• Television Drug Ads Sell Statins
• Antidepressants Given Near Delivery Associated with More Postpartum Hemorrhage
• Duration of Overall and Abdominal Obesity Linked to Coronary Calcification
• Designated Drivers Don't Drink? A Sobering Finding
• Intravenous Iron Therapy Associated with Fewer Transfusions, But More Infections
• U.S. Circumcision Rates Down
• Citizen Watchdog Warns of "Safe Diet Drug Delusion" in the U.S.
• An Estimated 300,000 Americans Diagnosed with Lyme Disease Each Year
• Conflict of Interest Seen in Some prescribing Radiotherapy for Prostate Cancer
• Outpatient Back Pain Treatments: Not What the Doctor Should Order
• Celiac Disease and Risk for Lymphoma
• Lateral Wedge Insoles Ineffective for Knee Osteoarthritis
• 'Modest' Increase in Costs for health Insurance, as Deductibles Increase
• U.S. Travelers Warned of Cholera in Cuba
• Calcium-Channel Blockers Might Be Associated with Excess Breast Cancer Risk
• Pituitary-Adrenal Axis Suppression After Long-Term Prednisone
MM: There is no question that advertising is valuable to business but it can be abused when it comes to health and healthcare. Since we can be affected so much by advertising and the media, it makes a person wonder how many of our other viewpoints are being misguided and whether this is limited to only healthcare or does it lead to other political and social questions as well.
J Gen Intern Med 2013 Jul; 28:886
Television Drug Ads Sell Statins
Unfortunately, the sales might be to people who don't need them.
Direct-to-consumer (DTC) prescription drug advertisements have become a television fixture since regulations surrounding their use were relaxed in 1997. Back then, some commentators noted hopefully that, by raising patient awareness of various medical conditions, these ads actually might improve public health. A new study suggests otherwise.
Researchers correlated data from a private media registry that tracks local airing details of TV advertisements with data from a nationally representative survey that measures socioeconomic variables, including TV watching behavior and some health indexes. About 15% of >100,000 U.S. adults polled between 2001 and 2007 reported having high cholesterol levels, and about 10% were taking statins (both consistent with other national estimates). The odds of both self-reported hyperlipidemia and statin use were significantly higher among participants estimated to have seen the most TV statin ads. Both associations held for both men and women and were driven entirely by disease awareness and statin use among people at low risk for coronary heart disease (CHD), as assessed by usual risk factors. No association was found among people at high CHD risk. Adjustments for socioeconomic confounders and exposure to other drug ads did not change these findings substantially.
Comment: This intriguing study supports the hypothesis that drug ads do indeed increase disease awareness and treatment — but, alas, not among individuals most likely to benefit from the advertised drugs. Instead, these ads might simply expand a drug's market to those not proven to benefit from it. Editorialists affirm that, despite the study's limitations, it “lends credence to the charge that, at least in some clinical circumstances, exposure to DTC advertising promotes needless and possibly harmful prescribing.”
Citation(s): Niederdeppe J et al. Direct-to-consumer television advertising exposure, diagnosis with high cholesterol, and statin use. J Gen Intern Med 2013 Jul; 28:886.
(http://dx.doi.org/10.1007/s11606-013-2379-3)
Direct-to-consumer television advertising: Time to turn off the tube? J Gen Intern Med 2013 Jul; 28:862.
(http://dx.doi.org/10.1007/s11606-013-2424-2)
http://www.ncbi.nlm.nih.gov/pubmed/23463454?access_num=23463454&link_
type=MED&dopt=Abstract
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MM: The debate of whether taking antidepressants during pregnancy typically focuses on the unborn child but what about the mother? This article makes us shift our focus and consider that there are 2 human beings physically involved in a pregnancy and many more that that emotionally involved.
Antidepressants Given Near Delivery Associated with More Postpartum Hemorrhage
By Joe Elia
Women exposed to antidepressants near the time of delivery show an increased risk for postpartum hemorrhage, according to a BMJ study.
Researchers analyzed Medicaid data on some 100,000 women with a diagnosis of mood or anxiety disorder. They used pharmacy dispensing data to characterize exposure, with "current exposure" defined as having a supply of antidepressant medicine on hand that overlapped with the delivery date.
