Hearing Cites Lack of Regulation for Dietary Supplements Surveys show that almost 60 percent of Americans take one or more dietary supplements regularly, and two-thirds of them believe the federal government sees to it that their vitamins, minerals, and botanicals are safe and effective. But that’s far from the truth, chairman Tom Davis (R-VA) told a session of the U.S. House Committee on Government Reform called March 9 to hear testimony about the "massive and fast-growing supplement industry." The fact, Davis pointed out, is that the federal Food and Drug Administration (FDA), which tests and approves most pharmaceuticals, is barred from testing or approving supplements under a law passed by Congress in 1994, the Dietary Supplement Health and Education Act (DSHEA), which specifies that dietary supplement manufacturers do not need FDA approval before manufacturing, labeling, distributing, and marketing their products. The federal law, which was passed at the urging of Utah Senator Orrin Hatch, in whose state most supplement manufacturers are located, also says manufacturers are not required to alert the FDA to any adverse effects from supplements, and requires the FDA to prove a "significant and unreasonable risk to health" before it can remove a dietary supplement from store shelves. Given all of those restrictions, Davis asked representatives of three federal agencies to tell the committee what, if any, role the federal government has in dietary supplements. Speaking for the Center for Food Safety and Applied Nutrition in the Food and Drug Administration, Director Robert Brackett said FDA is pretty much limited to requiring the label to say it’s a dietary supplement, along with the name and address of the manufacturer, packager, or distributor, and nutrition information in the form of a "facts" panel. If the label makes any claim "relating to an effect on the structure or function of the body," it also has to note that the FDA hasn’t evaluated the claim. And the label may not say that the supplement will "diagnose, treat, cure, or prevent any disease." The FDA works with another federal agency, the Federal Trade Commission (FTC), which has responsibility for enforcing bans on advertising—the FTC can act if supplements advertise that they can treat or cure serious diseases, or if the supplements are deceptively marketed to children and adolescents. And a third agency, the National Institutes of Health (NIH), has a separate division, the National Center for Complementary and Alternative Medicine, that looks into potential benefits or possible risks from dietary supplements, including such widely used supplements as glucosamine and chondroitin sulfate for the relief of pain from arthritis and Gingko biloba for treatment of Alzheimers. Paul Coates, director of the Office of Dietary Supplements at NIH, pointed to instances in which hopes pinned on dietary supplements for improving health have been realized by modern scientific testing, including use of folic acid to reduce the risk of neural tube defects, iron supplementation during pregnancy to reduce risk of maternal anemia, and the use of vitamin B-12 and D supplements to ensure vitamin and calcium absorption. Coates noted, however, that some ingredients used in dietary supplements have been shown to be harmful to some individuals, including the common ingredient beta-carotene, which has been found to increase the risk of lung cancer in smokers. A nonprofit organization that has looked extensively into the supplements industry told the committee that the 1994 Dietary Supplement Health and Education Act "opened the floodgates to thousands of untested dietary supplement products." While many dietary supplements, including most vitamins and minerals taken within recommended limits, are safe and can have important health benefits for consumers, a lot of products now on store shelves would never have been allowed on the market if they had been subjected to pre-market safety testing, Consumers Union told the committee. Among a "dirty dozen" supplements that Consumers Union staff were easily able to purchase in stores and online were aristolochic acid, comfrey, androstenedione, chaparral, germander, kava, bitter orange, organ/glandular extracts, pennyroyal oil, skullcap, and yohimba, several of which are banned as dangerous in other parts of the world. Another consumer group, ConsumerLab.com, which said it has tested more than a thousand dietary supplements from 300 different brands, found the most common problem a lack of ingredient or substandard ingredient, followed by contamination with lead and other heavy metals and pesticides, tablets that won’t disintegrate to release their ingredients, and products that actually contain more ingredients than listed, with potential for toxicity. The dietary supplement industry is aware of these and other criticisms, a representative of the National Nutritional Foods Association (NNFA) told the House committee. Calling the Dietary Supplement Health and Education Act "an effective framework for governing supplements," the NNFA, which lists itself as a nonprofit organization dedicated to the natural products industry, called special attention to companies that have marketed drugs or steroids as dietary supplements, saying this practice has wrongly implicated a legitimate industry. The nonprofit United States Pharmacopeia (USP) testified that its aim is to help consumers select supplements they can trust. To that end, said USP vice president for verification V. Srini Srinivassan, the USP subjects vitamin, mineral, amino acid, and botanical products to rigid tests before they are allowed to display a USP-Verified mark. Its standards are designed to ensure consistency of product, eliminate foreign ingredients, and "provide reasonable certainty that the consumer is getting what he or she paid for," Srinivassan said. The USP maintains that its third-party verification "fills a void in the federal regulation of dietary supplements created by DSHEA" and says it has encouraged supplement manufacturers to take steps to assure that their products are high quality and consistent with their labeling. Commenting on the fact that people have to resort to a third party
to let them know which supplements are safe to take and which are not,
committee chairman Davis asked, "What is the average consumer to
do? How many of those 29,000 supplements really contain what they claim?
