Kids in Danger · Consumer Federation of America
Consumers Union · National Research Center for Women & Families

For Immediate Release
Friday, November 16, 2012

Chicago, IL — A coalition of consumer groups praised the Maryland Department of Health and Mental Hygiene and its Director Joshua Sharfstein for announcing a ban on the sale of crib bumper pads, effective June 21, 2013.

The decision followed a more than year-long investigation by the Maryland Department examining the safety of crib bumper pads. The department conducted its own review of evidence, convened a panel of health experts, held two public meetings, and reviewed public comment. The department concluded that the risks crib bumper pads pose towards infants far outweigh any potential benefits.

Maryland becomes the first state in the nation to ban the sale of crib bumper pads. Chicago, Illinois adopted a ban that became effective in April 2012. In addition, most states already prohibit the use of the product in licensed child care facilities.
The groups — Consumer Federation of America, Consumers Union, National Research Center for Women & Families and Kids in Danger — hailed the act as a major step forward in protecting infants.

“Our organization has been working with families whose children suffocated on this unnecessary crib decoration,” stated Nancy Cowles executive director of Kids In Danger. “We applaud Director Sharfstein and his department for their thorough study of the issue and courage in taking the lead on this safety issue.”

Consumer, safety and health care organizations all agree that a baby sleeps safest alone, on their back in a bare crib that meets current safety standards. Adding soft padding to that environment in the form of pillow, bumper pads or comforters increases the risk of suffocation or entrapment. The American Academy of Pediatrics recently updated their safe sleep guidelines to warn against the use of bumper pads.

“While standards might be appropriate to address the safety of many products, for this unnecessary decorative item which poses danger to infants, Maryland’s action to ban the product will be more effective,” stated Rachel Weintraub, Legislative Director and Senior Counsel of the Consumer Federation of America. “The regulation gives the department the ability to move to a standard if one is developed that is as protective of safety as the ban.”

The regulation defines baby bumper pads as “a pad or pads of non-mesh material resting directly above the mattress in a crib, running the circumference of the crib or along any of the interior sides of the crib, and intended to be used until the age that an infant pulls to stand.” The ban does not apply to vertical bumpers that wrap tightly around each individual crib rail or to mesh crib liners. The Department nonetheless does not recommend the use of these or other novel products.

“This ban will save lives and serve as a model for other states,” added Diana Zuckerman, President of the National Research Center for Women & Families. “As a Maryland resident, mother, and president of a nonprofit group that is dedicated to improving the health and safety of kids and adults, this decision makes me very happy.”

“Action on the state level has historically been effective in addressing emerging hazards and bringing them to the general public’s attention,” concluded Ami Gadhia, Senior Policy Counsel of Consumers Union, the policy arm of Consumer Reports. “We urge CPSC to consider national action against this suffocation hazard.”

Dr. Diana Zuckerman

November 14, 2012

The FDA law is supposed to make sure that all medical products sold in the U.S. are safe and effective.  Unfortunately, it doesn’t.

There are several giant loopholes in the law, including loopholes for compounding pharmacies, as well as companies that call themselves compounding pharmacies but aren’t.  That loophole is enormous, and that’s why hundreds of people are now sick with fungal meningitis and so many have died.

And that’s just the tip of the iceberg, because thousands of people got medications that are not proven safe and not proven effective.   And I’m not just talking about the injections that harmed Jerry, which we heard about today.  There have been many other examples of unsafe medical drugs sold through compounding pharmacies, including cancer drugs that were either weaker or stronger than they should have been.

There’s enough blame to go around, but I don’t want to play the blame game today.  Obviously, a major part of the blame is on the compounding pharmacies that didn’t care enough about patients to make sure the products they were making were safe.  This includes the specific pharmacies in Massachusetts that have been identified, but also includes many other compounding pharmacies.  We also have to wonder about the state and FDA inspectors and officials who knew that there were serious, life-threatening problems but didn’t do enough to fix them, and the doctors who ordered products from compounding pharmacies without considering safety issues.

The innocent victims are the patients who trusted their doctors and the FDA to make sure their medications are safe.  The costs to them are enormous, but the human costs and the financial costs.

This VALID Compounding Act is designed to close the loopholes that are so harmful to patients.  It is a well thought out, comprehensive, and balanced bill, and I congratulate Rep. Markey and his staff on the bill and on their excellent report.

The FDA will do a much better job of enforcement if the law is improved.  The FDA’s hands have been tied — they haven’t been able to get the information they needed to fully investigate.  FDA’s resources are very limited, so the agency tends to focus on the slam dunks, not the efforts that are less likely to be successful.

This law will save lives.  It will save a lot of lives if it isn’t watered down by those who care more about protecting companies than protecting people.  We heard a lot of opposition to safety regulations this past year in the House of Representatives, based on claims that safety regulations kill jobs.  Let’s remember that having more inspectors and requiring research evidence of safety will create jobs.  Personally, I’d rather make new jobs for inspectors and researchers, than jobs for people making unsafe medical products.  This law will make new jobs and it will save lives and healthcare dollars, a great combination.

In closing, I want to point out that the history of the FDA is a history of disasters followed by improvements in the law.  The Food, Drug, and Cosmetic Act passed in 1938 after 107 people died, mostly women and children, from taking an elixir made with an antifreeze that was added to improve the color.  That law was greatly strengthened in 1962, after the Thalidomide tragedy caused thousands of babies to be born without terribly deformed arms, legs, fingers, and toes, and in some cases no arms or legs. And, medical devices – even implanted ones – were not regulated until 1976, after many women died or became infertile from the Dalkon Shield IUD.

This is the latest tragedy, and it is an important opportunity to prevent similar tragedies in the future.  That’s why it is essential to act now.  It is not a partisan issue, and we look forward to working with Congress to act quickly.

By Morgan Wharton and Jessica Cote, BS

November 2012

Most Americans drink coffee every day.[1] The most widely known benefits and risks have to do with caffeine, which helps us stay alert but also may cause jitteriness and interfere with sleeping. A few studies have suggested that decaffeinated coffee also has a positive impact on health, perhaps because of other ingredients in the coffee bean such as natural antioxidants (which fight cellular damage) and acids.[2]

What are the health benefits of drinking coffee?

For years medical experts advised people to drink less coffee, mostly because of research suggesting coffee might increase the risk of heart disease. However, numerous studies conducted recently have discovered coffee’s unexpected health benefits. Like all well-designed research, most of these studies took into account factors that could affect the results such as age, sex, body mass index (BMI), physical activity, smoking status, and family cancer history. By controlling for those factors, researchers made sure they could separate coffee’s impact on health from the effects of people’s lifestyle and previous health problems.

