All posts by CPTFeditor

FDA Review Indicates Possible Association Between Breast Implants and a Rare Cancer

Breast Cancer, Other Cancers
January 26, 2011

This FDA press release was published on January 26, 2011 and was copied from its original location here.

Agency requesting health care professionals to report confirmed cases.

The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.

The FDA is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.

In an effort to ensure that patients receiving breast implants are informed of the possible risk, FDA will be working with breast implant manufacturers in the coming months to update their product labeling materials for patients and health care professionals.

“We need more data and are asking that health care professionals tell us about any confirmed cases they identify,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in FDA’s Center for Devices and Radiological Health. “We are working with the American Society of Plastic Surgeons and other experts in the field to establish a breast implant patient registry, which should help us better understand the development of ALCL in women with breast implants.”

According to the National Cancer Institute, ALCL appears in different parts of the body including the lymph nodes and skin. Each year ALCL is diagnosed in about 1 out of 500,000 women in the United States. ALCL located in breast tissue is found in only about 3 out of every 100 million women nationwide without breast implants.

In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide. This number is difficult to verify because not all cases were published in the scientific literature and some may be duplicate reports. An estimated 5 million to 10 million women worldwide have breast implants.

The FDA notification is based on a review of scientific literature published between January 1997 and May 2010 and information from other international regulators, scientists, and breast implant manufacturers. The literature review identified 34 unique cases of ALCL in women with both saline and silicone breast implants.

Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the ALCL diagnosis.

The FDA is recommending that health care professionals and women pay close attention to breast implants and do the following:

  • Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online1 or by calling 800-332-1088.
  • Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
  • There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants.  Although not specific to ALCL, health care providers should follow standard medical recommendations.
  • Women should monitor their breast implants and contact their doctor if they notice any changes.
  • Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.

The FDA published its literature review in a document posted on FDA’s website site today titled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.”

The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.

FDA Sees Possible Cancer Risk with Breast Implants

News Stories & Editorials
Associated Press: January 26, 2011

WASHINGTON (AP) – Federal health officials said Wednesday they are investigating a possible link between breast implants and a very rare form of cancer, raising new questions about the safety of devices which have been scrutinized for decades.

The cancer, known as anaplastic large cell lymphoma, attacks lymph nodes and the skin and has been reported in the scar tissue which grows around an implant. The Food and Drug Administration is asking doctors to report all cases of the cancer so the agency can better understand the association.

The agency has learned of just 60 cases of the disease worldwide, among the estimated 5 million to 10 million women with breast implants. The agency reviewed the scientific literature going back to 1997 along with information provided by international governments and manufacturers.

Most of the cases were reported after patients sought medical care for pain, lumps, swelling and other problems around the surgical site. […]

 

A handful of researchers have published papers on instances of the lymphoma in breast implant patients over the last three years, prompting FDA’s review. Some research suggests bits of silicone can leak into cells around the implant, triggering the cancer. Even saline implants include trace amounts of silicone to help them maintain their shape.

The lymphoma is an aggressive form of cancer though it is often curable, according to experts. Treatments include radiation, chemotherapy and a bone marrow transplant, if the disease returns. […]

 

The FDA pulled silicone breast implants off the market in 1992, saying manufacturers had not provided medical data showing their safety and effectiveness. At the time, there were worries about a connection to a variety of diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.

But in 2006 the agency returned the implants to the market after most studies failed to find a link between silicone breast implants and disease.

The approval came with conditions, including a requirement that the companies complete 10-year studies on women who have already received the implants to study leaks, as well conduct new decade-long studies of the safety of the devices in 40,000 women.

The FDA said the companies have continued to pursue those studies, though several of them have enrolled less than half of the patients needed to make them statistically significant.

Dr. Diana Zuckerman said the studies “will be completely useless unless the FDA can convince the companies to do more to keep women in their studies.” Zuckerman’s group, National Research Center for Women & Families, opposed the FDA’s decision to re-approve silicone implants. […]

 

FDA Explores Possible Link Between Breast Implants, Cancer

News Stories & Editorials
Andrew Zajac, Los Angeles Times: January 26, 2011

The Food and Drug Administration announced Wednesday that it has begun investigating the possible connection between breast implants and an increased risk of a rare form of cancer.

Though the number of women who may develop the disease is small, there is apparently no way to identify those who are likely to develop it — making it a source of potential concern to all women with the implants.

Among women who do not have implants, the cancer — anaplastic large cell lymphoma, or ALCL — develops in the breast tissue of about 3 out of 100 million women nationwide.

But among women who do have implants, FDA investigators say they have identified as many as 60 women who have developed ALCL worldwide, out of an estimated global population of 5 million to 10 million women with implants.

The FDA did not provide an incidence number for women with implants who developed the disease in the United States alone.

The agency said the number of known cases was too few to draw a conclusion that implants were linked to the disease.

FDA officials emphasized the small risk and said that women with implants don’t need to do anything more than be vigilant.

The FDA advised women not to change their routine medical care, but it said they should consult a physician if they notice swelling, pain or lumps around implants after postsurgical healing.

“Women who are not showing any symptoms or problems require only routine follow-up…. FDA is not recommending the routine removal of breast implants,” said William Maisel, chief scientist and a deputy director of the FDA’s medical device office.

ALCL is a treatable cancer of the immune system, and its occurrence in the breast does not equate to breast cancer, Maisel said.

“I think there’s reason to be concerned about this, but there shouldn’t be reason for panic,” said Phil Haeck, president of the American Society of Plastic Surgeons. Signs of ALCL associated with implants “are pretty dramatic. There’s a lot of swelling and pain. They won’t miss it,” Haeck said.

To better understand the development of ALCL, the plastic surgeons group has agreed to report all cases of ALCL to a national registry established by the FDA.

The FDA also will ask the two U.S. manufacturers of implants, Allergan of Irvine and Mentor Worldwide Santa Barbara, to update product labeling to include information about ALCL.

“We fully support FDA’s efforts to gather additional data and study ALCL in patients with breast implants,” Mentor said in a statement.

An Allergan spokeswoman said in a statement that when ALCL has occurred, “most of the patients have responded to a variety of treatments, including simple removal of the implant and surrounding scar capsule.”

“A woman is more likely to be struck by lightning than get this condition,” the statement said.

But the head of a leading women’s health advocacy group said that the risk, while small for individuals, is still alarming.

“It raises a red flag about what other immune disease could be occurring that are not obvious,” said Diana Zuckerman, president of the National Research Center for Women & Families.

Zuckerman noted that there have been reports that Allergan and Mentor have lagged in meeting benchmarks for 10-year safety studies of implant recipients required by the FDA. […]

 

Read the original article here.

Maryland Woos Away Top Deputy at the FDA

News Stories & Editorials
Lyndsey Layton and John Wagner, Washington Post, January 5, 2011

Joshua M. Sharfstein, the second-in-command at the Food and Drug Administration, is leaving that post after less than two years to become Maryland’s top public health official, Gov. Martin O’Malley said Tuesday.

The offer from O’Malley (D) came two weeks ago after John M. Colmers told the governor that he intended to step down after four years as Maryland’s secretary of health and mental hygiene, Sharfstein said.

“It was not that I was looking to leave or was burned out,” Sharfstein said in an interview Tuesday. “I was committed to the FDA. But opportunities like this don’t come along very often. It’s a really great job at a really important moment in time, and with terrific leadership in the state.

“It was impossible to turn it down.”

The new job, which Sharfstein will start next week, touches a broad array of public health issues, including infant mortality, HIV/AIDS, substance abuse, mental health and implementation of health-care reform.

The FDA had no comment on Sharfstein’s departure, according to spokeswoman Karen Riley.

Sharfstein, 41, led the FDA transition team for the Obama administration and aimed to restore the agency’s public health mission. Critics had complained that the FDA grew too cozy with the industries it regulates during the George W. Bush administration.

