Category Archives: Health

Panel reveals new details of 1940's experiment (AP)

ATLANTA – A presidential panel on Monday disclosed shocking new details of U.S. medical experiments done in Guatemala in the 1940s, including a decision to re-infect a dying woman in a syphilis study. The Guatemala experiments are already considered one of the darker episodes of medical research in U.S. history, but panel members say the new information indicates that the researchers were unusually unethical, even when placed into the historical context of a different era. "The researchers put their own medical advancement first and human decency a far second," said Anita Allen, a member of the Presidential Commission for the Study of Bioethical Issues. From 1946-48, the U.S. Public Health Service and the Pan American Sanitary Bureau worked with several Guatemalan government agencies to do medical research — paid for by the U.S. government — that involved deliberately exposing people to sexually transmitted diseases. The researchers apparently were trying to see if penicillin, then relatively new, could prevent infections in the 1,300 people exposed to syphilis, gonorrhea or chancroid. Those infected included soldiers, prostitutes, prisoners and mental patients with syphilis. The commission revealed Monday that only about 700 of those infected received some sort of treatment. Also, 83 people died, although it's not clear if the deaths were directly due to the experiments. The research came up with no useful medical information, according to some experts. It was hidden for decades but came to light last year, after a Wellesley College medical historian discovered records among the papers of Dr. John Cutler, who led the experiments. President Barack Obama called Guatemala's president, Alvaro Colom, to apologize. He also ordered his bioethics commission to review the Guatemala experiments. That work is nearly done. Though the final report is not due until next month, commission members discussed some of the findings at a meeting Monday in Washington. They revealed that some of the experiments were more shocking than was previously known. For example, seven women with epilepsy, who were housed at Guatemala's Asilo de Alienados (Home for the Insane), were injected with syphilis below the back of the skull, a risky procedure. The researchers thought the new infection might somehow help cure epilepsy. The women each got bacterial meningitis, probably as a result of the unsterile injections, but were treated. Perhaps the most disturbing details involved a female syphilis patient with an undisclosed terminal illness. The researchers, curious to see the impact of an additional infection, infected her with gonorrhea in her eyes and elsewhere. Six months later she died. Dr. Amy Gutmann, head of the commission, described the case as "chillingly egregious." During that time, other researchers were also using people as human guinea pigs, in some cases infecting them with illnesses. Studies weren't as regulated then, and the planning-on-the-fly feel of Cutler's work was not unique, some experts have noted. But panel members concluded that the Guatemala research was bad even by the standards of the time. They compared the work to a 1943 experiment by Cutler and others in which prison inmates were infected with gonorrhea in Terre Haute, Ind. The inmates were volunteers who were told what was involved in the study and gave their consent. The Guatemalan participants — or many of them — received no such explanations and did not give informed consent, the commission said. The commission is working on a second report examining federally funded international studies to make sure current research is being done ethically. That report is expected at the end of the year. Meanwhile, the Guatemalan government has vowed to do its own investigation into the Cutler study. A spokesman for Vice President Rafael Espada said the report should be done by November. ___ Associated Press writer Sonia Perez in Guatemala City contributed to this report. ___ Commission Website: http://www.bioethics.gov/ Follow Yahoo! News on Twitter, become a fan on Facebook

Need a C-section? Protection from blood clot urged (AP)

