ChronicleMONDAY
From the publishers of THE CHRONICLE OF CANCER THERAPY, THE CHRONICLE OF CARDIOVASCULAR & INTERNAL MEDICINE, THE CHRONICLE OF NEUROLOGY & PSYCHIATY, THE CHRONICLE OF SKIN & ALLERGY, THE CHRONICLE OF UROLOGY & SEXUAL MEDICINE, PHYSICIANS’ CHRONICLE, THE CHRONICLE OF HEALTHCARE MARKETING, LINACRE’S BOOKS, and chronicl*e group
WE’RE NOT LANDSCAPE PAINTERS, PAL
FOR A COMPANY THAT EMPLOYS 66,800 staff worldwide, you wouldn’t think seven workers could cause all that much grief to AstraZeneca. However, a mysterious cadre of whistleblowers purportedly on the AZ payroll has been conducting a campaign to alert the media, critics of the pharma industry, and US government officials of alleged improprieties in the marketing of breast Ca Rx anastrozole (Arimidex.) The group, which insists on anonymity, calls itself the “Group of Seven.” (Editorial comment: Well, with a name that unimaginative, it’s pretty obvious they’re bona-fide drug marketers. Anyone else would be capable of coming up with a clever name, such as “Sgt. Fury and his Howling Commandos.”) The dissatisfied Seven have been posting alleged company documents on the Internet, to the consternation of AZ officials, and the alarm of regulators. One embarrassing example is an extract from an in-house newsletter that describes oncology practices as “a big bucket of money” and exhorts reps to “reach your hand in the bucket and grab a handful. The more times you are in, the more money goes in your pocket.” AZ quickly fired the manager responsible for the document, and said he breached company policy. Potentially more problematic is the allegation that the US field force was instructed to sell Arimidex against letrozole (Femara, Novartis.) If true, that would disturb Washington, which required AZ to sign a consent decree in 2003, following an investigation into the marketing of prostate Ca Tx goserelin (Zoladex.) That previous little misunderstanding cost the company a US$350 million settlement. According to the Group of Seven, their concerns over Arimidex were expressed five months ago to senior management, to no avail. Contacted by the marketing trade publication BrandWeek, a party identified as “number three of seven” explained why the guerilla group operates incognito: “We are all in fear of retaliation from AZ. Jobs and family are on the line… We don’t want any phone records or direct contact with the media other than anonymous e-mail & even that we consider dangerous.” AstraZeneca tells BrandWeek they’re conducting a probe of the matter.
WOUND CARE ON A TEAR
THE DIABETES EPIDEMIC and other factors are driving growth in the global wound care market, according to a new research report. Piribo, the UK think-tank, places the value of the worldwide market at Cdn$8.3 billion, with 57 per cent of sales in the US. Stateside revenues in the category are growing at 10 per cent annually, the researchers say. Contributing to the increase: the ageing population, along with technology advances and improved efficacy in new biological Txs, such as skin substitutes, tissue-engineered products and growth factors. Piribo says devices are playing a larger role in wound care, with technologies such as negative pressure wound therapy becoming more prominent. Other emerging treatments include: electrical stimulation, low level laser Tx, and therapeutic ultrasound.
DO I AT LEAST GET MY PARKING VALIDATED?
IF IT TYPICALLY TAKES A CERTAIN AMOUNT of valor to appear before a regulatory advisory panel, Merck’s Peter Kim deserves recognition for courage above and beyond the norm. The company’s R&D boss last week remained relatively composed while the FDA’s analgesics expert committee performed the clinicians’ equivalent of forcibly depantsing Dr. Kim. What did the poor man do to provoke the panel’s anger? He filed a dossier on behalf of Merck for COX-2 pain Tx etoricoxib (Arcoxia), the updated version of the notorious rofecoxib (Vioxx.) To put it mildly, the FDA experts were not impressed with Dr. Kim’s data. Said one: “What you’re talking about is a potential public health disaster.” Asked another: “Based on the history and based on the evidence, my question is, why are we even having this meeting?” Concerned that widespread use of Arcoxia might cause 30,000 MIs a year in the US, the panel voted 20-to-one against approving the Rx. Cheer up, Dr. Kim. At least it was close.
CORNER-OFFICE ROTISSERIE
AMBRILIA BIOPHARMA, the 20-year-old Montreal Rx developer formerly known as Procyon, last week revealed a Hans-off policy, announcing that CEO Hans Mader has ankled. Mader, the former Ciba-Geigy kingpin, ran the company for the past decade. He’ll continue to consult for Ambrilia for a year. Says he: “I am leaving the company on good terms to pursue other endeavors.” Moving into the corner office is Stephen Sudovar, a former hand at Hoffmann-La Roche and a current board member at Nabi Pharmaceuticals of Florida. In an unrelated development, Nabi last week sold its injectable Ca adjunct Tx allopurinol (Aloprim) to a division of Bioniche Pharma of Montreal. Price: $3.7 million, spread over two years. Says Nabi nabob Leslie Hudson: “Aloprim was no longer a strategic component of our product portfolio.”
REAL ESTATE REPORT: AVAILABLE SUB-LET
LESS THAN A MONTH after Danish drugmaker H. Lundbeck eighty-sixed its sleep disorder Tx candidate gaboxadol, the company woke up and realized it really wasn’t going to need a US headquarters after all. Lundbeck last week said it would shutter its stateside command-centre in a Philadelphia suburb, which it established way back in January of this year. With gaboxadol out of the picture, insomniacs may be tempted to try one of those all-natural insomnia aids, such as Eden Herbal Formulations Serenity Pills II, sold via a Calgary herbalist. Not so fast, says Health Canada. The regulator last week advised that good old Serenity contains unlisted quantities of estazolam, a prescription benzodiazepine which carries a whack of contraindications and side-effect warnings. The agency says it has issued three previous alerts about similar products since last August.
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