Compared with nonexposed women (i.e., those having no drug supply within 5 months of the delivery date), those with current exposure showed a roughly 1.5-fold increased risk for postpartum hemorrhage. The authors calculate a number need to harm of 80 for patients on serotonin reuptake inhibitors and 97 for nonserotonin reuptake inhibitors.
They speculate that the effect could be partly explained by the effect of blocking serotonin reuptake in platelets, but the association with nonserotonin inhibiting drugs is "unexpected and should be confirmed
http://www.bmj.com/content/347/bmj.f4877
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MM: Obesity of America could lead to our downfall. It shortens our lives, decreases the quality of our lives and increases the cost of extending and maintaining our lives. We cannot continue to live in denial and say, "I've tried but there is nothing that I can do about it." The simple fact that almost 69% of Americans are either overweight or obese is not an acceptable fact. The old adage that an ounce of prevention is worth a pound of cure applies here. We need to start with our youth and need to lead by example. We need to increase our overall activity, eat healthier, eliminate inflammatory foods such as gluten, processed sugar and fried foods and consider weight loss treatments and protocols that work like the HCG weight Loss protocol. The move by big pharma to get products like Belviq on the marketplace are an insult to the American people and undoubtedly there will be plenty of practitioners who will act like sheep and simply follow the big pharma lead and not take an appropriate stance of looking their patients in the eye and telling it to them straight because they are simply afraid or ignorant of the potential benefits of the HCG weight loss and metabolic syndrome protocol.
JAMA 2013 Jul 17; 310:280
Duration of Overall and Abdominal Obesity Linked to Coronary Calcification
In a long-term study in young adults, risks for new and worsening subclinical coronary artery disease increased by 2%–4% per additional year of obesity.
The obesity epidemic is rampant, particularly in children and young adults. However, the consequences of long-term obesity are largely unknown. To find out more, investigators used data from the CARDIA study on 3275 young adults (aged 18–30; 51% women; 46% black) who were nonobese at baseline in 1985–1986 and were examined for the presence and degree of coronary artery calcification (CAC) at least once at years 15, 20, and 25.
At 25 years, 40.4% of participants had developed overall obesity (mean age of onset, 35.4), and 41.0% had developed abdominal obesity (mean age of onset, 37.7). Mean duration of obesity was 13 and 12 years for overall and abdominal obesity, respectively. CAC was present in 27.5% of all participants; in 38.2% of those with overall obesity of more than 20 years' duration; and in 39.3% of those with abdominal obesity of more than 20 years' duration. Rates of CAC increased significantly with increasing duration of obesity (adjusted hazard ratios, 1.02 and 1.03 per additional year of overall and abdominal obesity, respectively), and CAC was more likely to progress over 10 years in obese than in nonobese participants (adjusted odds ratio, 1.04 per additional year of overall or abdominal obesity). The association between obesity and CAC was not affected by race or sex.
Comment: In this large analysis, increased duration of both overall and abdominal obesity was associated with increased prevalence and progression of coronary artery calcification — a strong marker of subclinical atherosclerotic disease — even after adjustment for multiple cofactors. These findings have important epidemiological implications and should prompt a redoubling of our efforts to combat childhood obesity and reduce cardiovascular risk in later life.
Citation(s): Reis JP et al. Association between duration of overall and abdominal obesity beginning in young adulthood and coronary artery calcification in middle age. JAMA 2013 Jul 17; 310:280.
(http://dx.doi.org/10.1001/jama.2013.7833)
http://www.ncbi.nlm.nih.gov/pubmed/23860986?access_num=23860986&link_
type=MED&dopt=Abstract
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MM: As our young people are returning to their colleges and universities it may be a time for us to practice our parenting skills in order to potentially save their lives. Don't be afraid of alienating or embarrassing your kids with this topic. It's simply too important.
J Stud Alcohol Drugs 2013 Jul; 74:509
Designated Drivers Don't Drink? A Sobering Finding
About one third of designated drivers tested positive for drinking in this onsite survey, and one half of these were impaired.
When a group drinks, a designated driver (DD) is often chosen who is presumably safe to drive. Investigators administered a validated measure of drinking habits and breath analyzer tests to 1071 adult patrons (mean age, 28) of a bar and restaurant district near a university; 165 participants identified themselves as DDs.
