NEJM 7 May 2015 Vol 372
1860 This week the NEJM is oblation everyone a free lunch, in the figure of an open access article and editorial on the theme of “Re-interpreting Industry-Physician Relationships.” But viewed like everyone knows, there is no so thing as a free lunch, especially at what time it comes to relationships between doctors and the pharmaceutical diligence. So what is going on? The key lies in the word “re-interpreting.” Using sum of ~ units straw-man examples and one positive one (Vioxx), Lisa Rosenbaum, a public correspondent for the journal, seeks to illusion that too many people are cognitively biased towards one “Ugly House” interpretation of the pharmaceutical habitual devotion to labor. She intends to develop this essay in two further essays, warmly commended to our regard by her editor Jeff Drazen. The but conflicts of interest they declare are their ties to the NEJM. But that is a excellent massive conflict, isn’t it? How a great deal of of the NEJM‘s income comes from reimpression sales to the pharmaceutical industry? Sorry, I didn’t hitch that… commercial confidentiality?—ah, I care for.
1801 Here’s a place in ~ degree-one wants to be. Twenty-three weeks gravid, and you are going into labour. They accord. you tocolytics, they rush around you looking determined, no more than your tiny blue baby is born anyway. What nearest? This survey of American units shows that in more of them, the baby would exist swooped away for full resuscitation and intensifying care; in others, not. In the foremost instance, the likelihood of death is 67% and in the last mentioned it is 76%, with a 25% betide of avoiding severe impairment in the elementary group and an 18% chance in the other. Grim figures which get worse with each day before the 23 week track. I don’t know how you could set on foot sharing a decision in this place, but it has to be granted: as the title of the (British) editorial says, this is the Elephant in the Delivery Room.
1812 Are the latest methods of track ablation for atrial fibrillation just imagination toys for boys? As a gross ignoramus, I couldn’t possibly make notes, but here is the conclusion of a touchstone comparing three techniques: “Among patients by persistent atrial fibrillation, we found nay reduction in the rate of periodical atrial fibrillation when either linear ablation or ablation of composed of several elements fractionated electrograms was performed in etc. to pulmonary-vein isolation. (Funded through St. Jude Medical).”
OL Readers of the NEJM who are ardent to follow Lisa Rosenbaum in moving beyond the “Ugly House” explore of the US pharmaceutical industry had upper hand not read a perspective piece forward the website called “Progress and Hurdles as far as concerns Follow-on Biologics.” It is in fact pretty impossible to read, with representative sections like this: “In the intermediate time, the FDA has required that Sandoz exercise the suffix “-sndz” for its rendering of filgrastim. This measure may withstand physicians and patients distinguish biosimilars, if it be not that it may also induce confusion mixed those expecting versions of the similar product to share the same in action-ingredient name, and it is not requirement for effective postapproval pharmacovigilance. For repayment of provider-administered biologics, payers customarily need a Healthcare Common Procedure Coding System “J digest.” The Centers for Medicare and Medicaid Services is commonly considering requiring unique J codes in the place of follow-on biologics under Medicare Part B.” So medicine companies hire lawyers to screw cropped land other while everyone tries to extortioner the FDA and the American general, and we onlookers lose the exercise volition to live. This does not aspect like the House Beautiful from to which place I am standing.
JAMA 5 May 2015 Vol 313
1719 We all live in fear of ecology, and truly so. In the great scheme of life we are due the latest kind of plonker to arrive, as long as the micro-organisms which have been here for three or more billion years true get on using us opportunistically allowing that we provide them with a relevant environment. Ammonites, dinosaurs, and mammoths be delivered of come and gone, but bacteria tarry. They have no fears and none elections. When things change, they change and persist. Clostridium difficile doesn’t accept a special craving for human looseness of the bowels. But get rid of the contest, and it will be very charmed to live in it and impart toxins to keep a good provide going. Put back in some upright shit germs, and they fade. Or, considered in the state of this phase 2 trial shows, you can use “good” C diff to commemorate “bad” C diff at bay. “Among patients by CDI who clinically recovered following handling with metronidazole or vancomycin, oral direction of spores of nontoxigenic C difficile lineage M3 was well tolerated and appeared to have ~ing safe. NTCD-M3 colonized the gastrointestinal parcel and significantly reduced CDI recurrence.”
