Mayonnaise, olive oil and petroleum jelly are popular home remedies for suffocating head lice and, at first blush, they appear to work. Unfortunately, lice have external structures called spiracles that protect the entry points to their breathing apparatus. Closing the spiracles protects the lice from the suffocating effects of the home remedies and, when the agent is removed, the lice often appear to have a miraculous resurrection.  A newly approved over-the-counter drug called Ulesfia seems to get around this problem by shocking the spiracles open, according to a report in the journal Pediatric Dermatology.

Of course, over-the-counter products containing the neurotoxin permethrin and prescription drugs containing malathion and lindane are also available. Because these contain neurotoxins, however, they can be used only every 10 days or so and are not appropriate for very young children. Reinfestation often occurs much quicker and the lice, furthermore, appear to be developing resistance to the pesticides.

Ulesfia, manufactured by Shionogi Pharma Inc. of Atlanta, is based on a lotion that suffocates the lice, but it also contains a 5% concentration of benzyl alcohol that shocks the spiracles open. Phase 2 and phase 3 clinical trials conducted for Shionogi by  the drug-testing company Global Health Associates of Miami compared use of Ulesfia to use of the lotion only in 250 children with head lice. A caregiver applied the lotions to the hair for 10 minutes at the beginning of the study and a week later. Company president Terri L. Meinking and her associates reported in Pediatric Dermatology that 91.2% of those using Ulesfia had no lice on Day 8 and 75.6% had none on Day 14. Among those using only the lotion, 27.9% had no lice at Day 8 and 15.5% had none on Day 14.  Irritation of the application site was the most commonly reported side effect, affecting 2.3% of users. 

"Because benzyl alcohol lotion kills by suffocation, resistance should not be an issue," Meinking said in a statement.

-- Thomas H. Maugh II

A study coming out in tomorrow’s edition of Archives of General Psychiatry may prompt doctors and patients to reconsider the merits of using antiepileptic drugs to treat people with bipolar disorder.

Just last year, the U.S. Food and Drug Administration issued an alert that antiepileptic drugs -- such as Neurontin (generic name gabapentin), Lyrica (pregabalin), Topamax (topiramate) and Tegretol (carbamazepine) -- increased the risk of suicidal thoughts and behaviors. That’s particularly important for patients with bipolar disorder, because they already have a higher risk of suicide compared to healthy people.

But the new analysis finds that bipolar people who took one of 11 antiepileptic medications had the same rate of suicide attempts -- 13 per 1,000 patients per year -- as those who didn’t take any drugs for their condition. That rate was slightly lower than for bipolar people who took lithium (18 suicide attempts per 1,000 patients per year). It was also much lower than the rate of suicide attempts among bipolar people in the year before they began taking antiepileptic medications (72 per 1,000 patients per year).

The findings are based on records of 47,918 patients with bipolar disorder who were included in the PharMetrics medical claims database. The study was conducted by researchers from the Center for Health Statistics at the University of Illinois at Chicago and the Columbia University College of Physicians and Surgeons in New York. Two of the researchers have produced expert testimony for Pfizer Pharmaceuticals in litigation involving Neurontin. Pfizer purchased the dataset from PharMetrics for $15,000 but was not involved in the research and didn’t influence or review the results, according to the researchers.

The work was funded by grants from the National Institute of Mental Health and the Agency for Healthcare Research and Quality.

You can read the FDA’s 2008 statistical review of antiepileptic drugs and suicidal ideation and behavior here. The most up-to-date info from the agency is online here.

-- Karen Kaplan

Photo: Perhaps this drug is safer, and more useful, than thought. Credit: Pfizer Inc.

The development of statins, a class of drugs that lower bad cholesterol, have made a big effect. A study published today found that the prevalence of American adults with high levels of LDL cholesterol (that's the bad kind) fell by about one-third from 1999 to 2006. Paradoxically, the study also found that a huge number of people still have excessively high levels of bad cholesterol, are not being treated for it or may even be unaware of their levels.
 
The study, published in the Journal of the American Medical Assn., examined LDL cholesterol levels among more than 7,000 men and women across four study cycles: 1999-2000, 2001-2002, 2003-2004 and 2005-2006. Rates of high LDL cholesterol decreased from 31.5% in 1999-2000 to 21.2% in 2005-2006.
 
Yet researchers from the federal government found that many people had elevated rates of bad cholesterol, particularly those at the highest risk for developing heart disease. Fewer than 70% of adults nationwide were screened for cholesterol levels in the 2005-2006 period. During that time period of the study, 64.5% of people received cholesterol screening, 39.6% were screened but were untreated or inadequately treated and 24.9% were not told the results of screening.
 
In two commentaries accompanying the study, experts noted that cholesterol screening guidelines have become too complex and should be simplified so that more people receive statins. Dr. J. Michael Gaziano and Dr. Thomas A. Gaziano noted in one editorial that the last set of cholesterol guidelines, published in 2002, was 280 pages long. The guidelines are not only complicated, they are far from perfect, sometimes leading doctors to prescribe statins to someone with elevated LDL cholesterol but who has an overall low risk of heart disease and not prescribing drugs to someone with normal LDL cholesterol but who has an overall high risk of developing heart disease.
 
