The Republican corporate prescription

All is revealed with the GOP's new slogan: "The change you deserve," borrowed, we now know, from the antidepressant drug Effexor.

The difference, of course, is that the Republicans don't have to reveal side effects to potential consumers.

"Are depression symptoms keeping you from where you want to be?" Effexor's maker, Wyeth Pharmaceuticals, asks in its promotions. "Not feeling as good as you used to?"
House Majority Leader Steny Hoyer (D-Md.) told reporters today that a safer remedy would "Democrats, not drugs, is what the American people need," he said. He flashed the Effexor side effects on a large flat-screen television. "Nausea, up to 58 percent," Hoyer said. "Actually it's higher than that for Republicans."
Hoyer didn't even mention the warning label, which states that patients should be watched to see if they are "becoming agitated, irritable, hostile, aggressive, impulsive, or restless."

All so true.

Also in the news today was the sad fact that relentless for-profit marketing has turned Americans into a bunch of pill-poppers. More than half of all insured Americans are taking prescription medicines regularly for chronic health problems. The causes are worse public health, better meds, and advertising. The biggest jump in use of chronic medications was in the 20- to 44-year-old age group where it was up 20 percent over six years. The chronic conditions served are mainly depression, diabetes, asthma, attention-deficit disorder and seizures.

There are some good books out on the pharmaceutical industry's success in the United States. Here are four, with their descriptions from Amazon:

Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer, by Shannon Brownlee
Award-winning health and medicine writer Brownlee notes that Americans spend between one-fifth and one-third of health-care dollars on unnecessary treatments, medications, devices, and tests. What's worse, there are an estimated 30,000 deaths per annum caused by this unnecessary care. The reason for what amounts to a national delusion that more care is better care is rooted, she says, in a build-it-and-they-will-come paradigm that rewards doctors and hospitals for how much care they deliver rather than how effective it is.

Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, by Melody Petersen
Much of what [former New York Times reporter Petersen] recounts — such as the glut of copycat drugs like antacids, and marketers' lavish wining and dining of doctors—has been covered in books by others, like Marcia Angell. But Petersen fleshes out these issues and names prominent doctors who, she says, are on the take. She is particularly strong on the ghostwriting of medical journal articles by advertising agencies. She also covers less familiar matters, like the environmental impact of drug residues in water.

Before You Take that Pill: Why the Drug Industry May Be Bad for Your Health," by J. Douglas Bremner
Recent scandals involving diabetes drugs, Vioxx, and many other medications reveal the serious and undisclosed risks of some of the most commonly used prescription drugs in this country. Dr. Bremner, a researcher and clinician at Emory University whose study on Accutane and depression made headlines, offers an inside look at the pharmaceutical industry, as well as a scientifically backed assessment of the risks of more than three hundred prescribed medications, vitamins, and supplements.

The Truth About the Drug Companies: How They Deceive Us and What to Do About It, by Marcia Angell
The pharmaceutical industry, according to former New England Journal of Medicine editor Angell, is fraught with corruption and doing a disservice to customers, the federal government, and to the medical establishment itself. She explains how a huge portion of the revenue generated by "Big Pharma" goes not into research and development but into aggressive marketing campaigns to sell their product. She describes how, even though the drug companies claim that it costs them an average of $802 million per drug to develop new medicines, that figure is obscenely inflated since it factors in marketing as well as expected interest the company would have received had they invested the money in the open market. Meanwhile, most of the R & D work is done by colleges and universities funded by the government. There are also problems with the drugs themselves, since a majority are "me-too drugs", slightly modified versions of existing products which meant to address concerns of consumers most likely to spend money on pharmaceuticals. Thus, the market is filled with remarkably similar drugs to treat depression and high cholesterol while potentially life-saving medicines for diseases afflicting third-world countries are discontinued because they aren't profitable.

Pharmaceutical Ads Since 1997

Amazing. The FDA only gave its blessings to "direct to consumer" ads for prescription drugs in 1997. Those ads now sponsor our nightly news and pay the production costs of our magazines. That was just 10 years ago -- who paid in 1996?

The LA Times has an opinion piece on how the ads have "fundamentally altered the doctor-patient relationship by forcing physicians to respond to people's demands for heavily touted drugs, rather than taking the initiative in suggesting treatments."

