Gardiner Harris, New York Times: January 13, 2009

An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.

The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.

Nine agency scientists complained in May to Andrew C. von Eschenbach, the F.D.A. commissioner, and the agency began an internal review. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one. Last week, the scientists wrote a similar letter to President-elect Barack Obama’s transition team.

Agency documents that are part of the internal investigation, including e-mail messages, were provided to The New York Times. Details of the investigations have not previously been made public.

The documents show that front-line agency scientists, like many outside critics of the agency, believe that F.D.A. managers have become too lenient with the industry. In medical reviews and e-mail messages, the scientists criticize the process by which many medical devices gain approval without extensive testing. And in e-mail correspondence, they contend that an agency supervisor improperly forced them to alter reviews of the breast imaging device and others.

William McConagha, the agency’s assistant commissioner for integrity and accountability, said he was continuing to investigate the scientists’ claims. Mr. McConagha said that Dr. von Eschenbach had offered to meet with the nine scientists before Friday, his last day in office.

“We in the Office of Commissioner are extremely concerned about allegations like this,” Mr. McConagha said.

In the documents, Representative Christopher Shays, a Connecticut Republican who lost re-election in November, is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that is supposed to help radiologists detect breast tumors.

The device, the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, is used with screening equipment made by Fujifilm Medical Systems.

Fujifilm Medical is based in Stamford, Conn., the heart of Mr. Shays’s former district. In the documents, Mr. Shays is referred to as “Congressman Fuji.”

“I am the Fuji congressman because I represented that district,” Mr. Shays said in an interview Friday.

Mr. Shays said he had called the agency supervisor only to demand that the agency make a final decision, not that it approve the product.

He scoffed at suggestions in the documents that his call led the supervisor to overrule scientists and approve the device. “That would be idiotic for someone to approve something they don’t think should be approved,” he said.

A spokeswoman for Fujifilm Medical, Courtney A. Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the F.D.A. process.”

The dissenting scientists protested, according to the internal documents, that “iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all F.D.A. submissions.”

An internal review said the risks of the iCAD device include missed cancers, “unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation.”

Ken Ferry, iCAD’s chief executive, said, “We have done all the appropriate testing to get the product approved.”

Mr. Ferry said that F.D.A. scientists were increasingly asking for more rigorous testing of devices, and that his company complied with those demands.

Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zuckerman, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”

The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.

A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews. […]

Read the original article here.

Natasha Singer, New York Times: December 23, 2008

For many cancer patients undergoing mastectomies, reconstructive breast surgery can seem like a first step to reclaiming their bodies.

But even as promising new operations are gaining traction at academic medical centers, plastic surgeons often fail to tell patients about them. One reason is that not all surgeons have trained to perform the latest procedures. Another reason is money: some complex surgeries are less profitable for doctors and hospitals, so they have less of an incentive to offer them, doctors say.

“It is clear that many reconstruction patients are not being given the full picture of their options,” said Diana Zuckerman, the president of the National Research Center for Women and Families, a nonprofit group in Washington.

One patient, Felicia Hodges, a 41-year-old magazine publisher in Newburgh, N.Y., chose a double mastectomy after she was found to have cancer of the right breast in 2004. She consulted a plastic surgeon, who offered her only reconstruction with breast implants, she said.

Ms. Hodges chose implants filled with saline, a procedure for which more than a third of reconstruction patients underwent a follow-up operation, studies show.

Ms. Hodges developed wound-healing problems that required her surgeon to remove her right implant, and she was left with a concave chest with a quarter-size hole in it, she said; she described the experience as “worse than the mastectomy.”

Then Ms. Hodges discovered a chat room on the patient-information Web site breastcancer.org, where women share detailed information about breast reconstruction beyond what they may have heard from their doctors.

Ms. Hodges learned of newer, more complex procedures that involve transplanting a wedge of fat and blood vessels from the abdomen or buttocks, which would be refashioned to form new breasts.

“It’s unfortunate that a lot of general surgeons, breast surgeons and plastic surgeons don’t mention it,” said Ms. Hodges, who underwent one of the surgeries, known as a GAP flap, last year. A lifelong athlete and a karate enthusiast, she is now back at her dojo.

To raise awareness of breast reconstruction and to market it to patients, the American Society of Plastic Surgeons has adopted the vocabulary of the movement to support a woman’s freedom to choose an abortion, adjusting it for women with breast cancer. Although women “don’t choose their diagnosis, they can choose to go ahead with reconstruction or not, and with the aid of a knowledgeable plastic surgeon they can choose what their options might be,” Dr. Linda G. Phillips, a plastic surgeon in Galveston, Tex., said in a telephone news conference organized by the plastic surgery society to mark Breast Cancer Awareness Month in October. “Then they have that much more power over their lives if they have that power to choose.”

