plastics in humidifier and tubing

Oh now HUSH!

I love you too.

Not wise, occasionally fabulous, generally cranky, look like I'm about two months past due pregnant in overalls....

Anyway, given the current economic condition, my new retirement strategy is to spend it now, live a fun, unhealthy life, and die before I retire.

LOL,
B.

Howdy everyone. Hope y'all are doing well. I haven't posted anything in a while. I just kind of stepped back to take a breath about this BPA thing. I still haven't gotten a urine test yet. I spoke to my rheumatologist and he seems to think many of my conditions MAY be linked to BPA exposure by is at a loss for a way to prove it. I'm still waiting on a response from my internist. Anyway, there have been two developments since my last post. Here are the articles that will update everyone. The most astonishing is the first one. An independent panel hired by the FDA says the FDA has failed at its evaluation of BPA

Scientific Advisers Criticize FDA’s Exoneration of BPA
Posted by Jacob Goldstein; The Wall Street Journal

The latest bombshell in the rolling controversy over the chemical bisphenol A comes from a panel of scientific experts convened by the FDA.

In a report posted on the FDA’s Web site, the experts conclude that “the Margins of Safety defined by FDA as ‘adequate’ are, in fact, inadequate.”

The agency has said BPA, a chemical found in hard plastic containers and in the liners of canned food, doesn’t pose a risk at current exposure levels.

The report also questions the FDA’s analysis of BPA levels in baby formula, a key question given that concerns about the safety of the chemical focus largely on its effects on infants. Some research has suggested that exposure to the chemical could raise the risk of developmental problems.

Specifically, the report finds that the FDA used too few samples of formula in its analysis. And the agency should have accounted for the variability of BPA levels in different samples, rather than relying on the mean for its estimates, the report suggests.

The report will be hashed out at a meeting on Friday.

Canada recently moved to ban baby bottles containing BPA, and Wal-Mart and other retailers have said they will stop selling baby bottles that contain the chemical in the U.S. And another U.S. agency said earlier this year that exposure to the chemical may carry risks for infants and children.

In a statement yesterday, the FDA said “the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.”




Health Canada makes it official: BPA is health hazard
Thursday, October 16, 2008

OTTAWA - Canada on Saturday will become the first country to formally declare bisphenol A hazardous to human health and officially inform the baby-product industry it will no longer be able to use the chemical in baby bottles.

Canada's announcement comes six months after Health Minister Tony Clement surprised the chemical industry by announcing the government's plan to place bisphenol A on its list of toxic substances and ban its use in baby bottles.

In unveiling the "precautionary and prudent" move, Clement proposed a limited ban of the widely used chemical, also found in hard plastic sports bottles and the lining of food cans.

Most Canadians "need not be concerned" about the health effects of bisphenol A, Clement said at the time. "This is not the case for newborns and infants."

The government's final decision will appear in the Canada Gazette, which publishes the official regulations of the government.

Rick Smith, executive director of Environmental Defence and co-author of the forthcoming book Slow Death by Rubber Duck: How the Toxic Chemistry of Everyday Life Affects Our Health, said the expected declaration is a "good start."

But he said new evidence continues to pile up, pointing to the detrimental health effects of bisphenol A on adults.

"There's new science coming out on a weekly basis pointing to this chemical being a health concern for adults. Baby bottles are a good start, but the government now needs to take a look at getting this chemical out of the lining in cans."

The latest research, the first large BPA study in humans published last month by the prestigious Journal of the American Medical Association, found a "significant relationship" between exposure to the ubiquitous estrogenic chemical and heart disease, diabetes and liver problems.

Meanwhile, the U.S. Food and Drug Administration is under fire after determining last month in a draft report that BPA was safe for food storage. On Thursday, the Washington Post published an editorial arguing the FDA's final recommendation, expected this month, could be "seen as less than fully independent."

The influential newspaper cited the recent donation of $5 million to the University of Michigan's Risk Science Center from Charles Gelman, the retired head of a medical device manufacturing company and outspoken proponent of bisphenol A.

