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April 2008 Issues

Fda Advisory Committee Reaffirms Lasik Safety But Recommends Clearer Labeling -- Quick Pulse

Summary: An estimated 6 million Americans have had LASIK (laser-assisted in situ keratomileusis) eye surgery to reduce their dependency on eyeglasses or contact lenses. The FDA’s Ophthalmic Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH) met to discuss whether there is enough information about potential problems with LASIK and with phakic intraocular lenses (IOLs) in patient labeling and on the FDA’s website and whether that information should be modified. The FDA does not regulate LASIK; it only regulates the equipment used in the procedure.

2008 Annual American Society For Laser Medicine And Surgery (ASLMS)

Summary: Fractional CO2 and non-invasive procedures received the most attention at ASLMS, both in terms of buzz and in the number of new products. ♦ The laser market is very competitive, but laser prices are holding relatively steady, with mostly normal discounting. ♦ The U.S. economic downturn did not appear to be discouraging doctors attending ASLMS from cutting back drastically on laser or cosmetic device purchases, but doctors also didn’t have long shopping lists this year. Industry officials offered a mixed sales outlook. ♦ Doctors expressed interest in a wide variety of products, including fractional lasers, new handpieces for existing devices, hair removal, skin tightening, fat removal, and semi-ablative fractional lasers. ♦ Lumenis, Reliant, and Cynosure appeared to be the leaders, but Candela, Cutera, and Alma Lasers are not far behind. Thermage and Palomar generated little excitement.

March 2008 Issues

American Society of Clinical Oncology (ASCO) 2008 Gastrointestinal Cancers Symposium

Summary: K-ras may prove to be a marker for response to EGFR inhibitors, but doctors aren’t ready to start K-ras testing, in part because there is no commercially available test. ♦ Use of Imclone’s Erbitux is growing slowly but steadily, but there is game-changing data coming at ASCO 2008. ♦ Oncologists were taking a more subdued or reasoned approach to Genentech’s Avastin in various cancers. ♦ The news was positive but not dramatic about Bayer/Onyx’s Nexavar. U.S. doctors are divided on how long liver cancer patients should stay on it; some treat through progression, and others stop on progression. The outlook in Asia will depend on reimbursement. ♦ The data in GIST for Novartis’s Gleevec were described as “remarkable.” ♦ Worldwide safety and efficacy data on Pfizer’s Sutent showed no new toxicity and expected efficacy, but Pfizer’s tremelimumab failed in gastric and esophageal cancer. ♦ Taiho/Sanofi-Aventis’s S-1, an oral 5- FU, looks promising, but there is concern that the Japanese data are not sufficiently rigorous, and American doctors want to see the results of the ongoing U.S. trial in gastric cancer. ♦ Genomic Health has a genomic assay in development for CRC similar to its breast cancer test, Oncotype DX.

Stent Update -- Quick Pulse

Summary: Directors and managers of 15 cardiac cath labs across the U.S. were interviewed to check on stent trends, particularly drug-eluting stents ( DES ). Medtronic’s Endeavor was approved on February 1, 2008 , but there appears to be little enthusiasm for it. In contrast, there is a good deal of excitement about Abbott’s Xience V (which will also be sold by Boston Scientific as Promus), which is expected to gain FDA approval by summer.

Cardiovascular Revascularization Therapies ( CRT )

Summary: Interventional cardiologists want both PCI and DES volume to start increasing again, but there were no real signs that this is happening, and the FDA is raising the bar for new DES . ♦ There was more excitement about Abbott’s not-yet-approved Xience V than Medtronic’s newly-approved Endeavor, and doctors predicted that Endeavor would take <10% market share but Xience could capture “significant” market share, affecting Boston Scientific’s Taxus and Johnson & Johnson/Cordis’s Cypher almost equally. ♦ Percutaneous valves remain a technically challenging procedure. The regulatory path is almost as challenging, and it doesn’t appear to be getting simpler. ♦ European doctors haven’t been able to choose between Edwards Lifesciences’ Sapien THV and CoreValve’s ReValving System percutaneous aortic valves, and use of both is still limited. A new problem has emerged: patients needing a permanent pacemaker post-valve implantation.

FDA Advisory Committee Recommends Keeping Anemia Drugs on the Market but with New Limits

Summary: An FDA Advisory Committee voted that ESAs should remain available to cancer patients with chemotherapy-induced anemia but that patients receiving potentially curative treatments (such as adjuvant breast cancer patients) should not take them. The panel favored stronger written informed consent, but rejected the idea of a restricted distribution system. The panel was divided on whether ESA use should be restricted to small cell lung cancer patients only and on whether patients with metastatic breast and/or head & neck cancer should take ESAs. Some panel members favored using hemoglobin ≤10 for ESA initiation in asymptomatic patients without comorbidities, but others wanted more physician discretion.