But for many patients, the options may be limited because their doctors are not proficient in the latest procedures. Dr. Michael F. McGuire, the president-elect of the American Society of Plastic Surgeons, said it is not unusual for surgeons to omit telling patients about operations they do not perform. He compared the rise of more complex breast reconstruction to the advent in the late 1980s of minimally invasive laparoscopic surgery of the gallbladder.

“At the time, only a small percentage of surgeons were doing them and doing them well,” said Dr. McGuire, who is chief of plastic surgery at St. Johns Hospital in Santa Monica, Calif. “If you were not familiar with laparoscopic gallbladder surgery, you were still doing it the traditional way with an open great big scar across the abdomen.”

Uneven information about reconstructive options is a subset of a larger problem, said Dr. Amy K. Alderman, an assistant professor of plastic surgery at the University of Michigan Medical School in Ann Arbor. Only one third of women undergoing operations for breast cancer said their general surgeons had discussed reconstruction at all, according to a study by Dr. Alderman of 1,844 women in Los Angeles and Detroit that was published in February in the journal Cancer.

“In the big picture, it would be great if we could just get doctors to tell people they have an option of reconstruction,” Dr. Alderman said.

Once patients are so informed, she added, plastic surgeons should tell them of options beyond implants. “The next hurdle would be letting them know that using their own tissue is an option, because my guess is that they are not even getting that far in the discussion,” Dr. Alderman said.

About 66,000 women in the United States had mastectomies in 2006, the latest figures available, according to the federal government. And about 57,000 women had reconstructive breast surgery last year, according to estimates from the plastic surgery society.

For many of these women, the operations were more about feeling whole again than about restoring their appearance.

Implant surgery is the most popular reconstruction method in the United States. Often performed immediately after a mastectomy, it initially involves the least surgery ­ usually a short procedure to insert a temporary balloonlike device called an expander ­ and the shortest recovery time.

But implants come with the likelihood of future operations. Within four years of implant reconstruction, more than one third of reconstruction patients in clinical studies had undergone a second operation, primarily to fix problems like ruptures and infections, and a few for cosmetic reasons, according to studies submitted by implant makers to the Food and Drug Administration. (Reconstructive patients are more likely to develop complications after implant surgery than cosmetic patients with healthy breast tissue.)

Complication rates for newer flap procedures like the one Ms. Hodges had have not been well studied, though many surgeons say they are less likely to require follow-up operations. […]

Read the original article here.

Reed Abelson, New York Times: October 26, 2008

After a surgeon removed a cancerous lump from Karen Medlock’s breast in November, he recommended radiation, a routine next step meant to keep cancer from recurring.

But he did not send her for the kind of radiation most women have received for decades.

Instead, the surgeon referred her to a center in Oakland, Calif., specializing in a newer form of treatment where radioactive “seeds” are inserted in the tumor site. It could be completed in only five days instead of the six weeks typically required for conventional treatment, which irradiates the entire breast using external beams.

To Ms. Medlock, it seemed an obvious choice. The newer treatment ­ given through a system called MammoSite ­ has been performed on about 45,000 breast cancer patients in this country since the Food and Drug Administration cleared it for use in 2002.

Only when Ms. Medlock, 49, sought a second opinion did she learn a startling truth: MammoSite is still highly experimental.

The MammoSite system is among the thousands of devices the F.D.A. lets onto the market each year after only cursory review and with no clear evidence that they help patients. Doctors are free to use those products as they see fit, without telling patients that the devices are not proved. And because the doctors are frequently paid more by Medicare as a way to compensate them for the extra time and expense of adopting new procedures, these unproven products can become widely adopted.

F.D.A. officials defend the quick-review process as a way to promote innovation. Because most new products are simply an improvement on an existing device, they say, there is rarely need for a full review.

Demanding lengthy study of such devices would be “very, very inappropriate and a waste of resources,” said Dr. Daniel G. Schultz, the director of the F.D.A.’s Center for Devices and Radiological Health.

The agency let MammoSite on the market on the basis of a study involving only 25 women that did not answer the fundamental question of how effective it is against breast cancer. Six years later, many cancer specialists say there is still no conclusive proof that it works as well as conventional radiation. The F.D.A. says it did require a label warning that the system had not been shown to be a substitute for conventional radiation.

Dr. Valery Uhl, the radiation oncologist who provided Ms. Medlock’s second opinion, outlined the evidence behind the available treatments. Ms. Medlock chose conventional external-beam radiation because of its well-documented record of success in preventing the return of cancer. To use an unproven therapy like MammoSite, Dr. Uhl said, “makes me really nervous.”

Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax. More devices, they say, should get the same scrutiny applied to new drugs. While that process is not perfect, a new drug is typically studied in hundreds or even thousands of patients before the F.D.A. will approve it as safe and effective.

But under the fast-track review for most devices, a product’s effectiveness is never directly established. Regulators simply determine if the device does what its maker says it does ­ in MammoSite’s case, that it delivers radiation ­ and whether it poses any undue safety risks.