The acting director of the university centre is Martin Philbert, a toxicologist who is also head of the FDA advisory panel poised to deliver its risk assessment of BPA.

Philbert did not disclose the gift to the agency as part of the disclosure process when he was appointed to the panel; he told the Milwaukee Journal Sentinel he did not need to, since he does not stand to gain from it. The FDA is looking into a possible conflict of interest.

Wow. Thanks for keeping up with this, JD. You're right... the first article especially is astonishing. And your persistence is kicking me back into action. I'd had a thought back then, but never followed through on it. I will, and I'll post back here if it comes to anything.

(Stop in more often! I know we'd all benefit from the addition of your perspective to the mix. )

Marsha

Dear Marsha,

Did you notice this passage in the second article.

"The influential newspaper cited the recent donation of $5 million to the University of Michigan's Risk Science Center from Charles Gelman, the retired head of a medical device manufacturing company and outspoken proponent of bisphenol A."

Here's why this is significant.

Charles Gelman, retired from Gelman Sciences, now donates his wealth through the Gelman Educational Foundation. Gelman is a vocal critic of chemical regulation and supporter of free-market organizations that fight regulation. The foundation gave a 5 million dollar gift to the University of Michigan School of Public Health Risk Science and Communication Center, which Gelman has called his "legacy". That center is directed by the head of the FDA panel which will review the safety of bisphenol A (BPA).

Will the decision of the FDA committee be compromised?

I would say it did. I would also like to know what medical devices his company manufactures.

Oh yes. And here's an article related to the topic of Gelman and conflict of interest inthe BPA study.
Donation raises questions for head of FDA’s bisphenol A panel
By SUSANNE RUST and MEG KISSINGER

Posted: Oct. 12, 2008

A retired medical supply manufacturer who considers bisphenol A to be "perfectly safe" gave $5 million to the research center of Martin Philbert, chairman of the Food and Drug Administration panel about to make a pivotal ruling on the chemical's safety.

Philbert did not disclose the donation, which is nearly 25 times larger than the $210,000 annual budget of the University of Michigan Risk Science Center, where he is founder and co-director. FDA officials learned of the link from the Journal Sentinel.

Donor Charles Gelman, once labeled the second worst polluter in Michigan by the state's Department of Natural Resources, said in an interview that he considered the chemical, which is used to make baby bottles and aluminum can liners, to be safe. Worries about health problems that may be caused by the chemical are exaggerated by "mothers' groups and others who don't know the science," Gelman said.

He said that he had made his views clear to Philbert in "several conversations."

Philbert denied that.

"At no time have the Gelman family or any other interested/disinterested person, persons, corporations or other entity contacted me or attempted to influence my scientific judgment on the matter," Philbert said in an e-mail response to questions from reporters.

Norm Fost, director of the bioethics program at the University of Wisconsin, said Philbert should have disclosed the donation.

"The public has a right to know about those connections whether they have any effect on the outcome or not," Fost said. "It sounds like a conflict of interest."

Philbert was chosen to chair the FDA's subcommittee on bisphenol A by Barbara McNeil, head of the FDA's Science Board. She selected him from a list of 12 scientists on her board. Philbert then filled out a conflict of interest statement but did not list Gelman's donation.

McNeil said she could not recall exactly when she picked Philbert to head the committee, but she thought it was sometime in July.

Gelman's donation to the Michigan center was made in July.

Philbert's committee is expected to release its opinion this month. It will advise the FDA on whether to accept, reject or amend a draft released by the agency in September. That draft found that products made with bisphenol A are safe for food storage.

The decision of Philbert's committee is being watched carefully by chemical-makers and is expected to have huge implications on the regulation and sale of the chemical in items such as baby bottles, reusable food containers and plastic wraps.

Developed originally as a synthetic form of the hormone estrogen, bisphenol A is used to make hard clear plastic in water bottles, baby bottles and other household products. It is also used as a liner in aluminum cans and in many dental sealants. The chemical has been detected in the urine of 93% of Americans tested.

In the late 1990s the FDA and other government agencies discovered that bisphenol A was leaching from baby bottles. It was also migrating into liquid infant formula from cans.

