Day: 05/20/2015

Having More Sex Doesn’t Make Couples Any Happier; It’s The Quality, Not Frequency, That Counts

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Let’s talk about sex. Are you having enough of it to make you and your spouse happy? Because it turns out frequency might not even matter. A team of researchers from Carnegie Mellon University studied how sex plays a role in our levels of happiness, and found frequency can make or break the mood. The study, published in the Journal of Economic Behavior & Organization, found a busy bed doesn’t mean a happy marriage.

Researchers randomly assigned sex frequencies to 64 healthy married couples between the ages of 35 and 65.  Half of the participants were nominated to have twice as much sex as they normally would in a week while the other half maintained the same pace, at their leisure, for three months. Each person was required to complete three different surveys throughout the experiment, with questions asking about a range of things, including health behaviors, happiness levels, frequency of sex, and types of sexual pleasures.

Participants weren’t happier the more they did the deed. In fact, they were less happy. The researchers explained this by saying an increase in sex frequency led to a decline in desire and enjoyment. In other words, it was the experiment’s fault.

“Perhaps couples changed the story they told themselves about why they were having sex from an activity voluntarily engaged in to one that was part of a research study,” said the study’s lead author George Loewenstein, from Herbert A. Simon University Professor of Economics and Psychology, according to CBS News. “If we ran the study again, and could afford to do it, we would try to encourage subjects into initiating more sex in ways that put them in a sexy frame of mind, perhaps with babysitting, hotel rooms, or Egyptian sheets, rather than directing them to do so.”

Human beings were created to want to have sex because their biology is dictated by the need to procreate, according to the Harvard Business Review. Our instincts drive us to the bedroom, where women find a mate with quality genes and men find a mate healthy enough to bear a child. From an evolutionary standpoint, instincts naturally kick in to increase frequency, and neurohormones such as oxytocin and vasopressin are released, flooding the body with happy feelings that keep us wanting more.

The study may have put a damper on the sexual impetus. All of a sudden, participants weren’t drawn to each other with the primal urge to procreate, but instead to follow through on their assignment by increasing the frequency of intercourse. Sexual satisfaction relies more on thequality of sex than the quantity, as it relies more on those happy hormones flowing without pressure than tallying up notches on a bedpost.

“The desire to have sex decreases much more quickly than the enjoyment of sex once it’s been initiated,” said Tamar Krishnamurti, a research scientist in CMU’s Department of Engineering and Public Policy, who designed the study. “Instead of focusing on increasing sexual frequency to the levels they experienced at the beginning of a relationship, couples may want to work on creating an environment that sparks their desire and makes the sex that they do have even more fun.”

Source: Loewenstein G, Smyth R, Krishnamurti T, and Cheng Z. Sex and happiness. Journal of Economic Behavior & Organization. 2015.

WHO Seeks Sensitivity in Disease Naming

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If you’re a scientist and have just identified a dangerous new disease in Peru originating from pigs then please don’t call it paralytic Peruvian pig pox.

Disease names like swine flu or Rift Valley fever risk stigmatizing communities and damaging economies, the World Health Organization (WHO) warned on Friday as it called for a rethink on naming new human diseases.

Point is to avoid stigmatizing regions, individuals, or animals.

“This may seem like a trivial issue to some, but disease names really do matter to the people who are directly affected,” said Keiji Fukuda, WHO’s assistant director-general for health security.

“We’ve seen certain disease names provoke a backlash against members of particular religious or ethnic communities, create unjustified barriers to travel, commerce and trade, and trigger needless slaughtering of food animals. This can have serious consequences for people’s lives and livelihoods.”

The world health body issued guidelines for the naming of new human infectious diseases to minimize any negative impact.

Terms to be avoided include geographic locations such as Middle East respiratory syndrome or Spanish flu, people’s names as in Creutzfeldt-Jakob disease and Chagas disease, and animals such as bird flu or monkey pox.

Cultural or occupational references are also a no-no, as are words that incite undue fear like “fatal” and “epidemic”.

Diseases are often given common names, which quickly gain currency as they spread via the Internet and social media, WHO said. Once they are in use they are hard to change.

“It is important that whoever first reports on a newly identified human disease uses an appropriate name that is scientifically sound and socially acceptable,” WHO added.

The guidelines say a name should consist of generic descriptive terms based on the relevant symptoms such as respiratory disease, neurologic syndrome or watery diarrhea.

More specific descriptions like progressive, juvenile, severe or winter can be included when it becomes clear how the disease manifests, who it affects, its severity or seasonality.

The pathogen that causes the disease should be part of the name if it is known, for example, coronavirus or salmonella.

The guidelines, aimed at scientists, national authorities and the media, do not affect names that are already established.

The final name of any new human disease is assigned by the International Classification of Diseases (ICD), which is managed by WHO. Its new guidance is meant to cover the gap between identification and the assigning of the final name.

Lessons From Swine Flu: Avoid Geographic Location When Naming New Infectious Diseases, WHO Says

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The World Health Organization (WHO) is reminding scientists and public health officials to take care when naming new human infectious diseases; the wrong name can have adverse side-effects.

