Home  |  Patients  |  Physicians  |  In the News  |  Hours/Location  |  Contact
        Bio-Identical Hormones
             Hormones for Women
             Hormones for Men
             Hormone Drug Info
      • Erectile Dysfunction
      • HCG Weight Loss
      • NasoNeb & Sinus Meds
      • Pain Management
      • LDN, MS & Autoimmune
      • Sterile Clean Room
      • Veterinary Compounding

             Drug Shortages
             AMA Recognition
             Legal Information
             Insurance Services
        Nutritional Products
             Product Review Process
             Synergy Blends
        Veterinary Products
             Drug Shortages
        What is the Rose Garden
        Compression Hosiery
        Bras & Camisoles
        Swim Suits
        Hats & Turbans
        Lymphedema Garments

     • Rental, Repair, Sales
     • NasoNeb & Sinus Meds
     Breast Pumps & Nursing
     • Product List

        Product List
        Product Review Process
        Synergy Blends
        Veterinary Products
        •  Compounds
        •  Supplements

        PCAB Accreditation
        Legal Information
      • Staff Members
        History of Mark Drugs

Content 7


The Doctor and the Pharmacist

Radio Show Articles:
February 27, 2016

Back to Specialties button

Cardiac Events in Patients with Gout treated with Colchicine
Appropriate Antibiotic use in Adults with Acute Respiratory Tract Infections
CDC: Flu Vaccine nearly 60% Effective, Egg-Allergic Patients may receive
   Live Attenuated Vaccine
Sharp Increase in Marijuana-Related ED visits in Colorado by Non-Residents
   After Recreational Legalization
Managing Cancer Pain: Two Randomized Trials
Mindfulness Meditation confers Mixed Benefits in Patients with Chronic
   Low Back Pain
Trends in BRCA Mutation Testing and Prophylactic Mastectomies among
   Young Women with Breast Cancer
Vaginal Progesterone shows No Significant Effect on Neonatal or
   Childhood Outcomes
Breast Concerns affect Girls' Participation in Sports and Exercise
A Standardized Fecal Microbiota Preparation for Recurrent C.
   difficile Infection
"Socially Transitioned" Prepubescent Transgender Kids have similar Mental Health
   to their Peers
Do Electronic Toys affect Language Development?
Vaginal Seeding of Babies born by C-Section Potentially Unsafe, Editorialists Say
A New Approach to Finding an HIV Vaccine?
Pot Is Becoming More Potent — and Riskier

MM: This is an interesting outcome but I would be a bit leery about the conclusion from the data. One thought that comes to mind is that "pain" is a great motivator. Anyone who has ever experienced a gout attack will likely concede that it is a miserably painful experience and that they would likely do just about anything to prevent a recurrence. This is where I contend that the pain associated with a gout attack, as a motivation, can lead to a healthier diet and lifestyle that has the added benefit of being more "heart healthy". Colchicine recently went from a very inexpensive generic drug to the brand name only product "Colcrys". This served to increase the price of colchicine significantly. Given the economic benefit of increasing the number of indications and the resultant number of potential patients who might use colchicine for cardiovascular issues, makes me suspicious of this data. Additionally, it is possible that a new indication could increase the life of the patent for this product resulting in even greater potential profits for the drug manufacturer.
Ann Rheum Dis 2015 Nov 18
Cardiac Events in Patients with Gout treated with Colchicine
Cardiovascular risks were lower with colchicine use, in an observational study from a single medical center.
Colchicine, a gout treatment that downregulates inflammation in part by blocking formation of microtubule spindles, has been found to provide protection from recurrent cardiac events in patients with various heart diseases. But little is known about its effect in patients with gout. These researchers linked data from an electronic medical records database with 2006–2011 Medicare claims data to identify patients with a diagnosis of gout.
The investigators compared 501 patients who were new colchicine users with 501 age- and sex-matched nonusers (mean age, 73; men, 64%). Hypertension rates and use of statins, nonsteroidal anti-inflammatory drugs, and steroids were higher in the colchicine group.
At a median follow-up of 1.3 years, the primary composite outcome of myocardial infarction, stroke, or transient ischemic attack was less common among colchicine users than nonusers, although the two groups had similar incidence rates for revascularization interventions. Colchicine use was associated with lower all-cause mortality. In the statistical model adjusting fully for group differences, the risk for the primary cardiovascular outcome was 49% lower with colchicine use.
COMMENT: New use of colchicine is associated with lower cardiovascular risk among patients with gout. As the authors note, a randomized, controlled trial of colchicine in patients with gout is warranted. Clinical trials are under way evaluating colchicine for secondary prevention in patients with gout.
CITATION(S): Solomon DH et al. Effects of colchicine on risk of cardiovascular events and mortality among patients with gout: A cohort study using electronic medical records linked with Medicare claims. Ann Rheum Dis 2015 Nov 18; [e-pub]. (http://dx.doi.org/10.1136/annrheumdis-2015-207984)
Top of Page


