• Medicare Cheats are Cheating You!
• More Drugs Dropped by Express Scripts
• Study "CONFIRMS" Link Between Low Vitamin D Levels and Dementia, Researchers Say
• No More Baby Pictures in Doctors' Waiting Rooms
• Exogenous Testosterone's Effects in Menopausal Women: A Matter of Dosage?
• Breast Feeding Rates Increasing in the U.S.
• Acupuncture Tied to Improved Symptoms in Breast Cancer Patients Taking
Aromatase Inhibitors
• Bisphosphonates Not Associated with Reduced Breast Cancer Risk
• Human Growth Hormone Use on the Rise in Teens
• Physical Therapy and Steroids Similarly Effective for Shoulder Pain
• Noninvasive DNA-Based Colon Cancer Screen Approved
• Fecal Transplantation for CDI Is Safe and Effective in Immunocompromised Patients
Medicare Cheats are Cheating You!
Medicare spent more than $30 million in 2012 on questionable HIV medication costs. The report describes several possible fraud schemes, all paid for by Medicare's prescription drug program known as Part D.
- In Detroit, a 77-year-old woman purportedly filled $33,500 worth of prescriptions for 10 different HIV medications. But there's no record that she had HIV or that she had visited the doctors who wrote the prescriptions.
- A 48-year-old in Miami went to 28 pharmacies to pick up HIV drugs worth nearly $200,000, almost 10 times what average patients get in a year. The prescriptions were supposedly written by 16 health providers.
- Two pharmacies in Miami dispensed drugs to 321 beneficiaries receiving more than $350,000 for the drugs dispensed; most of them were women with an average age of 74, two decades older than the typical patient who received HIV drugs in Medicare.
The handling of Medicare Part D is in question. A series published last year showed Medicare's lax oversight enabled prescribing massive quantities of inappropriate medications, wasted billions on needlessly expensive drugs, and exposed the program to rampant fraud. Part D cost taxpayers about $65 billion in 2013.
http://www.washingtonpost.com/politics/watchdog-some-medicare-spending-on-hiv-drugs-appear-questionable-in-2012-audit/2014/08/05/fda4875c-1cd6-11e4-ae54-0cfe1f974f8a_story.html
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MM: Express Scripts (ESI) continues to make huge profits while denying coverage to patients. How can this insurance company get away with this and there is no outcry from consumers who are paying for these services and medications yet are being denied coverage? If, as a consumer, I walk into a restaurant and pay my bill with the promise of receiving food but fail to get the food, I am upset. Why is this not the case with ESI?
More Drugs Dropped by Express Scripts
Express Scripts, the largest U.S. pharmacy benefit manager, has announced it will remove an additional 25 products from its list of preferred drugs in 2015, including Epogen, Aranesp, Incivek, a testosterone gel, and extended release Zohydro.
http://www.reuters.com/article/2014/08/01/express-scr-amgen-anemia-idUSL2N0Q72VO20140801
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MM: It's pretty powerful when a study proclaims that something is "confirmed." When a journal as prestigious and as conservative as Neurology publishes an article with this statement it has to raise some eyebrows. What is especially impressive about this study is that there is no big Pharma involvement and therefore much less bias than many other "drug" studies may be associated with. I will continue to read the literature and will also continue to promote D3 for my patients.
Study "CONFIRMS" Link Between Low Vitamin D Levels and Dementia, Researchers Say
By Amy Orciari Herman
A new study in Neurology adds to the mounting evidence linking vitamin D deficiency with increased risk for dementia and Alzheimer disease (AD).
Some 1700 older adults free of dementia, stroke, and cardiovascular disease underwent serum 25-hydroxyvitamin D measurement and then were followed for roughly 6 years. During that time, some 170 developed all-cause dementia and 100 developed AD.
Compared with participants with sufficient baseline vitamin D levels (50 nmol/L or higher (20ng/ml)), those with deficient levels (25–50 nmol/L) had significantly increased risks for dementia (hazard ratio, 1.5) and AD (HR, 1.7). Relative risks were even higher for those with severely deficient vitamin D levels (HR, 2.2 for either dementia or AD).
The researchers conclude, "Our results confirm that vitamin D deficiency is associated with a substantially increased risk of all-cause dementia and Alzheimer disease. This adds to the ongoing debate about the role of vitamin D in non-skeletal conditions."
http://www.neurology.org/content/early/2014/08/06/WNL.0000000000000755
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MM: I certainly understand the issues of HIPAA and am sensitive to a desire of anonymity in certain situations but is displaying a picture of a baby, without any patient information on it, truly a breach of patient confidentiality? Granted, this is a semi-public location but it is still a reasonably controlled environment. I have to wonder if we are taking confidentiality a step too far.
