October 19, 2014- Interviewed by Steven E. Greer, MD
Alessio Fasano, MD of Harvard discusses his 10-year-long study in children testing whether the delayed introduction of gluten into the diet reduced the eventual incidence of celiac disease. Dr. Fasano is most responsible for raising awareness of gluten intolerance after his 2003 NEJM and Archives of Internal Medicine papers were published.
October 19, 2014- Interviewed by Steven E. Greer, MD
Did you know that one out of three Americans think that they are “gluten intolerant”. Of those 100 Million people, only 13 Million really have a medical problem caused by gluten.
Alessio Fasano, MD, director of the Center for Celiac Research and Treatment at MassGeneral Hospital for Children, is the man who started all of the gluten hype back in 2003 with a paper in the Archives of Internal Medicine. Hoping to reduce some of the current “gluten hysteria,” he has written a book explaining what gluten is, who can and can’t eat it, and why. We interviewed him.
In the general news, British Parliament voted to recognize the Palestinian state. The nurse in Spain and two in the U.S. infected with Ebola recovered, as the CDC was profoundly criticized for poor handling of the scare. The stock markets reacted by selling off 10%. In media, HBO and CBA announced a de-bundling plan that would sell their products on the Internet, meaning a quicker end to cable TV.
In healthcare business news, earning began with JNJ posting strong drug revenue. The Abbvie (ABBV) and Shire inversion merger was cancelled. Steris (STE)acquired Britain’s Synergy Health for $1.9 Billion for the inversion tax benefits. Lastly, Mankind (MNKD)reaped a $150 Million milestone on Afrezza, sending the stock up 16%.
On the data front, Regeneron’s (REGN) Eyleaoutperformed Roche’s Avastin and Lucentis in diabetics. Alnylam (ALNY) posted 6-month data onPatisiran to treat rare Familial Amyloidotic Polyneuropathy.Lastly, NewLink Genetics (NLNK)tested an Ebola vaccine.
From the FDA, Roche’s Esbriet and Boehringer Ingelheim’s Ofev were approved to treat idiopathic pulmonary fibrosis. Also, a panel voted to keep the black box warnings on Pfizer’s (PFE) Chantix.
The mainstream media has correctly reported on the numerous missteps made by the Dallas Presbyterian Hospital when the first Ebola case, Thomas Eric Duncan, presented to them, and then the subsequent “protocol” mistakes that caused two nurses to become infected with Ebola. However, the press still characterizes the decision to discharge the patient, even when he arrived with a fever and had a history of travel from Africa, as a “misdiagnosis”. Read more »
In the general news, global Ebola fears dominated the news, from Africa to Spain to Dallas, where a patient died, then a nurse caring for him also became infected.
In healthcare business news, Becton Dickinson (BDX)acquiredCareFusion (CFN) for $12 B. Endo InternationalacquiredAuxilium (AUX) as part of a tax-reduction inversion deal. Also, Actavis (ACT)made a move to acquire Allergan (AGN) as the Valeant (VRX) attempt stalls.
From the FDA, a third FDA panel. once again, recommend approval of the Boston Scientific (BSX) left atrial occlusion device called Watchman. The Bard (BCR) Lutonix drug coated balloon to treat peripheral vascular disease was approved. Salix’s (SLXP) foam delivery of drug Uceris (budesonide) to treat ulcerative colitis was approved. Eisai’s drug Akynzeo for nausea was approved. Regeneron (REGN) received a label expansion for Eylea to treat retinal vein occlusion macular edema, and Gilead’s (GILD) combo pill Harvoni (ledipasvir and sofosbuvir) was approved.
In other regulatory news, Senator Bernie Sanders and Rep. Elijah Cummings launched an investigation into price gouging by generic drug companies. Also, The White House and the CDC prepared plans to treat Ebola patients in remote hospitals away from urban areas as the military put boots on the ground in Africa to help stem the source of the outbreak.
New drugs have been developed to treat the growing problem of C. diff colitis. They focus on the problem of newer virulent strains of clostridium difficile that are resistant to most antibiotics, but is that the proper or only approach?
More patients are becoming chronically infected by C. Diff and require lifelong vancomycin. Is something else other than a super virulent organism causing this problem? Is antibiotic usage altering the normal GI tract microbiota rendering these patients susceptible to recurrent bouts of C. diff colitis?
Infectious disease specialist, Dr. Vincent Young, MD PhD of the university of Michigan, discusses these issues.
Infectious disease specialist Dr. Vincent Young from the University of Michigan discusses the NIH project to catalog the bacterium that normally live within the human body and assist in normal physiology.
Leonard Saltz, MD, of Memorial Sloan-Kettering Cancer Center, discusses how the targeted cancer drugs developed within the last 5 years (Avastin, Tarceva, Sutent, Nexavar, etc) are escalating the total cost burden per cancer patient to unsustainable levels.
In the general news, pro-democracy protestors in Hong Kong dominated the news, as another hostage was beheaded by ISIS in Syria. In the U.S., one case of Ebola created a TV-panic, and the jobless rate fell below 6% for the first time since 2008.
In healthcare business news, the Physician Payment Sunshine Act website went live. Medtronic (MDT)pledged to continue to acquire Covidien (COV) despite the Treasury removing the inversion tax incentives. JNJacquiredAlios BioPharma to obtain their HCV and RSV drug pipeline for $1.56 Billion. Lastly, Amag (AMAG)acquired women’s health product company Lumara.
On the positive data front, Puma’s (PBYI) cancer drug for lung cancer, PB272, succeeded in Phase 2. Merck’s (MRK) PD-L1 drug Keytrudamet endpoints in a bladder cancer trial. Ardelyx’s(ARDX) drug tenapanor to treat opioid-induced constipation met endpoints. Portola Pharma’s (PTLA) drug andexanet alfawas effective at reversing the effects of blood thinner Eliquis. Lastly, Novo Nordisk is working on once-weekly insulin for Type-2′s.
On the failure front, EliLilly (LLY) cancelled its Lupus program, which benefited shares of Israel-based XTL Biopharmaceuticals Inc. Tonix Pharma’s (TNXP) pain drug TNX-102 also failed.
From the FDA, the Progenics (PGNX) and Salix (SLXP) drug Relistor was approved for a label expansion to treat opioid-induced constipation in patients with chronic non-cancer pain (i.e. addicts). Also, Ariad Pharma’s (ARIA) lung cancer drug AP26113 won breakthrough therapy status.
Jeffrey F. Peipert, M.D., Ph.D. of Washington university discusses his original article in the NEJM that studied a large cohort of young females who were given free long-term birth control. The results were a dramatically lower incidence of birth and unwanted pregnancies compared to the overall population. He then discusses why the effective contraception methods are underutilized.