“In recent years, several new human infectious diseases have emerged. The use of names such as ‘swine flu’ and ‘Middle East Respiratory Syndrome’ has had unintended negative impacts by stigmatizing certain communities or economic sectors,” Dr. Keiji Fukuda, WHO’s assistant director general health security, said in a press release. “This may seem like a trivial issue to some, but disease names really do matter to the people who are directly affected.” Fukuda added he’s seen certain names provoke a backlash among particular religious or ethnic communities, which then “create unjustified barriers to travel, commerce and trade, and trigger needless slaughtering of food animals.”

While the International Classification of Diseases (ICD) has final say on what a new infectious disease is called, it’s that much harder to implement when those outside the ICD and scientific community are referring to it as something else. These unofficial names tend to spread online, particularly across social media networks, and ultimately cause confusion. In which case, WHO has collaborated with the ICD, the World Organization for Animal Health, and the Food and Agriculture Organization of the United Nations to come up with best practices.

These practices indicate any name applied to a new disease “should consist of generic descriptive terms, based on the symptoms that the disease causes, such as respiratory disease, neurologic syndrome, watery diarrhea.” In addition to a generic description of symptoms, there should be more specific terms regarding “how the disease manifests, who it affects, its severity or seasonality.” And if the pathogen responsible for the disease is known, it should be factored into the final name. For example, salmonella is caused by a group of bacteria with the same name.

That said, name should not consist of geographic locations, people’s names, any species of animal or food, nor should they consist of any cultural, population, industry, or occupational references. Additionally, names alone should not be fear-inducing. Think of “unknown,” “fatal,” and “epidemic.”

“The new best practices do not replace the existing ICD system, but rather provide an interim solution prior to the assignment of a final ICD disease name,” WHO explained. “As these best practices only apply to disease names for common usage, they also do not affect the work of existing international authoritative bodies responsible for scientific taxonomy and nomenclature of microorganisms.”

Breast Ca Patients Need Better Cardiac Monitoring

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Physician characteristics had more influence than patient factors on adequate monitoring.

 Breast cancer patients received suboptimal cardiac monitoring during treatment with trastuzumab (Herceptin), according to a large population-based study.

Among more than 2,000 patients, only 36% of evaluable participants received adequate monitoring for cardiotoxicity in accordance with current guidelines, reported Mariana Chavez-MacGregor, MD, of the MD Anderson Cancer Center in Houston, and colleagues.

Interestingly, physician characteristics had more influence than patient factors on cardiac monitoring, they wrote in the Journal of Clinical Oncology

“We suspected that the rates of cardiac monitoring were going to be low, but we were surprised on how low, particularly in this high-risk group of patients,” Chavez-MacGregor, a medical oncologist, told MedPage Today in a separate interview. “Of particular concern was that even among patients with cardiac comorbidities the rates of cardiac monitoring were not higher.”

Specifically, female sex and graduating with a medical degree after 1990 were associated with an increased likelihood of adequate cardiac monitoring. “It is possible that younger graduates are more familiar with the use of trastuzumab, its side effects, and the current guidelines,” said Chavez-MacGregor. “It was surprising, however, to see a gender difference.”

Because trastuzumab-related cardiotoxicity is reversible, efforts to improve the adequacy of cardiac monitoring are needed, particularly in a vulnerable population,” the authors wrote, adding that adequate monitoring among these patients should be considered a marker of quality of care. Disseminating current guidelines should be a priority for hospitals, training programs, and medical societies, they added.

“In terms of trends, probably the more reassuring finding is that the rates of adequate cardiac monitoring are improving with time, suggesting that, as providers, we are becoming more aware of the current guidelines and recommendations,” Chavez-MacGregor said. “But all changes in patterns of care take time.”

They used the Surveillance, Epidemiology, and End Results, the Medicare and the Texas Cancer Registry, and Medicare-linked databases, to identify 82,751 patients, ages 66 and older, diagnosed with nonmetastatic breast cancer from 2005 to 2009. The study-eligible cohort was narrowed to a much smaller cohort of 2,203 stage I-III patients with full Medicare coverage who received adjuvant trastuzumab-based chemotherapy.

According to the manufacturer’s insert, patients on trastuzumab therapy need to have baseline cardiac assessment and frequent subsequent cardiac monitoring.

Baseline cardiac evaluation was performed in 78.8% of patients, and 68.2% had a test within the first 4 months of therapy. However, subsequent monitoring — one cardiac evaluation at least every 4 months during therapy — was performed in only 42.6%. In the entire cohort, only 36% of the patients had guideline-adherent cardiac monitoring according to the definition and current guidelines. Older patients were less likely to receive adequate monitoring (P=0.001).

By multivariable analysis, factors associated with optimal monitoring included a more recent year of diagnosis. Using 2005 as a reference year, the hazards ratios were as follows:

  • 2007: HR 1.42 (95% CI 1.07-1.88)
  • 2008: HR 1.65 (95% CI 1.21-2.27)
  • 2009: HR 1.83 (95% CI 1.32-2.54)

Other predisposing factors were anthracycline use (HR 1.39, 95% CI 1.14-1.71), a female treating physician (HR 1.37, 95% CI 1.10-1.70), and a physician graduating after 1990 (HR 1.66, 95% CI 1.29-2.12).

