Mother-To-infant HIV Infection Reduced By Novel Pouch

By using medications packaged just like fast-food ketchup, HIV-positive mothers in developing countries can more easily provide protection to newborn babies born at home.



Biomedical engineers at Duke University have developed an inexpensive and easy-to-use system that allows mothers to give their newborns a potentially life-saving dose of an anti-HIV medication shortly after birth. This is especially important since such drugs can only be found in clinics or hospitals, which can be days away from an expectant mother.



Timing is crucial for the newborn.



In order to be effective, the drug, known as Nevirapine, must be given to the newborn within days of birth. The challenge to date has been reaching distant mothers who give birth at home. Since most mothers are not up to traveling that soon after delivery to get medication, the biomedical engineers developed a way of providing the medication in a simple manner and with a long shelf-life --- pouches made of foil and plastic that can hold a single dose of Nevirapine.



"In Africa, the World Health Organization (WHO) estimates that more than 90 percent of 430,000 new cases of AIDS in 2008 were attributable to mother-to-child transmission," said Carolina Gamache, program coordinator in senior researcher Robert Malkin's Developing World Healthcare Technology Laboratory at Duke's Pratt School of Engineering. "A single dose of Nevirapine right after birth has been shown to be effective in protecting the baby from the virus, but it has been difficult for many reasons to make this option available to women who give birth at home."



Gamache presented the results of the Duke research in London at the Appropriate Healthcare Technologies for Developing Countries conference, which is sponsored by WHO and the Institute of Engineering and Technology. Her paper describing the team's results was selected by judges as the conference's top research paper.



While healthcare workers in Africa have in the past tried packaging single doses by other means - syringes and containers - they have all suffered from evaporation during storage and loss of preservatives. This is not an issue for bulk quantities of the drug, which are common in clinic and hospital pharmacies.



Also, as Gamache explained, drug manufacturers have not shown much interest in devising single-dose systems because of development costs and limited marketing potential outside the Third World. The new pouch, which was fabricated at Duke, has been shown in tests to greatly reduce evaporation while remaining potent at various temperatures - all greatly extending its life span.



"In our system, the pharmacist can fill an individual pouch for women early in their pregnancy, and they can take it home with them," Gamache said. "When the baby is born, the mother can then easily rip off the corner of the pouch and empty the drug into the newborn's mouth. Further treatments can be given to the baby at the clinic or hospital later when travel becomes easier for the mother."



The WHO estimates that just 32 percent of infants born to HIV-positive mothers received prophylactic antiretroviral drugs like Nevirapine, compared to 45 percent of their pregnant mothers.



"If borne out in upcoming clinical trials, it would be expected that the current gap in anti-retroviral prophylaxis between mothers and their children could be reduced with the pouch," Malkin said. "This could be accomplished at little additional cost and could be a significant step in creating a generation of children free of HIV."



The team has conducted field testing the past year on the use of the pouches with nurses and pharmacists in Tanzania, and based on the encouraging results, they are planning clinical trials to determine if the new system can reduce the number of mother-to-child cases of HIV transmission.



Although the latest studies were conducted with Nevirapine, the Duke researchers also plan to test the system with other anti-HIV medications and combinations of medications.



The research was supported by Duke's Research in Practice Program and the Provost's Common Fund. Pratt undergraduates Michael Spohn, Shannon Skinner and Peter Horgan were also part of the team.



Source:

Richard Merritt

Duke University

Actions Taken On HPV Proposals Legislation In Alaska, Indiana, Washington State

The following highlights recent state news related to human papillomavirus vaccines. Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. CDC has added Gardasil to its Vaccines for Children Program, which provides no-cost immunizations to children ages nine to 18 covered by Medicaid, Alaska Native and American Indian children, and some uninsured and underinsured children (Kaiser Daily Women's Health Policy Report, 3/22). GSK last month announced that it has filed for FDA approval of Cervarix (Kaiser Daily Women's Health Policy Report, 4/5). Summaries appear below.

Alaska: The Department of Health and Social Services last week announced that by early summer it will distribute more than 20,000 doses of Gardasil to public and private health clinics in the state, the AP/Helena Independent Record reports (Quinn, AP/Helena Independent Record, 4/9). Nearly two-thirds of Alaska girls qualify to receive the vaccine at no cost, Laurel Wood, state immunization program manager said (Shinohara, Anchorage Daily News, 4/10). If all women and girls eligible to receive Gardasil at no cost through the Vaccines for Children program are vaccinated this year, the cost would total $16 million, Wood said, adding that it is unlikely all eligible females will be immunized. Wood estimates that the state program for the vaccine will cost about $5 million this year, which is enough to vaccinate more than 17,000 females (AP/Helena Independent Record, 4/9). Planned Parenthood of Alaska has been offering Gardasil at a cost of $480. Chris Simon, CEO of PPA, said the organization has vaccinated "a little under 50" people statewide (Anchorage Daily News, 4/10).














