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The Killer Cure: ; A Deadly Dose; FDA-Approved Language Called "Extremely Dangerous"
By Scott Finn (sfinn@wvgazette.com ) and
(c) 2006 Sunday Gazette
Published: 2006/06/06
© RedOrbit 2005
© 2002-2005 redOrbit.com. All rights reserved All other copyrights remain the property of their respective owners
The language approved for methadone packaging, by the FDA, could be misinterpreted with serious or dire consequences. The wording is: "The usual adult dosage is 2.5 mg to 10 mg every three or four hours as necessary," reads the drug's package insert under "For Relief of Pain." This could be interpreted to mean that an adult can take up to 80 milligrams of methadone in 24 hours (a day). Most people taking this dosage would die, according to experts.
The FDA said they will consider the matter, but it is not a priority. More modern drugs have stronger language (black-box warning.)
Please read the article for the medical aspect of the story. The article itself is quite detailed and informative.
Facts:
- 50mg could kill someone not used to strong pain killers.
- 80mg would kill most people.
- The drug is cheap and an effective painkiller.
- Doctors who prescribe the drug also tell patients what dosage to take.
Language Issues:
- The message, as reported, is open to misinterpretation. The language is not precise, especially for such a product. It does not give time limits.
- The use of the word ‘usual’ is very ambiguous; usual to what standard? To the pain killer one takes for a headache?
- If ‘usual’ is ambiguous, the numbers, 2.5 and 10 as a range is also wide. Surely, words cannot have meaning outside a context.
- I have a theory, and although I have not had the opportunity to read it elsewhere I am sure it is not original, which says that in our Western society we depend more on the written word for information than verbal instructions. If this is the case, then the message on the packaging becomes even more important. What if one forgot/lost the instructions of the GP?
- A message can also be communicated with icons; maybe the pharmaceutical and health care industries can develop a labelling system for drugs on the same lines as the textile industry has.
Comments:
- The industry can have a free phone number or even a web site for people to consult if they have a doubt about the use of a particular drug.
- Would a reasonable patient misinterpret the message? Or is it impossible for a patient, who is suffering serious pain, to be reasonable, both in the legal and intellectual sense?
Bottom-Line:
Is drug packaging an ethical issue, a medical issue or a business issue?
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