The Food and Drug Administration has approved the first in-home test for HIV, the virus that causes AIDS. An advisory panel to the government agency recommended its approval in May.
Sold over-the-counter, the OraQuick In-Home HIV Test allows people to self-administer the test in the privacy of their home. Users simply swab their upper and lower gums and obtain results within 20-40 minutes.
The agency stressed that a positive result from the test does not mean the user is definitely infected with HIV, but that they should consult a medical professional for additional testing.
A Medical News Today story on the FDA announcement notes that based on clinical studies, the test produces one false positive out of every 50,000 results and one false negative out of every 12 results.
Long-term use of prescription pain killers greatly increases the risk of death by overdose, according to a new Centers for Disease Control and Prevention study.
WebMD reports that the study found the number of people who abused opioid pain relievers for 200 to 365 days in the last year rose by nearly 75% between 2002-03 and 2009-10. In contrast, the overall number of people who used painkillers for less than 200 days and reported abuse or nonmedical use stayed constant over the two research periods.
(The WedMD article notes that “[n]onmedical use or abuse of prescription pain killers is defined as using the drug without a prescription or simply for the experience or feeling it causes.")
The biggest increases in abuse were seen among seen among men and young to middle-aged adults. People 35 to 49 years old saw a 135% increase, while abuse by 26- to 34-year olds was up 81%. Men reported a 105% increase between the two periods.
Based on their findings, researchers say about one million Americans 12 years and older would be classified as chronic prescription drug abusers in 2009-2010.
“These findings underscore the need for concerted public health and public safety action to prevent nonmedical use of these drugs,” wrote researcher Christopher M. Jones, PharmD, MPH.
Last week, the Food and Drug Administration approved the first prescription weight loss pill in over a decade. But prior to that, another government panel essentially said it was a bad idea.
The Boston Globe reports that the US Preventive Services Task Force recommended that doctors instruct obese patients to diet, exercise and get weight-loss counseling, but did not advise prescribing diet drugs.
“One of the problems with drugs is that the clinical trials just show short-term outcomes,” said Dr. David Grossman, a Seattle pediatrician who led the USPSTF panel that issued the updated recommendations. “Once a person stops taking the drug, we don’t know what happens with long-term weight gain.”
The Pharmalot blog, commenting on the Globe story, notes that the FDA is feeling the pressure from the growing obesity crisis in this country – so its approval last week of the diet drug Belviq could be interpreted as something of a desperation move, especially considering that the medication offers only minimal help in losing weight.
Indiana and Ohio will be the first two states to test a program designed to make it easier for doctors, pharmacists and emergency departments to access patients’ prescription drug records.
Reuters reports that the Obama administration is launching the pilot program in hopes of reducing the number of overdoses from prescription drugs, currently the leading cause of accidental deaths in the United States.
Even though 49 states already allow prescription drug monitoring programs, which collect information from pharmacies and practitioners, the difficulty in navigating through the data has put off potential users. Lack of real-time information is also a concern.
“Part of the problem we have with the prescription drug abuse problem is we are always playing catch-up,” said Marty Allain, a senior director at the Indiana Board of Pharmacy. “We are moving towards early identification of a problem and toward the preventive side of a problem – to keep things from getting worse or to prevent problems for some patients in the first place.”
MedBen maintains its own prescription drug database – albeit one geared toward patient, not provider, use. RxEOB allows members to review personal prescription history, detail and benefit coverage, plus offers lower cost drug alternatives to save you out-of-pocket expense. To make a visit, simply log on to the MedBen Access site and click on “My Rx”.
For the first time in over a decade, the Food and Drug Administration has approved a prescription diet pill. Lorcaserin, which will be sold under the name Belviq, was approved for use by obese people (those with a body mass index of 30 or more) and overweight people with a BMI of 27 or more who have at least one weight-related health condition, according to NPR.
“Obesity threatens the overall well-being of patients and is a major public health concern,” Janet Woodcock, director of the FDA’s drug center, said in a statement. “The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
Observing “a healthy diet and lifestyle” is indeed important, as the drug itself provides relatively small weight loss. Studies found that about half of patients taking Belviq lost only about 5% of their body weight after a year. But with roughly one-third of Americans considered obese, the FDA decided that some additional help, however minor, was warranted.
Notable side effects of the drug include headache, dizziness, fatigue, nausea, dry mouth, and constipation. Arena Pharmaceuticals, the maker of Belviq, must monitor the drug’s safety through continued study, as a condition of its approval.
There is no word yet when Belviq will be available in pharmacies, or its cost.