Colorectal cancer

Meta-analyses combine data from several comparable studies to make one very large study. These results are usually more accurate than any one study can be. Taken together, three meta-analyses suggest that drinking about four or more cups of coffee per day may reduce the chances of getting colorectal cancer by 11-24%.[3][4][5]

Endometrial (uterine) cancer

Using data from 67,470 women who participated in the Nurses’ Health Study, researchers found that women who drank four or more cups of coffee per day had a 25% lower risk of endometrial cancer than women who drank only one cup of coffee per day. Compared to women who did not drink any coffee, those who drank four cups or more per day were 30% less likely to develop endometrial cancer. Decaffeinated coffee was just as effective as caffeinated coffee, but caffeinated tea did not lower the risk of endometrial cancer.[6]

Liver cancer and cirrhosis (scarring of the liver/chronic liver disease)

One study found that the risk of the most common type of liver cancer was reduced by drinking coffee. People who drank only one or two cups of coffee per day had a slightly lower risk of getting the disease compared to non-drinkers, but people who drank three or four cups of coffee were about half as likely as non-drinkers to get this kind of liver cancer. Meanwhile, people who drank five or more cups per day had an even lower risk than that (about one-third the risk of non-drinkers).[1]

Similarly, a study in Japan found a 76% decrease in the risk of that type of liver cancer in people who drank at least five cups of coffee per day compared to those who did not drink coffee. The strongest benefit was seen in individuals with hepatitis C, a disease which increases a person’s risk of developing liver cancer, although the researchers were not sure why.[7]

A study of 120,000 Americans over an 8-year period found a 22% reduction in the risk of cirrhosis per cup of coffee per day.[2] In Norway, a 17-year study of 51,000 citizens found that those who drank two or more cups of coffee per day were 40% less likely to develop cirrhosis compared to those who did not consume coffee.[2]

Skin cancer

Using data from two enormous studies, the Nurses’ Health Study and the Health Professionals Follow-up Study, researchers found that men and women who drank more than three cups of caffeinated coffee per month had a 17% lower risk of getting basal cell carcinoma compared to people who drank less than one cup per month. Basal cell carcinoma is the most common and least dangerous type of skin cancer.

Decaffeinated coffee was not associated with higher or lower basal cell carcinoma.[8]

Type 2 diabetes mellitus

People in Finland consume more coffee than almost any other nation, and a study of 14,000 people over 12 years  found that men who drank 10 or more cups of coffee daily had a 55% lower risk of developing type 2 diabetes mellitus than men who drank 2 cups of coffee a day or fewer.  Even more dramatic, women who drank 10 or more cups per day had a 79% lower risk of developing type 2 diabetes than those who drank fewer than 2 cups daily.[9]

A different Finnish study of 5,000 sets of identical twins found that individuals who drank more than seven cups of coffee per day had a 35% lower risk of type 2 diabetes than their twins who drank two cups or fewer per day.[2] Because identical twins are so biologically similar, the difference in disease risk can more confidently be attributed to coffee consumption levels. Studies of fewer people in other countries have found less dramatic but similarly positive results.

Parkinson’s disease

A study of more than 8,000 Japanese-American men found that men who did not drink coffee at all were three to five times more likely to develop Parkinson’s disease within 30 years than men who drank four and a half cups or more of coffee per day.[2]

Suicide

Because suicide may be related to alcohol intake, medications, and stress levels, suicide studies took those factors into account.  A 10-year study of 128,000 people in California found that the risk of suicide decreased by 13% for every additional cup of coffee consumed per day. Even one cup of coffee per day seemed to reduce the risk of suicide.[2] A different 10-year study of 86,000 women found a 50% lower risk of suicide for those who drank two or more cups of coffee per day compared to women who did not drink coffee.[2]

Brain power and aging

A study of 676 healthy men born between 1900 and 1920 suggested that coffee helped with information processing and slowed the cognitive decline associated with aging. Cognitive functioning was measured by the Mini-Mental State Examination, a 30 point scale. Men who regularly consumed coffee experienced an average decline of 1.2 points over 10 years, whereas men who did not drink coffee saw a decline of 2.6 points over 10 years. The greatest benefit occurred in men who drank three cups of coffee per day-their cognitive decline was only 0.6 points over 10 years.[10]

Even old mice are sharper with caffeine: a study using a mouse model of Alzheimer’s disease showed that coffee actually reversed the cognitive decline and slow-down in processing that occurred with age. Mice given caffeine in their water showed signs of recovering their memory during testing.[11]

What about the risks?

Childbearing

Two separate studies found that 300 mg of caffeine (two to three cups of coffee) decreased a woman’s chances of getting pregnant by more than a third. This same amount of coffee also increased the risk of women having low birth-weight babies by 50%. These studies took into account additional factors such as contraception used in the past and infertility history.[2]

Hip fracture

According to data from the Nurses’ Health Study, women aged 65 and over who drank more than four cups of coffee per day experienced an increased risk of hip fracture over the next six years-approximately three times the risk of women who did not drink coffee. Researchers took important factors into consideration such as calcium intake.[2]

Parkinson’s disease among post-menopausal women taking estrogen-only hormone therapy

Other researchers used data from the Nurses’ Health Study to evaluate the risk of Parkinson’s disease among women who drank coffee while using estrogen after menopause. For women who were NOT using estrogen therapy, those who drank four or more cups of coffee per day were about half as likely to develop Parkinson’s disease as women who did not drink coffee. For women who DID use post-menopausal estrogen, however, those who drank four or more cups of coffee were about twice as likely as those who didn’t drink coffee to develop Parkinson’s.[12]

Heart disease

Two different meta-analyses found that people who drank five or more cups of coffee per day had a 40-60% increased risk of developing heart disease compared to those who did not drink coffee at all.[2] Other studies have also shown that high coffee use (five to ten cups per day) increases the risk of heart disease, while moderate consumption (three to four cups daily) was not associated with a higher risk. Only coffee drinkers who consumed more than nine cups a day had a greater risk of dying from heart disease.[2] It is important to consider that  people drinking close to 10 cups of coffee a day are likely to have other health problems, such as stress or sleep deprivation, and this could contribute to higher risk of heart disease and death regardless of coffee use.

The bottom line

For most people, drinking coffee seems to improve health more than harm it. Many of coffee’s health benefits increase with the number of cups per day, but even one cup a day lowers the risk of several diseases. However, women who want to get pregnant or already are pregnant and women over 65 should probably limit their coffee intake because, in their case, the risks may outweigh the health benefits.

Even though numerous studies show coffee to be beneficial, it’s still not clear why. How can one popular beverage help metabolism (for example, lowering the risk of type 2 diabetes) and also protect against a range of cancers? Until further research can solve that puzzle, most adults should continue to enjoy their cup (or two, or three) of Joe. Finally, remember that nearly all studies on coffee and health have been done on adults. Coffee may affect children and teens differently.

[1] Cadden ISH, Partovi N, Yoshida EM. Review article: possible beneficial effects of coffee on liver disease and function. Alim Pharmacol Therap 2007; 26(1): 1-8.

[2] Higdon JV, Frei B. Coffee and Health: A Review of Recent Human Research. Critical Reviews in Food Science and Nutrition 2006; 46(2): 101-123.

[3] Giovannucci E. Meta-analysis of Coffee Consumption and Risk of Colorectal Cancer. Am J Epidem 1998; 147(11): 1043-1052.

[4] Yu X, Bao Z, Zou J, Dong J. Coffee consumption and risk of cancers: a meta-analysis of cohort studies. BMC Cancer 2011; 11(96):1-11.

[5] Je Y, Liu W, Giovannucci. Coffee consumption and risk of colorectal cancer: A systematic review and meta-analysis of prospective cohort studies. Int J Cancer 2009; 124:1662-1668.

[6] Je Y, Hankinson SE, Tworoger SS et al. A Prospective Cohort Study of Coffee Consumption and Risk of Endometrial Cancer over a 26-Year Follow-Up. Cancer Epidemiology Biomarkers & Prevention 2011; 20(12): 2487-2495.

[7] Inoue M, Yoshimi I, Sobue T, Tsugane S. Influence of Coffee Drinking on Subsequent Risk of Hepatocellular Carcinoma: A Prospective Study in Japan. Journal of the National Cancer Institute 2005; 97(4):293-300.

[8] Song F, Qureshi AA, Han J. Increased Caffeine Intake is Associated with Reduced Risk of Basal Cell Carcinoma of the Skin. Cancer Research 2012; 72: 3282-3289.

