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US FDA Staff Say Agency May Need New Device Powers

News Stories & Editorials
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.[…]

 

Read the original article here.

Statement by Diana Zuckerman on Maryland’s Senate Bill 213 "Child Care Articles and Toys Containing Bisphenol-A Prohibition," February 17, 2010

Legislation
Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, February 17, 2010

Thank you for the opportunity to testify about Senate Bill 213 on behalf of the National Research Center for Women & Families and our Cancer Prevention and Treatment Fund.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific health and safety issues.

In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, a resident of Maryland, and I was previously the chair of the Women’s Health Promotion Council for the state of Maryland, appointed by the Governor.

I was trained in epidemiology and public health at Yale Medical School; was on the faculty at Yale and Vassar; and directed a longitudinal research project at Harvard, and I bring that scientific perspective to my testimony today. I have worked on health policy issues in Congress, the White House, and for nonprofit organizations for 26 years.

Our Center strongly supports Senate Bill 213, which will help to ensure that Maryland’s children are better protected from the adverse health effects of BPA.

Bisphenol A (BPA) is a chemical used to make plastics, and is frequently used in baby bottles, water bottles, and medical devices.  It is also used in an epoxy coating on the inside of almost all food and beverage cans-including infant formula cans.

We think of plastic as being solid, but research shows that BPA leaches out of the plastic or epoxy lining into the liquid or food in the container.  The Centers for Disease Control and Prevention found BPA in the bodies of more than 93 percent of the U.S. population studied.[1]

BPA mimics and interferes with estrogen-an important hormone in reproduction and development.[2]   Scientists are concerned about BPA’s behavioral effects on fetuses, infants, and children at current exposure levels, and whether it can increase the risk of prostate cancer and breast cancer, cause early puberty, or affect the brain and behavior.[3]

There is research that claims that the levels of BPA in consumer products are not harmful, but that research is funded by companies with financial ties to BPA.  It is not objective research, and it is not credible research.  That is why the FDA has finally admitted their concerns about BPA and is funding new research to better understand the risks and the FDA is working with companies to decrease or eliminate BPA in its area of jurisdiction (such as food and beverage containers).  The U.S. Department of Health and Human Services is also providing information to consumers on how to reduce exposure to BPA.

While the federal government is studying BPA, who is protecting Maryland’s children?  Parents shouldn’t need a PhD in chemistry when they shop for baby bottles, infant formula, and children’s products.  Most parents assume that potentially harmful chemicals are not allowed in products made for children.  If only that were true.

BPA levels are especially high in the bodies of infants and children,3 and children are especially vulnerable to BPA.  So it makes sense that this legislation focuses on children.

New Research Shows BPA Increases Health Risks

A study published last month based on a major government data set, the NHANES, found that adults with higher levels of BPA in their urine were more likely to have heart disease, even when other variables were statistically controlled.[4]  That study replicated the findings of an earlier study published in the Journal of the American Medical Association, which found a link between BPA levels and diabetes and heart disease, even when obesity was statistically controlled.[5] While this shows that BPA in adults is potentially very harmful, remember that these types of health problems can start in childhood.  That’s why this bill is so important.

 If a pregnant woman is exposed to BPA, then even before her child is born, he or she will be exposed to the chemical.  Pregnant women don’t have a special diet of canned foods and beverages-they eat the same food as everyone else.  That’s why we need to be concerned about BPA exposure from all containers for foods and beverages commonly consumed by adults.  And, of course, we need to remove BPA from liquid infant formula cans.

BPA may interfere with chemotherapy, especially for breast cancer patients.  A study published in Environmental Health Perspectives in February 2009 found that the effectiveness of chemotherapy could be undermined by exposure to BPA among breast cancer patients.[6]  This means that BPA in all foods and beverages consumed by adults are potentially dangerous for chemotherapy patients.

Alternatives Available

Senate Bill 213 explicitly states that BPA may not be replaced with chemicals rated by the EPA as carcinogens or reproductive toxicants.  Safer alternatives to BPA are available.  Japan has reduced BPA in consumer products, such as canned beverages and plastic tableware. They are using different linings for beverage cans that are much safer, and plastic tableware that had BPA has been replaced with tableware that does not.[7]  Canada has designated BPA as the highest priority chemical in need of regulation and in effect has banned its use in infant products.

Several cities and states across the U.S. have weighed the scientific evidence and are seeking to implement bans. Suffolk County in New York became the first in the U.S. to ban BPA in baby bottles and sippy cups, in March 2009.  In Congress, bills were introduced in the U.S. Senate and House of Representatives (S. 593/H.R. 1523) to ban BPA in children’s products.  However, given the numerous stalemates in the U.S. Congress, it is crucial that Maryland protects its children by passing Senate Bill 213.

Responsible retailers are not waiting for state or federal governments to act. Wal-Mart and Toys-R-Us have pledged to remove products containing BPA from their shelves.[8] Bottle manufacturers, such as Playtex and Nalgene, are using non-BPA materials for their products. SUNOCO, a BPA manufacturer, announced last year that it would require customers to confirm that no BPA would be used in food or water containers for children under 3 years of age.[9] Despite this progress, however, baby bottles and child care articles with BPA are still being sold and being used by our babies and children in Maryland and most other states.

