021927502-medicine-pillsWhy are prescription drugs so expensive? One answer to that question is unquestionably greed, as evidenced in a study in JAMA Internal Medicine Rick and I discuss on PodMed this week. And while that conclusion is completely expected, some of the details and the extent to which pharmaceutical companies are manipulating data and information are noteworthy, and worth protesting.

This study took a look at 10 new cancer drugs from 10 companies, using data provided to the US Securities and Exchange Commission to pinpoint research and development (R&D) costs by the pharmaceutical companies.  The authors found that the median time to develop a new drug was 7.3 years at a cost of $648 million. Here's what the drug makers earned:"The revenue since approval is substantial (median, $1658.4 million; range, $204.1 million to $22 275.0 million). Taken in aggregate, profits in about 4 years post approval were about 9 times the costs of bringing the drug to market. One element included in the data pharma provides to the SEC is that research undertaken with public dollars in research grants to universities, a cost that should clearly be removed. And finally, these numbers are very different from those provided by pharma to justify huge price tags on new drugs relative to R&D.  As Rick and I agree, profit is fine, gouging is not. In view of the fact that most people with cancer cite financial concerns as a major source of worry, some scrutiny and modification of this practice seems indicated. It's also worth noting that such price gouging is not limited to cancer drugs, and is something that cries out for redress.

Other topics this week include two from JAMA:Effect of Sentinel Lymph Node vs Full Axillary Dissection on Overall Breast Cancer Survival and Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality, and in NEJM: Hospital-Readmission Risk — Isolating Hospital Effects from Patient Effects. Until next week, y'all live well.

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

036507010-vaccineResponsible parents everywhere seek to protect their children, and for some, that means avoiding routine immunizations for a host of unsubstantiated reasons. Now a research letter Rick and I discuss on PodMed this week as published in JAMA details a trend that's rather disturbing, where parents in California are seeming to seek medical exemptions for their children since the personal belief loophole regarding avoiding vaccination has been closed. Here's the story:

Prior to the 2016-17 school year, California bill (SB)277 eliminated the personal belief exemption from school vaccine mandates, which had allowed parents to cite religious or philosophical objections to required vaccines but enroll their children in school. The exemption for medical reasons remains, and was in fact expanded somewhat under the bill. The authors examined data from 1996 to 2016 from incoming kindergartners and tallied statewide medical and personal belief exemptions over the time period. In the first year under the new law, medical exemptions increased from 0.17% to 0.51%, while exemptions for personal beliefs dropped from 2.37% to 0.56%. Clearly, while there was an overall decrease in exemptions it appears that some have shifted to a medical exemption. And as Rick opines, that's gaming the system, with physician collusion. It's well known that herd immunity depends upon a large number of us being immunized, so choosing not to do so has potentially deleterious or even deadly consequences for others. We both agree that exemptions need to be closely scrutinized for the good of all.

Other topics this week are all from NEJM: Third Dose of MMR VaccineTiotropium in Early-Stage COPD, and Tezepelumab in Adults with Uncontrolled Asthma. Until next week, y'all live well.

 

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

iStock-157614058Fat has been excoriated in the diet world for decades, but now a study known by the acronym PURE has challenged conventional wisdom, Rick and I discuss on PodMed this week. The study was published in the Lancet and presented at the European Society of Cardiology meeting, and caused me to ask "should you live PURE?" Here's what you need to know to answer that question:

The acronym PURE stands for Prospective Urban Rural Epidemiology study, and it was conducted in over 130,000 low and middle income participants in 18 countries between 2003 and 2013, with a median follow up of 7.4 years. Using that favorite tool, the validated food frequency questionnaire, researchers carefully assessed specific nutrient intake and correlated that with total mortality and major cardiovascular events. Correlations were calculated based on carbohydrate, total fat, saturated fat, polyunsaturated fat and monounsaturated fat. In short, the study found that high carbohydrate intake was associated with greater risk of mortality, while fat of any type was associated with a lower risk. Neither total fat nor types of fat were associated with cardiovascular disease, heart attacks or death from heart disease, and most interestingly, there was an inverse relationship of fat consumption and stroke. Well.  Flies in the face of years of previous research, no? As Rick and I discuss in the podcast, there is no assessment of exercise or daily activity, often higher in those of low and middle income, nor is there data on BMI. One question that arises is is higher fat consumption in those of lower BMI and higher daily activity advantageous?

Other studies this all-heart week include two from NEJM:Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease and Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation, and in Annals of Internal Medicine: Accuracy of Cardiovascular Risk Prediction Varies by Neighborhood Socioeconomic Status. Until next week, y'all live well.

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

047081331-cannabis-leafAnecdotal reports abound about the ability of cannabis or marijuana to relieve chronic pain and the anxiety associated with post traumatic stress disorder, or PTSD, but do these claims have any basis in fact? On PodMed this week, Rick and I examine two studies in Annals of Internal Medicine, and agree with the authors that the evidence is lackluster at best. What did they do?

