Thursday, March 07, 2013

Sometimes the New Zealand Government Get It Wrong

Direct to consumer advertising is allowed here in New Zealand.

I couldn't believe it when I saw an ad for the smoking cessation drug, Chantix [known as Champix in NZ] - generic name varenicline.

Apparently, the powers that be, here in NZ, have evaluated all the evidence related to suicide and Champix. In fact, Medsafe, the NZ drug watchdog, made the following recommendation whilst investigating the suicide links, "patients should continue to use Champix tablets because the "benefits of the treatment" continue to outweigh the risks".

Hmmm, really? Not for the people who killed themselves on the drug while being monitored by Medsafe.

Medsafe set up a specific post marketing monitoring project for Champix in 2007 [New Zealand Intensive Medicines Monitoring Program].

Here's the conclusion of their report to Medsafe

"The postmarketing study of 3415 New Zealand patients demonstrates that psychiatric adverse events are commonly reported in association with varenicline. Approximately 3% of patients experienced symptoms of depression and the majority of these cases appeared to have a causal association with varenicline. Serious psychiatric reactions, including suicide, suicidal ideation and psychotic reactions, were also identified, but
these were less frequently reported."

How did Medsafe react to this?

Well, they stood by the Champix datasheet which states that a causal association between the product and certain psychiatric symptoms, including depression, has not been established. Stewart Jessamine, Medsafe's manager, added that people who smoke are more prone to depression. [2]

Here we are in 2013 and some breaking news for the powers that be here in NZ.

Pfizer, the company behind Champix, have just agreed to settle a lawsuit in the US, this after settling two other Champix cases late last year and early this year.

In October Pfizer reached a settlement with the widow of Mark Alan Whitely, who killed himself after taking the smoking cessation drug. Judy Ann Whitely, widow, filed a lawsuit and was set to go to trial in mid October. Miraculously, Pfizer settled just a week before the trial.

In January the company settled claims with Billy Bedsole. Bedsole claimed that he suffered suicidal thoughts and behaviors from Champix side effects, causing him to be institutionalized for psychological problems. Once again, just a week before trial, Pfizer settled.

When settlements are reached it's usually the guilty party, in this instance, Pfizer, that have something to hide. Sources claim that the Bedsole and Whitely settlements allowed Pfizer’s CEO, Ian Read, to avoid taking the witness stand to testify about whether the drug maker knew about the potential risk of Champix problems when he was on its development team. Under oath he would have had to have told the truth.

Because of these settlements Pfizer will escape further investigation. Today's news sees Pfizer settle 80% of the 2,700 lawsuits pending cases against them.

Why are Kiwi government officials so ignorant about Champix?

In 2010 Pharmac, the New Zealand Government's Drug Purchasing Agency, decided to fund treatment to help New Zealand smokers kick the habit - that treatment was Champix. Pfizer proudly announced this on their webpage back in 2010 [3]

More about Pharmac later in this post.

There's a huge campaign here in NZ, a bunch of do-gooders want New Zealand to be smoke free by 2025. I'd much prefer if New Zealand was suicide free. A fierce supporter of this campaign is Dr Marewa Glover, Director of the Centre for Tobacco Control Research at New Zealand's largest university. Dr Glover.

Pfizer, who manage the Champix NZ webpage, are right behind the smoke free campaign... well, they would be, wouldn't they. Here's two graphics from the Champix NZ page.

Combine these with the millions spent on advertising Champix on TV here in NZ and one begins to understand who pulls the strings.

Let's just put anti-smoking campaigner, Dr Marewa Glover, under the spotlight, shall we?

In 2006, Glover co-authored the New Zealand smoking cessation guidelines which was subsequently published in the New Zealand Medical Journal. Here's what she and her co-authors had to say about smoking cessation medication:

"Bupropion [Zyban ] is an antidepressant medication that doubles the chances of long-term abstinence compared with placebo."

Zyban is marketed and sold by GlaxoSmithKline as a smoking cessation medication. It is, as the authors correctly point out, an antidepressant. However, despite mentioning the brand name [Zyban] the authors fail to mention it's other brand name [Wellbutrin].

In the UK there have been over 9,000 adverse events reported to the British drug regulator [MHRA] regarding Bupropion, 83 of those adverse events have resulted in death [FIG 1]

FIG 1 - Bupropion realted deaths and adverse events

Glover and and her co-authors also mention Varenicline [Champix ], here's what they claim:

"It approximately triples the chances of long-term abstinence compared to placebo. To date, Varenicline has demonstrated a good safety profile, with transient nausea being the most commonly reported side effect."

Once again I refer to the MHRA adverse reaction system. You can see from the pic [FIG 2] that there have been over 8,000 adverse reactions reported, 101 of those have resulted in death.

FIG 2 - Varenicline related deaths and adverse events

Remember, this is just adverse events reported in the UK. I'm using their system as it's far easier to navigate the MHRA website than it is Medsafe's.

Now, let's take a look at what Glover and co said about Champix again:

"To date, Varenicline has demonstrated a good safety profile."

Hmmm, 101 deaths related to Champix use in the UK now equates to a good safety profile?

The authors of this particular paper are Hayden McRobbie, Chris Bullen, Marewa Glover, Robyn Whittaker, Mark Wallace-Bell, Trish Fraser.

Could they be biased in any way?

Well, if one reads the full paper the evidence suggests that their findings may be influenced.

"Competing interests: Dr Glover has undertaken research and consultancy for (and received honoraria for) speaking at meetings from the manufacturers of smoking cessation medications. She has also provided smoking cessation training for Novartis and Te Hotu Manawa Maori for the Aukati Kai Paipa Pilot and Quitline. Drs McRobbie, Whittaker and Wallace-Bell have undertaken research and consultancy for, and received honoraria for speaking at meetings from the manufacturers of smoking cessation medications."

