Health Highlights: Aug. 12, 2013
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
New HIV Drug Approved by FDA
A new drug to treat HIV infection was approved by the U.S. Food and Drug Administration on Monday.
Marketed as Tivicay, the medication interferes with an enzyme that is essential to the ability of the HIV virus to multiply and spread within the human body, the agency said in a news release. It is a pill that is to be taken once a day with other HIV drugs, according to the FDA.
"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in the release. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."
Approved for use in both people who have been diagnosed with HIV but have never taken medications to treat the virus and in those who have taken other HIV drugs, Tivicay (dolutegravir) is also approved for certain children under the age of 12.
The approval was based on the results of five clinical trials involving more than 2,500 patients. Insomnia and headaches were common side effects of the medication, along with hypersensitivity and abnormal liver function in HIV patients who have also been diagnosed with hepatitis B and/or C, the agency said in the release.
Almost 50,000 Americans are infected with HIV every year, according to the U.S. Centers for Disease Control and Prevention, and more than 15,000 died of the disease in 2010.
Tivicay is made by GlaxoSmithKline, based in Research Triangle Park, N.C., according to the FDA.
Foreign-Trained Docs Could Ease U.S. Physician Shortage: Report
The United States has thousands of foreign-trained immigrant doctors whose valuable skills go unused due to the highly demanding requirements they need to fulfill in order to get their license to practice here.
There is a shortage of doctors in many parts of the country and it is expected to get worse when millions more Americans get health care insurance in 2014 as part of the new health care law, The New York Times reported.
It said that the challenging testing and often duplicative training that foreign doctors must complete are meant to ensure they meet the United States' high quality standards.
However, many foreign doctors and their supporters say the process is unnecessarily restrictive and time-consuming. They also contend that these restrictions are one reason why health care services in the U.S. cost far more than in other countries, The Times reported.
Advocates say that the country needs to take advantage of the skills of foreign-trained doctors. They point to Canada's efforts to recognize high-quality medical training programs in other countries.
"It doesn't cost the taxpayers a penny because these doctors come fully trained," Nyapati Raghu Rao, the Indian-born chairman of psychiatry at Nassau University Medical Center and a past chairman of the American Medical Association's international medical graduates governing council, told The Times.
"It is doubtful that the U.S. can respond to the massive shortages without the participation of international medical graduates. But we're basically ignoring them in this discussion and I don't know why that is," Rao said.
The U.S. has long been training too few doctors to meet its needs, partly due to industry-set limits on the number of medical school spaces available. About 25 percent of doctors in the U.S. were trained in other countries, including a significant number of American citizens who could not get into a U.S. medical school, The Times reported.
Arguments against allowing foreign-trained doctors to practice in the U.S. include concerns about quality and that doing so will draw more doctors from poor countries, leaving those nations with doctor shortages.
"We need to wean ourselves from our extraordinary dependence on importing doctors from the developing world," said Fitzhugh Mullan, a professor of medicine and health policy at George Washington University in Washington, told The Times.
"We can't tell other countries to nail their doctors' feet to the ground at home. People will want to move and they should be able to. But we have created a huge, wide, open market by undertraining here, and the developing world responds," he said.
Use of Antipsychotics in Children Under Investigation by HHS
An investigation into whether certain antipsychotic drugs are being prescribed too often to treat behavioral problems in youngsters covered by Medicaid is being conducted by federal health officials.
The review has been underway for several months and is being conducted by the inspector general's office at the Department of Health and Human Services. In a parallel move, various agencies within HHS are telling state officials to tighten oversight of prescriptions of such drugs to Medicaid recipients who are 17 and younger, the Wall Street Journal reported.
The focus is on a class of antipsychotic drugs called "atypicals," which include brand names drugs such as Abilify, Risperdal, Seroquel and Zyprexa. This class of drugs was originally developed to treat psychoses such as schizophrenia, but some were later approved by the Food and Drug Administration to treat children with conditions such as bipolar disorder and autism-associated irritability.