Once Obama tapped him to help lead the agency, Sharfstein reviewed the FDA’s approval process for medical devices and drugs. He led an investigation into the controversial approval of a knee surgery device, which resulted in the unusual finding that the FDA had incorrectly approved the device because of political pressure.

Under Sharfstein and FDA Commissioner Margaret A. Hamburg, the FDA has stepped up enforcement, cracking down on deceptive claims by foodmakers, quality problems with over-the-counter pediatric medicines, and producers of caffeinated alcoholic beverages.

Sharfstein also tried to get the agency to do a better job of explaining its actions to the public.

Diana Zuckerman, president of the National Research Center for Women & Families, said Sharfstein “inherited a dysfunctional agency, and he made substantial progress on many fronts. His efforts have saved lives, but there’s a lot more work to be done.” […]

 

Read the original article here.

A Closer Look at HPV and the HPV Vaccine

Cervical Cancer & HPV
Megan Cole, Diana Zuckerman, PhD, Brandel France de Bravo, MPH, and Janet A. Phoenix, MD, Cancer Prevention and Treatment Fund

What is HPV?

The human papillomavirus virus, also known as HPV, is the most common sexually transmitted infection-both in the U.S. and around the world. In fact, approximately 20 million Americans are currently infected with HPV, and another 6 million become newly infected every year.[1] By age 50, 70-80% of all women will have contracted at least one strain of HPV. The virus is transmitted through skin-to-skin contact and is usually sexually transmitted-vaginally, anally, or sometimes, orally. However, many of the HPV types can be transmitted through non-sexual contact as well.

This virus may lead to several types of cancers in women, including cancers of the cervix, vulva, vagina, and anus. However, a person is much more likely to get cervical cancer than the other three cancers combined. There are approximately 130 strains of HPV, some of which may cause warts and others which may cause cancer. Of these strains, two types cause 70% of cervical cancer cases (strains 16 and 18) and two types cause 90% of genital warts cases (strains 6 and 11).[1] Most HPV infections in adolescents are short term-70% of infections disappear within a year and 90% disappear within two years. However, while most HPV infections go away on their own, it is possible for abnormal cells to develop on the cervix, vulva, vagina or anus when high-risk types of HPV persist over time. If those high-risk abnormal cells (CIN 2, CIN 3 or HSIL, which stands for “high-grade squamous intraepithelial lesions”) are not detected and treated, they can eventually cause cancer.[2]

It takes about 15-20 years for this to happen, and meanwhile, the women are unlikely to have symptoms. That’s why HPV can go undetected and cause cancer, especially for those without access to regular Pap smears or other medical care.[3]

Although HPV and cervical cancer are a concern for all women, in the U.S., the women with the highest rates of cervical cancer are minority and low-income women. While far fewer women die of cervical cancer in the U.S. compared to many other countries, it is still a deadly disease for thousands of women every year.  African-American women are twice as likely to die from cervical cancer as white women. One study found that cervical cancer rates for whites were 9.2 per 100,000, compared to 12.4 for African Americans and 16.8 for Hispanics. The same study reported death rates of 2.7 per 100,000 for whites, compared to 5.9 for African Americans and 3.7 for Hispanics.[4]

When women die of cervical cancer, it is usually because they have not had a Pap smear in many years, if ever, and their cancer is caught very late. Pap smears detect cervical cell changes early on, helping to save lives. In fact, having a regular screening every 2 to 3 years greatly reduces a woman’s risk of getting cervical cancer. The widespread use of the Pap test has reduced cervical cancer in the U.S. by more than half over the past 30 years.[5]

Poverty is a risk factor as well: a 2007 study showed that 23% of women living below the poverty line tested positive for high-risk HPV (strains 16 and 18), while only 12% of women living at least three times above the poverty line tested positive for high-risk HPV.[6] This is probably due to lower-income women having fewer Pap smears.

To reduce your risk of death from HPV causing cervical cancer, the best strategies are:

1.  Get regular Pap smears. They detect changes in the cervix caused by HPV.

2.  Use condoms. They reduce your chances of getting infected with HPV but they don’t eliminate your risk, because skin-to-skin contact still occurs when a condom is used.

3.  Limit your number of sex partners.

4.  Get an HPV vaccine. HPV vaccines help protect against the most common types of HPV. The first HPV vaccine became available in 2006.

The HPV Vaccine

Gardasil was approved by the Food and Drug Administration (FDA) in June 2006 and received a lot of publicity as “the first cancer vaccine.” Gardasil is approved to protect girls and women, ages 9 through 26, from the two types of HPV infection that are responsible for 70% of cervical cancer cases and two other types of HPV infection that are responsible for 90% of genital warts cases. It has very limited effectiveness, however, against other types of HPV that cause approximately 30% of cervical cancers. For that reason, girls and women who are vaccinated with Gardasil will still need regular Pap smears to detect cervical cancer in its early stages when treatment is most effective. In 2008, Gardasil was also approved to protect against vaginal and vulvar cancers.[7]

The Gardasil vaccine is administered in three doses over a six-month period. The vaccine data so far are short-term, and vaccine producer Merck states very clearly on the home page of its Gardasil website (www.Gardasil.com) that: “The duration of protection of Gardasil has not been established.”

Several clinical trials have been conducted, but most for under five years and none for 10 years or longer.  We still cannot be certain whether Gardasil will be effective for all women for 5 years, nor do we know what percentage of women will be protected for longer than 5 years. Because cancers take so long to develop, we will not know the true impact of Gardasil on cervical cancer for several decades. It is important to know if Gardasil will require a booster shot in order for it to offer long-term protection, but those studies have not yet been conducted.

A second HPV vaccine, known as Cervarix, was approved by the FDA in October 2009. It is produced by GlaxoSmithKline and became available in May 2010. Cervarix was approved for use in girls ages 10 to 25, and like Gardasil, is given as a three dose series over six months. Cervarix costs about the same as Gardasil: on average, $385 for the three doses of the vaccine. Unlike Gardasil, Cervarix only protects against two HPV strains-types 16 and 18, which are the leading causes of cervical cancer. Like Gardasil, the long-term effectiveness is still unknown and the need for a booster shot to maintain protection is uncertain.

What’s the Difference Between the Two Vaccines? Are They Both Safe?

While no head-to-head studies have been done comparing the overall effectiveness of Cervarix and Gardasil, we do know about some differences. In clinical trials, Cervarix was shown to be 93% effective in preventing cervical pre-cancers associated with HPV 16 or HPV 18 in women-this means that it protects against abnormal cervical changes that could lead to cervical cancer. It may also provide protection against other strains of HPV, including types 45 and 31, which also cause cervical cancers. In clinical trials, Cervarix was 75% effective at protecting against three cancer-causing types of HPV that are not part of the vaccine, while Gardasil is only 50% effective at protecting against other cancer-causing HPV types.

As with any vaccine, it is important to consider the vaccine’s safety and potential side effects. The safety of the HPV vaccine was studied in clinical trials before it was licensed. For Gardasil, over 29,000 males and females participated in the trials, while Cervarix studied over 30,000 females from around the world.