Ann Intern Med 2016 Jan 19
Appropriate Antibiotic use in Adults with Acute Respiratory Tract Infections
Antibiotics should not be prescribed for most patients with uncomplicated bronchitis, sore throat, or acute rhinosinusitis.
Sponsoring Organizations: American College of Physicians (ACP), Centers for Disease Control and Prevention (CDC)
Target Audience: All clinicians who provide care to adults in ambulatory settings
Antibiotics are prescribed during more than 100 million adult ambulatory visits annually; an estimated 50% of these prescriptions might be unnecessary or inappropriate. This paper from the ACP and the CDC is an update of 2001 guidelines on appropriate antibiotic use for acute respiratory tract infection in adults (NEJM JW Gen Med Apr 15 2001 and Ann Intern Med 2001; 134:479) and includes advice on managing bronchitis, pharyngitis, and rhinosinusitis. The focus of the update is healthy adults without chronic lung disease or immunocompromising conditions.
Key Points and Recommendations

COMMENT: Unnecessary antibiotic use contributes to drug resistance and preventable morbidity and mortality. Although randomized trials have demonstrated that antibiotics are ineffective for most acute respiratory tract infections, such infections are the most common reason for prescribing antibiotics in adults in ambulatory settings. The authors acknowledge that patient demands might drive antibiotic misuse and offer guidance on how to address patient expectations (e.g., label acute bronchitis as a “chest cold” or “viral upper respiratory infection”). The CDC provides patient information sheets about appropriate antibiotic use and alternatives to antibiotics for symptom management.
CITATION(S): Harris AM et al. Appropriate antibiotic use for acute respiratory tract infection in adults: Advice for high-value care from the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med 2016 Jan 19; [e-pub]. (http://dx.doi.org/10.7326/M15-1840)
Top of Page


CDC: Flu Vaccine Nearly 60% Effective, Egg-Allergic Patients May Receive
Live Attenuated Vaccine

By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
The 2015–16 influenza vaccine is 59% effective so far — comparable to past seasons with good matches between vaccine and circulating virus strains — according to data presented at the CDC's Advisory Committee on Immunization Practices (ACIP) meeting on Wednesday. When broken down by virus type, the estimated effectiveness is 51% against the H1N1 viruses causing most influenza this season, 76% against all influenza B viruses, and 79% percent against the B/Yamagata lineage of B viruses. Flu activity started slowly this year, not becoming elevated until mid-January. Activity has remained elevated since then and "is still on the upswing and expected to continue for several weeks," said Dr. Joseph Bresee, chief of the CDC's Epidemiology and Prevention Branch.
Also at the meeting, ACIP updated its flu vaccine recommendations to note that patients with egg allergy may now receive live attenuated vaccine. (A 2015 study in The BMJ demonstrated its safety in egg-allergic children; see link below.)
Top of Page