Another approach to treating cholesterol, said the authors of the other commentary, is to prescribe generic statins to all adults based on age. This approach may be justified, they said, in light of the large number of people who could benefit from statins but are not getting the medication; because statins have been shown to be safe and because generic versions of the medications are inexpensive. 

However, that approach may overly simplistic, said Michael Gaziano and Thomas Gaziano. Arbitrary, fixed LDL thresholds for prescribing statins should be abandoned, they said.

"The guideline should begin with simple risk assessment with the goal of classifying patients into only two strata: those for whom lipid-lowering therapy should be considered and those for whom it is not warranted," they wrote. "The use of a simplified risk-based approach could increase the ease of implementation of treatment and increase the number of patients receiving beneficial lipid-lowering therapy."
 
-- Shari Roan
 
Photo credit: Bob Chamberlin / Los Angeles Times

Doctors assume antibiotics to be fairly safe during pregnancy -- and their use is quite common -- but data comparing classes of drugs are scant. Researchers at the Centers for Disease Control and Prevention decided to clarify the safety and the risks.

Using the National Birth Defects Prevention Study, they analyzed data on more than 13,000 women whose babies had birth defects, comparing their antibiotic use before and during pregnancy to that of almost 5,000 women whose babies didn't have birth defects.

Penicillins, erythromycins and cephalosporins didn't raise any red flags. Two cases of birth defects were associated with erythromycins; and penicillins and cephalosporins were associated with one case each.

The researchers wrote: "Determining the causes of birth defects is problematic. A single defect can have multiple causes, or multiple seemingly unrelated defects may have a common cause. This study could not determine the safety of drugs during pregnancy, but the lack of widespread increased risk associated with many classes of antibacterials used during pregnancy should be reassuring."

But sulfonamides, among the older antibiotics, and nitrofurantoins, often used to treat urinary tract infections, gave the researchers pause. These drugs were associated with "several" defects, they said.

The new research appears in the Archives of Pediatrics & Adolescent Medicine. Here's the abstract -- and more on pregnancy and birth defects from the CDC.

The data don't indicate cause and effect, but rather -- the researchers stress -- a reason for further inquiry.

They point out that participants might not have recalled exactly when they took the drugs or even the correct name of those drugs. Further, the authors wrote: "Another limitation is that it is not possible to determine whether the birth defect is associated with the antibacterials used or the underlying infection."

As they say, more inquiry is needed.  

-- Tami Dennis

Credit: Los Angeles Times

Without prescription-drug websites, our ability to contribute to antibiotic resistance might be more limited by now.

In a new study, researchers at the University of South Carolina noted that doctors are trying to do a better job of prescribing antibiotics only when warranted. (Sniffles or a cough rarely qualify.) But they wondered about folks who diagnose and treat themselves. So a few Google and Yahoo searches later, they found what could be a significant contributor to the development of more deadly germs.

In short, they learned, antibiotics are darned easy to get online.

Among 138 sites selling the drugs without a prescription, 36% didn't even go through the formalities of requiring some sort of official diagnosis; 64% offered prescriptions based on those less-than-stringent health questionnaires.

Good, old-fashioned penicillin? Not a problem. It was available on 94% of websites, they reported; macrolides could be found on 96%. Fluoroquinolones and cephalosporins could be had on almost 62% and 56% of the sites, respectively.

The researchers wrote in their conclusions:

"This reservoir of antibiotics is likely to be used inappropriately—the Web sites promote self-diagnosis and self-medication, and antibiotics are likely to be used in inappropriate dosages. Furthermore, the quantities available and the interval between ordering and receiving the medication suggest that these transactions will likely be used by individuals storing the drugs for future self-diagnosis and treatment or for sale."

This doesn't bode well.

(Antiviral resistance could become a problem as well, as staff writer Shari Roan recently noted in her story on the drugs used to fight the new pandemic H1N1 virus.)

The new study is published in the current issue of Annals of Family Medicine.

-- Tami Dennis

Photo: Some strains of the bacterium Staphylococcus aureus are becoming resistant to antibiotics, leading to hard-to-treat infections.

Credit: Visuals Unlimited

Breast cancer therapies are being tailored today to fit the genetic profile of the patient. This approach, called personalized medicine, can help doctors choose the best treatments for their patients. But a study published today in the journal Cancer found many women aren't getting tested to see if they are candidates for one important medication.

Women with early-stage breast cancer should be tested to see if their tumors express the HER2 protein. Those who test positive are candidates to receive the drug Herceptin, which can dramatically lower the risk of the cancer recurring. But the study by researchers at UC San Francisco - which was an analysis of medical literature - concluded that up to 66% of patients who are eligible for testing had no documentation of having the test in their medical records. Up to 20% of patients receiving the drug were not tested or had no record of testing. The study also found that about 20% of HER2 test results may be incorrect.
 