"DTC advertising increases people's awareness of diseases and available treatments," Pharmaceutical Research and Manufacturers of America, an industry group, says on its website. "Studies show DTC advertising brings patients into their doctor's office and starts important doctor-patient conversations about health that might otherwise not have happened."

For example, how many people would have thought to ask about "restless legs syndrome" until pharmaceutical giant GlaxoSmithKline launched a DTC campaign in 2003 to raise awareness of the problem.

Good point. It appears that the industry is now moving to tackle the problem of "excessive sleepiness." They've got something other than a cup of coffee in mind -- and it's not a recommendation to get more sleep...

Brisbane. What state is that in?

A leading maternal-fetal medicine researcher has inexplicably ended up at the University of Queensland in Brisbane, Australia -- a far piece from where the only possible environment for innovative research exists -- right here in the U.S.

Only our free-for-all, ignore-the-bodies-they're recyclable-anyway market economy nurtures pharmaceutical companies -- with private health insurance footing a good part of the bill and no government negotiations for pharmaceuticals. Ask Rush Limbaugh if you don't believe me.

So this news doesn't make a bit of sense. But here it is anyway: Professor Nicholas Fisk says that the current research and development and business model of the pharmaceutical industry is failing pregnant women, and describes pregnancy as a virtual "pharma-free zone." He analyzed an industry database that tracks drugs under development since 1981 and found only 17 drugs under active development for maternal health. Only one new class of drug has been licensed in the last 20 years -- and that one case did not take place in either the U.S. or Australia.

Professor Fisk's research looks at the pharmaceutical market's "push" mechanisms (funding to encourage investment from universities and companies) and "pull" mechanisms (funding to purchase drugs once they are on the market) have not been effective in the area of maternal health.

Curiouser and curiouser. Haven't we been assured that market mechanisms are what make the U.S. unique in the world? And that they are responsible for most if not all of the pharmaceutical advances of the past decades? A different way is possible?

Professor Fisk says that manufacturers avoid the need of pregnant women because said women are likely to sue them should the drug result in fetal abnormalities, because of the small market size for conditions affecting pregnant women, the limitations of a shareholder model, and a regulatory system that allows endemic off-label use of drugs in pregnancy, discouraging pharmaceutical investment in the long term.

The professor thinks that drugs for pregnant women should instead be developed under a model like the Neglected Diseases Initiative, which does not rely on profit for innovation.

Libertarians and free-market ideologues reading this should not be alarmed. Research has also shown that when we read or hear something that is dissonant with our deeply held ideological beliefs, we throw the facts out the window, not our beliefs. Such readers have already -- already! -- successfully rationalized this tidbit into support for their own beliefs.

Conflict of Interest at the Docs

A Duluth health system got rid of all their pharmaceutical-supplied mugs, pads, etc., and shipped them to Cameroon. Twenty shopping carts worth. Here's the story.

Why? "The backlash against the cozy relationships between doctors and drug makers gained steam from article in the Journal of the American Medical Association in 2006. It said research had shown that even cheap gifts, such as pens, can affect doctors' prescribing decisions."

(Thanks Eliza. It is a small step..)

Unfavorable drug tests buried or changed

Hard to believe, isn't it? And yet Reuters reports that an Oregon Health Sciences University study shows that nearly a third of anti-depressant drug students are never published. Evidently because they showed the drug was ineffective.

Perhaps it's just a coincidence that most of the unpublished studies show that the drug being tested didn't work. It could be information that your physician didn't need to know anyway. We all know that a positive attitude can work wonders.

Of the 74 studies that started for the 12 antidepressants, 38 produced positive results for the drug. All but one of those studies were published.

However, only three of the 36 studies with negative or questionable results, as assessed by the FDA, were published and another 11 were written as if the drug had worked.

Wait a minute. Rewritten as if the study showed success?

To name names:

• GlaxoSmithKline's Paxil -- 7 negative studies; 5 never published
• GlaxoSmithKline's Wellbutrin SR -- 3 studies, 2 of them negative, neither ever published
• Pfizer's Zoloft -- 5 studies, 3 of them negative and never published; a 4th, questionable one (in the FDA's opinion) written and published with the inference that the drug worked

$61,000 per physician

Big Pharma spends $61,000 per physician annually in marketing. That's about twice what they spend on research and development — much of that for copy-cat drugs that have been shown to make a lot of money, like Viagra — and about a quarter of their sales dollar.

