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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
September 10, 2016

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Higher Free Thyroxine Levels Raise Risks for Sudden Cardiac Death
Antibacterial Soap Disappearing
Mylan Announces Plans for Generic EpiPen
Pan Drugs of India Warned-Data Integrity and Sanitation (Rodents/Lizards)
China Manufacturing Plant Full of Holes, Chipped Paint, and Insects
China Drug Sales to U.S. Growing but with Safety Concerns
A New Direction for Treatment-Resistant Depression
Sexual Dysfunction Common Among Young People After MI
What's the Purpose of Human Female Orgasm?
First-Trimester MRI Appears to Be Safe, Gadolinium-Enhanced MRI Still Risky
Electric Fans May Not Benefit Elderly During Extreme Heat
More Exercise Could Mean Less Money Spent on Healthcare
Exercise vs. Arthroscopic Surgery in Middle-Aged Patients with Degenerative
   Meniscal Tears
Adolescent Obesity and Functional Limitations in Young Adulthood
Bariatric Surgery Improved Mobility and Reduced Musculoskeletal Pain in
   Severely Obese Teens

Higher Free Thyroxine Levels Raise Risks for Sudden Cardiac Death
By Joe Elia, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Higher levels of free thyroxine (even in the high-normal range) show an association with sudden cardiac death, a Circulation study finds.
Some 10,000 participants aged 45 and older in the prospective Rotterdam Study cohorts were followed for a median 9 years. Those characterized as euthyroid on the basis of their thyroid-stimulating hormone levels — but with high-normal thyroxine levels — showed a 2.5-fold higher risk for sudden cardiac death. With increasing thyroxine levels still in the normal range, the absolute 10-year risk rose from 1% to 4%.
The authors observe that the mechanism for this effect remains unknown and that "no conclusions on the benefits or risks of thyroid medication" to lessen the risk should be drawn from their results.
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Antibacterial Soap Disappearing
Antibacterial soaps will soon disappear from store shelves says the FDA, as they provide no benefits over regular soap. Products with 19 antibacterial ingredients, including triclosan and triclocarban, must be reformulated or removed from stores within a year.
NOT covered by this ruling are hand sanitizers and wipes designed to be used without water and containing more than 50% alcohol and cleansers in hospitals or nursing homes.
Triclosan and the other 18 ingredients are present in more than 2,100 products, or roughly 40% of the soaps on the market. Manufacturers have not demonstrated that they are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.
The FDA will allow products with another three ingredients to remain on the market for the moment. Manufacturers have until February to present information on the safety of products containing benzalkonium chloride, benzethonium chloride, and chloroxylenol. 
Note from Editor: Here is a list of the newly banned chemicals:

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Mylan Announces Plans for Generic EpiPen
Mylan, which makes the EpiPen autoinjector, said on Monday that it would launch a generic version of the device, following an uproar over recent cost hikes.
The generic, expected to be on the market within weeks, would cost $300 per pack, roughly half the cost of the brand-name version.
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Pan Drugs of India Warned-Data Integrity and Sanitation (Rodents/Lizards)
For the second time in less than a year, the FDA has issued a warning letter to Indian active pharmaceutical ingredient maker Pan Drugs over data integrity and sanitation violations. Due to the extent and repeated nature of the violations, the FDA says Pan must carry out a comprehensive plan to investigate and address the issues.
The warning letter also cites Pan for failing to keep its facilities and equipment clean, noting the presence of mold, rodent feces, and a lizard in the company's processing area, as well as rust and dirt on some of its manufacturing equipment. According to the FDA, a Pan representative told investigators the company "had no cleaning procedure for the equipment or facility." 
