Quitting baskets: Hand and cases

By Suzanne Danforth

March 27, 2008 6:00 AM

Everywhere I turn these days it seems as if the entire world is going to hell in a hand basket. It could be me, it is springtime after all. I ascribe, always have, to the tune "Spring Can Really Hang You Up the Most."

The song, devastatingly sung by Betty Carter, is the modernist's answer to the raw vernal landscape of T.S. Eliot's "The Wasteland," which reminds us that "April is the cruelest month, breeding lilacs out of the dead land, mixing memory and desire, stirring dull roots with spring rain."

Similar to the beautiful woodcuts in the book "My Dog's Brain," a drawing of my brain of late would depict pockets of worry that range from personal to global.

First, there is the collapse of the investment bank Bear Stearns and the subsequent bailout by the Federal Reserve. Their Web site puts the collapse down, simply, to extraordinary market conditions. Mix a little Alan Greenspan in, call the crisis inevitable, and there I am having nightmares involving box cars and wrathful grapes covered in dust.

Truly, though, the magnanimous gesture by the Fed was the first time the government has lent money to a security firm since the Great Depression. That's a hand basket, I'd say.

This is mere steps away in my mind to the sub-prime housing crisis. The ballooning of all those adjustable rates on the McMansions could bring a whole new class of folks into Cross Roads House. Nobody'll be complaining about it being Bums Motel anymore. Instead, decorative grasses will be planted out front and a cappuccino maker installed in the dining area. Something to make the imminent homelessness for who-knows-how-many a little more, well, tolerable.

The health-care crisis is located right next door to the housing crisis. This one looms a lot lately. For example, I took a receipt for a $3,000 shot just an hour or so ago (helps with the white blood cells). Every time I do that, I wonder if people on Medicaid get to have this drug. I wonder if people on Medicaid know that both Republican and Democratic governors oppose Boy Bush Government's new rules on Medicaid. Haven't heard about 'em yet?

Let's see, the rules reduce federal payments to public hospitals, teaching hospitals and services for the disabled. I have an idea, though, about how to fix this one. If doctors, professors and the disabled start dressing up like a Bear Stearns executive when they go to access Medicaid, I'm sure there won't be a problem getting the money.

Don't worry, don't worry. All you privately insured folks who get your care at hospital corporations are going to be fine, just fine. And pay no mind that you are part of a shrinking demographic — more for you in the long run.

Next to health care, in this tour of my worried brain, is global warming. It is easy, however, after this endless-winter to be lulled into the gun rack argument that global warming is a myth perpetrated on us by people who actually like regulation. La Nina pshaw. Those disappearing song birds, frogs and honeybees were probably just coming up to the end of their time on the evolutionary ladder anyway.

The upside here is that cruisers up in Alaska right now are promenading out on the Lido deck dressed in nothing but their fleece jackets. I wouldn't know, but would hazard a guess that there is nothing more awesome than seeing a skyscraper size chunk of ice slide off a piece of an Artic ice floe. What a splash!

Over there is China. Ah, China. Land of tainted heparin, and landlord to Tibet. Except for that pesky moral authority, China is an honest-to-goodness nation-state. Near China (due north, actually) is the Soviet Union and Vladimir Putin's dismantling of democracy. Who will play him in the Steven Soderbergh film, do you think? Will something better looking than Uggs be popular at the film festival that year? Let's hope so.

On to more personal worries, here we see that I wonder when I am going to re-discover my desire and commitment to be a person who does not smoke. Ever. At all. Not even one I bum. Over there, I wonder what to do when my right to buy in to health insurance (albeit at highway robbery rates) lapses. Yonder, you can see me wondering how my mom's grave is doing and when I will get home to clean it up.

Finally, every time the phone rings, I worry. I keep expecting to pick it up to find Condi Rice on the other end informing me that someone looked into my dossier and that she is calling to apologize and offer me stock in J.P. Morgan in return for the oversight.

It's not all that bad. I was just having fun writing this and got carried away. suzanne.danforth@gmail.com.

Quitting: Feedback goes up in smoke

By Suzanne Danforth

March 20, 2008 6:00 AM

My experiences with Chantix and my belief that it came to market too soon and significantly understudied inspired strong reactions last week in everyone who took the time to read and then write to me.

It's no news that information travels near the speed of light these days. Still, it was unsettling to wake up last Thursday morning, just two hours after this column was posted on the Internet, to find my inbox full of e-mails alternately praising or chastising me.

It was equally strange to realize that only a fraction of the mail was regional; the rest was from far-flung outposts around the country. I read through each and was at times puzzled, humored, disbelieving or grateful. One letter made me cry.

I almost wish I were an investigative reporter again in working this story. I would get to break out the trench coat, make lots of phone calls on someone else's dime and have resources in legal to call when I get nervous.

Not only will the story not go away, I suspect that what we know and what is available publicly is just the tip of the proverbial iceberg. The tobacco industry needed a whistleblower at some point, and perhaps the pharmaceutical companies do too. Granted, the basic ethics of tobacco companies and pharmaceutical companies differ greatly, but the bottom line is still big business.

