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  • 28
    Sep
    2012
    1:56pm, EDT

    FDA warns of rising risks of online pharmacies

    By Linda A. Johnson, The Associated Press

    The Food and Drug Administration is warning U.S. consumers that the vast majority of Internet pharmacies are fraudulent and likely are selling counterfeit drugs that could harm them.

    The agency on Friday launched a national campaign, called BeSafeRx, to alert the public to the danger, amid evidence that more people are shopping for their medicine online, looking for savings and convenience.

    Instead, they're likely to get fake drugs that are contaminated, are past their expiration date or contain no active ingredient, the wrong amount of active ingredient or even toxic substances such as arsenic and rat poison. They could sicken or kill people, cause them to develop a resistance to their real medicine, cause new side effects or trigger harmful interactions with other medications being taken.

    "Our goal is to increase awareness," FDA Commissioner Dr. Margaret Hamburg told The Associated Press, "not to scare people away from online pharmacies. We want them to use appropriate pharmacies."

    That means pharmacies that are located in the U.S., are licensed by the pharmacy board in the patient's state and have a licensed pharmacist available to answer questions. In addition, the pharmacy must require a valid doctor's prescription for the medicine. Online drugstores that claim none is needed, or that the site's doctor can write a prescription after the customer answers some questions, are breaking the law.

    Research by the National Association of Boards of Pharmacy, which represents the state pharmacy boards, found that of thousands of online pharmacies it reviewed, only about 3 percent follow state and federal laws. In fact, the group's website lists only a few dozen Internet pharmacies that it has verified are legitimate and following the rules.

    Most consumers don't know that. An Internet survey, conducted by the FDA in May, questioned 6,090 adults. It found that nearly one in four Internet shoppers has bought prescription drugs online, and nearly three in 10 said they weren't confident they could do so safely.

    The campaign comes after some high-profile cases of counterfeit drugs reaching American patients earlier this year.

    In February and again in April, the FDA warned doctors and cancer clinics around the country that it had determined they had bought fake Avastin, a pricey injectable cancer medicine, from a "gray market" wholesaler. The fake Avastin vials originated in Asia or Eastern Europe and were transferred through a network of shady wholesalers before being sold to clinics by a wholesaler claiming to be in Montana.

    In another case, the FDA issued a warning in May after learning consumers shopping on the Internet had bought fake versions of generic Adderall, a popular medication for attention deficit hyperactivity disorder.

    No deaths or serious injuries have been linked to those fakes, but Hamburg notes that when drugs don't help patients get better, doctors usually blame the disease or assume a different medicine is needed. That means most fakes aren't detected.

    So the FDA, which has put increasing focus on the counterfeiting problem, on Friday launched a website, www.FDA.gov/BeSafeRx , that shows consumers how to determine if an online pharmacy is safe.

    "Buying prescription medicine from a fake online pharmacy can be dangerous, or even deadly," the site warns.

    It includes tips on how to spot illegal pharmacies, links to state databases of licensed pharmacies and explanations of all the dangers of rogue pharmacies. Besides likely getting fake drugs, that includes the risk that they will infect your computer with viruses, sell your personal and financial information to other rogue websites and Internet scammers, or charge you for products you never ordered or received.

    Many rogue pharmacies claim to be in Canada — because Americans know medicines are cheaper there and assume that's why they're getting a deal. Many fraudulent sites even put the word Canada in their name, or display the Canadian flag prominently on the site. Their web storefronts are slick and look professional. And they all offer prices that are unbelievably low.

    "If the low prices seem too good to be true, they probably are,' Hamburg said.

    The FDA is collaborating with several other federal agencies and departments and even Interpol in the campaign, Hamburg said, and it has asked medical and pharmaceutical industry groups to join in.

    It's also reaching out to doctors, pharmacists and medical facilities to spread the word. They'll get access to materials they can download, from patient fact sheets and discussion guides to sample blog items and web banners for a practice's own website. There's also a list of tips to help doctors determine if a patient may be buying medicine online.

    The agency will do a follow-up survey to see if the campaign's message is reaching the public.