Among the DDs, 108 did not drink and had breath alcohol concentrations (BrACs) of 0. About half of the 57 drinking DDs had mean BrACs below 0.05 g/210 L (mean, 0.03 g/210 L), and the other half had mean BrACs of 0.09 g/210 L. Greater habitual levels of drinking predicted higher BrACs among DDs.
Comment: Anyone would be concerned that 18% of designated drivers met criteria for driving under the influence. Even the lower concentrations in the other drinking DDs are not reassuring because driving performance can be inhibited at blood alcohol concentrations of 0.02%. Slight impairment may be exacerbated by the presence of drunken passengers, increasing the risk of an accident further. Patients should be informed that a DD should not drink at all and that riding with a driver who has had anything to drink is not safe.
Citation(s): Barry AE et al. Breath alcohol concentrations of designated drivers. J Stud Alcohol Drugs 2013 Jul; 74:509.
(http://viajwat.ch/16Lqd7h)
http://www.ncbi.nlm.nih.gov/pubmed/23739013?access_num=23739013&link_
type=MED&dopt=Abstract
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Intravenous Iron Therapy Associated with Fewer Transfusions, But More Infections
By Joe Elia
Intravenous iron therapy seems to reduce the need for blood transfusion, but at the cost of increasing the likelihood of infection, according to a BMJ meta-analysis.
Researchers evaluated outcomes from over 70 trials involving almost 11,000 participants. The trials compared intravenous versus with oral or no iron (or both).
Overall, hemoglobin concentrations increased by 0.65 g/dL compared with oral or no iron. The need for transfusion was reduced by roughly 25%, but after excluding studies with high risk for bias, that association was no longer significant. The risk for infection was increased by about 30% with intravenous iron.
The authors conclude that controlled trials are needed "to define whether [intravenous iron therapy] should be used as a first line treatment."
http://www.bmj.com/content/347/bmj.f4822
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U.S. Circumcision Rates Down
By the Editors
The national rate of newborn in-hospital circumcision declined from 64.5% in 1979 to 58.3% in 2010, according to a report from the CDC's National Center for Health Statistics.
Rates fluctuated over the 32-year period, peaking at 64.9% in 1981 and dipping to 55.4% in 2007. Fluctuations usually followed changes to the American Academy of Pediatrics' circumcision guidance. For example, in 1999, the AAP stated that there was insufficient evidence to recommend routine circumcision. In 2012, the academy again stopped short of recommending it routinely.
http://www.cdc.gov/nchs/data/hestat/circumcision_2013/Circumcision_2013.htm
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MM: The newly approved diet drug Belviq (locaserin) is a dangerous drug. It causes hallucinations, has addictive properties and the typical weight loss with the drug is about 1.5 lbs/month. To make it even worse, the studies that were used to get approval of the drug demonstrated that those on placebo had better long term weight loss and weight maintenance than those using Belviq!
Citizen Watchdog Warns of "Safe Diet Drug Delusion" in the U.S.
By Kelly Young
A citizen watchdog takes the FDA to task in BMJ for its recent approval of two diet drugs that the European Medicines Agency declined to approve on safety grounds.
The founder of Public Citizen's Health Research Group, which petitioned the FDA to reject both drugs, says there is a "safe diet drug delusion."
In clinical trials, lorcaserin (Belviq) was associated with a nonsignificant increase in heart valve damage and only 3% more weight loss than placebo. Meanwhile, of 740 patients taking phentermine plus topiramate (Qsymia), six experienced serious adverse cardiovascular outcomes, while no patients taking placebo did. Qsymia was associated with 6.7% more weight loss than placebo.
The author concludes: "This is not to say that the EMA is perfect but rather that its recent record on drugs such as these puts the FDA to shame. It is ... the intermittently dangerous malleability of the FDA that is the problem in the cases discussed here."
http://www.bmj.com/content/347/bmj.f5140
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An Estimated 300,000 Americans Diagnosed with Lyme Disease Each Year
By the NEJM Journal Watch Editors
Over 30,000 cases of Lyme disease are reported to the CDC each year, but the actual number of annual cases is roughly 10 times higher, according to an analysis of three studies presented at the 2013 International Conference on Lyme Borreliosis and Other Tick-Borne Diseases.