Indiana: The Senate on Monday voted 45-3 to approve an amended version of a bill (SB 327) that would require schools in the state to provide parents and guardians of girls entering the sixth grade information about Gardasil and the link between HPV and cervical cancer, the Fort Wayne Journal Gazette reports. According to the Journal Gazette, the measure would require parents and guardians to submit a written statement that says whether the student has received the vaccine, is going to receive the vaccine or will not receive the vaccine, or if the parent chooses not to answer the question. Answers in the statements, which will not affect a student's ability to attend school, would be used by the State Department of Health to track Gardasil's effectiveness at preventing cervical cancer, the Journal Gazette reports. The bill now heads to Gov. Mitch Daniels (R) (Kelly, Fort Wayne Journal Gazette, 4/17).

Washington: The House on Saturday voted 76-18 to approve an amended version of a bill (HB 1802) that would require all schools in the state to provide information about HPV and HPV vaccines but would not require private schools to distribute the information at school, the AP/Olympian reports (Byrd, AP/Olympian, 4/14). Under the original bill, sponsored by Rep. Jeannie Darneille (D), all public and private schools would have been required to give parents of children entering the sixth grade information on HPV, its symptoms and causes, and places where vaccines can be obtained (Kaiser Daily Women's Health Policy Report, 3/15). The amended version of the legislation, which passed the Senate, still requires public schools to provide parents with the information but only requires private schools to notify parents that the information is available to pick up. State lawmakers also included funding in the budget to add the HPV vaccine to the state's universal vaccine program, which would make it available to girls ages nine to 18 at almost no cost, the AP/Olympian reports. Parents and guardians only would have to pay the doctor visit fee, according to the AP/Olympian. The bill now heads to Gov. Chris Gregoire (D), who is expected to sign it into law, according to spokesperson Holly Armstrong (AP/Olympian, 4/14).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.



View drug information on Cervarix [Human Papillomavirus Bivalent; Gardasil.

GOP Letter To Obama Urges 'Common Ground' On Health Reform, Restrictions On Abortion Funding

House Republicans on Wednesday sent President Obama a letter urging "open and constructive dialogue across party lines" on health care reform and calling on him to maintain current restrictions on federal funding of abortion services, Politico reports. The letter, signed by House Minority Leader John Boehner (Ohio), House Minority Whip Eric Cantor (Va.), House Republican Conference Chair Mike Pence (Ind.) and six other Republican House members, outlines the Republicans' positions on health care reform. It says achieving those objectives "can be accomplished through health reform that maintains current law provisions regarding restrictions on federal funding of abortion services, restricts federal funds from flowing to abortion providers and does not impose mandates either on insurance carriers or medical providers to participate in activities that violate their religious and moral beliefs."

The letter says that Republicans have several "areas for potential common ground on health care reform." In all, it mentions the phrase "common ground" four times in eight paragraphs, Politico reports (Allen, Politico, 5/13).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


© 2009 The Advisory Board Company. All rights reserved.

60% Of People With Embryos In U.S. Fertility Clinics Would Consider Donating Them For Stem Cell Research, Survey Says

About 60% of people who have embryos stored at U.S. fertility clinics would be very or somewhat likely to donate them for stem cell research, according to a survey published Thursday in the online edition of the journal Science, Reuters reports (Dunham, Reuters, 6/20). For the survey, Anne Drapkin Lyerly, associate professor of gynecology at Duke University, and Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, sent questionnaires to 2,000 random couples at fertility clinics around the country (AP/CBS News, 6/20). They received responses from 1,020 people who have embryos stored at nine fertility clinics in California, Colorado, Maryland, Missouri, New Jersey, North Carolina, Oregon, Pennsylvania and Washington, D.C. (Reuters, 6/20).

