The Canadian government today declared bisphenol A, a chemical in plastics also known as BPA, to be toxic.

A scientific assessment of the impact of human and environmental exposure to bisphenol A has determined that this substance constitutes or may constitute a danger to human health and the environment [Official notice]

The chemical has been linked to heart disease, impotence, and diabetes, while animal and cell culture experiments have shown that it can mimic the female hormone estrogen. It is found in some plastic containers, and some food cans are lined with it.

While Canada is forging ahead, most other governments are dithering about whether or not the chemical poses a health threat.

How much exposure is too much, though? There is no clear answer. Two weeks ago, the European Food Safety Authority declared that BPA did not pose sufficient risk to stop using it in food containers. While tiny amounts can leach out into food, they cannot raise human exposure to unacceptably risky levels, the authority concluded after an assessment of existing scientific studies. [Nature]

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UPDATE: In a terse statement (pdf) released today—Thursday, Sept. 9—the U.S. Court of Appeals has issued a stay on the ruling of District Court judge Royce Lamberth against federal funding for embryonic stem cell research. Earlier in the week, Lamberth refused to grant a stay on his own ruling; see below. This doesn’t mean the appeals court is siding with the Justice Department against Lamberth’s ruling; it simply means the three judges want adequate time to consider the ruling and its repercussions. And because the stay lasts until September 20 at least, the National Institutes of Health can re-up the $54 million in projects currently due for annual renewal.

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The ruling stands, for now.

The Obama Administration asked U.S. District Court judge Royce Lamberth to grant a stay of his injunction against federal funding for embryonic stem cell research, insisting that it could trigger job losses and research setbacks. But yesterday the judge issued an order in which he refused to lift the ban, and dismissed the Justice Department’s arguments that the ruling would cause chaos by immediately shutting down all research.

Lamberth indicated that his injunction was less restrictive than had been interpreted by the Obama administration. “Defendants are incorrect about much of their ‘parade of horribles’ that will supposedly result from this Court’s preliminary injunction,” Lamberth wrote. The ruling did not necessarily apply to research that had been funded under guidelines issued during the Bush administration or that had previously been “awarded and funded,” Lamberth wrote. [Washington Post]

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In about a week and a half, officials at the Food and Drug Administration must complete their final deliberations over whether or not to approve a genetically modified salmon as the first GM animal in the world sold for human consumption.

It would seem they’re leaning toward “yes.”

Last Friday, while the country was preparing to go on vacation, the FDA released an analysis (pdf) of the transgenic salmon created by AquaBounty Technologies of Waltham, Massachusetts, declaring it safe to eat and safe for the environment.

The AquAdvantage Atlantic salmon contains a growth hormone gene from the Chinook salmon that is kept active all year round by a genetic on-switch from a different fish, the ocean pout. Normally, salmon produce growth hormone only in warm weather. So with the hormone produced year round, the AquAdvantage salmon grow faster [The New York Times].

“Faster” is an understatement. A normal Atlantic salmon requires about 30 months to grow large enough so that it can be sold at market. But a GM salmon with year-round growth hormone bulks up to market size in barely more than half that time—16 months or so.

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Hallucinogenic drugs are making a comeback–not among the restless youth of today, but among medical researchers. Doctors are increasingly testing illegal drugs like LSD, psychedelic mushrooms, and the party drug ketamine for beneficial effects, and are suggesting that these discredited drugs could have a place in modern medicine. The latest study, published in the Archives of General Psychiatry, found that the active ingredient in hallucinogenic mushrooms helped alleviate depression and anxiety in terminal cancer patients.

“This is a landmark study in many ways,” said Dr. Stephen Ross, clinical director of the Center of Excellence on Addiction at New York University‘s Langone Medical Center, who was not involved in the research. “This is the first time a paper like this has come out in a prestigious psychiatric journal in 40 years.” [Los Angeles Times]

The small pilot study included only a dozen volunteers, so the findings are far from conclusive. The volunteers ranged in age from 36 to 58; all had been diagnosed with advanced-stage cancer and had considerable anxiety as a result of their disease. Each patient had one session in which they were given psilocybin, the active ingredient of magic mushrooms, and another session when they were given a placebo that caused a physiological reaction–still, in most cases the patients could figure out if they’d been dosed or not. In all the sessions the patients were kept under supervision for six hours and were encouraged to lie in the dark while listening to music (no word from the researchers on whether Pink Floyd was provided).

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The U.S. Department of Justice has now officially asked Royce Lamberth, the District Court judge who ruled that the Obama administration’s expansion of embryonic stem cell research violated federal law, to suspend the injunction he issued last week that prevents any more funds from going to stem cell projects. The DOJ is also taking the case to the Court of Appeals.