As primary care doctors expand the number of patients they accept, and the number of those patients taking medications rises, pharmacists have taken on an increasingly important role. And some drugstore chains, as well as independent pharmacies, are hoping to foster customer loyalty by making their pharmacists even more accessible:
“They are counseling patients face-to-face and on the phone, contacting patients who don’t refill prescriptions and checking for potential interactions between drugs prescribed by different doctors. Pharmacists can’t actually prescribe drugs, but with a patient’s permission they can call the physician to discuss recommended medications that may have been overlooked and ask whether the doctor wants to prescribe them.
“Many patients, especially those with chronic conditions like diabetes and heart disease, don’t adhere to medication regimens. Studies show only 25% to 30% of medications are taken properly, and only 15% to 20% are refilled as prescribed.
“Pharmacy groups and drugstore chains say an enhanced role for the pharmacist makes it easier for patients to stay on the wagon and significantly reduces unnecessary hospitalizations and emergency-room visits that can occur when patients skip their meds.”
The Pharmalot blog reports that drugmakers may spend about $1.58 billion on online advertising this year, nearly a 25% leap from 2011, according to a market research analysis from eMarketer. But while dollars-and-cents spending will continue to go up over the next few years, actual spending growth is expected to drop dramatically during this period (see chart).
Does this mean pharmaceutical companies are backing off on their advertising efforts and putting more money into other areas, such as research and development? Not exactly. “Drugmakers have been slow to shift to online tactics. Without definitive online marketing guidelines from the FDA for direct-to-consumer advertising, many marketers prioritize spending in print and broadcast media, for which there is a clearer road map. The shift to digital is under way, but has not progressed as quickly as it has in less-regulated industries,” the firm writes.
eMarketer also notes that the growing emphasis on newer drugs that target more specific patient populations have led drugmakers to refocus their marketing efforts at patients and health care providers.
A bit of Marketing 101: Proceed extra-cautiously when promoting children’s medicines.
According to The New York Times, the drug company Merck is catching flack because of a marketing campaign for Children’s Claritin using animated characters from the movie “Madagascar 3: Europe’s Most Wanted.” The Public Health Advocacy Institute and 10 other groups have filed a complaint with the Federal Trade Commission, calling the promotion for the allergy drug dangerous and deceptive.
Among the campaign components the group objected to: character stickers included in some boxes; activity books that parents can download for their children; and the enlistment of a team of mothers who blog to hold Claritin-themed “Madagascar” viewing parties for their children and friends.
The group also expressed concern that children could confuse the grape-flavored Claritin tablets and syrup for candy, as the same character are used to promote other children’s products, such as candy and gummy snacks.
Kelley Dougherty, a Merck spokeswoman, said the company was reviewing the matter, but added, “We advertised in appropriate venues to reach those parents of children who may benefit from the use of Claritin, and not to the children themselves.”
The number of prescriptions dispensed for children and teenagers fell from 2002 to 2010 – but prescriptions for some individual medications saw big increases, WebMD reports.
Overall, doctors wrote 7% fewer prescriptions for children and teens during that period, based on the results of a new study from the U.S. Public Health Service. Among the larger decreases were allergy medicines (a 61% decline in 2010 compared to 2002) and cough and cold medicines without expectorant (down 42%). Both antibiotic and pain medicine prescription both dropped 14%.
Conversely, some prescriptions for younger people went way up, such as contraceptives (a 93% spike), ADHD drugs (up 46%) and asthma drugs (up 14%).
The executive vice president of the Institute for Safe Medication Practices is pleased by the falling rate of antibiotic prescriptions. “For the last decade, the pediatric professional societies and infection control groups have been pushing to say, ‘Every time you have the sniffles or a cold, you don’t need an antibiotic,’” Allen Vaida, PharmD told WebMD. He was not involved in the study.
As for the rise in ADHD prescriptions, Donna Halloran, MD, MSPH, of St. Louis University noted that it could be good news – “there are so many kids who respond so beautifully to the medicines,” she said to WebMD – or bad, “because there is plenty of evidence out there that there are plenty of kids labeled as ADHD and it’s not accurate.”
The New York Times reports that pharmacy and drugstore representatives have successfully lobbied against efforts to impose stricter controls on painkillers and other commonly abused prescription drugs.
The new restrictions, had they been passed by Congress, would have required patients to seek new prescriptions for refills of Vicodin and other hydrocone products, required a higher level of security for the storage and transportation of the drugs, and increased penalties for misuse.
Though the Senate approved the controls as part of a bill reauthorizing user fees for the Food and Drug Administration, the House of Representatives didn’t include a similar provision in their legislation. Negotiators from both houses reached a bipartisian agreement on the overall bill, omitting the restrictions.