In addition to clinical trials, safety information is available through the Vaccine Adverse Event Reporting System (VAERS).  As of September 30, 2010, of the 32 million doses of Gardarsil that have been distributed in the U.S., 17,160 adverse events have been reported. Of these reports, 92% were considered non-serious, which includes fainting, pain and swelling at the injection site, headache, nausea, and fever. It should be noted that fainting is common following most injections and vaccinations. In addition, 8% of the reported events were considered serious. All of these serious reports have been carefully reviewed by medical experts and no common medical problems caused by the vaccine were found. However, there have been some reports of individuals getting blood clots after receiving the vaccine, although these individuals had other blood clot risk factors such as using birth control pills, smoking, and obesity. As of September 30, 2010, there have been 56 U.S. reports of death among females who have received the Gardasil vaccine, with 30 of the reports confirmed. Of the confirmed reports, there was no unusual pattern to suggest that the deaths were caused by the vaccine.[8]

In spite of this finding, there has been some concern about a link between Gardasil and a rare nervous system disorder known as Guillain-Barré syndrome (GBS). In a 2010 study in Vaccine, Nizar Souayah and co-authors looked at the VAERS database between June 2006 and September 2009 and compared the occurrence of Guillain-Barré syndrome after vaccination with Gardasil to the occurrence after vaccination with Menactra and influenza.[9] The researchers concluded that the average weekly reporting rate of GBS for the six weeks after vaccination was 6.6 events per week per 10 million subjects, which is double what it was for Menactra (also administered to children 11 and up), and about five times the weekly reporting rate for flu vaccine. When limited to the first two weeks after vaccination, the average weekly reporting rate of GBS jumped to 14.5 cases per week per 10 million subjects vaccinated with Gardasil as compared to 5.7 cases among subjects vaccinated with Menactra.

Three CDC researchers have criticized Souayah’s study, pointing out that the VAERS database has numerous shortcomings and that the authors used as their denominator the number of doses distributed, divided by 3, even though not everyone receives all three doses. They also maintain that being a new vaccine, adverse reactions to Gardasil were over-reported.

There are, in fact, problems with VAERS-it is a passive system-but usually the problem is under-reporting. Most parents don’t know how to report problems or don’t find the time to do so, and many doctors under-report as well. If there was extensive under-reporting of problems associated with Gardasil, then that may have partly offset Sourayah’s overestimation of the number of people getting all 3 doses. Clearly, more research will need to be done to determine if Gardasil slightly increases the very low risk of GBS.

Cervarix has only been linked to 3 adverse event reports so far. This low number is due to the fact that the vaccine was only recently approved in the U.S., and relatively few individuals have received it so far.

National Recommendations

On June 29, 2006, the CDC Advisory Committee on Immunization Practices (ACIP) recommended that Gardasil be given routinely to all 11-12 year old girls. The recommendation was based on less than two years of efficacy, safety and immunogenicity data provided to the FDA from clinical trials with 16-23 year-olds, combined with safety and immunity studies in 9-15 year old girls.[10] In October of 2009, the CDC’s ACIP also recommended Cervarix for 11-12 year old girls, but this too was based on short-term data. However, Cervarix’s approval was based on several studies where subjects were followed for an average of 3 to 7.5 years-a longer period than the Gardasil studies, but still not long enough to know the longer-term effects of the vaccine.

If the goal is to prevent cervical cancer in females, either Cervarix or Gardasil may be used, said the committee, which further noted that one vaccine could be substituted for the other, if needed, to complete the three-dose series.

Who should get it? Who should not?

The data that Merck presented to the FDA in 2006 indicated that Gardasil would not be effective against strains of HPV that the women were currently infected with at the time of vaccination. This finding has often been misunderstood. What it means is that the vaccine will not treat existing infections. However, data show that having a previous HPV infection that has cleared by the time you get the vaccine will not interfere with the vaccine’s effectiveness. But, if you have an ACTIVE infection that has not cleared, the vaccine will not be as effective against that type of HPV in the future.

At what Age is it Most Effective?

Because HPV exposure may occur even in the first 10 years of life through non-sexual skin-to-skin contact, or while being born, there is no age at which the vaccine will always be effective for everyone. According to the Centers for Disease Control (CDC), “the best way a person can be sure to get the most benefit from HPV vaccination is to complete all three doses before beginning sexual activity.”[11] While researchers still do not understand or agree on the level of antibody titers necessary to have protection from HPV, there are data to indicate that most teenagers and women who are vaccinated after being previously exposed to HPV have even more antibodies than those who are vaccinated before they become sexually active.[12]

So, is it a good idea to vaccinate girls as young as 12? It is difficult to answer that question because we don’t know how long the vaccines last. A few years from now, the vaccine manufacturers may announce that booster shots are needed. If that’s the case, will young adults who were vaccinated as children actually get them?  What if the booster is expensive and they don’t have coverage for it?

In spite of these unknowns, several states are considering laws requiring HPV vaccines for school attendance. In Virginia and Washington, D.C., for example, all girls entering sixth grade in the fall of 2009 were required to be vaccinated against HPV unless a parent specifically requested a waiver. While the vaccine may be safe for girls as young as 12, we do not yet have enough data on how effective it is or how long it lasts to justify this policy, particularly given the high cost of the vaccine to working class and middle class parents and to government health programs for the poor. The vaccine’s safety and antibody response was tested on girls as young as 9 and 10, but the impact on lesions or disease was not studied in girls under 16. Since data show that the antibodies protecting vaccinated girls and women against HPV 18, a major cause of cervical cancer, appear to decrease over time, many girls vaccinated at age 12 could possibly lose much of their immunity against HPV 18 just as they are becoming more sexually active at ages 16 or 17.

As with any sexually transmitted disease, all it takes is exposure to one infected partner to acquire HPV. The chances of HPV and cervical cancer increase with the number of sexual partners, and the number of sexual partners of their sexual partners. Research is now underway to evaluate the effectiveness of Gardasil among women 27 to 45, and also in boys and men.

To view statements and testimony on NCHR’s opinions and recommendations for the HPV vaccine, visit http://www.center4research.org/2009/04/testimony-of-dr-diana-zuckerman-before-dc-health-committee-on-hpv/ or http://dev.stopcancerfund.org/p-cervical-cancer-hpv/hpv-q-a/

How Do I Get an HPV Vaccine?

The retail price of the vaccine is about $125 per dose (or $375 for full series), but most large insurers cover the costs of the vaccine, which may be administered by your doctor.

It is estimated that 85-89% of children with health insurance are covered for the HPV vaccine and other routine vaccinations.[13,14,15] The CDC Committee has also recommended that the HPV vaccine be included in the Vaccines for Children (VFC) Program, the federal program which provides free vaccinations to children 18 years of age and under who are uninsured, on Medicaid, protected by the Indian Health Services Act, or underinsured.[15] Children enrolled in the VFC program receive the vaccine free of charge. Approximately 41% of all childhood vaccines in the United States are purchased by and administered through the VFC Program.[16] However, the CDC recommendation does not include a booster shot, and even if it did, once girls are older than 18 years, the VFC Program would not cover the cost of the HPV vaccine or a booster.

Additional details regarding the Vaccines for Children Program, including what it is, who is eligible, what it covers, and how to enroll, may be found at http://www.center4research.org/vaccines-children-program-vfc/

The Great Debate: Is it Worth it?

There are certainly both benefits and drawbacks for the HPV vaccine, with some people benefiting more than others. From a broad perspective, the vaccine may not be cost effective because long-term effectiveness is unknown and we don’t yet know if booster shots are necessary to sustain protection against the virus. According to a modeling analysis done by Ruanne Barnabas, a cervical cancer vaccine must last at least 15 years in order to prevent cancer and not just postpone it.[18]

Getting regular Pap smears and screenings and limiting your number of sexual partners are effective strategies whether you are vaccinated or not, so spending money on Pap smears may be the most economical way to protect women against HPV and cervical cancer. However, for women who are less likely to undergo regular Pap smears, and especially for women at highest risk for getting HPV and cervical cancer (such as Hispanics and blacks), the HPV vaccine reduces risk.

Who’s Getting Vaccinated?