 The presence of cardiac comorbidities was not a determinant. Of the variance in the adequacy of monitoring, 15.3% was attributable to physician factors and 5.2% to measured patient factors.

The study had limitations, including its retrospective nature, the challenges of research based on data from insurance claims, and the relatively small proportion of patients treated with adjuvant chemotherapy — an example of the undertreatment that is “a well-described phenomenon among the elderly,” they wrote.

Antitibiotic-Chemo Combo Cuts Infection Risk in AML

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Children with acute myeloid leukemia (AML) had a significantly lower incidence of certain bacterial infections if they received fluoroquinolone prophylaxis after chemotherapy, a small retrospective study showed.

Children treated with levofloxacin had more than a 50% reduction in the incidence ofStreptococcus viridans infections compared with children who received chemotherapy without antibiotic prophylaxis, but did not eliminate infection by the organism. Gram-negative infections also occurred significantly less often with antibiotic prophylaxis.

Despite the benefits, the overall incidence of any clinical infection during chemotherapy was not significantly lower in the levofloxacin group, reported Asmaa Ferdjallah, MD, of Children’s Healthcare of Atlanta and Emory University, and colleagues here at the American Society of Pediatric Hematology/Oncology meeting.

“Prophylactic use of levofloxacin reduces the incidence of strep viridans infections,” Ferdjallah said. “However, strep viridans resistance is common in patients receiving levofloxacin prophylaxis. Levofloxacin prophylaxis reduces gram negative infections during period of neutropenia.”

Other potential contributors to the lower incidence of infection could not be ruled out, she added. During implementation of antibiotic prophylaxis for patients with AML, a strategy to improve central line care also was implemented. Additionally, chlorhexidine baths and oral hygiene protocols were initiated.

Bacterial sepsis is a leading cause of morbidity and mortality in patients with AML. Contemporary studies have found microbiologically confirmed infections in one-third tothree-fourths of patients, associated with mortality of 6% to 11%.

Studies involving adults with cancer have suggested that fluoroquinolone prophylaxis can reduce infection-associated mortality. One study involving children with acute lymphoblastic leukemia showed an association between antibiotic prophylaxis and lower rates of hospitalization, intensive care admissions, and bacteremia.

The National Comprehensive Cancer Network suggests “consideration of fluoroquinolone prophylaxis” in patients with AML treated with chemotherapy, Ferdjallah said, and theInfectious Diseases Society of America specifically mentions consideration of levofloxacin prophylaxis, including consideration of use in high-risk pediatric patients.

In 2012, Children’s Healthcare of Atlanta implemented a policy of levofloxacin prophylaxis for all patients with newly diagnosed AML. Ferdjallah and colleagues examined the impact of the policy on bacterial infections during induction therapy and episodes of chemotherapy-induced neutropenia. Secondarily, they evaluated the incidence of fungal infections in patients receiving levofloxacin prophylaxis.

Investigators conducted a retrospective chart review of patients with newly diagnosed AML treated from September 2010 to September 2014, covering the 2 years before and after institution of the levofloxacin prophylaxis policy. The protocol stipulates initiation of levofloxacin on the first day of chemotherapy and continuation until cell count recovery.

They defined a bacterial infection as a positive blood, wound, or tissue culture and a fungal infection as a positive culture or CT findings in association with signs and symptoms consistent with infection.

The study population consisted of 39 patients who had a median age of 11 and age range of 15 months to 20 years. The patients received a cumulative total of 132 courses of cytarabine-containing chemotherapy: 80 courses with levofloxacin prophylaxis and 52 courses without levofloxacin.

Overall, gram-positive infections occurred during 23 (28.75%) courses of chemotherapy with levofloxacin prophylaxis and 20 (38.46%) courses of chemotherapy without prophylaxis, a difference that did not achieve statistical significance (P=0.213).

When Ferdjallah and colleagues analyzed infectious by S. viridans status, they found a significant reduction in S. viridans infections, from 28.85% during the period without levofloxacin prophylaxis to 12.5% with prophylaxis (P=0.024). Prophylaxis did not significantly affect the incidence of non-S. viridans infections (16.25% versus 9.6%,P=0.312).

Gram-positive organisms accounted for most of the chemotherapy-associated infections. Nonetheless, no patients who received levofloxacin prophylaxis developed a gram-negative infection as compared with five infections (9.62% of chemotherapy courses) in the no-prophylaxis group (P=0.024).

Levofloxacin prophylaxis was not associated with an increased risk of fungal infections, Ferdjallah said. Fungal infections occurred during two (2.5%) courses of chemotherapy in the prophylaxis group versus five (9.62%) courses in the no-prophylaxis group (P=0.112).

The total infection rate was substantially reduced with levofloxacin prophylaxis, but the difference did not achieve statistical significance (33.75% versus 50.0%, P=0.067).

Three patients died during induction or intensification of chemotherapy, including one infection-related death in a patient who did not receive levofloxacin prophylaxis.

