Death by Inhaler
Should your doctor inform you about the risk of death when prescribing some popular asthma inhalers?
The January 2006 issue of the most prestigious allergy journal (JACI) contains articles and editorials regarding the FDA's new "black box" warning for very popular inhalers used by patients with asthma. Serevent (salmeterol), Advair (salmeterol and fluticasone), and Foradil (formoterol). Salmeterol and formoterol are long-acting bronchodilators.
The black box quotes data from the "SMART" study of 26,000 adults with asthma randomly given Serevent or placebo for six months (in addition to their usual asthma medications). This "postmarketing surveillance" (phase IV) study was begun ten years ago, and the four times higher asthma-related death rate in the Serevent group (13 deaths versus 3 deaths in the placebo group) was first known in September, 2002, but the study results won't be formally published for a few more months (in the journal CHEST). Put another way, the excess risk of death for those taking Serevent was about one extra death for every 700 patients taking the drug for one year.
Should your doctor tell you this if you are taking one of these three inhalers? Does your doctor even know this? Does she carefully weigh the benefits of adding a long-acting bronchodilator to your other asthma medications against this risk of death? Once your asthma is well-controlled using Advair or Symbicort, does she consider stepping down your therapy by discontinuing the long-acting bronchodilator?
Editors of the journal wondered if the FDA warning is a "wake-up call or just an over-reaction," stating that "physicians have mixed feelings about the discolsure of black box warning information to patients." They recommend that each medical society inform their members about the black box and how to convey this information to their patients. However, there are many medical societies and not all physicians who treat patients with asthma belong to one of these professional organizations. Furthermore, JACI is the publication of the largest professional society of allergists (the AAAAI), and this society has not yet provided such information. One editorial suggests that every patient with asthma should be given both a verbal and written warning by their doctor before such inhalers are prescribed, and they should sign that disclosure statement in order to protect the doctor from legal liability.
Many pulmonary specialists feel that long-acting bronchodilators are safe when inhaled corticosteroids are given at the same time, and the widely accepted NAEPP guidelines for asthma say that. However, the FDA advisory panel must not have been fully convinced by the data, thus they also required the black box warning for Advair (and will probably do so for Symbicort, which includes formoterol, if and when it is approved for marketing in the United States). Amazingly, the SMART study did not ask about the use of inhaled corticosteroid medications in the 27,000 participants during the study of Serevent, so a large new study will have to be done to know if combination inhalers are truly safe.
Sadly, it's hard for me to know who to believe. Certainly not the drug companies who make these inhalers -- that's like asking the fox to guard the chickens. The FDA's voluntary, minimalist system of post-marketing surveillance for drug side-effects (MedWatch) is woefully underutilized by doctors and patients alike, and it's unlikely that the same agency that's responsible for approval of new drugs can also be highly committed to proving itself wrong.
The professional societies receive tens of millions of dollars in "unrestricted" educational grants from drug companies each year; the journals receive millions of dollars from the drug companies for glossy advertising as well as reprints of articles about their drugs; many of the journal editors and manuscript reviewers have received tens of thousands of dollars each year from the drug companies for consulting, speaking, and research; and the drug companies themselves now design and fund the majority of the research on new pulmonary drugs. The investigators are overpaid for recruiting their patients into new drug studies. Your doctor probably has no idea about these many layers of conflicts of interest (unless she is a recipient of the generosity and has time to reflect on its influence).
Related Topics:FDA Panel: 3 Asthma Drugs Can Stay, Understanding Asthma: Treatment
The January 2006 issue of the most prestigious allergy journal (JACI) contains articles and editorials regarding the FDA's new "black box" warning for very popular inhalers used by patients with asthma. Serevent (salmeterol), Advair (salmeterol and fluticasone), and Foradil (formoterol). Salmeterol and formoterol are long-acting bronchodilators.