According to the CDC, in the general U.S. population of adolescents 13 to 17 years old, 37% have received at least one dose of the three-dose vaccination and 18% have received all three doses of the vaccination, as of 2008. Given that the vaccination was relatively new at the time of data collection, it’s safe to assume that these rates have increased over the past two years.[17] Also, as of 2008, 42% of adolescents living at or above poverty received at least one dose of the vaccine, with 36% receiving all three doses. In comparison, for those living below poverty, 41% have received at least one dose of the vaccine, while 46% have received all three doses of the vaccine. Girls and women living below poverty were fully vaccinated at a higher rate than those living at or above poverty. When looking at coverage by race/ethnicity, 35% of white adolescents have been covered by the vaccine, in comparison to 36% of blacks, 44% of Hispanics, 53% of American Indian/Alaska Natives, and 41% of Asians.[16] High rates of coverage among those at or below poverty level, and among American Indian/Alaska Natives, can be partly explained by the VFC program (see our article “The Vaccines for Children Program (VFC)”).

Effect of Vaccine and VFC on Racial and Social Differences in HPV and Cervical Cancer Rates

Because the HPV vaccination is provided under VFC, this may eventually reduce differences in HPV and cervical cancer rates by protecting the most at-risk individuals against the four primary HPV types. When looking at racial statistics about who is getting the vaccine, Hispanics and American Indians/Alaska Natives are receiving the vaccine at much higher rates than whites and blacks. Because Hispanics have higher rates of cervical cancer in comparison to whites and blacks, the VCF Program could narrow this gap.  The VFC Program can reach out to the medically underserved, who are less likely to receive regular cancer-prevention screenings. Assuming that the vaccine is effective in the long-run (which is still unknown), the VFC program could potentially prevent 70% of HPV cases in those who are vaccinated. As a result, expensive follow-ups to abnormal pap smears may also be avoided. However, even with the vaccine, it is still very important to get regular pap smears to stay healthy and prevent cervical cancer.

The Bottom Line

Like any public health strategy, a vaccine’s risks must be weighed against its benefits. That is why it is so important to determine how effective the vaccine is against preventing HPV and cervical cancer, and for how long. If the vaccine is offering less protection than it promises or is wearing off by the time most girls are becoming sexually active, then some people may decide that the cost and risks of the vaccine simply aren’t worth it. It’s important to remember that whatever you decide, you still need to get regular Pap smears. But for women who can’t or don’t get annual Pap smears and who can get the HPV vaccine at low or no cost through their insurance or through the VFC Program, the HPV vaccines (Gardasil or Cervarix) provide needed protection.

References:

  1. Centers for Disease Control and Prevention (CDC) (2009) Genital HPV Infection Fact Sheet. Retrieved from http://www.cdc.gov/STD/HPV/STDFact-HPV.htm.
  2. Cullins M. (2009) HPV: Planned Parenthood. Retrieved from http://www.plannedparenthood.org/health-topics/stds-hiv-safer-sex/hpv-4272.htm.
  3. Schiffman M and Castle PE (2003 Aug.) Human papillomavirus: epidemiology and public health. Archives of Pathology and Laboratory Medicine 127(8):930-934. Retrieved from (PMID 12873163) http://journals.allenpress.com/jrnlserv/?request=get-abstract&issn=0003-9985&volume=127&page=930.
  4. Ward E, Jemal A, Cokkinides V, Singh GK, Cardines C, Ghafoor A, et al (2004). Cancer Disparities by Race/Ethnicity and Socioeconomic Status. CA: A Cancer Journal for Clinicians 54 (2):78-93. Retrieved from http://caonline.amcancersoc.org/cgi/reprint/54/2/78.
  5. American College of Obstetricians and Gynecologists (20 Nov. 2009). First Cervical Cancer Screening Delayed Until Age 21– Less Frequent Pap Tests Recommended. Retrieved from http://www.acog.org/from_home/publications/press_releases/nr11-20-09.cfm.
  6. Kahn JA (2007 July). Sociodemographic factors associated with high-risk human papillomavirus infection. Obstetrics and Gynecology: 110 (1): 87-95.
  7. Food and Drug Administration (FDA) (2008 Sept. 12). FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116945.htm.
  8. Centers for Disease Control and Prevention (CDC) (2010 May 21). Reports of Health Concerns Following HPV Vaccination. Retrieved from http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html.
  9. Souayah N, Michas-Martin P.A., Nasar A, Krivitskaya N, Yacoub H, Khan H, Qureshi A (2010) Guillan-Barré syndrome after Gardasil vaccination: Data from Vaccine Adverse Even Reporting System 2006-2009. Vaccine. doi: 10.1016/j.vaccine.2010.09.020.
  10. Clinical Review of Biologics License Application for Human Papillomvirus 6,11,16,18 L1 Virus Like Particle Vaccine (S. cerevisiae) (STN 125126 GARDASIL), manufactured by Merck, Inc. (2006). Accessed on March 23, 2009, U.S. Food and Drug Administration Web site: http://www.fda.gov/cber/review/hpvmer060806r.pdf.
  11. Centers for Disease Control. HPV Vaccines. http://www.cdc.gov/hpv/vaccine.html.
  12. Garland SM, Hernandez-Avila M, Wheeler CM, et al. (2007) Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. New England Journal of Medicine, 356, 1928-43.
  13. Brown, D. (2006, June 30). HPV vaccine advised for girls. The Washington Post, p.A5.
  14. Financing vaccines in the 21st century: Assuring access and availability. (2003). Accessed March 23, 2009, Institute of Medicine. Web site: http://www.nap.edu/read/10782/chapter/1.
  15. Davis, M.M. & Fant, K. (2005). Coverage of vaccines in private health plans: What does the public prefer? Health Affairs, 24(3), 770-780.
  16. Lieu, T.A., & McGuire, T.G. & Hinman, A.R. (2005). Overcoming economic barriers to the optimal use of vaccines. Health Affairs, 24(3), 666-680.
  17. Center for Disease Control and Prevention (CDC) (2008). Statistics and Surveillance. Retrieved from http://www.cdc.gov/vaccines/stats-surv/default.htm
  18. Barnabas RV, Laukkaned P, Koskela P, Kontula O, Lehtinen M, Garnett GP. (2006) Epidemiology of HPV 16 and cervical cancer in Finland and the potential impact of vaccination: Mathematical modeling analyses. PLoS Med. 3 (e138).

The Cancer Prevention and Treatment Fund Responds to FDA’s Decision on Avastin for Breast Cancer

Press Releases
Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, December 16, 2010

FDA made the right decision in starting the process to remove the breast cancer indication for Avastin.  We commend the FDA for carefully considering the concerns of patients currently on Avastin who believe that Avastin has helped them, but ultimately, FDA’s decision needs to be based on science.  Scientific research results are clear: Avastin doesn’t prolong survival  — the data show it often reduces survival.  And, Avastin has potentially terrible side effects that harm patients’ quality of life.  Painful and potentially deadly perforations in the nose, stomach, and elsewhere are clearly a result of the Avastin, for example.

We hope that the FDA will move quickly to ensure that breast cancer patients are not harmed by Avastin.  We urge the agency to stick to the science and not be intimidated by the company or by those who don’t understand the need for scientific decision-making.  The company has made a lot of money selling Avastin to breast cancer patients, and they will fight the FDA’s decision with well-paid lobbyists and multi-million dollar public relations efforts.  Breast cancer advocates need to see through those lobbying and PR efforts, and help the FDA finalize their decision and thus safeguard patients’ lives and the quality of their lives.

We agree with the FDA that research is needed to figure out if there are breast cancer patients who can be identified as most likely to benefit from the drug.  If Genentech can identify a subgroup of patients who have a high likelihood of success and low risk of harm, FDA can consider an approval decision just for those types of patients.

Do Chemicals in our Environment Cause Weight Gain?

