Tag Archives: BPA

FDA shifts stance on safety of BPA in plastics

Scientists link BPA in plastics to heart disease
Wow. No sooner do I post a blog in which I say, “The U.S. Food and Drug Administration (FDA) is considering whether any action needs to be taken (about BPA). And I would expect them to express a more cautionary tone in the future. There’s just too much evidence now to not do so,” than the FDA announces a reversal of its position.

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

The FDA is now saying it has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.”

While the agency plans to “join other federal health agencies in studying the chemical in both animals and humans,” federal “officials said there was no proof that BPA was dangerous to humans.” FDA principal deputy commissioner Dr. Joshua Sharfstein said, “If we thought it was unsafe, we would be taking strong regulatory action.”

Dr. Sharfstein explained, “We have some concern, which leads us to recommend reasonable steps the public can take to reduce exposure to BPA,” the Washington Post added. “Sharfstein said the agency is conducting ‘targeted’ studies of BPA, part of a two-year, $30 million effort by the administration to answer key questions about the chemical that will help determine what action, if any, is necessary to protect public health.

The Los Angeles Times noted that the “FDA action, which was praised by industry officials and criticized by some food safety and consumer watchdog groups, comes after more than a year of controversy.”

USA Today reported that, along with the increased research, the FDA is “encouraging manufacturers to stop making baby feeding products containing BPA” and “wants to help manufacturers to find safer materials to line metal cans of liquid baby formula.”

The FDA “also is looking into ways to expand its authority to regulate BPA, in case scientists do find definitive evidence of harm, says Joshua Sharfstein.”

The Boston Globe reported that in precautionary recommendations, HHS suggested consumers “throw away scratched cups and bottles with Bisphenol A because small amounts of the chemical can seep out and be ingested by children.” Deputy HHS Secretary William Corr said, “Recent reports show subtle effects of BPA in lab animals that has raised concerns.”

In its report, CBS News correspondent Kelly Wallace asks University of Missouri professor Fred Vom Saal, “How convinced are you that elevated levels of BPA in people’s bodies can lead to cancers, heart disease, obesity and early puberty?”

Vom Saal replied, “I and other colleagues of mine at an NIH (National Institutes of Health) meeting said, with a very high level of confidence, we think Bisphenol A is a threat to human health.”

Here are a couple of my past blogs on BPA:

Scientists link BPA in plastics to heart disease

#mce_temp_url#With disagreement over baby bottle chemical (bisphenol A), what’s a parent to do?

Reuters Health in London is reporting that exposure to a chemical found in plastic containers is linked to heart disease. Scientists researching bisphenol A, known as BPA, have just confirmed earlier findings casting suspicion on BPA and adding to pressure to ban its use in bottles and food packaging — not only for those containers of food or drink for infants and children, but also adults.

British and U.S. researchers studied the effects of the chemical bisphenol A using data from a U.S. government national nutrition survey in 2006 and found that high levels of it in urine samples were associated with heart disease.

Bisphenol A, known as BPA, is widely used in plastics and has been a growing concern for scientists in countries such as Britain, Canada and the United States, where food and drug regulators are examining its safety.

David Melzer, professor of epidemiology and public health at the Peninsula Medical School in Exeter, England, who led the study, said the research confirmed earlier findings of a link between BPA and heart problems.

The analysis also confirmed that BPA plays a role in diabetes and some forms of liver disease, said Melzer’s team, who studied data on 1,493 people aged 18 to 74.

“Our latest analysis largely confirms the first analysis, and excludes the possibility that the original report was a statistical blip,” they said in a statement.

BPA, used to stiffen plastic bottles and line cans, belongs to a class of compounds sometimes called endocrine disruptors.

The U.S. Endocrine Society called last June for better studies into BPA and presented research showing the chemical can affect the hearts of women and permanently damage the DNA of mice.

“The risks associated with exposure to BPA may be small, but they are relevant to very large numbers of people. This information is important since it provides a great opportunity for intervention to reduce the risks,” said Exeter’s Tamara Galloway, who worked on the study published by the Public Library of Science online science journal PLoS One.

U.S. environmental health advocacy groups are urging a federal ban on BPA.

