EU bans bisphenol A chemical from babies' bottles

The European Commission has announced a ban on the use of bisphenol A (BPA) in plastic baby bottles from next year.The commission cited fears that the compound could affect development and immune response in young children.There has been concern over the use of BPA for some time, with six US manufacturers removing it in 2009 from bottles they sold in the US, although not other markets.But a UK expert said he thought the move was "an over-reaction".BPA is widely used in making hard, clear plastic and is commonly found in food and drink containers.A European Commission spokesman said the proposal had been approved after being presented to a committee of national government experts on Thursday - months earlier than scheduled - and approved.The European parliament had called for the ban in June.

Areas of uncertainty

John Dalli, Commissioner in charge of Health and Consumer Policy, said the ban was good news for European parents."There were areas of uncertainty, deriving from new studies, which showed that BPA might have an effect on development, immune response and tumour promotion," Mr Dalli said in a statement.

EU states will outlaw the manufacture of polycarbonate feeding bottles containing the compound from March 2011, and ban their import and sale from June 2011, the Commission said.But Professor Richard Sharpe, of the Medical Research Council's Human Reproductive Sciences Unit at the University of Edinburgh, said the commission's decision must have been made on political, rather than scientific, grounds."I do not know of any convincing evidence that bisphenol A exposure, in the amounts used in polycarbonate bottles, can cause any harm to babies as not only are the amounts so minuscule but they are rapidly broken down in the gut and liver.

"Babies have the necessary enzymes and are able to metabolise bisphenol A just as effectively as adults."

He added: "Personally I think this is an overreaction, but if satisfactory replacements chemicals are available then this can be done to placate those calling for action, but scientifically it's a retrograde step."I would be happy for a baby of mine to be fed from a polycarbonate bottle containing bisphenol A."

And Professor Warren Foster of the department of obstetrics and gynaecology at Canada's McMaster University, said the EU had acted with "extreme caution".

Mimicking

The National Childbirth Trust is a British charity which has campaigned for the ban.Its chief executive Belinda Phipps told the BBC: "When you put liquids into a bottle - particularly hot liquids or liquids containing fatty liquids - it leaches out of the plastic. And particularly as the bottle gets older and it gets more scratched, more and more leaches out and into the liquid."Ms Phipps said that when a baby drinks from a bottle which contains BPA, the baby absorbs the leached chemical into its fat."It's a chemical that mimics oestrogens, but not in a good way," she said. "It interferes with oestrogens getting into the receptors, and it can have some very unpleasant effects - and animal studies have shown significant effects."Canada was the first country to declare bisphenol A toxic in October, after it was concluded that the chemical might have harmful effects on humans, as well as the environment and "its biological diversity".The Canadian decision was strongly opposed by the chemical industry.

FDA approves new drug for prostate cancer

Provenge trains the body’s immune system to fight the disease

WASHINGTON - A first-of-a-kind prostate cancer treatment that uses the body's immune system to fight the disease received federal approval Thursday, offering an important alternative to more intensive treatments like chemotherapy.

Dendreon Corp.'s Provenge vaccine trains the immune system to fight tumors. It's called a "vaccine" even though it treats disease rather than prevents it.

Doctors have been trying to develop such a therapy for decades, and Provenge is the first to win approval from the Food and Drug Administration. 

"The big news here is that this is the first immunotherapy to win approval, and I suspect within five to ten years immunotherapies will be a big part of cancer therapy in general," said Dr. Phil Kantoff, an oncologist at the Dana-Farber Cancer Institute who helped run the studies of Provenge.

Experimental vaccines to treat other cancers — including the deadly skin disease melanoma and an often fatal childhood tumor called neuroblastoma — are already in late-stage development.

Currently doctors treat cancer by surgically removing tumors, attacking them with chemotherapy drugs or blasting them with radiation. Provenge offers an important fourth approach by directing the body's natural defense mechanisms against the disease.

The drug is intended to treat prostate cancer that has spread elsewhere in the body and is not responding to hormone therapy.

A milestoneMedical specialists hailed the approval as an important milestone, but stressed it will serve as an addition to current practice, not a replacement.

"This is just one step in a new pathway for treating patients," said Dr. Simon Hall, chairman of urology at Mt. Sinai Hospital "We have to make them realize this isn't a cure, it's very variable."

Company studies showed that taking Provenge added four months to the lives of men with advanced prostate cancer.

INTERACTIVE Prostate cancer: What you need to know

That may not sound like a lot, but it is longer than the three months afforded by Taxotere, the only chemotherapy approved for men in this situation. Doctors hope for even greater benefit if they give the drug earlier in the course of the disease.

Dendreon would give no cost estimate for Provenge, but analyst estimates range from between $60,000 to $100,000.

