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February 2010 Issues

Another FDA Risk Program: This Time for Asthma Medications -- Quick Pulse

Summary: The FDA wants the use of long-acting beta agonists (LABAs) to go down. To ensure that happens, the Agency has imposed a new Risk Evaluation and Mitigation Strategy (REMS) for these drugs, warning that they .should never be used alone in the treatment of asthma in children or adults..

American Academy of Pain Medicine (AAPM)

Summary: Risk management is definitely on the minds of pain specialists who are worried that overly aggressive regulations will affect patient access to appropriate medications. ♦ Industry and the FDA still appear to be far apart on the design of a class-wide REMS for long-acting opioids. ♦ There was little discussion of the new abuse-resistant and abuse-deterrent opioids in development. ♦ The REMS for Meda Pharmaceuticals’ buccal fentanyl, Onsolis, has opinion leaders outraged, but most other doctors don’t find it onerous. ♦ So far, doctors have been underwhelmed with Johnson & Johnson’s Nucynta IR. ♦ King Pharmaceuticals’ Embeda is catching on, but slowly. ♦ Experts were speculating that Abbott Laboratories will resume efforts to get Vicodin CR approved. ♦ The data from Jazz Pharmaceuticals’ second Phase III trial of Xyrem in fibromyalgia looked very good.

Eye FDA Institutes Risk Management Program for Erythropoiesis-Stimulating Agents (ESAs) Given to Cancer Patients -- Quick Pulse

Summary: Starting no later than March 25, 2010, Amgen will begin enrolling healthcare providers and hospitals in a new Risk Evaluation and Management Strategy (REMS) for all ESAs – Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) and Johnson & Johnson’s Procrit (epoetin alfa manufactured by Amgen). In a teleconference with reporters, FDA officials insisted the new REMS is designed to help cancer patients make more informed decisions about the risk:benefit ratio of using ESAs, not to ban ESA use, but they also said the program is “designed to help ensure the appropriate administration of these drugs.” 

Eye Care Update

Summary: For optometrists, the economic downturn appears to have bottomed, but no real pickup is expected this year. ♦ Contact lens fittings are holding relatively steady, with both daily disposable lenses and silicone hydrogel lenses picking up a little. ♦ Referrals for refractive surgery are down 16% vs. January 2009, and the outlook is for a flat 2010. ♦ When generic versions of Pfizer.s Xalatan become available in October 2011, it is likely to expand the patients treated for glaucoma, expand the number of patients on a prostaglandin, but cannibalize other branded prostaglandins in terms of both new and existing patients. Optometrists are already seeing fewer Xalatan samples and fewer visits by Pfizer sales reps. ♦ Use of Allergan.s Restasis for dry eye is increasing, but cost remains the main limiting factor. ♦ Use of Allergan.s Latisse to lengthen eyelashes is catching on. Most patients who try it, like it, and keep using it, so doctors are increasingly writing prescriptions for it.

American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI)

Summary: Colorectal cancer: Use of Amgen’s Vectibix in CRC is increasing slowly due to new data and lower pricing. Oncologists are anxious for a biomarker to predict response to Avastin in CRC. Some oncologists believe Genentech is impeding development of a predictive SNP, but Roche has a team working hard to find a biomarker. The N-0147 trial of adjuvant Lilly/ImClone’s Erbitux in CRC has been stopped due to lack of efficacy and safety, and first-line use of Erbitux is not catching on. ♦ Liver cancer: Negative data from Japan on Bayer/Onyx’s Nexavar in liver cancer is not worrying oncologists. ♦ Neuroendocrine tumors: The Phase III results of Pfizer’s Sutent were so positive that they are likely to be practice changing. ♦ Gastric cancer: The ToGA trial data on Roche/Genentech’s Herceptin in HER2+ gastric cancer have the potential to increase use of Herceptin by 35% in the U.S. and Japan together. ♦ Investigational agents: Oncologists are not optimistic about the outlook for AstraZeneca’s VEGF inhibitor Recentin (cediranib, AZD-2171) in CRC or Merck’s IGF-1R inhibitor MK-0646 in pancreatic cancer. ♦ Octapeptides: Diagnostic use is expected to go down in favor of CT/MR, but therapeutic use is holding steady.

January 2010 Issues

International Symposium on Endovascular Therapy (ISET) -- Quick Pulse

Summary: Coverage of this meeting hits only a few key areas: uterine fibroid embolization, patent foramen ovale (PFO) closure for stroke, brain stents for stroke, and peripheral atherectomy. Twenty doctors were interviewed: 13 interventional radiologists, 3 interventional cardiologists, 2 interventional neuroradiologists, 1 neurosurgeon, and 1 endovascular surgeon.