“There’s enough research to take definitive action on this chemical to reduce exposures in people and the environment,” Dr. Anila Jacob of the Environmental Working Group, a non-profit organization, said in a telephone interview.

The U.S. Food and Drug Administration is considering whether any action needs to be taken. And I would expect them to express a more cautionary tone in the future. There’s just too much evidence now to not do so.

U.S. government toxicologists at the National Institutes of Health concluded in 2008 that BPA presents concern for harmful effects on development of the prostate and brain and for behavioral changes in fetuses, infants and children.

Canada’s government plans to outlaw plastic baby bottles made with BPA. The charity Breast Cancer UK last month urged the British government to do the same because they said there was “compelling” evidence linking the chemical to breast cancer risk.

Experts estimate BPA is detectable in the bodies of more than 90 percent of U.S. and European populations. It is one of the world’s highest production volume chemicals, with more than 2.2 million tonnes produced annually.

My advice to my patients is to avoid, as much as possible, containers with BPA — and certainly not to heat or microwave items in BPA containers. Also, for parents I advise that they not feed their children using plastics containing BPA.

For now, I think it’s better to be safe than sorry.

Here are a couple of my past blogs on BPA:

The Top 10 Health Scares Of The Decade

With disagreement over baby bottle chemical (bisphenol A), what’s a parent to do?

While the past decade has seen great strides in medical technology, it hasn’t seen solutions to all of our health problems. There were novel viruses that threatened to kill us all. There were toxins in our children’s toys, and we were told to worry about the junk they were eating.

Some of these threats turned out to be almost nonexistent. Others were arguably overblown. Some caused widespread harm. So what new threats have been robbing you of sleep since the annual odometer rolled over from 1999 to 2000?

Here’s a list from ABC News of the top ten new threats of the last ten years.

1) Swine Flu (H1N1)

Since it came to public attention in the United States in April, the largest health scare of 2009 has been swine flu.

While other forms of the virus typically peak in February and largely affect the elderly, this strain of the H1N1 flu virus came out of season and mostly affected younger people.

In June, the World Health Organization declared the virus a pandemic, meaning that it was widespread on multiple continents.

Manufacturers began producing vaccine at the end of the spring, but there were shortages nationwide, even late into the fall.

While the majority of cases of the flu have been mild, thousands of American deaths have been attributed to the virus.

But no matter the severity, many health experts agree there are lessons to be learned.

“We just have to note, and this was a bit scary, that when H1N1 came along in communities… our capacity to take care of [patients] was stretched,” said Dr. William Schaffner, Chair of the Department of Preventive Medicine at Vanderbilt University Medical Center. “We don’t have a lot of reserve in the health care system anymore.”

Here are some of my blogs on the topic:

2) Bisphenol A (BPA)

While much of the alarm over the chemical bisphenol A, or BPA for short, has come lately, scientists have been looking at it for years.

In January of 2000, an article in the Journal of the American Dental Association discussed how BPA — which is used in some dental sealants — was not found at detectible levels in the body more than a few hours after the treatments.

Since then, studies have shown the chemical to cause birth defects in lab animals, and even create some problems in humans in high doses. The chemical, used in household plastics, has also been found in babies, leading to increased scrutiny from regulatory bodies.

But while we know it is present in humans and can create problems at high levels, it remains unclear what the effect of BPA is in humans at lower doses.

“I would say that there’s growing evidence that it is a significant concern, but it’s not clear yet how much of a concern,” said Joel Schwartz, a professor of epidemiology at the Harvard School of Public Health and director of the Harvard Center for Risk Analysis. “There’s a lot of things that still need to be understood, but there’s certainly enough things to say, ‘Yes, this is something that needs to be on our radar screen.'”

Here are some of my blogs on the topic:

3) Lead Paint On Toys From China

In 2007, a number of products made in China were recalled — but perhaps the recall that drew the most attention was of children’s toys containing lead paint, including some from the popular Thomas the Tank Engine line.

The problem wasn’t so much one of scientific analysis as it was of enforcement.

“We do know that lead is bad for you,” said Schwartz. “Kids and toys are a bad place to put that exposure together. That’s a case where that’s just outrageous.”

