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Jack Sisson's Life Ethics Blog

We must find new ways through many ethical issues, especially regarding bioethics, medical ethics, and criminal justice. Jack Sisson's 'Life Ethics' blog focuses on numerous areas of concern, including the philosophical and ethical dilemmas surrounding stem-cell research, abortion, medical research, and health care.

This article was of particular interest to me because I've inhaled Advair twice a day for several years now. Since I have only mild asthma, I plan to discuss alternatives during my next visit with my doctor.

From MedPage Today:

The 2001 product launch of the asthma drug Advair (fluticasone/salmeterol) was a lavish, Las Vegas affair.

Using images of a slot machine to illustrate their message, top GlaxoSmithKline executives took the stage in front of thousands of assembled sales reps. "There are people in this room who are going to make an ungodly sum of money selling Advair," one executive told the group.

He was right.

The Serious Business of Asthma

Millions of people with asthma, including many children, have gone on the drug and, according to data from IMS, Advair sales have exceeded $4 billion every year since 2007.

Yet even as profits mounted evidence began to emerge from independent medical studies and court records suggesting that the drug can be dangerous, especially to children and that overuse of the drug exacerbated the danger.

Asthma is not a benign condition.

According to the U.S. Centers for Disease Control and Prevention, asthma deaths in the U.S. have been declining since the late 1990s. In 2009, there were 3,388 asthma deaths.

The problem appears to be the long-acting beta-agonist salmeterol that is one component of Advair.

Asthma, which affects an estimated 25 million Americans, is caused by inflammation and swelling of the airways in the lungs as well as constriction of those airways. Long-acting beta-agonists, or LABAs as they are frequently referenced, which treat airway constriction, which provides symptom relief, while corticosteroids treat inflammation.

But long-acting beta-agonists have been linked to 1,900 asthma deaths from 2004 through 2011, according to an estimate provided by AdverseEvents Inc., a private firm that analyzes drug side effect data reported to the U.S. Food and Drug Administration. Because of the voluntary nature of those adverse event reports, it is likely that estimate is low.

In 2008 a different analysis by a researcher with the U.S. Food and Drug Administration estimated the drugs contributed to 14,000 asthma deaths from 1994 through 2007. Advair, approved in 2000, is by far the biggest seller.

The story of how a potentially dangerous drug became commonly prescribed comes from a Journal Sentinel/MedPage Today review of transcripts of FDA hearings, financial disclosures, medical journal articles, treatment guidelines and a U.S. Department of Justice complaint against GlaxoSmithKline.

Birth of a Blockbuster

Advair was considered a breakthrough in convenience because it combined the GlaxoSmithKline two effective agents, salmeterol to treat airway constriction and the corticosteroid fluticasone to treat inflammation.

Advair and similar drugs are considered appropriate treatment for severe, treatment-refractory asthma that is not controlled by corticosteroid treatment alone. But a 2010 study by Medco Health Solutions found nearly two-thirds of mild asthma patients were taking the combination drug -- often without trying a steroid first.

One theory for why Advair and similar drugs carry increased risk of deadly attacks is that the long-acting beta-agonists may mask worsening inflammation in the lungs. As a result, the patient "feels better" even as the disease worsens, thus setting the stage for a catastrophic asthma exacerbation. Assessing Risk, Risking Safety

In 2010, when the FDA approved more large-scale safety trials of the drugs, some of its own researchers called doing so unethical because it could put tens of thousands of patients at risk, according to a transcript.

Such trials would be especially dangerous for children, agency physician Andrew Mosholder, MD, warned, noting children "can't give consent themselves and one could argue the ethical burden is greater to protect."

The trials, which are not expected to yield results until 2017, will involve 46,800 adults and adolescents aged 12 and older. A separate trial involving 6,200 four- to 11-year-olds also is being conducted.

At a 2008 FDA advisory panel reviewing the use of the drugs, agency physician David Graham, MD, questioned whether it was worth putting an entire population on the drugs just to find that occasional patient who gets better control of their asthma, according to a transcript of the meeting.

"We have no way of identifying who's going to have that miraculous response to Advair," he said, "just as we have no way or predicting who's going to end up in the cemetery because of Advair."

Graham has a long-standing reputation as a FDA whistleblower, who has testified at Congressional hearings investigating the marketing of Merck's arthritis pain drug Vioxx, withdrawn after it was linked to heart attacks, and the diabetes drug Avandia, a GlaxoSmithKline drug, which was linked to increased risk of heart attacks.

FDA spokeswoman Morgan Liscinsky noted in an emailed statement that in 2010, the agency instituted new safety requirements for the drugs, including that they only should be used for the shortest duration necessary to achieve control of symptoms and then discontinued if possible.

In addition, the agency said long-acting beta-agonists should only be used with a steroid. The agency also issued warnings in 2006 about the increased risk of deadly attacks.

Liscinsky said the FDA believes the benefits of the drugs outweigh the risks when they are used properly.

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