Drug companies often exclude people with depression from clinical trials, even though it is well known among physicians that depression often coincides with other disorders. By purposefully eliminating this cohort from early testing stages, drug manufacturers hope to gain faster FDA approval, but they may be shooting themselves in the foot once the treatment is mass-marketed and its widespread effects are better known.
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A new study sheds light on the difficulties physicians experience when trying to control the lipid levels in patients with coronary artery disease. Published in the American Journal of Cardiology, the study reviewed the electronic records of approximately 10,000 patients seen at a cardiology practice between September 2008 and September 2009 to assess whether the patients were achieving recommended cholesterol and triglyceride goals.
Perhaps responding to ACSH’s Director of Chemical and Pharmaceutical Sciences Dr. Josh Bloom’s op-ed on the effect of the FDA’s overly-precautionary regulations on the pharmaceutical industry, the FDA is countering claims that it is not approving enough drugs. The agency published a statement arguing that the number of approvals for novel drugs, called new molecular entities (NMEs), has remained stable over the past decade.
Though the rate of smoking among U.S. adults has remained relatively stagnant over the past few years — hovering around 20 percent as reported by the CDC in September — there is still some good news to be had. A new study published in the Journal of the American Medical Association uses two large, population-based surveys comprising a total of 1,662,353 respondents to determine if smokers are smoking fewer cigarettes.
A meta-analysis of 16 studies published in the Annals of Internal Medicine finds that low-radiation heart CT scans, known as gated CT’s, are equally effective in diagnosing heart problems as a coronary angiography, the current gold standard. The angiogram, done via a catheter inserted through an artery into the heart, however, is invasive and not without risk, so some doctors resort to a CT scan for diagnosing patients with chest pain instead.
In a surprise ruling, the FDA determined last week that tobacco product maker Star Scientific Inc. is free to market and sell its Ariva-BDL and Stonewall-BDL dissolvable tobacco lozenges independent of FDA regulation since the products do not fall under the jurisdiction of the 2009 Family Smoking Prevention and Tobacco Control Act.
KV pharmaceuticals recently won exclusive rights to the marketing of the pre-term labor prevention drug they’ve branded Makena. Priced at a whopping $1500 per shot, the therapy may cost up to $30,000 per pregnancy since it usually requires 20 weekly injections to prevent premature labor in patients who have a predisposition to or a history of going into premature labor.
ACSH staffers were pleased to encounter a variety of pieces defending vaccines as a vital public health practice. A book review in today’s The New York Times, for instance, features an excellent work by informed consumer and Vanity Fair Contributing Editor Seth Mnookin. The Times’ Dr.
Some West Virginia University researchers are frying up a skillet of fear for pre-menopausal women. Published in the Journal of Clinical Endocrinology and Metabolism (JCEM), a new study alleges that the perfluorocarbons (PFCs) — referred to as “gender bending chemicals” by U.K.
On March 7, the Medicare Rights Center in New York won a lawsuit against the Department of Health and Human Services (HHS): a federal judge ruled the Medicare Part D drug coverage program is responsible for covering off-label use of drugs when treatment is medically necessary.
Yesterday the AP offered its readers a rather creepy story about at-home genetic testing intended to determine if children have certain genes associated with improved athletic performance.
In the developing world, more than 1,000 mothers and 2,000 newborn babies die each day from preventable birth complications. Many of these deaths could easily be avoided by providing pregnant women with trained midwives who can assist during birth.
The 22nd International Harm Reduction Conference is underway this week in Beirut, Lebanon, and an article published yesterday in The Lancet underscores the goals of the “Beirut Declaration on HIV and Injecting Drug Use: A Global Call for Action,” a new document released at the annual meeting.
Though measles was officially declared “eradicated” in the United States in 2000, a number of cases are still imported from people visiting countries that cannot or do not vaccinate against the disease. The CDC reports that in the first few months of 2011 alone, seven cases of measles have been imported by U.S. infant travelers aged 6 and 23 months. From 2001 to 2010, that number was 47.
Don’t let the Lexington-Herald Leader headline, “Madison County health board bans electronic cigarettes,” fool you. The Madison County Board of Health has actually added electronic cigarettes to their list of indoor smoking restrictions, perhaps due to an FDA warning in 2009 cautioning that the nicotine-delivery devices supposedly contain “toxic” ingredients.
Over the past few years, prostate cancer screening using the prostate-specific antigen (PSA) test has received a lot of media flack while various health organizations and physicians struggle to outline specific guidelines for the exam.
Unemployed and looking for a lucrative job in New York City? Don’t mind long walks and occasional arrests? This may be a job for you: According to an article in The New York Times, smuggling and reselling cigarettes on the streets is a profitable practice.
Monsanto is one step away from receiving FDA approval for their genetically modified soybeans that will produce omega-3 fatty acids. The new soybeans will be used to produce Monsanto’s brand “steridonic acid (SDA) soybean oil” to fortify consumer food products, such as cereals and baked goods. “This could be a beneficial, genetically improved product,” says ACSH's Dr.
According to a new report issued yesterday by the Partnership at Drugfree.org, a trend in substance abuse has been on the rise for the past three years among adolescents, following a decade of continuous declines in drug abuse. The number of teenagers who admitted to using marijuana within the past year increased from 32 percent in 2008 to 39 percent in 2010. During the same time period, teens who owned up to using the drug ecstasy climbed from 6 percent to 10 percent.
The FDA is requiring drug makers of tumor necrosis factor (TNF) blockers to include an additional warning to their product label, cautioning of an increased risk for Hepatosplenic T-Cell Lymphoma (HSTCL), a type of blood cancer primarily reported in adolescents and young adults on TNF blockers.
Recognized for her roles in such popular movies as Almost Famous and How to Lose a Guy in 10 Days, actress Kate Hudson is now better known around the mommy blogosphere for committing what is perceived to be the cardinal sin of pregnancy: imbibing a glass of wine.
The results of a small study on Pfizer’s smoking cessation drug Chantix (varenicline) underscore the difficulties smokers face when attempting to kick the habit for good. Published in the Archives of Internal Medicine, Peter Hajek of the UK Center for Tobacco Control Studies studied 101 middle-aged smokers. Half were randomized to start Chantix four weeks prior to quitting, while a control group took the drug just one week before stopping smoking.
ACSH staffers would like to give two thumbs down to the Cleveland City Council for recently passing some “extraordinary” public health bills. The first one will ban the use of trans fat in prepared foods in Cleveland restaurants, while the second is an outdoor smoking ban. Residents will no longer be able to light up in city-owned public parks, recreation areas, swimming pools, picnic shelters, public squares and some malls.
Falls are the leading cause of injury among people over the age of 65, and according to the CDC, it affects one in three adults each year. Jack Mills, a continuous quality improvement specialist for the Lake County Health Department’s Population Health Services, emphasizes that falls have “really a life-altering and quality-of-life-altering impact on older people,” which is why the Lake County Health Department established a Falls Prevention Task Force to disseminate prevention and awareness pamphlets to seniors.
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