“Nobody is looking to see whether they help patients,” said Diane C. Robertson, an executive with the ECRI Institute, a nonprofit group in Plymouth Meeting, Pa., that evaluates new devices for insurers and hospitals. “We’re never going to wisely allocate resources in health care unless we start to focus on what’s best for patients.”

In response to a Congressional request to study the effectiveness of the F.D.A.’s device-review process, the nonpartisan Government Accountability Office is expected to release a report next month.

Critics say that when the F.D.A. clears a device, the public may wrongly assume that the government has proof it is medically effective. F.D.A. approval has been “widely misinterpreted,” said Dr. Jay R. Harris, the chairman of radiation oncology at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.

Differing Opinions

Dr. Dennis R. Hill, the doctor who originally saw Ms. Medlock, scoffs at the notion that MammoSite is in any way experimental. “It is a proven method,” he said. He said the oncologist who told Ms. Medlock it was experimental was skeptical because she provides only traditional radiation.

But the oncologist in question, Dr. Uhl, says she has performed many radioactive-seed treatments but wants to make sure patients are fully informed about the range of options.

Of the 250,000 women in this country who are found to have breast cancer each year, around 200,000 are candidates for radiation treatment if they choose to undergo a lumpectomy or partial removal of a breast. Most still get conventional radiation.

MammoSite proponents say that is because most doctors simply recommend the treatments they know best. “There is a natural bias for radiation oncologists to do what they have been doing,” said David Harding, an executive at Hologic Inc., the company in Bedford, Mass., that markets MammoSite.

Many prominent specialists, though, say the gold standard remains conventional radiation, for which breast cancer local recurrence rates are 3 percent or less at five years. Success in preventing cancer recurrence is measured in long intervals of 5 or 10 years or more, and there has been little long-term study of MammoSite.

Even a radiation oncologist who is a leading proponent of the MammoSite treatment, Dr. Frank A. Vicini, wants to know how it compares with traditional radiation. He is directing a national study of MammoSite’s effectiveness, but he cautions that it could take decades to conclude whether it should be used in lieu of conventional radiation.

“We have to make sure patients know we don’t have 30-year data,” said Dr. Vicini, the chief of oncological services for Beaumont Hospitals in Royal Oak, Mich. “We simply don’t.”

A System From the Past

The nation’s system for regulating medical devices was set up more than three decades ago, when devices played a much smaller role in medicine. A growing chorus of doctors, consumer advocates and health insurance executives say it is overdue for an overhaul.

The process has become “a barrier to evidence development,” said Dr. Winifred S. Hayes, whose firm, Hayes Inc., evaluates new health care technologies.

Although federal drug regulation dates back more than 100 years, medical devices did not come under the government’s purview until 1976, after Congress responded to deaths linked to the Dalkon Shield, an intrauterine contraceptive device.

Because the new law would not apply to devices on the market before 1976, Congress did not want makers of newer products to be at a competitive disadvantage. So lawmakers provided the quick review process for any new product deemed “substantially equivalent” to something already on the market. That expedited process became known as a 510(k) review under the relevant section of the law.

But critics say that what Congress intended as a way to let simple devices quickly enter the market has expanded so much that even critical therapies are cleared without enough research.

“It is supposed to be for the Band-aids of the world,” said Diana Zuckerman, president of the National Research Center for Women and Families, a Washington advocacy group. “The 510(k) process should have been used less and less. It’s being used more.”

But defenders of the F.D.A. process, including the officials in charge of it, argue that tighter gatekeeping could deprive patients of promising alternatives. And they contend that most new medical devices introduced each year involve minor modifications to mundane items like thermometers.

To be sure, sophisticated devices like a new artificial hip or a novel heart stent do go through the same evidence-based scrutiny given to new drugs. Of the 41 medical devices that went through that full review last year and in which the F.D.A. reached a decision, 27 received approval.

But during those same 12 months, the F.D.A. reviewed 3,052 devices under the more cursory 510(k) process and cleared 2,640 of them. […]

Read the original article here.

Liz Szabo, USA TODAY: September 16, 2008

ROCKVILLE, Md. – A hormone-like chemical should be taken out of food packaging, especially baby bottles, infant formula cans and other products used by children and pregnant women, university researchers and consumer advocates told a Food and Drug Administration subcommittee Tuesday.

The FDA has said that the chemical, bisphenol A, or BPA, doesn’t pose a risk at the levels to which people are commonly exposed. BPA has been detected in the bodies of virtually all Americans tested.

But critics questioned why the FDA based that ruling on three studies funded by the chemical industry, all of which found BPA to be safe at current exposure levels. Hundreds of independent studies in animals and cells suggest the estrogen-like chemical poses serious risks.

The newest research – the first large study in humans – links BPA to both heart disease and diabetes in adults. Adults with the highest BPA levels in their urine were more than twice as likely to have heart disease or diabetes than those with the lowest levels, according to the study of 1,455 people, published online Tuesday in The Journal of the American Medical Association. The total number of people with these conditions was small: 79 had heart disease and 136 had diabetes.