That's from a new study at Science Daily and at One Good Move.

Stopping Reform: Public Thoughts

CNN Money has a piece with advice for health insurance companies and Pharma on what to do about all the talk of health reform. I'm wondering who the target readership is — perhaps mid-level management types?

Hard to say.

The advice boils down to this: Not to worry. Act reasonable, then after the elections lobby as usual.

Tidbits:

In a December report called "Beyond the Sound Bite," PricewaterhouseCoopers compared the health-related policies of seven major presidential candidates: ... Democrats Hillary Clinton, Barack Obama and John Edwards and Republicans Rudy Giuliani, Mitt Romney, John McCain and Fred Thompson. ...

The Democrats propose "broader and more immediate changes, with new mandates, programs and funding."

The Republicans want no new government programs, preferring "indirect approaches such as changes in tax incentives that could move insurance away from an employer-based model."

PWC boiled down the issues to these: covering the growing uninsured population, changing tax rules to support health system changes, controlling health costs, and improving quality of care....

[None of the] candidates propose a single-payer system along Canadian lines. All seven candidates tend to rely on expansion of the existing private insurance market.

But the report notes, "The Democrats say they would also create new public programs to offer more choice and compete with private insurers."

The PWC expert advised the insurance companies needed to devise a strategy to compete with the government, if Clinton's or Edward's plan goes through.

Even if the Democrats don't hold the Congress and/or take the White House, Republicans can't be expected to maintain the status quo, says John E. Calfee, a scholar at the American Enterprise Institute ...

That's because the momentum to do something to bring the 47 million uninsured into the system is too strong.

"You know there's going to be heavy action on the Hill over this even if the Democrats don't win," Calfee said.

He suggests that the insurance industry attack head-on the question of its efficiency. Some analysts put the cost of bureaucracy and paperwork at 30% of the $2.1 trillion (in 2006) spent on health care in the U.S.

As for Pharma, a USC professor of pharmaceutical economics says he expects that Medicare Part D will change, and receive the ability to negotiate drug prices. That could hold down prices and bring greater transparency to the market — a worrisome scenario for Pharma stockholders, no doubt.

The good professor's advice: "appear cooperative and happy to get along with a new regime. Then, after the election, lobby vigorously in Congress, as usual."

It really is Sicko, but a package arrived today

Donna Smith, who describes herself as "one proud American appearing in Michael Moore’s newest film, Sicko," wrote up this story about the time of her 31st wedding anniversary earlier this month. She and her husband Larry lost their home after both becoming ill around the same time. They're scraping by these days, walking wounded with him, after three heart bypasses, arguing the need for him to go back to work and her arguing that he mustn't. Donna, a newspaper editor who understands how unlikely it is that she'll ever work in that capacity again since taking up the cause of healthcare justice, wrote this up last week. Sicko opens June 29. Go see it that first weekend.

A package arrived today at my home. It was a welcome sight. It came from a friend, a SiCKO soul mate, who knows what it is to go without medications so that others might have theirs and because there just isn’t enough cash to go around.

Over the past several weeks, I have been weaning myself off of one of my most important medications, my Advair. It is the asthma inhaler that helps my lungs stay open and free from asthma attacks. And I have taken it for almost four years.
Advair is expensive. But even as the doctors in Cuba, where we went with Michael Moore, were taking me off of five other medications, including the beta blocker they said no asthmatic should ever take, they all agreed, “Take your Advair. It is perfect for you. It makes you better.”

But the doctors in Cuba don’t understand. No matter how perfect a medicine or a treatment may be for an American with health issues, unless that American has the cash to pay for the needed item or care, their body will go without.

I first started on Advair four years ago after a debilitating obstructive asthma attack that landed me in the hospital for three days. The pulmonary doctor who saw me then thought I might be helped by the inhaler, and he was right. My lung function dramatically improved with the medicine and my need for the short-acting inhalers to stop acute asthma attacks dropped to almost nil.

It seemed that within a few short months, my lung status was changed from one I feared every time I was outdoors in the cold or near one of my asthma triggers or – heaven forbid – I caught a cold, to one of a nearly normal person. Advair was a miracle for me.

But it' s pricy. Even at the local mega-discount chain pharmacy, Advair in my strength can be $200 a month.

