• FDA Warns of Permanent Loss of Skin Pigmentation with ADHD Patch
• Generic ADHD Drugs Remain on the Market, Despite Lack of Therapeutic Equivalence
• WHO Says Certain Insecticides and Herbicides Tied to Cancer
• IOM Offers Tips to Limit the Effects of Cognitive Aging
• Doctors Develop Calculator to Assess How Much Cancer Drugs Should Really Cost
• New Device Helps Blind People Use Their Tongues to Process Images
• Antibiotics Are a Reasonable Treatment Option for Some Patients with Appendicitis
• FDA: Partially Hydrogenated Oils Must Be Removed from Food Products Within 3 Years
• Anxiety Is Associated with Functional Dyspepsia
MM: I am a great proponent of transdermal dosage forms. There are wonderful benefits to many of these products such as ease of administration, more consistent blood levels, bypassing the first pass effect of the liver, obtaining different metabolic pathways to decrease side effects and oftentimes obtaining higher systemic levels while using lower doses that save the consumer money. However, when there is a problem then consumers need to be made aware of that problem so that they can make informed decisions. Cosmetic effects may show little clinical problems but can be life tormenting and have a significant effect on self-image that can last throughout a lifetime. Clinicians MUST make consumers aware of these potential or likely side effects with more than a printed addendum to a prescription but rather with an added verbal warning and explanation.
FDA Warns of Permanent Loss of Skin Pigmentation with ADHD Patch
By Kristin J. Kelley, Edited by Susan Sadoughi, MD
The methylphenidate patch (Daytrana) — used to treat attention-deficit/hyperactivity disorder — may cause loss of skin color, the FDA warned on Wednesday. The skin condition, chemical leukoderma, isn't physically harmful, but the results are permanent.
Patients and caregivers should notify their clinicians immediately if they observe new areas of lightened skin. The reported areas of pigmentation loss have included the area under the patch itself and spanned up to 8 inches in diameter. (See photos in the linked drug safety communication.)
Alternative treatments should be considered for affected patients.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm452595.htm
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MM: The premise of bringing a generic drug to market and utilizing an abbreviated New Drug Application (ANDA) insists that the new product must be biologically equivalent to the original product. If it fails to meet that criteria then it must be restricted from the market place. This rule is in place to protect consumers and to allow clinicians to predict an appropriate clinical treatment or endpoint. The failure to achieve this result is supposed to prevent products from reaching the market and from making the claim that they are equivalent to the original product. This is more than just a consumer or an insurance company saving money. This is necessary to prevent a sub-therapeutic or excessive, potentially harmful or fatal dosage. What isn't being said is that for a generic manufacturer to bring an equivalent or "AB-rated" product to market, they must provide data that the product is truly biologically equivalent. If these companies provided that data and the products are not truly equivalent then this is straight forward fraud and should be punished.
Generic ADHD Drugs Remain on the Market, Despite Lack of Therapeutic Equivalence
By Amy Orciari Herman Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM
Two generic versions of the attention-deficit/hyperactivity drug Concerta (methylphenidate hydrochloride extended-release tablets) continue to be available months after the FDA deemed them not therapeutically equivalent to the brand name version, the New York Times reports. A third generic version, sold by Actavis, has been confirmed to be equivalent to Concerta.In November 2014, the FDA found that the two generics — meant to be taken once daily — may begin to lose effectiveness after just 7 hours. Accordingly, the agency gave the drugs' makers 6 months to either confirm their bioequivalence to Concerta or take them off the market. Now, 7 months later, the drugs are still sold in major pharmacies and account for 30% of generic Concerta prescriptions — even though bioequivalence has not been proven.