"We know that routine surveillance only gives us part of the picture, and that the true number of illnesses is much greater," the CDC's chief of epidemiology and surveillance for Lyme disease said in a news release. "This new preliminary estimate confirms that Lyme disease is a tremendous public health problem in the United States, and clearly highlights the urgent need for prevention."
http://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html
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Conflict of Interest Seen in Some prescribing Radiotherapy for Prostate Cancer
By Joe Elia
The number of self-referrals for intensity-modulated radiation therapy (IMRT) of prostate cancer has increased in the U.S. in recent years, while use of this treatment has actually declined among non-self-referring groups, according to a Government Accountability Office report.
The number of self-referred claims for IMRT among Medicare recipients increased from 80,000 to 366,000 from 2006 to 2010. Non-self-referring claims dropped from 490,000 to 466,000 over the same period.
The GAO says its analyses "suggest that financial incentives for self-referring providers — specifically those in limited specialty groups — were likely a major factor driving the increase." The report recommends that providers be required to disclose their financial interests to their patients and that Medicare "should identify and monitor self-referral of IMRT services."
http://www.nytimes.com/2013/08/19/us/doctors-who-profit-from-radiation-prescribe-it-more-often-study-finds.html?_r=0
http://www.gao.gov/assets/660/656026.pdf
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MM: It is tough for a clinician to tell a person in pain that they should simply wait it out. Pain is invasive and no one likes to see another person suffer. Plus, patients want treatments that will give them relief now and get them "over the hump". For these reasons, clinicians look to narcotic analgesics and look for reasons why the patient is in pain. The desire to know a reason for the discomfort may outweigh the value of looking for the reason. Unfortunately the seeking may be a luxury that we can ill afford in our ever increasing cost of healthcare. Other alternatives that are not addictive and that have demonstrated efficacy should be considered. All Flex Pro Capsules may be a good alternative for many of these patients with back pain. Two capsules 2-3 times daily may be quite effective in getting a person "over the hump" and back on their feet.
JAMA Intern Med 2013 Jul 29
Outpatient Back Pain Treatments: Not What the Doctor Should Order
Treatment of back and neck pain increasingly relies on strategies that run counter to published guidelines.
Back pain treatment is costly and often includes overuse of imaging and referral to specialists. The total health costs for low back and neck pain increased 65% from 1997 to 2005 (from a mean of US$4795 per person to US$6096; JAMA 2008; 299:656).
To examine trends in outpatient treatment of back pain, researchers used data from federal surveys in 2-year increments between 1999 and 2010. Guideline-concordant use of NSAIDs or acetaminophen dropped from 37% to 25%, while guideline-discordant use of narcotics increased from 19% to 29%. Referrals for physical therapy remained unchanged at 20%, while referrals to other physicians for injections or surgery doubled, from 7% to 14%. Use of magnetic resonance imaging or computed tomography increased from 7% to 11%.
Comment: Most people arriving at their doctor's office with complaints of low back pain will get better within 4 weeks and will not need referrals to other physicians or imaging. If the back pain remains severe after 3 months, or there is an acute neurological compromise or other “red flags” including history of malignant neoplasm, then imaging might be advised. According to guidelines, imaging should be ordered only if there is a high degree of suspicion of a severe or specific condition, such as cauda equina syndrome or vertebral infection, or severe and progressive neurological deficits, such as motor weakness (Ann Intern Med 2011; 154:181). There is no question that we are over-imaging patients with neck and low-back pain. A large number of people when scanned have abnormal images like bulging disks, disk protrusion, nerve root compression, disk extrusion, and moderate-to-severe central stenosis (Spine 2005; 30:1541). Without clinical symptoms, this information is not that relevant. The danger is that some of these common findings might nonetheless make physicians feel obliged to do something about them. With health care costs increasing, using guidelines in the management of back pain represents an area of potential cost savings and improvement in quality of care.
Citation(s): Mafi JN et al. Worsening trends in the management and treatment of back pain. JAMA Intern Med 2013 Jul 29; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jamainternmed.2013.8992)
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MM: A person with gluten sensitivity may not have it develop into Celiac Disease (CD) but it has been demonstrated that many people with gluten sensitivity will have similar symptoms and medical developments to those with CD. This makes the increased presence of high gluten in our food chain a very scary issue.