[9] Tuomilehto J, Hu G, Bidel S et al. Coffee Consumption and Risk of Type 2 Diabetes Mellitus Among Middle-aged Finnish Men and Women. The Journal of the American Medical Association 2004; 291(10):1213-1219.

[10] Van Gelder BM, Buijsse B, Tijhuis M, et al. Coffee consumption is inversely associated with cognitive decline in elderly European men: the FINE Study. European Journal of Clinical Nutrition 2007; 61(2):226-32.

[11] Arendash W, Cao C. Caffeine and Coffee as Theraputics Against Alzheimer’s Disease. Journal of Alzheimer’s Disease 2010; 20: S117-S126.

[12] Ascherio A, Weisskopf MG, O’Reilly EJ, McCullough ML, Calle EE, Rodriguez C, Thun MJ. Coffee Consumption, Gender, and Parkinson’s Disease Mortality in the Cancer Prevention Study II Cohort: The Modifying Effects of Estrogen. American Journal of Epidemiology 2004; 160(10):977-984.

by Dr. Diana Zuckerman

Huffington Post

November 2012

Imagine that you took a medication on the advice of a doctor, it turned out to be contaminated, and you just found out it might kill you. Let’s take it a step further: What if this contamination was completely and utterly preventable, the result of carelessness, greed, and indifference?

More than 400 men and women have been diagnosed with meningitis contracted after receiving a contaminated pharmaceutical injection, and 31 have died. By the time you read this, the numbers are likely to be even higher. Thousands of apparently healthy men and women have been waiting to see if they will become ill, because there can be a delay of several months from the time of infection to the time that symptoms appear.

The tragic meningitis outbreak was absolutely preventable and, worse yet, follows a familiar pattern that has resulted in other tragedies in recent years. Here’s what needs to happen to prevent further human loss:

  • Close the giant loopholes in the law. Our laws, as they are now, allow many medical products on the market that are not tested for safety or effectiveness before they can be sold. (You might want to read that sentence again.) This past year we saw deaths and permanent harm caused from defective hip replacements and heart valve rings. In recent years, some compounding pharmacies were found to have sold diluted cancer drugs and other drugs that were either dangerously powerful or hopelessly weak, and to have killed patients with those formulations. Before that, the attention was on defective defibrillators, which were blamed for the deaths of dozens of men and women. Congress is well aware of these loopholes in our legal system, and when lawmakers had the chance to close them up with Food and Drug Administration (FDA) legislation that passed overwhelmingly a few months ago, they did nothing.
  • Educate doctors so they can educate patients. Doctors and patients don’t realize the risks of these products because they assume the FDA has required safety studies. All of the medical interventions listed in the above paragraph, for example, were presumed to have been tested and found safe and effective, but none had been.
  • Make noise to incentivize people to act. The FDA often waits until tragedy strikes to step up to the plate to prevent future problems. Many members of Congress suddenly express concerns–but not about the patients and consumers who are their constituents; they complain on behalf of the businesses (constituents and donors), and they couch it as a concern about job loss. Apparently, selling safe medical products is not conducive to creating jobs. Too many legislators seem to think it is more important to hire more factory workers than it is to hire more safety inspectors.

Sometimes tragedies happen because of unpredictable accidents, terrible weather, evil intent, or an unfortunate confluence of events. In contrast, a deadly outbreak due to contamination at a large compounding pharmacy is a preventable event. But when the pharmacy associations continue to oppose efforts year after year that are intended to prevent such outbreaks, when doctors and medical facilities aren’t paying attention to loopholes in the law, and when so many members of Congress side with industry instead of standing for patient safety, then they all share the blame.
Here’s the roadmap we need to follow to get out of this mess:

1. Make physicians sign an informed consent form that says they understand that a product hasn’t been proven safe or effective by the FDA, and then provide a copy of that form to patients. Of course, that won’t eliminate the problems with compounding pharmacies or untested medical devices, but it will discourage the use of untested products by doctors and might cause patients to ask a few more questions before agreeing to procedures.

2. Enforce the current laws regarding inspections. If a company fails an inspection, it should be shut down until it passes. Period.

3. Close the loopholes in the law. Require medical products to be proven safe and effective before they can be sold in the U.S., regardless of who makes them! Sounds logical, right?

In 2007, an unlikely trio–U.S. Sen. Ted Kennedy, a liberal Democrat, and two conservative Republican senators (Sens. Burr and Roberts)–considered legislation to help prevent tragedies like the meningitis outbreak. That bill died before it was introduced, but is getting new attention in the Senate this month. A few days ago, Rep. Ed Markey, a Democrat from Massachusetts who is active on health issues, introduced a similar bill in the House of Representatives. The goal is to try to pass a bipartisan bill on the matter when they return to Capitol Hill next week. Let’s do what we can to make sure they are successful, because we can’t afford to wait until the next tragedy.

For more information about FDA policies and unsafe medical products, and Rep. Markey’s proposed legislation, check out http://www.stopcancerfund.org/ and http://www.center4research.org/category/public-policy/testimony-briefings-statements/.

Stay informed, and please, spread the word.

The original post of this blog can be found here.

September 28, 2012

Joshua M. Sharfstein, M.D.
Secretary
Department of Health and Mental Hygiene
201 W. Preston St.
Room 512
Baltimore, MD 21201

Re: Request for Public Comment: ASTM International Standard Consumer Safety Performance Specification for Infant Bedding and Related Accessories.

Dear Dr. Sharfstein,

As members of the Patient, Consumer, and Public Health Coalition, we are writing to strongly oppose the use of ASTM International Standard (F1917-12) as a safety standard for baby bumper pads.  The standard is not a useful alternative to the Department of Health and Mental Hygiene’s (DHMH) proposed ban.  As we stated in our July 19, 2012 letter to DHMH, we agree with DHMH that “the pads pose a risk of suffocation, strangulations, and death.”[1]

We noted in our July letter that crib pads were originally developed to prevent an infant’s head from becoming entrapped between crib slats.  However, for many years cribs have been required to place their slats closer together, so that design problem has been solved without the use of risky crib bumper pads.[2] As a result, the pads are now purely decorative.

The Juvenile Products Manufacturers Association (JPMA) is attempting to use ASTM standards to distinguish between safe and unsafe baby bumper pads.  JPMA claims that bumper pads with a thickness of 2 inches (the ASTM standard) or less are safer than thicker bumper pads.  However, JPMA offers no scientific evidence to support this claim and it would be impossible to ethically conduct such research.  If a bumper pad (no matter how thick or thin) blocks an infant’s airway, the infant will suffocate.   And, although it may seem logical to conclude that thinner bumper pads are safer than thicker pads, that would not mean they are as safe as no pads at all.  Given that doctors on Maryland’s expert advisory panel reviewing crib baby bumpers concluded that there was no evidence for meaningful benefits of bumper pads to infants,[3] even a small risk is unacceptable.

The U.S. Consumer Product Safety Commission reviewed its databases from January 1, 1990 to May 6, 2010 and found “a total of 52 infant deaths where bumper pads were mentioned in the narrative.”   In ten of the reports, there were no other contributing factors to the deaths other than the infant sleeping face-down next to the bumpers.  The reports included statements such as “face obstructed by bumper pad” and “suffocated in corner against bumper pad.”[4] There is no evidence that a thinner bumper pad would not cause suffocation if the child is lying in a corner against the pad.  Any possible benefits from these new crib bumper pads would be wishful thinking and clearly eclipsed by the already established serious risks of suffocation and injury.[5]

ASTM F1917 waffles when it comes to safety. In section 1.4, ASTM issues a “safety hazards caveat” pertaining to the testing method. It states, “This standard does not purport to address the safety concerns, if any associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use” (emphasis in original).[6] However, in the Rationale section of the standard (Section X 1.1), it states that testing to limit “the overall thickness of bumpers [to 2 inches] has not been known to present a hazard.” ASTM provides no evidence to back up that statement, and it is inconsistent with the previously quoted statement.  Moreover, in section 8.2.1, it states: “Warning to reduce the risk of suffocation, keep top of bumper up and in position.” Obviously, the risk of suffocation still exists or they would not require a warning label about the risk.

