Trends-in-Medicine
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Trends-in-Medicine follows drugs and devices in development, regulatory issues, trends in healthcare, and other topics of interest to a primarily physician audience.
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| Publisher: | Stephen Snyder |
| Writers: | Lynne Peterson |
| Marta Weber | |
| Diana Woods | |
| Editors: | Kathleen Snyder |
| Betty Teel | |
Trends-in-Medicine has no financial connections with any pharmaceutical or medical device company. The information and opinions expressed have been compiled or arrived at from sources believed to be reliable and in good faith, but no liability is assumed for information contained in this newsletter.
Copyright©2008
No articles may be reproduced without written permission of the publisher.
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June 2009 Issues
Summary: Diet is effective in eosinophilic esophagitis, but almost impossibly difficult for patients to maintain. Biologics may offer the best hope, but experts weren’t particularly enthusiastic about any of them yet. ♦ Both XenoPort’s arbaclofen placarbil and AstraZeneca’s AZD-3355 look promising as add-on therapy to a PPI for GERD. ♦ Salix’s Xifaxin (rifaximin) is already being used off-label for hepatic encephalopathy, but cost – not insurance reimbursement – is a major issue, and general gastroenterologists do not believe that FDA approval will significantly increase their use of it. ♦ Data showed that Forest Labs/ Ironwood’s linaclotide is effective in IBS, but the clinical significance of the effect is still somewhat uncertain. ♦ Several less invasive or non-invasive approaches to bariatric surgery are being tested, and this has been accompanied by a flattening to slight decrease in use of banding procedures.
Summary: Progress on a REMS for long-acting opioids is moving slowly, and implementation is not likely until 2010 or even 2011. ♦ An FDA advisory committee meeting on the REMS is expected in the future. ♦ The FDA is not ruling out the possibility of pulling long-acting opioids from the market, but the Agency really considers that a last resort and does not expect that to happen. ♦ A consortium of 25 pharmas is working on a medication guide, a communication plan, and other elements to assure safe use of opioids, including a patient-physician agreement form, an implementation system, a timetable for submission of assessments, and cooperation with the DEA and state licensing bodies. ♦ Among the suggestions given to the FDA were: a pilot program, tracking systems, multidisciplinary approach, education, and patient contracts. ♦ Two generic manufacturers asked for a separate REMS for methadone products, but that appears unlikely. ♦ Patients are worried the REMS will restrict their access to opioids, and families who have lost loved ones charged that the FDA is not acting fast enough to restrict dangerous drugs. ♦ FDA officials insisted that the REMS is not holding up decisions on pending abuse-resistant opioids. ♦ Unapproved narcotics are being removed from the market, but the companies can submit ANDAs to get them approved. The question is: Will they?
Summary: Percutaneous aortic valves was the hot topic at PCR. Experts predicted the European explosion in these procedures will continue. The concern is minimizing off-label use. ♦ A SYNTAVI trial is being discussed to compare percutaneous aortic valves with surgery. ♦ A 51% 1-year mortality rate with transapical implantation of Edwards Lifesciences’ Sapien is concerning, but most doctors blamed that on patient selection. However, new data on CoreValve’s subclavian approach led some doctors to suggest tiering valve procedures in this order: transfemoral, subclavian, transapical, surgical. ♦ There was little excitement among European cardiologists about Evalve’s MitraClip mitral repair, though the data looked good, because the technology is not considered mature yet, the cost is high, and reimbursement remains a problem. ♦ The first data on J&J’s new drug-eluting stent, Nevo, looked good – beating Boston Scientific’s Taxus on late loss – but experts insisted this was not a surprise, the data are very preliminary, and deliverability could not be determined from the RES-I trial.