No More Baby Pictures in Doctors' Waiting Rooms
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Photos of babies that a clinician has delivered are considered protected health information under HIPAA and cannot be displayed in a medical office without written authorization from a parent. A front-page story in Sunday's New York Times puts a spotlight on the issue, with several clinicians weighing in.
Many providers have taken down their photo bulletin boards, albeit reluctantly. Some keep the photos in an album that patients can choose to open. Another, who continues to display baby pictures in an exam room, advocates having "some common sense with this HIPAA business," noting that "it seems strange" to discontinue such a long-standing tradition.
A spokesperson with the Department of Health and Human Services confirmed for the Times that displaying patient photographs (even in a waiting-room photo album) without authorization is illegal. She added that any authorization from a patient or parent must be on a "HIPAA-compliant form, including elements like an expiration date."
http://www.nytimes.com/2014/08/10/nyregion/baby-pictures-at-doctors-cute-sure-but-illegal.html?_r=0
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MM: Supraphysiologic doses of any hormone tend to cause long term problems. Perhaps we failed to learn this lesson from the Women's Health Initiative (WHI) studies. These dangers may include cardiovascular (CV) problems as well as stroke due to thromboembolic events. In my clinical experience. many women respond favorably to nominal testosterone supplementation as well as nominal transdermal estrogen supplementation with a combination of estradiol (E2) and estriol (E3). Unfortunately this study was unable to incorporate E3, which has been demonstrated in European studies and more than a 30 year clinical history of being extremely safe and effective. The bottom line is that lower hormone doses tend to work well in many women and with those lower doses are lower incidences of adverse reactions and side effects.
Menopause 2014 Jun; 21:612
Exogenous Testosterone's Effects in Menopausal Women: A Matter of Dosage?
In a short-term trial, only markedly supraphysiologic testosterone levels enhanced sexuality, lean body mass, and muscle strength.
Although androgen administration can augment sexuality as well as musculoskeletal parameters in menopausal women, data are insufficient to address the dosages and serum levels of testosterone needed to achieve these benefits. Investigators randomized post-hysterectomy menopausal women (mean total and free testosterone levels, 13.0 ng/dL and 2.2 pg/mL, respectively [below the range for healthy premenopausal women]) to 12 weeks of transdermal estradiol (0.05 mg daily) followed by 24 weekly intramuscular injections of placebo or testosterone enanthate at doses of 3.0 mg, 6.0mg, 12.5mg, or 25.0 mg while continuing transdermal estrogen.
In 62 evaluable women who received testosterone, total and free serum testosterone levels increased in a dose-dependent fashion. Among women randomized to the 25-mg (highest) dose, mean total testosterone serum level at 24 weeks was 210 ng/dL (5–6 times higher than values in healthy premenopausal women). Compared with women who received placebo, those who received the highest testosterone dose had better measures of sexual desire, arousal, frequency of sexual activity, lean body mass, and physical strength. Frequency of adverse effects was generally similar among groups; however, excess hair growth was significantly more common in women who received the two highest doses of testosterone.
Comment: This well-executed study confirms that, while testosterone can enhance sexuality and musculoskeletal parameters in menopausal women receiving estrogen, the levels needed to achieve these benefits are markedly supraphysiologic. The authors note that they did not recruit participants with low sexual desire; thus, it remains unknown whether lower doses of testosterone might provide benefits in women with baseline sexual dysfunction. In addition, this short-duration trial did not permit determination of cardiovascular risks or benefits associated with prolonged testosterone supplementation, underscoring the need for long-term randomized trials addressing safety concerns.
Citation(s): Huang G et al. Testosterone dose-response relationships in hysterectomized women with or without oophorectomy: Effects on sexual function, body composition, muscle performance and physical function in a randomized trial. Menopause 2014 Jun; 21:612. (http://dx.doi.org/10.1097/GME.0000000000000093)
http://www.ncbi.nlm.nih.gov/pubmed/24281237?access_num=24281237&link_
type=MED&dopt=Abstract
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MM: Although breast feeding may be statistically increasing nationwide, these increases tend to be focused in certain pockets of our nation and are still lacking in many others.
Breast Feeding Rates Increasing in the U.S.
Breast-feeding rates are continuing their steady climb in the U.S. — 79% of infants born in 2011 started to breast-feed, up from 75% in 2007, according to the CDC's Breastfeeding Report Card.
The rate of breast-feeding initiation ranged from 56.9% in Louisiana to 92.8% in California.