Pfizer, for example, in 2006, had no fewer than nine medications with product sales of more than $1 billion each, and that amounted to just 64 percent of their pharmaceutical revenues that year. If you don't think there is a machine out there protecting that, and if that doesn't inform the analysis of all the information available in reporting this story, then it is probably good you are not the reporter in this particular dyad.

Chantix became available to consumers in August 2006, after receiving priority review from the FDA. These are granted in cases where there is evidence of a big public health benefit. It doesn't mean corners are cut, it means that more scientists and resources are put on moving a particular medication through established channels.

Pfizer showed the FDA the results in six clinical trials, which demonstrated an overwhelming benefit in a total of 3,569 chronic cigarette smokers. Only problem was, Pfizer excluded from those trials the very demography that makes up a relative majority of smokers in this country.

It is a well-established fact that about half the chronic smokers of tobacco in the United States have some form of mental illness. You can find scientific articles all the way back to 1990 with titles like "Blue mood, blackened lungs."

But it was an epidemiological study published in the Journal of the American Medical Association in 2000 that is cited again and again for its accuracy in design and analysis. Its conclusion? That "persons with mental illness are about twice as likely to smoke as other persons." Encouragingly, it goes on to say these persons also demonstrate substantial quit rates.

The chronic smokers who made it into the Pfizer studies for Chantix made the screening cut for mental illness. The 3,569 chronic smokers studied did not meet criteria for mental illness. If they did, they were eliminated. At least half the population for which this drug was being developed was not included in the studies that were important for bringing it to market.

Was this an oversight, do you think? The result is that real-world effects remained a big unknown when it came to Chantix, until it reached population at large.

A read of the transcript of the press conference by the FDA on Feb. 1 of this year begs an underlying story. The FDA representatives used words like "increasingly concerned" and "a number of compelling cases." They were diligent to point out that evidence is pointing more to exposure to the drug rather than other causes (read: baseline craziness).

For those who would be quick to argue that the Chantix nut bags are only made up of people with either diagnosed or undiagnosed mental illness, I say not so quick. There are also cases occurring in people without history of depressive illness.

Dr. Bob Rappaport, a director at the FDA, said at the press conference that "the concern is that there are many patients out there who are taking this drug who — for whom these kinds of serious outcomes could be prevented simply by being aware of the problem."

The woman in Florida who wrote the letter that made me cry would probably agree. Her husband was taking Chantix.

"Had suicide been listed (as a warning)," she wrote, "I have might have been listening more clear to what he was mentioning the three days prior to his death." He died by hanging himself from a tree in their front yard on Jan. 7, 2008. She put what she called his personality change down to the rigors of quitting.

"As much as I wanted him to quit smoking, it certainly wasn't worth his life."

Suzanne Danforth can be reached at suzanne.danforth@gmail.com.

Quitting: Some in Chantix Evening

By Suzanne Danforth

March 13, 2008 6:00 AM

It's time once again to talk about the nasty weed, tobacco. I began this column last August and soon after was prescribed the quit-smoking drug Chantix. I had spent the week prior smoking more than I ever had, after somebody else's junior high-style gambit to force hands landed square in the middle of my life.

I was wretched, didn't want to smoke anymore but couldn't seem to shake the damn little marmoset off my back. I would do anything ...; and anything came my way in the form of a pill engineered to block pleasure receptors activated by smoking.

Here is a snippet of what I wrote about it last October:

—¦the pill has visited me with some strange effects. In detail, I can tell you that my Chantix odyssey has been a burst in creativity, sleeplessness and the kind of energy that is just shy of scary."

I went on to refer to writing with a vengeance, a brain buzz and a ramped-up internal engine. Seems because I was neither suicidal nor homicidal, I got off easy. I didn't write openly about the degree to which I was disturbed by Chantix. It permeated every waking and sleeping moment (when I could sleep) and truth tell it was not shy of scary, it was scary. The boundaries between sleeping and waking dissolved and at times I wasn't sure if I was asleep or not. Despite its success in keeping me from smoking, the potential sacrifice of the remaining shreds of my mental health just wasn't worth it. I quit.

On Feb. 1 this year, the FDA issued a public advisory that Chantix "may" be linked to mood changes, behavior changes, suicidality or actual successful suicide.

Finding the data on the heels of this meek admission has been difficult, but most outlets consistently cite the FDA as having received 430 reports of suicidal thoughts and behaviors, with 34 of those cases being successful suicides.

A plucky little news outfit in Texas made a Freedom of Information Act request to the FDA in November and was given a computer disk with no fewer than 5,157 complaints on it. The complaints were from Chantix users and consisted of mentions of anger, aggression, amnesia, hallucination and homicidal thoughts.

There isn't even any point in mentioning the dreams; evidently everyone has what in the vernacular have come to be known as "Chantix Dreams."

In FDA speak, this is all called post-marketing adverse events. How is that for euphemism?

I said it before and I'll say it again: we are all part of clinical trials these days. Whether a substance is approved by government agency or not is immaterial. We take experimental cancer drugs, cholesterol lowering statins and quit-smoking pills. We feed our babies from plastic bottles and microwave our Styrofoam. We eat genetically modified foods grown from genetically modified seeds and sprayed with proprietary chemicals, without which the seed would not sprout in the first place (thank you Monsanto).