One of the drug companies, UCB, says it submitted data last week that will prove its version's therapeutic equivalence. The other company, Mallinckrodt Pharmaceuticals, is fighting the FDA's decision in court.
http://www.nytimes.com/2015/06/17/business/generic-ritalin-drug-not-equivalent-to-the-brand-is-in-use-anyway.html?_r=0
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MM: It isn't much of a shock that there are pesticides and herbicides that are tied to cancer. What is especially distressing is that the number one chemical addressed is Lindane, which is commonly used on children from infants
WHO Says Certain Insecticides and Herbicides Tied to Cancer
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
The World Health Organization's International Agency for Research on Cancer has determined that two insecticides and one herbicide cause cancer — or may cause cancer — in humans. After reviewing recent studies, the group announced the following:
- The insecticide gamma-hexachlorocyclohexane (lindane) is carcinogenic to humans, given the 60% increased risk for non-Hodgkin lymphoma (NHL) observed in epidemiologic studies. Most countries already ban or restrict use of lindane.
- The insecticide dichlorodiphenyltrichloroethane (DDT) is probably carcinogenic to humans. This is based on sufficient evidence of carcinogenicity in animals and limited evidence in humans. Epidemiologic studies have found increased risk for NHL and testicular and liver cancers. DDT was largely banned in the 1970s, but the insecticide still persists in the environment.
- The herbicide 2,4-dichlorophenoxyacetic acid (2,4-D) is possibly carcinogenic, given limited evidence in animals and insufficient evidence in humans. Epidemiologic studies have not found an association with cancer, but some research has shown that the herbicide could induce oxidative stress and cause immunosuppression.
http://www.iarc.fr/en/media-centre/pr/2015/pdfs/pr236_E.pdf
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MM: Although this report makes some good, common sense recommendations, it also makes some that could be potentially harmful. Numerous studies have demonstrated that by keeping the brain active by learning new skills, languages or other intellectual challenges, a person stays sharper. This includes socialization and other social activities. We also know that patients in various care facilities who are chronically medicated with anti-anxiety or anti-psychotic medications tend to do more poorly and have a diminished Quality of Life (QOL) when compared to those who are less medicated. What appears to be under-emphasized is the need for regular contact with family or other loved ones as these interactions seem to stimulate endorphins as well as neurotransmitters that seem to maintain good neuronal communication.
IOM Offers Tips to Limit the Effects of Cognitive Aging
By Kelly Young, Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD
The Institute of Medicine has published steps clinicians can take to minimize the effects of cognitive aging in older adults. Below are the highlights, as discussed in a new commentary in the Annals of Internal Medicine.
The IOM recommends the following to clinicians:
- Conduct a formal cognitive assessment at primary care visits (the report doesn't endorse a particular screening tool). Clinicians should also consider screening for cardiovascular risk factors, alcohol use, smoking history, diet, exercise, depression, and other chronic conditions.
- Encourage patients to get regular physical activity, reduce their cardiovascular risk factors, maintain social engagement and learning, and get sufficient sleep.
- Minimize use of psychoactive medications and inappropriate medications, including anticholinergic drugs.
- Identify patients who could be at high risk for delirium before or at the time of hospital admission.
- Caution patients about the use of so-called "brain games" and nutraceuticals, which have little proven benefit.
The report also provides clinician resources related to driving and financial management.
http://annals.org/article.aspx?articleid=2337280
http://www.iom.edu/Reports/2015/Cognitive-Aging.aspx
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MM: It's about time that clinicians stood up and took a stand about the gouging of the public by Big Pharma! There is no shame in making a reasonable profit but greed is simply wrong and that is what Pharma is guilty of. DrugAbacus is a brilliant tool to make an informed decision as a patient or family member/caregiver to understand the cost vs benefits of different treatment approaches. We all complain about the excessive cost of healthcare but this tool allows us one of the first reasonable methods of assessing what that cost is and whether it is worthwhile. We make decisions every day about whether we can afford or wish to afford things. That is simply called budgeting. Healthcare should be no different.
Doctors Develop Calculator to Assess How Much Cancer Drugs Should Really Cost
By Amy Orciari Herman, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
A new interactive tool that takes into account a medication's side effects and the amount of life gained can help physicians calculate what the actual price of more than 50 cancer drugs "should" be, the Wall Street Journal reports.