During the discussion that followed her presentation, Ferdjallah acknowledged that a prospective randomized trial would be the optimal way to determine the value of fluoroquinolone prophylaxis during chemotherapy for AML. However, she questioned whether such a study would be feasible, given consistent evidence from observational studies in favor of prophylaxis.

Abandoned Painkiller Makes a Comeback

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In 2006, in the midst of a growing opioid epidemic, the FDA approved the new narcotic painkiller Opana.

It was a familiar drug.

Under the name Numorphan, it had been abused in the 1960s and 1970s until it was removed from the market. When injected, the drug is 10 times as potent as morphine.

And now there is a familiar problem.

Known generically as oxymorphone, the FDA approved the new version of the drug — made by Endo Pharmaceuticals — in 2006 as both an immediate-release and extended-release pill. Then in December 2011, the agency approved a new abuse-deterrent version — but users have been able to foil the anti-injection mechanism and have been shooting up Opana.

In addition to overdose risk, abuse of Opana by injection has been tied to a recentoutbreak of HIV in rural Indiana as well as a surge in hepatitis C infections in several Appalachian states.

It also has been associated with a blood-clotting disorder and permanent organ damage — a problem that didn’t occur with injection abuse of generics and the earlier version of the drug.

When Opana was approved, it joined more than a dozen other narcotic painkillers on the market.

“There certainly didn’t seem to be a need for it,” said James Roberts, MD, a professor of emergency medicine at Drexel University College of Medicine in Philadelphia. “There are plenty of narcotics around for pain relief.”

As Numorphan, the drug’s popularity among addicts was due to its quick and sustained effect, according to the 1974 report “Drugs and Addict Lifestyle” by the National Institute on Drug Abuse.

The report said the drug — which carried a street name of “blues” — was used primarily by white males and highlighted 309 Philadelphia area addicts who were interviewed about their Numorphan abuse in 1970. Many of the addicts said they preferred the drug over heroin.

Originally approved in 1959, FDA records indicate the pill form of Numorphan was taken off the market in 1979 for what is described as “commercial reasons.” Its intravenous and suppository formulations were allowed to remain on the market.

In an email, FDA spokesman Eric Pahon said opioids, including Opana, are important medications for the treatment of pain, when used properly.

“The FDA is concerned about the misuse and abuse of prescription opioids, which is a serious public health challenge, and is working in many ways to help prescribers and patients make the best possible choices about how to use these powerful drugs,” he said. “We must balance this effort, however, with ensuring prescribers and patients maintain access to these medications and a variety of treatment options are available.”

Opana ER generated 756,000 prescriptions and sales of $385 million in 2013, according to data supplied by IMS Health, a drug market research firm. Since 2009, its annual sales have ranged from $246 million to $640 million.

In an email, Endo spokesperson Heather Zoumas Lubeski said the drug “was approved by the FDA based upon its demonstration of safety and effectiveness in clinical trials and its successful submission of an application for approval.”

Meetings Impact Approval?

A Milwaukee Journal Sentinel/MedPage Today examination found oxymorphone’s re-appearance on the market followed a pattern identified in past investigations, including cozy relationships between regulators and drug company executives and the use of questionable clinical testing methods allowed by the FDA.

Endo was a frequent participant at meetings of an organization funded by pain drug companies that brought together pharmaceutical executives and federal regulators during the 2000s, records show.

The group, known as IMMPACT, was the subject of a 2013 Journal Sentinel/MedPage Today investigation.

The story highlighted how federal health industry officials, members of academia, and executives of companies that make pain drugs held private meetings at expensive hotels at least once a year beginning in 2002, according to emails obtained through a public records request.

Each year, a handful of drug companies paid up to $35,000 each to send a representative to the meetings where they could discuss clinical trial design with FDA officials.

The arrangement was criticized as appearing to be pay-for-play connection between regulators and companies anxious to get products onto the multibillion-dollar-a-year pain market.

In 2014, two U.S. senators wrote to the medical school dean at the University of Rochester demanding financial records related to the IMMPACT meetings. A researcher at the school was a co-founder of the group.

Sen. Joe Manchin (D-W.Va.) and Sen. David Vitter (R-La.) wrote that they were “deeply troubled by allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars to the University of Rochester Medical Center for the privilege to attend private meetings with FDA officials.”

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FDA spokesman Pahon said it is misleading to imply that the IMMPACT meetings were private meetings between FDA officials and members of industry.

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Though the meetings were invitation-only, he said, they were attended by a variety of government officials, academics, and pain advocates.

“These were large scientific meetings at which the outside experts almost always outnumbered the attending companies,” he said. “We are not aware of any separate, private meetings between FDA and pharmaceutical companies during or as a result of IMMPACT meetings.”

He said the meetings had no bearing on the approval of Opana and did not include the discussion of any particular product or the standards for FDA approval of pain products.

Stacking the Deck?

The IMMPACT meetings helped develop a new approach to winning approval of drugs known as enriched enrollment.