Both studies are meta-analyses, so admittedly hypothesis generating rather than conclusive.  With regard to chronic pain, the study notes the fact that 28 states and DC have legalized marijuana for medical purposes. Some of those same places have also done so for recreational purposes as well, yet the strength of the evidence that cannabis provides effective pain relief from 27 pain trials cited is of low quality. The harm side of cannabis use appears to be robust: 11 reviews and 32 primary studies indicate increased motor vehicle accidents, cognitive impairment and psychotic symptoms.

What of PTSD? This review states that more than one-third of those seeking cannabis in states where it is legal list this condition as their reason for doing so. With regard to evidence for its use, only two reviews and three observational studies were found, with no randomized trials. The authors conclude that our best hope is ongoing trials currently underway that are examining cannabis use in a more rigorous fashion.

Other topics this week include ABIM Maintenance of Certification: Randomized Trial of Open-Book Versus Closed-Book Examination, also from Annals, and two from NEJM:Five-Year Outcomes for
On-Pump vs. Off-Pump CABG
 and Cognitive Function in a Trial of Evolocumab. Until next week, y'all live well.

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

sick-child-photo-020647220_iconm-120x86Sounded like a great idea at the time: a flu vaccine that could be given via nose droplets rather than an injection, especially for kids. Now, as Rick and I discuss on PodMed this week and published in the New England Journal of Medicine, turns out kids are the very persons for whom this vaccine is essentially ineffective.  Sorry parents, it's back to the tried but true along with the tears, at least for now. What happened?

Vaccines against influenza are routinely assessed for their ability to prevent the infection. The two types of vaccines, killed or inactivated, which is administered by injection, and live attenuated, given by the nasal droplet method, are most often used in adults and children, respectively. In the 2013-14 flu season it was detected that the live attenuated vaccine was essentially ineffective in the pediatric population. The vaccine was reformulated and used in the 2015-16 season, where once again, data from this analysis indicate it was ineffective in preventing flu in those who received it, only providing an effectiveness of about 15%. This lackluster performance has caused the powers that be, including the WHO and the CDC, to advise parents to go back to the injection for their children.  What's still not known is why this happened, as early use of the live attenuated vaccine did seem efficacious. Only more study will tell.

Other topics this week include Screening for Nasopharyngeal Carcinoma, also in NEJM, Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial in Annals of Internal Medicine, and in JAMA: Cerebral Embolic Protection in Patients Undergoing Surgical Aortic Valve Replacement. Until next week, y'all live well.

 

 

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

iStock_000014270773_MediumIf you need a kidney transplant you've got a bunch of things to think about, and it would be great to check worries about kidney rejection off the list.  That may be possible with a new method for depleting antibodies from the blood of the recipient Rick and I talk about on PodMed this week, as published in the New England Journal of Medicine. The study uses an enzyme made by the bacterium Streptococcus pyogenes abbreviated IdeS to deplete the class of antibodies known as IgG.

Twenty-five people who required kidney transplantation were enrolled in this trial, 11 patients in Sweden and 14 in the US. All of them were highly sensitized, meaning they had high levels of antibodies that couldn't be depleted by other means. IdeS was able to eliminate IgG and another type of antibody entirely at the time of transplantation. Of the 25 kidneys transplanted, 24 functioned in the recipient. One transplanted kidney ultimately failed after antibodies other than the type depleted by the enzyme developed.

This study is good news for the many, many people who are waiting for kidneys on transplant lists as it allows kidneys that are not ideal from a matching standpoint to be received by folks with a bunch of antibodies on board. It may also prove useful for those who require two or more kidney transplants in their lifetime as they definitely become sensitized.

Other topics this week include Fees for Certification and Finances of Medical Specialty Boards in JAMA, Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults: 2015 National Survey on Drug Use and Health in Annals of Internal Medicine, and back to NEJM for Idarucizumab for Dabigatran Reversal. Until next week, y'all live well.

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

025043236-sugar-freeDo you use artificial sweeteners or drink diet sodas? We've been watching the evidence mount that these products really aren't very helpful in assisting people to lose or even maintain their weight, and now comes a study in the Canadian Medical Association Journal that Rick and I discuss on PodMed this week that shows the sweeteners may actually be harmful.

This study was a meta-analysis of 7 randomized controlled trials and 30 cohort studies,with just over 1000 subjects in the former, with a median follow up of six months, and over 405,000 in the latter with a median follow up of 10 years. In the randomized controlled trials use of these non-nutritive sweeteners did not impact on BMI, while the cohort studies showed an association with an increase in weight, waist circumference, obesity, high blood pressure, metabolic syndrome and type 2 diabetes, and cardiovascular events. I pose the question in the podcast of a mechanism by which these sweeteners may have such an impact over the long term, to which Rick posits that they may actually induce increased consumption of sugar since they sensitize individuals to very sweet foodstuffs. An open question is whether the sweeteners themselves have some other physiologic impact that contributes to the development of obesity by other means, and we're sure time will tell as more research is done.