If publication in a journal wasn't enough to get Champix on to the streets of New Zealand then maybe an associate health minister could help.

Step forward vocal MP and Associate Health Minister Tariana Turia who, back in 2010, applauded the  decision by Pharmac to subsidise Champix

Turia gave her point of view with regard to smoking in an eye-opening column in the Whanganui Chronicle in 2012 [4]

"We, as a nation, have set a goal to see Aotearoa become smoke-free by the year 2025. It is a bold target, but it is also an achievable one", adding, "It is a harmful habit that costs us millions of dollars a year, but even worse than that, it costs us lives."

Whilst I'm in agreement with Turia I can't help feel that one drug to stop another [Champix to stop smoking] is really the answer, particularly when there are alternative smoking cessation products and methods that do not cause, suicide and psychosis. So, there's approximately 5,000 smoking related deaths a year in NZ, we have 2,160 American citizens who thought Champix could help them quit smoking, all of whom have suffered serious adverse events as a result of taking Champix, some so serious that relatives have sued because Champix led to completed suicide. We also have the refusal of Pfizer's CEO to take the stand because in doing so he, under oath, would have to tell the truth and state that he, whilst on the Champix development team, knew there was a suicide risk with Champix.

Are the NZ government suggesting that smoking related death is appalling but Champix related adverse events, such as psychiatric disorders, suicidal thinking and completed suicide, are only mildly appalling?

It seems to be a case of 'Better the devil you know than the devil you don't know.'

Except, the New Zealand authorities have known but decided to ignore the warnings. Why would they do that?

Here's one theory. **Please note - given what we know about the pharmaceutical industry, this theory may need further investigation.

In 2010 the NZ government denied any link between Champix and suicide. Yet two years earlier Pharmac declined funding for Champix in 2008 citing safety concerns. In fact, Pharmac had twice considered backing Champix but rejected the move because of safety concerns. Pharmac papers stated that it "appears increasingly likely that there is an association between varenicline [Champix] and serious neuro-psychiatric events".

So why, in 2010, did Pharmac do an about turn?

Well, Pharmac media spokesman Simon England said in 2010 that the drug was initially turned down due to safety risks, but new information surfaced to mitigate those risks. He never actually cited any published papers or offered evidence for any layperson or indeed member of parliament to scrutinize.

At the time, CASPER CEO, Maria Bradshaw, raised the red flag regarding the announcement that Champix was going to be subsidised for Kiwi's. She told media outlets, "In the same week the Government has expressed concern about the fact that 10 people commit suicide every week in New Zealand, it has decided to promote the use of a drug that it knows increases suicide risk," adding "A government committed to reducing the suicide rate would not be making these drugs more widely available to a greater number of people." [5]

Bradshaw was right. In 2009 the FDA, the American drugs regulator, released a warning regarding Champix and the suicide link. Why did the NZ government choose to ignore this?

New Zealand is a country that, in the main, uses generic drugs and not branded ones. Instead of Prozac, doctor's will normally prescribe the generic version, fluox.

Pfizer, not liking the heavy use of generics in NZ, struck a deal and Pharmac agreed to take a package of four drugs from Pfizer.

For some time the NZ government had been wanting Pfizer's statin drug, Lipitor. The government wanted this particular drug because it's the only statin that, allegedly, reduces the risk of heart attacks. Pfizer, upon seeing the original Pharmac stance on Champix, would only sell if the NZ government took on a four package deal. One of those four drugs, you've guessed it, was Champix.

Pfizer were basically holding the NZ government to ransom and the government paid the fee - you, the citizens of New Zealand, are now picking up the tab.

Ten deaths have been related to Champix here in New Zealand, that's just the ones that have been reported.

Remember, adverse events are rarely sent in to CARM, as proven in an earlier post of mine, Sometimes Coroners Get It Wrong...

In June 2011, I uploaded a 54 page document I had obtained from the Federal Aviation Administration [FAA]. I'd requested this under the Freedom of Information Act. [6]

I learned that the FAA have banned pilots flying if they have been taking Champix, they also prohibit its use if you are an air traffic controller.

Take a look at the title of this post. Ask yourself if you think the NZ government got it wrong with regard to Champix.

Will Stewart Jessamine of Medsafe still defend the use of Champix?

Will the NZ government or any independent body now investigate Pharmac and the role they played with Pfizer and Champix?

In 2009 the FDA, the American drugs regulator, released a warning regarding Champix and the suicide link. Why did the NZ government choose to ignore this?

Does Dr Marewa Glover still stand by her findings that Varenicline has demonstrated a good safety profile, are her findings influenced by payments she has received from pharmaceutical companies that manufacture smoking cessation drugs?

Will Associate Health Minister, Tariana Turia, speak out against the use of Champix given the recent out of court settlement in the US and two previous settlements with Judy Ann Whitely and Billy Bedsole?

There are currently 11 suicides per week in New Zealand, it's an appalling statistic made worse when you look at how Champix has been given a clean bill of health by the NZ government despite overwhelming evidence that it causes suicidal thinking and completed suicide.

Bob Fiddaman

[1] Psychiatric Adverse Events Associated with Varenicline An Intensive Postmafketing Prospective Cohort Study in New Zealand - Mira Harrison-Woolrych and Janelle Ashton
[2] Kiwi Champix users warned of depression risk [link]
[3]  Important news for New Zealanders - Government funds new treatment to help New Zealand smokers kick the habit [link]
[4] Tariana Turia: Smoke free, our history, our future [link]
[5] Govt denies drug suicide link [link]
[6] FOI REQUEST FROM FAA Regarding SSRi Use In Pilots/Fiddaman [link]