In a letter sent to the FDA Tuesday, Sen. Charles Grassley, R-Iowa, Tuesday became the latest lawmaker to ask the agency FDA why it gave preference to industry-funded studies. Grassley – who noted that much of the research rejected by the FDA was paid for by the National Institutes of Health – asked the FDA to provide copies of all communication with the American Chemistry Council, which funded one of the pivotal studies cited by the FDA.

FDA scientist Laura Tarantino said the agency relied on industry studies because they were very large and included raw data, which allows the FDA to independently verify the findings. But Frederick vom Saal, a University of Missouri professor, says the industry studies’ flaws make them useless in deciding on a safe exposure level for BPA. “The FDA is ignoring all of this research,” vom Saal says. “While it has been doing that, Americans have been at risk.”

The FDA’s report puts it at odds with the National Toxicology Program, which this month expressed “some concern” that BPA alters the brain, behavior and prostate in fetuses and children. That study included many studies that were not weighed in the FDA safety standard. Babies are mainly exposed to BPA through liquid infant formula, which is usually sold in metal cans lined with the chemical, as well as bottles made of polycarbonate plastic, according to the FDA report. Powdered formula probably is much less contaminated with BPA. John Bucher, the toxicology program’s associate director, says this put formula-fed infants most at risk.

D. Gail McCarver, a pediatrician at the Medical College of Wisconsin, says the FDA report underestimates how much BPA children are exposed to. She notes that the report’s safety ruling is based on “average” exposures for formula-fed infants – even though some babies may consume much more than average. “I do not believe we should be protecting our children at an average level,” McCarver says.

Consumer activists have warned about the dangers of BPA for a decade. Now that research also finds disease in humans, activists say the FDA needs to revise its ruling that the chemical is safe in everyday use.

At the very least, the FDA should require a prominent warning on products made with BPA, says Diana Zuckerman, president of the National Research Center for Women & Families. Products made with BPA today are rarely labeled, making it difficult for consumers to avoid them.

The FDA received about 200 public comments on its draft report. About 20 people – most opposed to the use of BPA – spoke at the hearing. Sonya Lunder of the Environmental Working Group says it’s especially important to protect fetuses and infants from BPA, because they are the most vulnerable to hormonal influences. Yet she says babies are exposed to more than 12 times as much BPA per pound of body weight as adults.

McCarver says there’s a critical need to measure BPA exposure in babies, especially premature infants, who are exposed to many plastic medical devices and tubes while in the hospital.

But McCarver says she doesn’t support completely banning BPA, which is used to make life-saving bicycle helmets. If manufacturers replace it with another chemical, she says, there should be thorough tests to make sure the replacement is safe.

Jared A. Favole, CNNMoney.com: September 8, 2008

ROCKVILLE, Md. – (Dow Jones) – A panel of medical experts on Monday said Pfizer Inc.’s (PFE) proposed osteoporosis drug has benefits for postmenopausal women, but suggested the drug be restricted to women at high-risk of fracture or those who fail other treatments.

Pfizer is seeking U.S. Food and Drug Administration approval for the drug to treat osteoporosis, which generally leads to bone fractures, in postmenopausal women. Nine panel members said the benefits of Fablyn outweigh the risks, three said it didn’t and one member abstained.

Panel members, overall, said the drug would give women an alternative to other osteoporosis treatments, some of which have multiple side effects, and would most benefit postmenopausal women at “high risk” of fractures, said Chairwoman Sandra Carson, a professor of gynecology at Brown University.

Scott Monroe, director of the FDA’s urologic and reproductive product division, said the panel’s thoughts didn’t represent a clear rejection of the drug, “nor a clear endorsement.”

It’s unclear whether the FDA will approve the drug, and if it will suggest restricting it to a certain population of women. The FDA will consider the panel’s advice in its decision. The FDA has until sometime in October to make a decision. A rejection of Fablyn would be a setback for Pfizer as analysts estimate the drug could bring in peak sales of $1 billion.

For its part, Pfizer believes Fablyn offers “unique benefits” for postmenopausal women at high risk for fractures, spokesman Jack Cox said in a statement.

Fablyn belongs to a group of medicines that work like the hormone estrogen in some parts of the body and not in other parts. These drugs, called selective estrogen receptor modulators, may exert beneficial effects in some tissues without the side effects associated with estrogen. Eli Lilly & Co.’s (LLY) Evista osteoporosis drug is in that category.

FDA officials has raised concerns in pre-meeting documents that Fablyn puts patients at a higher risk of death than a placebo, but a majority of panel members said there wasn’t enough information for them to substantiate that claim.

“I’m really dismayed that we don’t have a head-to-head trial” of Fablyn with other FDA-approved drugs, said panel member Clifford Rosen. Rosen, a senior scientist at the Maine Center for Osteoporosis, added, “Without head-to-head trials, we really can’t make absolute definitions about what drugs work and don’t work.”