Members of the Patient, Consumer, and Public Health coalition support DHMH’s proposed ban on the sale of baby bumper pads in the state of Maryland.  The ASTM standard is absolutely not a viable alternative.  F1917-12′s performance requirements will not mitigate the severe risks (suffocations, strangulations, and entrapment) associated with bumper pads. The risk of bumper pads in cribs are well established while the safety or benefits of “safer” bumpers are unproven and certainly do not outweigh those risks. The performance requirements address the thickness of the pads, not the fact that the pads-no matter how thin or thick-can block an infant’s airways.

In the ideal world, parents would understand the risks of crib bumpers and would decide not to use them.  However, in the real world, not all parents understand these risks, and it is not uncommon for crib bumpers to be given as baby gifts, especially by adults who are not new parents and therefore unaware of the risks.  The ASTM standard that claims some bumper pads are less risky will muddle the safety issue even more and give parents a false sense of security.   Maryland’s proposed ban on crib bumper pads will help to protect more than 70,000 babies born in the state each year, and that is a bottom line upon which we should all agree.

American Medical Women’s Association
National Consumers League
National Research Center for Women & Families
National Women’s Health Network
Public Citizen
U.S. PIRG
WoodyMatters

For more information, contact Paul Brown at (202) 223-4000 or pb@center4research.org

 

[1] Maryland Department of Health and Mental Hygiene (2012). Q & A – Proposed Regulations Banning Baby Bumper Pads.

[2] Pediatrics, SIDS and Other Sleep-Related Infant Deaths: Expansion of Recommendations for a Safe Infant Sleeping Environment; Pediatrics 2011; 128; e1341; originally published online October 17, 2011.

[3] Maryland Department of Health and Mental Hygiene (2012). Background and Assessment for Proposal to Prohibit Safe of Baby Bumper Pads.

[4] Consumer Product Safety Commission (2010). White Paper – Unsafe Sleep Settings Hazards Associated with the Infant Sleep Environment and Unsafe Practices Used by Caregivers: A CPSC Staff Perspective.

[5] ASTM published new infant bedding standard (August 14, 2012). Kids Today. http://www.kidstodayonline.com/article/554341-ASTM_publishes_new_infant_bedding_standard.php

[6] ASTM F1917-12 (2012).  Standard Consumer Safety Performance Specification for Infant Bedding and Related Accessories.  http://www.astm.org/VIEWER_TEMP_PDFS/F1917_md_dhmh.8982.pdf

October 31, 2012

The Honorable Edward J. Markey
Energy and Commerce Committee
U.S. House of Representatives
2108 Rayburn
Washington, DC 20515

Dear Congressman Markey,

As members of the Patient, Consumer, and Public Health Coalition, we thank you for your commitment to the health of patients and consumers by introducing the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012. This bill would strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.

The current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk. We are very grateful to you for your leadership on this very important, life-saving bill.

The VALID Act would protect the activities of traditional small compounding pharmacies while ensuring that compounding pharmacies that are essentially operating as drug manufacturers are regulated by the FDA the same way as other drug manufacturers. It would require pharmacies that engage in interstate commerce to register with the FDA and comply with minimum safety standards. The bill would require compounding pharmacies to report deaths and other serious adverse events to the FDA in a timely manner, so that other patients would not be harmed. It would authorize the FDA to inspect pharmacy facilities, which is absolutely essential. It would also require a warning to patients that compounded drugs have not been approved safe and effective by the FDA.

We look forward to working with you on the VALID Act, and share your desire to make sure that waivers are available when the public health is at stake, but are not used to undermine the integrity of the legislation.

The scandal around the lack of oversight of compounding pharmacies has alarmed lawmakers on both sides of the aisle.  We will make every effort to secure bipartisan support for this bill.

Cancer Prevention and Treatment Fund
Jacobs Institute for Women’s Health
National Consumers League
National Research Center for Women & Families
Our Bodies Ourselves
Union of Concerned Scientists

The original letter can be found here.

Press release from Representative Markey.

November 1, 2012
Washington, D.C.

VALID Compounding Act will give FDA authority it needs to ensure the safety of the compounding pharmacy sector nationwide

Today, Congressman Edward J. Markey (D-Mass.) announced legislation he plans to introduce tomorrow that will strengthen federal regulations for compounding pharmacies. The New England Compounding Center (NECC), a compounding pharmacy located in Rep. Markey’s Congressional District, has been found to be the source of contaminated injectable steroids that have led to 28 deaths and 377 illnesses in 19 states. The Verifying Authority and Legality in Drug (VALID) Compounding Act will give the Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country.

“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” said Rep. Markey, senior member of the Energy and Commerce Committee. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies. I look forward to working with my colleagues in Congress on a bipartisan basis to move this legislation forward.”

A copy of the VALID Compounding Act can be found HERE. A one-page description of the legislation can be found HERE.

The VALID Compounding Act will:

  • Preserve state regulatory authority for traditional small compounding pharmacy activities;
  • Ensure that compounding pharmacies that are operating as drug manufacturers are regulated by the FDA as drug manufacturers;
  • Allow compounding pharmacies with a legitimate reason to compound drugs before the receipt of a valid prescription to request a waiver to enable them to do so;
  • Allow the FDA to waive the requirement to compound drugs solely for individual patients with valid prescriptions in the event of a drug shortage or to protect public health;
  • Allow the FDA to waive the requirement to compound drugs only if they are not copies of commercially-available drugs if doing so is necessary to protect public health or well- being; and
  • Increases transparency to the public by mandating that compounded drugs be labeled to ensure that recipients know that the drugs have not been tested for safety or effectiveness, publishing a “Do Not Compound” list of unsafe or ineffective drugs, and reporting of bad reactions to compounded drugs or any drug that poses a safety risk.

“This bill will save lives by ensuring that compounding pharmacies play by the rules that are essential to protect patients,” said Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund. “This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable. We call on Congress to work in a bipartisan manner to pass Congressman Markey’s legislation, which is necessary to protect our families from these predictable, preventable tragedies.”

The legislation has been endorsed by Cancer Prevention and Treatment Fund, Jacobs Institute for Women’s Health, National Consumers League, National Research Center for Women & Families, Our Bodies Ourselves, and Union of Concerned Scientists. A copy of the endorsement letter can be found HERE.

Earlier this week, Rep. Markey released the report “Compounding Pharmacies, Compounding Risk”, which revealed that even before the current outbreak, problems at compounding pharmacies led to at least 23 deaths and 86 illnesses in 34 states, and that state regulatory bodies typically focus on more non-safety related traditional pharmacy licensing activities. A timeline of Rep. Markey’s work on compounding pharmacies can be found HERE.

