may be required,” said Heather Rosecrans, director of the FDA office that oversees such reviews, known as 510(k).

Devicemakers, industry consultants and investors said some smaller changes could improve the current process. They cautioned that a major overhaul could stifle innovation and prevent newer technologies from reaching patients and doctors.

FDA is weighing potential changes to the way it evaluates medical devices after a number of high-profile safety problems with heart defibrillators, contact lens solution and other products raised public concerns. Critics say the accelerated process is used too widely and can lead to problems after devices are sold.

Devicemakers are worried they could see longer review times, higher costs and other hurdles that may make it harder to get their products on the U.S. market. The threat of greater regulation affects smaller manufacturers as well as larger ones such as General Electric’s (GE.N) GE Healthcare and Siemens AG’s (SIEGn.DE) Siemens Healthcare.

Unlike traditional new drug and device applications, 510(k) reviews do not necessarily require clinical data on use of the device in patients. Just 8 percent to 10 percent of expedited device applications have patient data, FDA staff said.

Agency officials have said the meeting will help inform an internal task force charged with highlighting changes the agency can make with existing powers. An outside report from the Institute of Medicine, due next year, will focus more broadly on the FDA’s device division and what additional power or changes it needs.

Industry representatives were heavily represented at the meeting, something noted by the few practicing physicians and consumer advocates who also spoke.

Mark Leahey, president and CEO of the Medical Device Manufacturers Association, called the 510(k) process “one of the great successes” of the FDA, noting that “There are always areas for improvement.”

FDA staff said most devices are recalled because of manufacturing or design problems, something Medtronic Inc (MDT.N) Senior Vice President Susan Alpert said would not change even if the agency implemented changes to the approval process.

The FDA could issue more guidelines for companies to follow and focus more on staff training, other industry experts said.

Diana Zuckerman, the only consumer advocate to speak at the meeting, said newer, slightly different products are not necessarily better for consumers and can sometimes cause injury and death. She cited recent problems with Baxter’s (BAX.N) infusion pumps and massive recalls in 2007 of contact lens solution by Advanced Medical Optics, now part of Abbott Laboratories (ABT.N).

“In many cases these innovative devices are either not as safe as other products on the market, or not as effective,” said Zuckerman, president of the research and advocacy group National Research Center for Women & Families.

FDA officials have said they will accept public comments for the next month before making its task force’s recommendations public in June.[…]

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Meg Kissinger, Journal Sentinel: January 15, 2010

The U.S. Food and Drug Administration on Friday reversed its much-criticized position on BPA safety, saying it was concerned about the chemical’s effects on fetuses, infants and children.

The agency said it would work to reduce exposure to the chemical, which is found in the urine of 93% of Americans tested. But it stopped short of a ban, saying more studies are needed to better know the chemical’s effects.

The agency also said it will move to expand its regulation of the chemical by trying to get manufacturers to report how much BPA they produce, where it is being made and how it is being used.

“We’d like a more nimble position to regulate this chemical,” said FDA Commissioner Margaret Hamburg.

The agency’s action, which was hailed by health and environmental groups, follows three years of investigative reports by the Journal Sentinel into the government’s failure to limit the chemical’s exposure, despite hundreds of studies that found BPA to cause harm.

In 2008, the FDA declared that BPA was safe for all uses based on two studies, both of which were paid for by the chemical industry.

The Journal Sentinel found that lobbyists for the chemical industry wrote entire sections of that decision.

The newspaper later obtained other e-mails that showed the FDA relied on chemical industry lobbyists to examine the chemical’s risks, track legislation to ban it and even monitor news coverage.

More than 6 billion pounds of the chemical are manufactured each year, accounting for nearly $7 billion in sales.

The chemical is used to line nearly all food and beverage cans. It is used to make hard clear plastic for baby bottles, tableware, eyeglasses, dental sealants, DVDs and hundreds of other household objects.

BPA, which leaches into food and drink when it is heated, has been linked to prostate and breast cancer, reproductive failure, obesity, heart disease, diabetes and behavioral problems.

BPA manufacturers, however, have maintained it is safe – and they did so again Friday. Lobbyists for the chemical-makers have regularly pointed to the FDA’s earlier ruling as proof for their stance.

The American Chemistry Council, the primary lobbying group for the  ac repair San Diego industry, characterized the FDA’s statement Friday as attempting to address “public confusion” on BPA, not valid safety concerns.

The group said it was “disappointed that some of the recommendations are likely to worry consumers and are not well-founded.”

The chemical has been banned for use in baby bottles in Canada, Minnesota, Connecticut, the city of Chicago and two counties in New York. Similar bills are being considered in Wisconsin, Pennsylvania and Washington. A federal ban for all food contact items has been proposed in Congress.

Some Seek More Action

U.S. Rep. Edward Markey (D-Mass.), who introduced a federal bill to ban BPA from all food contact items, praised the FDA’s move.

“It is clear that BPA poses serious health risks, and this finding is a major step toward eliminating exposure to this toxic substance,” he said.

Environmental and health groups also praised the announcement, though some said it did not go far enough.

The Environmental Working Group, which has been working to ban BPA from baby bottles and the lining of infant formula cans, said Friday’s announcement was a “Waterloo” for the chemical.

Others Were More Measured.

“This is a dramatic and overdue about-face for the FDA,” said Diana Zuckerman, president of the National Research Center for Women & Families. “They have finally admitted concern. They are moving cautiously, which is appropriate because you don’t want to substitute a new chemical that is equally dangerous. But it is essential that they not move too slowly.

“There is growing and disturbing research evidence that the health of children and adults is at stake.”

Recent studies showed 90% of U.S. newborns tested had BPA present in umbilical cord blood and that Chinese factory workers exposed to huge amounts of the chemical experienced sexual dysfunction.

Groups including the Breast Cancer Fund and the Consumers Union said they were disappointed the FDA did not take stricter action. […]

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