How many truly have an exhaustive list of all ingredients on their labels?"
He hopes, the congressman said, that his committee will be able to "shed
some light on this enormous industry." See also: FDA Will Prohibit Sale of Dietary Supplements Containing Ephedra at http://www.healthinschools.org/ejournal/2004/jan4.htm Co-Morbidities of Childhood Overweight Discussions of childhood overweight often concentrate on the likelihood that children who are overweight will become diabetic or will grow up to be obese adults, but some health problems are more immediate, says a physician writing in the current issue of the journal The Future of Children. "The epidemic of overweight and obesity in children and adolescents has intensified the pace of research" into the question of whether children face the same set of risks as adults—or risks unique to their age group—from those conditions, says Dr. Stephen Daniels, a professor of pediatrics at the University of Cincinnati College of Medicine. To get a handle on that question, Daniels assessed disorders related to childhood obesity by body systems and estimated their prevalence in pediatric populations. Among his findings:
And whether one looks at the immediate effects on children’s health of being overweight or the implications of that overweight for the future adult population, "Preventing childhood obesity is of urgent importance," Dr. Daniels concludes. The article "Consequences of Childhood Overweight and Obesity," appears in the Spring 2006 issue of The Future of Children, a publication of the Woodrow Wilson School of Public and International Affairs at Princeton University and the Brookings Institution and is available online at www.futureofchildren.org Note: The Future of Children uses the terms "overweight" and "obesity" interchangeably to mean a range of body mass index percentiles. See also: Childhood Overweight: What the Research Tells Us at http://www.healthinschools.org/sh/obesityfs.asp and Keeping Kids Healthy: Overweight, Nutrition & Physical Exercise at http://www.healthinschools.org/sh/obesity.asp. Chickenpox Vaccine—A Success Story There was a time when almost everyone got chickenpox as a child—it’s estimated that there were approximately 4 million cases in the United States every year, and 100 to 150 deaths from the disease. All of that changed when a live attenuated varicella vaccine was licensed in 1995 and became one of the recommended childhood vaccinations the following year. And it now appears that the chickenpox vaccine is a star in terms of the number of children who are immunized and in the degree to which it seems to have reduced racial and ethnic disparities in coverage. Why all of that has happened is not entirely clear, say researchers who analyzed data from the National Immunization Survey (NIS), which tracks annual vaccination coverage for children 19 to 35 months of age. They noted, however, that varicella vaccine is now available free to eligible children through the federal Vaccines for Children program and the State Children’s Health Insurance Program (SCHIP). What is most surprising, they said, is that the data show white children are often less fully fully immunized against chickenpox than their black and Hispanic peers, a trend that is the opposite of experience with most other childhood vaccinations. They note that this makes varicella vaccination "a success story in eliminating racial and ethnic disparities." Things look so good, in fact, the researchers said, that it’s likely a Healthy People 2010 goal of 90 percent coverage for varicella vaccine will be met ahead of schedule. There are cautions, however. Cohorts of children born before the vaccine became available, and who never caught chickenpox when they were small, are now adolescents and at risk of serious illness unless they, too, are immunized. That means it is increasingly important to monitor vaccine coverage and disease history among older children and adults, for whom chickenpox can be a critical illness. For children up to 18 years of age, the 2006 recommended childhood immunization schedule calls for two doses of varicella vaccine, administered at least four weeks apart. It is not clear how long immunity to chickenpox will last, following infant vaccination. If the effects should wear off in adolescence and adulthood, as many experts believe may happen, people who were immunized before they were three years old may be susceptible to the illness later in their lives. Another unknown feature of varicella vaccination is whether the immunity it confers will protect older persons from the condition known as shingles, in which dormant chickenpox residing in nerve tissues is triggered by some environmental or immune event, causing a painful and sometimes very serious rash, usually in the waistline but sometimes in the face and eyes. Whether the live attenuated virus in the vaccine given to children will remain in the body for years, possibly triggering later shingles, is not yet known. The researchers noted that, unlike for other vaccines, living in a non-metropolitan area seemed to increase the possibility that children will not receive varicella vaccination. This "strong and persistent risk factor" may be due, they speculated, to the fact that varicella vaccine must be kept frozen at less than minus 13 degrees Centigrade, and deep freezers may not be readily available in rural areas or their cost may be prohibitive for small practices. They also noted