An advisory panel to the Food and Drug Administration has supported approval of the experimental drug riociguat to treat two types of pulmonary hypertension, Reuters reports. The agency typically follows such recommendations.
Produced by Bayer, riociguat is designed to treat chronic thromboembolic pulmonary hypertension, a rare disease typically caused by blood clots that restrict the flow of blood from the heart to the lungs. The drug would be used for patients who are not candidates for surgery to remove the clots.
It is also designed to treat pulmonary arterial hypertension, in which arteries of the lungs constrict, forcing the heart to work harder. Symptoms of both conditions are similar and include shortness of breath, fatigue, weakness and potential heart failure.
Dr. Stuart Rich, a panel member and professor of medicine at the University of Chicago Pritzker School of Medicine, said he was impressed with the apparent ability of a 1.5 milligram dose of the drug to increase cardiac output, or the volume of blood pumped by the heart per minute.
If approved, the drug would be sold under the brand name Adempas.
Is the term “cancer” overused nowadays? Absolutely, a group of medical experts argue.
In a Journal of the American Medical Association editorial, an advisory panel to the National Cancer Institute states that only the lesions that typically kill if left untreated should be classified as cancer. In cases where the lesions pose no immediate danger, patients should be told they have an IDLE disorder, the authors write. IDLE is an acronym for “indolent lesions of epithelial origin,” which is also a synonym for their lazy behavior.
According to USA Today, the panel contends that overdiagnosis of cancer leads to overtreatment – an opinion shared by Dr. Otis W. Brawley, chief medical officer of the American Cancer Society.
“The truth be told, this is very much kind of like racial profiling,” Brawley said. “It looks like what killed somebody 160 years ago, but that doesn’t mean it is going to grow, spread and kill. It may very well be genomically programmed to stay just a 5-millimeter lesion for the next 70 years.”
In a separate interview with NPR, Brawley also noted that by renaming non-threatening lesions, it would help doctor and patient alike understand the true level of the risk.
Dr. David Penson, the senior author, advised that physicians closely monitor slow-growing tumors, rather than treating them as a lethal cancer. “Whether you are using a term like IDLE, indeterminate or indolent, if you take away the word ‘cancer,’ people get to see things a lot differently,” Penson said.
As often happens when a public figure has a medical issue, its treatment undergoes media scrutiny. Such was the case yesterday when it was announced that former president George W. Bush received a stent to clear blocked arteries in his heart.
USA Today reports that stenting is fairly common, with about one million Americans a year getting the procedure. And because placing stents is a much less invasive procedure than open heart surgery, it’s a preferable – and less risky – option.
However, as we’ve previously noted on this blog, such procedures are sometimes unnecessary. A 2011 study found that one in eight U.S. patients who have non-emergency stenting procedures are likely to see more harm than good from the procedure.
A spokeman for Bush said that even though he not been experiencing symptoms commonly associated with a cardiac event, such as chest pain, the stent was necessary.
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Good news about health care reform! Well, good if you’re working on Capitol Hill, anyway…
A ruling by the Office of Personnel Management (OPM) approved the continuation of federal contributions to members of Congress and their staff when they buy insurance through health insurance exchanges, Reuters reports.
The decision, supported by President Obama, corrects a snafu that lawmakers overloked during the run-up to pass health care reform in 2010. To get more Republicans on board, Democrats approved an amendment by Sen. Charles Grassley (R-Ia.) that required Congress to use the same exchanges available to regular Americans.
A noble gesture, to be sure. Trouble is, no one bothered to add language that ensured Congress would continue to receive federal contributions toward their health plans, which would cover about 75% of the premium costs. That error led to concerns that higher health care costs would incite staff members to leave federal service – a crisis presumably thwarted by the OPM’s action.
Lawmakers and staff still must purchase plans on the exchanges for coverage that starts in January, OPM said, and they will not be eligible for tax credits to offset premium payments.