By Jessica Cote

January 2013

 

Pancreatic cancer has one of the worst survival rates of all cancers: 94% of patients die within five years of diagnosis. Pancreatic cancer is the fourth-leading cause of cancer-related deaths in the U.S. and is expected to claim over 37,000 American lives in 2012.[1]

Early detection would improve survival rates

Like most cancers with low survival rates, pancreatic cancer is usually not diagnosed until after it has grown and spread to other parts of the body. Because the pancreas plays such a large role in the absorption of foods and the regulation of blood sugar levels, an advanced tumor in the pancreas severely impairs the digestive system and hormone regulation. When the cancer is finally found at this advanced stage, it can be very difficult to remove because the tumor has expanded into nearby blood vessels or organs such as the liver. For those lucky enough to discover the cancer early (only 10% to 15% of cases), tumors can be surgically removed, along with part or all of the pancreas (pancreatectomy).For the more than 80% of cases of pancreatic cancer that can’t be removed by surgery because it is too advanced, treatment includes radiation therapy, chemotherapy, or surgery to remove part of the pancreas, or a combination of the three.[2] These treatments don’t cure the cancer but they can help shrink tumors and slow the cancer’s spread.

Survival rates for pancreatic cancer patients could be greatly improved with a better method for finding and diagnosing the cancer at earlier stages. There is no simple screening test for pancreatic cancer, but new research suggests that testing for oral bacteria using a sample of saliva, gum or plaque might help doctors figure out who has the greatest risk of developing pancreatic cancer.

Could oral bacteria serve as a warning sign for pancreatic cancer?

A study by Dr. Dominique Michaud and colleagues at Brown University, published in 2012 in the journal Gut, focused on whether high levels of certain types of bacteria in the mouth could serve as a warning sign that a person might later develop pancreatic cancer.[3]

The researchers looked at health data from 519,978 people from 10 European countries, most of whom had provided blood samples as part of a study. Among the half million who participated in the study, 578 had developed pancreatic cancer, and these cancer patients had no additional malignant tumors except some had non-melanoma skin cancer. Only 405 of these patients had previously provided blood samples (five years prior to diagnosis, on average), so they were the focus of this study. The pancreatic cancer patients’ blood samples were compared with blood samples from 416 people of the same sex and close in age who didn’t have any cancer.

The blood samples were then tested for antibodies, or proteins produced by the immune system that would show whether or not certain types of bacteria had been present in the person’s mouth.

The people who were diagnosed with pancreatic cancer had higher amounts of three kinds of oral bacteria compared to people without pancreatic cancer. Perhaps most surprisingly, people who had one particular strain of bacteria in their mouth, called Porphyromonas gingivalis, were twice as likely to have developed pancreatic cancer compared to those without the bacteria. Because the blood samples of patients with pancreatic cancer were taken an average of five years before diagnosis of the cancer, it seems like the presence of these specific oral bacteria could serve as a warning sign for pancreatic cancer.

Some bacteria are harmless, and some bacteria are considered “good” rather than dangerous (such as those included in yogurt with active cultures or dietary supplements). People who had lots of harmless or good oral bacteria had almost half the risk of pancreatic cancer compared to those without such high levels of good bacteria.

Together with findings from other research studies, these results suggest that doctors may someday in the future prescribe good bacteria as a treatment, rather than antibiotics which kill bad bacteria. Good bacteria would likely be taken in the form of probiotics, which are supplements designed to reduce damage from antibiotics and other medicines and restore a healthy internal world of bacteria. Researchers are only beginning to learn about the ways bacteria can improve our health, and in what form to deliver good bacteria to people who need them.

What is Porphyromonas gingivalis?

In addition to its link to pancreatic cancer, P. gingivalis is a type of bacteria that is the major cause of periodontal disease, more commonly known as gingivitis or gum disease. Gingivitis is generally caused by long-term deposits of plaque on your teeth. The disease causes inflammation and infection that destroys the tissues around the gums and teeth. Common symptoms of gingivitis include bleeding gums, mouth sores, and sensitive or swollen gums.[4]

To make matters a bit more complicated, the 2012 study also found that some people with healthy gums had quite a bit of P. gingivalis in their mouths.[3] This means that the bacteria don’t always cause gingivitis and some people may have loads of P. gingivalis living in their mouth without knowing it. A doctor or dentist might need to perform a test using a sample of saliva, plaque or gum to locate the bacteria.

The researchers at Brown don’t fully understand the relationship between harmful oral bacteria and pancreatic cancer. For instance, they don’t know if oral bacteria like P. gingivalis lead to pancreatic cancer or if cancer in the pancreas somehow promotes the growth of P. gingivalis in the person’s mouth. Or perhaps both the cancer and the bacteria are the result of something else–an infection or some other assault on the body causing inflammation?

Perhaps most importantly, it is still unclear whether treating gingivitis more effectively can reduce the risk of pancreatic cancer, or whether you should get tested for pancreatic cancer if you find out that you have P. gingivalis bacteria. There are several ways to test for pancreatic cancer, but they can be expensive and invasive: you can get an MRI (magnetic resonance imaging) of your pancreas, a CT scan (computerized tomography) of your pancreas, or your doctor can use a scope to take a picture inside your body or take a biopsy (tissue sample) from your pancreas.

Since smoking, being overweight or obese, or having diabetes or long-term inflammation of the pancreas increase a person’s chances of developing pancreatic cancer, you can reduce your risk if you quit smoking, lose weight, and keep your diabetes under control-especially if you have P. gingivalis bacteria.

[5] If you have any of those risk factors and haven’t been to the dentist or periodontist lately, get a check-up and ask to be tested for P. gingivalis. Although medical experts aren’t completely certain how to remove these bad oral bacteria, they usually recommend flossing and brushing teeth regularly as well as rinsing with mouthwash as the best ways to get rid of them.

More research is needed to understand the link between oral bacteria and pancreatic cancer, and it will take medical experts some time still before they figure out how best to reduce the number of harmful bacteria in our bodies and increase the good kind.

The bottom line:

  • Pancreatic cancer is typically fatal because it is difficult to detect at an early stage. A method for earlier diagnosis would greatly improve chances for survival.
  • New research suggests that people who have a specific type of oral bacteria (P. gingivalis) are twice as likely to get pancreatic cancer as those without the oral bacteria. Also, people with lots of healthy oral bacteria have a much lower risk of pancreatic cancer than those without healthy bacteria.
  • Researchers still aren’t sure if harmful bacteria in the mouth cause pancreatic cancer or if the cancer wipes out healthy bacteria and leads to a person having harmful oral bacteria. More research will help clarify the connection between oral bacteria and pancreatic cancer.
  • Until then, take good care of your teeth and gums (brushing and flossing your teeth, and gently massaging your gums with a toothbrush) and see your dentist regularly. You’ll have a healthier mouth, and you might just have a healthier pancreas, too.

[1] Howlader N, Noone AM, Krapcho M, Neyman N, Aminou R, Altekruse SF, Kosary CL, Ruhl J, Tatalovich Z, Cho H, Mariotto A, Eisner MP, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer Statistics Review, 1975-2009 (Vintage 2009 Populations). National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/csr/1975_2009_pops09/, based on November 2011 SEER data submission, posted to the SEER web site, April 2012.

[2] Sener SF, Fremgen A, Menck HR, Winchester DP. Pancreatic Cancer: A Report of Treatment and Survival Trends for 100,313 Patients Diagnosed from 1985-1995, Using the National Cancer Database. Journal of the American College of Surgeons 1999; 189(1):1-7.

[3] Michaud DS, Izard J, Wilhelm-Benartzi CS et al. Plasma antibodies to oral bacteria and risk of pancreatic cancer in a large European prospective cohort study. Gut 2012; 00:1-7.

[4] Gingivitis (Gum disease; Periodontal disease). In A.D.A.M. Medical Encyclopedia. PubMed Health: U.S. National Library of Medicine. Retrieved from http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002051/

[5] Pancreatic carcinoma (Pancreatic cancer). In A.D.A.M. Medical Encyclopedia. PubMed Health: U.S. National Library of Medicine. Retrieved from http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001283/

October 31, 2012

This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable, and follows a familiar pattern that has resulted in other tragedies in recent years.