Keeping Consumers Safe

The bottom line is that there is a growing body of scientific evidence that the cumulative exposures to BPA are endangering our children and probably also adults.  More than 100 well-designed scientific studies, many conducted by independent researchers without conflicts of interest, have raised doubts about the safety of BPA.  And, safer alternatives to BPA are available. If we want to protect our babies and children in Maryland, then it is important to ban BPA in infants’ and children’s products.

Thank you for your leadership by holding a hearing on Senate Bill 213.  We strongly urge you to support this important bill and join with us in finding ways to better protect Maryland’s children and adults from the risks of BPA.

References:

 

[1] Hileman, B. (2007, April). Bisphenol A on Trial. Chemical & Engineering News Government & Policy, Vol. 85, Number 16.  Retrieved April 3, 2009 from http://pubs.acs.org/cen/government/85/8516gov2.html

[2] Schierow, L., Lister, S.A. (2008, May). Bisphenol A (BPA) in Plastics and Possible Human Health Effects.

Congressional Research Service Report for Congress, The Library of Congress.

[3] National Toxicology Program. U.S. Department of Health and Human Services (HHS). (2008, September). NTP-CEHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A.  Retrieved April 3, 2009 from http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf

[4] Melzer, D., Rice, N.E., Lewis, C., Henley, W.E., and Galloway, T.S. (2010, January).  Association of Urinary Bisphenol A Concentration with Heart Disease:  Evidence from NHANES 2003/06. PLoS ONE, 5(1), e8673.  Retrieved January 13, 2010 from http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0008673

[5] Lang I.A., Galloway T.S., Scarlett A. et al. (2008). Association of Urinary Bisphenol A Concentration With Medical Disorders and Laboratory Abnormalities in Adults. Journal of American Medical Association 300(11),1303-1310.

[6] Barrett JR 2009. Trumped Treatment?: BPA Blocks Effects of Breast Cancer Chemotherapy Drugs. Environ Health Perspect 117:A75-A75. doi:10.1289/ehp.117-a75.  Retrieved January 13, 2010 from http://ehsehplp03.niehs.nih.gov/article/fetchArticle.action?articleURI=info%3Adoi%2F10.1289%2Fehp.117-a75

[7] Advanced Industrial Science and Technology. (2007). Risk Assessment Document: Bisphenol A.

[8] Parker-Pope, T., (2008, April 22). A Hard Plastic is Raising Hard Questions, The New York Times.

[9] Rust, S. and Kissinger, M. (2009, March 12). Maker acknowledges BPA worries. JSOnline. Milwaukee Wisconsin Journal Sentinel. Retrieved on April 3, 2009 from  http://www.jsonline.com/watchdog/watchdogreports/41186522.html

Letter to Hon. Andrea M. Boland, Maine House of Representatives, in support of “Children’s Wireless Protection Act,” February 1, 2010

Legislation
February 1, 2010

The Honorable Andrea M. Boland
State Representative
Maine House of Representatives
2 State House Station
Augusta, ME 04333

Dear Representative Boland:

The Cancer Prevention and Treatment Fund of the National Research Center for Women & Families strongly supports the “Children’s Wireless Protection Act.”  We are very pleased that your legislation would require cell phones sold in Maine to have a prominent warning label on the phone and its packaging stating that the device may cause brain cancer and that cell phone users-especially pregnant women and children-should keep the phone away from their heads and bodies.

We have discussed cell phone radiation issues with many of the experts that are recommending that pregnant women and children limit their cell phone use, and are very concerned about the possible long-term risks for adults and children.  A study published in 2008 in Physics in Medicine and Biology revealed that the brains of children under 8 absorb twice as much radiation from cell phones as adult brains.[1] According to Swedish researcher Lennart Hardell, people who begin using cell phones (and cordless landline phones) before the age of 20 are at an even higher risk of developing brain tumors than people who begin using these wireless phones as adults.[2], [3]

While most cell phone studies have focused on cancer, a study published in the medical journal Epidemiology suggests that cell phone exposure could affect children’s behavior.[4] The children in the study who were hyperactive or had emotional or behavioral problems, including trouble getting along with other kids, were much more likely to have mothers who used cell phones during pregnancy. The problems were even more pronounced for children whose mothers used cell phones both during pregnancy and during their children’s first seven years of life. These children were 80% more likely to have problems than children whose mothers rarely or did not use cell phones. While it is impossible to determine whether the problem is primarily from radiation exposure or if mothers who use cell phones frequently while caring for their children differ from other mothers in ways that affect their offsprings’ behavior, the research results have important implications that deserve further attention, and that parents would want to know about.

The extensive use of cell phones is a relatively recent phenomenon, and since cancers usually take at least 10-20 years to develop, it will be years before research is likely to conclude whether cell phones cause cancer or not. However, the growing body of evidence indicates cause for concern, and delaying warnings now could result in tragedies later.

A review of 18 studies of cell phones and brain tumors, published in Occupational and Environmental Medicine in 2007, concluded that studies of individuals using cell phones for more than 10 years “give a consistent pattern of an increased risk for acoustic neuroma and glioma,” with the risk being highest for a tumor on the same side of the head that the phone is used.[5] Gliomas are the most common cancerous brain tumor and acoustic neuromas are benign tumors of the acoustic nerve that can cause deafness.   Gliomas are the type of cancer that killed Sen. Kennedy and columnist Robert Novak.