Carcinogens and human tissues are decidedly less sexy without George Clooney to promote them, eh? The logic of the chemistry and technology that has catapulted us ostensibly forward in the past 50 years has demonstrated a continued failure of predictability. Our compounds and circuit boards and nanorobotics are born in laboratories and then set upon us, usually in the name of profit.

Sure, Pfizer can claim a medical noblesse oblige of sorts in its quest to assist the remaining stupid ones to quit smoking. That would be easier to swallow if the pill were covered by insurance and if Pfizer weren't banking on Chantix to provide blockbuster sales. (Blockbuster sales, by the way, are defined annually in the neighborhood of $1 billion.)

Instead, statins cause muscle weakness, quit smoking pills make you crazy and experimental cancer drugs ravage bodies in the name of tumor shrinkage. Still, as a species we fall short of anticipating the failures and we focus on the possibilities. I suspect that we will focus on the possibilities right into the greenhouse.

Speaking of smoke and mirrors, all this bluster leaves the question of whether I still smoke. I do. I could equivocate and tell you how much less I smoke now (true), how much less I spend (true) and how much better I feel when I hike local mountains (true).

But that would bring it in to the realm of the gray and we all know I'm not that. So, black it is. I'm smoking. Wanna step outside with me?

Despite appearances to the contrary, sanguine I am not. suzanne.danforth@gmail.com.

Quitting: Teapot Tempests or Lister Redux

By Suzanne Danforth

March 06, 2008 6:00 AM

Is anyone tired of this topic yet? I hope not. It was plain envy that initially compelled me to continue to expound on the Lister fallout.

If you had seen me reading the letters to the editor on Feb. 22, you might have noticed me pounding my head on the table and uttering the Homerian "D'oh!" over and over. I just hate it when the best, most obvious and supremely logical point is made by someone other than me.

In one letter former city business administrator Joe Bove posed a question to the sitting school board: —¦where were you when the school budget was presented for your examination and approval?"

This is the kind of point that is usually non-partisan on the surface, apparently beyond argument, and which engenders a sudden silence in the room. If anyone does bother to speak after such an astute observation, it is usually to say something like "never mind." This is the kind of point that masquerades as trump, reminding you to get back to your homework and stop playing with your food.

Unless, reader, unless you begin trying to chase down facts. Facts are funny things, is-ness is elusive. Fact is Bove's question is not as transparent as it seems.

Fact is Lister's salary in this year's budget does not reflect his sick payout. That line item is somewhere else, lumped into a number along with all the other sick payout for retiring personnel. Although budget makers review the budget in work sessions, this particular line item is not addressed specifically.

Facts is facts. Lister notified board chairman Kent LaPage in October of 2006 of his intent to retire three years hence, referring specifically to sick payout. Job done. Fact is LaPage could have called a non-public session according to New Hampshire state law, which specifically states that discussion around compensation of a public employee is reason to call such a meeting.

The information eventually made its way to the city human resource director in August of 2007, but fact is we don't know exactly how. We do know that most of the school board was left in the dark until Adam Leech put his math skills to good use.

In April 2004, when Kent LaPage was president of the N.H. School Board Association, the leadership advocacy group published rules of thumb for new board members, including:

• Only a majority of the board has the ability to set policy, hire and fire staff, negotiate contracts or make requests of the superintendent.
• Effective boards require TRUST (their caps).

When I opined two weeks ago in this here space, I made an assumption that LaPage was under some sort of obligation to keep the information about Lister's retirement confidential. Well, he was, per the contract, required to keep it confidential within the central office.

Does the school board constitute the central office? Um, I think so. Does the resignation of the superintendent constitute policy, hiring or firing staff? That is trickier but I'm going to say yes. The school board should have been apprised of Lister's intentions by Mr. LaPage and Mr. LaPage alone.

What do we want for our community? What should characterize the relationship between a city board and its city? Should our elected officials be able to read a budget? Or should the budget-makers be charged with demystifying the fine print? Should our boards and the city have a collaborative relationship? A watchdog relationship? What is forgiven for inexperience or oversight?

These are difficult questions. A long time ago in this very town, the leadership of a now-defunct upstart little newspaper brought in their comptroller to aid in a news investigation. The public record in this case consisted of years of tax returns. I remember the walls of the back office pasted with them.

We needed the experience of the comptroller to point out inconsistencies that mere mortals could never have gleaned otherwise. But we were all on the same side, unlike the current uneasy relationship of public versus private, confidential versus right-to-know.

In these past weeks we have seen fingers pointed at administrators, school board members, the fourth estate and even the candlestick maker. But it sure does seem like the one person in possession of the public information regarding Lister's retirement chose not to share it with the rest of the representatives of the community.

Here's a final fact for you. New Hampshire law states nothing about separate duties, roles or obligations of the chairperson of the school board than it does for any other school board member.

You are, truly, a body of one.

Turns out Suzanne was a coal mine canary when it comes to Chantix. Check in next week. suzanne.danforth@gmail.com