    "What's truly important to us is that consumers know how to look for an online pharmacy that's legitimate and safe," Hamburg said.

    Related stories: 

    • FDA warns of fake agents scamming drug buyers
    • Beware fake Adderall sold on the internet, FDA says

    Congressional investigators claim "fake pharmacies" are popping up around the country that purchase drugs in short supply, and then turn around and sell them at higher prices. NBC's senior investigative correspondent Lisa Myers reports.

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  • 17
    Feb
    2012
    6:53am, EST

    Studies: Health risk from toxic pavement sealant greater than previously believed

    Coal tar sealant is applied at a study site at the University of Texas in Austin.

    By Robert McClure, InvestigateWest

    When you think of pollution, you might picture an industrial center like Camden, N.J., or Jersey City. But new research shows that when it comes to a potent class of cancer-causing toxic chemicals, many American parking lots are a lot worse.

    New studies paint an increasingly alarming picture – particularly for young children – about how these chemicals are being spread across big swaths of American cities and suburbs by what may seem an unlikely source – a type of asphalt sealer. These sealants are derived from an industrial waste, coal tar.

    Four new studies (links are at the end of this article) announced this week further implicate coal tar-based asphalt sealants as likely health risks.  The creosote-like material typically is sprayed onto parking lots and driveways in an effort to preserve the asphalt. It also gives the pavement a dark black coloring that many people find attractive.


    Coal tar is a byproduct of the steelmaking industry. In 1992, the U.S. Environmental Protection Agency declared that it would not be classified as a hazardous waste, even though it met the characteristics of one, because it could be recycled for uses that include coating asphalt. That meant steel mills didn’t have to pay for costly landfilling or incineration of the waste.

     

     

     

    Only in recent years have scientists discovered the ill effects of this practice.

    Coal tar sealants are used most heavily in the eastern United States, but were applied in all 50 states until Washington state banned the products last year. More than a dozen local governments, including Washington, D.C., and Austin, Texas, also have banned the coal tar sealants in favor of the other major type of sealant, which is asphalt-based.

    Asphalt-based sealants contain about 1/1000th the concentration of the cancer-causing chemicals that coal tar-based products do. Home Depot and Lowe’s stores have dropped the coal tar sealants from their product lines, but still some 85 million gallons of the coal tar-based sealants are applied annually in the United States.

    The new research, published in peer-reviewed science journals, focuses on a class of chemicals found in coal tar and known as “polycyclic aromatic hydrocarbons,” or PAHs. Previously, researchers believed that people’s exposure to PAHs came primarily through food, which contains trace amounts produced primarily from smoking food or cooking it at high temperatures in practices such as grilling, roasting, and frying. PAHS are produced when any organic matter burns.

    The new research shows:

    • It appears that children – especially those from 3 to 5 years old – living by coal tar-sealed parking lots and driveways are getting a bigger dose of PAHs from house dust than from their food. The kids who put their hands in their mouth most often are likely receiving 9 ½ times more exposure through house dust than through food, according to research led by E. Spencer Williams, a Baylor University human health risk assessment expert. That’s just from the house dust. When the kids are outside in the yard or playing on coal tar-sealed pavement, they likely are picking up much larger doses.
    • While researchers previously theorized that airborne PAHs come mostly from power plants, factories and cars’ and trucks’ tailpipe emissions, U.S. Geological Survey researchers measured large amounts vaporizing into the air off coal tar-sealed parking lots.  The concentrations coming off parking lots in suburban Austin, where the researchers are based, were higher than in centers of heavy industry, including Jersey City and Camden, N.J.; Chicago; London and Manchester, England; and Guangzhou, China. The Austin parking lots tested were three to eight years old. Much more off-gassing occurs in the first few years after the sealants are applied, researchers said.
    • Concentrations measured four feet above the coal tar-sealed lots in some cases exceeded health-protection guidelines recommended by a European Union science panel to protect against cancer. The United States has no similar guidelines.
    • Extrapolating from the 85 million gallons of coal tar sealants laid down annually and the out-gassing rates measured in Austin, Geological Survey researchers calculated that nationwide, more PAHs are getting into the air from coal tar-sealed parking lots, driveways and playgrounds than from all the auto and truck exhaust.