The approach allows drugs companies to weed out people who don’t respond well to a drug or who can’t tolerate taking it before an actual clinical trial for the drug begins.

Independent doctors say that approach makes it much more likely a drug will be found effective and possibly win FDA approval. It’s also cheaper for drug companies to conduct such trials.

Critics say the approach essentially stacks the deck in favor of the drug. More importantly, experts say, drugs tested that way are not likely to reflect what will happen when a medication gets on the market and is prescribed for large numbers of people.

When Endo tried to get Opana approved in 2003, the FDA said the drug didn’t appear effective enough in clinical trials. It also raised safety concerns after several postoperative pain patients overdosed on the drug and had to be revived with naloxone.

So Endo conducted new clinical trials using enriched enrollment.

In those trials, only the patients who initially responded to the drug were entered into a randomized, controlled trial, where they were given either Opana or a placebo. The idea is that the drug’s effects can be clearly demonstrated in comparison with placebo because it is already known to work for all of the patients.

The results of those trials helped get the drug approved by the FDA in 2006. But the FDA’s own medical review of the drug acknowledged that, given the enriched study design, “one could argue that the results may not be generalizable to the wider chronic pain population.”

“The FDA should be in the business of requiring high-quality evidence and not short-cut evidence,” said Lewis Nelson, MD, a medical toxicologist at NYU Langone Medical Center. “Unfortunately, they’re under pressure to make pharmaceuticals available to the general public.”

Nelson said the enriched trials “find the people who are most likely to respond to a drug and not suffer from side effects.”

“I don’t think enriched enrollment studies are truly valid,” he added.

FDA spokesman Pahon said companies use a variety of strategies to select those in the general population in which the effect of a drug can be more readily shown.

He would not say whether the FDA encouraged Endo to use enriched enrollment for Opana.

“You’ll need to FOIA [apply under the Freedom of Information Act to see] those pre-approval meeting minutes,” he said.

Opana is not the only opioid approved using enriched enrollment. In 2013, drugmaker Zogenix used the strategy to win approval for Zohydro, a high-dose, hydrocodone-only drug that was originally approved without any abuse-deterrent mechanisms.

The FDA approved the product despite its own advisory committee on pain drugs voting 11-2 against it.

The Diet Drug Dilemma

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What role should weight-loss medications play in the treatment of obesity across specialties?

A MedPage Today/Milwaukee Journal Sentinel report last month indicated that weight-loss medications such as Belviq, Qsymia, and Contrave were approved by the FDA based on a minimal weight loss (5% of body weight) but have not been shown to reduce cardiovascular events or other hard endpoints.

We contacted a variety of healthcare professionals by e-mail to ask:

Is a reduction of 5% of body weight a reasonable criteria for FDA approval?

What is the proper role, if any, for medications to promote weight loss?

Is it reasonable to assume that medication-induced weight loss will reduce obesity-related health risks?

Given that these medications seldom produce large and persistent weight losses, how much risk of adverse effects is appropriate?

The participants this week are:

Arti Bhan, MD, head of the division of endocrinology at Henry Ford Hospital in Detroit

Olveen Carrasquillo, MD, MPH, professor, medicine and public health sciences, chief, division of general internal medicine at the University of Miami Miller School of Medicine in Florida

Spyros Mezitis, MD, PhD, clinical endocrinologist, Lenox Hill Hospital in New York City

Carl “Chip” Lavie, MD, FACC, medical director, cardiac rehabilitation, and prevention at the John Ochsner Heart and Vascular Institute in New Orleans (Dr. Lavie discloses he received an honorarium as a consultant and potential speaker for Novo Nordisk, which has a new obesity medication. He is also the author of The Obesity Paradox.)

Gina Moore, PharmD, MBA, assistant dean for clinical and professional affairs, CU Skaggs School of Pharmacy and Pharmaceutical Services, Anschutz Medical Campus at the University of Colorado in Denver

A Multifactorial Approach

Arti Bhan, MD: “Obesity is a complex and multifactorial condition with numerous underlying genetic and environmental contributors. The approach to obesity treatment has to be multifactorial as well. Emerging research has shown that chronic weight gain leads to neurohormonal adaptations in the body, which make weight loss difficult. As physicians, we realize that the vast majority of people need adjunctive measures in order to achieve and sustain weight loss. Medication-induced weight loss is effective in decreasing the risk of obesity-related conditions. Ultimately, it is the amount of weight lost which has an impact on the degree to which complications are reduced; not the means by which the given weight loss is achieved.”

Olveen Carrasquillo, MD: “In general the long-term impact of weight loss medications on body weight is relatively small for most people who take them. Weight loss of at least 5% body weight is one of the most commonly used benchmarks used to determine if the medication has any effect. But the mainstay of any healthy weight-loss program is a combination of appropriate diet and exercise (both aerobic and strength). In my practice that is what I tend to emphasize over medications. ”

Spyros Mezitis, MD: “Obesity is a worsening epidemic in the developed world associated with increased risk for chronic disease including diabetes and cardiovascular disease. Lifestyle changes in the past 40 years including increased caloric intake of fatty foods and lack of exercise due to the dramatic increase of the service sector and the aging population have fueled the obesity pandemic.”