American Academy of Orthopedic Surgeons

Summary: Falling reimbursement may cause a shortage of orthopedic surgeons doing joint replacement surgery at the same time that demand is increasing, and this could affect company growth predictions. ♦ Gender-specific hips and knees are both viewed as a marketing gimmick. ♦ Many orthopedic surgeons are dubious about hip resurfacing, many of those who perform it believe it should be restricted for ≤10% of hip patients – mostly younger men. Doctors are somewhat more optimistic about knee resurfacing. ♦ Stryker does not appear to have lost much if any market share due to its problems with Trident hip manufacturing or the government subpoena on its foreign trade practices, and its hip resurfacing system may take some share in that small market. ♦ Government investigations of the orthopedic industry – and surgeons themselves – are not over, but the investigations do not appear to be affecting brand loyalty, at least not yet. Likewise, the decrease in consulting agreements or the amounts paid to consultants does not appear to be affecting brand loyalty. ♦ Hospital pressure on implant prices and surgeon choice of devices is accelerating.

Heparin Contamination Expands Beyond the U.S.

Summary: The FDA found a contaminant in some batches of the active pharmaceutical ingredient ( API ) used in Baxter International’s recalled heparin sodium, and that contaminant is believed to have been introduced in China . German health officials also reported that they found the same contaminant in some German-made heparin used in their country, but the source of the German heparin has not yet been released, so it is not known if that contamination originated in China .

February 2008 Issues

American Stroke Association's International Stroke Conference (ISC) -- Quick Pulse

Summary: There were no blockbuster drug or device trials released at this year’s stroke meeting. Much of the “news” was “soft” and did not have implications for specific drugs or devices. However, the meeting did provide an opportunity to take a look at some of the technology and medications being used or considered in this field.

ASCO 2008 Genitourinary Cancers Symposium

Summary: Prostate cancer: Cougar Bioscience’s abiraterone looks very promising in prostate cancer. There are competitors, including Medivation’s MDV-3100, in this new class of drugs, but they are further behind. ♦ Oncologists have little interest in Nanosphere’s supersensitive PSA test, insisting that there is no real need to measure PSA at super low levels, even in men who have recently undergone a prostatectomy. ♦ Renal cell carcinoma: Genentech’s Avastin does not appear to be any more effective than Pfizer’s Sutent in RCC, and doctors are divided on how they would choose between the two if Avastin gains FDA approval in RCC. But new data suggest that the two agents will not be combined because of excessive toxicity, though sequential therapy may work. ♦ Heart failure with Sutent occurs almost twice as much in the real world as in clinical trials, so doctors should monitor for this, but experts did not recommend avoiding Sutent because of this. ♦ Testing: Nanosphere’s Verigene assay can detect super low levels of PSA , but oncologists don’t see the utility of this test.

Lab Automation 2008 -- Quick Pulse

Summary: More than 4,600 people from 40 countries attended the annual LabAutomation meeting, sponsored by the Association for Laboratory Automation ( ALA ). About half of these were scientists, researchers, and managers from a variety of laboratory settings – academia, big pharma, biotech, contract research organizations (CROs), hospital labs, and large commercial labs. Their time was split between highly technical lectures – often given or sponsored by industry and often barely more than sales pitches – and visiting some of the 242 companies on the exhibit floor. The meeting also was a way for exhibitors to network, since, in many cases, vendors in this space collaborate or are each other’s customers.  

January 2008 Issues

LASIK Update -- Quick Pulse

Summary: Thirteen refractive surgeons were interviewed to check on LASIK trends in 2008.

Eyecare Update

Summary: Refractive surgery referrals by optometrists are down slightly and likely to remain flat through 2008, but multifocal IOL use, primarily for cataract patients, is increasing. ♦ Contact lens sales are slightly down, a trend expected to continue through 2008. ♦ Silicone hydrogel lenses now account for more than 50% of fittings, and that is growing. Johnson & Johnson/ Vistakon’s Acuvue Oasys is the most popular silicone hydrogel, but CooperVision’s Biofinity is catching on, though it doesn’t have a full range of powers yet. ♦ Alcon’s Opti-Free Express is the contact lens solution most frequently recommended by these optometrists. ♦ Inspire’s antibiotic, AzaSite, hasn’t caught on yet among optometrists, but its less frequent dosing is starting to attract attention. ♦ High cost and poor patient compliance are the key reasons that use of Allergan’s dry eye medication, Restasis, isn’t growing. ♦ Use of Combigan, Allergan’s new combination glaucoma medication, is growing, and in a year 15% of glaucoma patients could be taking it. ♦ Alcon’s Patanol is the No. 1 ocular allergy medication, but most doctors would switch to a generic if it became available because of cost.

CMS Expands Competitive Bidding Program in Effort to Reduce Medicare Fraud -- Quick Pulse

Summary: On January 8, 2008 , the Centers for Medicare and Medicaid Services ( CMS ) announced it is expanding a competitive bidding program on equipment, which it said would lower out-of-pocket costs and reduce fraud and abuse. The expansion affects durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). DMEPOS items include standard and complex power wheelchairs, walkers, oxygen supplies and equipment, certain devices, and hospital beds.

American College of Neuropsychopharmacology -- Quick Pulse

Summary: The American College of Neuropsychopharmacology (ACNP) meeting offered an interesting look at a variety of drugs in development for addiction, anxiety, bipolar disorder, depression, migraine, obsessive compulsive disorder, and schizophrenia. The meeting also offered an overview of several new classes of agents, including endocannabinoids, histone deacetylase (HDAC) inhibitors, neurosteroids, metabotropic glutamate receptors (mGLuRs), and glycine T inhibitors.