Federal funding for human embryonic stem cell research currently is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by President Bush on that date. Bush on Wednesday vetoed a bill (S 5) -- called the Stem Cell Research Enhancement Act of 2007 -- that would have allowed federal funding for research using stem cells derived from human embryos originally created for fertility treatments and willingly donated by patients (

Opinion Pieces Respond To Obama's Call For 'Empathy' In Supreme Court Justice

Two newspapers recently published opinion pieces responding to President Obama's comments on the need for "empathy" in candidates to replace retiring Supreme Court Justice David Souter. Summaries appear below.

~ Ellen Goodman, Boston Globe: When discussing Souter's replacement, Obama said he will seek a nominee "'who understands that justice isn't about some abstract theory. ... It is also about how our laws affect the daily realities of people's lives,'" Globe columnist Goodman writes in an opinion piece. According to Goodman, Obama's emphasis on the need for judicial "empathy" has sparked outrage among a "phalanx of horrified conservatives" who claim that "empathy is just a code word for the sentimental liberal bias in favor of underdogs over the Constitution." However, she continues, "let us remember that empathy is not sympathy. It doesn't require that we take sides. Nor is it an emotional shortcut that upends all legal reasoning to declare a winner." According to Goodman, empathy "is rather the ability to imaginatively enter into the experience of others." She writes that the "capacity to recognize another person's reality is not just liberal," adding that empathy "doesn't trump reason, it informs reason." Goodman writes, "The truth is that we want judges who 'get it,'" adding that the "myth of justice as a matter of pure objective reasoning that could be meted out by a computer is just that, a myth" (Goodman, Boston Globe, 5/22).

~ Mike Rosen, Denver Post: Although Obama's emphasis on empathy might seem "[c]ompassionate and seductive" to some, his stance "represents a radical and dangerous departure from traditional American jurisprudence," radio host Rosen writes in a Post opinion piece. Rosen writes, "When empathetic judges rule on their feelings, they are exceeding their authority," adding that the "role of the judicial branch of our government is to rule on the Constitution as written and the law as passed by Congress and signed by the president." According to Rosen, the courts "are a co-equal branch of government, not a superior branch," and judges should not "rule on what they think the law ought to be" because that would be "government by a presumptuous, unelected judiciary." Rosen continues that "judges are referees, not rule makers" because they are "not there to empathize with the fans or the players. They represent the rule book, and they aren't authorized to … make it 'fairer.'" According to Rosen, the "dispute between conservatives and liberals on judicial activism is philosophical and irreconcilable." He concludes that Senate confirmation hearings for Obama's nominee "should make for an interesting debate on these principles" (Rosen, Denver Post, 5/22).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


© 2009 The Advisory Board Company. All rights reserved.

EMILY's List Launches Campaign Against Nev. Congressional Candidate Heck

EMILY's List is launching a two-week television ad campaign in Nevada that portrays Republican House candidate Joe Heck as hostile toward women's health issues, Politico reports. EMILY's List, which supports female candidates who are in favor of abortion rights, is backing Heck's opponent, Democratic incumbent Rep. Dina Titus. The ad is produced through Women Vote!, an independent expenditure of EMILY's List.

According to Politico, the race between Titus and Heck is "one of the most competitive House contests" this election cycle, with a mid-August Mason-Dixon poll showing the two candidates in a statistical tie of 43% for Titus and 42% for Heck. A "significant offensive" against Heck could give Titus a boost in the campaign, Politico reports.

The new ad attacks a vote Heck made while serving in the Nevada state Senate against a bill that would have required health plans to cover the human papillomavirus vaccine, which prevents some forms of HPV that can cause cervical cancer. The ad states that Heck "actually voted against requiring insurance companies to cover the vaccine" and "said women wouldn't need it if they did not engage in risky behavior." The ad continues, "This from a man who graduated from medical school. ... If we can't trust Heck with our health, can we trust him with our future?"

The ad campaign is "precision-targeted" toward women ages 18 through 49, Politico reports. It will air on TV shows and websites where young Nevada women are likely to see it, including during MTV's "Teen Mom" and "Jersey Shore," on the Internet TV site Hulu, and during TV shows like "Grey's Anatomy," "30 Rock," and "Real Housewives of New Jersey." A simultaneous campaign will run on Facebook, with ads reading "What the Heck?" and "Heck: Bad for Our Health."

EMILY's List spokesperson Jen Bluestein Lamb said the group "will do everything we can to ensure voters know the truth and get out to vote" (Burns, Politico, 9/8).

Associated Press Fact Checks Anti-Health Reform Claims

Several Republican candidates and their supporters are airing campaign ads attacking the federal health reform law (PL 111-148) and the Democratic candidates who voted for it, the AP/ABC News reports in a fact check of such ads. The ads "often resor[t] to exaggeration and omission to make their points," including claims regarding abortion, the AP/ABC News reports.