"The limited evidence available suggests that there are important variations in testing practices and key gaps in knowledge about" HER2 testing strategies," the authors wrote.

As more gene mutations are identified and more targeted therapies become available, testing strategies should be clarified for doctors and patients, they said.
 
"Given the rapid growth in this area - for example, there are more than 6,000 articles on gene-disease associations this year and more than 1,300 genetic tests making their way to market - evidence-based information will become a necessity if these new technologies are to be used wisely."
 
More information on HER2 testing can be found on the American Society of Clinical Oncology's website.

-- Shari Roan

Photo credit: Carlos Chavez  /  Los Angeles Times

The Food and Drug Administration requires a lot of detailed information on the labels that come with prescription drugs. But labels don't provide doctors and patients with information on how the medication compares to other drugs. That's a serious oversight that should be corrected, according to the authors of an essay appearing today in the New England Journal of Medicine.

When drugs are in development, they are usually compared with placebos and are ultimately approved because they are safe and more effective than the placebo. But studies typically don't test whether New Drug A is better than Old Drug B. Indeed, the fiercely competitive nature of the pharmaceutical business means that manufacturers often create "me too" drugs that are quite similar to existing drugs, say the authors of the essay, from Stanford University's Prevention Research Center. New drugs are typically heavily advertised and cost more.

"If the FDA label were required to indicate what is known and not known about a product's superiority to other treatments, clinicians, patients, and payers would likely be less willing to pay more for a new treatment without proof that it improved health outcomes," the authors state. And manufacturers would have an incentive to conduct comparison trials.

Labels should carry what the Stanford researchers call "comparative effectiveness" information. The labels could say something like, "Although this drug has been shown to lower blood pressure more effectively than placebo, it has not been shown to be more effective than other members of the same drug class," the essay suggests.

The drug development process is lengthy and expensive. But consumers deserve honest information about what is known and not known about medications.

"A few products will be breakthroughs that improve health outcomes; most will offer little, if any, advantage over existing treatment," the authors state. "At the time of FDA approval, it is rarely clear whether a new drug or device falls into the first or second category."

-- Shari Roan

Photo credit: Scott Olson / Getty Images

An ongoing clinical trial of the asthma drug Xolair suggests that patients taking the medication may have an increased risk of blood clots, heart failure, stroke, cardiac arrhythmias and heart enlargement when compared to patients not treated with the asthma drug, the Food and Drug Administration said Thursday. The agency announced it was assessing the significance of the preliminary findings to determine if further regulatory actions are necessary to protect patients.

Omalizumab, marketed as Xolair, is approved as a treatment for adults and children older than 12 who suffer from moderate to severe asthma complicated by seasonal allergies. The concern over possible side effects has arisen out of a trial comparing 5,000 Xolair users and 2,500 asthmatics not taking Xolair over a five-year period. Xolair was approved by the FDA in 2003, and last year, brought its maker, Genentech, $517 million in revenues.

The FDA said that "interim data" provided by Genentech from that trial "suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events" among users of Xolair. The agency's announcement emphasized that no causal link between the drug and the adverse events has been established, and advised patients prescribed the drug not to discontinue its use at this time.

The FDA's announcement is termed an "early communication."

Unless the FDA calls a halt to the safety trial, it is expected to continue, with final results expected in 2012. The FDA in 2007 required Xolair's maker to include a "black box warning" -- the agency's highest level of consumer alert -- warning patients that Xolair may cause potentially fatal anaphylactic reactions.

--Melissa Healy

Flomax is a name known by many, if not most, men suffering with an enlarged prostate gland. How could it not be?

It's one of the nation's most-prescribed drugs with a hefty marketing budget behind it. But Consumer Reports says it might not be the best choice for many patients, just the more expensive choice.

In an analysis of 60 studies of drugs that treat enlarged prostate, the much cheaper doxazosin came out on top. Using that drug instead of Flomax, Consumer Reports says, could save patients about $3,000 a year.

More on Flomax (tamsulosin) and doxazosin from RxList.com.

And the full Consumer Reports Best Buy Drugs report.

-- Tami Dennis

Getting a prescription filled doesn't do much good if you don't know how or when to take the drug.

A new study from Northwestern University suggests how un-illuminating many pharmacy-counter exchanges might be for those who speak only Spanish. Researchers there surveyed pharmacies in Texas and Colorado (which have had, for some time, large Latino populations) and Georgia and North Carolina (which have burgeoning Latino populations).

Of 764 pharmacies, only 43.3% could solidly offer instructions in Spanish, 21.7% offered some translation services and 34.9% offered no such  services.

The Northwestern news release. The journal abstract, in the June issue of the journal Medical Care. Y Manual Merck de información médica para el hogar.

The abstract concludes: "The majority of pharmacies surveyed offered limited or no translation services. Lack of translation services is not isolated to rural areas or locations with a marginal Latino population. Spanish-speaking patients encounter barriers to acquiring instructions that support the safe and effective use of medications."

— Tami Dennis

Photo: Taking prescription drugs, such as the antidepressant Effexor, requires guidance.

Credit: Getty Images