Diet, Habits, & Other Behaviors, Environmental Exposures
Keris Krenn Hrubec, Diana Zuckerman, PhD, and Sarah Miller, RN, Cancer Prevention and Treatment Fund

Today’s obesity epidemic is also an epidemic of the health problems resulting from excess weight, such as diabetes, heart disease, some types of cancer, and early onset of puberty. The best way to combat obesity is to exercise more and eat less. However, it is not clear that eating more and exercising less are the only reasons for the current increase in obesity in the U.S. and many other countries. Our current obesity epidemic coincides with an increase in industrial chemicals being released into the environment over the past 40 years.

Humans are exposed to so many different chemicals that it is difficult to figure out which are the ones causing harm. This is why studies with animals are important. While researchers can’t experiment on humans, they can experiment on mice by deliberately exposing a group of mice to one particular chemical (at different doses for different periods of time) and comparing that group to a group of mice who have not been exposed. For instance, we know now that exposure to specific chemicals while in the womb can affect the size and weight of mice after they are born.This suggests that the chemicals we are exposed to before we are born could potentially increase our likelihood of becoming obese later in life.

Hormones, Environmental Chemicals, and Obesity

For any kind of developmental change to happen in the body, cells need signals from hormones telling them what to do. Hormones are involved in almost every process in the human body, including how much fat the body stores, and where in the body it is stored. Usually, hormones help to control how many of our calories to burn right away and how many to store as fat for the body’s energy needs.

Many of the chemicals from industry that are released into the environment resemble hormones. These chemicals can provoke the same response in the body that a natural hormone would.

In addition, some chemicals that we are exposed to through our food, water, and the products that we use can interfere with our natural hormones, including our sex hormones. The chemicals that do this are called “endocrine disruptors” because they change the way our hormones (our endocrine system) operate. Chemicals can cause the body to “think” that it has to store more fat than it actually does, or they can interfere with the processes our bodies use to make fat cells. Babies developing in the womb are especially vulnerable to these kinds of chemicals. There is evidence that babies who are exposed to endocrine disrupting chemicals in the womb may be at higher risk for obesity and other problems as adults.DES: A miscarriage treatment gone wrong

Diethylstilbestrol, or DES, is a synthetic version of the hormone estrogen that was given to pregnant women in the 1940s through the 1970s to prevent miscarriages. It was later learned that DES did not prevent miscarriages but instead harmed the babies, increasing the risk of cancers when those babies were young adults, and even increasing the risks of cancer in the next generation.

If pregnant mice are treated with DES, we see similar cancers in their offspring to those we saw in humans. Mice that are exposed to DES in the womb also have higher levels of body fat, even when they eat the exact same diets and do the exact same activities as mice who are not exposed. They are also hungry for more food than they actually need.

Today, DES is no longer used as a medication because of its deadly risks. Based on what we know about DES, however, scientists are studying the long-term effects of other hormone-disrupting chemicals, because those chemicals may act similarly to DES and “trick” pregnant women’s bodies into reacting as if the chemicals were estrogen. Some chemicals can also bind to receptors and block hormones from getting to the receptors. These chemicals can cause changes in the development of babies, many of which are not obvious until after the babies grow up.

Chemicals that influence our hormones and can lead to obesity are called “obesogens.”  These chemicals are not just causing us to gain weight. They are actually modifying our genes and changing which ones get used and which ones don’t. They may turn off genes that we need to keep us trim, or turn on genes that will make us store more fat but still feel hungry. We still don’t know the full extent to which they affect us, but one thing seems likely: obesity may no longer just be influenced by food and exercise.

Bisphenol A (BPA)

Bisphenol A (BPA) was also developed as a synthetic estrogen, although it stopped being used for that purpose when DES was developed, because DES was more similar to estrogen. BPA is now used in many hard plastics, including some food and beverage containers, and until recently was used in plastic baby bottles and sports water bottles. It is still used in the lining of all canned food and beverages. BPA has been linked to heart disease and diabetes in adults, possibly because it increases the risk of obesity.

Studies of mice exposed to BPA in the womb found that these mice tended to put on more body fat after birth., However, as adults, the BPA-exposed mice were the same size and weight as mice who were not exposed to BPA in the womb. This finding does not mean that the BPA had no effect on the mice’s development as adults, but no one is quite sure yet what that effect is. For more information on BPA, read “Are Bisphenol A (BPA) Plastic Products Safe?”

Phthalates

Phthalates are another category of hormone-disrupting chemicals. They are used to soften plastic (for soft plastic books and toys) as well as to provide fragrances for many household and personal care products, such as lotions. Although a law passed in 2008 that prevents the riskiest phthalates from being used in baby and toddler toys and plastic products, babies, children, pregnant women, and other adults are still exposed to phthalates every day, in products such as nail polish, creams, shampoo, and air fresheners.

Unlike BPA, phthalates do not act like estrogen, but rather block androgens (male hormones). What BPA and phthalates have in common is that they appear to contribute to a similar imbalance of sex hormones. There is research evidence, for instance, that they could potentially cause abnormal genital development, especially in baby boys, and that exposure may increase the risk of testicular cancer.

Based on what we know about the effects of phthalates on our cells, it is also possible that exposure to phthalates could increase a person’s risk of becoming overweight or obese.A study of 1,443 men in the U.S. found that those who had higher levels of some types of phthalates in their urine samples at the time of the study also had larger waist measurements and were more resistant to insulin, which put them at higher risk for diabetes.

One study has also linked phthalate exposure to girls developing breasts at an early age. It is not clear, though, whether this is because the girls are more likely to be overweight or whether the breast development is more likely regardless of the girls’ weight.,

Studies with mice have been more difficult to interpret, in part because mice do not respond to phthalates the same way humans do. For instance, in one study, one group of mice was engineered to have the human type of a gene that is activated by phthalates and the other group was not interfered with genetically. This study found that for the group that kept the mouse version of the gene, the phthalate DEHP was surprisingly protective against obesity, while in the group of mice with the human gene, DEHP was not protective against obesity. This research may help explain why some mice studies found no connection between phthalate exposure and adult obesity. For more information on phthalates, read “Phthalates and Children’s Products.”

Tributyltin (TBT)

Tributyltin (TBT) is a chemical used to kill fungi (for example, mold). This fungicide disrupts hormones by blocking estrogen from being made in the body. This causes higher than normal levels of testosterone. Testosterone is a male hormone and therefore a type of androgen; females have testosterone too, but at lower levels than males.

TBT was formerly in paint used for boats to keep mold and barnacles away, but this use is now prohibited because it was found to be causing abnormalities in fish (including fish that people eat) and even causing some species of female fish to become male. It is still in use, however as a fungicide in fruit, vegetable, and grain crops; as a component of PVC pipes (where it can get into our drinking water); and in various other consumer products, including disposable diapers.

A study found that undifferentiated cells from humans and mice that were exposed to TBT were more likely to become fat cells, even though those undifferentiated cells had the potential to become either bone, cartilage, or fat cells.

Another study, in which one group of adult mice was not fed TBT and three other groups were fed three different amounts of TBT, found that the mice who were fed the second-highest amount of TBT had higher levels of body fat even though they ate the same amount and had the same activity levels as the other mice. The mice with the second-highest dose of TBT also had higher levels of insulin in their blood but similar blood sugar levels to the other mice, meaning that they were more resistant to the effects of insulin. All of the mice who ate TBT had higher levels of leptin in their blood than the mice who did not eat TBT, but ate the same amount of food. Leptin is a hormone that is secreted by fat cells, and which turns off the “hunger signal” to our brains, letting us know when we have eaten enough. This could mean either that they were more resistant to the effects of leptin or that they simply had more fat cells, which were releasing more leptin. All the mice that ate TBT had fattier livers than the mice that did not eat TBT.

The researchers speculate that the reason only the mice who ate the second-highest amount of TBT and not the highest amount had the most significant effects was that the high dose of TBT was toxic to the liver, which interfered with the body’s ability to convert calories into body fat.Other researchers have found similar results.