May 2009 Issues
Summary: Vaccine growth will be ~8% annually over the next 10 years, driven by expansion into new disease targets – particularly cancer, dengue fever, Alzheimer’s disease, and tick-borne disease – and broader age groups vaccinated with current vaccines. ♦ The 2009 swine flu epidemic will spur even more investment in pandemic research. ♦ The major threats to the U.S. vaccine market are increasing regulatory safety requirements and a growing anti-vaccine movement. ♦ The U.S. economic stimulus package will add some short-term funds to pandemic vaccine manufacturers. ♦ Vaccine manufacturers are watching the possibility of a pathway for biosimilars in the U.S., but that is not discouraging them – yet. ♦ Manufacturers are confident there will be sufficient supply of pandemic and seasonal flu vaccines for the next flu season. ♦ GlaxoSmithKline was recognized as having the best vaccine pipeline; Sanofi Pasteur partners on almost everything, and Merck is doing more partnering; Novartis believes the future is vectors, adjuvants, and cell culturebased vaccines; Wyeth is waiting for FDA approval of a revised Prevnar vaccine. ♦ The outlook for the biologic market is good, although manufacturers worry about the high cost of research. ♦ New technologies to watch include reverse vaccinology, new administration methods such as nasal sprays and patches as well as new manufacturing processes.
Summary: Pain specialists are worried that FDA efforts to limit abuse, misuse, and overdose with long-acting opioids will result in access problems for pain patients, and FDA plans to impose a risk management program for these drugs was an underlying theme at the meeting. This has also caused a lull in new drug development, though the risk management program probably won’t go into effect until 2010. FDA officials insisted that approvals are not being held up to wait for finalization of this program. ♦ Immediaterelease opioids are still getting approved, like Johnson & Johnson’s Nucynta (tapentadol IR), but the FDA does not appear willing to grant an abuse-resistant/ deterrent label to any of the new formulations – and there are quite a few vying for that label. ♦ Pfizer’s nerve growth factor, tanezumab, looks very interesting and may be a game changer. ♦ There are now three drugs to treat fibromyalgia, but it is a difficult disorder to treat, and Forest/Cypress has been slow to get its marketing push for Savella (milnacipran) going.
Healthcare Information and Management Systems
Summary: The economic stimulus package is giving new life to IT vendors, but it may be the end of 2009 or early 2010 before this translates into real sales. ♦ Hospital IT budgets are not yet getting much of a boost from the stimulus package; rather CIOs are reallocating existing money. CIOs are waiting to find out what the system requirements are to qualify for the incentives, and this is causing a bit of a pause in purchasing. ♦ Even the CMS incentives are not causing doctors to rush to buy an EMR. ♦ Athenahealth’s web-based EMR is an interesting option for doctors, but the company hasn’t been very successful in selling it to its existing installed base of billing system customers. ♦ eClinicalWorks has started to sell its ambulatory EMR through Sam’s Club for very small practices (1-3 doctors).
Summary: The economic downturn is hurting optometrists, with patients skipping appointments and stretching how long they wear their contact lenses. Patients also are not upgrading or buying as many accessories. ♦ Contact lens fittings are down very slightly vs. 6 months ago, but they are expected to hold steady over the next 6-12 months. ♦ Prescriptions for oncedaily soft contact lenses are up. ♦ Contact lens manufacturers have increased their incentives, with CooperVision the most aggressive, and that appears to be paying off because CooperVision is gaining market share with Biofinity and Avaira silicone hydrogel lenses at the expense of both Bausch & Lomb and Johnson & Johnson/Vistakon. ♦ Abbott Medical Optics (AMO) appears to have a winner with its new, over-the-counter dry eye drop, blink Tears. Use of Allergan’s prescription Restasis is stagnant, primarily because of cost. ♦ Optometrists are dragging their feet on electronic medical records, and half never plan to adopt EMRs.