Developed at Memorial Sloan Kettering Cancer Center in New York, the DrugAbacus tool allows users to assign a monetary value to an additional year of life conferred by a medication, impose a "toxicity discount" based on adverse effects, and adjust for the cost of drug development. In many cases, the resulting "price" is lower than market value. For example, Blincyto (blinatumomab), used to treat a rare form of leukemia, currently costs over $64,000 for a month's treatment. But when DrugAbacus values an extra year of life at $120,000 and then deducts 15% because of side effects, the suggested price is just $12,600.
The physician who led the project told the Journal, "Right now, manufacturers have total price control, and total control of prices has led to irrational pricing behaviors."
http://www.wsj.com/articles/how-much-should-cancer-drugs-cost-1434640914
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MM: This is truly an amazing approach to patient care. It's a little bit like the character Geordi La Forge in Star Trek: The Next Generation, in that a person wears a visor that records data, translates it into an impulse that can then be interpreted by a functional sense in lieu of primary sight. It may be only a matter of time before other products will be able to translate impulses for direct brain stimulation to the visual cortex! I pray that I live to see the day when those deprived of sight are able to have it restored in one of these innovative manners.
New Device Helps Blind People Use Their Tongues to Process Images
By Kristin J. Kelley, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
The FDA has approved marketing for a device that can help blind people process images by using their tongues. The BrainPort V100 is intended for use with another form of assistance, such as a guide dog.
The battery-powered device consists of a mouthpiece containing electrodes that is connected to sunglasses equipped with a video camera. The camera collects and transmits visual data via pulses on the tongue. With training, individuals can interpret the signals to determine the location and size of objects, and to determine if they're moving or stationary.
Approval was based on a study of 74 blind patients. After a year of training with the BrainPort V100, almost 70% successfully completed an object recognition test.
Thus far, patients haven't reported any serious adverse events associated with the device. Some have experienced stinging, burning, or a metallic taste caused by the mouthpiece.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451779.htm
http://www.wicab.com/en_us/v100.html
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MM: We know that by definition, appendicitis is an inflammatory condition and this research demonstrates that harmful bacteria or other microorganisms may be the root of that inflammation. This is supported by the effects of antibiotics on that inflammation. However, the greatest criticism of this approach is the likelihood of recurrence. That means that the antibiotics are merely "band-aid treatments". They do not address the root of the issue, that is a primary imbalance in the microorganisms in the appendix and the gut in general, known as 'Dysbiosis'. The use of probiotics in very high doses to reverse the dysbiosis and the concomitant use of digestive enzymes to reduce the inflammation and break down food entities that may be inherently inflammatory coupled by a dietary change to a less inflammatory diet would likely address the primary problem while decreasing the likelihood of a recurrence of the appendicitis. The problem with any approach that does not surgically remove the sensitive organ is patient compliance and that still remains a potential problem.
Antibiotics Are a Reasonable Treatment Option for Some Patients with Appendicitis
By Daniel Pallin, MD, MPH
Many patients treated with antibiotics instead of appendectomy for acute uncomplicated appendicitis do not need surgery during the subsequent year, according to a JAMA trial.
Finnish investigators randomized 530 adults with computed tomography-confirmed uncomplicated acute appendicitis to receive surgery or antibiotics (intravenous ertapenem for 3 days followed by oral levofloxacin plus metronidazole for 1 week).
In the surgery group, all but one patient had successful appendectomy. In the antibiotic group, 27% of patients underwent appendectomy for recurrence during 1 year of follow-up. No patient died from appendicitis. Complications — mostly surgical site infections and possible adhesion-related gastrointestinal symptoms — were more prevalent in the surgery group than the antibiotics group.