Other Chemicals

Many other chemicals also disrupt hormones, including those found in pesticides and in air near manufacturing facilities and trash incinerators. A study of people who were tested for various chemicals by the Centers for Disease Control and Prevention (CDC) found that people who tested positive for endocrine-disrupting chemicals from pesticides and air pollution were more likely to be overweight.

How Does This Happen?

At very high doses, many of these chemicals cause a person’s body to burn fat rather than storing it., So, why have several studies shown that people are more likely to be overweight it they were exposed to these chemicals while they were infants or whose mothers were exposed while pregnant?

One theory is that this increased tendency to burn fat may cause a baby’s body to think that it is malnourished and cause the baby to develop a “slow” metabolism for life, which tends to store more fat to prevent starvation. This is similar to the paradoxical effect of extreme dieting, which can result in a body conserving calories to prevent starvation, and thereby storing extra fat.

It is possible that people whose metabolisms develop in this way may be less sensitive to certain hormones. One of these hormones is leptin, which as noted earlier, is secreted by fat cells and lets us know when we have eaten enough. People who are less sensitive to leptin are more likely to continue to feel hungry even after they have consumed enough food.

People whose metabolisms have developed in this way may also be less sensitive to insulin, which is a hormone secreted by the pancreas. Insulin brings sugar from our bloodstream into our cells so that we can use it for energy. People who are less sensitive to insulin may develop chronically high blood sugar levels. When these levels become very high, this is what is known as type 2 diabetes.

Research on human cells shows that some hormone-disrupting chemicals can activate hormone receptors in the parts of our cells that house DNA. This could be especially harmful to developing babies because some of their cells are “undifferentiated,” meaning they have the potential to become different types of cells. Hormones can turn genes in a cell’s DNA on or off to determine what type of cell it will become. The research suggests that hormone disrupting chemicals may interfere with this process and cause more cells to develop into adipocytes or “fat cells.”

Is This Why I Can’t Lose Weight?

If you are like many people who struggle with weight loss, you may eat the number of calories you are told that you need, but still feel hungry, or eat the same number of calories as thinner people but still gain weight when others stay thin. When you exercise, you may not see results as quickly as expected.

After reading this article, you may wonder whether exposure to hormone-disrupting chemicals is contributing to the difficulties so many people have with weight loss.

There are no human studies that can conclude whether exposure to chemicals in infancy or later in life contributes to these weight control problems. It would be unethical to intentionally expose anyone to these chemicals, and it is difficult to measure all the many factors that might affect weight. However, as shown in this article, there is growing evidence to suggest that reducing exposures to endocrine-disrupting chemicals could help to prevent obesity as well as other health problems.

Web Resources for Avoiding Harmful Chemicals

Environmental Working Group:

http://www.ewg.org/

Green Guide

http://www.thegreenguide.com/

References:

Grun, F; & Blumberg, B; Endocrine disruptors as obesogens; Molecular & Cellular Endocrinology, 2009, 304(1-2) pp. 19-29.

Grun, F; & Blumberg, B; Endocrine disruptors as obesogens; Molecular & Cellular Endocrinology, 2009, 304(1-2) pp. 19-29.

Newbold, RR; Padilla-Banks, E; & Jefferson, WN; Environmental estrogens and obesity; Mollecular and Cellular Endocrinology, 2009, 304 (1-2) pp. 84-89.

Lang, IA; Galloway, TS; Scarlett, A; Henley, WE; Depledge, M; Wallace, RB; & Melzer, D; Association of urinary bisphenol A concentration with medical disorders and laboratory abnormalities in adults; JAMA; 2008, 300(11), pp. 1303-9.

Somm E, Schwitzgebel VM, Toulotte A, Cederroth CR, Combescure C, Nef S, Aubert ML, Hüppi PS. Perinatal exposure to bisphenol a alters early adipogenesis in the rat. Environ Health Perspect. 2009 Oct;117(10):1549-55.

Ryan KK, Haller AM, Sorrell JE, Woods SC, Jandacek RJ, Seeley RJ; Perinatal exposure to bisphenol-a and the development of metabolic syndrome in CD-1 mice. Endocrinology. 2010, 151(6):2603-12.

Main, KM; Skakkebaek, NE; Virtanen, HE; & Toppari, J; Genital abnormalities in boys and the environment; Best Practice and Research in Clinical Endocrinology and Metabolism; 2010 24(2), pp. 279-89.

Stahlhut, RW; Van Wijngaarten, E; Dye, TD; Cook, S; & Swan, SS; Concentrations of uninary phthalate metabolites are associated with increased waist circumference and insulin resistance in adult U.S. males; Environmental Health Perspectives; 2007, 115(6), pp. 876-81.

Colo´n I, Caro D, Bourdony CJ, Rosario O 2000 Identificationof phthalate esters in the serum of young Puerto Rican girls with premature breast development. Environmental Health Perspectives; 108:895-900

 

Diamanti-Kandarakis, E; Bourguinon, JP; Guidice, LC; Hauser, R; Prins, GS; Soto, AM; Zoeller, RT; & Gore, AC; Endocrine-disrupting chemicals: An endocrine society scientific statement; Endocrine Reviews;2009, 30(4) pp. 293-342.

.Feige JN, Gerber A, Casals-Casas C, Yang Q, Winkler C, Bedu E, Bueno M, Gelman L, Auwerx J, Gonzalez FJ, Desvergne B; The pollutant diethylhexyl phthalate regulates hepatic energy metabolism via species-specific PPARalpha-dependent mechanisms. Environ Health Perspect. 2010;118(2):234-41

Casals-Casas C, Feige JN, Desvergne B; Interference of pollutants with PPARs: endocrine disruption meets metabolism Int J Obes (Lond). 2008;32 Suppl 6:S53-61.

Kirchner S, Kieu T, Chow C, Casey S, Blumberg B. Prenatal exposure to the environmental obesogen tributyltin predisposes multipotent stem cells to become adipocytes. Mol Endocrinol. 2010; 24(3):526-39. Epub 2010 Feb 16.

Zuo Z, Chen S, Wu T, Zhang J, Su Y, Chen Y, Wang C. Tributyltin causes obesity and hepatic steatosis in male mice. Environ Toxicol. 2009.

Grun F, Blumberg B.. Environmental obesogens: Organotins and endocrine disruption via nuclear receptor signaling. Endocrinology 2006 147:S50-S55.

Elobeid, MA; Brock, DW; Allison, DB; Padilla, MA; & Ruden, DM; Endocrine disruptors and obesity: An examination of persistent organic pollutants in the NHANES 1999-2002 data; International Journal of Environmental Research and Public Health; 2010; 7, pp. 2988-3005.

Hanson, MA, & Gluckman, PD; Developmental originsof health and disease: New insights; Basic and Clinical Phramacology and Toxicology; 2008 102(2), pp. 90-3.

Sargis, RM; Johnson, DN; Choudhury, RA; & Brady , MJ; Environmental Endocrine Disruptors Promote Adipogenesis in the 3T3-L1 Cell Line through Glucocorticoid Receptor Activation; 2010 Obesity, 18(7) pp. 1283-8.

Breastfeeding: the Finest Food for your Infant Isn’t Sold in any Store

Breast Cancer, Diet, Habits, & Other Behaviors, Ovarian Cancer
Margaret Aker, Cancer Prevention and Treatment Fund

For years evidence has been mounting about the health advantages of breastfeeding for both mother and child. From a reduced risk of obesity to an increased resistance to disease, study after study shows that breast milk is the ideal food for your newborn child. Can you believe it? Our own bodies produce the best food we can give our children? And for free!

How is Infant Formula Different from Breast Milk?

Infant formula is an imitation of human breast milk. It is made by blending various dairy substitutes. Formula, however, can never exactly duplicate a mother’s breast milk. Formula is more difficult for a baby to digest, it lacks antibodies that help infants fight off diseases and infections, and it doesn’t change to accommodate a growing baby’s nutritional needs the way natural breast milk does.