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China Manufacturing Plant Full of Holes, Chipped Paint, and Insects
The Import Alert list has two plants added by the FDA that are operated by Xinxiang Tuoxin Biochemical in Xinxiang City, Henan, China. Inspectors looking the facilities over last year found buildings full of holes, insects flying in manufacturing areas, and equipment in total disrepair. The inspectors found non-dedicated drug manufacturing equipment "in a state of disrepair" with reactors that contained significant product buildup and chipped paint. The buildings were just as bad with chipped paint on the ceiling directly above open equipment used for manufacturing, gaps around windows and doors, holes in ceilings directly above equipment, and "lying insects that were observed in cleanrooms."
China now has 50% of the global active pharmaceutical ingredients market; exports of pharma products from Chinese companies to the U.S. grew 4% last year. 
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China Drug Sales to U.S. Growing but with Safety Concerns
Chinese drugs and pharmaceutical ingredients worldwide jumped 3% to $56 billion last year. Pharma companies of China exports to the U.S. rose 4% last year. Also growing are questions about the safety of its products. Last year, about 700 Chinese firms were told by China regulators to review their pending applications to sell new drugs and voluntarily withdraw any that were false or incomplete. About 75% were retracted by the manufacturers or rejected by Chinese officials.
China now has nearly 5,000 drug factories supplying the domestic market and more than 500 facilities registered to sell to the U.S. An example of the problem is when Chinese regulators arrived unannounced at the warehouses of a generic drug maker called Hainan Yier Pharmaceutical Co.; samples were taken and tests done. The results showed three batches of pharmaceutical ingredients intended for anti-depressant tablets didn't meet quality standards and were only a kind of starch. Some also contained poor quality ingredients. 
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MM: An issue not directly addressed in this article is the inability of many people to activate vitamins such as folic acid or B-12 via methylation. This inability to convert chemicals through methylation, an elemental chemical body function may lay at the bottom of many of the health issues from vitamin deficiencies that we face today.
Am J Psychiatry 2016 Aug 13 2011 Aug 8/22; 171:1363
A New Direction for Treatment-Resistant Depression
More than a third of treatment-resistant patients had cerebral folate deficiencies, and all who were treated with folinic acid showed some improvement in depression.
About one third of patients with major depression don't respond to first-line treatments; 15% are resistant to all treatments (treatment-resistant depression [TRD]). After successfully treating TRD in a patient deficient in cerebrospinal fluid (CSF) tetrahydrobiopterin (necessary for biosynthesis of several neurotransmitters) with sapropterin (synthetic form of tetrahydrobiopterin's active isomer), investigators searched for this and other potential metabolic abnormalities in 33 TRD patients.
Patients had failed >3 medication trials (mean age, 26; 76% women; age at onset: ≤17 years, 91%; <10 years, 33%); 85% had comorbid diagnoses, primarily anxiety disorders, post-traumatic stress disorder, or both. Of their first-degree relatives, 82% had histories of depression and 24% had attempted suicide.
Metabolic abnormalities examined in CSF, blood, and urine involved tetrahydrobiopterin, 5-methyltetrahydrofolate (5-MTHF; related to vitamin B9), pyridoxal-5-phosphate (vitamin B6), amino-adipic semialdehyde (biomarker of low cerebral pyridoxine), and major neurotransmitter metabolites (homovanillic acid, 5-hydroxyinoleacetic acid). CSF metabolic abnormalities were detected in 21 patients. Twelve (36%) had cerebral folate deficiency (CFD; low CSF 5-MTHF with normal serum folate); one also had tetrahydrobiopterin deficiency. Nine patients had other abnormalities. CFD patients received 6 weeks of adjunctive folinic acid treatment. All 10 patients with follow-up data showed improved depression scores, which reached normal range in 4. Of 5 patients with elevated suicide scores, 3 showed reductions below threshold.
COMMENT: This first-ever metabolomics survey specific to the central nervous system in TRD patients lacking neurological symptoms reveals many actionable abnormalities. We need to identify biomarkers not requiring spinal taps and explore how abnormalities might reflect sequelae of depression or other acquired or genetic effects. Although additional study is needed before clinicians begin adopting this adjunctive approach, the authors mention that clinicians wishing to try it in select patients who have failed all other options should use folinic acid (1–2 mg/kg/day), which acts earlier in folate pathways than L-methylfolate.