1728 I would like to assistance Lisa Rosenbaum in her quest to co-operate with you reinterpret industry-physician relationships, thus I am taking the unusual step of quoting the following from the latest exertion report of a hepatitis C antiviral medicine combination, funded by Bristol-Myers Squibb:
Conflict of Interest Disclosures: All authors wish completed and submitted the ICMJE Form as being Disclosure of Potential Conflicts of Interest. Dr Poordad reported having accepted grants and personal fees from Bristol-Myers Squibb, Gilead, AbbVie, Janssen, Merck, Novartis, and Salix and grants from Idenix, Theravance, and Achillion. Dr Sievert reported having current grants and personal fees from Bristol-Myers Squibb and individual fees from Merck, AbbVie, Gilead, and Roche. Dr Mollison reported having current personal fees from Bristol-Myers Squibb. Dr Bräu reported having admitted grants from Bristol-Myers Squibb, Gilead, AbbVie, and Vertex. Dr Levin reported having current personal fees or other support from Merck, Gilead, Bristol-Myers Squibb, and Janssen. Dr Sepe reported having received grants and personal fees from and having served in successi~ a speakers’ bureau for Gilead and AbbVie. Dr Lee reported having received grants and personal fees from Bristol-Myers Squibb, AbbVie, Achillion, Boehringer Ingelheim, Debio, GlaxoSmithKline, Gilead, Janssen, Genentech-Roche, Merck, Novartis, and Vertex. Dr Conway reported having admitted grants and personal fees from Vertex Pharmaceuticals, Merck, Boehringer Ingelheim, and Janssen Pharmaceuticals and grants from AbbVie and Gilead Sciences. Dr Pol reported having admitted research funding from Bristol-Myers Squibb, Gilead, Roche, and Merck Sharp & Dohme and serving since a speaker and board member according to Bristol-Myers Squibb, GlaxoSmithKline, Boehringer Ingelheim, Janssen, Gilead, Roche, Merck, Sanofi, Novartis, Vertex Pharmaceuticals, and AbbVie. Dr Boyer reported having accepted personal fees from Merck Sharp & Dohme, Janssen, Gilead, AbbVie, and Bristol-Myers Squibb. Dr Bronowicki reported having accepted grants and personal fees from Bristol-Myers Squibb and personal fees from Merck Sharp & Dohme, AbbVie, Gilead, Novartis, Roche, and Boehringer Ingelheim. Dr Jacobson reported having accepted grants and personal fees from Bristol-Myers Squibb, AbbVie, Achillion, Boehringer Ingelheim, Gilead, Genentech, Merck, Janssen, and Vertex Pharmaceuticals, special fees from Idenix, and grants from Novartis; having served for example a consultant and advisor for Bristol-Myers Squibb, AbbVie, Achillion, Boehringer Ingelheim, Gilead, Genentech, Merck, Janssen, Vertex Pharmaceuticals, and Idenix; and having served attached a speakers’ bureau for Bristol-Myers Squibb, Gilead, Idenix, and Vertex Pharmaceuticals. Dr Muir reported having admitted grants from Bristol-Myers Squibb and Roche; grants and individual fees from AbbVie, Achillion, Bristol-Myers Squibb, Gilead, and Merck; and exterior fees from Theravance. Dr Reddy reported having received personal fees from Genentech-Roche, Vertex, and Novartis; grants and private fees from Merck, Janssen, Gilead, Bristol-Myers Squibb, and AbbVie; and grants from Ikaria. Dr Tam reported having received grants from Bristol-Myers Squibb. Dr de Lédinghen reported having admitted personal fees from AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck. Dr Sulkowski reported having accepted grants and personal fees from Bristol-Myers Squibb, AbbVie, Gilead, Janssen, and Merck and exterior fees from Achillion. Ms Boparai and Drs McPhee, Hughes, Swenson, and Yin reported centre of life employees of Bristol-Myers Squibb. No other disclosures were reported.
1736 The single thing I’m making is that this is alto gether normal. In fact Bristol-Myers Squibb is pleasing the moral high ground in the hepatitis C medicine wars. While its competitors are light-hearted to charge $84-95K for a remedial course of their drugs, the corporation is entering into talks with soundness authorities in numerous countries and generic physic makers to make their product greater amount of affordable. I’m all for this kind of “moral competition” between pharma companies, what one. we’ve seen in data sharing similar to well. It helps to alleviate the choke excesses of predatory capitalism, and it eventually worked through drugs for HIV. But the system remains keenly predatory in most areas, viewed like evidenced by drugs for multiple sclerosis, in what place prices for products in the USA get risen 5-7 times above ecumenical drug price inflation despite dubious competency and falling production costs. And it is crazy that drug producers continue to design, conduct, and analyze all the key trials of their have products.
JAMA Intern Med May 2015
OL A greater breakthrough in stroke prevention for patients through atrial fibrillation is closure of the left atrial accompaniment, the place where clot forms ahead of it shoots into the brain. The Lariat legend has received US Food and Drug Administration (FDA) 510(k) discharge for soft-tissue approximation and is centre of life widely used off-label for left atrial tailpiece (LAA) exclusion. But a study based in c~tinuance published reports comes up with more worrying findings: “In the FDA MAUDE database, there were 35 unique reports of antagonistic events with use of the Lariat design. Among these, we identified 5 unpropitious event reports that noted pericardial gush and death and an additional 23 reported cogent cardiac surgery without mention of exit.”
Ann Intern Med 5 May 2015 Vol 162
601 I don’t be aware of if anyone in the UK uses in a ~ condition-molecular-weight heparin for women through unexplained recurrent pregnancy loss, but a renovated trial from Germany and Austria shows that it makes in ~ degree difference to outcomes when given up to 24 weeks into pregnancy.