Senator Joe Manchin III (D.-WV), who led the push for new controls, said in an interview that chain pharmacies and drugstores should rethink their business model in regard to painkillers. “These are legal drugs needed by some people. But they can also be addictive. They are so readily accessible, so easy to obtain, that they are ravaging society and ending many young lives,” he said.
The older a person is, the less likely he or she is to read the warning labels on pill bottles, researchers have found.
MedPage Today reports that a study of medication vial reading tendencies determined that only 54% of older participants (ages 51 to 77) concentrated on the prescription warning labels, compared with 91.8% of the younger group (ages 20 to 29).
Laura Bix, PhD, of Michigan State University in East Lansing, Mich., and colleagues say that based on the results, many older patients fail to grasp the information on the warning label and act on it – an even greater danger considering that it’s common for that group to take multiple medications. By paying less attention, they put themselves at higher risk for adverse drug events.
The researchers also observed that the color of the warning label had no effect on the probability that participants would notice it.
With all the fish oil studies popping up on Internet news sites, one can’t help but wonder if researchers are purposely working 24/7 until every last bit of information about its effects has been gleaned. In the past couple days alone, we’ve stumbled across these articles – none of them particularly positive about the benefits of omega-3 fatty acids (the type found in fish oil):
Fish oil supplements may not prevent mental decline (Reuters): Taking daily omega-3 fatty acid supplements doesn’t seem to provide any protection against declines in thinking and memory skills in older adults, a new review of medical evidence suggests. Researchers theorized that because the brain is rich in the type of polyunsaturated fatty acids found in fish oil, adding more could boost memory – but trials have been disappointing.
Fish oil won’t save diabetics’ hearts, research suggests (HealthDay): People with type 2 diabetes who take omega-3 fatty acid supplements are neither helping nor harming their heart, a new study finds. Researcher Dr. Hertzel Gerstein speculated that diabetics may react differently to these supplements, or their risk of cardiovascular disease is so severe that a higher dose of the supplement would be needed to see an effect.
Fish oil no help for heart patients’ depression (Reuters): A new clinical trial has found that fish oil pills and B vitamins don’t appear to help ward off depression symptoms in people with a history of heart attack or stroke. In fact, men who were randomly assigned to take fish oil actually displayed increased signs of depression.
Taking low doses of vitamin D and calcium supplements do little to prevent broken bones in postmenopausal women, according to the U.S. Preventive Services Task Force (USPSTF).
Reuters reports that the government-backed panel determined that while daily doses lower than 400 IU of vitamin D and 1,000 milligrams (mg) of calcium contribute only minimally to bone health, they do carry a slightly increased risk of side effects, such as kidney stones.
Note, however, that the recommendation applies specifically to low doses of supplements, and only to postmenopausal women. The Institute of Medicine recommends that men and women get at least 600 IU of vitamin D and at least 1,000 mg of calcium every day, depending on age and sex. The thinking, apparently, is that the benefits of larger doses outweigh the potential risks.
“We know vitamin D is very important for the body and it’s important for everyone to eat a healthy diet that includes vitamin D and calcium,” said Kirsten Bibbins-Domingo, a member of the panel and a professor at the University of California, San Francisco.
USA Today features a Q&A with endocrinologist Bess Dawson-Hughes regarding the USPSTF recommendations.
When you pick up a prescription medication from your local pharmacy, you also receive a reminder from the pharmacist – written, verbal or both – of potential negative interactions with food, beverages and other drugs. But when you buy over-the-counter drugs, it’s easier to overlook the warnings.
The American Academy of Family Physicians suggests how to reduce the risk of adverse effects from OTC drugs (via HealthDay News):
Remember that study we wrote about last week that said taking aspirin reduces your odds of developing skin cancer? Well, because researchers like nothing more than to make other researchers look bad (no, just kidding), a new study suggests that unless you’re at high risk for cardiovascular disease, that taking an aspirin every day probably isn’t a good idea.
According to HealthDay, researchers determined that daily low-dose aspirin (300 milligrams or less) use may significantly increase the chance of major gastrointestinal or cerebral bleeding. Therefore, any benefits of benefit of low-dose aspirin in preventing heart disease could be offset by that risk.
“Aspirin is not effective in protecting a person from a first cardiac event – a heart attack or stroke,” said study author Dr. Antonio Nicolucci, head of the department of clinical pharmacology at nonprofit biomedical research organization Consorzio Mario Negri Sud in Santa Maria Imbaro, Italy. “In addition, taking aspirin has significant risks, and thus shouldn’t be part of primary prevention unless you’re at moderate to high risk of heart disease.”
