Mila Mimica and Tracee Wilkins, NBC4 News Washington: June 13, 2013

A brand new playground in Greenbelt, Md. closed this week over concerns about a potentially toxic material in the mulch used for ground covering.

Just a few weeks after the playground opened, the City of Greenbelt closed it down because the mulch used was made of old tires.

“It’s actually a product that not too long ago President Obama put in the White House playground,” Greenbelt Assistant City Manager David Moran said. “The science we saw particularly from the EPA showed that it was below levels of concern.”

However, Diana Zuckerman with the Cancer Prevention and Treatment Fund said parents had good reason to be concerned about that mulch.

“Rubber mulch contains phthalates, which are chemicals that affect hormones, and other chemicals that are known to be harmful to our health,” Zuckerman said.

Monday night, Greenbelt County Council agreed to try an alternative called “Poured-In-Place” rubber.

The park remains closed in the near future until the mulch is replaced.

To view the original article, click here.

Lena Sun, Washington Post: May 23, 2013

Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.

The bill, approved Wednesday by the Senate Health, Education, Labor and Pensions Committee, would create a new category of regulation by the Food and Drug Administration for these companies. The bill now heads to the full Senate.

The House has not drafted a bill, but a House subcommittee will hold a hearing Thursday about state and federal laws governing the specialized pharmacies.

The Senate bill would establish a new category of FDA oversight that would apply to a part of the industry that has grown rapidly over the past two decades, from small corner pharmacies into businesses that operate like large-scale drug manufacturers. Many of these pharmacies, known as compounders, make a wide array of sterile medications, including antibiotics and painkillers, and ship them across state lines. Unlike traditional compounding pharmacies that custom-mix medication for individual patients based on prescriptions, these compounders often ship drugs without a prescription.

These products, unlike drugs made by major pharmaceutical manufacturers, are not ­FDA-approved. And the enterprises do not face the same level of scrutiny from the FDA that traditional drugmakers do.

Under the Senate bill, companies that make sterile products without or in advance of a prescription and sell those products across state lines would be required to register with the FDA and be subject to regular inspections.

Some consumer groups say the category is too narrowly defined. Only companies that meet all the criteria would be covered. Excluded would be large compounding pharmacies that sell defective or life-threatening oral drugs,topical creams and gels, said Nasima Hossain with the U.S. Public Interest Research Group, a consumer advocacy organization.

A compounder that sells in only one state would also be exempt. In addition, “anything in pill form wouldn’t qualify, and many chemotherapy drugs are in pill form,” said Diana Zuckerman, president of the Cancer Treatment and Prevention Fund.

Public Citizen, a consumer advocacy group, has opposed the creation of a separate category of FDA oversight for large-scale compounding pharmacies. It says it would be better to require the companies to follow the safety requirements that apply to commercial drug manufacturers.

The FDA has sought greater oversight of certain types of compounding pharmacies since the fall outbreak. But in a statement, the FDA said it was concerned that certain aspects of the Senate bill would limit the agency’s enforcement ability.

“Unfortunately, the proposed bill does not yet provide the clarity necessary to appropriately oversee this industry and may limit FDA’s ability to effectively protect the public health,” the statement said.

One small wording change in the bill that passed the Senate panel could weaken the FDA’s authority, industry experts said. It says traditional compounding pharmacies are to be defined “pursuant to state law.”

State laws vary, so a company that might be considered a drug manufacturer in one state could be defined as a traditional compounding pharmacy in another and be regulated differently depending on state law.

Allan Coukell, an expert on drugs at the Pew Charitable Trusts, said Pew supports the Senate approach even though it has limitations. “We do think big compounders ought to be under FDA oversight,” he said.

In the fall outbreak, the New England Compounding Center of Framingham, Mass., shipped more than 17,000 vials of steroid shots to doctors’ offices and clinics in 23 states. Some of the vials were contaminated; the outbreak killed 55 people and sickened 686. In the eight months since the NECC-linked meningitis infections, at least 48 compounding companies have been found to be producing and selling drugs that are contaminated or created in unsafe conditions, according to a report by the Senate committee.

Allison Preiss, a spokeswoman for Sen. Tom Harkin (D-Iowa), chair of the panel, said the bill is a work in progress and will continue to be refined as it moves through the legislative process.

To view the original version in the Washington Post, click here.

John Fauber, Journal Sentinel: March 27, 2013

By Kristin Wartman for Huffington Post

August 14, 2012

Recently, the U.S. Food and Drug Administration (FDA) announced a ban on the use of bisphenol A, or BPA, in baby bottles and children’s cups. BPA is an estrogen-mimicking chemical that has been used in hard plastics, the linings of cans, food packaging, dental fillings and even receipts for years. This move essentially made official a practice that many manufacturers of baby bottles and cups already follow in response to growing pressure from consumers.

