Regulatory Affairs Syndicator

Consultation or corruption? The ethics of signing on to the medical-industrial complex.

J Vasc Surg. 2006 Jan;43(1):192-5

Authors: Jones JW, McCullough LB, Richman BW

A prominent vascular surgeon is approached by a representative of a large medical device company with a proposal to implant a new self-sealing patch for closing open carotid endarterectomies. The patch is made of a new synthetic material that establishes immediate hemostasis and inhibits restenosis in animal studies. It has just been approved for human use by the Food and Drug Administration. The cost of the new patch is much higher than for established comparable products, even when potential long-term benefits are considered, but using it would reduce the operative time required for achieving hemostasis. The manufacturer’s representative tells you that the company will pay a selected group of vascular surgeons $500 apiece each time they insert the patch on their patients and complete a one-page report. Surgeons with the highest volume of cases utilizing the patch will be offered a paid clinical consultancy with the company. You’ve used another company’s product for several years and found it entirely satisfactory, but have followed development of the new patch with interest and considered trying it in your patients having carotid endarterectomies. What should you do? A. Join the study. You probably would have used the new patch on your patients anyway. B. If the early data warrant, implant the patch on a trial basis without enrolling in the project, and finally decide whether to continue using it based on your clinical experience and additional published reports. C. Call some of the other investigators who have already enrolled in the project and ask them about their experience. D. Decline the invitation immediately. Refuse to ever speak to the representative again. E. Estimate the ability of your patients to sustain the high cost of the new product and decide accordingly whether to use it.

PMID: 16414412 [PubMed - in process]

Cervical disc arthroplasty: a controlled randomized prospective study with intermediate follow-up results. Invited submission from the joint section meeting on disorders of the spine and peripheral nerves, March 2005.

J Neurosurg Spine. 2005 Dec;3(6):424-8

Authors: Hacker RJ

OBJECT: The authors of studies of anterior cervical fusion for disc-related disease have documented satisfying clinical results and infrequent complications. Recently, cervical disc arthroplasty has entered clinical trials as an alternative to fusion. Although the results of anecdotal reports and prospective studies support this procedure, these studies have not conferred the validity of a controlled randomized study. In the present study, the author presents data obtained in such a study. METHODS: After symptoms failed to respond to conservative therapy, 46 patients with one-level discogenic cervical radiculopathy and/or myelopathy were randomized to undergo arthroplasty or fusion as part of a US Food and Drug Administration medical device study. In all patients there was a minimum follow-up duration of 1 year. Equivalent results for the relief of arm pain and neck pain were noted in both treatment groups. Treatment parameters other than operative time were similar. No neurological or serious systemic complications occurred. CONCLUSIONS: Although extended follow-up data and larger patient populations are needed, the results of this study indicate that arthroplasty is a viable alternative to cervical fusion.

PMID: 16381203 [PubMed - in process]

Billings Gazette - COLUMBIA, S.C. — A pet food company has advised retailers in more than 20 states to stop selling some of its dog and cat food that may be contaminated with toxic fungus. Several dogs have gotten sick and some have died. The fungus produces poisonous …

MSN MoneyCentral - MIAMI (AP) - Noven Pharmaceuticals Inc., a maker of patches used to deliver drugs through the skin, said Friday the has issued an approvable letter for a drug Noven is developing to treat attention deficit hyperactivity …

Red Herring - Drug maker Alexza Pharmaceuticals has filed for an $86.25-million initial public offering as it looks to develop several drugs it has in trials as well as a drug inhalation technology. Alexza did not specify the number of shares to be offered or the …

Oscient Pharmaceuticals Corporation and the US Food and Drug Administration have agreed to a Special Protocol Assessment (SPA) for the continued clinical development of ramoplanin for the potential treatment of clostridium difficile-associated disease (CDAD). By reaching consensus on the SPA, the company has received guidance on the specific components of the phase III programme that, if

The United States Food and Drug Administration (FDA) has given a tentative approval of stavudine oral solution, 1 mg/ml to be manufactured by Aurobindo Pharma.

The US Food and Drug Administration has approved Roche’s supplemental new drug application (sNDA) extending the prophylaxis (prevention) indication for Tamiflu (oseltamivir phosphate) to include children aged from one to twelve.

FRIDAY, Dec. 23 (HealthDay News) — The Roche Pharmaceuticals drug Tamiflu (oseltamivir phosphate) has been approved by the U.S. Food and Drug Administration to prevent flu in children 1 to 12 years of age.

PRINCETON, N.J., Dec. 23 /PRNewswire-FirstCall/ — Bristol-Myers Squibb Company announced today that the U.S.

St. Louis Business Journal - The U.S. granted a priority review for a new smoking-cessation pill from Pfizer Inc. , the company said recently. The new drug application is for varenicline tartrate, which the company intends to market under the brand …

WebWire - The (FDA) and the Agency for Healthcare Research and Quality (AHRQ) are about to launch an effort to advance scientific research and foster research partnerships on drug effectiveness and safety. “Through this …

They’re banned in Europe, but found all across the U.S. They’re a chemical in plastics called phthalates .

WHIO TV - BOSTON — Starting Jan. 1, manufacturers will be required to list trans fat on food labels. But some companies have yet to comply with the new regulations. Trans fat is fat — and not the good kind, reported WCVB-TV in Boston. “It increases your risk …

Bryan-College Station Eagle - AUSTIN - Texas Attorney General Greg Abbott says a new state law that would help Texans buy less expensive prescription drugs from Canada violates a federal law. The state law, enacted by the Legislature this spring, had been put on hold pending …