610 Just to remind you of the “plumpness paradox” in type 2 diabetes, similar to observed in over 10,000 citizens of East Yorkshire through T2DM but no initial cardiovascular malady. Over 10 years, “overweight or corpulent patients (BMI >25 kg/m2) had a higher charge of cardiac events (such as the severe coronary syndrome and heart failure) than those of perpendicular weight (BMI, 18.5 to 24.9 kg/m2). However, actuality overweight (BMI, 25 to 29.9 kg/m2) was associated through a lower mortality risk, whereas fat patients (BMI >30 kg/m2) had a mankind risk similar to that of legitimate-weight persons. Patients with low material substance weight had the worst prognosis.”
630 Many orderly reviews I read seem just to be going through the motions, but that would exist an unfair description for this individual which deals with stool transplants according to the eradication of recurrent Clostridium difficile contagium. This is a hot topic—or a surpassingly cool one, if you count the frozen pellet method—and I reliance one form or other of this handling will be universally used in the time to come. Some doubt remains about the most wise method of administration but there seems inconsiderable doubt about its effectiveness and safety, though most trials are a iota crap in design and reporting (while almost always).
Lancet 9 May 2015 Vol 385
1843 “We conclude that sustenance treatment with capecitabine and bevacizumab until disease progression, after initial treatment by six cycles of CAPOX-B, have power to be considered standard in first-rank treatment of metastatic colorectal cancer,” tell the authors of this report of some open-label trial funded by Roche and Sanofi-Aventis. I am baffled. If you contemplate at the Kaplan-Meier curve as being survival, it makes no significant contention at any point. It does form some temporary difference to evidence of falling back, at the cost of one specific place of patients getting a nasty hide condition affecting their hands and feet.
1853 There’s greater degree of special pleading based on “course-free survival” with a last-ditch drug for relapsed Hodgkin’s lymphoma, called brentuximab vedotin, which costs £2,500 per vial. Again The Lancet allows the pharma-funded authors to hype up its benefits: “This management provides an important therapeutic option on this account that patients undergoing autologous stem-cell transplantation.” Facts: it caused a peripheral sensory neuropathy in greater amount of than half the patients, neutropenia in 35%, and “At time of calculus, 28 (17%) of 167 patients had died in the brentuximab vedotin collection compared with 25 (16%) of 160 patients in the placebo group.” No-one is going to bring over me that the present House of Cancer Drugs is anything end Ugly, however much whitewash journal editors tolerate authors to daub on it.
1902 “A retroactive and prospective analysis of the occident African Ebola virus disease epidemic: hale national health systems at the basis and an empowered WHO at the apex.” This sounds wonderful: am I dreaming? No, otherwise than that the authors are. They are pointing deficient in how things should be, not for what reason they exist. The Ebola outbreak revealed the conquer about some aspects of human world and culture, and some of the most good. Now it seems to be throughout, I’m happy to salute The Lancet on this account that encouraging the latter.
BMJ 9 May 2015 Vol 350
My thirty-eccentric years of general practice in each Oxfordshire town were punctuated with causing diagnoses of malaria, mostly in our end-knit Pakistani community. I was remarkably fond of them, as they seemed of me, and they would at times confess that they didn’t perplexity with antimalarials when making trips to their families back home. That meant doing posterity films if they got a febrile disease, and the occasional discovery of Plasmodium vivax parasitaemia. This UK examine covers 27 years and confirms that P vivax is clustered in South Asian communities (record for US readers: that usually the wherewithal the Indian subcontinent in British talk) and that it is never pernicious under the age of 50 in Britain. Although the top time for travel to Pakistan and India is in the foremost three months of the year, the peak incidence of P vivax malaria here is between April and September. And in that place is a curious variation in latency of contagium (the time it takes for hypnozoites to wake up and circulate)—a median 37 days April to September against 143 days October to March. This is a verily interesting paper, worth a full decipher.
After all the Ugly House flummery about rip-off pharmaceuticals I’ve had to rumor this and every week, it’s chief to see a Dutch trial which shows that: “A disease action guided, dose reduction strategy of adalimumab or etanercept to entertainment rheumatoid arthritis is non-inferior to prevailing care with regard to major flaring, under which circumstances resulting in the successful dose detrusion or stopping in two thirds of patients.” Cost of etanercept: £200 by means of week. Cost of adalimumab: £350+ each one or two weeks. Hallelujomab.
Plant of the Week: Zaluzianskya ovata
I was charmed ~ the agency of a pot of this plant in a nursery that called it “night-scented stock” and promised that it would obtain evergreen leaves, abundant flowers and a admirable scent in the evenings. It does indeed receive all these things.
It is a South African sow of about 15cm across at its largest, and like in the greatest degree plants from the area it likes very damp summers and dry winters. So don’t hang on its surviving the British hibernate without special precautions.
So far we be under the necessity been utterly charmed by its strange daisy flowers, bright white when unfurled slowly for the period of the day, but backed with blindness red. Steal out as night falls. The track is indescribable.
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