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Posts Tagged ‘drug and safety’

The inherent risk surrounding nutraceuticals

May 20, 2015 Leave a comment

pills2Nutraceuticals, a $30 billion industry in the United States, come in the form of capsules, bars, drinks, lotions, pills, and powders. The medical and therapeutic benefits they claim to offer vary from renewed sexual drive, to enhanced athletic performance, to fewer wrinkles. Many are nutritional supplements which, according to JAMA Internal Medicine, were taken by 45 percent of people to “improve” and 33 percent of people to “maintain” overall health. However, only 23 percent of products were recommended by a healthcare provider.

When taking dietary supplements, bear in mind that they are not required to be tested or registered with the United States Food and Drug Administration (FDA). The FDA’s job in oversight is primarily registering facilities, confirming those facilities are operating within proper manufacturing practices, and investigating products after they hit the shelves. Nutraceutical companies may assert that their product has been Read more…

Drug rationing discussed in New England Journal of Medicine

September 23, 2010 Leave a comment

A report in the New York Times reviewed a position in the New England Journal of Medicine it called “unusual” – arguing two sides of a medical point in one issue. The study in question was about a new blood thinning medicine which was proven to be effective but at significant cost. It would make a difference to one person in 88 at a cost of $180,000 for those 88 persons. The improvement in outcome did not save lives but rather prevented great though temporary pain in one person.

This type of analysis is likely to increase as the federal government, and those who feed the debate like the New England Journal of Medicine, will look more and more to cost effectiveness. This is not a new issue in other Western countries that routinely review new drugs for these efficiencies. But, in the United States, this is often viewed as health care “rationing”, putting limits on individual freedom to receive all of the health care that they want from their providers, drug makers and health insurers.

 

Allergan pleads guilty and agrees to pay $600 million to settle charges that it marketed Botox for off-label uses

September 9, 2010 Leave a comment

According to the Department of Justice, Allergan made it a “top corporate priority” to maximize sales of Botox for off-label uses by employing illegal marketing tactics. Those tactics included 1) calling on providers who typically treated patients with Botox for off-label conditions, 2) conducting workshops on how to bill for off-label uses of Botox and 3) operating a hotline that provided free on-demand services to doctors for off-label uses. In addition, Allergan lobbied government health care programs to expand coverage for off-label uses, officials said.

Pharmaceutical companies should be aware of the fact that bodily injury claims resulting from off-label promotion may not be covered by their Product Liability insurance. Read more…

Product withdrawal opens drug companies to litigation

Yesterday’s New York Times describes possible harm to customers of biotechnology giant, Genzyme Corporation, arising out of the reduced availability of Genzyme’s products as a result of a plant shutdown caused by a virus contamination at Genzyme’s plant. The story relates that such a viral contamination is not uncommon in the production of biological products. The inability to supply life-saving drugs that have no easy replacement from other manufacturers, not surprisingly, may have led to adverse outcomes for Genzyme’s patients and this type of exposure to harm exists for many other drug and device manufacturers. Read more…

New legal requirements for conducting clinical trials in Italy

March 12, 2010 Leave a comment

Italy Clinical TrialsA decree goes into effect March 14th requiring minimum insurance for any company conducting clinical trials in Italy. The new requirements were established by Italy’s Ministry of Labor, Health and Social Policy to safeguard participants in clinical trials conducted wholly or in part in that country.

The requirements state that the insurance policy must cover any civil liability of the sponsor and investigator without excluding any damage which may have been caused by accident or attributed to negligence. In addition to death and permanent and/or temporary injury, damages include economic loss directly resulting from participation in the clinical trial. Read more…

First national drug and saftey network will help limit liability

January 4, 2010 Leave a comment

drug safetyThe recent merger of the iconic Physicians’ Desk Reference (PDR®) found in every physician’s office, clinic and hospital, with the Health Care Notification Network (HCNN), the only network that delivers FDA-required drug Alerts to physicians and other prescribers online, has created a new combined service that provides FDA-required Alerts, monthly specialty-specific clinical updates and a copy of the 64th edition of the PDR with regular insert updates to all to medical providers. This effort to minimize “information errors” is a crucial step for prescribers of medicines across the healthcare spectrum. Read more…