Questions of safety remain when it comes to the use of any plastic products that come in contact with our foods. The FDA ban is raising concern and creating headlines about what manufacturers will substitute in place of the BPA. A 2011 study published in Environmental Health Perspectives found that all plastics contain estrogenic activity (EA) and in some cases, those labeled “BPA free” leached more chemicals with EA than did BPA-containing products. The study’s authors write, “Almost all commercially available plastic products we sampled — independent of the type of resin, product, or retail source — leached chemicals having reliably detectable EA, including those advertised as BPA free.”

EA interferes with our endocrine system, a complex signaling network that is made up of glands (the thyroid) as well as glandular tissue and cells within organs (testes, ovaries, pancreas, etc). Our endocrine systems use hormones that send signals to our various organs and tissues that work over minutes, hours, weeks and years. The processes these hormones regulate include metabolism, growth and development, and sexual reproduction. As hormones travel in the blood to reach each body part, the specific molecular shape of each hormone fits like a key-in-a-lock into receptors on target tissues. Endocrine disrupting chemicals may interfere with, block or mimic the action of our hormones. As a result, EA and endocrine disruptors have been linked in hundreds of studies to brain development problems, breast and prostate cancer, birth defects, learning and behavioral problems in children, early onset of puberty, and obesity.

Manufacturers are now flaunting their “BPA-free” versions of products as though they are safe and free of toxins — but it turns out BPA is possibly just the tip of the iceberg. Bisphenol S, or BPS, is another chemical that manufacturers are using to replace BPA and it may be just as harmful. In a study this year in Environmental Science and Technology, researchers wrote,

“As the evidence of the toxic effects of bisphenol A (BPA) grows, its application in commercial products is gradually being replaced with other related compounds, such as bisphenol S (BPS). Nevertheless, very little is known about the occurrence of BPS in the environment.”

In this study, the authors found BPS present in 16 types of paper products, including thermal receipts, paper currencies, flyers, magazines, newspapers, food contact papers, airplane luggage tags, printing paper, paper towels and toilet paper. The thermal receipt paper samples contained concentrations of BPS that were similar to the concentrations of BPA reported earlier and raised alarm for some scientists. BPS was also detected in 87 percent of currency bill samples. The authors write that several other related compounds are also used to replace BPA: bisphenol B, bisphenol F and bisphenol AF. BPA and BPS are found in high concentrations in canned foods, BPF has been found in surface water, sewage sludge, and sediments, and BPB was found in human serum in Italy. “Limited studies have shown that BPS, BPB and BPF possess acute toxicity, genotoxicity, and estrogenic activity, similar to BPA,” the authors write, adding, “The environmental biodegradation rates of BPS and BPB were similar to or less than those of BPA. Although considerable controversy still surrounds the safety of BPA, the potential for human exposure to alternatives to BPA cannot be ignored.” The researchers also note that people may be absorbing BPS in much larger doses — 19 times more than the BPA they absorbed when it was more widely used.

Bruce Blumberg, professor of developmental and cell biology and pharmaceutical sciences at the University of California, Irvine, wrote in an email,

“There are emerging data to show that BPS is an estrogen but relatively less on the other chemicals. Therefore, it is hard to say with certainty at the moment whether the BPA replacements lack estrogenic activity. BPA free means simply that — that the product is stated to be BPA free.”

I asked Diana Zuckerman, president of the National Research Center for Women and Families if she was concerned about the substitutes being used in place of BPA:

“We are very concerned that BPA could be replaced with products that are just as risky, or even more risky. The federal government is not doing what is needed to protect the American public, either in their regulation of BPA or any of these potential substitutes.”

But the FDA continues to insist that BPA is still safe. In a recent New York Times article, Michael Taylor, deputy commissioner for foods, said that the agency “has been looking hard at BPA for a long time, and based on all the evidence, we continue to support its safe use.”

Zuckerman added that part of the problem lies in the heavy influence that industry has on members of Congress and the FDA.

“Whenever the FDA does something to improve patient safeguards, Members of Congress get lobbied by the industry involved and some of those Members pressure [the] FDA to back off,” she wrote in an email. “This has happened for years but the last few years have been even worse than usual.”

At Mother Jones, Tom Philpott points out that the heavily monied interests behind BPA are none other than the chemical giants Dow and Bayer, which produce the bulk of BPA. Frederick S. vom Saal, curators’ professor at the University of Missouri-Columbia and BPA researcher, told me that BPA represents a $10 billion a year industry. It’s important to note that the recent FDA ban comes at the behest of the American Chemistry Council, an industry trade group that denies any negative health effects from BPA. Why would they have done this?

“[The American Chemistry Council’s] petition to the FDA puts it plainly: ‘All Major Product Manufacturers Have Abandoned the Use of Polycarbonate’ (BPA). In other words: Go ahead and ban it — it’s already been phased out and a ban gives the appearance of strict oversight,” Philpott writes.