WASHINGTON – New advice for pregnant women: If you're getting a C-section, special inflating boots strapped on your legs may lower the risk of a blood clot. Hospitals already use these compression devices for other major operations, such as hip replacements, and a growing number have begun offering them for at least some of their cesarean deliveries, too. Now guidelines for the nation's obstetricians say it's time to make the step routine for most C-sections, which account for nearly a third of U.S. births. The new recommendations promise to raise awareness of what is a silent threat not just for pregnant women but for thousands of other people, too: Blood clots in veins that can masquerade as simple leg pain. Called a DVT, for deep vein thrombosis, this kind of clot usually starts in the leg or groin. But it can kill if it moves up to the lungs, where it's called a pulmonary embolism. These clots make headlines every few years when seemingly healthy people collapse after long airplane flights or similar prolonged inactivity. Certain surgeries also can trigger a DVT. Earlier this year, tennis star Serena Williams was treated for clots in her lungs discovered after foot surgery and cross-country travel. Obesity, some types of injuries, even some birth control pills can increase the risk, too. A woman's risk of a DVT jumps during pregnancy and the six weeks afterward. That's partly because of slower blood flow from the weight gain, and because mom is less active in the last trimester and during those first few weeks of recovery from childbirth. It's also because pregnancy temporarily changes blood to make it clot more easily. "This is a consequence of nature's protecting women against the bleeding challenges of childbirth," explains Dr. Andra James of Duke University, who co-authored the new guidelines from the American College of Obstetricians and Gynecologists. Add a C-section and, like any major surgery, it further increases that risk. As many as two of every 1,000 pregnant women will experience a DVT, James says. Fortunately, pregnancy-related deaths are very rare in this country, but when they happen, those clots are one of the leading reasons. Yet too few people even know the warning signs, she says: Pain or swelling in one leg, especially the calf or thigh. Redness or warmth in one spot on the leg. If the clot has reached the lung, shortness of breath or chest pain. The new guidelines urge obstetricians to closely monitor their patients for DVTs — and to check if they have additional factors that would put them at extra risk. Women who've had a DVT earlier in life, or whose close relatives had one — or who have certain inherited clotting disorders — may need anti-clotting medicines throughout the pregnancy, say the recommendations, published in the September issue of the journal Obstetrics & Gynecology. Then there are those compression devices, which slip over each leg and regularly inflate and deflate, sort of like a massage, to help blood flow more briskly. The obstetricians' group acknowledges that there haven't been large studies with C-sections to prove how much difference the gadgets could make. But it decided to recommend them anyway because in other types of surgery, the devices can cut the clot risk by two-thirds, James says. The guidelines recommend strapping them on before the C-section begins, unless there's no time before an emergency operation or the woman is taking anti-clotting medication. Mount Sinai Medical Center in New York began using the devices for C-sections a few years ago, and deputy chief medical officer Dr. Erin DuPree says they add $14 to the cost of care. Women typically remove and replace them as they ease out of bed throughout the first day after surgery, and no longer need them by the second day, she says. "It's an easy thing to do that really does not cause harm and could potentially help," she says. James stresses that leg compression shouldn't lull a woman into thinking she can rest in bed rather than push herself to walk — and a new mom should remain alert to symptoms when she goes home because half of pregnancy-related DVTs occur in those weeks after childbirth. ___ EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press. ___ Online: DVT info: http://www.cdc.gov/ncbddd/dvt/index.html Follow Yahoo! News on Twitter, become a fan on Facebook

FDA approves gene-targeting lung cancer drug (AP)

WASHINGTON – The Food and Drug Administration has approved a new Pfizer drug for a subset of lung cancer patients with a particular genetic mutation. The twice-a-day pill, called Xalkori, is part of a new wave of personalized medications that fight disease by targeting specific genes found in certain patients. Last week, the FDA approved another drug that uses similar gene targeting technology to treat two rare forms of lymph node cancer. Xalkori is approved to treat a small subset of non-small cell lung cancer patients, less than 7 percent, who have an abnormal gene that stimulates cancer cells and causes tumor growth. It works by blocking proteins produced by the gene. "It's another example of how we're using molecular medicine to subtype lung cancer into more specific and treatable diseases," said Dr. Roy Herbst, a lung cancer expert who is chief of medical oncology at Yale University. Including previously approved targeted therapies, "we have specific therapies now that we can offer for about 18 percent of lung cancer patients that are far superior to chemotherapy and that in many cases can cause their tumors to melt away with few side effects," Herbst said. The FDA said it also approved a genetic test to screen for the mutation, known as an abnormal anaplastic lymphoma kinase gene. The test is made by Abbott Laboratories. About 187,000, or 85 percent, of the 220,000 lung cancer cases diagnosed each year are non-small cell lung cancer. Roughly three-fourths of patients aren't diagnosed until tumors have spread, and only 6 percent of those patients live five years. "It's pretty exciting," said Dr. David Carbone, a lung cancer specialist at Vanderbilt University, one of the sites that tested the drug. Only a small share of lung cancer patients have the gene mutation this drug targets, "but for those people it makes a huge difference," he said. Analysts predict Xalkori could be a blockbuster product for Pfizer, eventually reaping more than $2 billion in annual sales by 2021. The FDA approved the drug under its accelerated approval program, which speeds up the clearance of therapies that show promising early results. Pfizer released follow-up data on the drug in June, reporting that 88 percent of patients in one study saw their tumors shrink at least somewhat after one year on Xalkori. In a second study, 54 percent of patients had their tumors shrink by about a third or more and 83 percent had tumors shrink somewhat. Most patients had only mild side effects, but two of the nine patient deaths during that study were considered treatment-related. The most common side effects of the drug include vision disorders, nausea, diarrhea and inflammation. The FDA's accelerated approval program has come under criticism in the last year after follow-up studies showed the best-selling cancer drug Avastin did not extend the lives of patients with breast cancer. The FDA granted the drug accelerated approval because a single study suggesting it slowed tumor growth. The FDA is now in the process of trying to remove the drug's indication, though the drug maker, Roche, has appealed the decision. ___ AP Medical Writer Marilyn Marchione contributed reporting from Milwaukee. Follow Yahoo! News on Twitter, become a fan on Facebook

Teen vaccinations against cervical cancer lagging (AP)