Twenty-eight men and women have already died and thousands more are waiting to find out if they will get potentially deadly meningitis, all because of giant loopholes in the FDA laws and regulations regarding compounding pharmacies.  The loopholes have allowed companies that manufacture prescription drugs to call themselves compounding pharmacies and because of the misnomer don’t need to prove that their “medications” are safe or effective.

These loopholes are similar to those for medical devices, including everything from heart valves to hips, which also can be sold without being proven safe or effective or inspected to make sure they are not contaminated with deadly bacteria.

We call on Congress to work in a bipartisan manner to pass legislation necessary to protect our families from these predictable, preventable tragedies.

By Jessica Cote, BS

Updated February 2013

 

Many of us are bombarded with spam advertising various weight loss products that we are happy to ignore, but when Dr. Oz showed his enthusiastic support for green coffee bean extract, it caught our attention. Since then, Dr. Oz has shown support for several other weight loss products, and green coffee beans are no longer flying off the shelves.

So what’s the verdict? The hype sounds too good to be true, and usually that means it isn’t true. This time, there’s some intriguing research to back it up, but if these pills really worked, wouldn’t the fad have lasted longer? Here’s what we know so far.

 

What are green coffee beans?

Green coffee beans are the raw, unroasted version of the roasted black coffee beans we use to make coffee. Because green coffee beans are bitter, they are usually consumed in the form of a supplement made from green coffee bean extract. The extract is made by simmering the raw beans in distilled water for 15 minutes. If bought in pill form, it should consist of 50% chlorogenic acid and does not need to contain caffeine.

 

Does green coffee bean extract really work for weight loss?

Human study #1: Effects on body weight, BMI, body fat, and heart rate

A study by Vinson, Burnham and Nagendran, published in a diabetes journal in 2012, tested 16 overweight but otherwise healthy adults over a period of 22 weeks. The men and women were randomized into three different treatments: high dose green coffee extract (1050mg), low dose extract (700mg), and a placebo (no active ingredient). After each six-week treatment, subjects went through a two-week “wash-out” period in which they stopped taking pills to cleanse their system. The order of these three testing conditions was random for each person and neither the subjects nor researchers knew which testing condition the subjects were assigned and when (that is referred to as a “double-blind study”). Dr. Nagendran tells us that the men and women were urged to consume no more than 1500 calories a day and had to report their diet in weekly journals. That should have resulted in weight loss for everyone, especially since the calorie intake was almost identical for all three groups during the 22 weeks of the study.[i]

What happened? Over the 22 weeks of the study (which included 10 weeks with either placebo or no pills at all), the men and women lost an average of about 17 lbs, which was more than 10% of their body weight on average. In addition, their percent body fat was reduced by an average of 16%. Heart rate and blood pressure either improved or stayed the same, indicating no serious health risks from the extract, and no other adverse reactions were reported. During the six weeks that they took placebo, they didn’t lose any weight. Perhaps most surprising, each of the 16 men and women lost weight during the 22-week period, which is extremely unusual in any weight loss study.

The study has three enormous shortcomings, however. The first is the very small number of patients (only 16) and the second was the short number of weeks (22). Dr. Nagendran tells us that in the weeks after the study was completed and the pills were no longer available, weight loss was generally maintained and some continued to lose some weight. However, those data were not presented in the article.

The study’s third weakness is that there are many companies selling green coffee bean extract in the U.S. and we don’t think any of them are the same company that made the pills for this study. Since neither the FDA nor any other agencies monitor the actual ingredients in dietary supplements, there is no way to know which (if any) green coffee bean products sold in the U.S. would work as well as those in the study.

There are a few other studies that also indicate the possible benefits of green coffee.

Human study #2: Effects on body weight

A peer-reviewed study published in 2007 tested 30 overweight people for 12 weeks.[ii]

They were randomly assigned to drink either regular caffeinated instant coffee or coffee enriched with chlorogenic acid. The researchers and subjects were not told which coffee each person was drinking.

Did anyone lose weight? The people who drank the enriched coffee lost an average of about 12 lbs, while those who drank normal instant coffee only lost an average of 4 lbs. Although the coffee enriched with chlorogenic acid might not have tasted exactly like regular coffee, it is unlikely that knowing whether or not they were taking the extract resulted in such a large difference in weight loss.

Human study #3: Effects on sugar absorption

In the same 2007 article, a second experiment tested 12 normal-weight healthy people. Each volunteer drank four types of beverages: regular caffeinated instant coffee, regular decaffeinated instant coffee, chlorogenic acid-enriched coffee, and water. Subjects drank one of the beverages with sugar and then researchers followed their sugar levels for two hours. The individuals waited one week between each testing phase and the order of beverages for each subject was randomly assigned. All researchers and subjects were blind to what they were taking, and their diets did not change during the study.[ii]

Results of this study showed that when people drank a coffee enriched with chlorogenic acid they absorbed 7% less glucose compared to when they drank the caffeinated and decaffeinated regular instant black coffee and water. Glucose, a type of sugar derived from the carbohydrates we eat, is absorbed by our intestines and the excess glucose not used to “fuel” our bodies is converted into fat. Reduced glucose absorption seems to lead to less fat production.

It works for mice

The studies of people were conducted after green coffee extract was shown to be effective with mice. A study published in 2006 showed that mice who ate green coffee bean extract gained less weight over two weeks than mice eating a regular diet. The green coffee bean extract also reduced the fat between their organs by 50% and slightly reduced levels of triglycerides (a type of fat) in the bloodstream.[iii] A similar study published in 2010 showed that mice who ate a special diet enriched with chlorogenic acid gained 16% less body weight and had 46% less fat mass after eight weeks compared to mice on a diet that was identical except it did not include chlorogenic acid.[iv]

 

Does it really work, and if so, why?

Before we draw any conclusions, we’d need larger human studies which last for more than a year. These preliminary results suggest that green coffee bean extract is safe and we know it’s relatively inexpensive. However, we really do not know if it works.

The black coffee beans used to make coffee have been roasted at 350-600°F. This extreme heat changes the chemical composition of the unroasted beans, greatly reducing the chlorogenic acid found in raw coffee beans. A study that tested seven different types of coffee beans from South America, Asia and Africa found that raw, green coffee beans contain anywhere from 34-43mg of chlorogenic acid per gram of beans, whereas the same beans roasted only contain between 2-9mg of chlorogenic acid per gram of beans.[v]

While experts are still not certain of all the roles chlorogenic acid plays in the human body, they believe that chlorogenic acid slows the release of glucose into the bloodstream, perhaps by inhibiting sugar absorption from starch consumption, thus decreasing caloric input and thereby reducing fat production.[i],[ii] Researchers also believe that chlorogenic acid increases the liver’s processing speed.[iv] This is important because the liver is in charge of breaking down insulin, a hormone that plays a major role in metabolizing carbohydrates and fats in the body.

Scientists designed an experiment to confirm that our bodies can digest and use chlorogenic acid. The results showed that humans can almost fully metabolize the acid. This finding confirms that chlorogenic acid might play a key role in altering metabolism.[vi]

In addition to raw coffee beans, chlorogenic acid is also found in sunflower seeds, apples, potatoes and eggplant. However, the levels are much higher in green coffee beans.

 

Could green coffee bean extract also provide other health benefits?

Whether or not green coffee bean extract can help you lose weight, could it have other health benefits? Studies in humans and animals have shown that using green coffee bean extract lowers blood pressure.[vii],[viii] A new study showed that chlorogenic acid might have the ability to target and kill some cancer cells. This cancer-fighting potential is most likely related to chlorogenic acid’s activity as an antioxidant, which can fight cellular damage.[ix] These results sound promising, but more research is still necessary to further investigate all potential health benefits.