Since then, a host of studies have found that the chemical causes cancer, heart disease, obesity, reproductive failures and hyperactivity in laboratory animals.

In April, Canada proposed classifying bisphenol A as a toxin and banning its use in baby bottles and other products for children. A number of manufacturers, such as Wal-Mart, Nalgene and Toys "R" Us, have said they will begin phasing out its use.

The National Toxicology Program, formed to advise the FDA, released its report in September citing some cause for concern about the chemical's impact on the development of children, infants and fetuses.

The discrepancy between the FDA and its advisory program has been confusing to consumers.

Last year, the Journal Sentinel reviewed 258 research papers and found that a large majority of those studies showed bisphenol A was harmful to lab animals. Those that didn't find harm overwhelmingly were paid for by the chemical industry.

Gelman, a retired manufacturer of syringes and medical filtration devices, has fought against government regulation of pollutants for years.

He is an anti-regulation activist and an outspoken supporter of organizations including JunkScience.com, the Cato Institute and the Competitive Enterprise Institute that attack the credibility of government and academic scientists on such topics as global warming and hazardous chemicals.

Gelman said he and Philbert talk often. He said Philbert eventually told him that he did not want to have any more discussions on the subject of bisphenol A because he was concerned about the appearance of impropriety. But, Gelman said, "He knows where I stand."

Norris Alderson, the FDA's associate commissioner of science, learned of the link from the Journal Sentinel. He looked into the matter and said he was satisfied there was no conflict of interest because Philbert's salary is not paid by the donation.

Still, the connection troubles scientists familiar with the chemical controversy.

"This definitely raises some red flags," said Sarah Vogel, a post-doctoral fellow at the Chemical Heritage Foundation in Philadelphia who did her dissertation on the politics of bisphenol A. "Is there an expectation that Dr. Philbert would vote one way or another?"

Philbert serves as co-director of the University of Michigan's Risk Science Center, which he helped develop in 2003 to assess health risks from environmental agents.

Gelman said he hopes his grant money to Philbert's center will get people to consider risks of chemicals outside a highly charged political atmosphere.

"Too often politicians are responding to what they think a small part of the public wants," Gelman said.

Philbert said Gelman's gift was made with the understanding that it conformed to the rules and policies of the Standard Practice Guide of the University of Michigan.

"No influence may be exerted on the Center, its management, direction or on the statements made by members of the Center," Philbert said.

He steadfastly denied any conflict of interest.

"Until today, no question has been raised with respect to my impartiality in this matter," he said in an e-mail to the Journal Sentinel. "I am not open to any undue influence and have taken on this (unwelcome) task with all due diligence and seriousness."

The announcement of the Gelmans' gift was hailed in university publications as a way to position the University to become the nation's premier center to determine health risks from environmental agents. Philbert was pictured with Gelman and his wife, Rita, in publicity press about the donation.

The FDA draft has been criticized by environmental groups for relying on two industry-funded studies and for selecting Philbert, who has no expertise or background in bisphenol A.

There are seven members of Philbert's subcommittee. Two are from the Science Board and five were picked by Philbert and McNeil. One of those five is a faculty member at Philbert's Risk Science Center.

It is not yet clear whether unusual amounts of BPA is getting leached into the breathed air from the heated humidifier of cpap machines, but most all heated humidifier chambers are made with the type of plastic that has BPA and heating increases leaching. It appears though that bpa can be absorbed by breathing it in. While this may remain controversial for a while, I wish to finesse this if possible. The following is my plan.

What I would like to do is a test for my urine concentration of BPA while I am normally on cpap with HH. If it turns out to be much higher than the average (most of us seem to get bpa, but the concentrations may be relatively low) then I would do another test after being off of the cpap for a couple of days. The half life of bpa in the urine is extremely short, of the order of only a few hours. If the concentration is significantly reduced, I would conclude that HH is a significant contributor of this possibly toxic material. Then I would think of ways of designing a new HH of my own without plastic. This last task is not that difficult, I already have a design in mind.

