In the New York Times today, a roundup of the latest rumblings in Congress and the medical profession over Robert Jarvik's role as spokesperson for Pfizer's Lipitor. I'm pleased to note that the Times has been hitting dehype posts for leads lately.
First of the year. Seems like a good time to consider what this site's about. Hype is not going away. The question: how to live a relatively sane, sensible life when you're surrounded by it. I think most of us succeed, actually. The early start to our Presidential season actually makes me feel pretty good. Politics don't seem to be nauseating me so much. I think we're a little more awake. Surely, the Republican machine doesn't seem so strident this year. That's smart of them. Even the most jaded of them seem to realize they can't do things the same way as before and expect to command the loyal. Likewise the Democrats. The presence of Obama seems to have changed the tone of their primary campaign. The media people are trying to whip up some fear and loathing, but I think the Clinton-Obama War story is a non-starter. I think they're lobbing macaroons at each other and the voters aren't paying attention to that stuff. I think both parties have learned something from the past six and a half years (Year One being 2001), and I hope the press and TV media do too, eventually. Me, I've slacked off in recent times on this site, though a lot of you come around looking for info on Cymbalta and Dr. Jarvik. Mostly, you're curious, and not much interested in my chronic outrage at drug advertising. It has helped ruin our health care system, but it isn't the only thing. We've put up with it. We share a major part of the blame. Even with all the hooha about all the issues and politics, only about half of us vote. No amount of hype has gotten the rest of us participating in cleaning up our various messes. How about checking your gut. If you spend one minute a year wondering how some of this stuff'll get fixed, shut up. Unless you at least know what's going on, and cast a vote. Thanks for dropping by.
Here's a link to ABC's Jarvik-Lipitor story, complete with video from Good Morning America, on which Robert Jarvik, Pfizer's sorta-doc spokesman for its anti-cholesterol drug, showed up and submitted to a gentle thrashing from Diane Sawyer last week. How many years has it taken for somebody in Congress, or anywhere, to get itchy enough with the idea of an apparent MD endorsing a particular drug on TV? Of course, the story behind the story is that Lipitor is slipping; has been since Zocor went generic, as the New York Times reported last November. See, the Zocor generic is much cheaper than Lipitor, which has its patent until 2010, and insurance companies and docs are switching patients to the cheaper drug, which is, by all accounts, just as effective. One little fact reintroduced in all this coverage: only the U.S. and New Zealand allow direct-to-consumer prescription drug advertising. We really need this debate, seriously conducted: is free enterprise always good for our health?
UPDATE 1949 hours 012208: Required reading: a nytimes.com health blog fills us in on the recent Zetia flap. Link.
The House Energy and Commerce Committee has ordered Pfizer to cough up all data on how much they've paid Robert Jarvik, star of their Lipitor campaign for, oh, years, now. Could we finally be heading for a little self-examination here? Our commercial culture has stood there and let pharmaceutical companies sell prescription drugs like sneakers and beer for, what, twenty years? Go see the House's letter to Pfizer at Slate.com.
This is the link of the day, if you're on the fence about the effects of pharmaceutical marketing. Go visit the New York Times Magazine.
Not exactly news. But it gets a link from me. The Seattle Times, Thanksgiving Day.
If you're an insomniac you can go to your doctor and demand a TV pill, or demand sleep counseling. Research shows that, eureka! Simple changes in behavior can put you to sleep better than pills. Read all about it here. And turn off the TV.
Yes, they're still hurting, those high pressure TV campaigns for exotic prescription drugs. It's good that so many of you drop in on this site and others to check out the claims. And now we've got company from that most respected non-commercial consumer watchdog, Consumer Reports. On their newly redesigned Website, CR is featuring an analysis of Requip commercials. That's the Glaxo drug promoted for the relief of Restless Legs Syndrome, which I've written about before -- see the Dehype Hall of Fame links in the right column. You should watch the Consumer Reports video analysis and read their report on this drug. Learn how GlaxoSmithKline repurposed a Parkinson's Disease drug for a bigger market -- people who have...or think they have...Restless Legs. Here's the link.