Neurosurgeon Vini Khurana, Lennart Hardell and other scientists, conducted a meta-analysis of 11 studies published in peer-reviewed journals on long-term cell phone use and the risk of developing brain tumors.  The authors concluded, in their article in Surgical Neurology in September 2009, that using a cell phone for ten or more years “approximately doubles the risk of being diagnosed with a brain tumor” on the side of the head where the cell phone user holds the phone.[6]

Research also indicates that cell phone radiation (known as Radio Frequency-Electromagnetic Radiation or RF-EMR) harms sperm and may result in reduced fertility.[7] The lead researcher on that study, Dr. John Aitken from the University of Newcastle in Australia, recommends that men of reproductive age who would like to have children should avoid carrying cell phones in their pockets or anywhere below the waist. It is noteworthy that this warning is based on the much lower level of radiation emitted while a phone is on in a pocket but not being used for a call. Cell phones emit a higher level of radiation during a phone conversation.

Cell phone companies insist that evidence shows their phones are safe, but the industry tends to focus on studies they fund themselves and that draw conclusions that will keep their business booming.   Generally, industry-funded studies do not evaluate on which side of the head the phone was used, have rarely included business customers with corporate accounts (who tend to be the heaviest cell phone users), and their studies measure regular cell phone use as at least one call per week, and most of the people in their studies have used cell phones for less than 9 years.[8] These shortcomings almost ensure that the studies will not find a significant increase in cancers.

Prominent cancer researchers are not waiting for definitive studies, but are urging people to curb their cell phone use now.   For example, the director of the University of Pittsburgh Cancer Institute, Dr. Ronald Herberman, warned his staff in July 2008 that the risks from cell phone radiation justified precautions, such as using ear pieces and minimizing cell phone usage by children.[9]

For the above reasons, the Cancer Prevention and Treatment Fund of the National Research Center for Women & Families strongly supports your pioneering, proactive legislation.  The “Children’s Wireless Protection Act” would help protect the health of Maine residents by making the state the first to require warning labels that radiation from cell phones may cause brain cancer.

Sincerely,

Diana Zuckerman, PhD

President

Cancer Prevention and Treatment Fund

National Research Center for Women & Families

References:

[1] Wiart J, Hadjem A, Wong MF, Bloch I. (2008) Analysis of RF exposure in the head tissues of children and adults. Physics in Medicine and Biology 53(13): 3681-3695 (15).

[2] Hardell L, Carlberg M, Hansson Mild K. (2009) Epidemiological evidence for an association between use of wireless phones and tumor diseases. Pathophysiology 16 (2-3): 113-122.

[3] Hardell L, Hansson Mild K, Carlberg M, Hallquist A. (2004) Cellular and cordless telephones and the association with brain tumours in different age group. Archives of Environmental Health 59 (3): 132-137.

[4] Divan HA, Kheifets L, Obel C, Olsen J. (2008) Prenatal and Postnatal Exposure to Cell Phone Use and Behavioral Problems in Children. Epidemiology 19(4): 523-529.

[5] Hardell L, Carlberg M, Soderqvist F, Hansson Mild K, Morgan LL (2007). Long-term use of cellular phones and brain tumours: increased risk associated with use for = 10 years. Occupational and Environmental Medicine 64(9):626-632.

[6] Khurana VG, Teo C, Kundi M, Hardell L, Carlberg M (2009) Cell phones and brain tumors: A review including the long-term epidemiologic data. Surgical Neurology 72(3): 205-214.

[7] De Iuliis GN, Newey RJ, King BV, Aitken RJ (2009) Mobile Phone Radiation Induces Reactive Oxygen Species Production and DNA Damage in Human Spermatozoa In Vitro. PLoS One 4(7):e6446.doi:10.1371/journal.pone.0006446. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0006446 (Accessed August 17, 2009).

[8] Schuz J, Jacobsen R, Olsen JH, et al. (2006) Cellular telephone use and cancer risk: Update of a nationwide Danish cohort. Journal of the National Cancer Institute 98: 1707-1713.

[9] “Researcher warns of brain cancer risk from cell phones. July 24, 2008. The New York Times. http://www.nytimes.com/2008/07/24/technology/24iht-cellphone.4.14767955.html

Complete warning from Herberman can be read at: http://www.upci.upmc.edu/news/pdf/The-Case-for-Precaution-in-Cell-Phone-Use.pdf

FDA Does About-Face on Exposure to BPA

News Stories & Editorials
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. […]

 

Read the original article here.

F.D.A. Concerned About Substance in Food Packaging

News Stories & Editorials
Denise Grady, New York Times: January 15, 2010

In a shift of position, the Food and Drug Administration is expressing concerns about possible health risks from bisphenol-A, or BPA, a widely used component of plastic bottles and food packaging that it declared safe in 2008.

The agency said Friday that it had “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children,” and would join other federal health agencies in studying the chemical in both animals and humans.

The action is another example of the drug agency under the Obama administration becoming far more aggressive in taking hard looks at what it sees as threats to public health. In recent months, the agency has stepped up its oversight of food safety and has promised to tighten approval standards for medical devices.