Pfizer said the increased number of deaths appears to be due to an unusually low mortality rate for the placebo group during the study period.

Groups representing women made presentations during the public portion of the meeting, and came down against Fablyn.

“Clearly the benefits of this drug are really small,” said Diana Zuckerman, president of the Washington-based nonprofit National Research Center for Women & Families.

Cindy Pearson, executive director of the National Women’s Health Network, a consumer advocacy group, said there isn’t enough information presently for women to make decisions on whether this drug is good for them.

Pfizer has brought this drug before the FDA two other times. In 2005, the FDA rejected Pfizer’s application of the drug – then called Oporia – for prevention of osteoporosis and in 2006 rejected it for a second indication of vaginal atrophy, both times because of concerns about increased risk of endometrial cancer. Pfizer resubmitted the drug with all-new data last December as Fablyn for treatment of osteoporosis.

Meghan McCarthy, CQ Healthbeat News: September 4, 2008

A new report from the Advanced Medical Technology Association, or AdvaMed, aims to stress the safety and efficacy of the current Food and Drug Administration (FDA) process for approving medical devices to counter criticism of the process that could appear in an upcoming Government Accountability Office (GAO) report.

GAO reports released in January and May of this year have been highly critical of the FDA’s medical device approval processes. The reports found that the agency has not met requirements to inspect domestic plants manufacturing medical devices every two years, and that FDA also faces major challenges inspecting foreign establishments. The new GAO report is expected to be released in September.

The approval process — also known as a 510(k) — is used for products that the FDA determines to be a low or moderate risk to consumers and are similar to devices already approved. A 510(k) is significantly faster — usually around 90 days — than the pre-market approval process used for higher risk devices, which can take more than 180 days. Additionally, 510(k) approval is less expensive, as companies are not required to conduct clinical trials on the products.

The industry has argued that the 510(k) process draws unfair criticism because it is frequently misunderstood despite its ubiquitous use by the FDA. AdvaMed estimates the 510(k) process is used to approve 90 percent of medical devices on the market.

“This process is misunderstood because people look at legislation and look at regulations, and they don’t always remember that some of these things need to be quite broad in order to apply to a whole range of medical devices. People who are not intimately involved with the process, who don’t have to put together the submissions can easily come to that conclusion,” said Susan Alpert, senior vice president at Medtronic and a former director of the FDA’s Office of Device Evaluation.

But many believe that the 510(k) process is neither safe nor effective. Last year, the process came under congressional scrutiny by the House Energy and Commerce Health Subcommittee, which reviewed the safety and efficacy of the expedited approval process in the lead-up to legislation (HR 3580 – PL 110-85) that extends the user-fee programs for medical devices and mandates the GAO report on 510(k) approval.

In the report, AdvaMed said patient injuries that occur as a result of devices that have been approved through 510(k) are not evidence of a faulty approval system; instead, report authors highlight faulty manufacturing processes as the cause of device failure, and also emphasize the impossibility of knowing all risks associated with a device in the pre-market phase.

“Further, the long-term effects of devices will never be fully identified and problems eliminated by clinical evaluation in the pre-market period, whether the FDA review is through the PMA or 510(k) processes. In essence, the experience cited by the program’s critics is independent of the pathway to market.”

The report references the deterioration of a jaw implant made by Vitek Inc. as a case that critics use to highlight the pitfalls of 510(k) approval. The report said that injuries occurred due to manufacturing problems, not the 510(k) process.

“Based on this unfortunate experience, it has been inferred that had the device been regulated through the more rigorous PMA program, the failures would not have occurred. This line of thinking is simply flawed.”

In congressional testimony last year, National Research Center for Women and Families President Diana Zuckerman called attention to Boston Scientific’s ProteGen bladder sling, which was approved through the 510(k) process despite being made with a synthetic material different from its predecessor. After implementation, some ProteGen devices began to break down in patients’ bodies, causing major infections and significant harm.

A Boston Scientific spokesman said the company could not comment on the ProteGen device. “Due to pending litigation, it is not appropriate for us to comment at this time,” he said.

AdvaMed members emphasized the historical precedence set by Congress in permitting the FDA to interpret what makes devices similar. In 1990, Congress codified the FDA’s definition of “substantial equivalency” as a device that maintained a similar intended use to its predecessor, and it could include technological developments if the safety of the product was not brought into question.

“Intended use is a pretty broad term, and it really gave the FDA a fair amount of discretion in determining what was and was not a new intended use. The agency typically made that determination based on risk,” said Pat Shrader, senior vice president of corporate, regulatory and external affairs at BD. “Congress did not see a need to go back and make a fundamental change, they merely adopted what FDA was already doing.”

In an interview Zuckerman said, “The problem is that the definition of what is an ‘substantially equivalent’ device has become such a loose definition that it no longer has a scientific or logical meaning. The original definition was pretty good . . . it did not mean you could change what the thing is made out of, and it doesn’t mean you can use a different mechanism of action.”