On July 19 I published a post about the new GlaxoSmithKline over-the-counter drug alli (they're pronouncing it like "ally," and modestly presenting it without an initial capital letter), which is promoted as the first non-prescription weight loss medication approved by the FDA. I think the theme of my post bears repeating for emphasis. Hype? This is what I'm talkin' about.
Alli's main effect is to prevent your body from absorbing and retaining some of the fat you eat. It, in effect, flushes some fat through your body. As you can figure out for yourself, this produces some unpleasant and potentially uncontrollable experiences. Pretend you're a marketing-advertising professional. How do you sell something that does that?
Well, I'll tell you. The brilliant marketers of Glaxo and other pharmas are the best in the business. They have to be; they daily zig and zag through the minefield of semantic hazards and actually make you want to buy their clients' products.
With Alli (I'm not going along with the no-cap style), the immediate user experience is going to be nasty. So, the marketers had to turn this "side effects" problem into a plus. Well, if not a plus, how about just presenting it as a feature? Thus, "treatment effects" was born. Believe me, this is a breakthrough in the long and storied history of weasel words. But it's not the first, so it can't be thought of as a virgin birth.
When the marketers of Lilly-Icos' erectile drug Cialis decided to include the potentially disastrous side effect, priapism, in the side effects disclosure portions of their ads, I doubt it was because they were deeply concerned about the long-term health of their customers. I think they wanted to use the phrase "erections lasting more than four hours" in ads for a drug many men see as a sexual enhancement aid. No one at the FDA could effectively question their motives. That's what weasel words are all about, folks. (George Carlin noticed the paradox.)
Now, with the Alli campaign, Glaxo's selling diarrhea as a cure for obesity, and because the commercials are dead straight about the effects and offer...no, virtually demand that the user enter the drug's "program," they're expecting us to love the ordeal.
Of course, you don't have to follow the Alli program -- this is an over-the-counter drug, so you don't have to get the authorization and advice of a doctor to buy it. How many Alli users will consult their doctors about it? How many will join and rigorously follow the drug company's laudable instructions for its use?
What we have here is a drug marketing campaign--for a product that significantly distorts normal physical processes--that bypasses medical supervision. How tough was it to get this drug and its marketing past the FDA? Stay tuned.
Have you seen the ads for Alli? They tout it as the only FDA-approved, over-the-counter diet pill -- that is, you don't need a prescription.
With the rollout of this new product, we see a whole new way of talking about side effects -- those pesky problems that may crop up in the course of using a medicine. In the Alli materials, "side effects," which carries a rather negative connotation, is replaced after one use of the words by "treatment effects." There, isn't that much nicer?
The FDA, which may stand for Friendly Drug Approvals, is well accustomed to approving drugs that cause varying levels of trouble for patients. In this case, since Alli works by inhibiting your body's ability to digest fat, the problem can be, oh, just...frequent, oily, difficult to control bowel movements. You can go read the other unpleasant details for yourself here.
For the promised upside -- 50% more weight lost than a low fat diet alone -- and, excuse the expression, the downside, of Alli, you can click right over to drugstore.com and pick up a month's supply (90 caps) for only $59.99.
In fairness, for the desperate and untherapied overweight person, this drug, with its sensible diet advice, is at least a miracle pill that apparently works, as certified by our government, and so may be worth the discomfort.
I can't help wondering how many people will be inspired to eat more healthily by Alli's marketing. And then there's the gnawing suspicion that this is the FDA as retooled and defanged by the Bush years. What have they protected us from lately? Caveat dieter.
Links: Glaxo, the manufacturer; FDA's Alli label information; drugstore.com's price page
It's a classic marketing challenge. You've got a good product, but it's just like all the others. You weren't the first into the market, so you don't have brand name recognition. What do you do?
There are lots of prescription drugs for depression. It's one of the miracles of pharmacology. First, there was Prozac. But, of course, there couldn't be just one drug -- all the drug companies had to have one, to get a piece of the depression market. Wyeth wasn't the first on the market. And Lilly, the Prozac company, beat them to the "new-improved" space with Cymbalta, touted to be the first drug that replaces norepinephrine, as well as serotonin. So, now, what does Wyeth do to elbow into this mature market with their me-too Cymbalta-type drug, Effexor XR?