By 6 months, however, only 49% were breast-feeding (vs. 43% in 2007), and by 12 months, that figure dropped to 27% (vs. 22%) — rates that still fall short of the Healthy People 2020 objectives.
The number of lactation consultants and counselors has also continued to rise, but in 11 states, there is still limited access to such resources.
http://www.cdc.gov/breastfeeding/pdf/2014breastfeedingreportcard.pdf
http://www.usbreastfeeding.org/LegislationPolicy/FederalPoliciesInitiatives/
HealthyPeople2020BreastfeedingObjectives/tabid/120/Default.aspx
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MM: Acupuncture treatment has been a focal point of oriental medicine for centuries. It focuses on the placement of very fine, sterile needles along proposed axises of the body. By interrupting these axis lines, the body interrupts the foreign process and health is restored. Although my experience is limited, in my practice, I have seen the most dramatic results with patients who are getting pain management treatments. I am not surprised that electroacupuncture shows promise for a variety of conditions but I am a bit confused at the "sham" acupuncture results.
Acupuncture Tied to Improved Symptoms in Breast Cancer Patients Taking Aromatase Inhibitors
By Kelly Young; Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Acupuncture may help improve fatigue and psychological distress in women with breast cancer who have joint pain related to use of aromatase inhibitors, according to a study in Cancer.
Nearly 70 patients with early-stage breast cancer and arthralgia linked to aromatase-inhibitor treatment were randomized to one of three groups: usual care, sham acupuncture, or electroacupuncture. All participants received education on staying physically active, managing joint pain, and continuing their current medications.
Both acupuncture groups received 10 treatments over 8 weeks. The electroacupuncture group received electrical stimulation through needles inserted around the joint with the most pain. Other needles were inserted in spots intended to alleviate non-pain symptoms. Meanwhile, the sham acupuncture group had non-penetrating needles at non-acupuncture points and no electrical stimulation.
At 12 weeks' follow-up, the electroacupuncture group had significant improvements in scores of fatigue, anxiety, and depression, compared with the usual care group. Sham acupuncture outperformed usual care only for depression.
http://onlinelibrary.wiley.com/doi/10.1002/cncr.28917/abstract
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MM: Not only does this chemical class produce bone of poor quality that has a tendency to break, and, increase the risk of jaw necrosis associated with dental treatments/surgery, but now the claims of being breast protective have been shot down. Is it time to consider withdrawing this drug from the market yet??
Bisphosphonates Not Associated with Reduced Breast Cancer Risk
By Amy Orciari Herman, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
The bisphosphonates alendronate and zoledronic acid do not reduce the risk for breast cancer among postmenopausal women, according to findings from two randomized trials published in JAMA Internal Medicine.
In one trial, some 6200 women without histories of breast cancer who were at risk for fracture were randomized to receive oral alendronate or placebo daily and followed for roughly 4 years. In the other, nearly 7600 women were randomized to annual infusions of zoledronic acid or placebo and followed for about 3 years. The incidence of invasive breast cancer did not differ significantly between active treatment and placebo in either trial.
The authors note that observational studies, which suggested a chemopreventive benefit from bisphosphonates, "may represent ... confounding by indication". That is, women with low bone density — who are likely to receive bisphosphonates — have lower estradiol levels and higher sex hormone-binding globulin levels and therefore are less likely to develop estrogen-receptor-positive breast cancer in the first place.
http://archinte.jamanetwork.com/article.aspx?articleid=1893923
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MM: I am shocked by these numbers. I am especially confused as to what these young people are actually using. Legitimate HGH is extremely expensive. The cost can be as much as thousands of dollars monthly and effective doses are at least $1000/month.
Human Growth Hormone Use on the Rise in Teens
By Amy Orciari Herman, Edited by Susan Sadoughi, MD
The percentage of U.S. teens who reported ever using synthetic human growth hormone without a prescription more than doubled from 2012 to 2013 — from 5% to 11% — according to findings released last week by the Partnership for Drug-Free Kids.
Over 3700 high school students were surveyed in 2013. Among the other findings:
- Black and Hispanic teens were more likely than white teens to report ever using HGH (15% and 13%, respectively, vs. 9%).
- Both boys and girls had used synthetic HGH (12% and 9%, respectively).
- The proportion of teens who perceived HGH use as moderately or greatly risky dropped to 81% (from 86% in 2012).