that pediatricians, who are more likely than general practitioners to offer varicella vaccine to their patients, are under-represented in rural areas. The article, "Uptake of Varicella Vaccination Among Young Children in the United States: A Success Story in Eliminating Racial and Ethnic Disparities," appears in the April issue of the journal Pediatrics. See also: CHHCS News Alert, August 17, 2005 -- Chickenpox Is Down and So Are Health Costs at http://www.healthinschools.org/2005/aug17b_alert.asp A Look Back at an Allergic Child’s Death A Washington State appeals court ruled March 9 that Spokane School District No. 81 may continue to withhold from a local newspaper information about the death five years ago of a child known by the district to be allergic to peanuts who was offered a sack lunch containing peanut butter sandwiches and cookies on a school field trip. When notified of the child’s death from anaphylactic shock during the field trip, the school district, in anticipation of a "wrongful death" lawsuit, immediately contacted its private attorneys, who hired a retired policeman to investigate the death. In its March 9, 2006, ruling, the appeals court held that because the district’s attorneys were responsible for the investigation, the resulting information falls under attorney-client privilege, and the school district is not obliged to give the findings to The Spokesman-Review, the newspaper that has requested records of the investigation. As part of its opinion, the appeals court outlined what is known about the death of 9-year-old Nathan Walters in May 2001. The court wrote that: "A child died from an acute allergic reaction to peanuts while on a field trip with his elementary school class. His medical condition was well known to the District’s food staff, the boy’s teacher, and the organizers of the field trip, including two school nurses and several parent volunteers. Nevertheless, only peanut-laden snack lunches were provided. The child reported that he did not feel well after tasting a peanut-based cookie. The chaperones did not want to curtail the activities for the other children. So they put the sick child in the school bus to wait. His condition became acute and he was finally taken to a hospital by car. He received an epinephrine injection for the first time while on the way. The response was too late and the child died." Washington State has a public disclosure law that requires a government agency to release to members of the public who request it "any writing containing information relating to the conduct of government," but the law makes an exemption for records that are "attorney work products." The details of the investigation into Nathan’s death were an attorney work product, the court decided, since the investigation was conducted under supervision of the school district’s attorneys. The March 9 decision in the Washington State Court of Appeals, Division III, was Cody Soter et al. v. Cowles Publishing Company. See also: School Health Issues: Food Allergies at http://www.healthinschools.org/sh/sissues.asp. WORTH NOTING Car Safety Seats Are Too Small for Obese Children The current "epidemic" of childhood overweight got some new credibility this month as researchers reported that a lot of children one to six years of age are having trouble fitting into car safety seats designed to accommodate smaller youngsters. Using 2005 Child Safety Seat Ease of Use ratings from the National Highway Traffic Safety Administration, the researchers found that it would be difficult if not impossible for overweight children to use existing car seats, with only four models currently available for their age-and-weight group, and those costing between $240 and $270. The majority of the children in the study were three years old and weighed more than 40 pounds, above the maximal weight for safety seats. "While we wait reductions in the childhood obesity epidemic, options for maximizing the protection of obese children in automobiles must be identified," the researchers said in an article published in the April issue of the journal Pediatrics. ‘Diagnostic Substitution’ and Autism Prevalence Whether the incidence of autism as a medical condition is increasing in the child population, or whether physicians and parents are turning to a diagnosis of autism as a means of obtaining needed services for children is the subject of debate in a series of articles published in the journal Pediatrics. Writing in the April issue of the journal, author Paul Shattuck notes that it is hard to answer the "intractable and perhaps unanswerable question of whether autism’s true prevalence has increased over the past two decades," but he observes that autism diagnosis is based on observing behavior, rather than clearly identifiable biologic markers, making clinicians willing to give a diagnosis of autism for "children with ambiguous symptoms." That may be resulting in "diagnostic substitution" or a change in prevalence from one category to another, as clinicians shift from a diagnosis of such conditions as developmental delay or learning disabilities to a diagnosis of autism, Shattuck believes. The article, "Diagnostic Substitution and Changing Autism Prevalence," is published in the April issue of Pediatrics. March News Alerts The following information appeared during the month of March 2006 on the News Alerts section of the website of the Center for Health and Health Care in Schools, at www.healthinschools.org. March 