Other topics this week include two from JAMA: Weight Gain During Adulthood and Major Health Outcomes Later in Life and Association of Reduced Hospital Readmission Rates With Mortality Rates After Discharge, and from Annals: Dose Reduction or Discontinuation of Long-Term Opioids. Until next week, y'all live well.

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

UnknownCoffee drinkers have been on a bit of a roller coaster for some years, with studies seeming to conflict on the risk/benefit profile with respect to quaffing the beverage. Joy indeed then has come with a study in Annals of Internal Medicine Rick and I discuss on PodMed this week. Actually there are two of them, both huge in size and scope, and the take home is clear: if you drink coffee you don't have to worry about negative consequences of your habit, at least as long as it doesn't exceed a few cups a day.

One of the studies analyzed data from the European Prospective Investigation into Cancer and Nutrition study, following over 521,000 subjects. Relative to coffee consumption, the mean follow up was 16.4 years. During that time almost 42,000 deaths occurred, with an inverse relationship apparent with drinking coffee that did not vary by country or coffee preparation method. The second study looked at consumption of the beverage and mortality among non-white and some white individuals in the Multiethnic Cohort, comprising over 185,000 subjects. The same inverse relationship between coffee drinking and mortality was seen, whether death was due to heart disease, cancer, respiratory disease, stroke, diabetes, or kidney disease. The only subpopulation in whom the benefit wasn't as great was Hawaiian Americans. As I quip to Rick in the podcast, that's confirmation enough for me to continue my practice!

Other topics this week include Long-Term Results of the PIVOT Prostate-Cancer Trial and Diet Quality and Total and Cause-Specific Mortality in NEJM, and in JAMA,Effects of Antidepressant Switching vs Augmentation on Depression.

Also, here's the update on resistant HCV infection, as promised a couple of podcasts ago: http://www.journal-of-hepatology.eu/article/S0168-8278(17)30011-9/fulltext

Until next week, y'all live well.

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

039680310-woman-holds-empty-white-plate-Should you fast? Advocates of fasting believe it improves human longevity, perhaps via a mechanism of reduced inflammatory factors and things like LDL cholesterol. Now comes a study Rick and I discuss on PodMed this week and published in JAMA Internal Medicine that seems to refute this assertion, at least in the setting of weight loss. The specific aim of this study was to assess whether alternating days of fasting, with calories restricted to 25% of each subject's daily energy needs, versus standard caloric restriction of 75% of energy needs daily, or no intervention produced more, sustainable weight loss and improvement in cardiovascular risk factors.

100 adult participants with an average BMI of 34 were randomized to six months of the intervention or control followed by six months of follow-up. The study found that alternate fasting did not improve weight loss or sustainability, and that LDL cholesterol was actually higher in the fasting group relative to the daily caloric restriction group. Other metabolic markers, including blood pressure, heart rate, triglycerides, fasting glucose, fasting insulin, insulin resistance, C-reactive protein, or homocysteine concentrations at month 6 or 12, were the same between groups. Moreover,  about 40% of the fasting group dropped out of the study, finding compliance simply too difficult. Hmmm. Sounds like for either weight loss, maintenance, or improvement of metabolic risk factors alternate day fasting isn't helpful.

Other topics this week include Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Type 1 Diabetes and in Type 2 diabetes in JAMA, Declining Risk of Sudden Death in Heart Failure in NEJM, and in JAMA Pediatrics, Educational and Health Outcomes of Children Treated for Attention-Deficit/Hyperactivity Disorder. Until next week, y'all live well.

 

 

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments

microneedleWe're all about self these days, it seems. Selfie sticks, self-testing for any number of infectious diseases, and now self-vaccination! While some of the emphasis on self may be suspect, Rick and I agree on PodMed this week that a novel method for self-vaccination appears to have nothing but upside, as published in the Lancet.

Researchers describe a phase I study in which 100 volunteers were randomly assigned to one of four groups: a group that received a single dose of inactivated flu vaccine via injection, or by microneedle patch, or placebo- all administered by a provider, or a self-administered patch applied by the subject. Said patch, pictured above, has tiny little dissolvable needles that have a bit of the vaccine adhered to them. When applied for several minutes, the vaccine is delivered through the skin and elicits an immune response. How good an immune response? Every bit as good as the traditional injection, their data show.  And there are a multitude of other advantages: no cold storage chain needed, easy and preferable for the majority of subjects, inexpensive, and safely disposable after use. Rick and I are looking forward to further studies, and hope to see the technology employed for many other vaccinations.

Other topics this week include two from NEJM: Air Pollution and Mortality in the Medicare Population and Aspirin vs. Placebo for Preterm Preeclampsia, and in the BMJ: Physical activity, cognitive decline, and risk of dementia: 28 year follow-up of Whitehall II cohort study. Until next week, y'all live well.

VN:F [1.9.17_1161]
Rating: 0.0/5 (0 votes cast)
No Comments