For example, radio ads by AUL Action, the legislative arm of Americans United for Life, claim that three House Democrats who voted for the health reform law -- Reps. John Boccieri (Ohio), Christopher Carney (Pa.) and Baron Hill (Ind.) -- "voted for taxpayer-funded abortion." The ads also call the law "the largest expansion of taxpayer-funded abortions ever."

However, the AP/ABC News reports that an executive order signed by President Obama after the bill's passage reaffirms that the reform law prohibits the use of federal funds to pay for abortion coverage.

AUL argues that Obama's executive order could be reversed and that courts "could interpret" the law as permitting federal funding for abortion services. Such situations "are hypothetical, and the trend is in the other direction," the AP/ABC News reports. For example, HHS announced in July that the high-risk insurance pools created under the law are prohibited from covering abortion except in cases of rape, incest or to save the life of the woman (Kuhnhenn, AP/ABC News, 9/8).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families.


© 2010 National Partnership for Women & Families. All rights reserved.

FDA Warns Bayer About Two Illegal Aspirins

The US Food and Drug Administration (FDA) has written warning letters to drug company Bayer HealthCare about two over the counter (OTC)
aspirins that contain supplements and claim to be effective not only for pain relief but against heart disease, and this constitutes a use for which the
drugs have not been given approval and therefore makes them illegal said the agency in a statement on Tuesday.


The two aspirins are: Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart
Advantage).


Bayer Women's has aspirin and calcium carbonate in a single tablet and Bayer Heart Advantage has aspirin and phytosterols in a single tablet. They
both carry labels that describe them as being a drug and a dietary supplement, but when these are together in one tablet the product is subject to FDA
regulation said the FDA.


Mike Chappell, the FDA's acting associate commissioner for regulatory affairs said in a statement that:


"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process."


Chappell said the federal agency was prepared to enforce action against manufacturers who broke the law or who tried to get around the drug approval
process.


The two aspirins are labelled not only as pain relievers, but also carry claims that they reduce the risk of heart disease, said the FDA statement. Bayer's
Women's also claims to "fight" osteoporosis. Neither of these uses is approved by the FDA. Moreover, the drugs are misbranded said the agency since such uses take the products out of the OTC
category because these conditions should be diagnosed by a healthcare professional who then advises which medication to take and then supervises the
patient on the drug.


Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said she was troubled by the marketing of these unapproved
drugs.


"Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these
aspirin-containing products can put consumers at risk for internal bleeding and other adverse events."


"It is essential that companies obtain FDA approval and fully comply with FDA regulations."


The FDA said the labels also carry mixed messages about long versus short term use because the instructions for the aspirin content conflict with the
instructions for the supplement content.


It would seem that part of the problem is in the wording. Claiming to fight a disease or directly claiming to lower cholesterol is not the same as
claiming to reduce the risk of these conditions.


The label on the Bayer Heart Advantage product claims that the phytosterols are intended to lower blood cholesterol and the label on the Bayer
Women's product claims that the calcium is intended to strengthen bones to "fight" osteoporosis.















Although some dietary supplements that contain calcium are allowed to claim to "reduce the risk of osteoporosis", claims to fight or treat the
condition directly requires approval by the FDA. Similarly, some supplements containing phytosterols are allowed to claim they "reduce the risk of
coronary heart disease" and may say they do this by lowering blood cholesterol, but a direct claim to lower cholesterol is the same as saying the drug
prevents or treats coronary heart disease and hypercholesterolemia, for which FDA approval is necessary.


Not only should the company apply for new drug approval for such claims, but they would not be approved for OTC use anyway and to market them as
such is another reason that makes them illegal, said the FDA.


There are some conditions under which the FDA allows OTC drugs to be marketed without first getting FDA approval but the agency said these two drugs
do not meet the conditions because they do not comply with "set requirements for the drugs' labeling and formulation, as well as the indications (uses)
for which the drugs can be marketed".


The FDA said it was not aware of any significant adverse events arising from use of these products.


According to Reuters, a Bayer spokesperson told the press that the company stands by both products and defends its right to market them as labelled.
The drug company said advertisements tell consumers to check with their health professional before taking aspirin with supplements, and the label on
the Bayer Aspirin with Heart Advantage also says it does not replace cholesterol-lowering medication.


Sources: FDA, Reuters.


: Catharine Paddock, PhD.