What are the Health Benefits of Breastfeeding?

Breastfeeding has significant health benefits for you and your child. Exclusive breastfeeding (meaning no formula or other food) during at least the first three months offers the greatest benefits, although some breastfeeding is better than none.

Benefits for your Child

Protection from Disease: Breastfed infants have lower rates of allergies, infections, and respiratory disorders, such as asthma. They also have lower rates of diseases such as diabetes and leukemia.

  • Antibodies that protect infants from disease are transferred from a mother to her child through breast milk.
  • Infant formula can’t provide these antibodies. Breast milk is the first example of “personalized medicine.”

Defense against Obesity: Breastfeeding decreases the likelihood that an infant will become overweight or obese.[1]

  • Breastfeeding is better for teaching infants how to stop eating when they are full. While parents sometimes find it reassuring that they can tell by looking at the bottle how much food their baby has consumed, they also tend to overfeed when bottle-feeding. Instead of looking for cues from their baby showing that he or she is full, parents look at whether the bottle is empty or not.
  • Breast milk contains the flavors of the food the mother is eating. It therefore exposes infants to a wider range of tastes at an early age. This may lead the infant to later accept a well-balanced diet containing a wide variety of foods.

Benefits for You

Protection from Disease: Breastfeeding reduces the mother’s risk of certain types of cancers.

  • Women who breastfed for 18 months or longer are much less likely to develop ovarian cancer than women who never breastfed.[2]
  • The risk of breast cancer decreases the longer a woman breastfeeds her child. Research now shows that this decreased risk has less to do with the number of children a woman breastfeeds and more to do with the length of time she spent breastfeeding each child.[3]
  • Many experts believe these benefits are the result of the delayed return of a woman’s period while she is breastfeeding. Other factors may play a part as well.

Weight loss after Pregnancy and Childbirth:

  • Breastfeeding helps women return to their pre-pregnancy weight. Exclusively breastfeeding is said to burn up to 600 calories a day![4] That’s about the same number of calories burned by running 6 miles or doing the Stair Master for about an hour. (Of course, breastfeeding will only help you lose weight if you don’t eat 600 calories more each day.)
  • Breastfeeding may help to delay the return of your period. The hormones that trigger the production of breast milk may also delay the release of hormones that bring on your period. This does not always happen, however, so if you don’t want to have another child anytime soon you should not be rely on breastfeeding as a form of contraception. For more information about safe contraceptives to use while breastfeeding check out our “Guide to Selecting Safe Medical Contraception.”

Benefits for you Both: Building a Close Relationship Between Mother and Child.

  • Women who breastfeed often have more physical contact (skin-to-skin) with their babies than women who bottle feed. This kind of close contact promotes closeness between mother and child. With breastfeeding, nothing comes between a baby and mother.
  • Feeding-whether by breast or bottle-is an important demonstration of love and an opportunity for bonding. One of the advantages of bottle-feeding is that others can participate in the duty and pleasure of feeding, but that can sometimes be a drawback. Because it is easy to pass the baby to someone else for feedings, and even to teach the infant to hold the bottle and feed himself, a mother who is rushing to get everything done may miss out on some of the time she would otherwise spend bonding with her child.

The Health Benefits of Breast Milk are Unmatched by Baby Formula. So Why Would any Mother not Breastfeed?

Given the multiple benefits mentioned above, there are many reasons why it is a good idea for you to breastfeed your child. It is important to keep in mind, however, that there are also many reasons why a mother might not be able to or might choose not to breastfeed. Every mother’s situation is different. It does not make you a bad mother if you don’t breastfeed your child.

In addition to the physical inability of some women to produce sufficient milk, some reasons that women may be unable or unwilling to breastfeed include:

  • Cost: Breast milk is free, but most newborn babies request around 8-12 feedings each day. So, committing to exclusively breastfeed may entail taking paid-time off work to stay at home with the child, go home for feeding breaks, or pump breast milk. While this type of commitment may be feasible for women whose employers offer great maternity-leave benefits or who do not work, for many it isn’t.
  • Disease: Many women are concerned about breastfeeding when they are sick, have an infection, or are taking a medication. For most illnesses and many medications, it is safe for the mother to continue to breastfeed as normal. Women infected with HIV/AIDS, active tuberculosis, or undergoing certain medical treatments, however, may be required to stop breastfeeding temporarily or permanently. The best thing to do if you are concerned about whether or not breastfeeding is safe for you and your child is to ask your doctor.
  • Food Habits: You are what you eat, and breast milk is essentially what a mother eats. It is important, therefore, that a breastfeeding mother eat well in order to provide good nutrition to her child. Mothers who are not likely to eat a balanced diet or limit their intake of caffeine and alcohol might find it in the best interest of their child to refrain from breastfeeding. No mother using illegal drugs should breastfeed. Talk to your doctor if you have any questions about whether your lifestyle is compatible with breastfeeding your child.
  • Discomfort: Some women simply do not enjoy breastfeeding. They may find it uncomfortable or frustrating. This is not a reflection on the type of mother that you are. Since the pain and difficulty almost always goes away, women are encouraged to try breastfeeding for at least 14 days before giving up.[5] A mother who is having trouble should consider asking her doctor where she can get free advice or help on breastfeeding. However, it is important that each mother considers her own needs when deciding whether to breastfeed. If a mother finds the breastfeeding experience incredibly unpleasant, it will only get in the way of mother-child bonding. Try to be patient, but don’t be a martyr.

When it is possible, breastfeeding is the ideal way to feed your child. Breast milk is naturally manufactured to protect and nourish a growing infant, as well as to help your body bounce back from pregnancy-and, it does a great job at both of these tasks. It is amazing that women’s bodies have outdone the efforts of thousands of scientists and food manufacturers to create the perfect food for infants!

Breastfeeding is not a feasible option for every mother. The multiple benefits of breastfeeding for you and your child, however, make it worthwhile to try to make breastfeeding work. And remember, if you need to supplement breastfeeding with bottles while you’re at work or sometimes in the middle of the night so you can get more sleep, that kind of compromise will still give you and your baby most of the benefits of breastfeeding.

In the end, each mother must personally decide the best way to feed her child. While the health benefits of breast milk are great, there are many other factors that will determine if breastfeeding is right for you and your family.

References:

  1. Breastfeeding: The First Defense Against Obesity. California WIC Association and the UC Davis Human Lactation Center. (2006 March). http://www.calwic.org/docs/reports/bf_paper1.pdf.
  2. Danforth K, Tworoger S, Hecht J, Rosner B, Colditz G, and Hankinson S. Breastfeeding and Risk of Ovarian Cancer in Two Perspective Cohorts. Cancer Causes & Control. Vol. 18, No. 5 (2007 June), pp. 517-523.
  3. Chang-Claude J, Eby N, Kiechle M, Bastert G, and Becher H. Breastfeeding and Breast Cancer Risk by Age 50 among Women in Germany. Cancer Causes & Control. Vol. 11, No. 8 (2000 Sept), pp. 687-695.
  4. Kramer F. Breastfeeding reduces maternal lower body fat. Journal of American Dietician Association. (1993), pp. 429-33.
  5. Love S, Lindsey K. Dr. Susan Love’s Breast Book. Perseus Publishing. 3rd Ed, (2000), pp. 33-50.

Statement of Brandel France de Bravo, MPH, Cancer Prevention and Treatment Fund, to the Pediatric Advisory Committee

Testimony & Briefings
Brandel France de Bravo, Cancer Prevention and Treatment Fund, December 7, 2010

I am pleased to have the opportunity to testify on behalf of the National Research Center for Women & Families, and our Cancer Prevention and Treatment Fund.  I have a Master’s in Public Health and am here today to comment on Gardasil.