Carl Lavie, MD: “Substantial evidence suggests that those overweight and mildly obese appear to have a better prognosis than do normal weight patients with similar CVD, and the research by my colleagues and me suggests that improving fitness may be more important for these patients than weight loss. On the other hand, most studies show that moderate or Class II obesity and certainly severe or Class III obesity is associated with a poor prognosis, and these patients would likely benefit from weight loss. The prevalence of severe obesity in our society is increasing, and now over 3% of the U.S. population have BMI>40.”

Right Medication, Right Patient

Gina Moore, PharmD: “I think medications are truly a last resort for weight loss and too often consumers are looking for a quick fixrather than addressing the underlying causes of excess weight. Weight-loss medications might be used short term (no more than 3 to 6 months) in individuals who have failed in previous attempts to lose weight for initial motivation, but patients should be closely monitored for weight loss, potential adverse effects, and that they are being compliant with other weight-loss strategies. We know that weight loss reduces obesity-related health risks, but medication-induced weight loss only occurs as long as an individual takes the medicine. The effects of the medicine plateau after a period of time, and unless an individual has undertaken a comprehensive, long-term strategy for weight loss, it is unreasonable to think they’ve done much to improve their long-term health risks. ”

Bhan: “In 1998, the NIH stated that ‘obesity is a chronic disease, and both patients and the practitioner need to understand that successful treatment requires a life-long effort.’ Most interventions leading to weight loss show initial success, with long-term studies showing weight regain. Weight loss medications work as long as they are being used. Given the difficulty patients have in maintaining weight loss, I think that using weight-loss drugs in the right patient is reasonable and will improve their metabolic parameters and quality of life. The ‘right patient,’ for example, is someone with a BMI ≥27 with diabetes, sleep apnea, and symptomatic osteoarthritis.”

Lavie: “It is likely that many patients with more severe obesity would benefit from weight-loss medications that produce 5% to 7% weight loss, and maybe even more so with greater weight loss with bariatric surgery. These therapies may improve quality of life, reduce use of other medications, reduce co-morbidities, and possibly reduce CV events and survival. Proving this will obviously be essential.”

Risks vs. Benefits

Mezitis: “Anti-obesity medications on the market working via increasing metabolism or suppressing appetite may cause at least 5% weight loss that is related to improvement in glycemic and lipemic control and possible decrease in vascular disease. Cardiovascular trial results with these medications are pending and their safety is being monitored. The treating physician must discuss their risks and benefits with each potential patient user, evaluate weight loss and blood test results on an ongoing basis, consider modifying other medications used in conjunction with anti-obesity medications, and register cardiovascular events during treatment.”

Carrasquillo: “Some of these medicines also have unwanted side effects such as gastrointestinal symptoms, which is another reason I seldom use them. In addition, for clinicians who are more evidence-based, we really want to see data that the medications reduce not only body weight but also reduce obesity-related health risks such as diabetes, hypertension, and heart disease. So far, I have not seen much good evidence on those outcomes. That is why I prefer to prioritize diet and exercise. The evidence linking these two lifestyle changes to improved health outcomes is quite clear.”

Moore: “It’s difficult to comment on risk in absolute terms, but in my opinion, bothersome side effects such as loose stools or flatulence that occur with Orlistat are reasonable. Although they aren’t pleasant for the individual taking the medication, you wouldn’t expect to see long-term health consequences. The FDA has been under pressure to approve weight-loss drugs given the obesity epidemic in the U.S., but I think consumers are better served by looking at holistic weight-loss approaches other than relying on medications.”

Lavie: “At present, there is no proven long-term safety of these new obesity medications and also no proven impact on survival or major CV events. Additionally, some of these new medications may increase heart rate, which normally is a marker of adverse autonomic tone. Although the mechanism of the heart rate increases may differ with the various agents, including by direct sinus node stimulation, a new heart failure (HF) medication is being approved because it reduces heart rate by direct sinus node inhibition, which leads to a reduction in HF adverse events. Therefore, higher heart rates with these medications could hurt prognosis in some patients. Some of the weight-loss medications may increase BP and have other potentially serious adverse events, all of which makes demonstrating long-term safety and efficacy, not just for weight loss but for major clinical CV events, more important.”

Bhan: “Weight-loss drugs are not completely without risks. Appropriate patient selection is the key to successful weight loss and decreased risk of side effects. It is imperative that providers prescribing these medications, monitor patients regularly. If weight loss of more than 5% is not achieved in 3 months, a different strategy should be applied. The potential benefit of improving existing comorbidities and preventing additional future problems may outweigh the risk of adverse effects from weight-loss drugs. Long-term follow-up data will give us more information regarding cardiovascular risks and benefits of these medications.”

Are E-Cigs a Gateway to Smoking?

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Lots of questions remain about the effects that using electronic cigarettes have on adolescents, including whether they are a “gateway” drug to regular cigarettes, several speakers said Wednesday.

Most young people who use them also use other forms of tobacco.