The exact effects of the oversight are unknown, but it did shine a spotlight on imported goods.

“It’s doing a little more to make sure this stuff doesn’t keep slipping in,” said Schwartz.

4) Trans-Fats

Concern over trans-fats — found in such crowd-pleasing but doctor-disapproved foods as doughnuts and French fries — came to a head in 2006, when New York City became the first city to ban trans-fats from restaurants.

“The issue became viral, and a lot of it was related to population studies that came out of Harvard University,” said Keith-Thomas Ayoob, director of the nutrition clinic at the Albert Einstein College of Medicine. “The problem with them is they tend to raise bad cholesterol and lower good cholesterol.”

In response to doctors’ concerns, most trans-fats have been removed from food products — but in many cases they may have been replaced by saturated fat, which can also be harmful in excess.

Ayoob said trans-fats were “an easy whipping post.”

Trans-fats may have disappeared because they were easy to replace with other ingredients. And ultimately, the virtual disappearance of trans-fats may be a better testament to the power of economics in responding to consumer demand than that of regulation responding to public complaints.

“It’s box office poison now, is what it is. No one really wants to list that on an ingredient list,” said Ayoob. “That’s one where the food industry responded much more quickly than government ever would have. It just didn’t pay to keep it in there.”

Here are a couple of my blogs on the topic:

5) Bird Flu (H5N1)

This year’s swine flu pandemic wasn’t the first time Americans were concerned with a strain of flu named for an animal.

At the beginning of the decade, avian influenza was a concern in Southeast Asia because of the devastation it was causing in chicken populations. But concerns soon arose about its spread to humans and the possibility it would mutate into a form that could spread from person to person.

“These new influenza viruses usually are modified viruses that come from birds, and now, we know, swine,” said Schaffner. “We know that influenza viruses change on an annual basis… The world’s population will be or will virtually be completely susceptible.”

But concerns over avian flu did have one positive effect for the flu vaccine industry, which has been maligned for its reliance on old technologies to create the vaccine each year. Because antigens for flu vaccines are grown in chicken eggs, it was hard to develop a vaccine for a virus that was deadly to birds, and so work had to be done to begin developing a means of creating antigen without using eggs.

Although the new manufacturing processes are not available yet, “It was exactly H5N1 bird flu that stimulated a number of new ways to create new vaccine,” said Schaffner. “What we see now actually came forward as a consequence of all that concern with H5N1.”

6) Severe Acute Respiratory Syndrome (SARS)

SARS was the first novel virus to captivate the world’s attention this decade after it was identified by the World Health Organization in February 2003.

The respiratory infection was first reported in Asia and then spread to North America, South America and Europe before being contained.

Like influenza, the virus could spread through airborne particles, but it was far more deadly when it infected someone. According to the WHO, 8,096 people were infected worldwide. 774 people died. The virus receded by the end of 2003.

“SARS-like infections, I think, epitomize the emerging infectious diseases,” said Schaffner. As for whether the strain could re-emerge, he said, “My crystal ball is pretty cloudy about that… Trying to anticipate whether it would come back or not would be very, very difficult.”

7) Methicillin-Resistant Staphylococcus Aureus (MRSA)

MRSA is the best-known of a number of bacteria that resist many of the antibiotics used to treat them. The emergence of MRSA and other bacteria has been blamed on a combination of heavy use of antibiotics and a lack of incentives for drug companies, leaving these bacteria, as Schaffner calls it, “a real, very vital threat”

Schaffner said the existence of these bacteria puts responsibility on both food producers and people who would use antibiotics to be more prudent. But he also said the problem could be compounded by the fact that there is currently little financial incentive for drug companies to devise new antibiotics that could fight the threat.

“Clearly, pharma sees the development of new antibiotics to help us treat these drug-resistant infections as high-risk and low-profit,” said Schaffner. “I can think of no new product in any line of industry that, once it’s released, the experts in that area say, ‘Don’t use it,’ and that’s the circumstance when any new antibiotic is created.”