"The results of this study further demonstrate the importance of educating young people, their parents and coaches on the risks associated with the use of performance-enhancing drugs," said the CEO of the U.S. Anti-Doping Agency, in a Partnership for Drug-Free Kids press release.
http://www.drugfree.org/newsroom/pats-2013-teens-report-higher-use-of-performance-enhancing-substances
http://www.drugfree.org/wp-content/uploads/2014/07/PATS-2013-FULL-REPORT.pdf
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MM: This is another potential nail in the coffin of steroid injection use for orthopedic purposes. Not only are steroid injections not significantly better than other treatments but they have more adverse side effects that last longer than the potential benefits of the steroids. These include adrenal fatigue, compromised immune function and local deterioration of the affected/injected joint.
Physical Therapy and Steroids Similarly Effective for Shoulder Pain
By Amy Orciari Herman, Edited by Jaye Elizabeth Hefner, MD
For patients with shoulder impingement syndrome, physical therapy and corticosteroid injections offer similar relief, but injections lead to more healthcare utilization, according to an Annals of Internal Medicine study.
Some 100 adults with unilateral shoulder impingement syndrome at one military medical center were randomized to receive either subacromial injection of triamcinolone acetonide (40 mg; up to 3 injections over 1 year), or physical therapy (6 sessions over 3 weeks) plus home exercises.
At 1 year, both groups had achieved a 50% improvement in average pain and disability score, with no significant differences between the groups at any time during the study. However, the steroid group had more primary care visits for shoulder pain and more additional steroid injections than the physical therapy group.
Editorialists write: "In choosing a management plan, clinicians should consider patient preference, availability of practitioners, and other health care use... If the patient prefers a corticosteroid injection, its effectiveness, safety profile, and potential for additional health care should be discussed."
http://annals.org/article.aspx?articleid=1892615
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MM: I have frequently counseled patients who were scheduled for colonoscopies simply because they were 50 years of age or older. They typically experience a great deal of anxiety regarding the preparation prior to and the procedure itself. If this stool sample test shows very few false positives then it could be a wonderful alternative that will potentially save lives and decrease healthcare screening costs. Time will tell.
Noninvasive DNA-Based Colon Cancer Screen Approved
By Kristin J. Kelley, Edited by David G. Fairchild, MD, MPH,
and Lorenzo Di Francesco, MD, FACP, FHM
The FDA has approved a novel colorectal cancer screening test — Cologuard — that detects DNA mutations and hemoglobin in stool samples. Patients testing positive should follow-up with colonoscopy.
In a clinical trial of some 10,000 patients, Cologuard accurately detected more advanced adenomas and colorectal cancers than fecal immunochemical testing. The new test, however, did not correctly rule out cancer as accurately as the older test.
The FDA notes that this approval does not change the U.S. Preventive Services Task Force's guidelines, which recommend screening using colonoscopy, sigmoidoscopy, or fecal occult blood testing.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409021.htm
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MM: This type of fecal transplantation has been performed for more than a decade, both in the U.S and Australia. It's effectiveness has been consistent with a relatively low adverse set of events and a high level of success. Although this is a process that may be repulsive to certain patients, according to several studies, the vast majority of those polled who were candidates for such a procedure have been very receptive to the idea, "if their doctor recommends it".
Am J Gastroenterol 2014 Jul; 109:1065
Fecal Transplantation for CDI Is Safe and Effective in Immunocompromised Patients
The overall cure rate was 89%, with one death occurring from aspiration.
Given that immunocompromised patients are at increased risk for infection, is it safe to perform fecal microbiota transplantation for treatment of Clostridium difficile infection (CDI) in this population? Researchers addressed this question — as well as the effectiveness of fecal transplantation in this setting — in a multicenter, retrospective trial of 99 patients at 16 centers.
In the 80 patients eligible for inclusion, reasons for immunocompromised status were immunosuppressive therapy for inflammatory bowel disease (36 patients), organ transplantation (19), cancer (7), HIV/AIDS (3), and other medical conditions or medications (15). A single fecal transplantation resulted in cure in 62 patients (78%), who had no recurrence at 12 weeks posttransplantation. A second transplantation was performed in 12 patients, of whom 8 were cured, for an overall cure rate of 89%. Twelve patients experienced serious adverse events within 12 weeks; 10 patients were hospitalized, and 2 died. One death resulted from aspiration during sedation for fecal transplantation administered by colonoscopy. No infections were definitely attributed to colonoscopy.
Comment: These results indicate that fecal transplantation is safe and effective for the treatment of recurrent or refractory CDI in immunocompromised patients
Citation(s): Kelly CR et al. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol 2014 Jul; 109:1065.
(http://dx.doi.org/10.1038/ajg.2014.133)
http://www.ncbi.nlm.nih.gov/pubmed/24890442?access_
num=24890442&link_type=MED&dopt=Abstract
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