In a 23-page legal filing, Justice Department lawyers said the stay was needed to avoid terminating research projects midstream and negating years of scientific progress toward finding new treatments for devastating illnesses. The department said the ruling would cause irrevocable harm to “millions of extremely sick or injured people” who could benefit from stem-cell research, as well to scientists and taxpayers “who have already spent hundreds of millions of dollars on such research through public funding of projects which will now be forced to shut down and, in many cases, scrapped altogether.” [Wall Street Journal]

Most ongoing projects had been allowed to continue for now, but only if they used National Institutes of Health money to research at their home universities. However, NIH head Francis Collins notes (pdf) the $54 million in projects due for renewal at the end of this month—without a change in the ruling, NIH is forbidden to renew them. Additionally, projects underway on the NIH campus itself have been ordered shut down.

DISCOVER will keep you posted on further updates.

Related Content:
80beats: Stem Cell Decision Fallout: What’s Next, and Who Were the Plaintiffs?
80beats: Judge: Obama’s Expansion of Stem Cell Research Violates Federal Law
80beats: The Trouble With Lab-Created Stem Cells—and Why They Won’t Displace Embryonic Ones
80beats: FDA Green-Lights First Trials Using Embryonic Stem Cells (Again)

Image: iStockphoto

Stem cell work will go on. But the shape of its long-term future is a mystery.

A court ruling yesterday that said the federal government can’t fund embryonic stem cell research even if no money goes to destroying embryos has thrown the field into confusion. Today, though, NIH head Francis Collins says that while the government can’t fund new projects (at least until the legal dispute is resolved), researchers in the middle of federally funded projects can continue.

Chronic fatigue syndrome’s headaches, muscle aches, tiredness, and concentration problems have no known cause, so a paper published online yesterday, in which researchers report finding a type of virus in 87 percent of 37 chronic fatigue syndrome (CFS) patients tested, seems a promising step. But in statements to the media the researchers stress caution in interpreting results. The group also noted that it had delayed publishing the paper, originally meant to appear in the Proceedings of the National Academy of Sciences in May, due to conflicting reports from other scientists.

The National Institutes of Health’s Dr. Harvey Alter, senior author of the paper,  said in a conference call with reporters, “It’s an association, but that’s all it is.” He was careful to say the findings don’t prove that a virus causes CFS. [NPR]

Alter’s caution is understandable, especially given recent CFS research history:

October 2009: A virus, XMRV (xenotropic murine leukemia virus–related virus), is found in 68 of 101 CFS patients.
January 2010: XMRV is not found in a British study that tested CFS patients.
July 2010: XMRV is not found in a Center for Disease Control study testing CFS patients.

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Is it medicine, or is it not?

In May, the University of California, Berkeley unveiled its “Bring Your Genes To Cal” program. The idea was, Berkeley’s 5,500 or so incoming freshman would have the option to have their DNA tested for three particular characteristics: Their metabolism of folate, tolerance of lactose, and metabolism of alcohol. Though the program was limited, it raised privacy hackles. And now the State of California has ruled: This is a medical test, and Cal can’t do it unless it’s in a clinical setting.

Mark Schlissel, UC Berkeley’s dean of biological sciences and an architect of the DNA program, said he disagreed with the state Department of Public Health’s ruling that the genetic testing required advance approval from physicians and should be done only by specially-licensed clinical labs, not by university technicians. The campus could not find labs willing to do the work and probably could not afford it anyway, Schlissel said. He also contended that the project deserved an exemption from those rules because it was an educational exercise [Los Angeles Times].

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Yes, you saw a similar headline in 80beats in January of 2009, but this time we mean it. We think.

Back in 2009 the FDA approved an application from Geron Corporation to begin the first human safety trials of a therapy derived from embryonic stem cells, a move that was heralded as a strong vote of confidence in this controversial but exciting area of medicine. But before the treatment of patients with spinal cord injuries could begin, the FDA reversed course and put a hold on the trial, noting that Geron had discovered cysts in some rats injected with the cells.

Since then, Geron has been scrambling to prove that its treatment is safe via new animal studies, and has agreed to change some procedures to minimize the likelihood of cyst formation. Now that the FDA has signed off, Geron expects to begin the small safety trial (involving only 7 to 10 patients) before the year’s end.

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When you hear mention of BPA, or bisphenol-A, plastic bottles and food containers likely come to mind. Now, a report presented by activists at the Environmental Working Group says the chemical is also in some paper store receipts.

In the study, which has not been peer reviewed, the environmental group looked for BPA in 36 sales receipts. They found that about forty percent used thermal paper (which has a chemical coating that changes colors when heated) that contained 0.8 to nearly 3 percent pure BPA by weight, 250 to 1,000 times greater than the amount of BPA typically found in a can of food or a can of baby formula. Other research, their report says, shows that BPA can transfer from receipts to a person’s skin, but how much BPA transfers or if it penetrates into the bloodstream remains uncertain. A chemical-industry trade group says the amount transferred is low:

“Available data suggests that BPA is not readily absorbed through the skin,” a spokeswoman from [The American Chemistry Council] said. “Biomonitoring data from the U.S. Centers for Disease Control shows that exposure to BPA from all sources, which would include typical exposure from receipts, is extremely low.”[Washington Post]

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The summer of our government’s discontent (with personal genetics tests) continues. Yesterday an investigator with the Government Accountability Office reported back to Congress on its undercover investigation of the tests on the market, saying that testing the DNA of GAO staffers returned frequently contradictory and confusing answers.