By creating the ban, the FDA at least acknowledges that babies and children should lessen their exposure to BPA. But what about the rest of the population?

“BPA remains in millions of food and beverage containers that affect the BPA levels of pregnant women, children of all ages, and all adults,” Zuckerman wrote to me in an email. “The impact on the developing fetus and young children, and on breast cancer patients undergoing chemotherapy, are of particular concern to our Center. One study indicates that BPA may interfere with the effectiveness of chemo for breast cancer patients.”

The FDA should concede that if BPA is a risk for babies and children, it is most likely a risk to all of us. And what about the various substitutes that will be used for BPA and the numerous other toxins lurking in the plastics and other containers that package our foods and drinks? “FDA’s decision is a step in the right direction, but it is a baby step,” Zuckerman said. “They have done the minimum.”

Blumberg added that the answers to all of these questions are complex. “We do not know nearly as much as we need to know,” he said. “I think that it is prudent to reduce our consumption of packaged foods of all sorts for a variety of reasons, including reducing exposure to contaminants from the containers.”

A version of this post appeared on Civil Eats

Lena Groeger, ProPublica: May 3, 2012

Each prescription drug you take has a unique code that the government can use to track problems. But artificial hips and pacemakers? They are implanted without identification, along with many other medical devices. In fact, the FDA doesn’t know how many devices are implanted into patients each year – it simply doesn’t track that data.

The past decade has seen numerous high profile cases of malfunctioning medical devices, which have led to injury or even death. Critics say the FDA’s minimal monitoring of devices contributes to these problems.

“If you’re lucky, you might find a sticker on the operating room note that was left over from the product,” said Richard Platt, who runs the Harvard Pilgrim Health Care Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices already on the market. The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the FDA,” said cardiologist Frederic Resnic of Brigham and Women’s Hospital, who has worked with the FDA on medical device safety monitoring. “The FDA is relying on anecdotal and very variable information about the safety of medical devices.”

If manufacturers get word from a doctor or hospital about a death or injury that occurred as a result of their product, they are legally obligated to investigate the event and report it to the FDA. But the process isn’t straightforward, as has become clear in the recent controversy over the malfunctioning St. Jude’s Riata defibrillator leads (wires that connect a defibrillator to the heart). The FDA said an individual doctor’s report helped alert them to the problem, but it was months before the device was recalled.

According to attorney William Vodra, a regulatory law expert and member of the Institute of Medicine panel that published a report on medical device safety last year, the number of doctors who actually contact manufacturers is small.

And after being notified of patient harm, manufacturers can minimize their own responsibility if they point the blame elsewhere, said health policy expert Diana Zuckerman, president of the National Research Center for Women & Families.

For example, if someone dies from complications in a surgery to remove an implant, the manufacturer may argue that it was the surgery – not the implant – that killed the patient.

“You have a system that is not rigorous, the standards are not always understood, and they are interpreted differently by different people,” Zuckerman said.

The FDA responds to the criticism by pointing out that while every medical device carries a potential risk, the vast majority of devices perform well and improve patient health. An FDA spokeswoman emphasized that the agency must evaluate thousands of medical devices each year, and is constantly looking for ways to better and more quickly identify problems.

While the FDA makes the adverse event reports publically available in a searchable database, it doesn’t have a standardized system for reviewing reports once they are sent in, said Vodra, the attorney. A disclaimer on the site specifically states that the data is “not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”

“What you would normally consider the simplest kind of data analysis is not done,” said Zuckerman. Often, doctors catch a malfunctioning device before the FDA ever notices.

In one case, a group of Pennsylvania doctors noticed that several patients were showing severe complications a few years after getting an IVC filter – a device designed to capture blood clots. Bits of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart. In 2010 the doctors conducted their own study and found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006, and that the device was meant to be removed after a few months, not left in permanently.

There have been numerous attempts at reform. Five years ago Congress ordered the FDA to set up a post-market surveillance system to track the safety of all medical projects, but a system hasn’t yet been set up for medical devices.

A year later the FDA announced the Sentinel Initiative, which would combine existing data from electronic health records and medicalclaims to track drugs, vaccines, and devices. Some groups of hospitals or other organizations have voluntarily set up registries to collect information about the make and model of devices.

While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt, who is the principal investigator of Mini-Sentinel, the FDA’s pilot program for the national system. The data isn’t there.

The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago. No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress. A proposed Senate bill, which cleared the Health, Education, Labor and Pensions Committee last week, sets a timeframe for implementing a unique identification system, among other reforms.

“If UDI’s were used in a consistent way, we could use the same kinds of techniques we’ve developed for drugs for devices,” said Platt. “It would be a huge breakthrough.”