Alpert said the development of the 510(k) process along with technological advances in the medical device industry has allowed the FDA to keep up with industry and consumer needs.

“When the program first started most products were tool-type products. This industry has evolved significantly in 30-plus years and the program has evolved right along side that . . . it gives the FDA the authority and capacity to state and design specific controls for different technologies to uniquely regulate the different types of products while building off knowledge that has been gained in these many years,” Alpert said.

Zuckerman said improvements to the 510(k) process start with a redefinition of what low- to moderate-risk products are. “A lot of these devices are not of lower risk to patients. An implanted device is never lower risk — it may not be life-saving, but it could become life threatening — once you put something into someone’s body it can do some harm. Anything implanted should go through the pre-market approval process.

“The requirement that GAO do a report was just the first step in dealing with this problem, which I believe has gotten worse over time and is worse today than when I testified a year ago,” Zuckerman said.

Christopher Lee, Washington Post: August 16, 2008

A controversial chemical commonly found in can linings, baby bottles and other household products does not pose a health hazard when used in food containers, according to a draft assessment released by the Food and Drug Administration yesterday.

The report stands in contrast to more than 100 studies performed by government scientists and university laboratories that have found health concerns associated with bisphenol A (BPA). Some studies have linked the chemical to prostate and breast cancers, diabetes, behavioral disorders such as hyperactivity and reproductive problems in laboratory animals.

Exposure to the small amounts of BPA that migrate from the containers into the food they hold are not dangerous to infants or adults, the draft said.

“FDA has concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses,” regulators wrote in the draft report, which will be reviewed Sept. 16 at a meeting of members of an FDA advisory committee studying the safety of the chemical.

The chemical industry and the agencies that regulate the use of BPA, the FDA and the Environmental Protection Agency, have deemed the chemical safe, largely on the strength of two industry-funded studies that found no problems. The American Chemistry Council welcomed the findings of the new report.

“FDA is the premier agency responsible for the safety of our food,” Steven G. Hentges, an executive of the group, said in a statement. “FDA’s thorough analysis confirms that food contact materials containing BPA can continue to be used safely.”

FDA critic Diana Zuckerman, president of the National Research Center for Women and Families, said the agency lacks sufficient data to declare the chemical safe.

“Clearly, their effort was to minimize people being concerned about this,” Zuckerman said. “It just seems that whenever there is an opportunity to look at a new, important issue, they just seem to be siding with industry’s point of view.”

BPA, in commercial use since the 1950s, is found in many everyday items, including compact discs and automobiles. One federal study estimated the chemical is present in the urine of 93 percent of the population.

Concerns about the safety of BPA have kept the chemical industry on the defensive in recent months.

Canadian regulators recently decided to ban the controversial compound in baby products. Wal-Mart, the nation’s largest retailer, and Toys R Us, the largest toy seller, have said that by January their shelves will be free of children’s products containing BPA.

Democrats in Congress have introduced one bill that would ban the chemical in products intended for use by children younger than 8, and another that would restrict its use in food containers. Neither bill has advanced beyond the committee stage.

“Ask any mother of a child if there is an adequate margin of safety for the things that she puts her child in contact with,” said Liz Hitchcock, public health advocate for U.S. PIRG, a consumer advocacy group. “When you’re talking about the stuff that’s going to carry your child’s food into their body, you want the safest thing possible.”

Kevin Freking, AP news services: August 4, 2008

WASHINGTON –Outside experts may not participate in federal advisory committee meetings on drugs and medical devices if they have more than a $50,000 financial interest in the companies governed by their decisions, according to new guidelines released Monday.

The Food and Drug Administration’s guidance formalizes draft policy issued in March 2007. If an adviser’s financial interest falls below $50,000, the FDA may grant them a waiver that allows them to participate, but will do so only if they find there is an essential need for the adviser’s particular expertise.

“It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent,” Randall Lutter, a deputy FDA commissioner said Monday.

Advisory committee members often represent the world’s leading authorities on a particular disease or condition. Drug and device makers often pay them lucrative consulting and speaking fees, but such financial arrangements also can lead to the appearance of a conflict of interest.

Last year, the FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of a new anticancer drugs for use in children.

Jill Hartzler Warner, a senior policy adviser at the FDA, said excluding people from committees who have some financial interest in the drug and device industry would make it extremely hard to find qualified advisers. “The industry relies on recognized experts. So do we,” she said.

In 2006, researchers reviewed 221 meetings by 16 boards. They found that disclosure of conflicts of interest at advisory committee hearings was commonplace and rarely results in someone being barred from participating. The researchers, writing in the Journal of the American Medical Association found a “weak relationship” between the financial conflicts and voting behavior. However, excluding committee members from the vote would not have altered the outcome at any of the meetings studied.

Dr. Sidney Wolfe, one of the authors of that study, said the agency weakened proposed restrictions for those with a financial interest of less than $50,000. Previously, the FDA proposed allowing participation in meetings, but not a vote. Now, it will consider waivers that could allow them to vote. Still, he described the guidance as a step in the right direction.