MM: This is not a surprising statistic. It is very similar to those who have an early experience with over-consumption of alcohol resulting in a hangover and all the maladies associated with that. It is especially notable that the occurrences of problems are greater with edible products rather than those that are inhaled. It can take 1-2 hours for an edible product to demonstrate effectiveness but the duration of it's effects tends to last several hours (4-6 hours) compared to an inhaled product that may last only an hour or so but takes effect almost immediately. This delayed effect, so common in edibles, leads people who are naive to the products to think that it is ineffective or an insufficient dose leading them to take a second dose of equal or greater quantity that results in a temporary overdose. Fortunately the euphoria effects of these products tend to be quite temporary and results rarely, if any, significant negative consequence beyond a significant scare to the unfortunate person who has over-indulged.
Sharp Increase in Marijuana-Related ED visits in Colorado by Non-Residents after Recreational Legalization
By Cara Adler, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Marijuana-related emergency department visits increased more steeply among non-Colorado residents ("marijuana tourists") than among residents after retail sales of recreational marijuana began, according to a letter to the New England Journal of Medicine.
At a Colorado hospital, rates of ED visits possibly related to cannabis use increased significantly among non-residents between 2013 and 2014 (rate ratio, 1.98), but not among residents. Statewide hospital data showed similar results for non-residents (RR, 1.46) and a smaller but significant rise for residents (RR, 1.17).
In a separate review in Annals of Emergency Medicine, the authors note that supportive care is the primary management for acute marijuana intoxication, and most adult patients can be discharged after symptoms improve. They caution that intoxication from ingesting edible marijuana products can cause severe symptoms, particularly in children.
Dr. Ali Raja of NEJM Journal Watch Emergency Medicine comments, "Clinicians throughout the country, especially those who practice in states where marijuana is now legal, should be prepared for the severity of symptoms and emphasize to their patients that regardless of legality, it is a drug with significant untoward, and for edibles, unpredictable side effects."

Top of Page


MM: There are still gross misunderstandings and prejudices concerning the treatment of pain and other symptoms that are associated with cancer. Cancer pain is quite different from typical somatic pain and responds differently to medications. Opiates may decrease some of the pain and some of the anxiety as well as assisting in various breathing problems often associated with pain and anxiety but they are not always the answer to the various "pains" that may be present. NSAIDs such as ibuprofen is often very effective as an adjunct to opiates for bone pain associated with cancer. They can decrease the dose of the opiate necessary as well as increase the duration of effect that the opiate may have while not suppressing breathing to a dangerous level. Medical Marijuana is often a viable adjunctive treatment that works on different pain receptors in the brain having an effect on how the body interprets the pain stimulus while also having an effect on inflammatory modulating messengers in the body referred to as cytokines and interleukins.
J Clin Oncol 2016 Feb 10; 34:436
Managing Cancer Pain: Two Randomized Trials
One study challenges the WHO analgesic ladder, and another challenges the effectiveness of pregabalin for painful bone metastases.
Two recent studies in the Journal of Clinical Oncology add to our understanding of cancer pain treatments.
The World Health Organization's traditional three-step analgesic ladder consists of nonopioids, weak opioids, and strong opioids for treating patients with mild, mild-to-moderate, and moderate-to-severe cancer pain, respectively. But some experts argue that skipping weak opioids (step 2) and moving directly to low doses of so-called strong opioids (e.g., morphine) is reasonable when nonopioid analgesics are inadequate.
In an open-label randomized trial from Italy, researchers assigned 240 opioid-naive cancer patients with moderate pain to receive either step-2 analgesics (codeine or tramadol, usually combined with acetaminophen and titrated to maximal recommended doses) or oral immediate-release morphine (starting with 5 mg every 4 hours and transitioning eventually to slow-release equivalent dosage). During 4 weeks of follow-up, the morphine group achieved better pain control than did the weak-opioid group, with no higher incidence of side effects.
In a randomized double-blind trial from the U.K., researchers addressed the uncertain effectiveness of the anticonvulsant analgesic pregabalin for painful bone metastases in 233 patients, most of whom had breast, lung, or prostate cancer. Patients received radiotherapy plus 1 month of either pregabalin (titrated to a maximum dose of 300 mg twice daily) or placebo. At 1 month, the proportion of patients with adequate pain relief was virtually identical in both groups.
COMMENT: The study from Italy supports those who question the usefulness of the distinction between steps 2 and 3 in the WHO analgesic ladder; compared with step-2 drugs, oral morphine was more effective and equally well tolerated. The U.K. study suggests that pregabalin is ineffective for treating patients who are receiving radiotherapy for painful bone metastases. However, editorialists argue that pregabalin might require more than 4 weeks for maximal effect and that pregabalin might have been effective if the study had focused specifically on patients whose bone pain had neuropathic features.
CITATION(S):Bandieri E et al. Randomized trial of low-dose morphine versus weak opioids in moderate cancer pain. J Clin Oncol 2016 Feb 10; 34:436. (http://dx.doi.org/10.1200/JCO.2015.61.0733)

Fallon M et al. Randomized double-blind trial of pregabalin versus placebo in conjunction with palliative radiotherapy for cancer-induced bone pain. J Clin Oncol 2016 Feb 20; 34:550

Raman S et al. Does pregabalin still have a role in treating cancer-induced bone pain? J Clin Oncol 2016 Feb 20; 34:524.