The black box quotes data from the "SMART" study of 26,000 adults with asthma randomly given Serevent or placebo for six months (in addition to their usual asthma medications). This "postmarketing surveillance" (phase IV) study was begun ten years ago, and the four times higher asthma-related death rate in the Serevent group (13 deaths versus 3 deaths in the placebo group) was first known in September, 2002, but the study results won't be formally published for a few more months (in the journal CHEST). Put another way, the excess risk of death for those taking Serevent was about one extra death for every 700 patients taking the drug for one year.
Should your doctor tell you this if you are taking one of these three inhalers? Does your doctor even know this? Does she carefully weigh the benefits of adding a long-acting bronchodilator to your other asthma medications against this risk of death? Once your asthma is well-controlled using Advair or Symbicort, does she consider stepping down your therapy by discontinuing the long-acting bronchodilator?
Editors of the journal wondered if the FDA warning is a "wake-up call or just an over-reaction," stating that "physicians have mixed feelings about the discolsure of black box warning information to patients." They recommend that each medical society inform their members about the black box and how to convey this information to their patients. However, there are many medical societies and not all physicians who treat patients with asthma belong to one of these professional organizations. Furthermore, JACI is the publication of the largest professional society of allergists (the AAAAI), and this society has not yet provided such information. One editorial suggests that every patient with asthma should be given both a verbal and written warning by their doctor before such inhalers are prescribed, and they should sign that disclosure statement in order to protect the doctor from legal liability.
Many pulmonary specialists feel that long-acting bronchodilators are safe when inhaled corticosteroids are given at the same time, and the widely accepted NAEPP guidelines for asthma say that. However, the FDA advisory panel must not have been fully convinced by the data, thus they also required the black box warning for Advair (and will probably do so for Symbicort, which includes formoterol, if and when it is approved for marketing in the United States). Amazingly, the SMART study did not ask about the use of inhaled corticosteroid medications in the 27,000 participants during the study of Serevent, so a large new study will have to be done to know if combination inhalers are truly safe.
Sadly, it's hard for me to know who to believe. Certainly not the drug companies who make these inhalers -- that's like asking the fox to guard the chickens. The FDA's voluntary, minimalist system of post-marketing surveillance for drug side-effects (MedWatch) is woefully underutilized by doctors and patients alike, and it's unlikely that the same agency that's responsible for approval of new drugs can also be highly committed to proving itself wrong.
The professional societies receive tens of millions of dollars in "unrestricted" educational grants from drug companies each year; the journals receive millions of dollars from the drug companies for glossy advertising as well as reprints of articles about their drugs; many of the journal editors and manuscript reviewers have received tens of thousands of dollars each year from the drug companies for consulting, speaking, and research; and the drug companies themselves now design and fund the majority of the research on new pulmonary drugs. The investigators are overpaid for recruiting their patients into new drug studies. Your doctor probably has no idea about these many layers of conflicts of interest (unless she is a recipient of the generosity and has time to reflect on its influence).
Related Topics:FDA Panel: 3 Asthma Drugs Can Stay, Understanding Asthma: Treatment
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3 Comments:
As a school nurse, I encourage parents to report back to their doctor how a medicine works for their child, or if it does not. Many people seem to be unaware that they need to be in a partnership with the doctor. He cannot read minds as to how the prescribed treatment works. I try to facilitate communication which at least makes me feel like I am doing something. I wish more doctors would use peak/flow meters to monitor how their patients are doing. Seems to be helpful to my parents...any opinions on this?
"Nurse Nancy"
Appreciate your blog,mental health consumers are the least capable of self advocacy,my doctors made me take zyprexa for 4 years which was ineffective for my symptoms.I now have a victims support page against Eli Lilly for it's Zyprexa product causing my diabetes.--Daniel Haszard www.zyprexa-victims.com
With this much risk of death, I can't believe my doctor actually prescribed me this cocktail. I've been ill lately without knowing why.
What course of action should I take if taking Advair and Symbicort within hours of each other?
Thanks,
Greg
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