MRSA is not untreatable, but when using the stronger antibiotics for it, “You get yourself into a very restricted corner,” Schaffner said. “You get patients to whom these drugs are incredibly toxic or you may need to keep patients in the hospital rather than send them home.”

Here’s one of my blogs on the topic:

8) Hormone Replacement Therapy

At the start of the decade, millions of women were using hormone replacement therapy to relieve unpleasant symptoms of menopause. It was also used prevent osteoporosis and bone fractures, and heart disease as well.

But as early as 2000, some doctors were recommending against the treatment because of a study in the Journal of the American Medical Association suggesting that it increased the risk of breast cancer.

That alarm greatly increased in 2002 when researchers cut short the Women’s Health Initiative study of the treatment, citing concerns over heart problems and strokes in women in the study who received HRT.

Some researchers supported the decision to stop the study, leading many women to stop their HRT, but others felt that it discouraged women who should continue the treatments. Meanwhile, studies have come out with contradictory findings, further confusing women who were unsure what to do. Controversy over HRT continued in 2008, when the International Menopause Society released new guidelines saying that HRT was effective for post-menopausal symptoms and should be considered by women and their physicians.

Following the release of the new guidelines, ABC News contributor Dr. Marie Savard wrote a column for this site in which she tried to clear up some of the confusion.

“There is no question that for a woman with severe hot flashes, sleep disturbance and an annoyingly dry vagina, nothing else works as well as estrogen,” Savard wrote. “But the risks of breast cancer, stroke and blood clots from estrogen are hard to ignore… So once again, women are asked to balance the benefits of hormones with the risks and make the best decision for them.”

Here are some of my most popular blogs on the topic:

Here are some of my logs on Bio-identical Hormones:

9) Anthrax

After the collapse of the World Trade Center in 2001, five people died after inhaling anthrax bacteria sent through the mail.

But the public at large had little to fear from a tainted envelope.

“That was obviously not a major health problem but a significant problem for a small number of people who have been getting exposed,” said Schwartz. “I think the primary concern was this might be being used to kill some people.”

Senators Tom Daschle of South Dakota and Patrick Leahy of Vermont, among other public figures, had letters mailed to their offices containing anthrax.

No one was ever convicted of sending the letters, but the Federal Bureau of Investigation reportedly planned to charge government researcher Bruce Ivins in the case before he committed suicide in the summer of 2008.

10) Cell Phones

As cell phones became more popular this past decade, concerns over the radiation they emit – and what effect they might have on human health — have proliferated. Some have worried that their use may be linked to the development of brain tumors.

Thus far, however, most research suggests there is little to worry about.

Animal studies have shown that magnetic fields can affect melatonin levels, so while radiation only shows up in low levels, it’s unclear what effect it has on humans. And a Scandinavian study released last week in the Journal of the National Cancer Institute confirmed what many have been saying about cell phone safety, showing no increase in brain cancer among cell phone users.

“Whether they do something worth worrying about, that’s another question,” said Schwartz. Similar questions are raised about high-voltage power lines, but Schwartz urged calm. “It seems to be an issue where it hasn’t completely resolved, but I would say the evidence is that if something is going on it’s not that big.”

Of course, cell phones present an unquestioned safety hazard to Americans, but not for reasons related to radiation. Studies have shown that their use while driving poses a very real hazard.

“That’s pretty clear – talking on a cell phone and driving is like driving drunk,” said Schwartz. “The radiation effects – that doesn’t look like that’s a major public health issue. That doesn’t look very compelling.”

Here is a blog of mine on the topic:

With disagreement over baby bottle chemical (bisphenol A), what’s a parent to do?

USA Today is reporting on the confusion that consumers, in general, and parents, in particular, are having about the safety of chemicals in plastic. Even federal government agencies don’t agree about the hazards posed by bisphenol A, or BPA, an estrogen-like chemical used in plastic that has been detected in the bodies of 93% of Americans tested. The FDA says it’s safe, but new studies question its safety.

My Take? Continue reading

FDA Official Says Baby Bottles With Bisphenol A Safe

According to the Associated Press, the FDA is declaring that “Plastic baby bottles and water bottles are safe.” Thus, the FDA is seeking to ease public concerns about the health hazards of a chemical used in the products. Continue reading