Entries in the ‘Drugs and Devices’ Category:

 

Zicam and the Many Roads to FDA “Approval”

More than ever, American’s are purchasing over-the-counter (OTC) medications, supplements, and herbal remedies to self medicate and promote good health. But does the fact that these products can be purchased freely imply that they are absolutely safe for consumption? Do they go through the same FDA approval processes as other pharmaceutical products? [...]

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Doctors, Off-Label Prescriptions, and A New Legal Precedent (Cont.)

Ben Cade brought up some strong points in response to the first post of Doctors, Off-Label Prescriptions, and A New Legal Precedent. In summary, he argued that the case of Dr. Ames v. Wash. State MQAC could not be used as legal precedent for considering off-label (non-FDA approved) prescribing of drugs and devices as malpractice. If some evidence of efficacy could be presented, then the burden of harm would not be reached, he suggested. [...]

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Doctors, Off-Label Prescriptions, and A New Legal Precedent

The ability to prescribe medications for off-label uses (those not explicitly approved by the FDA) provides physicians with the freedom to innovate — a freedom that has enabled the discovery of many new uses for old drugs. For example, physicians prescribed aspirin for the prevention of heart attacks long before the FDA approved its use in that context. Although it lacked FDA approval, the drug was obviously clinically effective.

However, the Washington State Supreme Court recently affirmed a ruling by the Medical Quality Assurance Commission (MQAC) that expands what is considered medical malpractice in Washington State. As a result of loose wording in the conclusion, the ruling sets a new precedent for malpractice and threatens doctors who promote off-label use of drugs and medical devices. [...]

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Lost In the Numbers: Drug Advertisement Statistics

I don’t think I have ever read an advertisement for a new medication without pausing at some eye-catching statistic. “BlogCor can reduce your (Insert Lab Value) by 50%,” seems to be the garden variety statistical claim.

At age 23, I’m part of the “young invincible” (the group of healthy uninsured in their twenties), but, everywhere I look, I see a new condition that I “might be at risk for”. How healthy am I really? Should I start to worry and pursue prescriptions for these medications to better my health? The statistics sure seem to suggest so. [...]

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Psychiatric Group Ends Industry-Sponsored Seminars

The American Psychiatric Association recently said they would stop accepting industry money to fund seminars and annual meetings. [...]

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A Conflict of Interest?: Drug Companies and Doctors

I always imagined that doctors chose devices and prescriptions based on their benefits to a patient’s health. After all, “I will prescribe regimens for the good of my patients according to my ability and my judgment,” is in the Hippocratic Oath. However, drug companies muddle this process by tempting doctors with vacations, free lunches, and huge salaries for their work as “consultants”. If a doctor is that deep in bed with a manufacturer, how are they to maintain an unbiased opinion on all of the drugs and devices available? [...]

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