CITATION(S): Pan LA et al. Neurometabolic disorders: Potentially treatable abnormalities in patients with treatment-refractory depression and suicidal behavior. Am J Psychiatry 2016 Aug 13; [e-pub].
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Sexual Dysfunction Common Among Young People After MI
By Kelly Young
Young adults who have had an acute myocardial infarction often experience sexual problems in the subsequent year, finds a JAMA Cardiology study.
Researchers prospectively studied 2800 Spanish and American patients aged 18 to 55. One year after MI, 73% of women and 85% of men were sexually active. Of these, 59% of women and 46% of men said they experienced at least one sexual problem. Among women, lack of interest, trouble lubricating, and trouble breathing during intercourse were common; for men, erectile difficulties, lack of interest, and anxiety were common.
Just 19% of women and 31% of men reported discussing resuming sexual activity with their physician.
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J Exp Zoolog B Mol Dev Evol 2016 Jul 31
What's the Purpose of Human Female Orgasm?
Evolutionary theory suggests that dissociation of female orgasm from ovulation has “freed orgasm to gain secondary roles.”
Unlike male orgasm, which propels sperm into the female reproductive tract, female orgasm seems superfluous to human reproduction and, in fact, is difficult to achieve through penetrative intercourse. These authors ask, “What is female orgasm there for?”
Physiologically, many mammals can only reproduce during a limited season with specific environmental cues and conditions (e.g., daylight length, pheromones, copulation) and availability of a mate to induce ovulation. In humans, ovulation is spontaneous — reliant on a hormonal cycle independent of copulation or other cues — but may have originally been copulation-induced, as evidenced by the surges of prolactin and oxytocin that still accompany female orgasm. In mammals in which copulation-induced ovulation is anatomically triggered by clitoral stimulation, the clitoris is close to or within the vaginal canal. Studies in humans have shown that the distance between the urethral orifice and clitoris negatively correlates with likelihood of intercourse-induced orgasm.
COMMENT: The authors postulate that, ancestrally, ovulation in humans and some other mammals was copulation-induced, and the clitoris was located near or within the vaginal canal. With increasing availability of mates and access to sexual intercourse, spontaneous ovulation evolved, and the clitoris became superfluous for reproduction; thus, female orgasm no longer “serves the purpose for which it originated,” and the dissociation from ovulation might “free orgasm to gain secondary roles.” Female orgasm and its achievement is the topic of numerous lay publications. Medical education urges us to address sexuality with our patients. Although this evolutionary theory might not aid us in counseling, it provides an interesting perspective on why some women find intercourse-related orgasm elusive.
CITATION(S): Pavličev M and Wagner G.The evolutionary origin of female orgasm. J Exp Zoolog B Mol Dev Evol 2016Jul 31; [e-pub].
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First-Trimester MRI Appears to Be Safe, Gadolinium-Enhanced MRI Still Risky
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
First-trimester MRI does not lead to adverse fetal or childhood outcomes, according to a retrospective study in JAMA. In contrast, gadolinium-enhanced MRI in any trimester appears to be risky, thus reinforcing guidelines advising against its use.
Using healthcare databases from Ontario, Canada, researchers studied over 1.4 million deliveries that occurred between 2003 and 2015. Some 1700 of these pregnancies were exposed to MRI in the first trimester, and 400 were exposed to gadolinium-enhanced MRI at any time.
Compared with unexposed pregnancies, those with first-trimester MRI showed no increase in risk for five outcomes assessed from birth through age 4 years. These outcomes included stillbirth or neonatal death; congenital anomaly; neoplasm; vision loss; and hearing loss.
However, gadolinium MRI was associated with a 36% increased risk for any rheumatological, inflammatory, or infiltrative skin condition through age 4, and also with nearly a fourfold increase in risk for stillbirth or neonatal death (although there were just 7 such events).

