"Claritin and Schering-Plough: A Prescription for Profit http://bit.ly/Im6lLG 2001 article that should be read by all."
Back in the dawn of time [early seventies], I was an Internist on an Air Force Base in rural England – a posh assignment considering the alternatives. England has an allergy season from hell and my wife was then its major target. So at work, I spent my days with asthma and hay fever, and I came home to the same affliction. I had all the pills [I’ve forgotten their names]. We called them by color – the red ones, the green ones, the blue and white capsule, etc. I tried all the tricks [kind of like the KOLs with the antidepressants]. I sequenced them, combined them, augmented them with anti-inflammatory drugs, etc. I don’t know that any of that made much difference. We ended up believing that rotating them was the secret, but I don’t even know if it really mattered or was just a myth-to-keep-us-busy.
After we came back to the States, my wife got desensitized, and was one of the only total cures I’ve ever seen from allergy shots – a miracle cure by any measure. But cruel fate intervened and as the years passed, I gradually became the poster child for seasonal allergies, having been spared until my 40s. And I went through the same drill as before. Rotating did nothing for me. By then, the non-sedating antihistamines were around, and so I settled into taking too much Claritan, which worked pretty well for the three or four weeks of my discontent each Spring. I changed to Allegra for unrecalled reasons, and was delighted when it became OTC. I still take it. Periodically, I try the old sequencing, combining, augmenting, rotating methods, always ending up with the myth-to-keep-us-busy conclusion.
Last Spring, I was on a trip during the season, and my Allegra [now fexo-fenadine] got lost in the shuffle. A fellow sufferer produced Claritan. It was fine [too much Claritan, I might add]. That has happened before and the ancient Chlor-Trimeton [too much Chlor-Trimeton] is a fine substitute too. If this topic comes up at a party, we allergy types light up and the various personal regimens begin to flow – doctors and non-medical people alike. I think of it as antecdotal magic, but I admit that I join in with gusto – and I even talk aloud to the direct-to-consumer ads about allergy medicines that show up on television, arguing with the beautiful people that skip merrily through fields of flowers and camp in the forests. When they get to the inevitable, "Ask your doctor if … is right for you," I sometimes become postal. I’ll spare you the rants.
There’s only so much that a symptomatic medicine can do by blocking histamine release, and we want so much more. Yearly, we go through the ritual of asking more from the medicine than it’s capable of giving us. My head is filled with myths and anecdotal magic, but in the end, I really think that just about any of the mainstream antihistamines will do, and the cure for my April miseries is the coming of May. I think the same thing about the antidepressants. They are symptomatically helpful to some people if they don’t ask for too much. Too much antidepressant is no solution. There are side effects and dangers that need careful attention: akathisia, libidinal problems, suicidality, flatness, withdrawal, etc. – much more than with antihistamines. Our tainted KOLs spent years obsessing on the anecdotal magic side of the equation, and not giving patients or even fellow physicians the necessary information about the side effects and dangers [information they knew].
” and I even talk aloud to the direct-to-consumer ads about allergy medicines that show up on television, arguing with the beautiful people that skip merrily through fields of flowers and camp in the forests. When they get to the inevitable, “Ask your doctor if … is right for you,” I sometimes become postal. I’ll spare you the rants.”
i’ve noticed that pharma loves to market their drugs like they’re some type of “short” film. always it starts off with some average looking individual in a “normal” world. this individual takes the medication and voila, boundless fields of green grass and sunshine.
… with brighter colors, big smiles, and joy in their hearts!
That was a great read. I get a vicarious feeling of linearity reading investigative reports; but I could have gladly lived the rest of my life without knowing about the mouse-paw edema test.
Just last night, my partner in life and I were talking about allergies. He never thought of himself as being allergic, but his sinuses have been taking over sometimes and making him miserable— lately and at this time of year in the past. So we’re thinking he might have allergies. He has normal symptoms like sneezing and coughing and mostly phlegm related symptoms like sinus headaches and just a whole lotta phlegm. I’ll recommend that he don’t take Claritin.
I cough some at night, but mostly feel spaced out like I’m having some kind of sensory deprivation, my eyes feel like fuzzy ping pong balls; my ears get stopped up with wax, but feel like they’re filled with water, and my mind feels scatterbrained.
In 1999 I tried fexofenadine— the first antihistamine I ever tried that didn’t give me a feeling of impending doom. It cleared up all those symptoms and was great. Unfortunately, it had side effects that made it sadly not worth taking, but those aren’t a problem anymore and I want it now. Somehow I ended up with loratadine the last time I asked for an antihistamine. I;m pretty sure it was my error, but I want it rectified last week. I had been thinking that Claritin wasn’t working, and last night, during our conversation, I told myself for about the sixth time to find out what Claritin is. Then forgot. Again. Seeing this article reminded me— I looked it up, it’s not fexofenadine. I’ve gotten MS and have been put on quite a few drugs that affect cognition since I tried it, so I wasn’t sure if the drug was not working, though I was looking at Claritin commercials like they were the only reason it was popular. My suspicion appears to have been confirmed before I was conscious of it.
“The Schering representatives gave as good as they got. One suggested that Straus was guilty of statistical mischief; he had selectively looked at variables, subsets and time points, “and this is, as I am sure everybody in this audience knows, the perfect method of proving any claim one wants.” Dr. William Darrow, a senior vice president at Schering, acknowledged that Straus’s concerns were legitimate, “but for us the question is whether we have demonstrated consistently superiority and adequate efficacy over placebo by the 10-milligram dose. And we stand on our data there.”