It’s noteworthy that the study found an association an association between daily aspirin use and bleeding, but did not prove cause and effect. In either case, if you do take aspirin every day, it’s best to let your doctor know about it.
If you’ve never used a particular prescription medication, it’s a good idea to get to know it better before taking it. To that end, you should have your physician or pharmacist break the ice a bit.
At KevinMD.com, pharmacist Carlene Oleksyn suggests five questions to ask about your prescription, which we summarize below:
MedBen clients using Pharmacy Data Management (PDMI) as their PBM can also take advantage of RxEOB, a useful resource to research medications as well as search for equivalent, lower-cost drugs. Just go into MedBen Access and click on your name under “My Rx Claims".
T-DM1 sounds like something out a “Star Wars” movie, but it’s actually an experimental drug that may prove a powerful tool in the fight against breast cancer.
CNN reports that T-DM1 is designed to treat women with advanced HER2-positive breast cancer. It combines the targeted drug trastuzumab (the “T” in T-DM1), better known by the brand name Herceptin, and a very powerful chemotherapy drug called emtansine (the “DM1″ part).
According to lead study author Dr. Kimberly Blackwell, Herceptin acts as a carrier pigeon, delivering emtansine to the cancer cell. (The chemo drug is too toxic to deliver directly into the bloodstream.) DM1 then kills the cell.
The experimental drug, it should be noted, doesn’t cure breast cancer. But in a clinical trial, women getting T-DM1 had 9.6 months of progression-free survival, the time between starting the treatment and the cancer getting worse again. That’s compared with 6.4 months in the standard therapy group – a median improvement of three months.
Blackwell says that after two years, 65% of women getting T-DM1 were still alive, compared with 48% in the control group. She added that women on the drug didn’t suffer from such common chemotherapy side effects as nausea, vomiting and hair loss.
Remember back in 2010, when you could use your flexible spending account funds to buy over-the-counter medicines without a prescription? Good times, they were. Of course, thanks to the health care reform law, that’s all in the past.
But then again…
Not to get your hopes up too high, but there’s been an effort in Congress of late to turn back the clock and allow health FSA participants to purchase their aspirin, cough medicine and other OTCs without having to call their doctor first.
On May 31, the will markup on H.R. 5842, the Restoring Access to Medication Act. The bill would repeal the Afforable Health Care Act provision that disqualifies OTCs for non-prescription purchases.
Assuming the Committee approves H.R. 5842 – pretty much a certainty – it will then move on to the full House of Representatives. Majority Leader Eric Cantor has indicated that this could happen as early as the week of June 4 – and there’s a high likelihood that the bill will pass the House with flying colors.
Of course, that leaves the small matter of approving the bill (or similar legislation) in the Senate. But given the unpopularity of the OTC provision – and the fact that it’s an election year, to boot – don’t be surprised if, come 2013, FSA participants can once again purchase their ibuprofen tax-free.
H.R. 5842 is available for review at the Ways and Means Committee website.
UPDATE: On May 31, The House Ways and Means Committee passed the bill by a vote of 24 for to 9 against.
A warning to those of you who buy medications through pharmaceutical websites: A counterfeit version of the attention deficit hyperactivity disorder (ADHD) drug Adderall is showing up online, the Food and Drug Administration reports.
According to MedCity News, the 30 mg tablets to treat narcolepsy as well as ADHD contain improper ingredients. The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers.
Adderall is among the medications that have experienced shortages in the past year.
Is there anything aspirin can’t do… assuming, of course, that you take all the studies extolling its virtues at face value?
HealthDay News reports that taking aspirin – or other nonsteroidal anti-inflammatory drugs (NSAIDs), such as Motrin and Aleve – may significantly lower the risk for developing several major forms of skin cancer, according to a new Danish study. And the longer you take them, the stronger the apparent protective impact appears.
“Our study showed that users of common painkillers, known as NSAIDs, have a lower risk of the three major types of skin cancer, [including] malignant melanoma, basal cell carcinoma and squamous cell carcinoma,” said study lead author, Sigrun Alba Johannesdottir, at the department of clinical epidemiology at Aarhus University Hospital in Aarhus, Denmark.
“The greatest effect,” she noted, “was found for squamous cell carcinomas and malignant melanoma, especially when [these painkillers were] taken frequently and over a long time period.”
The researchers noted that similar levels of protection were found in prescription medicines called COX-2 enzyme inhibitors, such as Celebrex, in addition to over-the-counter NSAIDs.