The approval marks a remarkable turnaround for Seattle-based Dendreon, whose shares plummeted three years ago when the FDA delayed a decision on the therapy, asking for more proof of safety and effectiveness. That delay came despite an expert panel's recommendation for approval.

Dendreon shares jumped 19 percent to new highs ahead of the news, rising to an all-time high of $47.32. Trading of the stock was halted at 12:34 p.m. Eastern, 35 minutes before the FDA announced its decision. At the time, Dendreon shares were up $5.88, or 14.8 percent, at $45.50.

The company does not have any products on the market.

Tailored therapyAnalysts expect the product to reach blockbuster sales status — over $1 billion — by 2016, as the company expands production capacity.

Video   How prostate cancer therapy drug works   April 29: Dr. Andrew Armstrong of Duke University Medical Center shares more information on Provenge, the breakthrough prostate cancer treatment. Nightly News

Each regimen of Provenge must to tailored to the immune system of the patient using a time-consuming formulation process.

Doctors collect special blood cells from each patient that help the immune system recognize cancer as a threat. The cells are mixed with a protein found on most prostate cancer cells and another substance to rev up the immune system. The resulting "vaccine" is given back to the patient as three infusions two weeks apart.

Initially, Dendreon will identify Provenge patients through the medical centers that helped test the drug. But researchers have been told the company will only be able to provide vaccines for a few patients at each site per month.

"There are going to be a lot of patients that want it and there will be limited resources as they are getting this up and running," said Dr. Deborah Bradley of Duke University School of Medicine

About 192,000 new cases of prostate cancer were diagnosed in 2009, and 27,000 men died of the disease, according to the FDA. Prostate cancer most often affects older men.

Side effects of Provenge are relatively mild, such as chills, fatigue, fever, and headache. By comparison, side effects of chemotherapy typically include hair loss, nausea, anemia and diarrhea.

 

Premature births still medical mystery

Half a million babies are born early in the U.S. each year

After rising for 16 years, the rate of premature births in the United States dropped for the second year in a row, according to a report released this month. Despite the good news, still more than half a million babies are born early in the country, putting them at risk for conditions such as respiratory disorders, blindness, and learning disabilities.

While recent medical advancements mean most preemies will survive, preventing early birth in the first place is a different story. Doctors have no way of knowing which pregnancies will be preterm, and in about half of all cases, they don't know why a mother delivers early. However, science is beginning to divulge some clues, such as social stress, bacterial infection and hereditary influences, which might be tied to early births.

In many cases, the cause of premature birth is likely a complex interplay between the mother, the fetus, and their respective environments. Adding difficultly to the situation is the fact that scientists don't completely understand what sets off any type of labor, full-term or preterm. But modern research tools could help to uncover specific genes and other components involved in labor that might help us understand what triggers early delivery, said Dr. Louis Muglia, a professor of pediatrics at Vanderbilt Kennedy Center in Nashville. 

"I think there are a number of studies, that are just starting to be revealed, that are hopefully going to lead to new insights about the birth process," Muglia said.

Preemie basicsNormal pregnancies last around nine months, or between 38 and 42 weeks. A pregnancy is considered preterm if the baby is born at 37 weeks or earlier.

While full-term babies are completely dependent on mom and dad for feeding and diaper-changing, that dependency is taken to an extreme for preemies. The organs and physiological systems of the little fetuses are not completely formed, and when they get cut off from mom's umbilical cord too soon, their systems aren't ready to go solo.

For instance, a lot of brain development happens before 39 weeks, so even the so-called "late-preterm" baby born between 34 and 36 weeks is at risk for learning problems. (The brain at 35 weeks weighs only two-thirds of what it will weigh at full-term, according to the U.S. March of Dimes, an organization that aims to prevent premature birth, birth defects and infant mortality.)

Here's a breakdown of global preemie stats:

• About 70 percent of preemies around the world are born between 34 and 36 weeks, according to the March of Dimes. These babies usually weigh between 4.5 and 6 pounds (2 to nearly 3 kilograms). While they're healthier than babies born earlier, they're still at risk for problems, such as breathing difficulties.
• About 12 percent of preemies are born between 32 and 33 weeks and weigh about 3 to 5 pounds (about 2 kg).
• 10 percent are born between 28 to 31 weeks, weighing around 2 to 4 pounds (under 2 kg).
• The smallest babies, born earlier than 28 weeks, account for 6 percent preemies and often weigh less than 2 pounds, about the weight of six bananas. These tiny babies usually have the most complications, including not being able to feed on their own.

From 1990 to 2006, the premature birth rate in the United States rose by more than 20 percent. This rise is due, in part, to an increase in induced labors and C-sections. Doctors sometimes need to induce labor because of complications with the pregnancy, like preeclampsia (high blood pressure during pregnancy). Such situations account for 25 percent of all premature births in the United States.