Swine Flu Update -- Quick Pulse
Summary: On April 27, 2009, the White House declared a Public Health Emergency due to an outbreak of H1N1 flu in Mexico that spread to the U.S. and elsewhere. Initially, this flu was referred to as the swine flu or the Mexican swine flu, but pig farmers and pork producers complained about the nomenclature since the flu doesn’t come from and is not spread by eating pork. Thus, the politically correct name is now the (influenza A) H1N1 flu.
American Society for Laser Medicine and Surgery (ASLMS)
Summary: The recession continues to cripple the aesthetic laser business, with business down 40%-50%. While a few industry sources believe that business has hit bottom, doctors did not have any plans for big purchases. Rather, U.S. surgeons and dermatologists are making do with their current lasers, not buying new ones. Very few are even buying handpieces or other accessories. However, doctors from other countries were doing some shopping. ♦ Patients want procedures that are quick and cost effective. They are opting out of larger ticket procedures, and any money they are spending goes for Allergan’s Botox, hair removal, or laser-assisted lipolysis (LAL). ♦ Technology is advancing only incrementally. The greatest interest was in fractionated CO2 non-ablative devices and, to a lesser extent, laser-assisted lipolysis. Doctors are also interested in non-ablative therapy and minimally invasive devices. ♦ Future devices include radiofrequency and high-powered LED machines, although these are still in the early stages of development (and don’t appear to work very well). ♦ Solta continues to lead in fractionated CO2 devices, but doctors do not like disposables, and that may hurt Solta in the long term. ♦ Fat “melting” is gaining popularity as well as tightening without surgery and other procedures with minimal surgical intervention.
April 2009 Issues
American Society of Cataract and Refractive Surgery
Summary: The recession is hurting most practices, and many refractive doctors have already transitioned to other procedures, such as cataract and glaucoma surgery, cut spending for new equipment to little or nothing, and reduced salaries and staff hours. Reimbursement continues to be a problem. ♦ Refractive surgeons are making do with their current lasers and not buying new ones. Although doctors like the Alcon Wavefront technology, they said it is expensive. ♦ Premium IOLs were the hot topic at the meeting, but they are still being put in a small percentage of patients (<10%) because of their cost. Alcon’s ReStor +3.0 was getting the most attention, followed by AMO’s Tecnis. Both will likely cannibalize their own prior lenses, though ReStor may take some market share from Bausch & Lomb’s Crystalens. No doctors interviewed currently use AMO’s ReZoom. ♦ Doctors are delaying getting electronic medical record software for as long as they can, citing unreasonable expense, no advantage for their patients, and lack of standardization. ♦ A new ASCRS task force on LASIK safety, scheduled to publish its results later this month, reinforced the safety of LASIK.
FDA Advisory Committee Says One Diabetes Drug is Safe but Another Needs More Study -- Quick Pulse
Summary: The FDA’s Endocrinological and Metabolic Drugs Advisory Committee reviewed the safety of two diabetes drugs, Bristol-Myers Squibb’s Onglyza (saxagliptin) on April 1 and Novo Nordisk’s Victoza (liraglutide) the next day. The panel voted 10 to 2 that saxagliptin does not pose a cardiovascular (CV) safety risk, clearing the way for probable FDA approval, but the panel also unanimously agreed that the company must do long-term postmarketing studies in higher-risk patients, and Bristol-Myers Squibb (BMS) pledged to do those trials. The panel was less convinced of the CV safety of liraglutide, and the panel basically said the thyroid safety of liraglutide needs more study. The panel actions and comments by FDA officials during the two sessions suggested that the path has gotten tougher for some other diabetes drugs in development.
FDA Panel Rejects Stryker's OP-1 Putty -- Quick Pulse
Summary: Under the cloud of a federal grand jury investigation of Stryker Biotech’s marketing of OP-1, a spinal putty with a human device exemption (HDE) for certain lumbar spine fusions, the FDA’s Orthopaedic and Rehabilitation Devices Advisory Committee rejected premarket approval (PMA) for OP-1 by a 7-1 vote.