 

Can green coffee beans harm you?

Individuals taking green coffee bean extract have not noticed any side effects during these clinical trials. However, there are some potential risks that have been identified. A study published in 2001 showed that chlorogenic acid, a major component of the raw beans, slightly raised concentrations of homocysteine in the blood.[x] Homocysteine is an amino acid that tends to be more prevalent in people with cardiovascular disease than in healthy people. Experts are still debating whether or not high levels of homocysteine cause cardiovascular disease, but even if they do there is no evidence that small increases in homocysteine would be harmful.[xi] A 2012 study demonstrated that chlorogenic acid might cause damage to DNA (the genetic “blueprints” of our bodies) in regular cells, but these results are very new and need further investigation.[ix]

Because the studies have only tested very small groups of people so far, it is difficult to know how safe or effective the extract would be if taken by thousands of people.  The largest studies to date, which are also quite small, were financed by companies with interests in the sales of the extract. A study by Dr. Dellalibera and colleagues that was published in a French journal in 2006 tested 50 overweight volunteers for 60 days.[xii] The people who took green coffee extract lost 11 lbs on average while those who took placebo lost an average of 5 lbs.  A second study tested 62 overweight volunteers for only four weeks.[xiii] People who drank a caffeinated coffee enriched with chlorogenic acid lost an average of 3 lbs while people who drank regular coffee only lost a quarter of a pound on average.

Green coffee bean extract is currently sold by different companies with varying directions and dosages.  We think the best advice for anyone taking the extract is to follow the directions that were used in Human Study #1 (above). They found that a total daily dose of either 700 or 1050 mg of chlorogenic acid was safe and effective, taken 350 mg at a time either two or three times a day. Dr. Nagendran told us that the men and women took the pills two or three times a day, either before or during meals. Their patients were told to try to take the pills approximately six hours apart.

 

The bottom line

  • Small studies of humans have shown that green coffee bean extract might help you lose weight and body fat.
  • So far, people taking the extract in small studies have not experienced any serious side effects but it is important to do studies of the impact on heart disease.  Diarrhea has been mentioned sporadically in online forums. As always, if you are on any medications or have any health problems, you should check with your doctor before taking any supplement. It might be helpful to bring a copy of this article, because many physicians are unfamiliar with the latest research on green coffee beans.
  • Dietary supplements aren’t usually inspected by the FDA, which means that they may not contain the ingredients that are listed on the label. For the safest options, the only ingredient in the supplement should be Green Coffee Bean Extract (Chlorogenic Acid 50%).
  • There are no studies examining long-term health effects.

[i] Vinson JA, Burnham BR, Nagendran MV. Randomized, double-blind, placebo-controlled, linear dose, crossover study to evaluate the efficacy and safety of a green coffee bean extract in overweight subjects. Diabetes Metab Syndr Obes 2012; 5:21-7.

[ii] Thom E. The Effect of Chlorogenic Acid Enriched Coffee on Glucose Absorption in Healthy Volunteers and Its Effects on Body Mass When Used Long-term in Overweight and Obese People. J Int Med Res 2007; 35(6): 900-908.

[iii] Shimoda H, Seki E, Aitani M. Inhibitory effect of green coffee bean extract on fat accumulation and body weight gain in mice. BMC Complement and Altern Med 2006; 6:9.

[iv] Cho AS, Jeon SM, Kim MJ, Yeo J, Seo KI, Choi MS, Lee MK. Chlorogenic acid exhibits anti-obesity property and improves lipid metabolism in high-fat diet-induced-obese mice. Food Chem Toxicol 2010; 48(3): 937-943.

[v] Moon JK, Yoo HS, Shibamoto T. Role of Roasting Conditions in the Level of Chlorogenic Acid Content in Coffee Beans: Correlation with Coffee Acidity. J Agric and Food Chem 2009; 57(12):5365-5369.

[vi] Farah A, Monteiro M, Donangelo CM, Lafay S. Chlorogenic Acids from Green Coffee Extract are Highly Bioavailable in Humans. J Nutr 2008; 138(12): 2309-2315.

[vii] Mubarak A, Bondonno CP, Liu AH, Considine MJ, Rich L, Mas E, Croft KD, Hodgson JM. Acute Effects of Chlorogenic Acid on Nitric Oxide Status, Endothelial Function, and Blood Pressure in Healthy Volunteers: A Randomized Trial. J Agric Food Chem 2012; 60(36):9130-9136.

[viii] Suzuki A, Kagawa D, Ochiai R, Tokimitsu I, Saito I. Green coffee bean extract and its metabolites have a hypotensive effect in spontaneously hypertensive rats. Hypertens Res 2002; 25(1):99-107.

[ix] Burgos-Moron E, Calderon-Montano JM, Orta ML, Pastor N, Perez-Guerrero C, Austin C, Mateos S, Lopez-Lazaro M. The Coffee Constituent Chlorogenic Acid Induces Cellular DNA Damage and Formation of Topoisomerase I- and II-DNA Complexes in Cells. J Agric Food Chem 2012; 60(30):7384-7391.

[x] Olthof MR, Hollman PC, Zock PL, Katan MB. Consumption of high doses of chlorogenic acid, present in coffee, or of black tea increases plasma total homocysteine concentrations in humans. Am J Clin Nutr 2001; 73(3): 532-538.

[xi] Wald DS, Morris JK, Wald NJ. Reconciling the Evidence on Serum Homocysteine and Ischaemic Heart Disease: A Meta-Analysis. PLoS One 2011; 6(2): e16473.

[xii] Dellalibera O, Lemaire B, Lafay S. Svetol, green coffee extract, induces weight loss and increases the lean to fat mass ratio in volunteers with overweight problem. Phytotherapie 2006; 4(4): 194-197.

[xiii] Ayton Global Research. Independent market study on the effect of coffee shape on weight loss- the effect of chlorogenic acid enriched coffee (Coffee Shape) on weight when used in overweight people. 2009.

Nyedra W. Booker, PharmD, MPH

October 2012

Is your child playing on rubber instead of grass at the playground? The use of human-made surfaces on playgrounds has increased dramatically over the years. Developed during the 1960s primarily for athletic fields,[1] these artificial surfaces were also part of a strategy to provide children with more opportunities for outdoor physical activity, particularly in the inner city where outdoor playgrounds were scarce.[2] The first artificial turf (marketed as “Chemgrass”) was made of plastic, yet looked a lot like natural grass. As its use for various sports activities increased significantly over the years, so did the concerns. Athletes began to complain that the surface was much harder than natural grass, as some studies also began to show that the use of artificial turf could increase the risk for football and other sports-related injuries. This prompted a ban on the use of artificial turf by the English Football Association in 1988, while many ballparks and professional sports stadiums in the United States began converting back to using natural grass during the 1990s. [2] Over time, material such as rubber was added to keep the blades of “grass” in place and provide more cushioning. [2] Some of the benefits of artificial turf are that it’s a long-lasting “all-weather” material that does not require a lot of maintenance or potentially dangerous pesticides. Artificial turf containing rubber and other cushioning materials is also believed to reduce sports-related injuries, but study results have been mixed.[3] Artificial turf is currently used on approximately 4,500 playgrounds, tracks and fields in the U.S. [1]

From Tire Swings to Play Surfaces Made from Tires

Do you remember when children use to play on tire swings in the backyard or at the park? Those same tires are now being put to a new and possibly hazardous use! Recycled rubber tires have become one of the top choice materials for surfacing children’s playgrounds.[4] According to the U.S. Environmental Protection Agency (EPA), approximately 290 million scrap tires are generated each year, with 28 million being ground up for various surfaces.[5] Logically, tire scraps seemed like a surface that would be less likely to harm children if they fell. Recycling tires for use in playgrounds also keeps them out of landfills where they take up space, harbor rodents and other animals, and trap standing water that serve as breeding grounds for mosquitos and other disease-bearing insects. In addition, tires that have been thrown away can catch fire and that releases many different harmful chemicals into the air and ground water. [5] [6]

The tire material used on playgrounds can include the following:

  • Uncompressed/loose tire shred (rubber mulch) or “crumb” on a surface that can be raked
  • Tire shreds combined with a binder and then poured onto a permanent surface
  • Tiles made from tire shreds and binder that have been factory-molded then glued to a playground surface4

Are Playground Surfaces Made with Recycled Tires Safe?