Ann Intern Med 2013 Aug 6; 159:169
Celiac Disease and Risk for Lymphoma
Patients without mucosal healing on follow-up biopsies had an elevated risk for intestinal non-Hodgkin lymphoma.
Celiac disease (CD) is a gluten-sensitive autoimmune enteropathy that leads to intestinal villous atrophy. Although an elevated risk for intestinal lymphomas is well established in patients with CD, the relationship between lymphoma and the lack of mucosal healing on gluten-free diets is unknown.
Now, investigators have performed a retrospective, population-based, cohort study to identify all CD patients in the Swedish National Pathology Database who had a duodenal or jejunal biopsy between 6 months and 5 years after an initial diagnostic biopsy. Patients with mucosal healing versus persistent villous atrophy were assessed for the development of non-Hodgkin lymphoma (NHL), and the incidence of NHL was assessed in these patient groups and the general Swedish population.
Of 7625 CD patients with follow-up biopsies (median time to repeat biopsy, 1.3 years), 43% had persistent villous atrophy. The median duration of follow-up after the initial CD diagnosis was 10.6 years, and the median time to diagnosis of lymphoma was 4.9 years. The risk for lymphoma was higher in patients with villous atrophy than in the general population (102.4/100,000 person-years; standardized incidence ratio, 3.78) and in those with mucosal healing (SIR, 1.50). The risk for developing lymphoma decreased over time, possibly due to better dietary adherence prompted by the repeat biopsy findings. NHL subtype was not determined in all cases, but T-cell lymphoma appeared to be more common than B-cell lymphoma.
Comment: These results suggest that the risk for non-Hodgkin lymphoma risk can be reduced by adherence to a gluten-free diet. However, underlying biologic differences in those with poor mucosal healing or bias in selection of patients for repeat biopsy (e.g., new or persistent symptoms) cannot be excluded. Although no data on dietary adherence and biopsy findings were available, the findings support the use of repeat biopsy to verify mucosal healing.
Citation(s): Lebwohl B et al. Mucosal healing and risk for lymphoproliferative malignancy in celiac disease: A population-based cohort study. Ann Intern Med 2013 Aug 6; 159:169.
(http://annals.org/article.aspx?articleid=1722497)
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Lateral Wedge Insoles Ineffective for Knee Osteoarthritis
By Kelly Young
Lateral wedge insoles do not appear to be effective in reducing pain associated with medial knee osteoarthritis, according to a meta-analysis in JAMA.
Researchers analyzed the results of 12 studies that randomized nearly 900 patients with medial knee osteoarthritis to a lateral wedge insole or a control treatment, such as an empty shoe or a neutral control wedge. When all studies were considered, the treatment group had a small but significant reduction in self-reported pain; however, there was a high level of heterogeneity across the studies. When only neutral insole control groups were included in the analysis, there was no treatment effect.
The authors conclude: "These results suggest that compared with control interventions, lateral wedges are not efficacious for the treatment of knee pain in persons with medial knee osteoarthritis."
http://jama.jamanetwork.com/article.aspx?articleid=1730513
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'Modest' Increase in Costs for health Insurance, as Deductibles Increase
By Joe Elia
A Kaiser Family Foundation survey of 2013 employer-sponsored health insurance costs in the U.S. shows a "modest" increase in both single and family coverage (increases of 5% and 4%, respectively).
In 2013, the average worker contributed roughly $1000 for single coverage and $4600 for family coverage. Deductibles add to those costs: The percentage of workers with a general annual deductible of $1000 or more for single coverage rose from 34% in 2012 to 38% in 2013. The average deductible for single coverage is $1135, up from $735 in 2008.
A New York Times story quotes an executive of a national business group: "If you are comparing [the increase] to 10 years ago in health care, it seems modest. If you compare it to the economy and what inflation is doing, I don't think it's modest at all."
http://www.nytimes.com/2013/08/21/business/survey-finds-modest-rise-in-health-insurance-premiums.html
http://kff.org/private-insurance/report/2013-employer-health-benefits/
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U.S. Travelers Warned of Cholera in Cuba
By the NEJM Journal Watch Editors
People should take precautions when traveling to or residing in Cuba after reports of cholera in Havana and eastern Cuba, the U.S. State Department said in a security warning on Tuesday.