1, 2006 While type 2 diabetes is on the rise due to poor diet and lifestyle choices, genetics may play a significant role in many cases, according to researchers who conducted studies of type 2 diabetes in Iceland, Denmark, and the United States. The genetic variation identified by the research team is located within a gene that encodes protein and occurred significantly more often in persons with diabetes than in a control group. A test that could determine if an individual has the at-risk variant would be helpful in preventive health care, the researchers said, with diet and exercise especially important in warding off disease in persons with the variant. Estimating that 21 percent of the population may carry the high-risk gene, the researchers noted "That means that if you removed this one single variant from the population you would get rid of 21 percent of all type 2 diabetes in the population." A report on the research appears in the March 1 2006 issue of the Journal of the American Medical Association. March 1, 2006 Emergency and critical care available to children varies by regions of the country and type of hospital, with larger hospitals more likely to have a pediatric ward, a pediatric intensive care unit, and a board-certified pediatric emergency physician on staff, according to a February 28 report from the Centers for Disease Control and Prevention (CDC). Children account for about 30 million visits a year to hospital emergency rooms, and some of those facilities do not have supplies and equipment that are small enough for children or staff with expertise in treating children. A 2002-2003 survey found that although 90 percent of U.S. hospitals admitted pediatric patients, fewer than half had separate inpatient pediatric wards, and fewer than 6 percent of emergency rooms had supplies on hand in a range of sizes. Only 25 percent of emergency departments had written protocols outlining when to call in a pediatric specialist. The CDC says an additional survey scheduled for this year will evaluate ambulatory care and will include a larger number of children’s hospitals. The CDC report, "Availability of Pediatric Services and Equipment in Emergency Departments" is available online at www.cdc.gov/nchs. March 2, 2006 Calling methamphetamine "a uniquely destructive drug," the Substance Abuse and Mental Health Services Administration (SAMHSA) today reported that admissions to treatment for methamphetamine addiction increased nationally in the decade from 1993 to 2003, moving across the country from West to East. Methamphetamine is the most powerful drug in the category known as amphetamines and is believed to be highly addictive. States in the Midwest and South that had few admissions due to methamphetamine/amphetamine abuse in 1993 experienced high rates of admissions in 2003, with Arkansas, California, Colorado, Hawaii, Idaho, Iowa, Kansas, Minnesota, Missouri, Montana, Nebraska, Nevada, Oklahoma, Oregon, South Dakota, Utah, Washington, and Wyoming reporting the highest rates. The states of Alabama, Georgia, Illinois, Indiana, Louisiana, North Dakota, and Texas also reported large increases in admissions. The report, "Trends in Methamphetamine/Amphetamine Admissions to Treatment, 1993-2003," is available online at www.oas.samhsa.gov. March 2, 2006 Secretary Mike Leavitt reported today that the Department of Health and Human Services (HHS) has just added 1,.75 million treatment courses of the influenza antiviral drug zanamivir (Relenza) from GlaxoSmithKline and 12.4 million treatment courses of oseltamivir phosphate (Tamiflu) from Roche to the stockpile of drugs the government want to have on hand in the event of a flu pandemic. Stockpiling antiviral medicines is part of the federal government’s overall planning for a possible pandemic, Leavitt pointed out, which also includes research on developing new flu vaccines. The goal for the National Strategic Stockpile is to have enough antiviral medicine in stock to treat 25 percent of the U.S. population if a pandemic occurs. March 8, 2006 The United States Court of Appeals for the Eighth Circuit ruled today that a student with disabilities can sue his school district under Section 504 of the Rehabilitation Act for "bad faith and gross misjudgment" because the district failed to protect him from discrimination and harassment by other students after a teacher disclosed his medical condition to the student body. The student, identified only as M.P., charged that New Prague, Minnesota, Independent School District No. 721 "failed to take appropriate action to protect M.P.’s academic and safety interests after the disclosure." Specifically, the student says that once his medical condition was disclosed, the school district "failed to provide him with accommodations in the educational environment; and failed to investigate the allegations of disability discrimination, student-against-student harassment, hostile educational environment, and disclosure of personal information." The case, M.P. v. Independent School District No. 721, has been in federal courts for several years and has now been referred back to district court for further consideration of the Section 504 claims. March 10, 2006 Noting the "increasing impact"of HIV/AIDS on women and girls in the United States and throughout the world, the director of the National Institute of Allergy and Infectious Diseases (NIAID) in the National Institutes of Health (NIH) called attention to