ATLANTA – Only about half of the teenage girls in the U.S. have rolled up their sleeves for a controversial vaccine against cervical cancer — a rate well below those for two other vaccinations aimed at adolescents. The vaccine hit the market in 2006. By last year, just 49 percent of girls had gotten at least the first of the recommended three shots for human papilloma virus, or HPV, a sexually-transmitted bug that can cause cervical cancer and genital warts. Only a third had gotten all three doses, the Centers for Disease Control and Prevention said Thursday. In contrast, the CDC said about two-thirds of teens had gotten the recommended shot for one type of bacterial meningitis and a shot for meningitis and tetanus, diphtheria and whooping cough. Granted, it can take many years for a new vaccine to catch on and reach the 90 percent and above range for many longstanding childhood vaccines. But use of HPV vaccine has been "very disappointing" compared to other newer vaccines, said the CDC's Dr. Melinda Wharton. "If we don't do a much better job, we're leaving another generation vulnerable to cervical cancer later in life," said Wharton. Why aren't more girls getting HPV shots? The vaccine can be very expensive, and it can be a bit of a hassle. It takes three visits to the doctor over six months. But sex no doubt has something to do with it, experts said. Girls are supposed to start the series when they are 11 or 12 — before most girls become sexually active. The vaccine only works if a girl is vaccinated before she's first exposed to the virus. But some parents may misunderstand, thinking their daughters don't need it at such a young age because they aren't sexually active. Others may believe that it would require a discussion about sex and sexuality — a talk they may not feel ready to have, some experts said. The government needs to be more aggressive about changing those perceptions with a major education campaign, Jeff Levi, executive director of the Trust for America's Health, a Washington, D.C.-based research group, said in a statement. Millions of Americans — women and men — become infected with HPV each year, though most show no symptoms and clear the virus on their own. But some strains persist and can cause genital warts and cancer. About 12,000 women are diagnosed with cervical cancer each year, and about 4,000 die from it, according to CDC statistics. The new study was based on a 2010 telephone survey of the parents of more than 19,000 adolescents ages 13 to 17, who allowed researchers to check their kids' vaccination records. Rhode Island and Washington had the highest HPV vaccination rates, both around 70 percent for at least one shot. Idaho had the lowest rates, at about 29 percent. The study was published online in a CDC publication, Morbidity and Mortality Weekly Report. ___ Online: The CDC report: http://www.cdc.gov/mmwr Follow Yahoo! News on Twitter , become a fan on Facebook

Report: Vaccines generally safe, some side effects (AP)

WASHINGTON – Vaccines can cause certain side effects but serious ones appear very rare — and there's no link with autism and Type 1 diabetes, the Institute of Medicine says in the first comprehensive safety review in 17 years. The report released Thursday isn't aimed at nervous parents. And the side effects it lists as proven are some that doctors long have known about, such as fever-caused seizures and occasional brain inflammation. Instead, the review comes at the request of the government's Vaccine Injury Compensation Program, which as the name implies, pays damages to people who are injured by vaccines. Federal law requires this type of independent review as officials update side effects on that list to be sure they agree with the latest science. "Vaccines are important tools in preventing serious infectious disease across the lifespan, from infancy through adulthood. All health care interventions, however, carry the possibility of risk and vaccines are no exception," said pediatrician and bioethicist Dr. Ellen Wright Clayton of Vanderbilt University, who chaired the institute panel. Still, the report stresses that vaccines generally are safe, and it may help doctors address worries from a small but vocal anti-vaccine movement. Some vaccine-preventable diseases, including measles, are on the rise. "I am hopeful that it will allay some people's concerns," Clayton said. The review echoed numerous other scientific reports that dismiss an autism link. But it found convincing evidence of 14 side effects: _Fever-triggered seizures, which seldom cause long-term consequences, from the measles-mumps-rubella, or MMR, vaccine. _MMR also can cause a rare form of brain inflammation in some people with immune problems. _The varicella vaccine against chickenpox sometimes triggers that viral infection, resulting in widespread chickenpox or a painful relative called shingles. It also occasionally can lead to pneumonia, hepatitis or meningitis. _Six vaccines — MMR and the chickenpox, hepatitis B, meningococcal and tetanus-containing vaccines — can cause severe allergic reactions known as anaphylaxis. _Vaccines in general sometimes trigger fainting or a type of shoulder inflammation. There's suggestive evidence but not proof of a few other side effects, including anaphylaxis from the human papillomavirus, or HPV, vaccine and short-term joint pain in some women and children from the MMR vaccine. On the other hand, the report cleared flu shots of blame for two long-suspected side effects: Bell's palsy and worsening of asthma. That doesn't mean there aren't other side effects — the review couldn't find enough evidence to decide about more than 100 other possibilities. Some vaccines are just too new to link to something really rare. Another example: Flu shots have long come with a caution about rare, paralyzing Guillain-Barre syndrome, but Clayton said research hasn't settled if that's a coincidence since the disorder is more common during the winter. The Health Resources and Services Administration, which runs the vaccine compensation program, is reviewing the report but said it's too early to predict if it will prompt changes to the injury list. Follow Yahoo! News on Twitter , become a fan on Facebook