Top of Page


JAMA Intern Med 2016 Feb 22.
Mindfulness Meditation Confers Mixed Benefits in Patients with
Chronic Low Back Pain

Reductions in severe pain were sustained, but functional improvements were not.
The high prevalence of chronic pain and increasing concerns about risks associated with anti-inflammatory and opioid analgesics have focused attention on nonpharmacological approaches to pain control. In this study, 282 community-dwelling older adults (mean age, 75; 66% women) with functional limitations related to moderate-intensity low back pain (duration, ≥3 months) were randomized to mindfulness meditation or usual education. Mindfulness meditation training consisted of eight weekly 90-minute group sessions on mind–body techniques, including directed breathing and mindful awareness of thoughts and sensations. Control participants received eight weekly group sessions focused on health education. Patients with serious illnesses or mental health problems were excluded.
At 8 weeks, functional impairment (the primary outcome) was significantly improved from baseline in the mindfulness group compared with the control group, although this difference was of modest clinical importance; functional improvement did not differ between groups at 6 months. A higher proportion of mindfulness patients than education patients reported reductions in the most-severe pain (36% vs. 22%) at both 8 weeks and 6 months and marked symptom improvement (45% vs. 8%) at 6 months.
COMMENT: This study shows that mindfulness meditation training has some potential for reducing pain and symptoms in older patients with low back pain, with some measures showing a benefit for as long as 6 months. Standardization of training and a better understanding of which training components are associated with specific outcomes would be helpful.
CITATION(S): Morone NE et al. A mind-body program for older adults with chronic low back pain: A randomized clinical trial. JAMA Intern Med 2016 Feb 22; [e-pub]. (http://dx.doi.org/10.1001/jamainternmed.2015.8033)
Top of Page


JAMA Oncol 2016 Feb 11. Blazer KR et al. JAMA Oncol 2016 Feb 11
Trends in BRCA Mutation Testing and Prophylactic Mastectomies among Young Women with Breast Cancer
Although more women are being tested appropriately, concerns are emerging..
Because prevalence of BRCA1 and BRCA2 mutations is higher among young women with breast cancer, NCCN guidelines recommend carrier testing for women with diagnoses at or before age 50. In the Young Women's Breast Cancer Study, researchers in the U.S. and Canada enrolled women diagnosed with breast cancer at age ≤40.
Among 897 participants recruited between 2006 and 2014 (mean age at diagnosis, 35.5), 86.1% were non-Hispanic white, 84.5% had at least a college education, and 99.8% were insured. BRCA testing was performed within 1 year of diagnosis in 87.0% of participants, with uptake rising from 76.9% in 2006 to 95.3% in 2013. Rates of specific test outcomes were 7.6% (BRCA1 mutation), 4.5% (BRCA2 mutation), 4.6% (indeterminate result of unknown clinical significance), and 81.3% (negative result). Among mutation carriers, 86.4% proceeded with risk-reducing bilateral mastectomy; among women not found to be carriers, 51.2% did so.
COMMENT: Although it's encouraging to see that rising proportions of young women with breast cancer are receiving genetic counseling and testing, these findings in highly educated, largely white, affluent women are not generalizable to all U.S. women with breast cancer diagnosed at a young age. Nonetheless, it's a concerning reflection of nationwide trends that more than half of BRCA-negative participants chose bilateral prophylactic mastectomy (a procedure not recommended in this population). The increasing use of next-generation sequencing (which yields information on moderate- and low-penetrance genes in addition to BRCA status) means that women and their providers are increasingly confronted with test results that call for formal genetics expertise to interpret. Unfortunately, genetic counselors remain scarce — and many clinicians without the requisite training are offering these tests. As editorialists note, these trends may further increase the likelihood that low-risk women will elect bilateral mastectomy. I continue to refer my patients whose histories indicate high-risk status to cancer genetics counselors for education and possible testing.
CITATION(S): Rosenberg SM et al. BRCA1 and BRCA2 mutation testing in young women with breast cancer. JAMA Oncol 2016 Feb 11; [e-pub]. (http://dx.doi.org/10.1001/jamaoncol.2015.5941); Blazer KR et al. Increased reach of genetic cancer risk assessment as a tool for precision management of hereditary breast cancer. JAMA Oncol 2016 Feb 11; [e-pub].
Top of Page