today, March 10, as the first National Women and Girls HIV/AIDS Awareness Day. In 2004, said Dr. Anthony Fauci, 27 percent of all AIDS cases in the United States occurred in women, compared to only 7 percent in 1985. He also noted that 38 percent of all persons diagnosed with HIV/AIDS in the period 2001-2004 were females younger than 25 years. "In the early days of the pandemic, relatively few women were infected with HIV/AIDS," Fauci said. "Today, however, women and girls represent one of the fastest-growing groups affected by HIV/AIDS." To stop the disturbing trend of an increasingly female HIV/AIDS pandemic, Fauci urged that women be empowered to exert control over their own lives, particularly in sexual relations, and that educational campaigns include gender-based AIDS education. Noting that women experience HIV/AIDS differently than men, with different responses to antiretroviral therapy and progression of the disease at lower levels of the virus, Fauci said the NIAID is seeking more women to participate in clinical trials aimed at developing microbicides that may help women protect themselves from HIV and other sexually transmitted diseases. March 15, 2006 The Spring 2006 issue of the ongoing Future of Children series is devoted to childhood obesity, with chapters on the potential causes and consequences of childhood overweight and the roles of various players in children’s lives in either causing the problems or intervening to prevent them. A chapter on the role of schools in obesity prevention covers the school food environment, the school physical activity environment, the health curriculum, the role of school health services, current state and local nutrition and physical activity policies, federal policy initiatives, and some school-based obesity-prevention interventions. "With more than 54 million children in attendance daily, the nation’s schools offer many opportunities for developing strategies to prevent childhood obesity," say authors Mary Story, Karen Kaphingst, and Simone French. The Future of Children issue "Childhood Obesity" is online at www.futureofchildren.org.
March 16, 2006 For the 14th year, the National Inhalant Prevention Coalition is calling attention to use of inhalants by young children as a major and often fatal drug problem. Noting that more than 1,000 everyday products, including cleaning, office, and art supplies and solvents, gases, and shop chemicals have the potential to be abused as inhalants, the coalition asks parents, schools, and health care providers to put inhalant abuse on their radar when dealing with children. Funded by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the federal National Institute on Drug Abuse (NIDA), the coalition describes symptoms of inhalant abuse to look for and offers extensive lists of substances that youngsters inhale. The coalition also points out that there is no safe level of inhalant use—41 percent of deaths from inhalants occur as the result of first-time use. Materials for use by parents and schools are available at www.inhalants.org. March 16, 2006 President Bush yesterday named Dr. Andrew von Eschenbach to head the federal Food and Drug Administration. Eschenbach has been serving as acting FDA commissioner since last September, when Dr. Lester Crawford abruptly resigned as FDA commissioner just months after the Senate had confirmed his nomination to the post. Hope that the FDA, which has been without a permanent head for most of the Bush administration, will now have one seemed unlikely for the immediate future, however. Two senators, Hilary Clinton (D-NY) and Patty Murray (D-WA) announced they will put a hold on the Eschenbach nomination until the drug agency decides whether or not to approve over-the-counter sales of the "morning after" contraceptive known as Plan B. Plan B is currently available only by prescription and the FDA has rejected the manufacturer’s application to make the drug available OTC, on the ground that it would encourage promiscuity in teenagers. The two senators had lifted a hold on Crawford’s nomination after the FDA promised to act on a new application from the manufacturer that would make the contraceptive available over the counter for women but forbid OTC sale to teenagers, but the agency failed to take the promised action. This time around, they will continue to hold the nomination up until they see real action on Plan B, the two senators said. Under Senate rules, only a vote by the full Senate can lift a hold on executive nominations, and observers say the Senate is highly unlikely to take that step. March 20, 2006 The National Consumers League and the manufacturer of a drug used in treating attention deficit hyperactivity disorder today announced a new website aimed at helping parents understand their treatment options once ADHD has been diagnosed. The initiative by the League and Specialty Pharmaceuticals, a division of pharmaceuticals company McNeil-PPC, Inc., maker of the ADHD drug Concerta, came two days before a scheduled meeting March 22 of the Pediatric Advisory Committee of the U.S. Food and Drug Administration, which will hear and discuss a report on adverse neuropsychiatric or cardiovascular events "possibly related" to ADHD drugs. The March 22 meeting is expected to deal primarily with drugs other than methylphenidates, the widely used class of medications to which Concerta and Ritalin belong, which were the subject of a previous advisory committee meeting, but the