Concerns about BPA are based on studies that have found harmful effects in animals, and on the recognition that the chemical seeps into food and baby formula, and that nearly everyone is exposed to it, starting in the womb.

But health officials said there was no proof that BPA was dangerous to humans.

“If we thought it was unsafe, we would be taking strong regulatory action,” said Dr. Joshua Sharfstein, the principal deputy commissioner of the drug agency, at a news briefing.

Nonetheless, health officials suggested a number of things people could do to limit their exposure to BPA, like throwing away scratched or worn bottles or cups made with BPA (it can leak from the scratches), not putting very hot liquids into cups or bottles with BPA and checking the labels on containers to make sure they are microwave safe. The drug agency also recommended that mothers breastfeed their infants for at least 12 months; liquid formula contains traces of BPA.

BPA has been used since the 1960s to make hard plastic bottles, sippy cups for toddlers and the linings of food and beverage cans, including the cans used to hold infant formula and soda. Until recently, it was used in baby bottles, but major manufacturers are now making bottles without it. Plastic items containing BPA are generally marked with a 7 on the bottom for recycling purposes.

The chemical can leach into food, and a study of more than 2,000 people found that more than 90 percent of them had BPA in their urine. Traces have also been found in breast milk, the blood of pregnant women and umbilical cord blood.

Reports of potential health effects have made BPA notorious, especially among parents, and led to widespread shunning of products thought to contain the chemical. Canada, Chicago and Suffolk County, N.Y., have banned BPA from children’s products.

The government will spend $30 million on BPA research in humans and animals, to take place over 18 to 24 months, health officials said at a news briefing on Friday.

Dr. Linda Birnbaum, director of the National Institute of Environmental Health Sciences, said the research would involve potential effects on behavior, obesity, diabetes, reproductive disorders, cancer, asthma, heart disease and effects that could be carried from one generation to the next.

Activists on both sides of the passionately debated issue said they were disappointed in the government’s action. The American Chemical Council, which represents companies that make and use BPA, issued a statement saying BPA was safe, praising the health agencies as confirming that there was no proof of harm to people by it, but also saying, “We are disappointed that some of the recommendations are likely to worry consumers and are not well founded.”

Diana Zuckerman, president of the National Research Center for Women and Families, said the F.D.A. had not gone far enough, because its recommendations put the responsibility on families and not on companies making products containing BPA. In addition, Ms. Zuckerman said, the focus on safety should not be limited to children, because studies have linked the chemicals to heart and liver disease and other problems in adults.[…]

 

Gardiner Harris contributed reporting from Washington.

Read the original article here.

Patient and Consumer Coalition Letter to Congressional Leaders, January 8, 2010

Legislation
January 8, 2010

The Honorable Nancy Pelosi
Speaker
United States House of Representatives
Washington, DC 20515

Dear Speaker Pelosi:

Thank you for your tireless efforts to expand quality, affordable health care coverage to millions of Americans. In merging the House and Senate health care bills, members of the Patient and Consumer Coalition strongly urge you to include the House language on comparative effectiveness research.

The Senate language proposes the establishment of a non-profit “Patient-Centered Outcomes Research Institute,” and requires that the Governing Board include several members representing “pharmaceutical, device, and diagnostic manufacturers or developers.”

In a recent New England Journal of Medicine (NEJM ) article entitled, “Industry Influence on Comparative-Effectiveness Research Funded through Health Care Reform,” well-respected health policy experts Dr. Harry Selker and Dr. Alastair Wood noted that “Embedded in the Senate legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research.”

By proposing that the center for comparative effectiveness research be within the Agency for Healthcare Research and Quality (AHRQ), the House language avoids industry conflict-of-interest. AHRQ is well-established and well-respected, and comparative effectiveness research is consistent with AHRQ’s mission of improving “the quality, safety, efficiency and effectiveness of health care for all Americans.” The House language allows comparative effectiveness research to be done scientifically and objectively. Comparative effectiveness research done in this manner should save lives and improve medical care by reducing the use of ineffective treatments, including pharmaceuticals, medical devices, and inaccurate, unreliable, or potentially dangerous medical tests.

We realize that AHRQ has received some criticism for guidelines proposed by the U.S. Preventive Services Task Force. We want to point out that the Task Force is an independent entity and is not comprised of AHRQ employees, nor does AHRQ control their guidelines or how those guidelines are communicated. Whether you admire the Task Force for their work over the years or criticize them for their conclusions or communication skills, is irrelevant to the issue of whether AHRQ should be the entity entrusted with comparative effectiveness research. Clearly, AHRQ has the expertise and objectivity needed for the comparative effectiveness research that will provide patients and healthcare providers with the information they need to make the best possible medical decisions.

Objective comparative effectiveness research is urgently needed. In 2009, an Institute of Medicine report on the topic stated: “All too often, the information necessary to inform…medical decisions is incomplete or unavailable, resulting in more than half of the treatments delivered today without clear evidence of effectiveness.”

The goal of comparative effectiveness research should be to provide patients, physicians, and healthcare providers with the best available information to help assess the effectiveness of various treatments and therapeutics. This cannot be done if the studies are influenced by companies whose products are being evaluated or conducted by researchers with financial conflicts-of-interest. For this reason, we strongly urge you to include the House language on comparative effectiveness research in the final health care reform bill.