March 2009 Issues
FDA Panel Recommends Approval of New Drug for Atrial Fibrillation -- Quick Pulse
Summary: The FDA’s Cardiovascular and Renal Products (Cardio-Renal) Advisory Committee voted 10 to 3 to recommend that the FDA approve Sanofi-Aventis’s Multaq (dronedarone) to treat atrial fibrillation or atrial flutter. The question never was efficacy, just safety, and the panel agreed that dronedarone should not be used in unstable heart failure patients or patients with liver disease. Several panel members also cautioned that dronedarone needs more study and should not totally replace amiodarone until there are more data.
FDA Advisory Committee Recommends Approval of First New Oral Anticoagulant in 55 Years -- Quick Pulse
Summary: The FDA’s Cardiovascular and Renal Products (Cardio-Renal) Advisory Committee recommended approval of Johnson & Johnson/Bayer’s Xarelto (rivaroxaban) for the prevention of blood clots in orthopedic surgery. However, the level of concern within the FDA over possible liver toxicity still may delay approval beyond the FDA action (PDUFA) date, which is May 28, 2009.
Pittsburgh Conference (PITTCON) 2009
Summary: 2009 is likely to be a challenging year for analytical tools companies. They are hopeful that the economic stimulus bill will translate to at least flat year-to-year sales, particularly to academic labs, but prices are under heavy pressure, and all customers are being very cautious about big ticket purchases. ♦ Most laboratories are stretching the life cycle of existing equipment by at least a year, only replacing things when they become unreliable or break. ♦ Pharmas are still buying capital equipment but carefully and cautiously, with heavy oversight on expensive items. Pharma mergers are not expected to affect equipment sales to other pharmas, but universities, contract research organizations, and non-pharma companies, particularly smaller ones, are likely to snap up any surplus pharma equipment. ♦ Food safety is one possible growth area for tools, with a mixed outlook for environmental testing and stem cell research. ♦ Academic labs will have stimulus and NIH money to spend, and one key thing they want is mass spectrometry devices, which may translate to sales by the end of this year. ♦ The new products generating the most interest were hand-held detection devices that can be used to identify contaminants.
American Academy of Orthopaedic Surgeons
Summary: Total joint implants have not yet been affected by the recession, but for 2009 the outlook is for volume to be down 5%. There continues to be hospital pressure on implant prices, but no increase in that. ♦ Industry was a bit circumspect in marketing at AAOS this year, but business was getting done, though no share shifts were apparent. Zimmer, in particular, seemed “back to normal.” ♦ Orthopedic surgeons are likely to be slow to abandon warfarin for newer anticoagulants, but Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) and Boehringer Ingelheim’s Pradaxa (dabigatran) may replace LMWH quickly. ♦ Robotic systems like Mako’s Rio are fascinating, but hospitals are not expected to spend nearly a million dollars for such technology in the current budget environment. ♦ Spine surgeon use of BMP is decreasing, but surgeons are hopeful about stem cell products for the future. Artificial discs are slowly gaining acceptance. ♦ Smith & Nephew is now competing with Kinetic Concepts in negative pressure wound therapy. ♦ CMS will continue to pursue value based purchasing, with an emphasis on patient outcomes. ♦ The FDA is concerned about several off-label orthopedic practices.
MedCAC Meeting on Genetic Testing -- Quick Pulse
Summary: A Medicare advisory panel told Medicare that genetic tests are more complicated than other diagnostic tests and need tougher proof in order to qualify for coverage. The Medicare Evidence Development and Coverage Advisory Committee (MedCAC) told the Centers for Medicaid and Medicare Services (CMS) that the evidence needed for diagnostic genetic tests is different from that of diagnostic testing in general, and that genetic testing resulting in direct patient-centered healthcare outcomes such as mortality, functional status, and adverse events should be required for a CMS coverage decision.