committee has announced that it may look at other approved drugs, as well. Listed as drugs to be discussed March 22 are clofarabine (CLOLAR), ibesartan (AVAPRO) sibutramine (MERIDIA), and the mixed salts amphetamineproduct ADDERALL. The parents’ website announced today by the National Consumer League is www.ResponsibleRx.com. March 23, 2006 Tuberculosis is rare in the United States, but when it does occur, the disease is increasingly resistant to the drugs that have previously been used to treat it, according to a statement from the Centers for Disease Control and Prevention (CDC) issued as part of a worldwide commemoration of World TB Day March 24. A total of 14,093 TB cases were reported in the United States in 2005, making the rate of infection (4.8 cases per 100,000 persons) the lowest since reporting began in 1953. At the same time, the number of persons with TB that is resistant to two first-line therapies, isoniazid and rifampin, increased 13.3 percent in the U.S., the largest single-year increase in a decade. Multi-drug-resistant TB is difficult and costly to treat and can be fatal, the CDC points out. "Extensively drug-resistant TB" in which as many as six known drugs may be ineffective, is emerging worldwide and remains a threat to the United States because it is widely distributed geographically, often occurring in this country in populations that have come from parts of the world where tuberculosis is endemic. The CDC said it is working with officials in Mexico and other countries to improve TB control on U.S. borders, improve overseas screening for immigrants and refugees, and provide diagnosis and care to recent arrivals from countries with a high incidence of TB. Information on World TB Day is available at www.cdc.gov/nchstp/tb/WorldTBDay/2006. March 27, 2006 The U.S. Senate Judiciary Committee today declined to go along with a House bill that would make it a criminal offense to provide food, shelter, medical care, or counseling to illegal immigrants. The House of Representatives voted in December to make offers of non-emergency aid a felony, an action that has provoked protests by immigrant and advocacy groups around the country. The Judiciary Committee’s rejection of the House approach came as Congress prepared this week to debate tough issues surrounding immigration in general, including proposals for stepped-up border controls, a guest-worker program, or allowing illegal immigrants to work for a specific number of years before applying for citizenship. The House ban on non-emergency aid is intended to prevent charitable organizations and individuals from assisting illegals, but it has raised questions about whether government agencies, such as schools, could be liable if they gave health care or counseling to illegal immigrants. March 28, 2006 Children who are born in the United States to noncitizen parents, foreign-born children with noncitizen parents, and foreign-born children whose parents are naturalized citizens are all likely to have limited access to health insurance and health care, according to a research report in the April 2006 issue of the American Journal of Public Health. Using data from the 1999 National Survey of American Families, the researchers found that parental citizenship plays a strong role in children’s health care, with children of citizen parents faring slightly better than those of non-citizens. That may be so, they speculated, because to become citizens, parents have to have lived in the United States for from 5 to 10 years and are therefore more familiar with the health care system than more recent arrivals, and also because citizen parents are more likely than non-citizens to access public insurance such as Medicaid and the Children’s Health Insurance Program, which many non-citizens avoid because of fear of possible entanglements with authorities on unrelated issues. They note that recent welfare reforms that tightened eligibility rules for legal immigrants until they become citizens are encouraging parents "to avoid Medicaid." The researchers point to a need for outreach to encourage immigrant families to enroll their children when they are eligible, and they urge that existing law be modified to restore health insurance coverage to legal immigrants and pregnant women. Reprints of the article, "Health Status and Health Service Access and Use Among Children in U.S. Immigrant Families," published in the April 2006 issue of the American Journal of Public Health, are available at zh34@georgetown.edu. March 29, 2006 The federal Food and Drug Administration (FDA) announced today that it has approved another drug, Relenza (zanamivir), for preventing seasonal influenza A and B in adults and children five years of age and older. The effectiveness of Relenza was demonstrated in four large-scale studies where the drug substantially limited spread of the disease within families and in communities that were experiencing flu outbreaks, the FDA said. Relenza is the second drug to gain FDA approval for flu prevention; another drug, Tamiflu (oseltamivir phosphate) was approved several months ago. In today’s announcement, the FDA noted that Relenza is not recommended for either treating or preventing influenza in persons with underlying airways disease such as asthma, and the agency cautioned that neither Relenza nor Tamiflu is a substitute for regular annual flu shots. "Consumers should continue receiving an annual flu vaccination," the announcement said.
|