Litigation

Warning: This Life-Saving Drug Is Known To The State Of California To Cause Cancer In Lab Animals

By Bruce Nye

    I'm glad something like this happens once in awhile to remind us just how stupid, counter-productive and wasteful the entire Proposition 65 system is.  

    More after the jump.

     As regular readers know, Proposition 65 requires the State of California to maintain a list of chemicals "known" to the state to cause cancer or reproductive or developmental harm.  Chemicals go on  the list under one of four mechanisms:  the "state's qualified experts" mechanism, the "authoritative bodies" mechanism, the "state or federal government required label" mechanism or the "Labor Code" mechanism.  Health and Safety Code section 25249.8.  

    OEHHA, Proposition 65's lead agency, has given notice that it intends to list a bunch of chemicals, including the drug AZT, under the Labor Code mechanism.  Why is this?  Under the Labor Code mechanism, the state must list chemicals as carcinogens if they are identified by the International Agency for Research on Cancer (IARC) or the National Toxicology Program (NTP).  AZT has been identified by IARC as carcinogenic to laboratory animals, and therefore ?possibly carcinogenic to humans."  Under Proposition 65, "possibly carcinogenic to humans" translates to "known to the State of California to cause cancer."

    AZT is used in conjunction with other drugs to slow the progress of the HIV virus.  Now, does that mean that patients diagnosed with HIV (who have plenty to be anxious about) must now be warned that the medication slowing down the development of this virus is "known to the State of California" to cause cancer?  No.  Because the regulations implementing Proposition 65, specifically 27 CCR section 25603.3(c), provides as follows: 

For prescription drugs, the labeling approved or otherwise provided under federal law and the prescriber's accepted practice of obtaining a patient's informed consent shall be deemed to be a clear and reasonable warning.

    In other words, the Proposition 65 warning is met by the FDA approved warning (which warns that AZT causes an increased incidence of tumors in laboratory rodents at 3 to 24 times the human dose) and what the doctor, in his or her professional judgment, tells the patient.

    And so we are going through this entire listing exercise because . . . . ?

Full post as published by CalBizLit on January 15, 2010 (boomark / email).