Radiological Society of North America (RSNA)

December 2009 Issues

FDA Public Meeting on Opioid Risk Management

Summary: The FDA is not impressed with industry’s proposals for opioid risk management. ♦ The FDA will hold an advisory meeting sometime in spring 2010. ♦ The industry proposal is for a phased-in risk management program over several years, but the proposals appeared to be weaker – focusing on patient medication guides, letters to healthcare practitioners, and voluntary training – than the FDA would like. ♦ Industry also wants to link physician training to physician Drug Enforcement Agency (DEA) certification, which would be a daunting task because Congress would have to pass a law requiring it and because strong opposition is expected, even from the DEA itself.

 38th Global Congress of Minimally Invasive Gynecology hosted by the American Association of Gynecologic Laparoscopists (AAGL)

Summary: Use of robots like Intuitive Surgical’s da Vinci is increasing, not only in urology but also in gynecology; 85% of hospitals checked already have at least one da Vinci, and 21% plan to get another in the next 1-2 years. ♦ Single incision surgery doesn’t have tremendous appeal in gynecology because many procedures already are done laparoscopically with small incisions, but patient demand could drive a change. ♦ Better contraceptive devices, particularly Bayer’s Mirena IUD, are so good and so popular that growth is projected to be relatively flat over the next year for permanent contraceptive devices – such as Hologic’s Adiana or Conceptus’ Essure. Mirena is even affecting endometrial ablation procedures, so no growth is expected for Hologic’s NovaSure. ♦ Bayer’s Yaz birth control pill remains popular despite lawyers trolling for clients who have had an adverse event. ♦ Mesh remains a useful tool in female surgery, but use of vaginal mesh is down slightly due to safety concerns. However, use of minimally invasive slings with mesh is increasing.

American Heart Association (AHA) Scientific Sessions

Summary: More bad news for Merck’s ezetimibe – lack of efficacy and a safety signal in the ARBITER- 6-HALTS trial. ♦ Niacin and HDL-raising drugs are getting new attention, though cardiologists are waiting for the AIM-HIGH trial to prove that raising HDL is beneficial. ♦ More data were presented confirming the efficacy and safety of AstraZeneca’s antiplatelet agent Brilinta (ticagrelor) and Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran). But the CHAMPION trials of The Medicines Company’s cangrelor didn’t hold out much hope for that IV platelet inhibitor, and platelet resistance testing is unlikely to take off without data from a large outcomes trial, if ever. ♦ In anemia, more bad news for Amgen’s Aranesp, with new data that mortality was higher in stroke survivors who took Aranesp vs. placebo. But IV iron may be more helpful than previously thought, especially in non-anemic heart failure patients. ♦ CardioDx has an interesting gene test for obstructive coronary artery disease, Corus CAD, but so far cardiologists are skeptical. ♦ Continuous flow LVADs – and destination therapy – got a big boost with new data on Thoratec’s HeartMate-II showing 58% two-year survival.

November 2009 Issues

American Society of Nephrology’s Renal Week -- Quick Pulse

Summary: An important focus of Renal Week was on the management of conditions such as anemia, hyperphosphatemia, fibrosis, and hypertension in chronic kidney disease (CKD) and end-stage renal disease (ESRD).  Overall, many of the results presented at Renal Week did not look favorable for the risk:benefit profile of erythropoiesis-stimulating agent (ESA) use in CKD patients.

American Academy of Ophthalmology (AAO)

Summary: Ophthalmologists and their patients are feeling the impact of the recession, but things don’t appear to be getting worse. ♦ LASIK surgery appears to have bottomed and is likely to remain flat for the next 6-12 months. ♦ Premium IOLs have lost a little market share overall, but within their niche, Alcon’s new ReStor 3.0 is a big improvement and is luring customers from Bausch & Lomb’s Crystalens HD, which many doctors view as worse than the old Crystalens 5.0. Abbott’s Tecnis has mostly replaced ReZoom but is a minor player. ♦ Doctors are very interested in femtosecond cataract surgery, and LenSx, LensAR, and OptiMedica are leading the way. ♦ The glaucoma device pipeline doesn’t look very promising. Generic latanoprost is expected to take huge market share. ♦ Retina surgeons are waiting for the results of the CATT head-to-head study of Avastin and Lucentis in wet AMD while investigating a number of potential new treatments for dry AMD. ♦ Autofluorescence is the hot new topic in imaging, picking up things that current OCT does not. ♦ Financial issues – especially Medicare reimbursement and healthcare reform – are a big concern, but ophthalmology appears in a better position than some other medical specialties.

FDA Advisory Panel Votes Overwhelmingly to Approve Acorda’s Fampridine-Sr for Multiple Sclerosis -- Quick Pulse

Summary: The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted overwhelmingly (12 to 1) to recommend approval of Acorda Therapeutics’ Ampriva (fampridine-SR), a 10 mg 4-aminopyridine (4-AP) sustained-release (SR) tablet for the symptomatic improvement of walking ability in patients with multiple sclerosis (MS). It would be a new indication, never before granted by the FDA, as currently-approved MS drugs are indicated to decrease relapse rate and, in some cases, to prevent the accumulation of disability.