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 treatments and prevention strategies. We do not accept contributions from companies that make medical products.

Guillain-Barré syndrome is one of the “conditions of special interest” being closely monitored among individuals vaccinated with Gardasil. In the general population, GBS has an average weekly incidence of 0.65-2.57 cases per week per ten million people. As those numbers indicate, this sometimes fatal condition causing temporary and even permanent paralysis is, thankfully, exceedingly rare. It is, however, one of the known neurological sequelae of vaccination. The question is: Is GBS more prevalent among people receiving Gardasil?

In a new study to be published in Vaccine, Nizar Souayah and co-authors looked at the VAERS database between June 2006 and September 2009 and compared the occurrence of Guillain-Barré syndrome after vaccination with Gardasil to the occurrence after vaccination with Menactra and influenza. The researchers concluded that the average weekly reporting rate of GBS for the six weeks after vaccination was 6.6 events per week per 10 million subjects, which is double what it was for Menactra (also administered to children 11 and up), and about five times the weekly reporting rate for flu vaccine. When limited to the first two weeks after vaccination, the average weekly reporting rate of GBS jumped to 14.5 cases per week per 10 million subjects vaccinated with Gardasil as compared to 5.7 cases among subjects vaccinated with Menactra.

Three CDC researchers appropriately point out that the VAERS database has numerous shortcomings and that the authors used as their denominator the number of doses distributed, divided by 3, even though not everyone receives all three doses. They also maintain that being a new vaccine, adverse reactions to Gardasil were over-reported. We disagree. While the authors may have worked with too small a denominator, we believe they also worked with too small a numerator. Because VAERS is a passive system that depends on voluntary reporting, adverse reactions are always under-reported. Most parents don’t know how to report problems or don’t find the time to do so, and many doctors under-report as well.

Should we be concerned about the safety of Gardasil?

All of us are here today because we care about the safety of pediatric medications and vaccines. Moreover, as public health professionals we all recognize that a certain amount of individual risk is acceptable for the public good. This is why we can’t talk about Gardasil’s safety without discussing its efficacy.  We must ask what level of protection does it offer and for how long? We must weigh the vaccine’s risks and costs against its benefits, knowing that the balance sheet will look different in each country and even in different communities.

Gardasil’s use continues to expand in the U.S, even though cervical cancer screening is affordable and widely available, and penile cancer and vulvar cancer, for instance, are extremely rare. Here in the U.S., Gardarsil’s main benefit is a reduction in abnormal PAP tests and excisional therapies for CIN2 and 3 lesions. Will Gardasil prevent cervical cancer? We still don’t have the long-term data to determine that. Similarly, we don’t know how long this vaccine-one of the most expensive vaccines and the most expensive routine vaccination ever-lasts. Without that information, vaccinated girls and women, as well as boys and men, could become complacent and fail to take proper precautions.

The modeling analysis done by Ruanne Barnabas shows that a cervical cancer vaccine must last at least 15 years in order to prevent cancer and not just postpone it. According to the data we have on Gardasil so far, its protection is expected to last at least five years. While no one understands or can agree on the level of antibody titers necessary to have protection from HPV, there are data indicating that a significant percentage of vaccinated girls lose their antibody response within five years. Are they still protected? What about 8 years after being vaccinated? What about 10 years after? If we find out that booster shots are needed, will young adults who were vaccinated as children actually get them? What if the booster is expensive and they don’t have coverage for it?

Unless the long-term data prove that Gardasil’s protection lasts significantly longer than five years, we may find that girls and boys vaccinated as pre-teens are losing their immunity when they are most sexually active.

Although Gardasil is safe for most people, Souayah’s study found that girls and young women vaccinated with Gardasil were 8.5 times more likely to visit the ER, 12.5 times more likely to be hospitalized, 10 times more likely to have a life-threatening event, and 26.5 times more likely to have a disability than young people vaccinated with Menactra.

Those numbers would be acceptable if Gardasil saves lives, but we don’t yet know if it will.

In summary, the FDA approved Gardasil on the basis of short-term research, and we don’t yet know how long Gardasil provides protection or when a booster shot will be needed. We also don’t know whether vaccinated girls will grow up to be women who are less likely to undergo PAP smears or HPV testing because they think they are guaranteed to be “one less” woman with cervical cancer, as the ad campaigns have promised. There are a lot of unanswered questions, and we hope you will recommend that the FDA regularly re-evaluate Gardasil’s use as new research data on safety and efficacy become available.

Danger at the Dentist’s (and Orthodontist’s) Office: Children Exposed to Radiation

Medical Treatments with Cancer Risks
Margaret Aker, Cancer Prevention and Treatment Fund

 

Has your child been to the orthodontist this year? Was he or she exposed to dangerous levels of radiation?

According to research reported in the New York Times,[1] more and more dentists and orthodontists are using an imaging device that delivers significantly higher doses of radiation than regular X-rays. While people usually don’t have any immediate problems from such radiation, exposure can be harmful over the long-term and has been linked to an increased risk of developing cancer.[2]

Promoters of the cone-beam CT scanner claim that this technology is a safe way to obtain highly detailed images of a patient’s mouth and skull that can be used to help treat complicated dental problems more accurately. Health experts, however, are concerned about the cumulative effects of radiation from these scans, and think they shouldn’t be used routinely.

For patients with more serious dental issues, such as cases involving implants or impacted teeth, the scanner’s comprehensive images may justify the radiation exposure. But in most cases, traditional X-rays, which expose patients to far lower levels of radiation, provide perfectly adequate images. It is worrisome, therefore, that some orthodontists, apparently misinformed about the risks of these scans, are using the cone-beam technology to scan all patients-many of whom are children.

The use of the cone-beam CT scanner is even more controversial for children, because they are more susceptible to the effects of radiation than fully developed adults. These scans put children at greatest risk for several reasons: they are smaller, their bodies are still developing, and the earlier they begin getting scanned, the more exposure they are likely to have over their lifetime. The main concern is cumulative exposure, not just a single strong dose of radiation.

In addition to the cone-beam scanner, there is also concern about the safety of X-rays taken during annual visits to the dentist. Despite a national campaign to reduce radiation levels to those absolutely necessary for proper imaging, many dental offices are still using outdated X-ray machines that emit more radiation than the newer machines.  As evidenced by the cone-beam CT scanner, newer does not, of course, always mean less radiation.

Misuse or overuse of the cone-beam CT scanner also points to a much larger issue that has nothing to do with radiation: the extensive financial relationships that exist between doctors and the companies that make medical products. When manufacturers and doctors get too cozy, conflicts of interest arise, and patient care suffers.  The cone beam scanners have become popular, in large part, because the machine’s primary manufacturer, Imaging Sciences International, has paid dentists and orthodontists to promote it. Although these health professionals may endorse the use of this scanner because they truly believe in its benefits, their enthusiasm may be influenced by these payments and the biased information they receive from the companies that make them. After a health professional has received a check, a dinner, or been to a conference at a fancy hotel with all expenses paid, dozens of research studies show that his or her opinion on a given product will probably be more positive than it otherwise would have been.

It is true that each scan only very minimally increases the risk of cancer. Unfortunately, the risk of these scans adds up quickly if every other trip to the orthodontist or dentist requires one. Dentists, orthodontists, patients, and parents need to ask: is this really needed? Especially when the patient is a child and when safer options are available, is the additional exposure to radiation really worth it?

To read more about radiation and how much we are exposed to from the environment, medical imaging and other sources, read our article “Everything you ever wanted to know about radiation, but were afraid to ask.”

References:

[1] Bogdanich W, Craven McGinty J. Radiation Worries for Children in Dentists’ Chair. The New York Times. 22 November 2010.

[2] Gonzalez A. Risk of Cancer from Diagnostic X-rays: Estimates for the UK and 14 Other Countries. The Lancet. 2004;363:345-351.