Vaginal Progesterone Shows No Significant Effect on Neonatal or
Childhood Outcomes

By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Vaginal progesterone to prevent preterm birth in high-risk women showed no significant effect on neonatal or childhood outcomes in aLancet study.
Over 1200 women with singleton pregnancies at risk for preterm delivery were randomized to administer progesterone (200 mg) or placebo capsules at bedtime, from 22–24 weeks' through 34 weeks' gestation. Risk factors for preterm birth included short cervix, prior preterm birth or second-trimester loss, or past cervical procedures for abnormal Pap results.
There were three primary outcomes: fetal death or delivery before 34 weeks' gestation; a composite of neonatal death, bronchopulmonary dysplasia, or brain injury; and cognitive scores at age 2 years. After multivariable adjustment, none of these outcomes differed between the groups.
Commentators say that because progesterone showed no harms, the decision to use it "becomes an issue of shared decision making." They also note that there were fewer neonatal deaths with progesterone than with placebo (1 vs. 6) — a finding that could influence some parents' decision.
Dr. Allison Bryant of NEJM Journal Watch Women's Health adds: "The findings call into question the overall benefit of vaginal progesterone for those at risk of preterm birth; however, the effects of progesterone injections, used now for women with prior preterm birth, were not specifically investigated."
Top of Page


J Adolesc Health 2016 Feb; 58:167
Breast Concerns Affect Girls' Participation in Sports and Exercise
In a U.K. survey, 73% of adolescent girls reported concerns about their breasts — most commonly breast bounce — that influenced their participation in these activities.
In a recent study, 17% of women cited breast concerns as a barrier to sports and exercise participation (J Phys Ac Health 2015; 12:588). To study this issue in adolescents, investigators surveyed 2089 U.K. school girls aged 11 to 18 years (57% white, 22% Asian, 10% black). Nearly all reported breast development and wearing some kind of breast support.
Larger-breasted girls (cup size D or larger) were less likely than smaller-breasted girls to participate in compulsory sports at least once per week, but breast size was not associated with participation in noncompulsory sports. More larger-breasted (63%) than smaller-breasted (45%) girls reported their breasts had some effect on sports/exercise participation. Overall, 73% of girls reported at least one breast-specific concern, most commonly breast bounce (38%), embarrassment when getting changed (34%), breast pain during exercise (30%), and needing a sports bra (29%). Almost 40% of larger-breasted girls worried their breasts were too big to exercise. More than half of girls reported never wearing a sports bra. Nearly 90% of girls wanted to know more about breasts.
COMMENT: In the U.S., only 37% of high school girls, compared to 57% of boys, are physically active at least 60 minutes per day at least 5 days per week. Hence, removing barriers to girls' participation is important. This study suggests that concerns about breasts — especially among girls with larger breasts — may be one important barrier. A recent Australian study demonstrated that providing breast education information to adolescent girls improved knowledge about bra fit and support (J Physiother 2010; 56:19). Pediatricians can provide similar information to teenage girls and their mothers: Two good resources are here and here.
CITATION(S):Scurr J et al. The influence of the breast on sport and exercise participation in school girls in the United Kingdom. J Adolesc Health 2016 Feb; 58:167. (http://dx.doi.org/10.1016/j.jadohealth.2015.10.005)
Top of Page


Clin Infect Dis 2016 Mar 1; 62:596
A Standardized Fecal Microbiota Preparation for Recurrent C. difficile Infection
Enema therapy using a commercial pool of donated stool was safe and highly effective.
Transplantation of a fecal microbiota preparation (FMP) is a highly effective therapy for recurrent Clostridium difficile infection (CDI). However, its use is limited by ambiguous regulations and the lack of a standardized product or a common method of administration.
Now, investigators have conducted an industry-funded, multicenter, phase II study to assess the safety and efficacy of a commercially prepared, standardized FMP given by enema to 34 patients with recurrent CDI. The preparation was obtained from four healthy individuals screened for systemic and gastrointestinal pathogens. Each dose consisted of 50 g of stool in 150 mL of saline with polyethylene glycol and contained ≥107 live organisms/mL of frozen suspension in a ready-to-use enema bag.
Among 31 evaluable patients, 28 experienced some adverse events, which were mostly gastrointestinal and self-limited; no serious adverse events related to use of the preparation were reported. A total of 16 patients (52%) were treated successfully after one dose, and of 14 evaluable patients requiring a second dose, 11 (79%) were treated successfully, for an overall success rate of 87%.
COMMENT: The availability of a commercial, screened FMP that has a high success rate after enema infusion could overcome some hurdles that currently plague clinicians seeking to use this treatment and become a very useful tool in the management of recurrent CDI.
CITATION(S): Orenstein R et al. Safety and durability of RBX2660 (microbiota suspension) for recurrent Clostridium difficile infection: Results of the PUNCH CD study. Clin Infect Dis 2016 Mar 1; 62:596.