“Consumers need to know that today, genetic testing for certain diseases appears to be more of an art than a science,” said GAO investigator Gregory Kutz [CBS News].

Here at 80beats, we’ve gone over some of the potential problems with these tests. DISCOVER blogger Ed Yong covers them in great detail in a post he wrote this week after getting his genes tested by 23andMe, including the dearth of data appropriate for interpreting results if you’re of Asian rather than European descent, and deciding whether to peek into the data that says whether you have a much higher than average risk for Parkinson’s disease.

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Replacing a traditional needle with a fingernail-sized patch may one day make some immunizations painless and possibly more effective. A study published in Nature earlier this week shows that a patch–a square of “microneedles” that are too short to register a typical shot’s sting and that dissolve in the skin–effectively immunized mice against a strain of the flu virus.

The researchers have yet to test the patch on humans, and that next step could take a few years; the move from a successful animal trial to a human trial isn’t a small feat. Still, many see this patch’s promise. As Paul Offit, director of the Vaccine Education Center and chief of infectious diseases  at Children’s Hospital of Philadelphia, says:

“The caveat is, this needs to be extended to humans…. It’s not uncommon for vaccines or vaccine delivery systems to look very promising in experimental animals, then fail in humans. But there is every reason to believe this kind of technology could be applicable to children and adults.” [HealthDay News]

If the patch proves successful in human studies, here are some reasons it might quickly catch on.

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In a development that’s certain to stir passions in the abortion debate, the Royal College of Obstetricians and Gynaecologists in the UK published a report today on “fetal awareness.” The group states, citing a review of current research, that human fetuses cannot feel pain before 24 weeks.

The group’s reasoning, as described in a press release, is based on these points:

-The fetus cannot feel pain before 24 weeks because the connections in the fetal brain are not fully formed
-The fetus, while in the chemical environment of the womb, is in a state of induced sleep and is unconscious
-Because the 24 week-old fetus has no awareness nor can it feel pain, the use of analgesia is of no benefit
-More research is needed into the short and long-term effects of the use of fetal analgesia post-24 weeks [Royal College of Obstetricians and Gynaecologists]

This is certainly not the first debate over whether a fetus can feel pain. Fetal surgeries have led doctors to ask this question, as they determined whether anesthesia was appropriate and at what stage in development. As summarized in a 2008 New York Times Magazine article, researchers have looked at fetal flinch responses, heart rate, and levels of stress hormones. But any metric has remained controversial. Take stress hormones, for example. Do you say that any fetus that can release these hormones feels pain? Or do you wait until it develops the nervous system to register those hormones? Or do you say that an undeveloped nervous system makes the fetus more susceptible to pain, since it hasn’t developed the system to suppress it?

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The International Society for Stem Cell Research has had enough. When the organization of stem cell scientists met last week in San Francisco, its leaders promised to get serious about unregulated stem cell treatments.

First, society president Irving Weissman declared his intention to “smoke out the charlatans,” New Scientist reported. The ISSCR is investigating its members who provide advice to clinics that offer experimental stem cell treatments (no such treatments have yet received FDA approval).

At a press briefing on 17 June, he revealed that these members are being told to explain their connections with such clinics. Expulsion from the society was a possibility for members who continue to associate themselves with unproven “therapies”, added Sean Morrison of the University of Michigan in Ann Arbor, a member of the ISSCR board of directors [New Scientist].

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A woman with kidney disease has died after receiving an experimental stem cell treatment at a private clinic in Thailand, and a postmortem examination of her kidneys revealed that the treatment was almost certainly responsible for her death. Last week we reported that Costa Rica’s health ministry had closed a stem cell clinic that catered to foreigners, which sparked lively debates around the Internet about whether patients should be able to willingly take on risks associated with experimental treatments. This new case offers a sobering reminder of what can happen when patients travel abroad looking for a miracle cure.

The woman suffered from lupus nephritis, a disease in which the immune system attacks the kidneys. When medications no longer controlled her disease, she went to a still-unnamed clinic in Bangkok where doctors said they could treat her disease using stem cells drawn from her own bone marrow. There was some medical rationale for this:

Bona-fide trials in European clinics about six years ago showed that some people with similar kidney disease benefited if stem cells from their own bone marrow were injected into their blood. The body’s immune system was first deliberately destroyed with powerful immunosuppressive drugs, then the reinjected stem cells helped to stop the attacks on the kidney by rebuilding and rebalancing the immune system. [New Scientist]

However, the Thai clinic didn’t inject the stem cells into the patient’s blood stream, instead they injected them directly into her kidneys. That means the stem cells did nothing to stop the immune system’s attack on the organs–and they instead produced never-before-seen side effects.

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