Sincerely,

Breast Cancer Action
Center for Medical Consumers
Community Access National Network
Consumers Union
Government Accountability Project
National Consumers League
National Physicians Alliance
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
National Women’s Health Network
Reproductive Health Technologies Project
Steven E. Nissen, MD
THE TMJ Association
Union of Concerned Scientists
U.S. PIRG
Woodymatters

The Patient and Consumer Coalition includes nonprofit organizations that represent patients, consumers, health care providers, scientists, researchers, and other stakeholders who believe that our nation’s health care will improve if based on the best possible objective evidence to support sound medical decision-making.
For additional information, contact Paul Brown at the National Research Center for Women & Families, (202) 223-4000 or pb@center4research.org

Read the original letter here.

FDA Defends Plastic Linked To Health Risks

News Stories & Editorials
Allison Aubrey, National Public Radio: September 17, 2008

Read the original article here.

The Food and Drug Administration defended Tuesday a controversial compound found in plastic baby bottles and in food packaging. A major study has linked bisphenol A to possible risks of heart disease and diabetes.

Transcript:

STEVE INSKEEP, host:

The Food and Drug Administration has taken another step toward allowing continued use of a chemical. It’s a chemical found in everything from baby bottles, to food containers, to sunglasses, to compact discs. It’s called bisphenol A, or BPA. But a number of scientists say BPA is dangerous, and their side got a boost this week from a new study, as NPR’s Allison Aubrey reports.

ALLISON AUBREY: At a public meeting yesterday, the Food and Drug Administration made its case to a panel of scientific advisers. Michelle Twaroski, a staff toxicologist at the FDA, presented a PowerPoint on how her team assessed the risks of BPA using the best available animal studies, and she summed up the agency’s thinking.

Dr. MICHELLE TWAROSKI (Staff Toxicologist, Food and Drug Administration): In conclusion, FDA has considered the available data and determined that the margin of safety for bisphenol A exposure in all populations is adequate, and the continued use of bisphenol A in the manufacturer of food contact substance is concluded to be safe.

AUBREY: But during the next two hours of the hearing, the panel heard from members of the public and outside scientists who take issue with this conclusion. Diana Zuckerman heads an advocacy group called the National Research Center for Women and Families. She criticized the FDA for including so few studies in its assessment. She argued that relying on industry-funded animal studies is not a comprehensive approach.

Dr. DIANA ZUCKERMAN (President, National Research Center for Women and Families): Since these food containers are not proven safe, the FDA should not be assuring us that they are safe. It does feel like there’s been a rush to judgment by the FDA, and that does none of us any good.

AUBREY: One the studies not included in the FDA review is published this week in the Journal of the American Medical Association. It comes from researchers in Great Britain. They studied about 1,400 adults, the largest human study to date of BPA. And they found that people who had the highest levels of BPA in their urine were more than twice as likely to have developed diabetes and heart disease. This is compared to those who had the lowest levels of BPA in their urine. The study finds an association between these diseases and BPA, but it does not prove a cause and effect. Environmentalist John Peterson Myers wrote an editorial on the study that was also published in the medical journal. He spoke at the hearing yesterday.

Dr. JOHN PETERSON MYERS (Founder, CEO, Chief Scientist, Environmental Health Sciences): It is very clear that the FDA cannot conclude with certainty that BPA is safe. That option is no longer open to you given these new data.

AUBREY: Concerns about BPA have grown in recent years largely on the basis of animal studies. Some have shown that the chemical, even at low doses, can harm fetuses and offspring of mice and rats. Other studies, including some financed by the chemical and  action solar industries, find no cause for alarm. Steven Hentges heads the Polycarbonate/BPA Global Group of the American Chemistry Council. He says he trusts the FDA’s assessment.

Dr. STEVEN HENTGES (Executive Director, Polycarbonate/BPA Global Group, American Chemistry Council): We actually think the FDA draft report is quite comprehensive, it’s quite thorough. It included assessments from international bodies who have reviewed the scientific literature comprehensively.

AUBREY: The panel of FDA advisers now has six weeks to review the agency’s assessment and weigh in on whether they agree that the continued use of BPA in food containers is safe. Allison Aubrey, NPR News, Washington.

FDA posts list of potential problem drugs

News Stories & Editorials, Skin Cancer
By Ricardo Alonso-Zaldivar
Associated Press
2008

 

WASHINGTON – The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients.

The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed.

Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.

“My message to patients is this: Don’t stop taking your medicine,” said Dr. Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”

At least five of the drugs on the list had problems that already have been publicized. These included the blood thinner heparin, recalled earlier this year, and immune-suppressing medications being studied for a link to cancer in youngsters.

One emerging concern that previously got little attention involved Tysabri, a newer, widely used multiple sclerosis drug. The FDA said it is investigating a potential link to skin melanoma, a dangerous cancer. Doctors in Boston had reported two cases of melanoma in Tysabri patients in a letter to the New England Journal of Medicine in February. Tysabri suppresses the immune system, and it has also been linked to a rare kind of brain infection that is often fatal. Manufacturer Biogen Idec Inc. said it does not believe there is an increased risk of melanoma.

