CMAJ • March 3, 2009; 180 (5). doi:10.1503/cmaj.090175.
© 2009 Canadian Medical Association or its licensors
All editorial matter in CMAJ represents the opinions of the authors and not necessarily those of the Canadian Medical Association.
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NEWS

For the record

Wayne Kondro and Roger Collier

CMAJ

Ethical disclosure

The Association for Medical Ethics has issued guidelines for ethical rules of disclosure recommending that all physicians and scientists "disclose in all publications and presentations the precise nature and amount of any financial conflicting interest exceeding $500 per calendar year."

Only through such full disclosure is it possible to determine whether research findings have any measure of independent validity, the association argued.

The new guidelines (www.ethicaldoctor.org/Ethical_Rules_of_Disclosure.html), also recommend that scientists doing "publishable clinical research should eliminate substantive personal financial interests, if present, prior to engaging in such research. Grants from industry may be directed, but should be unrestricted and departmental."

The guidelines are the latest call for stricter regulation of conflicts of interest in the wake of concerns that industry handouts are increasingly influencing therapeutic decisions and compromising the medical profession's reputation, (CMAJ 2008;178[13]:1651-2 and CMAJ 2008;179[11]:1118). — Wayne Kondro, CMAJ

Shoddy production

In mid-January, the United States Food and Drug Administration (FDA) announced that the pharmaceutical firm Actavis Inc., which closed one of its plants because of shoddy manufacturing practices, could resume making and selling certain drugs only if it meets "Good Manufacturing Practice" requirements.


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Actavis recalled its heart drug Digitek (one brand of digoxin) on Apr. 25, 2008, after it was discovered that some tablets, produced in New Jersey, were twice as thick as they should have been. This meant, of course, that each tablet contained double the dose of the powerful heart drug, known generically as digoxin. Actavis claims, however, that no incorrectly manufactured pills entered the consumer market.

Yet, according to The Center For Public Integrity, Digitek was cited as the "primary suspect" in 667 deaths reported to the FDA between Apr. 1, 2008, and Jun. 30, 2008.

Digoxin, which is used to treat heart conditions such as atrial fibrillation, atrial flutter and heart failure, has a narrow safety margin. Even a slight dosage increase can prove fatal.

Last August, Actavis closed the New Jersey plant to fix its manufacturing problems. In November, the US Justice Department asked a federal judge to keep the plant closed, at least until the company could prove it met "Good Manufacturing Practice" standards, as set by the FDA.

In late December, Actavis signed a "proposed consent decree" agreeing to this condition. The company might not, however, start making Digitek again, it has been reported.

Actavis Inc., based in Morristown, New Jersey, is a division of the Icelandic Actavis Group, which operates in 40 countries and has 11 000 employees. The pharmaceutical company is one of the world's 5 largest drug makers. — Roger Collier, CMAJ





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