“Over time, the percentage of people who have these (conflicts) will diminish,” said Wolfe, director of Public Citizen’s Health Research Group. “A lot of it will have to do with how much energy the FDA is willing to expend to find people who don’t have a conflict of interest.”

Diana Zuckerman, president of the National Research Center for Women & Families, said the $50,000 threshold was too high. She said she was concerned that too many advisers below the threshold would get waivers that allow them to vote.

“The FDA has consistently used a very low standard for granting waivers, and there is no evidence that this will change,” she said.

Hartzler Warner said the new guidance is much stricter than past policy. She said the agency will limit the number of waivers it grants and it will insist that an adviser show the waiver is necessary to provide the committee with essential expertise.

Rep. Maurice Hinchey, D-N.Y., said the FDA’s waiver policies had led to a broken system in which advisory panels were filled by experts with direct financial interests in the drugs and devices being reviewed.

“By making the standard for waivers more stringent and improving the voting system, the FDA is moving closer toward ensuring the only interest taken into account during these advisory panels is that of the American people,” Hinchey said.

The $50,000 cap was one of several policy changes announced Monday. The agency also recommended that advisory board members vote all at one time, rather than one at a time.

“Simultaneous voting avoids voting momentum, in which some voters may be influenced, even subconsciously, by the votes of those who precede them,” the agency said in a press release.

The agency also recommended that all votes be announced immediately at the meeting, and it said that all votes will be detailed on the FDA’s Web site.

——

On the Net:

http://www.fda.gov

Fox News: August 3, 2008

When someone well-known such as Christina Applegate is diagnosed with breast cancer, many adult women become concerned as to what the future holds for them.

While it’s true that 1 out of 8 American women will be diagnosed with breast cancer at some point in her lifetime, there are also a lot of misconceptions about the disease floating around.

Although Applegate is just 36 years old, the fact remains that breast cancer is more likely to strike women over the age of 50.

Still, many women under the age of 40 may now be tempted to run out and demand mammograms.

But mammograms are ineffective for most young women, Dr. Diana Zuckerman, president of the National Research Center for Women & Families, told FOXNews.com in October.

“Young women’s breasts are dense and if they get mammograms, their breasts show up very white on mammograms and cancer shows up as white,” she said. “But, as women get older, their breasts are less dense and show up gray on a mammogram, which makes it easy to identify the white cancer. If there is a family history, and women are worried, they can start earlier and in this case a digital mammography may work better than a traditional mammography.”

Here are five myths about breast cancer:

— There’s no history of breast cancer in my family so I won’t get it.

“That’s not true,” Dr. Marisa Weiss, an oncologist and the president of breastcancer.org, said previously. Although women with a family history are at a higher risk for the disease, environmental factors, drinking, smoking, medication and diet can all influence a woman’s chances of getting breast cancer.

Knowing the history of breast cancer on both sides of your family is also important. Just because a woman doesn’t have a history of breast cancer on her mother’s side, doesn’t mean she’s at a decreased risk. A paternal family history of breast cancer also increases a woman’s chances of getting it.

— I have breast cancer, so I have to get a mastectomy if I want to stop the spread and prevent the cancer from coming back.

Very few women diagnosed with breast cancer actually need a mastectomy, said Zuckerman. “In fact, most of the women who get mastectomies don’t need them,” she said. “And for women to lose their breasts, in addition to the normal emotional turmoil that they go through having breast cancer, is harmful emotionally and physically.”

Specifically, Zuckerman said that about 75 percent of the women who get breast cancer each year will not need mastectomies. Many women with stages 0, 1 or 2 breast cancer respond well to treatment that includes a lumpectomy with radiation and chemotherapy, she added.

“Women with early stage breast cancer usually do not need a mastectomy and will benefit from chemotherapy almost always,” said Zuckerman. “Women who get a lumpectomy will need radiation and that’s the difference. Women who get a mastectomy will not need radiation, but with a lumpectomy you always need radiation.”

— Young women are just as likely to get breast cancer as older women.

Both Weiss and Zuckerman agree that this also is not true. Women older than 50 are most at risk for this disease, explained Zuckerman.

“Breast cancer in women younger than 30 is so rare, and this is one of the things that concerns me,” she said. “I think the media focuses on young women, because it’s so shocking when someone in their 20s gets cancer. But what you end up with are women in their 20s and 30s who are terrified that they’re going to get cancer and women in their 50s who think they don’t need to worry about it, when the opposite is true.”

Of the nearly 200,000 women who will get breast cancer next year, half will be over the age of 61, said Weiss. About 25,000 women will be under the age of 40.

“It’s still a significant number, but when you compare it to the overall number of women who get breast cancer, it’s a small percentage,” she said.

— Breast cancer is fatal.

“Breast cancer is not fatal in and of itself,” said Zuckerman. “What makes it fatal is if it goes into other parts of the body and gets into the lymph nodes, lungs and other organs,” she said.