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Electric Fans May Not Benefit Elderly During Extreme Heat
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Electric fans may be of little use to the elderly — and may actually be harmful — during prolonged heat waves, according to a research letter in JAMA.
Nine participants aged 60 to 80 sat in a room that was 42 degrees Celsius (108 degrees Fahrenheit) for 100 minutes. The relative humidity was gradually increased from 30% to 70%. On separate days, participants sat in the chamber with and without a 16-inch fan blowing on them.
Fan use was associated with greater heart rate and core temperatures. There was no difference in sweat loss between the fan and no-fan conditions.
NEJM Journal Watch General Medicine's Thomas Schwenk comments: "The increase in temperature or heart rate with fan use is not clinically important, but the lack of a decline is. Clinicians should advise patients that a fan alone has no cooling value if used in a hot humid environment."
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More Exercise Could Mean Less Money Spent on Healthcare
By Kelly Young, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Optimal levels of moderate-to-vigorous physical activity are associated with lower healthcare expenditures, according to a study in the Journal of the American Heart Association.
Roughly 26,000 U.S. adults were surveyed about whether they engaged in at least 30 minutes of moderate-to-vigorous physical activity at least 5 days a week. Those who did were considered to have optimal physical activity, while those who didn’t had nonoptimal activity.
Overall, participants with optimal physical activity spent less on healthcare than those with nonoptimal activity ($4153 vs. $4867). This was true whether or not patients had cardiovascular risk factors or cardiovascular disease. Healthcare utilization was also lower with optimal physical activity.
The authors conclude: “These robust estimates for potential health care savings strongly support the [American Heart Association’s] strategic goals for optimizing [physical activity] levels as a means to favorably impact the increasing burden of CVD and associated costs.”
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BMJ 2016 Jul 20;354:i3740
Exercise vs. Arthroscopic Surgery in Middle-Aged Patients with Degenerative Meniscal Tears
In a randomized trial, exercise was as effective as arthroscopy in relieving pain and improving function.
Many studies suggest that arthroscopic partial meniscectomy is no more effective than nonsurgical treatments for alleviating knee pain in patients with degenerative meniscal tears (NEJM JW Gen Med Oct 1 2014 and CMAJ 2014; 186:1057). In this randomized trial, researchers compared exercise therapy alone with arthroscopic surgery alone in 140 patients (mean age, 50) with unilateral knee pain for >2 months and medial degenerative meniscal tears; most patients had no radiographic evidence of osteoarthritis (OA). The exercise group performed progressive strengthening exercises during supervised sessions (2 or 3 times weekly for 12 weeks); arthroscopy patients followed standard postoperative routines and were given instructions for simple daily range-of-motion exercises.
In intent-to-treat analyses, the exercise group showed significantly greater improvement in muscle strength at 3 months. At 24 months, both groups had clinically relevant improvements in knee pain, function, and knee-related quality of life, with no significant differences between groups. During the trial, 13 exercise patients crossed over to surgical treatment, and 2 meniscectomy patients required repeat operations because of persistent pain. No serious adverse events were reported in either group.
COMMENT: This is yet another study showing that an exercise program is as effective and as well tolerated as surgical intervention in patients with meniscal tears and minimal OA. Some patients randomized to exercise therapy crossed over to surgery because of persistent symptoms. Also, arthroscopy patients were not given as vigorous an exercise program as the exercise group — meniscectomy plus vigorous exercise might yield even better outcomes. However, until that study is done, initially directing patients with knee pain, mild OA, and degenerative meniscal tears to aggressive physical therapy or equivalent exercise seems prudent.
CITATION(S): Kise NJ et al. Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients: Randomised controlled trial with two year follow-up. BMJ 2016 Jul 20;354:i3740.