Well, they found a way. See, a particular drug doesn't always work for every patient. Doctors often have to try several with a patient before something clicks. So, Wyeth has just rolled out a TV-Internet campaign, suggesting that if you're taking an antidepressant and still have depression symptoms, it may be "Your time for a change." The TV spots mention no drug. The pitch is to talk to your doctor, and/or go see YourTimeForChange.com. The site doesn't mention a drug name either, just gives you information, offers you a checklist of symptoms, and talking points to use with your doctor. Subtle, no? Wyeth's name is on the TV spots and the site. Nothing illegal here. Oh, they do have another site, or at least a domain name, TheChangeYouDeserve.com, in a Google search ad, which takes you to the Effexor XR site.
You might call this the Ricochet School of Marketing -- finding work-arounds for a heavily regulated advertising marketplace. Wyeth is spending millions to, like, drop a few hints. As a public service? No, folks. Something tells me a depressed person already under a doctor's care would know to go back if she's not feeling better. Remembering that most meds take six or more weeks to kick in, right? And, of course, don't docs who prescribe powerful medicines know to tell you all these things? Ignore drug ads, folks. Things have gotten all out of balance. Focus on getting the most attention from your doctor.
The FDA is looking into Eli Lilly's promotion of Zyprexa for other conditions besides those for which it's approved: schizophrenia and bipolar disorder. Read about it here in the NYT, and notice especially the words of the Lilly sales executive. It's good, I guess, that FDA looks into problems like this. But who's looking into the physicians who actually prescribed the drug "off-label" after a Lilly rep's pitch? Who regulates fools who rely on drug reps to tell them how to treat their patients?
So I'm sitting on the couch watching Nick Cage in The Family Man, one of those holiday movies. You know, the kind Hollywood's been cranking out for decades. Hard-nosed-and-hearted businessman's life upended by some supernatural force--like, instantly plunged into an alternative reality, in which he must confront the road he didn't take, or did, and potential consequences of same. Comes to his senses, becomes loving human being, etc., etc. Right, science-fiction fantasy. No connection to 21st Century American reality. We love these stories. Loved 'em since Scrooge. Hello. Look around. How did this movie succeed? Isn't this the country where Congress passed a law that made it illegal for the Federal Government to negotiate lower prescription drug prices? Where the biggest retail chain encourages its workers to apply for public assistance? Where everything...everything...is marketing. O.K., we just shifted the Congressional balance of power a few bodies a week or so ago. Don't get comfortable. This is no movie.
It's called the Lunesta 7-Night Challenge. You can get a coupon, on the Web or in magazines, for seven free Lunesta tablets. It's one of the new breed of prescription anti-insomnia drugs. Anybody besides me feel creepy about this? Any physician out there been insulted by a patient handing you a coupon and asking if Lunesta's "right for him." Is it necessary to point out that this turns the practice of medicine on its head? Why is freebie marketing O.K. in the prescription pharmaceutical business? Ask your new Congressman or Senator if shutting this self-diagnosing-self-prescribing promotion game down is right for America.
One of the features of the Lunesta site is a cute animated "fact or fiction" quiz about insomnia causes, remedies and treatments, which confirms that warm milk often works. But, the quiz hastens to add, it isn't a cure, suggesting by pointing this out, without claiming it, that Lunesta could be one. High-quality weasel words. Well, Lunesta, and the rest of the new drugs, aren't cures for insomnia, either, according to the American Insomnia Association.
I heard that. I heard the voice on a Lipitor TV commercial say it: "...Dr. Robert Jarvik, inventor of the Jarvik Artificial Heart..." Those spots used to call Jarvik the "inventor of the artificial heart." Which many believe is not true, as my readers and I have reported before. I looked at the Lipitor site. They haven't changed the claim there. I'll be watching. You, too?
Every day, I learn something that makes me feel like a chump. Here I am, posting often about the evils of prescription drug marketing. Did I really think there aren't any prescription drugs that haven't been approved by the F.D.A.? This Bloomberg story, about some of the companies in the US that manufacture and market drugs without ever approaching the F.D.A., took my breath away. Some of these guys even buy listings in the PDR for their unapproved drugs. And send reps to call on docs. And, you know what, docs prescribe them. And insurance companies pay for them. You can write your own rant. I'm too tired.