The FDA said drugs will be placed on the list based on reports it receives from hospitals, doctors and patients.

“What’s new here is that we are telling the public really at the earliest stage what we are working on,” said Dr. Gerald Dal Pan, head of the FDA’s drug safety office. “I think the public told us, ‘We want to know what you are working on.’ And we are responding to that.”

The list is not just a reflection of raw data, but more like what a police officer would call “probable cause.” Officials said a drug will only be listed if FDA safety reviewers determine that a reported problem deserves a closer look.

“Our hope is that this list will serve not only as a means of communication to the public, but that it will also serve to encourage (medical) providers to provide us with additional reports should they see similar kinds of adverse events with the drugs that are on the list,” said Dr. Paul Seligman, who is responsible for the FDA’s safety communications.

Consumer advocates called the listing a positive step, but said it needs to be fleshed out.

“It’s a good thing to get started but it needs to have much more detail if it’s to have significant safety value,” said Thomas J. Moore, a senior scientist with the Institute for Safe Medication Practices. “A table with just a few words of description is quite limited.”

“It’s just the most basic warning system,” said Diana Zuckerman, president of the National Research Center for Women and Families. “It’s not going to say how many reports there were. It’s not going to say how many died and how many were hospitalized.”

Nor is it clear how drugs suspected of a problem will be removed from the list if later exonerated.

The Pharmaceutical Research and Manufacturers of America, the main industry lobbying group, said it supports giving more safety information to doctors and patients, but worries that some will be needlessly alarmed.

“Our reservation is that patients will be abruptly stopping therapy,” said Alan Goldhammer, a vice president of the organization. “One can’t generalize with an emerging safety notice. It may affect half the patients, a quarter of the patients, or only a small subset of the patients.”

Lung Cancer and Hormone Therapy: Bad News for Former and Current Smokers

Diet, Habits, & Other Behaviors, Lung Cancer, Medical Treatments with Cancer Risks
Stephanie Portes-Antoine and Brandel France de Bravo, MPH, Cancer Prevention and Treatment Fund

Because of the risks of breast cancer, stroke, and other serious health problems, experts warn that women should only use hormone replacement therapy if the symptoms of menopause are causing major problems in their quality of life. In those situations, they should use the lowest possible dosage for the shortest period of time.[1] As a result of decreased use of hormone therapy, the breast cancer rate has declined in the United States in recent years. Nevertheless, the combined form of hormone therapy—consisting of estrogen and progestin—is still used by about 15% of postmenopausal women, with more than 25 million prescriptions written every year.[2]

As of June 2009, there is yet another reason to avoid taking hormone therapy. New research shows that hormone therapy can increase a woman’s chance of dying from lung cancer. Lung cancer is the leading cause of cancer deaths in women.

A large government study of post-menopausal women, called the Women’s Health Initiative (WHI), has been the major source of scientific information about the risks of hormone therapy since 2002. A new analysis published in June 2009 found that women who took hormone replacement therapy for five or more years were more likely to die of non-small cell lung cancer than women in the study who did not take hormone therapy.[3] Non-small cell lung cancer accounts for 85% of all lung cancer cases.

There were 16,000 women participating in the WHI study, ages 50 to 79, who either took Prempro, a drug combining estrogen and progestin, or took a placebo. Smoking rates were similar in both groups: half had never smoked, 40% were past smokers, and 10% were current smokers.

The risk of developing lung cancer was similar in both groups, but the women taking the hormones were about 60% more likely to die of lung cancer than the women taking a placebo. Not surprisingly, the risk was highest for current smokers, followed by past smokers, and lowest for never smokers. Among the women who smoked (former or current smokers), 3.4% of those taking hormone therapy died of lung cancer compared to 2.3% for women taking the placebo.

Among women who never smoked, 0.2% of hormone users died from lung cancer, compared with 0.1% of those who got the placebo. While the risk of dying from lung cancer was very small for women who never smoked, almost twice as many women died in the hormone group than in the placebo group. Because of the small number of non-smokers who died from lung cancer in this study, the increase is not statistically significant, which means it could have happened by chance. Research with larger samples is needed to tell us whether even non-smokers are at greater risk of lung cancer if they take hormone therapy.

These findings are consistent with previous research suggesting a link between hormone therapy and non-small cell lung cancer.[4,5] In the Journal of Clinical Oncology in 2006, Dr. Apar Kishor Ganti and his colleagues at the University of Nebraska reported that women with lung cancer who used hormone replacement therapy did not live as long as women who did not use hormones, even though the women receiving hormone therapy were younger.[6] Hormone therapy’s effect on survival was especially pronounced for women with a history of smoking.

According to Dr. Karen Reckamp, assistant professor of medicine at City of Hope Cancer Center in Duarte, California, “We see more and more non-smoking women getting lung cancer in general and often younger women. We know that there are estrogen receptors in the lung and in lung cancers and so there’s definitely an interaction between the development of lung cancer and hormones.”[7] The results from the Women’s Health Initiative study indicate that for most women, the risks of hormone therapy are much higher than the benefits, and we now know this is especially true for women who smoke or used to smoke.