I have insurance, but that doesn’t solve the problem. That same pulmonologist that first prescribed my Advair quit seeing me because we declared bankruptcy in 2004, and his practice group wanted cash up front from me (and then they suggested I submit my own insurance claim). I was devastated since my insurance carrier had always paid handsomely for my care and the only amount this clinic in Rapid City, SD, lost was $200 that had to be listed in the bankruptcy action. So, I couldn’t see him anymore.
I waited until spring of 2007 in Havana, Cuba, to see a lung specialist again. I never got to see an allergist in South Dakota either. The only one my family doc would refer me to was in the same practice group with that “no-dirty-bankrupt-persons” sign on the door.

But over the years, I did manage to talk my way to a continued Advair prescription from whichever doctor I was seeing at the moment. I knew it was helping me, and I knew I had to take it.

Then the bottom fell out of our lives. Insurance premiums topped $600 monthly, and something had to give. Though I was deeply grateful to be participating in the Michael Moore project, that wasn’t going to fix the problems that made me perfect fodder for the film.

When I returned from Cuba, the Advair ran out. My new insurance has a deductible to meet, and it so happened that my Advair was the medication next up on the refill queue for us. My husband takes eight prescription medications for his coronary artery disease, peripheral artery disease, and other conditions. Though I had come off several meds in Cuba, I still needed four – including my expensive Advair.

One local doctor gave me a sample that lasted two weeks, and then offered a sample of a lesser drug. I took it. But as the days wore on, I could feel my lungs starting to tighten again. The pain I had lived without returned. Climbing stairs once again became more taxing; my sleep issues worsened. My asthma was back.

And the shame is all there too. How do I tell the world that I am still a failure – SiCKO “star” and all. I cannot even manage to spring loose $200 to meet my deductible and get my medicine.

The rent, the utilities, the food, the gas for me to get to work, the insurance, the loan payments… my husband’s medications… all must be paid. And my lungs will keep hurting, and all the ground I gained over the past four years will be lost for the lack of $200.

Ask for help, you say. Borrow the money, you say. Get another job. I did but it isn’t helping enough just yet. I’m sure it will if I work a little harder. Stop whining. Buck up, buck up… this is America where if you want it bad enough you can do it.

But how do you admit that no one close to you wants to hear any more health-related trauma? They’d rather buy you dinner or almost anything else than hear you need help to buy Advair.

Grown children might send you a Mother’s Day card, but do not want to help with a prescription. And it isn’t cruelty, it’s denial. Denial that the problem with health care really is as bad as it is in America and denial that your mother is a failure at solving it.

Folks want to hear about the potential fame and notoriety of a film part. What they cannot stand to face is the reality of the situation for me and for many Americans. Thousands and thousands of people will go to bed without their meds tonight.

Being a part of a film with so much potential did not adjust reality for me – not this part of the reality. It’s going to take work and compassion and intelligence to do that over time. Whether a new president will actually tackle the issue is by no means a given, and no one has yet explained to me in a way I can comprehend why the current Congress, including so many of these presidential candidates, cannot and will not act on behalf of the Americans like me who are sinking fast.

But then a package arrived today. My SiCKO sister, more a sister than she can know, sends me the Advair samples she can no longer take. This woman, this friend, stood at ground zero on 9/11. She was made sick by it… very, very sick. Her lungs hurt as mine do, but Advair doesn’t relieve her pain. So she gave it to me.

We also lack the political and moral will to care for her – and thousands of her fellow 9/11 workers. We make them beg for benefits and fight at hearings planned months into the distance. They were our heroes held up to the world yet now they apparently are our albatrosses. Dead weight. It is incomprehensible to me that one of our elected officials does not simply stand up and honor these people by demanding they be cared for compassionately and completely. No explanation suffices for the system failing my SiCKO sister.

The health care system that brought about this chain of events is making many of us sicker than we need to be, and it is costing us so very much.

I will spend, with my SiCKO sister, the next however-long-it-takes fighting for change. The health care system in this nation must change. And it should start today, not with the next presidential election. No, Senators Obama and Clinton – and all of the rest of you — not by the end of your first terms. That’s not good enough.

But for now, I cradle my gift given with only love and complete understanding for what I am going through. Tonight I will inhale my Advair, and a few weeks from now I will breathe easier again.