Top of Page


"Socially Transitioned" Prepubescent Transgender Kids Have Similar Mental Health to Their Peers
By Christine Judge, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Prepubescent children considered to be socially transitioned — presenting as transgender in all social settings, with full support from their families — have anxiety and depression levels similar to those in non-transgender children, according to a Pediatrics study.
Researchers studied 73 transgender children aged 3 to 12 years, assessing their levels of anxiety and depression using parental responses to a standardized assessment tool.
Compared with national population averages, transgender children had average levels of depression and above-average levels of anxiety (but below preclinical or clinical thresholds). Compared with two control groups of non-transgender children of similar ages and gender identities, transgender children had similar levels of depression and marginally elevated anxiety.
Dr. Alain Joffe of NEJM Journal Watch Pediatrics and Adolescent Medicine supports the value of these data for clinicians counseling parents with transgender children. However, noting the predominance of white, affluent families studied, he adds: "clearly we need to know if these results would apply to families of other races and ethnicities and those with less substantial economic resources."
Top of Page


JAMA Pediatr 2016 Feb 1; 170:132
Do Electronic Toys Affect Language Development?
Parents speak and respond less when infants play with electronic toys compared with traditional toys and books.
Early exposure to language at home is associated with enhanced language, reading, and academic outcomes. The quality of parent–child interactions also influences language development. Researchers evaluated whether parent–infant communication is affected by different types of toys used for playing (electronic, traditional, and books) in 26 parents and their infants (age range, 10–16 months).
A digital recording device placed in a pocket on the child's chest generated data on the amount of speech from the parent, the number of child vocalizations, and the number of parent–child conversational interactions during two 15-minute parent–infant play sessions with three sets of toys for 3 days. The play sessions took place at home, and the toys taught animal names, colors, and shapes.
Play sessions with electronic toys were associated with significantly fewer mean words per minute from parents than sessions with traditional toys or books (40, 56, and 67, respectively). The same was true for adult or child conversational responses, parent responses, and adult generation of content-specific words. Child vocalizations showed a trend in the same direction. The largest and most consistent differences were between electronic toys and books.
COMMENT: In this small observational study, playing with traditional toys and books was associated with better measures of parent–infant verbal interaction. The results support the current pediatric practice of encouraging parents to talk with their infants and promote play with traditional non-electronic toys. My recommendation to parents in the newborn nursery and at well-child visits is to “narrate your life” at every possible moment.
CITATION(S): Sosa AV.Association of the type of toy used during play with the quantity and quality of parent-infant communication. JAMA Pediatr 2016 Feb 1; 170:132. (http://dx.doi.org/10.1001/jamapediatrics.2015.3753)
Top of Page


Vaginal Seeding of Babies Born by C-Section Potentially Unsafe,
Editorialists Say

By Cara Adler, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
Demand for vaginal seeding — the practice of collecting a mother's vaginal fluid on a gauze swab and wiping it over her newborn's mouth, eyes, and skin shortly after cesarean birth — is increasing based on news reports of its potential benefit, yet there is no evidence that it is beneficial or safe, according to an editorial in The BMJ.
The idea behind vaginal seeding is that transferring the microbiota of the mother's vagina — as happens during vaginal birth — could alter the cesarean-born infant's microbiota to a more "natural" state and thereby decrease risk for some autoimmune and allergic diseases, such as asthma.
There is currently no evidence of benefit, caution the editorialists. Moreover, potential risks to the baby include infection from exposure to maternal pathogens, such as group B streptococcus and herpes simplex virus.
"Given that the benefits of microbiome transfer from the mother are unproven, I have reservations about providers promoting or providing this practice," says Dr. Anna Wald of NEJM Journal Watch Women's Health. "However, if parents are likely to do it themselves, perhaps advising them to swab the child's intact skin rather than eyes or mouth might be enough to transfer the bacteria but less likely to cause invasive disease."
Top of Page