References:

  1. Santoro E., DeSoto M., and Lee JH. Hormone Therapy and Menopause. National Research Center for Women & Families. February 2009. http://center4research.org/medical-care-for-adults/hormone-therapy/menopause-and-hormones/
  2. Smith M. ASCO: Combined Hormone Therapy Linked to Lung Cancer Mortality. MedPage Today. May 31, 2009. http://www.medpagetoday.com/MeetingCoverage/ASCO/14459
  3. Chlebowski RT et al. Non-small cell lung cancer and estrogen plus progestin use in postmenopausal women in the Women’s Health Initiative randomized clinical trial. Journal of Clinical Oncology, 2009 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 27, No 15S (May 20 Supplement), 2009: CRA1500.
  4. Negaard HFS, Eilertsen AL, Anders DA, Iversen PO. Decreased Lung Cancer Survival with Hormone Replacement Therapy: Caused by a Decreased Tissue Factor Pathway Inhibitor Level? Journal of Clinical Oncology. June 10, 2006; 24(7): 2683-2684.
  5. Siegfried JM. Hormone Replacement Therapy and Decreased Lung Cancer Survival. Journal of Clinical Oncology. January 1, 2006; 24(1): 9-10.
  6. Ganti AK, Sahmoun AE, Panwalkar AW, Tendulkar KK, Potti P. Hormone Replacement Therapy is Associated with Decreased Survival in Women in Lung Cancer. Journal of Clinical Oncology. January 1, 2006; 24(1):59-63.
  7. Karen Reckamp, M.D, assistant professor of medicine, thoracic oncology division, City of Hope Cancer Center, Duarte, Calif. May 30, 2009, American Society of Clinical

HPV: Q & A

Cervical Cancer & HPV
Brandel France de Bravo, MPH, Maushami DeSoto, Ph.D., and Krystle Seu, Cancer Prevention and Treatment Fund

Q: What do I need to know about HPV?

A: Human Papilloma Virus (HPV) is the name for a group of viruses that cause cervical cancer, genital warts and several other diseases. There are more than 120 different types of HPV. Many of them are spread through sexual contact and affect the genital areas of men and women. Although most types of HPV do not increase the risk of cancer, some types spread through sexual contact can cause cancers in male or female genitals, the anus, or the throat area. In fact, two types-HPV 16 and HPV 18-are responsible for approximately 70% of all cases of cervical cancer. You should also know that HPV infections are usually asymptomatic, meaning people who are infected don’t even realize they have the virus. Most of the time HPV infections clear up by themselves the same way a person with a cold virus gets better with time. Nine out of ten people are “over” their HPV, regardless of the type, in less than two years.

Q: What is this HPV vaccine, Gardasil?

A: Gardasil is the first vaccine ever sold in the U.S. to prevent cancer: cervical cancer. It was approved by the FDA in June 2006 for use among girls and women between the ages of 9 and 26. It helps protect them from 4 of the more than 120 types of HPV. It provides protection against HPV 6 and HPV 11, which cause 90% of genital warts, and against HPV 16 and HPV 18, which are responsible for 70% of cervical cancer cases. In addition to protecting girls and women who were never before exposed to HPV, it can also protect a sexually active girl or woman who was previously exposed to HPV from getting re-infected. If a girl or woman is actively infected with HPV at the time of vaccination, however, the vaccine would not protect her against cervical cancer. The vaccine does not protect against most of the other types of HPV that cause 30% of cervical cancers, and it can’t be used to “cure” or treat an active HPV infection. This is why it’s so important that women who are sexually active get regular PAP smears (every 3 years) starting at age 21. Pap smears are able to detect cervical cancer in its early stages when treatment is most effective.

Q: How long does the vaccine’s protection last?

A: According to Gardasil’s Web site (www.gardasil.com), it has not been established exactly how long the vaccine’s protection lasts. Gardasil is still very new, and because cancers can take years to develop it will be many years before we know conclusively how effective the vaccine is in providing lifelong protection against cervical cancer. However, studies of antibodies of vaccinated girls and women have shown that the vaccine’s protection against HPV 18-one of the two types of HPV that cause cervical cancer-may wear off for many girls and women in as little as 3 years. Uncertainty about the duration of the vaccine’s protection on top of the high cost (about $400-$1,000 for all three doses) should make you think twice about rushing out to get it.

Q: You’re saying that the protection may not last more than a few years. Is there a booster shot to make it last longer?

A: The manufacturer of Gardasil, Merck, has not publicly stated that a booster shot is needed, but in their key study for the FDA, the company gave a booster shot to all the girls and women after 60 months (5 years)-just a week before they tested their antibodies and concluded that the vaccine provided protection after 5 years! Even in the study, Merck didn’t call this additional shot a booster shot, but rather a “challenge dose”-as if they were trying to confuse anyone reading the study results. And it worked. Most health officials are not aware that the vaccine apparently requires a booster.

Even worse, the company did not compare women who got this extra (booster) dose to those who didn’t. As a result, nobody knows how long the vaccine lasts without a booster. And the company has not published any research to show how long the booster lasts either. Is it one year, 3 years, 5 years, 10 years? There is no public information about it.

Q: How much does the vaccine cost?