February 2009 Issues
Summary: The economy is causing patients to skip appointments, reducing patient flow in optometric offices. Refractive surgery referrals, contact lens fittings, and even glaucoma medication use are all off. Optometrists don’t expect the economy to stabilize before spring 2010 and not improve before early 2011. ♦ Cost – and the perception of cost – continues to explain why <10% of contact lens patients wear disposable daily wear soft contact lenses. ♦ Alcon’s Opti-Free is the No. 1 contact lens solution recommended, but patients are often buying cheaper solutions or switching to store brands because of cost. ♦ LASIK volume has bottomed or may go down a little more during 2009. Multifocal IOLs are off less, and their outlook is for stability or a slight uptick. ♦ Patients are interested in Allergan’s eyelash extender, Latisse, which some doctors expect to be popular with women. ♦ “Huge” numbers of patients are expected to switch to a generic prostaglandin for glaucoma when one is available. Meanwhile, Pfizer’s Xalatan is losing a little share to Alcon’s Travatan, and Allergan’s Combigan is expected to gain a little. ♦ Cost, lack of insurance coverage, and slow onset of action continue to limit use of Allergan’s Restasis for dry eye.
Conference on Retroviruses and Opportunistic Infections (CROI)
Summary: 21% of HIV+ people are unidentified – more commonly African Americans and Latinos – and testing designed to help identify them is picking up, but slowly. ♦ Evidence is building that treating HIV patients earlier, when their CD4 count is ~500, is beneficial, but experts do not expect guidelines to change until there are more definitive data. ♦ Data continue to suggest that there is an increased risk of heart attack with GSK’s Ziagen (abacavir). ♦ Neurocognitive impairment has reared its head again in HIV, and experts are urging that the choice of antiretroviral therapy be based, at least in part, on a new standard –a drug’s ability to penetrate the blood brain barrier. ♦ Doctors are very enthusiastic about integrase inhibitors, but a trial of switching patients stable on Abbott’s Kaletra to Merck’s Isentress failed to show noninferiority. ♦ Data show definitively that IL-2 is not beneficial in HIV. ♦ Doctors are excited about a potential replacement for new PK boosters such as Gilead’s GS-9350 and Sequoia Pharmaceuticals’ SPI-452 to replace Abbott’s Norvir.
FDA Imposing New Risk Management Program on Many Opioids
Summary: Citing an increase in the misuse, abuse, and unintentional deaths from some extended-release pain medications, the FDA said that it is taking sweeping steps to force 16 manufacturers of two dozen drugs to comply with a new risk evaluation and mitigation strategy (REMS). Opioid drugs formulated in extended-release versions of OxyContin, morphine, and fentanyl patches will be affected.
Summary: Cardiothoracic surgeons believe that the SYNTAX trial comparing PCI and CABG will boost CABG volume. ♦ In the current economic environment, hospitals – and surgeons – have pretty much lost interest in expensive technology such as Intuitive Surgical’s da Vinci robot. ♦ Surgeons are worried about reimbursement cuts and too few new surgeons getting trained, but they are upbeat and optimistic about percutaneous valves, viewing them as an opportunity, not a threat. ♦ Within 5 years percutaneous valves are expected to account for 22% of aortic valves, mostly through market expansion, even if the price is $20,000+ each. ♦ Earlier concerns about transapical valve performance have been resolved. ♦ Enthusiasm has waned for Abiomed’s Impella, and surgeons were negative about Evalve’s MitraClip. ♦ Atrial fibrillation ablation is growing, despite the Justice Department investigation of AtriCure.
Summary: With a 9 to 0 vote in favor of approval, the CardioRenal panel sent a strong message to the FDA that Lilly/Daiichi Sankyo’s Effient (prasugrel) – a new antiplatelet agent – should be approved to treat acute coronary syndrome (ACS) patients. Panel members described prasugrel as a “scientific advance” and a “major advance” and superior to clopidogrel (Sanofi-Aventis’s Plavix).
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