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DOC News    September 1, 2006
Volume 3 Number 9 p. 12
© 2006 American Diabetes Association

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What Is Safe Enough?

In a number of high-profile cases over the past few years, commonly prescribed drugs were found to have harmful effects. In this era of miracle drugs, laboratories supposedly are producing "smarter" medications that more closely mimic natural processes in the human body, more effectively and with fewer side effects. Efforts to regulate prescription drugs at the national level have focused on accelerating the cumbersome approval process by the Food and Drug Administration (FDA), resulting in greater emphasis on post-marketing surveillance to detect potential problems. But not everyone is convinced the "streamlined" process is working.

DOC News asked:

Are drugs safer now than in years past?


Figure 1

In the areas of insulin, they are a lot safer, like analogs [have] more predictable peaks. In terms of all agents, it may not be easy to compare the last 10 years to the previous 10 years because we are so aware of adverse events now. There is more scrutiny. In general, drugs are safer.

Ramim Alemzadeh, MD

Pediatrics

Milwaukee, Wis.

They are the same. People want more drugs, they take more, and we see more side effects. All drugs have issues, and as prescribers we have to be aware of them.

Stephanie Hsu, MD

Endocrinology

Baltimore, Md.


Figure 2

Some of the new COX-2 inhibitors—it makes you think. They're brand-new, and we haven't discovered the complications yet. I'm a little slow starting my patients on new drugs. I'm a little cautious.

Jim Harjo, DO

Primary Care

Creek Nation Community Hospital

Okemah, Okla.


Figure 3

Drugs are safer because there is more scrutiny and rapid dissemination of information. A good example is the latest alpha/gamma-PPAR [peroxisome proliferator–activated receptor]. All the information submitted to the FDA was available on the Web site. That's how people were able to access and analyze the data before the FDA made a final decision. That sort of thing was not available a few years ago.

Michael Bryer-Ash, MD

Director, Diabetes Center

University of California, Los Angeles

TALK BACK: UNDER THE INFLUENCE

The American Medical Association, the Pharmaceutical Research and Manufacturers of America, and other groups have adopted guidelines to limit the influence of drug companies in the clinical setting. Yet a study of 107 general practitioners in Great Britain shows that doctors are more likely to rely on information from drug companies than from other independent sources, even though the information may be misleading, biased, or inaccurate.1 Another study suggests that doctors who participate in clinical trials are more likely to prescribe the sponsors' drugs.2

What do you think? Do drug companies have too much influence over the prescribing patterns of physicians?

Send your comments to docnews{at}diabetes.org.

References

    1. Prosser H, Almond S, Walley T: Influence of GP's decision to prescribe new drugs—the importance of who says what. Fam Pract 20:61–68, 2003.[Abstract/Free Full Text]

    2. Andersen M, Kragstrup J, Sondergaard J: How conducting a clinical trial affects physicians' guideline adherence and drug preferences. JAMA 295:2759–2764, 2006.[Abstract/Free Full Text]


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