A: Gardasil is the most expensive vaccine to have ever been recommended for school-age children. The vaccine manufacturer charges $120 for each dose (not counting the doctor’s fee), and the total cost per patient for the initial 3-shot regimen ranges from $400-$1,000. If the HPV vaccine is mandated in your state and you can not afford to pay for it, the cost will be covered by the Federal Government which provides the vaccine to clinics and health providers that participate in the Vaccines for Children program. The high cost of the vaccine and the unknowns about the cost and frequency of booster shots raise serious concerns about mandating the vaccine for 12 year olds.

Q: What’s the best age to get vaccinated with Gardasil?

A: Because the vaccine’s protection against HPV 18 can wear off in as little as three years, a girl vaccinated at 12 could lose her protection against cervical cancer just when she is most likely to become sexually active-at 15 or 16.

Health officials have recommended that girls get vaccinated at age 12 based on Merck’s conclusion that Gardasil is not effective against current (active) HPV infections, and therefore is most effective for girls who are not yet sexually active. But the company’s own research shows that the vaccine is as effective or more effective among girls and women with previous (not active) HPV infections as among young girls who have never been exposed to HPV through sex. This is good news because older girls and women with past exposure to HPV are clearly sexually active and therefore are more in need of the protection that Gardasil provides. New research from France also supports this: a French researcher recently presented results of a study on 17,000 women and found that Gardasil prevented cervical lesions among women with previous HPV exposure at nearly the same rate as it did among women with no previous HPV exposure.

This new research means that the only girls or women who would not benefit from Gardasil are those that have current, active infections at the time that they are vaccinated. From a cost-effectiveness point of view, even if the vaccine is effective for a few years, it is probably better to wait until a girl or women is sexually active before vaccinating her, instead of vaccinating 12-year olds. But, unless a booster lasts a very long time, it will be very expensive to keep getting vaccinated, no matter how old a girl or woman is when she is first vaccinated.

Q: What are the side effects and risks of Gardasil?

A: As of August 2008, more than 20 million doses of Gardasil had been distributed in the U.S. and there were 10,326 reports registered through the CDC’s Vaccine Adverse Event Reporting System (VAERS). Minor side effects, such as pain or tenderness at the injection site, are quite common. The most common side-effect observed since Gardasil became available to the public is fainting after receiving the vaccine, which is being dealt with by warning health providers to keep patients under observation for 15 minutes after giving the shot.

Serious but rare side effects such as Guillain-Barré Syndrome (GBS), which causes muscle weakness, have been reported. According to the CDC, cases of GBS following administration of Gardasil do not represent a statistically significant increased risk, even though 9 of the 13 reported cases of GBS occurred during a biologically plausible time frame, meaning that the vaccine could plausibly be the cause. A few girls who were vaccinated with Gardasil have died, but it is not known if the vaccine is the cause.

More research is needed to determine if girls or women vaccinated with Gardasil are at an increased risk for GBS or other serious side effects.

Like any medical product, a vaccine’s risks must be weighed against its benefits. This is why it is so important to determine how long the vaccine lasts and how well it works. Since the vaccine is so expensive, if it provides only a few years protection, almost any risk becomes unacceptable.

Q: Does anyone else make a more effective or less expensive HPV vaccine?

A: Cervarix, made by Glaxo Smith Kline, has been approved for use in at least 66 countries in Europe and Australia. It is not yet approved for use in this country because the Food and Drug Administration (FDA) asked for longer-term studies of Cervarix than it required of Gardasil. Published studies suggest that Cervarix may provide protection against the two viruses that cause most cervical cancer (HPV 18 and 16) for at least 6.4 years. The FDA will not approve Cervarix until the necessary studies are completed, and we won’t know much about the studies until FDA reviews them. Comparisons of the two vaccines would enable policy makers to make better-informed decisions, and the availability of a second, competing HPV vaccine might help make vaccinating against HPV more affordable.

Q: What are other ways of preventing HPV?

A: Cervical cancer can be prevented with routine cervical cancer screening (Pap smears) and follow-up of abnormal results. The Pap test can identify abnormal or pre-cancerous changes in the cervix so that they can be removed before cancer develops. Even if you have been vaccinated with Gardasil, you have to get regular Pap screening because the vaccine doesn’t protect against all the types of HPV that can cause cervical cancer.

HPV is spread by skin to skin contact. Sexual intercourse is not necessary. The more people who you have been sexually active with, the more likely you are to get an HPV infection. This also applies to the number of sexual partners your partner may have had. When sexually active, using a condom correctly can greatly reduce the chances of being exposed to HPV as well as other sexually transmitted illnesses and viruses. But sex with just one person or even contact that you wouldn’t think of as sexual can be enough to spread HPV. According to the Centers for Disease Control, about 10% of all children have been exposed to HPV 16, the most cancerous of the HPV types, in their first ten years of life. This sounds scary but remember that 90% of cases of HPV clear up all by themselves-without any long-lasting effects-in two years or less.

Q: Should boys get Gardasil?

A: Merck is asking the FDA to approve Gardasil for boys and men, because it can prevent genital warts. It can also prevent anal and throat cancers, but those cancers are rare (although more common among gay men than heterosexual men).However, until we know how long Gardasil can protect against the viruses causing cancer or genital warts, and until we know more about the risks of side effects, it is impossible to know if the benefits outweigh the risks for boys and men.