“Do e-cigarettes cause children to progress to other tobacco products that are extremely harmful?” Andrea Villanti, PhD, MPH, director for regulatory science and policy at the American Legacy Foundation’s Schroeder Institute for Tobacco Research and Policy Studies here, asked at a briefing on public health challenges related to e-cigarette usesponsored by George Washington University. “To know that … we need to track patterns over time. We need to know if ‘never users’ stayed never users, transferred to combustible use, dual use, or e-cigarette use, and what happened over time.”

Whether e-cigarettes are a gateway to other types of tobacco use is unclear, but surveys do show that the number of young people using e-cigarettes alone is small, Villanti said. “The bulk of e-cigarette use is happening among people using other tobacco products.”

For example, the University of Michigan’s “Monitoring the Future” survey for 2014 found that among 12th graders, 62% had used neither e-cigarettes nor conventional cigarettes, while 4% had used e-cigarettes only, 21% had used conventional cigarettes only, and 13% had used both.

E-cigarettes have gone through several iterations since they were first introduced, explained Naomi Freedner-Maguire, principal researcher at ICF International, a Fairfax, Va., consulting firm. While first-generation products tried to mimic the look of conventional cigarettes, the next generation, also known as “personal vaporizers,” were two-part devices with a tank and a separate battery, and offered thousands of flavor choices to users.

Today, there is a third generation of devices available, with the biggest difference being “mods” — components that can be modified to change the vaping experience, Freedner-Maguire said. “This is a much more effective nicotine delivery system, and it’s moved into a subculture of e-cigarette users and ‘vapers’ that are really committed to creating mods that will increase the power of the device or the flavor.”

“Sub-ohming” — modifying the coils in the atomizer to produce more vapor — is a popular pastime among e-cigarette users, she continued. “There’s a whole vaping culture dedicated to producing as much vapor as possible.”

Some people call themselves “cloud-chasers,” said Freedner-Maguire, “and there are cloud-chasing competitions where people square off back-to-back and inhale, and release the biggest plume of vapor that they can. Somebody stands with a yardstick on the other side and measures the size and density of the plume, and there are cash prizes for things like this.”

“Dripping” is another popular practice, in which “nicotine e-liquid is dripped directly onto wicked material in the atomizer to simulate more closely the experience of smoking a cigarette,” she said. “You can find these things on blogs and all over online about how people inhale, and the difference between mouth inhalation versus lung inhalation — a ‘lung hit.'”

Surveying young people about their e-cigarette use is complicated for many reasons, saidJennifer Pearson, PhD, MPH, a research investigator at the Legacy Foundation’s Schroeder Institute. For one thing, “E-cigarettes have many names. What’s a vape pen to someone in California is an e-hookah to someone in the Northeast, and who knows what to someone in Texas,” she said.

In addition, “young adults might call products different things than older adults,” Pearson continued. “If it’s an older adult, they might call it an e-cigarette and a younger adult might call it an e-hookah.”

Then there’s the issue of dosing. “It’s easy to ask about cigarettes per day, but with e-cigarettes it’s not sensible to ask that — even disposable ones can last several days,” said Pearson. “We’re telling people a ‘use episode’ is when you use an e-cigarette, then put it down and don’t intend to pick it back up for a while.”

 The fact that e-cigarettes are used differently from conventional cigarettes also raises other questions, said Ray Niaura, PhD, associate director for science at the Schroeder Institute.

With conventional cigarettes, “They’re very much compelled to smoke the entire thing,” said Niaura. “That means the way nicotine is delivered into the brain is very different; you’re getting a very intense bolus of inhaled nicotine. With e-products, if you work at it, you can do that, but is that how people really use them?”

Instead, “you can take a puff, put it in your pocket … and walk around, then take another couple of puffs. I don’t know the liability [of that] for producing long-term addiction.”

Do e-cigarettes help people quit smoking conventional cigarettes? “The evidence there is mixed,” he said. “There are a couple of randomized trials, but they’re not slam-dunk positive and not slam-dunk negative.”

IBM’s Watson: A Healthcare Tool With Potential

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IBM announced this week that it has partnered with 14 major cancer centers in the United States to use Watsonfor the analysis of patient-specific genetic data to guide therapy.

Use of Watson in healthcare was one of the earliest applications envisioned after its famous “Jeopardy!” victory. And the pace of news about Watson in medicine has definitely picked up.

@Point of Care, which made the list of our Best New Apps of 2014, uses Watson to help answer patient questions about multiple sclerosis. And Pathway Genomics plans to deliver personalized health advice based on a patient’s genetic profile using Watson.

In a demonstration of its commitment, IBM recently launched a 2000-person Watson Health unit that will focus entirely on applications in medicine. At the same time, the company also announced a collaboration with Apple that will brings Watson’s analytic power together with the piles of data being collected through HealthKit.

In this latest partnership, IBM will collaborate with some academic heavyweights: Ann & Robert H Lurie Children’s Hospital of Chicago; BC Cancer Agency; City of Hope; Cleveland Clinic; Duke Cancer Institute; Fred & Pamela Buffett Cancer Center in Omaha, Neb.; McDonnell Genome Institute at Washington University in St. Louis; New York Genome Center; Sanford Health; University of Kansas Cancer Center; University of North Carolina Lineberger Cancer Center; University of Southern California Center for Applied Molecular Medicine; University of Washington Medical Center; and Yale Cancer Center.