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J Adolesc Health 2016 Jul 25
Adolescent Obesity and Functional Limitations in Young Adulthood
Compared with nonobese peers, adolescents who became or remained obese were approximately two times more likely to have a functional limitation in young adulthood.
Obese adolescents are at increased risk for adult morbidity, but less is known about their short-term health risks. Investigators used nationally representative longitudinal survey data to determine whether being or becoming obese during adolescence increases the risk for developing functional limitations in young adulthood.
Data were from 8032 adolescents (mean age, 15.5 years) surveyed during 1994–1995 (baseline), in 1996 (baseline obesity measure), and again in 2001–2002. Participants were classified by weight trajectory as becoming obese, persistently obese, persistently nonobese, or reversing obesity (going from obese to nonobese). Two measures of functional limitations (e.g., difficulty moving a table, pushing a vacuum, or bathing and dressing) were assessed.
The prevalence of functional limitations at follow-up was 21%–26%. Compared with nonobese peers and controlling for age, gender, race/ethnicity, and presence of chronic conditions and functional limitations at baseline, adolescents who became obese were 1.6–1.8 times more likely to have functional limitations in young adulthood, those with persistent obesity were 1.9–2.1 times more likely to have functional limitations, and adolescents with obesity reversal were not at increased risk for functional limitations.
COMMENT: Getting someone to change a behavior is challenging, and it might be difficult for an obese adolescent to be motivated to lose weight based on possible adverse health outcomes that are far off in the future or silent (e.g., hypertension). Focusing on short-term adverse outcomes that include physical limitations may be a more fruitful approach. It is encouraging to see that those who lost weight in this study were not at increased risk for functional limitations.
CITATION(S): Lee H et al. The association between adolescent obesity and disability incidence in young adulthood. J Adolesc Health 2016 Jul 25; [e-pub]. (http://dx.doi.org/10.1016/j.jadohealth.2016.05.015)
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JAMA Pediatr 2016 Jul 18
Bariatric Surgery Improved Mobility and Reduced Musculoskeletal Pain in Severely Obese Teens
Improvements in adolescents were similar to results in adults and persisted 2 years after surgery.
Severely obese teens suffer multiple complications, including chronic musculoskeletal pain and decreased functional mobility. Bariatric surgery in adults has improved such conditions, but whether teens might experience similar benefits was unknown.
In a prospective, observational study, 206 severely obese (mean body-mass index [BMI], 51.7 kg/m2) patients (age, 13–20 years) were followed for 2 years after bariatric surgery at one of five U.S. adolescent bariatric surgery centers. Data were analyzed at baseline, 6 months, 12 months, and 24 months after surgery. At each time point, investigators measured time to completion of a 400-m walk test, resting and posttest heart rate (HR), and mean HR difference (resting to posttest). Musculoskeletal pain concerns were recorded before and after the test. Adjustments were made for age, race/ethnicity, sex, baseline BMI, and surgical center.
At 6 months postsurgery, mean 400-m walk test completion time was reduced by 29 seconds (376 to 347), resting HR from 84 to 74, posttest HR from 128 to 113, and mean HR difference from 40 to 34. These changes persisted at 12 and 24 months. Compared with baseline, pain concerns were reduced at all time points after surgery.
COMMENT: Although some severely obese teens achieve significant improvements in body-mass index through lifestyle changes leading to improved mobility, maintaining such improvement is very difficult. As bariatric surgery becomes more broadly available to teens, evidence of benefit is critical to any review of treatment options. I care for severely obese teens who have been significantly debilitated by musculoskeletal pain, and I am encouraged that bariatric surgery may offer them some relief.
CITATION(S): Ryder JR et al. Changes in functional mobility and musculoskeletal pain after bariatric surgery in teens with severe obesity: Teen–Longitudinal Assessment of Bariatric Surgery (LABS) study. JAMA Pediatr2016 Jul 18; [e-pub]. (http://dx.doi.org/10.1001/jamapediatrics.2016.1196)

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