Doctor Who Sparked Vaccine-Autism Concerns Under Investigation
The doctor who ran a controversial British study that associated a common childhood vaccine with autism is under investigation for possible ethical misconduct, the Associated Press reported Monday.
Dr. Andrew Wakefield is being investigated by Britain's General Medical Council for allegedly failing to disclose his ties to autism litigators and for failing to secure the necessary ethical approval for the study, the AP said. Wakefield denies any impropriety.
Wakefield's study, published in 1998 in The Lancet medical journal, linked the combination measles-mumps-rubella (MMR) vaccine with autism, a little understood neurologic disorder. Widespread dissemination of the study's results led many parents to refuse to vaccinate their children with the MMR vaccine.
Ten of the study's 13 authors have since renounced the study's findings, and the medical journal has conceded that publishing the study was a mistake. The Lancet said Wakefield's ties to people involved in litigation against the makers of the vaccine were "a fatal conflict of interest," the AP reported.
Two of Wakefield's co-authors on the study also are under investigation by the British council, the wire service said. Hearings into the allegations are expected to last through October.
Wakefield's study suggested that children be vaccinated separately for the three diseases, although experts continue to favor the combined inoculation. Numerous studies conducted since the controversial research was published have found no link between the MMR vaccine and autism.
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New Test Spots Metastatic Breast Cancer
The first molecular laboratory test to help doctors detect whether breast cancer has spread to nearby lymph nodes has been approved by the U.S. Food and Drug Administration, the agency said Monday.
The GeneSearch BLN Assay detects molecules that are abundant in breast tissue but are normally rare in lymph nodes. The body's lymphatic system helps protect against infection.
The first lymph node that filters fluid from the breast is called the "sentinel node," which is commonly removed during a lumpectomy or mastectomy because it's where breast cancer cells are most likely to spread first, the agency said. The GeneSearch test offers an additional way to evaluate the sentinel node.
In clinical testing involving 416 women, the test accurately predicted that breast cancer had spread 88 percent of the time. Among women in whom cancer hadn't spread, the test was 94 percent accurate, the FDA said.
The test is manufactured by a New Jersey-based Johnson & Johnson subsidiary, Veridex, LLC.
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Grapefruit May Raise Breast Cancer Risk: Report
A daily serving of 1/4 grapefruit or more could raise a woman's risk of breast cancer by up to 30 percent, a study published in the British Journal of Cancer concluded.
Grapefruit is thought to boost the effects of estrogen, the female hormone that's been linked to an increased risk of breast cancer, researchers at the University of South Carolina and the University of Hawaii wrote.
Study leaders asked some 50,000 post-menopausal women how often they ate the fruit, and how large the portions were, BBC News reported.
The researchers conceded that more study was needed because the questionnaires did not account for consumption of grapefruit juice, only the fruit itself, the BBC said.
The report cited a nutrition scientist at the British Nutrition Foundation, Dr. Joanne Lunn, who agreed that follow-up research was needed.
"This study is simply a piece of the jigsaw that will eventually help us to understand how our diets affect our health," she said.
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Leukemia & Lymphoma Society Endorses Medical Marijuana
With the U.S. House of Representatives preparing to vote on a bill that would bar federal interference in state medical marijuana laws, the Leukemia & Lymphoma Society says it supports removing penalties for patients who use marijuana with a doctor's prescription.
The society issued a resolution saying it "supports legislation to remove criminal and civil sanctions for the doctor-advised, medical use of marijuana by patients with serious physical medical conditions."
The statement also calls for an end to federal prosecution of people in states that permit medical marijuana.
In a supporting statement, the Washington, D.C.-based Marijuana Policy Project said, "There is no medical organization anywhere that believes jailing the sick is good for them, and yet that is precisely what federal policy does."
The House is expected to vote on the bill later this month, the Marijuana Policy Project said.
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FDA Experts Weighing in on Artificial Spinal Disc
An expert panel advising the U.S. Food and Drug Administration will meet this week to advise the agency on whether an artificial spinal disc is as effective or better than surgery in treating worn discs.
In documents posted on the FDA Web site, the agency said it appears that Medtronic's Byran disc is as good as spinal fusion, the Associated Press reported. Some 200,000 people annually in the United States have the surgery, in which a diseased disc is removed and the surrounding portions of the spine are fused back together.
If the surgery is performed on the neck, the patient usually is not able to turn the head from side to side. By contrast, Minneapolis-based Medtronic says its titanium-coated plastic disc gives patients that ability, the AP reported.
Spinal fusion surgery costs an average of $34,000, the wire service said, citing an article in the New England Journal of Medicine. The surgery to implant the Medtronic disc is comparable in price, the AP said.
Some 15,000 operations to install the artificial disc have been performed outside the United States, where the device has been approved.
Last September, an expert panel unanimously recommended approval of a similar Medtronic disc made of stainless steel. The full FDA is not bound by the panel's recommendations, and has yet to rule on the stainless steel device, the AP said.
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Glucose-Measuring System Recalled for Mislabeling
A system used by diabetics to measure blood glucose levels has been recalled in Canada because a labeling error could cause some users to overestimate their sugar levels, the U.S. Food and Drug Administration said Monday.
Bayer's Ascensia Contour Blood Glucose Monitoring System erroneously reports levels in mg/DL, instead of the appropriate mmol/L, the agency said.
Users may misinterpret their results -- which could lead to a hypoglycemic reaction, the FDA warned.
Users with questions or concerns should contact Bayer at 1-574-256-3441.
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