Watson will be used to analyze genetic data being captured on cancer patients and compare that information to databases of known genes, medical literature, and more. Based on available reports, use here seems to be very much in pilot stages, looking for ways that Watson could help deliver scalable decision support in this context. As described by IBM, partners will use a new Watson Genomic Analytics platform:

Partners involved in the program will use Watson Genomic Analytics, a new solution specifically designed for genomic analysis. Watson Genomic Analytics is a cloud-based service for evidence gathering and analysis. It looks for variations in the full human genome and uses Watson’s cognitive capabilities to examine data sources such as treatment guidelines, research, clinical studies, journal articles and patient information. The solution then provides a list of medical literature that is relevant to the case, along with drugs that have been identified in the literature. The patient’s doctor then reviews this information alongside underlying evidence to make more informed treatment decisions. Watson Genomic Analytics constantly gets smarter as the system learns from patient data.

There’s clearly a lot of potential here. However, its also important to recognize that it’s still just “potential.” In a nice piece in the New York Times, Mayo Clinic physician Dr. Michael Joyner talks about how the promise of the Human Genome Project was, to some extent, stymied by the insights it gave us into the complexity of the most prevalent diseases.

That said, Watson is certainly a novel tool in medicine with an incredibly wide range of possible applications. These partnerships will help drive the thoughtful development and rigorous evaluation that will lead to Watson-based tools that can move use from novelty to improved outcomes for our patients.

Area around Fukushima is now a radioactive wasteland that will be uninhabitable for decades

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A foreign correspondent whose career consists of traveling to dangerous regions around the world has called the area around Fukushima, Japan, one of the most hopeless places he has ever visited, likening it to a “post apocalyptic ghost town.”

“I have seen abandoned villages before; most times there is a sense of finality to them,” writes Arglit Boonyai, host of the weekly Channel NewsAsia show Danger Zone. “It is as though the town’s time is up and the people have moved on. Fukushima is nothing like that. It’s like time just stopped.”

Danger Zone is a show about Boonyai’s visits to some of the world’s most dangerous places in order to try to understand of how ordinary people cope with living there. In addition to Fukushima, he has previously traveled to Iraq and into the heart of the Liberian Ebola epidemic.

Herculean cleanup effort

In March 2011, Japan was devastated by a massive earthquake and tsunami, which then triggered multiple meltdowns at the Fukushima Daiichi nuclear power plant. Explosions at the plant sent a massive plume of radioactive material spreading across the surrounding countryside.

Four years later, 70,000 people are still unable to return to their homes due to radioactive contamination. Local agriculture has been hobbled due to concerns over radioactive crops.

While filming the show, Boonyai and his crew visited the town of Tomioka, which was littered with signs of how abruptly the town had been abandoned, such as wedding albums and children’s toys scattered everywhere.

“If the tsunami had not destroyed most of the shops and houses in the area, there would be no explanation as to why the people there ever left,” he writes, “or why nature had slowly begun reclaiming the land covering collapsed buildings and the local train station.”

While some areas around Fukushima felt like ghost towns, others bustled with activity. The Japanese government has set a goal of completely cleaning up the radioactive waste from the disaster, even though radioactive material has infiltrated everything from the soil under people’s feet to the dust in the air they breathe.

“Workers work tirelessly to remove [radioactive fallout] inch by inch, mostly with the help of machines, but in some cases I witnessed clean-up crews scrubbing the side of buildings with steel tooth brushes,” Boonyai writes.

He notes that many locals have joined the effort as volunteers, particularly elderly residents who believe they are too old to worry about health effects from radiation.

“Lack of hope”

“But despite this shared sense of duty and extraordinary effort to return Fukushima to normal, I fear that here, more than anywhere else, has a distinct lack of hope,” Boonyai writes.

“Refugees living in temporary housing do not expect to return to their homes. Scientists and radiation specialists do not expect the land to be free from danger any time soon.”

Based on his visit to the region, Boonyai agrees with the assessment that the region will remain largely uninhabitable for decades.

The problems become more severe as one gets closer to the plant itself. In July 2014, Kyoto University assistant professor Hiroaki Koide described the area directly around the plant as a radioactive swamp. Plant operator Tokyo Electric Power Company (TEPCO) has been stockpiling radioactive water on the site — water used to cool the reactors and groundwater leaking into the failed reactors both become radioactive and build up rapidly — but numerous leaks have rendered the entire area highly dangerous.

Meanwhile, TEPCO has pushed back the timeline to begin decommissioning the crippled reactors themselves to 2025 due to technical difficulties. The company claims the project will be finished by 2051, but the head of the plant has publicly disputed this claim.

He says the technology does not yet exist to clean up Fukushima Daiichi, and it might not exist for centuries.

Learn more: http://www.naturalnews.com/049778_Fukushima_nuclear_meltdown_radioactive_waste.html#ixzz3ajg8UOO7