October 2009 Issues

FDA Advisory Committees Recommend Approval of Purdue’s Reformulated Oxycontin -- Quick Pulse

Summary: The FDA’s Anesthetic and Life Support Drugs Advisory Committee (ALSDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly recommended approval of Purdue’s reformulated OxyContin (oxycodone controlled-release) by a vote of 14-4, with one abstention. The FDA had previously turned down the new OxyContin, but panel members agreed that the data were much improved, though they asked for a post-marketing study due to continued concerns about safety. Although the panel expressed concern about the continued misuse and abuse of OxyContin, it saw the reformulated drug as the lesser of two evils.

ECCO-15 – ESMO-34 The 15th Congress of the European Cancer Organization (ECCO) and The 34th Congress of the European Society for Medical Oncology (ESMO)

Summary: The positive news:  ♦ Amgen’s denosumab is safe and effective for skeletal-related events. ♦ Amgen’s Vectibix is effective first-line in metastatic colorectal cancer but only if the patients are KRAS-wild type. ♦ Roche/Plexxikon’s PLX-4032 improves survival in metastatic melanoma. ♦ No new safety signals were seen with Roche’s Tarceva in non-small cell lung cancer. ♦ Regional hyperthermia improves mortality in sarcoma patients. The negative and mixed news: ♦ Bayer/Onyx’s Nexavar improves survival in metastatic breast cancer, but side effects are a concern. ♦ No first-line benefit was shown for Lilly/Bristol-Myers Squibb’s Erbitux in metastatic colorectal cancer. ♦ Roche’s Avastin showed no survival benefit in malignant melanoma.  

European Association for the Study of Diabetes (EASD)

Summary: Endocrinologists don’t believe the incretin mimetics cause pancreatitis, so FDA warnings are not dampening their enthusiasm. ♦ Doctors are dubious that long-acting insulin analogs promote tumor growth. Novo Nordisk is trying to distance Levemir from Sanofi- Aventis’s Lantus, suggesting that if there is a problem, it is with Lantus, not Levemir. ♦ Doctors are not convinced that Novo Nordisk’s GLP-1, Victoza (liraglutide), causes thyroid cancer and dismissed C-cell hyperplasia as an animal, not human, issue. ♦ Bristol-Myers Squibb’s DPP-4, Onglyza, was generating little excitement, but it is expected to expand the DPP-4 market which currently accounts for <10% of patients on oral diabetes drugs, especially in lieu of sulfonylureas, rather than taking share from Merck’s Januvia. The key limitation on DPP- 4s is cost. ♦ New drug ‘fatigue’ has settled on the diabetes community, and there is no excitement about new classes of drugs. Bristol-Myers Squibb/AstraZeneca’s dapagliflozin, the most advanced SGLT-2, has only modest efficacy, and doctors are very concerned about genitourinary infections, though there is no evidence they will lead to pyelonephritis. ♦ Roche’s once-weekly GLP- 1, taspoglutide, may be the category killer. Doctors speculated it may be as efficacious as Victoza, better than Amylin/Lilly’s Byetta, and more convenient than either.  

International Headache Congress (IHC) Hosted by the American Headache Society (AHS)

Summary: Allergan’s Botox migraine data looked positive, but doctors are very skeptical about the results. Still, patients are likely to ask for it, and it will be used at least as a last resort for those willing to pay for it or able to convince their insurance companies to cover it. ♦ MAP Pharmaceuticals’ Levadex, a self-administered, orally inhaled form of dihydroergotamine, seems to be effective, but doctors still want more data. ♦ Merck’s telcagepant, a calcitonin generelated peptide (CGRP) antagonist, works well, but enthusiasm was muted due to some confusion about whether or not the company has put it on hold due to questions about liver toxicity. ♦ NuPathe’s Zelrix, an iontophoretic transdermal sumatriptan patch, appears to work and is well tolerated by patients particularly those bothered by stomach problems and nausea associated with other treatments.

FDA Advisory Panel Unanimously Recommends Approfal of Auxilium's Xiaflex for Advanced Dupuytren's Disease -- Quick Pulse

Summary: The FDA’s Arthritis Advisory Committee voted unanimously (12 to 0) to recommend Auxilium Pharmaceuticals. Xiaflex (AA4500/collagenase clostridium histolyticum or CCH) for the treatment of advanced Dupuytren’s disease. Xiaflex is a novel, first-in-class, orphan-designated biologic injectable for the non-surgical treatment of Dupuytren’s contracture, a disorder caused by an abnormal buildup of collagen in the hands, eventually causing the fingers to bend and be unable to extend. The panel agreed that the benefits clearly outweighed any risks, and several members spoke of the compelling testimony of public witnesses who said that the procedure changed their lives.