Wednesday, July 22, 2015

Australian Therapeutic Goods Administration Acknowledges that Chantix Causes Suicide But Allows it On Market, While Banning E-Cigarettes with No Known Adverse Effects

The Therapeutic Goods Administration (TGA) in Australia has publicly acknowledged that Chantix causes suicide, and that the family members of patients taking this drug must carefully watch their loved ones to make sure that they don't kill themselves. Nevertheless, the TGA apparently has no problem allowing Chantix to stay on the market. Moreover, the Administration has not even required that a black box warning be placed on the drug's packaging.

At the same time, the TGA has banned electronic cigarettes, another effective smoking cessation tool, despite the absence of any evidence that it causes substantial adverse side effects.

According to an article on the web site of ABC News Australia: "The FDA in the US first implemented its so-called "black box" warning on Champix packets in 2009, and recently strengthened it, after a huge class action involving 3,000 litigants was settled by pharmaceutical manufacturer Pfizer. But Australia's Therapeutic Goods Administration (TGA) does not require a "black box" warning and Champix currently does not contain consumer medical information inside the box either. "We've been very concerned about the drug because it has so many more adverse reactions that have been reported than pretty much any other drug," Dr Zuckerman said."

"But the response to Champix in Australia by health professionals and the TGA has been markedly different. "The TGA continually reviews the adverse events and we believe that Champix PMI and CMI contains the appropriate information to assist in its safe and effective use," a TGA spokeswoman said. "This includes appropriate warnings on neuropsychiatric-adverse events, such as self-harm and suicidal tendencies. People taking this medicine [and their family or carer] need to pay special attention to your mood, behaviour and thinking while you are taking Champix." Champix was first introduced to the Australian market in 2007 and by 2010, 900,000 prescriptions had been filled. In that time, the TGA had more than 200 reports of suicide-related events for Champix patients."

The Rest of the Story

This is perhaps the most absurd policy rationale I have ever heard. We have a smoking cessation product that is so dangerous that it can cause suicide, so alarming that we need to warn the families of patients taking the drug to watch their loved ones carefully to be sure that they don't kill themselves, yet we don't take it off the market. On the other hand, we have another smoking cessation product with no evidence of any significant clinical harms, yet we ban that product because of uncertainty over the possibility of potential adverse effects if people were to vape regularly for 20 or 30 years.

I am not necessarily arguing that Chantix should be taken off the market. The risks need to be weighed against the benefits. However, if it is justified for Chantix to remain on the market despite its known association with suicide, then it makes absolutely no sense to take electronic cigarettes off the market, despite the lack of any evidence that it causes significant adverse side effects.

Why does the TGA even need to wait for studies to see if e-cigarettes have serious side effects? The Administration has already admitted that Chantix has life-threatening side effects but allowed that drug to stay on the market without even a black box warning. Does this mean that the TGA will finally approve electronic cigarettes once they are shown to have a serious side effect, like possible sudden death? Apparently, unknown risks are of far greater concern to the Administration than known risks.

I find it rather comical (but really, sad) that the TGA believes that it is appropriate to allow a drug that it thinks causes suicide on the market, as long as you warn family members to look out for suicide attempts.

But the worst part of this story is the argument by Professor Renee Bittoun for why a black box warning should not be included on the Chantix labeling. According to the article: "Respiratory physiologist Renee Bittoun started one of the world's first "quit smoking" clinics in Sydney. "The risk you take by putting a big warning on [Champix] is that people will not take it and smokers die from it. From smoking," Associate Professor Bittoun said."

This is not a good justification for failing to require a black box warning. The fact that a black box warning might scare people away from taking a drug is no reason to not require such a warning if it is otherwise justified. After all, one could make the same argument about any drug, and so this argument is tantamount to saying that no black box warning should ever be placed on a drug because it would discourage many people from using the drug. So it's actually quite scary reasoning. The only reason to not require a black box warning is if the warning is not justified based on the scientific studies of the side effects of the drug.

The rest of the story is that Australia's TGA is taking a completely nonsensical approach to the regulation of smoking cessation products. Apparently, they would rather that smokers use products with known, serious risks than products that are probably quite safe, but whose risks are not definitively characterized. Unknown risks can't be tolerated, but serious, life-threatening risks are fine, as long as they are known.

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