In a few other situations, doctors can likely explain why a mother gave birth early, for instance, if she is carrying twins or some set of multiples. But for those 50 percent that can't be explained, scientists have pieced together possible culprits. These include:

InfectionPathogenic infections are one of the lead suspects for causing preterm birth. In fact, they could account for about 25 percent of all unexplained premature deliveries, Muglia said.

Certain infections can activate the immune system — the body's natural defense against harmful organisms. In a pregnant mother, putting the immune system on overdrive might trigger preterm labor.

This might happen because the mom's immune response that's fighting the infection creates a hostile environment for the fetus, prompting early delivery, said Dr. Diane Ashton, the deputy medical director at the March of Dimes.

And from an evolutionary perspective, it makes sense to give birth prematurely if the infection might harm either the mother or the unborn infant.

"The risk of having a growing infection puts the mom's life certainly in jeopardy, if it was a severe infection, and also it would very much influence the fetus," Muglia said. "It seems like the most evolutionarily advantageous solution would be to deliver the one pregnancy early and then have the capacity to have a subsequent pregnancy."

Bacterial infections in the reproductive areas, like the amniotic fluid or the vagina, might pose such a threat. But the infection could also be farther away, like in the mouth. Many studies have tied periodontal diseases, such as gingivitis, to preterm birth. However, treating these diseases does not appear to reduce the risk of early delivery.

So if getting rid of infections doesn't help, what's going on?

One idea is that, by the time a woman shows symptoms of a disease like gingivitis while she's pregnant, it's too late to treat it in terms of preventing labor, Ashton said.

An unknown pathogen could also be to blame.

"There are many organisms that we can't culture, or may activate the immune system in more subtle ways that don’t have overt evidence of the mom having an infection," Muglia said.

Muglia added, "Maybe it's not those primary infections, but it's something about the maternal immune system interacting with the microbes that is slightly different in those women that augments their risk for preterm birth."

Genetics Hereditary factors, or the mother's genes, are also thought to play a role. They're suspected partly because prematurity seems to run in families.

"Women who have had relatives with preterm births, especially moms that have had sisters with preterm birth, or moms that have been born prematurely themselves — so their mothers gave rise to a preterm infant — have a higher incidence of having a child with prematurity also," Muglia said.

Also, mothers who give birth early one time are likely to delivery early in subsequent pregnancies. And from the other side of the spectrum, mothers who give birth late, after 40 weeks, are at increased risk for late labor with future children.

Research in this area is very preliminary, but scientists have pinpointed a few possible players, including genes involved in making the amniotic sac where the fetus grows. "Different genetic expressions cause that amniotic sac to be weakened and more susceptible to rupture," which in turn increases the risk of premature delivery, Ashton said.

Another possible culprit: genes involved in the immune system, specifically, the ones that promote inflammation in the body, which is sometimes triggered by infection. Inflammation in general is thought to be involved in any type of labor, but it's not clear if it relates to the timing of birth, Muglia said.

In February of this year, scientists from the National Institutes of Health announced they had identified genes in both the mother's and the fetus's immune system that increased the risk of premature birth, suggesting that it's not the mother's genes alone that lead to early delivery.

Genetic variations could also make some women's immune systems more sensitive so that a specific infection might activate an immune response in one woman but not another, Muglia said.

Social and lifestyle factorsBeyond biology, environmental factors such as eating and drinking habits, stress and a person's income appear to influence delivery time.

Smoking, alcohol consumption, drug use, high levels of psychological or physical stress during pregnancy, and improper prenatal care increase the risk of preterm birth. Also, certain medical conditions, such as being underweight, having diabetes, or being pregnant six to 18 months following a previous pregnancy might raise the risk, according to the March of Dimes.

Women in high poverty areas also have a higher risk of delivery early. This association is likely due to a number of factors, such as limited access to healthcare, or that concerns about housing and employment take priority over health, Ashton said.

Future outlookCurrently, there aren't good animal models for studying human labor, Muglia said. "The things we know lead to birth in mice and sheep and other animals don’t behave the same way in humans," he said.

And scientists obviously can't interfere with human pregnancies in order to study them. But they might be able to learn much more by analyzing the genes of pregnant women, a feat made possible through modern human genome sequencing technologies. 

A few big studies looking into the genetics of preterm birth are in the process of being completed, and should yield some results within the next year, Muglia said.

Also, scientists can apply that same technology to better understand how infections could trigger labor. For instance, scientists might miss certain bacterial species if they simply tried to grow them using traditional methods. But these elusive bacteria can be more easily spotted by sequencing their genes, Muglia said.

Once scientists know what's involved in the normal birth process, then they can delve deeper into how things might go wrong with early or late deliveries.