Taking antioxidant supplements won’t improve the chances of women who are trying to get pregnant, a new review shows.
According to HealthDay News, an analysis of 28 clinic trials that included a total of 3,548 women attending fertility clinics found that inactive placebos or standard treatment, including folic acid, proved just as effective as antioxidant supplements
“There is no evidence in this review that suggests taking an antioxidant is beneficial for women who are trying to conceive,” lead researcher Marian Showell, who works in obstetrics and gynecology at the University of Auckland, in New Zealand, said in a Cochrane Library news release.
On the plus side, the trials that looked at harmful effects of antioxidant supplements suggested that taking then doesn’t appear to potentially endanger women. But the researchers did note that antioxidants and other dietary supplements are unregulated and there is limited evidence on their safety and effects.
John Goodman of the National Center for Policy Analysis notes that a little-noticed brief released last week, using data from the U.S. Department of Health & Human Services website, contained some newsworthy information:
“[T]he Government Accountability Office confirmed that states which prevent accurate underwriting of health-insurance premiums by age impose higher premiums on young people. […]
“ObamaCare imposes 3:1 age rating rules nationwide. But actuarial consensus is that the average 62-year old incurs five times the medical costs of the average 22-year old. It is not possible to insure against aging. If we live forty years past our 22nd birthday, the likelihood of our turning 62 is one hundred percent. So, forcing insurers to charge the same premium to people of different ages does not reduce any individual policyholder’s risk – which is the purpose of insurance.
“In no way is this ‘just’ or ‘fair.’ It artificially makes health insurance too expensive for young people to afford without subsidy. When coupled with an individual mandate to purchase insurance, this necessarily imposes a burden of excess taxation on society, because high taxes are necessary to fund the subsidies.”
While there seems to be a general consensus that our population as a whole could be in better shape, that reality hasn’t motivated the United States to step up obesity-prevention efforts on a national or local level, says a report from the Institute of Medicine.
HealthDay News reports that compared to other countries, America’s investment in the crisis “is too sporadic, presenting serious barriers to understanding the impact of interventions and the need for future investments,” according to a news release from the institute, which advises the federal government on health issues.
The institute report also said current national monitoring of these programs and policies lack adequate leadership, coordination, infrastructure, guidance, accountability and capacity. Moreover, local communities lack the necessary resources to evaluate the scope of obesity problems or develop and monitor obesity-prevention efforts.
“This report is most important,” said Dr. Mitchell Roslin, chief of obesity surgery at Lenox Hill Hospital in New York City. “Sadly, it will find that current efforts are not working, especially in economic-challenged areas.”
For obesity-prevention programs to have an impact, “more funding and tough choices will need to occur,” Roslin said.
The delay in the Affordable Care Act’s employer mandate has emboldened some small businesses to consider expansion:
“Nearly a quarter, or 24.4%, of small-business owners affected by the delay said they will invest in equipment or facilities with money that would otherwise have gone into complying with the health-care law, according to July’s Wall Street Journal/Vistage Small Business CEO Survey. An additional 16% of small companies plan to hire new employees, 15% expect to provide raises or other benefits for their workers and 3% are planning to lower prices to gain a competitive edge.
“The announcement [of the delay] came as a relief to small-business owners like Monte Wood, who runs an event-management service outside of Portland, Ore. Although his company, Opus Events Agency LLC, offers health benefits to its 90 employees, bringing the firm into compliance with the health-care law would cost an estimated $100,000 because the law requires more robust coverage.
“‘We’ve made a couple of key hires with that money that we would have delayed until future years,’ said Mr. Wood, who added that he is happy to keep his company growing, despite the lingering health-care law, whose employer mandate provisions were pushed back until at least January 2015.”
Behold the awesome power of TV advertising: A new study found that adults exposed to commercials for cholesterol-lowering pills were 16-20% more likely to be diagnosed with high cholesterol and 16-22% more likely to be using a statin.
