For over a decade, the pharmaceutical industry offered only one option for severely overweight people desiring a weight-loss drug – Xenical, which was rarely prescribed and only somewhat effective. But within the last three weeks, two competitors have entered the market.
The Food and Drug Administration has approved Qsymia (pronounced kyoo sim EE uh) for treatment of obesity, The New York Times reports. Clinical trials have demonstrated that the drug offers a greater potential for weight loss compared to Xenical and Belviq, which the FDA approved last month. Participants who took a regimen of middle-dose Qsymia lost an average of 8.4% of their weight after one year, while high-dose patients lost 10.6%.
However, like the two competing drugs, Qsymia has side effects that must be weighed against its benefits. Earlier tests revealed that usage raises the risk of birth defects if used by pregnant women and can cause elevated heart rates and cognitive problems.
Qsymia is expected to be available in the fourth quarter, according to Vivus, the drug’s manufacturer.
The Food and Drug Administration has approved the use of the drug Truvada for individuals who have tested negative for HIV, the Los Angeles Times reports.
Clinical studies have shown that if taken once a day, Truvada could reduce transmission of HIV, the virus that causes AIDS, by as much as 75% if used in combination with safe sex practices. The drug had previously been approved in 2004 to help treat people already infected with the virus.
Reaction to the approval has been mixed. Marjorie Hill, chief executive of the AIDS group GayMen’s HealthCrisis, called it a “big step” to preventing the spread of the virus. “It’s going to save lives,” Hill said.
But Michael Weinstein, president of the AIDS Healthcare Foundation, worries that making Truvada available to those who have tested negative will take more risks. “If you look back five years from today, you will see this decision by the FDA will cause there to be more infections, not less,” Weinstein said.
The FDA will require that individuals first have an HIV test before receiving a prescription to ensure they are not infected, and get a follow-up test every three months thereafter. A year’s supply of the drug costs $13,900.
The Associated Press reports that the United States and other developed countries will experience slow growth in prescription drug spending over the next four years, according to a new forecast from IMS Health. The pharmaceutical data firm attributed the trend to a sharp rise in new low-cost generic drugs and slower increases in what those countries spend on brand-name medications.
Shed no tears for pharmaceutical companies, however… during the same period (2012 to 2016) emerging markets such as China, India and Russia will boost drugmakers’ bottom lines. Total spending worldwide will rise from about $956 billion in 2011 to just under $1.2 trillion in 2016, but rebates and discounts from drug companies will reduce the cost by about 15% that year, to a mere $1 trillion.
And while we’re on the subject… MedBen passes through 100% of negotiated discounts and delivers 100% of paid rebates back to the client. Additionally, we offer some of the most competitive generic drug discounts in the industry.
Our progressive approach to employee prescription benefits has consistently beat the odds by producing better-than-national results. Employers using the MedBen prescription program typically see cost trends of 5% lower than national trends, on average.
For further information about pharmaceutical planning, contract MedBen Vice President of Sales and Marketing Brian Fargus at 888-627-8683.
Most people still prefer face-to-face communication with their doctors when discussing medical matters. But regarding other aspects of health care, online interaction is increasingly the way to go.
As the results of a Accenture survey (via MedCity News) show, patients like having the ability to make appointments, receive reminders and refill prescriptions through websites, e-mail and mobile devices.
At MedBen, we have our own set of online tools for client convenience, including:
MedBen Access: With MedBen Access, plan members can check the status of a health claim, review benefit coverages, and more. For plan administrators, MedBen Access makes management of the company health plan simple and convenient.
RxEOB: This valuable site, available through MedBen Access, allows plan members to review personal prescription detail and benefit coverage, and compare lower cost alternatives. Employers also can use RxEOB to generate timely reports that will help them keep on top of cost trends.
MedBen Secure: MedBen Secure ensures that the personal health information of your plan members is fully protected. Employers can review or download current member reports, while multiple safeguards maintain privacy.
FSA/HRA Online System: MedBen FSA and HRA members can use this site to review claim submissions, check payments issued, see total deposits posted to date and get answers to a variety of questions.
More online services are available at MedBen.com.
In an effort to counter the growing prescription painkiller abuse crisis in the United States, The Food and Drug will require opioid medicine makers to fund safety training programs for doctors, Reuters reports.
Companies that make long-acting or extended-release opiods – including painkillers like oxycodone and methadone – must also provide information sheets to patients that promote proper use of the pills.
“The problem of prescription drug abuse and misuse is very real,” said Dr. Margaret Hamburg, the head of the FDA. “Educating healthcare professionals on how to safely prescribe (the medicines) is essential to address this critical public health issue.”
Overdose from prescription drugs has passed car crashes and the combined impact of cocaine and heroin as the leading cause of accidental death in this country.
One stumbling block to the FDA’s good intentions: the law does not require doctors to take the classes, which are scheduled to begin in 2013. Neverthess, Hamburg expects half of the nation’s 320,000 prescribers of painkillers to get the training by the program’s third year.
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.