Sneaky, sneaky— but not really. It often strikes me as bizarre that judges, for instance, can’t interrupt when appropriate to inform a jury that the last question or statement made by a lawyer sets up a logical fallacy that cannot honestly be answered with a “yes” or a “no” or whatever the lawyer demanded in return. Who stands up for logic and reason when it’s being legally abused ? There really should be a person other than the opposing lawyer to keep reality from being buried under semantics.
“The Claritin patent has been extended several times already, each extension reflecting laws passed by Congress in the last two decades that have modernized the F.D.A. review process and significantly extended the effective life of drug patents. The extensions began with the Drug Price Competition and Patent Term Restoration Act of 1984, known informally as the Hatch-Waxman Act.”
That’s good information for a citizen to have.
“There was an attempt, for instance, in the summer of 2000 to slip language at the last minute into a military-appropriations bill.”
mein gott
It’s marketing all the way down.
Parasites.
“If I had to pay $103 out of my own pocket, would I buy this medicine? Was it worth it?”
I don’t think it’s worth it, because it doesn’t work. I don’t want anyone to pay for it if it’s not working. It’s money that would have served anyone else better. If fexofenadine works like it did before, it will be worth it; at least when tree pollen, ragweed, or cottonwood fluff fills the air. I was getting sleepy from the Claritin, by the way, which was a selling point, at the time. Now I appear to be falling asleep quicker and sleeping longer before waking up, now that I’ve stopped taking trazodone, which I took to help me sleep. Rebound effect? Who knows. I took my last dose of it Friday, I’ll know in a couple of weeks. Or at least, think I know.
“… I found myself wishing that we had reviewers who would talk bluntly about new drugs, who could discuss efficacy, safety and value from the consumer’s point of view, who could deconstruct the advertising, who would include cost as a criterion.”
Yep.
What a coincidence, I was thinking about Teva about halfway through the article, and the devil appeared. It was named in that article as one of the companies that wants to make generic loratadine. They also make the MS drug Copaxone. In January of 2011, my neurologist’s team handed me a company product that looked like a marketing aid that might be handed out at conventions. I was supposed to consider it and call the company myself if I wanted to try it. The V.A. paid which is the only way I would have gotten it, because it costs more than I’ve ever made in a single year.
So, when the promotional material bragged and everywhere on-line where the promotional material was presented as educational material it bragged that the drug has been tested for 13 years and is proven safe. So, I called. They sent out a nurse who brought me a complementary auto-inject and trained me to use it. Then they sent me the meds (via the V.A.), a daily planner, an 8 x 11 refrigerator magnet with outlines of the human body front and back divided up into injection sites and a marker to write the day of each shot for each area in the rotation. (I’m not so cognitively degraded that I need such a visual aid, even when my brain-fog and fatigue is at eleventy.)
My welcome kit also included self-inspiring refrigerator magnets with the company logo and one that said, “I take Copaxone because ______(fill in the blank),” I have a serious distaste for this kind of psychobabble self-programming thing, but I like fridge magnets. The last time they called me, when the nurse asked me what else they could do for me, I said to send a refrigerator magnet. She did. At their prices, they can afford to. The company called at 1 month, 6 months, and 1 year, then finally quit calling. I’m happy to provide information for epidemiological purposes, but I would have felt better about it if Copaxone weren’t still under patent. They had had that patent for 13 years when I started on it. How much information did they need for scientific purposes? I’m guessing that those were mostly marketing calls. It’s hard for them to keep customers who have to pay for it.
Last summer, my neurologist let me know that’s it working, so I don’t have to try Interferon. Hurrah. It takes a year to start working if it does, then takes another year for a neurologist to be able to tell it’s working. Imagine, facing that with no insurance.
So, is Copaxone still under patent? I just looked. The patent is supposed to end this year, but Teva is lobbying the Supreme Court, Roberts in particular, to extend the patent for them.
http://www.fiercepharma.com/story/teva-entreats-scotus-block-copaxone-generics-till-patent-case-wraps/2014-04-08
“… with its most important revenues in jeopardy–Teva reaps $8.8 million a day from the multiple sclerosis blockbuster, easily its leading seller–the company is covering all its bases. That involves plugging away at its goal of switching as many Copaxone patients as possible over to a new, long-lasting formula approved in January, with an eventual conversion target of 30% to 50%.”
If he brings it up, I’ll tell my neurologist NO. I’m not a doctor, and I don’t play one on television, but I am part of my care team. What good is a “long-lasting” formula for a drug that takes a year to go into effect? It’s also a drug you can not take in a pinch with no worries because it won’t have a signficant effect if you don’t take it for a few weeks. It also hasn’t been tested for 13 years.
Rat basturds.
I remember reading the NYT article when it was published (the NYT Sunday magazine being one of my favorite medical journals). I had it sitting on my night table for years. This was before the internet so I copied it and tried to get it to as many people who would take it. It was one of the early pieces that confirmed what I had observed directly previous decade. These drugs were being oversold! It was followed by books by Angel, Peterson, Bass.
I really don’t get why a drug company has to beat a placebo to get approval. I mean what other industry gets away with that?
Imagine the military testing a new form of tank armor with that mentality. Armored Company A and B will be testing Quaxo Slick Whine’s new Tank Armor TghStff145. One of the armored companies will operate tanks covered with TghStff145. The other will operate tanks covered with placebo (cardboard made to look like TghStff145). Soldiers and their commanding officers will not be told which group they are in to maintain a double-blind. Both armored companies will be deployed into hostile territory where they will be exposed to IED attacks several times per week. Casualty rates will be used to determine the effectiveness of the new armor.
Of course, assuming it is anything more dense than cardboard, TghStff145 will come out as more protective than cardboard. So then Quaxo Slick Whine’s representatives lobby congress to appropriate a massive refitting of the armored divisions in the US military to use TghStff145.
This would be madness. But it is accepted practice in marketing drugs.