And that’s not all. According to Pharmalot, the likelihood of having such a diagnosis and increased use of cholesterol-lowering pill was driven almost exclusively by men and women who were at low risk for having a cardiac event. Meanwhile, those at a high risk of heart disease and exposed to TV ads for stains were not more likely to be taking one of the pills.
The odds of using a statin were higher for men exposed to 75 to 150 ads and 150 or more ads – 21% and 22%, respectively – than those with low exposure to ads. For women, the odds of a diagnosis of high cholesterol were 17% higher for those exposed to 40 to 74 statin ads and 20% higher for those exposed to either 75 to 149 ads or 150-plus ads. The associations for both genders were driven by individuals at low risk of developing cardiac disease in the future.
“The results raise questions about the extent to which [direct-to-consumer] ads may promote over-diagnosis and over-treatment for populations where risks (of statin use) may outweigh potential benefits,” the authors conclude. They based their findings on participant exposure to statin ads between 2001 and 2007 on national, cable and local television stations.
Americans say they’re more concerned about living healthy lifestyles, particularly in regard to their weight and diet, according to a new survey.
USA Today reports that the survey, conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA), found 58% say they’re paying more attention to personal health issues than in the past, and eating a healthy diet (57%), maintaining a healthy weight (54%) and reducing stress (45%) are their top concerns.
“What we’re really measuring is a feeling here, rather than a calculated prediction,” says Geoffrey Garin, president of Hart Research Associates, which conducted the survey for PhRMA. “The feeling is, even if my health isn’t great today, I have the potential to turn all that around.”
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As often seems to happen with government programs, good intentions sometime carry costly consequences. To wit:
“The Affordable Care Act expands a program called 340B, which siphons money from drug makers and insurers to subsidize certain hospitals. The program has been expanded as a way to offset some of the cuts that the law imposes on hospitals. One significant side effect: 340B is increasing the cost of cancer care – and harming its quality.
“Under 340B, eligible hospitals are allowed to buy drugs from drug companies at forced discounts of 25% to 50%. The hospitals can then bill government and private insurers for the full cost of the drugs, pocketing the spread. The arrangement gives 340B-qualified hospitals a big incentive to search for patients and prescribe lots of drugs. The costlier the drugs, the bigger the spread. So expensive cancer drugs are especially appealing.
“To goose the windfall, eligible hospitals are buying private oncology practices so they can book more of the expensive cancer drug purchases at the discount rates. More than 400 oncology practices have been acquired by hospitals since ObamaCare passed. […] In the process, treatment of the doctor’s patients is moved from an office setting to a hospital outpatient department.
“If these trends continue, the majority of cancer care will soon be delivered by hospitals. When the practice of oncology shifts to outpatient hospital clinics, the care is often less comfortable and convenient for cancer patients – and more costly.”
The Food and Drug Administration has announced it will now place warnings on the popular pain reliever acetaminophen, better known as Tylenol.
NPR reports that the goal of the agency’s action is not to make people nervous about using the drug, but rather to make the public aware that its use may cause skin disorders. This may be anything from a simple skin rash to the more serious Stevens-Johnson syndrome.
Johnson and Johnson, the manufacturer of Tylenol, said, “The FDA’s information should be viewed within the context of the millions who have benefited from acetaminophen. The skin conditions cited by the agency, including Steven-Johnson Syndrome, are extremely rare, the causes of which remain the subject of debate.”
According to The Wall Street Journal, the FDA has reported 107 cases of serious skin conditions that were possibly related to acetaminophen, from the years 1969 to 2012. Of their research they found 12 deaths. Johnson and Johnson stated they will work with the FDA with the label changes and warning.
The FDA already places warnings about the risk of these disorders on several over-the counter-drugs including Advil, Motrin, Aleve and Midol.
