Quitting: Letters from Chantix users

By Suzanne Danforth

April 24, 2008 6:00 AM

Quitting this week is going to visit some of the correspondence received from Chantix users around the country who wrote in about their own experiences on the drug, and end by updating you on Chantix news.

Stephanie from Virginia wrote that my description of the dissolution of boundaries between sleeping and waking made her say "YES! YES! YES! This is exactly what I was feeling after three weeks taking Chantix. While it worked beautifully at keeping me from smoking, I would wake up every morning like clockwork at 3:30 a.m. and begin the madness of being unable to fall back to sleep."

In addition to the sleep problems, Stephanie wrote that "funny enough, today I had such sad feelings all throughout the day, times where I would just want to sit and cry for no good reason."

From New Jersey, Bill writes that although he has never been prone to violence, "by the third week my wife said some little thing that set me off and I banged my fist on the kitchen counter so hard that literally half of my hand was discolored for over a week." A few weeks later, "when I began reading about the violence experienced by some otherwise non-violent Chantix users ...; I realized what had happened to me."

In an eloquent statement, Bill takes pains to communicate that he has a loving marriage, a job he likes and is good at, no debt beyond a mortgage and is a generally satisfied person. He goes on to describe both his experiences on Chantix and its lingering aftereffects.

After the fist-banging episode, Bill chose the eyes-wide-open approach and continued to take Chantix while monitoring and controlling the feelings of anger "since I knew what was causing it." He also experienced the Chantix Buzz, Chantix Dreams and sleeplessness. "I functioned OK at work, but only because I know what I'm doing. I couldn't have learned anything new if my life depended on it."

When nausea became a problem, Bill weaned off the drug and by mid-December "I was done, or so I thought. It is now mid-April and I haven't taken Chantix for four months. The buzz has diminished but still comes around when it feels like it." In addition to the buzz, Bill continues to experience fatigue "like someone just pulled the plug on my body" and counters that "the only thing I have to be depressed about is what I think Chantix is still doing to me."

Across the river in Maine, Kathleen brings a great sense of humor to her experience. She writes that she began Chantix reluctantly after her doctor suggested it. She chronicles the fact that she has never needed more than five hours of sleep a night "but now I wake up about every two hours (told my doc that people probably want to harm themselves or others because they are so freakin' tired)." In addition to exhaustion, Kathleen is missing the more oral side of things. She doesn't "know which is worse, being tired or being hungry all the time ...; I'll keep at this prescription at least for the 30 days (maybe) or until I'm so tired I forget to take the pill or so hungry that I take them all at one time."

From Alaska, Karen writes that in the third week "I was getting paranoia, persecution complex, memory loss and homicidal thoughts. One day my co-worker was leaning over my shoulder criticizing me and I was seriously trying to remember how to rip her throat out by hand." Karen's ex-boyfriend was a Marine trained in hand-to-hand combat.

And now for the news: Ralph Nader is at it again, but not as an election spoiler. His consumer advocacy group Public Citizen issued a call this month for the Food and Drug Administration to levy its highest category of warning, called a black box, on Chantix.

"Black box warnings" per FDA statements, "are designed to highlight special problems, particularly those that are serious, and to give health care professionals a clear understanding of a potential medical complication associated with a drug."

Many black box warnings are dire; heart attack, bone density erosion, liver failure. But the politics of them can be slippery. In February 2006, an FDA advisory panel on drug safety recommended a black box warning for most ADHD drugs, but a scant five weeks later another in-house advisory panel for pediatrics rejected the recommendation. The rejecters trumped.

A Chantix black box warning might alert consumers that taking Chantix could be life altering, if not life-threatening.

No public word yet from the FDA on whether it will accept the recommendation.

What's your bet?

E-mail Suzanne Danforth at suzanne.danforth@gmail.com.

Quitting: Consumer Watch - Johnson & Johnson and the FDA

By Suzanne Danforth

April 17, 2008 6:00 AM

What's worse than breast tenderness and nausea in the female effort to prevent pregnancy? Heart attack, stroke or death. Quitting this week is going to consider the everyday erosions of our medical liberties by the political and economic culture at large.

Loss of liberty is not necessarily obvious when we flip on the television at night and pharmaceutical advertising flows over us like, well, Flomax. Happy couples in which one has and one is free from genital herpes (Valtrex). Lumbering turtles or careless hares (Chantix). Heartburn grimaces (Nexium), or virile older couples sitting astride powerful motorcycles (Viagra, Levitra, Cialis).

The government watchdog of pharmaceuticals is the Food and Drug Administration; but since it is both a political animal and under-funded, it doesn't come nicely packaged into your living room to influence your drug choices, cajole you to ask your PCP for the brand-du-jour or conduct clinical trials of questionable design.

A current crop of lawsuits against health-care giant Johnson & Johnson over the Ortho Evra birth control patch is showing how the FDA is being ushered by the Bush administration ever closer to the anti-regulatory precipice.

The story is not quite like the Chantix one — where the company in question left out the very demographic meant for the drug — but the company's own documents show that it obscured critical information on dosing, leading to increased risk of blood clotting.

Johnson & Johnson documents show their scientists cooked some numbers on their Ortho Evra birth control patch back in 2000, after the clinical trials for the drug were finished, when pesky data came to light showing the patch delivered more estrogen than was legally allowed (read: safe). This recipe, which the company called a "correction factor," was buried deep in a document sent to the FDA and comprehensible only to a mathematician. It was not part of the original study protocol, not published publicly and not part of the rationale for the 2001 FDA approval of the drug.