“Also if it gets into the blood or the bones, it can kill a person. That’s the risk of metastasized cancer. That means it has spread and once it hits the lymph nodes, it can become out of control.”

Zuckerman said early detection is the best way to prevent cancer from spreading.

— Men don’t get breast cancer.

“This is certainly not true,” said Weiss. “Men do get it.”

The American Cancer Society estimates that about 2,030 new cases of invasive breast cancer will be diagnosed in men this year, and about 450 men will die after getting the disease.

Still, breast cancer is about 100 times more common in women, and women whose fathers are diagnosed with breast cancer are at an increased risk for the disease just as they would be if their mothers are diagnosed with it, added Weiss.

Lyndsey Layton,Washington Post: August 2, 2008

Samantha Rosenberg eyed the toy plastic cellphone that her 9-month-old daughter has chewed so much, the color is fading. She wondered if the shiny plaything, and others that fill her home, are endangering Addison’s health.

Congress this week approved a ban on a family of chemicals widely used in soft plastic toys and other baby products. Health advocates say the compounds, known as phthalates, have been linked to kidney and liver cancer and to reproductive disorders in fetuses and infants, especially boys.

Toymakers and the chemical industry ran an expensive lobbying campaign trying to block the legislation, arguing that phthalates have been used commercially since the 1950s, that they are safe and that the ban is an overreaction.

Rosenberg and other consumers are not sure what to think.

“Am I being neurotic, or is it really not safe?” Rosenberg, a 30-year-old District resident, said about the toy cellphone. “It just gets compounded, because everything is plastic and made in China. You end up worrying about lead paint, plastics, all these things our parents never worried about.”

Her questions are echoed by millions of parents who feel overwhelmed by conflicting information and are struggling to strike the right balance. For those discussing toy safety at neighborhood playgrounds, in Internet chat rooms and in the toy aisles of big-box stores, every plastic geegaw has grown suspect.

“In the past six months, I started freaking out about the BPA stuff and plastic toys,” said Sherri Bohinc, a 32-year-old mother of two young children who lives in Bethesda, referring to health concerns raised about bisphenol A, another additive used in plastic. “In Target, I’ll ask other moms shopping in the same aisles what they think about a toy. I’ve run into some really paranoid moms, and then I run into people who are like, ‘Eh, don’t pay attention.’ ”

Kara Dillon, 29, a mother of two in Surprise, Ariz., threw out baby bottles that contained BPA and replaced them with BPA-free bottles. Now the phthalates ban leaves her wondering whether to toss her children’s soft plastic toys, too.

“It’s really hard as a mom to know what to do,” Dillon said. “As consumers, we’re buying what’s out there, and you just trust the companies — especially when it comes to things designed especially for babies — that they’re safe.”

The United States is one of the last industrialized nations to outlaw phthalates in children’s products. The European Union has banned them since 1999. California was the first state to approve a ban; it takes effect in January. Lawmakers in Washington state and Vermont have followed suit.

The federal ban will take effect six months after President Bush signs it, which he is expected to do in the next several weeks. That means it would not be in place until after the holiday season. Wal-Mart, the nation’s largest retailer, and Toys R Us, the largest toy seller, have said that by January their shelves will be free of children’s products containing BPA and phthalates.

Chemical companies, including ExxonMobil, which manufactures the phthalate most often found in toys, have argued that banning the compounds could force toymakers to use substitutes that pose greater risks. But several alternative chemicals used to make toys for the European market have been found to be safer than phthalates, said Janet Nudelman of the Breast Cancer Fund, which pushed for the U.S. ban. Chemical makers say the alternatives are not as cheap or versatile as phthalates.

It is nearly impossible for consumers to tell whether a children’s product contains phthalates because chemical ingredients are not listed. Some toy manufacturers do not even know what is in the plastic they buy from suppliers.

Diana Zuckerman, president of the National Research Center for Women and Families, which lobbied in favor of the phthalates ban, suggested that parents get rid of soft, squeezable plastic teethers, rattles and other toys and wait until the ban takes effect before buying replacements.

“Don’t keep them around your house for visiting friends with children, or to gather dust in your child’s room,” she said. “And don’t give them as hand-me-downs to relatives or charities.”

Zuckerman stressed that she was referring to soft plastic toys, such as plastic books, rubber ducks and teething toys.

She also cautioned that many shampoos and lotions for babies and children contain phthalates. Personal care products are not covered by the ban because the legislation applies to the Consumer Product Safety Commission, which does not have jurisdiction over cosmetics, shampoos and lotions. Zuckerman said the next goal for health advocates is to bar phthalates from cosmetics, perfumes and products that children and adults slather on their skin, which readily absorbs the chemicals.

“Everybody in Congress is now well aware that phthalates are ubiquitous and exposure is coming from many different products,” Zuckerman said. “And children’s toys are probably not the main culprit. Clearly, the next step is personal care products.” […]

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