There has been increasing evidence that raises concerns about the safety of recycled tire material used on playground surfaces. While tire rubber includes natural rubber from rubber trees, it also contains phthalates (chemicals that affect hormones) -see Phthalates and Children’s Products), polycyclic aromatic hydrocarbons (PAHs), volatile organic compounds (VOCs) and other chemicals known or suspected to cause adverse health effects.[7] Polycyclic aromatic hydrocarbons, for example, are natural or human-made chemicals that are made when oil, gas, coal or garbage is burned. [8] According to the EPA, breathing air contaminated with PAHs may increase a person’s chance of developing cancer, and the Agency for Toxic Substances and Disease Registry (ATSDR) states that PAHs may increase the risk for cancer and also increase the chances of birth defects.[8] [9]

What the Scientific Studies Say

The California Office of Environmental Health Hazard Assessment (OEHHA) conducted three laboratory studies in 2007 to investigate the potential health risks to children from playground surfaces made from recycled tires. One study evaluated the level of chemicals released that could cause harm to children after they have had contact with or ingested loose tire shreds-either by eating them or by touching them and then touching their mouth. The other two studies looked at the risk of injury from falls on playground surfaces constructed from recycled tires compared to wood chips, as well as the potential contamination of air and water due to recycled tire shreds.[4]

The ingestion part of the study did not involve children ingesting tire shreds; instead, researchers developed a solution that mimicked the conditions of a child’s stomach and placed 10 grams of tire shreds in it for 21 hours at a temperature of 37°C. Researchers then measured the level of released chemicals in the solution and compared them to levels established by the EPA as risky. The part of the study meant to mimic a child touching the tire shreds and then touching her mouth was performed by wiping recycled tire playground surfaces and measuring chemical levels on the wipes. To look at skin contact alone, the researchers used guinea pigs and tested them to see how sensitive they were to rubber tire playground samples. This study assumed that children would be using the playground from the ages of 1 through 12. Results of the OEHHA studies showed that while a one-time ingestion of, or skin contact with tire shreds would probably not cause any health effects in children, repeated or long-term exposure might. Five chemicals, including four PAHs, were found on wipe samples. One of the PAHs-”chrysene”-exceeded minimal risk levels established by the OEHHA, and therefore, could potentially increase the risk of cancer in children. [4]

Out of the 32 playgrounds surfaced in recycled tires that the researchers in California looked at, only 10 met that state’s 2007 standard for “head impact safety” to reduce brain injury and other serious trauma in children who fall while playing. In contrast, all five surfaces made of wood chips met the safety standard.[4]

A 2012 study analyzing rubber mulch taken from children’s playgrounds in Spain found harmful chemicals present in all, frequently at high levels.[7] Twenty-one samples were collected from 9 playgrounds in urban locations and screened for various pollutants. The results showed that all samples contained at least one hazardous chemical, with most containing multiple PAHs found at high concentrations. Several of the identified PAHs can be released into the air by heat, and when that happens children are likely to inhale them. While the heat needed to do this was very high in some cases (140 degrees Fahrenheit/ 60 ºC), many of the chemicals also became airborne at a much lower temperature of 77 ºF (25 ºC). The authors concluded that the use of rubber recycled tires on playgrounds “should be restricted or even prohibited in some cases.”[7]

What the EPA Has Done

The EPA created a working group that collected and analyzed data from playgrounds and artificial turf fields that used recycled tire material. Samples were collected at six turf fields and two playgrounds in four study sites (Maryland, North Carolina, Georgia and Ohio). In a report released in 2009, the agency concluded that the level of chemicals monitored in the study and detected in the samples were “below levels of concern.” There were limitations to this study however. Due to the small number of samples and sampling sites used, the EPA stated that “it is not possible to extend the results beyond the four study sites or to reach any more comprehensive conclusions.”

A meeting was then convened by the EPA in 2010, bringing together various state and federal agencies to discuss safe levels of chemical exposure on playgrounds made from recycled tire rubber, and opportunities for additional research. [1]In the case of PAHs, the EPA has concluded that while there are currently no human studies available to determine their effects at various levels, based on laboratory findings, “breathing PAHs and skin contact seem to be associated with cancer in humans.” [8]

How to Protect Your Children?

So how can you protect your child at the playground? Remember that children are much more likely to be harmed by exposure to chemicals in their environment than adults because they are smaller (so the exposure is greater) and because their bodies are still developing. This is why it’s important to significantly reduce (or try to eliminate) any contact your child may have with substances that are known or suspected to be harmful. If you have more than one playground in your area, choose the one that doesn’t have a recycled rubber play surface.

Parents can actively persuade local officials that playgrounds should use wood chips rather than recycled rubber or other substances that are less safe when children fall, and more dangerous in terms of chemicals that they breathe or get on their hands.

The Centers for Disease Control and Prevention (CDC), Consumer Product Safety Commission (CPSC) and EPA all recommend that you teach your child the importance of frequent hand washing, especially after playing outside and before eating.[1] Also, if you notice any loose tire shreds or other debris on your child after being at the playground, remove his/her shoes and clothing before entering the home.[10]

[1] US Environmental Protection Agency (EPA). Fact Sheet-The Use of Recycled Tire Materials on Playgrounds & Artificial Turf Fields. http://www.epa.gov/nerl/download_files/documents/fs_tire_crumbs.pdf Accessed September 5, 2012.

[2] Claudio L. Synthetic Turf-Health Debate Takes Root. Environmental Health Perspectives, 2008; 116(3):A117-22.

[3] New York State Department of Health. . Fact Sheet: Crumb-Rubber Infilled Synthetic Turf Athletic Fields. August 2012 (last revised).  http://www.health.ny.gov/environmental/outdoors/synthetic_turf/crumb-rubber_infilled/fact_sheet.htm Accessed September 21, 2012.

[4] State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007. http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf Accessed September 5, 2012.

[5] US Environmental Protection Agency (EPA). Wastes-Resource Conversation-Common Wastes & Materials – Scrap Tires (Frequent Questions). http://www.epa.gov/osw/conserve/materials/tires/faq.htm Accessed September 5, 2012.

[6] Earth 911.com. Benefits of Recycling Tires.  http://earth911.com/recycling/automotive/tires/benefits-of-recycling-tires/ Accessed September 5, 2012.

[7] Llompart M, Sanchez-Prado L, Lamas JP, Garcia-Jares C, et al. Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 2012; Article In Press. http://dx.doi.org/10.1016/j.chemosphere.2012.07.053.

[8] US Environmental Protection Agency (EPA). Polycyclic Aromatic Hydrocarbons (PAHs)-Fact Sheet. January 2008. http://www.epa.gov/osw/hazard/wastemin/minimize/factshts/pahs.pdf Accessed September 5, 2012.

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