The primary risk factor is eating or drinking contaminated food or water. Potential sources of infection include unsterilized water, street vendor food, raw fish dishes like ceviche, and steamed shellfish.
http://photos.state.gov/libraries/havana/662225/pdf-english/Cholera-Outbreak-08-20-13.pdf
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JAMA Intern Med 2013 Aug 5
Calcium-Channel Blockers Might Be Associated with Excess Breast Cancer Risk
Other antihypertensives did not show this effect.
Several small studies have suggested an association between calcium-channel blocker (CCB) use and excess risk for breast cancer; other studies, particularly those with short follow-up, have shown no relation. To understand these conflicting results, investigators identified 1907 women (age range, 55–74) with breast cancer (invasive ductal or invasive lobular carcinomas) from a surveillance registry; cases were age-matched to 856 controls without breast cancer from a community population. Breast cancer patients were more likely to have family histories of breast cancer, be current alcohol users and smokers, and be current users of combined estrogen-progestin hormone therapy.
After adjustment for potentially confounding clinical and demographic variables, risk for both ductal and lobular breast cancer was about 2.5 times higher among current long-term CCB users (≥10 years) than among women who never used antihypertensive medications. Researchers found no excess risk associated with use of other classes of antihypertensives or short-term (<10 years) CCB use.
Comment: That calcium-channel blockers stand out compared with other classes of antihypertensives strengthens the association between CCBs and breast cancer, but no known biological mechanism accounts for these findings. An editorialist notes that calcium-channel blockers are the ninth most commonly prescribed drug class in the U.S. and would represent a major modifiable risk factor for breast cancer if these results were confirmed. These findings are worrisome but do not lead yet to specific clinical recommendations.
Citation(s): Li CI et al. Use of antihypertensive medications and breast cancer risk among women aged 55 to 74 years. JAMA Intern Med 2013 Aug 5; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jamainternmed.2013.9071)
Coogan PF. Calcium-channel blockers and breast cancer: A hypothesis revived. JAMA Intern Med 2013 Aug 5; [e-pub ahead of print].
(http://dx.doi.org/10.1001/jamainternmed.2013.9069)
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J Clin Endocrinol Metab 2013 Aug; 98:3199
Pituitary-Adrenal Axis Suppression After Long-Term Prednisone
About half the patients who received 5 mg to 10 mg daily had abnormal results on cosyntropin stimulation testing.
Many patients have suppression of the pituitary-adrenal axis after long-term corticosteroid therapy is stopped. French researchers conducted this retrospective study to examine the effect of cumulative dose and duration of steroid therapy on risk for adrenal insufficiency after stopping steroids.
Sixty patients, most with autoimmune diseases or vasculitides, had been taking 5 mg to 10 mg (mean, 7 mg) of prednisone daily when short cosyntropin stimulation tests were performed. Cumulative doses of prednisone ranged from 1 g to 132 g, and total duration of exposure ranged from 4 months to 32 years. Stimulation testing was normal in 51% of patients and abnormal in 49%. The authors' criterion for abnormal testing was either unstimulated baseline serum cortisol level <4 µg/dL or serum cortisol level <20 µg/dL at 60 minutes after receiving cosyntropin.
Both higher cumulative dose and longer duration of treatment were associated with higher risk for pituitary-adrenal suppression. The researchers identified no discrete cutoff of cumulative dose or duration that cleanly separated normal and abnormal test results.
Comment: About half the patients who had been taking prednisone for at least 4 months — and whose dose was 5 mg to 10 mg daily at the time of cosyntropin stimulation testing — exhibited suppression of the pituitary-adrenal axis. These patients would be at risk for adrenal insufficiency on stopping prednisone. Unfortunately, the authors don't tell us how long these patients had been receiving 5-mg-to-10-mg doses prior to testing.
Citation(s): Sacre K et al. Pituitary-adrenal function after prolonged glucocorticoid therapy for systemic inflammatory disorders: An observational study. J Clin Endocrinol Metab 2013 Aug; 98:3199.
(http://dx.doi.org/10.1210/jc.2013-1394)
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