The Obama administration’s decision to postpone implementation of the employer mandate until 2015 has bumped the cost of the Affordable Care Act up by $12 billion, based on a new estimate by the Congressional Budget Office. Reuters reports that the delay will also leave a million fewer Americans with employer-sponsored health insurance.
“Of those who would otherwise have obtained employment-based coverage, roughly half will be uninsured (in 2014),” CBO said in a July 30 letter to Representative Paul Ryan, Republican chairman of the House of Representatives Budget Committee. The agency added that the additional cost will be reflected in insurance-coverage provisions over the next decade.
In a separate piece on the CBO report, Employee Benefits News reports that the agency noted that even with the mandate’s delay, the health law is projected to reduce the deficit because of lower Medicare spending and other provisions that offset the cost of new coverage.
Meanwhile, a National Association of Health Underwriters spokeswoman says that while there are “short-term financial repercussions” to the employer mandate delay, “we believe this delay was necessary to continue the economic upturn we have seen in the past few months and ensure that American businesses will be able to provide their employees with the health insurance they want and need in the long term.”
What started as an aid to kick the cigarette habit has fast evolved into a trendy accessory that appeals to youth and teens as well as adult smokers. But are electronic cigarettes as harmless as their makers would have us believe?
“E-cigarettes”, while designed to look like the real thing, hold a battery that heats a liquid solution into a vapor. Puff on the device as you would a regular cigarette, and the device heats the liquid and changes it to a nicotine-filled vapor.
However, unlike chewing tobacco and traditional cigarettes, e-cigarettes are not regulated by the Food and Drug Administration. While marketed as a healthy alternative to smoking, the FDA and the American Lung Association do not support such claims.
According to the Licking County Health Department, a recent analysis of ingredients in the e-cigarette cartridge found levels of cancer-causing toxins. Also, the cartridges examined were inconsistent, with some nicotine found even in a cartridge marked as non-nicotine.
Eli Alelov, CEO of LOGIC Technology, maker of LOGIC e-cigarettes, told ABC News that e-cigarettes are not a health product, even though they contain no tar or tobacco, or produce no second-hand smoke. As for their usefulness as a smoking cessation tool, “We leave that up to the public: they can use their logic.”
An advisory panel for the Food and Drug Administration has recommended that Nasacort AQ, an allergy nasal spray, to allowed to switch from prescription to over the counter (OTC).
According to Medcape Medical News, the 10-to-6 vote supported the Sanofi drug’s switch to OTC status “for the treatment of seasonal and perennial allergic rhinitis for the temporary relief of hay fever and other respiratory allergies (nasal congestion, runny nose, sneezing, itchy nose).”
Nasacort would hardly be the first allergy medication to be available over the counter, but it is the first such drug to be made available as a steroid nasal spray, which is considered more effective than antihistamines, decongestants, and mast cell stabilizers.
Panel members expressed concern that people might not read all the instructions, might not know exactly what a “steroid” medication is, and might misuse it. Members all felt that the label, which as proposed would advise parents to tell their child’s doctor before using the spray, would need to clearly list potential risks to growing children.
While the FDA is not required to follow panel recomendations, it does more often than not.
Healthy teeth can contribute to a healthy mind, a new study indicates.
According to WebMD Health News, researchers from the University of Central Lancashire School of Medicine and Dentistry used donated brain samples to study a possible connection between oral health and Alheimer’s disease. Ten of the people had dementia, while 10 did not.
The researchers found the bacteria Porphyromonas gingivalis – a bacteria that may contribute to changes in the brain, leading to confusion and failing memory – in the brains of four of those with dementia. And improper diet and brushing habits could allow the bacteria to enter the brain.
This could mean that visits to the dentist could be vital for brain health, said Sim Singhrao, PhD, a senior research fellow at the university. “The future of the research aims to discover if P. gingivalis can be used as a marker, via a simple blood test, to predict the development of Alzheimer’s disease in at-risk patients.”