As I predicted, the doctors are rising up against the FDA and the Pharmas. Two new studies and articles in prestigious medical journals, as reported here, have called for new legislation to fix the FDA's fractured system -- this key health agency is not protecting our health from unproven prescription medicines, folks. And, as you may recall reading on this blog, the AMA has already declared a kind of muted war on drug marketing and advertising. Write your representative. Better yet, elect a new one. Much of Congress depends on the drug companies' deep pockets for their campaigns, and the Bush administration consistently appoints administrative saboteurs to the bureaucracies, including the FDA. Look it up.
TV News might get all steamy and call this a "medical breakthrough." Even though the research trial was conducted with only eighteen (18) severely, chronically depressed patients, including those who got the placebo.
Dr. Zarate said experimenting with novel approaches was crucial because the current crop of antidepressant drugs worked slowly and weakly, if at all, for millions of patients.
Is this true? Some studies upon which Dr. Zarate may be basing his brag, like this one, say things like this:
Although efficacy studies suggest equal potency among antidepressant treatments, their effectiveness in clinical practice appears more variable, particularly in that the newer antidepressants may be less effective in either more severe depression or the melancholic subtype of depression.
Again, they're talking about severe depression. but this study is getting publicity from the likes of ABC-TV, Fox News, and Forbes -- the latter for alert stock analysts, no doubt, who will not necessarily become severely depressed as a result of getting this news.
"Slowly and weakly" means that Prozac, Zoloft, Cymbalta and others take four to six weeks of daily doses, gradually ramped up over time for safety, to achieve effective levels of the drug in your blood in order to relieve depression.
[Full disclosure: About ten years ago, Zoloft relieved my own fairly mild depression after about six weeks, after I attended a depression screening event at a hospital auditorium, and my doc prescribed it without bothering to run blood tests on me--"I can either run tests or start treating you". Several years later a new doc had a hunch, ran tests and discovered my thyroid was underperforming, which probably triggered my depression. It was a time of intense marketing among competing drug companies, and the docs were cooperating, as they're wont to do--it's the way the system works. I'm happy I was helped. But it was expensive, and I've come to distrust the pharma-medical industrial complex. Zoloft cost me and my insurers a lot of money, when Synthroid (thyroid replacement), which costs pennies a pill, could have done the job. A blood test could have saved us thousands.]
Most interestingly, ketamine is a common enough brain drug to have made it to the street--it's known to be a popular "club drug." Chemical athletes love the side effects. Great, now the NIMH is injecting science into the mix. How much do you suppose the street price of this party popper will now jump?
Am I biased--over the top? I don't think so. Will you be asking your doctor if ketamine is right for you? How do you suppose we're going to get the pharma genie back in the phial, when FDA and NIMH are part of the marketing formula?
The reason I started this blog was to try to keep advertising and marketing hype from misleading or confusing you.
If you could see the searches some people type into Google and other engines, you'd know there's a need for this.
In the interest in clearing up some of the bewilderment caused by direct-to-consumer drug advertising on television, here's a quick list of currently advertised prescription drugs, and the conditions they're marketed to treat:
1. Cymbalta -- advertised to treat depression, NOT Restless Legs Syndrome or prostate problems.
2. Requip -- advertised for Restless Legs Syndrome, NOT depression or prostate problems.Presumably, the confusion created by advertising prescription drugs can be cleared up when you ask your doctor if the drug is right for you. So far as I know, physicians don't rely on television commercials to educate themselves on drugs or make diagnostic decisions.
3. Avodart -- marketed as a remedy for complications of an enlarged prostate, NOT depression or Restless Legs Syndrome.
The U.S. Food and Drug Administration has approved the use of "pearlescent pigments" to gussy up your prescription pills and potions. The Washington Post reports:
The pigments can produce sparkly metallic, satiny and shimmery finishes, as well as different hues of red and gold, depending partly on the color of the underlying drug.Would I kid you?
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