Ann Intern Med 2016 Mar 1; 164:1
A New Approach to Finding an HIV Vaccine?
In a phase II study, two novel HIV vaccine platforms were safe and immunogenic. Will they protect against HIV infection?
Finding an HIV vaccine has proven to be harder than anyone initially predicted. Up to now, only one of four efficacy trials has demonstrated (modest) protection against HIV infection (NEJM JW AIDS Clin Care Dec 2009 and N Engl J Med 2009; 361:2209). In a new, partially manufacturer-sponsored trial of safety and immunogenicity, prime-boost vaccine regimens using two uncommonly found human adenovirus vectors (Ad26 and Ad35) were tested in different combinations. The vaccine included an HIV clade A envelope gene. This vaccine has shown to be protective against HIV-1 in the nonhuman primate model as well as safe in phase I clinical trials.
Of 218 adults randomized in the U.S. and several African countries, 49% were women and 78% were black (67% of U.S. participants were white); 217 received at least one study vaccine and 210 (97%) completed follow-up. Local reactions were common in both vaccine (86%) and placebo arms (48%) but were graded mild or moderate. Of the 5% of vaccine recipients who reported severe systemic reactions, all were seronegative to the adenovirus vectors at baseline. The vaccines elicited humoral and cellular immune responses regardless of baseline vector immunity. In both homologous and heterologous regimens, titers of antibodies against the HIV envelope proteins increased after boosting. The heterologous regimen of Ad26–Ad35 elicited higher titers than the Ad35–Ad26 regimen. T-cell responses were modest, and East Africa participants had lower responses than the other populations by ELISpot.
COMMENT: These findings show that creating an effective adenovirus HIV vaccine is still possible and that boosting occurs with either a homologous or a heterologous vector. The challenge is now to see if this strategy proves effective in a phase IIB efficacy trial, where other adenovirus vaccines have failed. Although significant optimism exists that antiretroviral drugs will end the AIDS epidemic, in reality, an effective vaccine will be necessary to end the epidemic. Thus, research to develop a vaccine continues to be a priority.
CITATION(S): Baden LR et al. Assessment of the safety and immunogenicity of 2 novel vaccine platforms for HIV-1 prevention: A randomized trial. Ann Intern Med 2016 Mar 1; 164:1.
Top of Page


Biol Psychiatry 2016 Jan 19
Pot Is Becoming More Potent — and Riskier
An analysis of potency in plants from federal seizures yields unsettling results.
Although some states have legalized “medical” or recreational use of cannabis, illicit use remains more common. These investigators analyzed the proportion of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), and other cannabinoids in 37,606 samples of cannabis plants seized by the U.S. Drug Enforcement Administration from 1995 through 2014; the samples consisted of marijuana (female pollinated or male plants), sinsemilla (unpollinated female plants), ditchweed (hemp), and other preparations.
During the 20-year study period, the amount of THC in cannabis tripled, from 4% to 12%; CBD declined; and the ratio of THC to CBD rose from 15 to >80. THC concentration was found to be 61% higher in states with legalized medical use of cannabis than in those with illegal use only (8.73% vs. 5.42%).
COMMENT: The changes in cannabis potency (which is measured by THC content) may have reflected greater use of sinsemilla, which contains more THC than marijuana (although the increase in sinsemilla use was not statistically significant), as well as the removal of leaves to use in hashish. The increasing potency has been paralleled by a growing number of emergency department visits involving cannabis. Use of this drug by adolescents in particular has been linked to mental illness, impaired school performance and lifetime achievement, motor vehicle accidents, and vascular and pulmonary disease. To counteract the notion that “it must be safe if it is legal,” clinicians should warn patients about the increasing risks of legal or illegal cannabis use.
CITATION(S): ElSohly MA et al. Changes in cannabis potency over the last 2 decades (1995–2014): Analysis of current data in the United States. Biol Psychiatry 2016 Jan 19; [e-pub].
Top of Page

Home | Contact | Roselle (630) 529-3400 | Deerfield (877) 419-9898 | Careers | Sitemap