Panexa: Ask your doctor

This is at least a year old, but if you haven't seen it, who cares?

It's at Panexa.

Study in contrasts

Dennis Kucinich, campaigning in New Hampshire, "was most passionate about his plan for universal health care, which would create a nonprofit single-payer system designed to keep the insurance companies from interfering with national policy, he said. The plan would put more control in the hands of doctors and help re-establish the doctor-patient relationship, he added."

Sen. Max Baucus (D-Mont) thinks that the U.S. health care system is on the "verge of collapse," and that it's "exciting and fun" to work on preventing that. Oh — and he doesn't consider single-payer a possibility. Baucus says he's pragmatic — that's probably why he brokered the the Bush tax cuts of 2001 and the Medicare prescription drug plan. Thanks Max.

Real research vs. PR

Paul, Missy and Curtis

The health stories on the local news tonight were a Belgian heart study on endurance athletes at risk for ventricular arrhythmia and a British study on dogs being a better choice for keeping people healthy. Maybe because you have to walk ‘em.

Notice that those two studies weren’t in the U.S.

Fearmongers against healthcare reform spreads the lie that the free market alone can bring health advances. Not true: governments, including our government, are the major research funders for basic science. Big Pharma’s part in new meds is mostly confined to copying their competitors’ top sellers. So we now have lots of “purple pill” options, lots of erectile dysfunction cures of the pharmaceutical variety.

This 2003 Health Affairs page says that pharmaceutical companies now spend more than government: $30 billion to $20 billion.

A problem with that number is that Pharma counts “opportunity cost” as part of their research total. That means they add in what their $10 million or $100 million for research could have made in a bull market and then add that to the total.
John Mack has a good explanation of how this works on the Pharma Marketing Blog:

Assuming it takes my son only 4 years to complete his undergraduate study at Penn State, I will have spent over $100,000 on tuition, room, board, books, wine-in-a-box, transportation, etc. …
But wait! I forgot my lost opportunity to invest that $100,000 in the next best thing (whatever that is). I could have made another $100,000 with a better investment. So, I will really be spending $200,000 on my investment in my son's degree. I'll have to factor that in on my next IRS return!
But wait! Suppose my son, God forbid!, quit college in his junior year and never earned his BS degree? Did I actually spend $200,000 on his failed attempt? I mean, could I go around to my friends and relatives and say, it was a $200,000 failure?

That’s what Pharma does.

By that bookkeeping, the government still spends more money on research: $40 billion to $30 billion in 2003.

And what does Pharma spend their $30 billion on?

Merrill Goozner in The $800 Million Pill writes that after reviewing the 127 new drugs approved between 1989 and 1993, Dr. David Kessler, head of the FDA from 1990 to 1997 said,

“only a minority offered a clear clinical advantage over existing therapies. Many of the others are considered me-too drugs because they are so similar to brand-name drugs already on the market...”
"In 2002, just seven of seventeen new drugs were rated a priority by the FDA, which indicated they represented a legitimate medical advance..."

Some of the new drugs are dangerous.

“The diabetes drug Rezulin gained fast-track approval status in 1997 even though an FDA examiner warned that it might cause heart and liver damage. A Pulitzer Prize winning series in the Los Angeles Times later revealed that Rezulin caused at least thirty-three deaths and was kept on the market by Warner-Lambert despite there being at least nine other drugs for the condition. (The Rezulin case highlighted on the of the enduring truths about me-too drugs: Users of the new molecule were exposed to greater safety risks than consumers using tried-and-true drugs already on the market. Every one of the thirteen drugs withdrawn from the market for safety reasons during the 1990s failed to meet a medical need that wasn’t already served by a number of drugs already on the market…”

Pharma is offering fewer real advances as they concentrate on profits, but governments continue to fund research on real science, vaccines and preventatives — even dogs — even though there’s no profit in it. Just public health.

Swiss researchers make do

Did anyone notice that part of the news about amniotic stem cells was from Switzerland?

"Swiss scientists Dorthe Schmidt and Simon Hoerstrup of University Hospital Zurich have used amniotic stem cells to grow heart valves. They are currently testing them in sheep."

How on earth did that happen? I thought that the crippling effects of European single-payer healthcare, especially all that bargaining with big pharmaceutical companies, precluded European advances in medicine.