Federal health officials want to reduce "the unnecessarily high utilization of antipsychotics," according to Dr. Stephen Cha, a chief medical officer at the Centers for Medicare & Medicaid Services, WSJ reported.
Doctors need to consider other approaches, including therapy, to help children and families cope with psychological trauma that could be the cause of behavior issues, Cha said.
Medicaid spent $3.6 billion on antipsychotic medications in 2008, compared with $1.65 billion in 1999, according to an analysis by Washington, D.C.-based Mathematica Policy Research. That increase occurred even though pharmacy benefits for millions of Medicaid patients were shifted to Medicare in 2006, WSJ reported.
The number of people under age 20 receiving Medicaid-funded prescriptions for antipsychotic drugs tripled between 1999 and 2008, the Mathematica analysis found.
Children on Medicaid are prescribed antipsychotics at four times the rate of privately insured children, according to a study that examined 2004 data from 6- to 17-year-old children in seven states. The study was conducted by Stephen Crystal, a professor of health policy at Rutgers University, WSJ reported.
The HHS probe focuses on the five largest Medicaid states: California, Florida, Illinois, New York and Texas and covers a six-month period from January to June 2011. During that time, 84,654 children 17 and younger in those states were prescribed antipsychotics paid for by Medicaid. About 700 of those cases will be analyzed by pediatric psychiatrists.
"Through medical-record reviews, we will determine whether these prescriptions were medically indicated, and whether taxpayers were being billed for inappropriate, poor-quality care," said HHS Inspector General Daniel Levinson, WSJ reported.
All Sterile Products From Texas Company Recalled: FDA
A nationwide recall of all sterile products from a Texas company called Specialty Compounding was announced by the U.S. Food and Drug Administration.
The recall was prompted by 15 reports from two Texas hospitals of bacterial bloodstream infections potentially linked to the company's calcium gluconate infusions.
All sterile products made and distributed by Specialty Compounding are being recalled and none of these products should be given to, or used by, patients. Health facilities, health care providers and patients who have received the products since May 9, 2013 should immediately stop using the products, quarantine them and return them to Specialty Compounding, according to the FDA.
"The FDA believes that use of these products would create an unacceptable risk for patients," Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said in an agency news release. "Giving a patient a contaminated injectable drug could result in a life-threatening infection."
Autism May Be Linked to Cancer-Causing Gene Mutations
Certain gene mutations that cause cancer or tumors appear to be linked with autism in some people, according to researchers.
They found that 10 percent of children with mutations in a gene called PTEN -- which causes breast, colon, thyroid and other organ cancers -- have autism. So do about half of children with gene mutations associated with some forms of brain and kidney cancer, and large tumors in the brain and some other organs, The New York Times reported.
That is much higher than the autism rate in the general population. But scientists note that the findings apply to only a small percentage of people with autism.
The discovery of a possible link between cancer-causing gene mutations and autism has enabled researchers to genetically engineer mice with many autism symptoms, and has also led to the first clinical trial of a treatment for children with autism. The trial is testing a drug used to treat tumors with the same genetic basis, The Times reported.
Many scientists who had no role in the research linking autism and cancer-causing gene mutations say the work is changing their understanding of autism and why it develops.
The parallels between cancer and autism are "quite uncanny," according to Jonathan Sebat, chief of the Center for Molecular Genomics of Neuropsychiatric Diseases at the University of California, San Diego.
"We haven't solved it all; we have only solved a tiny bit. But the small bit we solved has been very illuminating," he told The Times.
But others question the findings. Autistic children with the cancer gene mutations have "a brain that is failing in many ways" and autism in these children could be due to general brain malfunction, according to Harvard University geneticist Steven McCarroll.
"The fact that autism is one of the many neurological problems that arise in these patients doesn't necessarily tell us anything penetrating about the social and language deficits that are specific to autism," he told The Times.