Does anybody here know where one can get the bpa urine test done? Most local hospital labs (even large ones) do not have the capability to test for bpa. I know CDC can do that, but I do not know whether somebody like us can get such a test done through CDC. If anybody here has any information about the availability of such a test or its costs or related items, I am very interested in hearing about it.

Thanks, jdennie for providing that information! I personally prefer to follow both sides of how this BPA controversy plays out.

feeling_better wrote:What I would like to do is a test for my urine concentration of BPA while I am normally on cpap with HH. If it turns out to be much higher than the average (most of us seem to get bpa, but the concentrations may be relatively low) then I would do another test after being off of the cpap for a couple of days. The half life of bpa in the urine is extremely short, of the order of only a few hours. If the concentration is significantly reduced, I would conclude that HH is a significant contributor of this possibly toxic material. Then I would think of ways of designing a new HH of my own without plastic. This last task is not that difficult, I already have a design in mind.

Just a reminder to control identically for all other BPA skewing environmental and diet exposures in those two tests. That means holding all other BPA exposures minimal and constant throughout both tests. But it also means finding out if there are any non-BPA chemicals, exposures, or other factors (such as physical activity) that can skew/bias measured results---and then controlling for those potentially skewing factors as well. That last recommendation only assumes BPA urine testing does not enjoy a perfect or 100% specificity of measurement.

Hmmm,

It's funny how the sleep story and the bpa story are one right after the other . . .

http://health.usnews.com/articles/healt ... -news.html

Thanks everyone for the work you've done in followup to my original concern some months age. Just checked back in to read all the more recent posts. I think this is an important issue as we try to live a healthy life. The fact that we use a cpap machine shows we care about our health.
I hope someone invents a steel or aluminum water chamber. How hard could that be? I don't like using my humidifier anyway because of condensation issues in my Headrest nasal tube. So I usually have the heat off.
Hopefully posts will continue here of any new info from the manufacturers about BPA.

I have friends that use medical supplies that have had this chemical taken out by the manufacture due to complaints and the product they have to use now is so stiff and uncomfortable it injures the skin. We need a good alternative before pushing for a change The product my friends are using are not CPAP equipment but other medical products.

I am new to this Forum..and I was wandering if we have any late news about this BPA problem in our humidifiers. (The postings that I saw were dated back in 2008)
Thank you in advance for your help on this matter..
Respectfully yours,
Renato.

I believe most of the manufacturers are designing in bpa free humidifiers, but I do not think anyone has announced the availability of any such new humidifiers.

There was a very extensive review article about this recently in NYTimes, but that did not consider the effect of breathed in bpa, and especially among more disease prone segment of the populations such as those with sleep apnea.
http://www.nytimes.com/2010/09/07/scien ... bpa&st=cse

Is it possible to find the MSDS (material safety data sheet) for the chamber in question?
It is my understanding that federal law mandates access of this info for EVERY product used or sold in this country.
--Worth a shot. . . Probably need a chemistry background to understand the data.

Looking at the MSDS is not going to help you much with bpa, because there is much controversy about it, and the potential harm concerns are new. There were even some allegation, many of which look highly likely to be true that the old FDA was influenced (bought off) by bpa manufacturers, including one company which has practically monopoly on bpa based medical syringes and related items. So most of current official docs list bpa as ok. Even if some of the current controversy is resolved, the issue of breathed in residual bpa from the likes of humidified is still far away to be resolved. But the potential threat of huge liability (read as in asbestos) is what has got the cpap companies to quickly redesign their humidifiers, while maintaining, of course, they use only govt approved materials.

I'm always leary of the chemicals used in things we interact with all day long. MY thinking is though, that if something is made of plastic and is not essential then I don't need it. I prefer glass/steel/stainless/wood/paper to Plastic/teflon/aluminum in anything to do with food or packaging for example. and will seek out products made from or packaged this way.. the problem with everything else is if you use a pwerfull enough method of examination there will be certain amounts of everything in the world in everything! the only way around it it to refine it clean and then worry about contamination later.. it's a crazy never ending game.