    “That’s a lot,” said Barbara Mahler, a USGS scientist involved in the research.

    Researchers previously had shown that coal tar-sealed parking lots were shedding tiny bits of the material, which was washed by rain into nearby waterways – killing, sickening and maiming aquatic creatures such as salamanders, minnows and, importantly, bugs at the base of the food chain. The chemicals kill tadpoles, cause tumors on fish, stunt growth of aquatic creatures and reduce the number of species able to live in a waterway.

    As a result of being washed into waterways by stormwater, these chemicals’ concentrations have been rising over the last two decades, even as levels of most contaminants are headed down, Geological Survey researchers showed.

    The chemicals are getting into the house dust, researchers think, when small bits are eroded off pavement and tracked into nearby homes.

    Scientists also had previously demonstrated that toxic constituents of coal tar were showing up in the dust of homes adjacent to parking lots and driveways, raising questions about health effects on children in those homes, especially toddlers who frequently put their hands in their mouths. Coal tar is known to cause cancer in humans, as well as genetic mutations in lab animals.

    One of the new studies helps quantify that risk. Kids who are average in terms of how often they put their hands into their mouths are getting 2 ½ times as many PAHs from house dust as from food, while those in the 95th percentile of hand-to-mouth behavior – they do it more than 94 percent of other kids – get 9 ½ times as much from the dust.

    Researchers still would like to know how much of a toxic dose those same kids are getting when they play outside in yards next to coal tar-sealed asphalt, or on the asphalt itself. The level of cancer-causing chemicals in the dust on the asphalt itself has been measured at about 37 times the levels found in house dust.

    “Those concentrations are a good bit higher and this study doesn’t include that at all,” said Williams, the Baylor researcher. “That may be important because just one little fingerful could be a relevant dose,” meaning one that worries health experts.

    While researchers have known about contamination of water and dust, the findings about air pollution are new. Significant amounts of PAHs continue to vaporize off coal tar-sealed lots even years after the sealant is put down.

    “When we look at a seal-coated parking lots, in any direction we look we see these really strongly elevated concentrations,” said Peter Van Metre, a U.S. Geological Survey scientist based in Austin. Of the dust on the coal tar-sealed pavement, he said: “It would just take a tiny amount of that to be a large enough dose for it to be significant.”

    Companies that sell and use the coal tar sealants have previously disputed the growing body of evidence of the coal tar sealants’ danger being amassed by scientists from the Geological Survey, the University of New Hampshire, Baylor and other institutions.

    Repeated attempts this week to reach an industry representative, Anne LeHuray, executive director of the Pavement Coatings Technology Council, for comment on the new studies were unsuccessful. In an email on Thursday, LeHuray said she was tied up at a meeting of the pavement council in Memphis.

    Generally, the pavement council has attacked previous coal tar research on technical grounds.

    Read previous articles on coal tar sealants:

    Study sees parking lot dust as a cancer risk

    State bans coal tar sealants in big win for foes

    The pavement council has fought bans – sometimes successfully – when they have been proposed by local and state governments. In addition to the local governments that have forbidden use of the coal tar sealants, some governments have placed restrictions on their use, including the state of Minnesota and the California Department of Transportation. Restrictions also are in effect in more than 40 Illinois municipalities.

    U.S. Rep. Lloyd Doggett, a Democratic congressman from the Austin area, has previously filed legislation calling for a nationwide ban on coal tar sealants. He plans to refile the legislation, a Doggett spokeswoman said, but is currently embroiled in a redistricting fight.

    Tom Ennis, an Austin city official who helped get coal tar sealants banned there, has now launched a campaign to support a nationwide ban.

    “You’re looking at a big urban air quality” problem, Ennis said. “It’s completely unacceptable and something needs to be done.”

    The studies announced this week appeared in the science journals Environmental Science and Technology, Chemosphere, Atmospheric Environment,  and  Environmental Pollution.

    InvestigateWest is a non-profit journalism center based in Seattle. If you value this kind of in-depth, independent news reporting, please consider making a tax-deductible donation to support further work of this kind.

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