More than 3,000 women, or their next of kin, are suing Johnson & Johnson because they wore that patch, took in a far higher dose of estrogen than is delivered in pill form and suffered something awful as a result, life-changing awful.

And yet, in a riveting "not my problem" defense strategy, Johnson & Johnson will be arguing in the Supreme Court (friend to big business) that it cannot be sued for the ruined lives because the FDA approved the drug, despite original labeling listing the wrong amount of estrogen. They knew, they knew. They knew taking this drug could, and likely would, end up in brain bleeding, pulmonary embolisms, and clots in leg muscles. And they sold it anyway.

The legal argument is one that attorneys, pharmaceutical companies and our very own Bush administration wants to see in place. It goes like this: the FDA is the expert for overseeing drugs and it should not be subject to court judgments. If the FDA says a drug should be approved, it should be approved and all liability to the original company should be forgiven. Forever.

Never mind that the agency is of a size nowhere able to match budgets, conduct independent research or levy sanctions that actually hurt. No, the FDA is really only in a position to rubber stamp whatever information the drug companies want it to have, in order to get things to market.

The director of the FDA, Andrew C. von Eschenbach, M.D, spoke publicly on Feb. 29 to the National Press Club, where he noted that the "FDA of the 20th century is not adequate to regulate the food and drugs of the 21st century." To his credit, he sketches out a detailed plan that might actually work — if someone funded it.

I do have an idea for a new FDA logo. Remember the seemingly fearsome abominable snowman in that Rudolph animation at Christmas? His fearsome visage became pathetic, if you recall when he opened his maw to show nothing more than gums.

Chantix antics are reaching Canada now. Back to that story next week. suzanne.danforth@gmail.com.

Quitting: Bailing on bailouts

By Suzanne Danforth

April 03, 2008 6:00 AM

Quitting this week is delving into hard news over health news.

Reporting has long been known as a "first rough draft of history." That elegant phrase was coined by the Washington Post's Phil Graham, who married into print but who thankfully treated it less as business and more as social imperative.

Social imperative was on the front page of the Sunday New York Times this morning in an article reported by Nelson D. Schwartz and Floyd Norris, two financial newsmen on the roster there. Although it was clearly flagged as news analysis, the piece accomplished what good reporting is at its heart; wake 'em up, shake 'em up.

The writers had advance copies of the United States Treasury white paper meant to curtail the spasms shaking our less than rock solid position in the global economic world. Bear Stearns, collateralized debt obligations, Countrywide shenanigans and the like.

The article notes that the proposals do "virtually nothing," give oversight a "light touch" and cement the neo-con commitment not to hamper the American markets with any kind of toothy regulation.

This interpretation stands in stark contrast to stories (not labeled analysis by the way) that lead with phrases like "creation of new regulatory agency" and "broad powers." These stories regurgitate the spin, shore up their own agenda of non-regulation or begin with names like Ann and end with Coulter.

By this Thursday morning, you will already have heard about the Bush government's attempts to right the ship, but unless you get (read: seek out) real news, you will have had a one-sided and diluted snippet of information, likely nestled between stories on a tasty spring recipe and the tale of another sad celebrity. One of the big network talking heads (the same networks that occupied the three channels available when we were kids) will mention it in passing, possibly with a furrowed brow at story's end.

Jon Stewart and Stephen Colbert will skewer it and aid us in tittering nervously while we digest dinner. But unless we read and make an effort to understand, our local, regional and national media will follow, rather than shape, the news.

It's an old refrain, but the media mavens have a vested interest in remaining mavens. No doubt Katie Couric really likes her apartment in the city. But here we are, regular Americans of all stripes, on our own killing fields five years later, with our civil liberties in tatters. The futures for Medicare, Medicaid and Social Security are uncertain, not because of execution but by dint of slow budget strangulation.

And to think, all we got was a picture of the president in codpiece on an aircraft carrier.

The piece in the Times, easily found by searching "Reluctant Eye Over Wall Street," also attains something far loftier; it is a historic call to economic arms. To paraphrase one of Portsmouth's very own teacher emeritus, the article merits rank as history-making because it reports the facts while paying homage to ideas that are socially useful and personally meaningful.

The writers point out that the regulatory umbrella created in the turbulent 1930s by F.D.R. would in fact grow bigger, with the trend being concentration of power in ever fewer agencies. Call it regulation lite as administered by mini-oligarchs.

Although observations such as these are easy to make, what to do about the state of our country is less clear. Vote, yes. But what else? It is unlikely that the single mothers in Baltimore or the elderly men outside of Chicago who are trying to restructure ballooning mortgages have time to hit the streets. It falls in part, or should, to the media to be the architects of agitation and stewards of American polity.

Recalling the 1970s kismet-like coming together of Deep Throat and plucky duo Woodward and Bernstein, can we dare hope for someone to step out of the shadows and ally with a member of the fourth estate sometime soon?

Modern history would do well to serve up a stew made of a smart reporter or two, a brave well-placed source, responsible editors and law to bring the ball home. Something, anything, to move these henchmen of the Carlyle Group on to greener pastures, say Antarctica, before our country is irrevocably dismantled for all but a few.

The $500,000 paid to the next of kin of each soldier killed in Afghanistan or Iraq seems to be one variable keeping folks quiet for now. But our lesson now needs to be regulation and oversight.

Michael Greenberger, law professor and former Clinton administration player, was quoted in the Times as saying the new regulatory policy is "equivalent to the builders of the Maginot Line giving lessons on defense."

It is worth exploring the details of this simile to drive home the underlying point. Get to work America.

Suzanne Danforth occasionally strays from health-related columns, but rest assured her battle against smoking continues. Write to suzanne.danforth@gmail.com.