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Some recent concerns that certain diabetes drugs may increase the risk of developing pancreatic cancer are unfounded, according to a spokeswoman from the Food and Drug Administration. Pharmalot reports that the agency’s conclusions about GLP-1 inhibitors are similar to those reached last week by the European Medicines Agency.
“The FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies,” the FDA spokeswoman wrote Pharmalot. “The agency believes that the current labeling for approved GLP-1 based therapies reflects the extent of our understanding of the safety signals at this point in time. FDA’s review is ongoing as pancreatitis and pancreatic cancer data are being collected in the cardiovascular outcome trials being conducted with this class of drugs.”
The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia; Onglyza, which is sold by Bristol-Myers Squibb and AstraZeneca; Byetta, which is also marketed by Bristol-Myers; the Tradjenta treatment sold by Eli Lilly and Boehringer Ingelheim, and Novo Nordisk’s Victoza.
Earlier ths year, a study published in Diabetes found, in humans, the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer. An ensuing review of pancreas from 20 deceased human organ donors with type 2 diabetes found no evidence to substantiate the claim.
In the past few weeks, the biggest news about the Affordable Care Act has included a delay in the employer mandate, a new fee for self-funded groups, and a Chamber of Commerce survey that found many small businesses were concerned about their prospects under health care reform. Small wonder, then, that the Obama administration wanted to end the month of July on an “up” note.
USA Today reports that Alan Krueger, chairman of the White House Council of Economic Advisers, recently extolled the slow increase of health care costs over the past few years, as well as positive prospects ahead. Among the facts cited:
Krueger also stressed that the ACA is not affecting job growth, as industries that have traditionally not provided health insurance for their employees, such as restaurants, have reported higher employment. Conversely, he pointed to several changes that have taken place since the health care law was enacted as reasons why costs are going down.
“The law includes provisions intended to foster coordinated care, reduce preventable health complications during hospitalizations, and promote the adoption of more efficient health information technology,” Krueger wrote.
Doctors increasingly prescribe painkillers and CT scans for the treatment of routine back pain even though clinical guidelines recommend otherwise, a new study revealed.
According to the Los Angeles Times, researchers at Massachusetts’ Beth Israel Deaconess Medical Center and Harvard Medical School found that from 1999 to 2010, prescriptions for narcotic painkillers to treat back pain jumped 51%. Simultaneously, prescriptions for non-opiate drugs had fallen by the same amount.
The study authors wrote that “well-established guidelines for routine back pain stress conservative management, including use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen and physical therapy.” But while physical therapy remained steady during the study period, more and more doctors choose opoids over NSAIDs, in spite of an earlier analysis that showed painkillers to be ineffective for acute or chronic back pain.
The medical guidelines also recommended that doctors avoid early imaging or other aggressive treatments, except in rare cases. But researchers found that the use of computed tomography (CT) or magnetic resonance imaging (MRI) had increased by 57% over the study period.
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John R. Graham, a chartered alternative investment analyst, offers a cautionary note to businesses regarding the 12-month delay of the employer mandate:
“[E]mployers need to be aware that they are offered only ‘transition relief’ for next year. IRS Notice 2013-45 states that employers are ‘encouraged to voluntarily comply with the information reporting provisions for 2014.’ Although political analysis suggests that the ‘relief’ will roll over to future years, the Notice waives only reporting requirements. Treasury cannot waive the actual tax.
“As a result, there may be little relief even from ‘red tape’. Will auditors grant relief from reporting a tax liability to businesses which owe the tax in 2014? This should be a topic of intense discussion within the accounting profession. If the profession sticks to the letter of the law, auditors will demand that businesses prepare good-faith calculations of taxes due to the employer mandate, and not to write them off until legislation really ‘fixes’ the problem. This should concern not only small business, but large businesses with low-wage hourly workers or franchisees.
“The delay of the employer mandate has caused more headache than relief.”