Antibiotic treatment as an alternative to surgery is controversial. For some patients with CT-proven uncomplicated appendicitis, antibiotic treatment may be a reasonable option — according to patient preferences, individualized surgical risk, and other factors — so long as everyone understands that the chance of a recurrence is quite high
http://jama.jamanetwork.com/article.aspx?articleid=2320315
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MM: I applaud the FDA for causing trans-fats to be removed from food products but one of the items that these harmful fats will be replaced with is palm Oil. This and other potentially allowable oils may be as detrimental or even moreso that what they are replacing. Unfortunately, the general public is unaware of this change or this problem and is likely to simply run into more associated health problems as time progresses.
FDA: Partially Hydrogenated Oils Must Be Removed from Food Products Within 3 Years
By Kristin J. Kelley
Food manufacturers must remove partially hydrogenated oils — the major source of artificial trans fats in processed foods — from their products within 3 years, the FDA has announced.
The agency finalized its determination, first proposed in 2013, that partially hydrogenated oils are not "generally recognized as safe" for human consumption. This action — in part a response to citizen petitions and based on data linking trans-fat consumption to health risks — will reduce coronary heart disease and prevent thousands of fatal myocardial infarctions per year, the FDA predicts.
After June 18, 2018, companies must petition the agency for approval to add partially hydrogenated oils to their products.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm451237.htm
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MM: This one probably belongs in the "Duh" file. If a person in anxious or nervous, they will frequently have an upset stomach. The data indicates that this happens in 70-80% of people who suffer from anxiety. I guess the question is should this group of people be treated or not and if yes, then with what? My recommendation would be a combination of probiotics and digestive enzymes in a chewable tablet. This provides soothing relief plus the swallowing action initiates peristalsis within the GI tract thereby getting the muscles going in a "mouth to south" direction that should further provide relief. I would recommend the product Heartburn Away as it incorporates all of these characteristics.
Gastroenterology 2015 May; 148:928
Anxiety Is Associated with Functional Dyspepsia
Depression, however, was not a risk factor. Neither were gastroesophageal reflux symptoms elevated in anxious patients.
Multiple studies have shown an association between anxiety or depression and functional gastrointestinal symptoms but have not established the direction of the association or causality.
To determine if anxiety or depression increases the risk for functional dyspepsia (FD) or gastroesophageal reflux symptoms (GERS), researchers conducted a 10-year follow-up of 887 participants randomly selected from a population-based cohort study in Sweden. Participants underwent endoscopy at baseline and completed the comprehensive Abdominal Symptom Questionnaire and the Hospital Anxiety and Depression Scale at baseline and 10 years later. The Rome III criteria were used to define FD, which excludes GERS (defined in this study as troublesome heartburn, acid regurgitation, or both).
At baseline, 15.6% of the patients had FD compared with 13.3% at follow-up. GERS was present in 38.8% of subjects at baseline and in 39.8% at follow-up. Anxiety at baseline was associated with new-onset FD at follow-up (odds ratio, 7.61; 95% confidence interval, 1.21–47.73) but not with GERS. Anxiety was associated with postprandial distress syndrome at both baseline (OR, 4.83) and follow-up (OR, 8.12) but not with epigastric pain syndrome. The authors conclude that anxiety, but not depression, at baseline increased the risk for the development of new FD, but not GERS, during a 10-year period in their study population.
Comment: The identification of anxiety prior to the onset of FD at follow-up in this study strengthens the evidence for possible causality. However, one study weakness is that endoscopy was not performed at the follow-up, raising the possibility that some patients might have had organic rather than functional disease. Also, because symptoms were measured at only two points in time, it is unclear whether changes in anxiety correlate with changes in FD.
Citation(s):Aro P et al. Anxiety is linked to new-onset dyspepsia in the Swedish population: A 10-year follow-up study. Gastroenterology 2015 May; 148:928.
(http://dx.doi.org/10.1053/j.gastro.2015.01.039)
http://www.ncbi.nlm.nih.gov/pubmed/25644097?access_num=
25644097&link_type=MED&dopt=Abstract
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