Monday, August 20, 2018

All I need is a miracle

Aimovig is the first FDA-approved drug specifically developed to prevent migraines.

It’s getting a lot of press. Some articles talk about it as a breakthrough, some on how it shows the pharmaceutical industry is now focusing on migraine as a real disease, some on how it represents a new era in diseases that affect predominantly women, and many other spins.

Of course, it isn’t alone. There are 2-3 similar agents on the launch pads to join it in the next year.

From my daily office view, the phone calls (and drug reps) come in, and inevitably I hear it referred to as “the miracle drug.”

“I want to try the miracle drug.”

“I saw an ad for that miracle drug.”

“Someone at work told me about this miracle drug.”

Amgen, to their credit (not that the FDA would allow it, anyway), has NOT claimed it’s a miracle drug. The information they provide doctors is the usual glossy graphics surrounding dry statistics and obligatory legal wording. (Note - neither Amgen, nor their competitors, or anyone else, has paid me to write this post. These are my own thoughts).

People seem to need to think a drug is a miracle, in spite of all evidence to the contrary. This isn’t a slight against Aimovig - it’s human nature. Just as people thought of the Titanic as unsinkable (a claim never in reality made by her builders, owners, or officers) there’s a desire to believe human intelligence has somehow overcome a problem and cured it.

It’s not like Aimovig is the first drug to get that label, either. Botox is a miracle drug. So was Imitrex in 1992. Interleukin-2 in the 1980’s. Penicillin in the 1940’s. Willow bark in 500 B.C. (that's where Aspirin came from, people). And too many others to list.

Are these bad drugs? Far from it. But, like every other drug ever discovered, they have a lot of limitations. They work for some conditions, but not others. They ALL have side effects (if someone tries to tell you a drug or supplement doesn’t have any side effects, they’re lying). And, most importantly, humans are not a biologically identical group. No medication will work for everyone. If you read the stats on any med you’ll see that approval is based on a percentage of people who respond to it - and it’s never 100%.

There is absolutely no way to predict with 100% certainty who will - or won’t - respond to any given drug. For that matter, there’s no way to know who will - or -won’t - have side effects, or even which ones.

This is a trial-and-error crapshoot, people. We make decisions based on facts, but an educated guess is still just that - a guess.

There is no such thing as a “miracle drug. " And there never will be.

You won’t hear me, or hopefully any other reputable physician, ever tell you that a drug or surgery or whatever is guaranteed to cure you, or has no chance of harming you. Medicine is about as imperfect a science as there is.

If someone is making such a claim to you, run away. They just want your money, and don’t care about helping you.

I’m not knocking Aimovig. For some people it will be life changing. For others it won’t do a damn thing. Still others will have an unpleasant side-effect. The jury on it and its cousins is still out, and will be for at least 2-3 more years.

But don’t go into any treatment plan, for anything, thinking it’s going to be a miracle. There’s nothing wrong with being hopeful, but you can still do that and keep reality in mind. Because in this field, there are no guarantees.


Anonymous said...

I suspect, it will be like most drugs for me and my migraines. it will work for a while and it will either stop working or I'll get some crazy side effect and have to stop taking it. There are no such things as miracle drug.


Amanda said...

Fantastically put. Not migraine-related, but for me, Lexapro (okay, the generic equivalent, but I can never remember its name) is a miracle drug. That doesn't mean I'm not aggravated to the ends of the earth at time by the insomnia it also gives me, but for the remainder of the effects, I'll take it.

Others' mileage varies. I even have read of people for whom the generic version doesn't work as well as the name-brand, but that hasn't been my experience.

Miracles are in the eye of the beholder/ end-user/ patient, etc.

Mad Jack said...

Thanks Grump. A good friend of mine has cancer and will try a new or different form of therapy in November - because it's inoperable and nothing else is working. She's a realist and hopes it will work, but knows it probably won't. The thing is that advertisements featuring New Discovery! and Miracle Drug! cause a false sense of hope and confidence. I, personally, think they should be illegal.

Anonymous said...

Good advice Doc. I hope this new drug does offer relief for a percentage of migraine sufferers though.

Bonnie said...

When I used to get migraines (don't anymore - blessed menopause!), I called the drug I was given for them a miracle. It cut down the pain considerably & the length of the migraine from 3 days to 1. The only drawback was it made me sleep for most of the day. I figured it was a decent trade-off - 1 day of sleeping vs. 3 days of pain.

I wish I had been given the drug many years before, but previous doctors (all male) dismissed my symptoms as not being "classic" migraine, so they let me suffer. A new doctor, when I described my symptoms to her, said, "We have a pill for that." I stuck to her like glue until she left the practice.

I have a feeling Dr. Grumpy is one of the rare male doctors who actually listens to his female patients.

Linda Myers said...

I think Zoloft is a miracle drug but Prozac and Paxil aren't. Thanks for this excellent post.

McDuckGA said...

People in general have totally unrealistic ideas about medications, their benefits and side effects. Trust me, we have the same problem on the veterinary end of things.

As an aside, I won $20 at bar trivia thanks to the Miracle Mets. The host read off the starting lineup for the '69 Mets, and I was the only one in the place (I'm in GA) who knew who they were. An advantage of growing up in the '60s in North Jersey.

tbd88 said...

I had a psychiatrist who gave me an excellent "there are no miracle drugs" lecture many years ago. In the same lecture he also said "if any doctor give you medication and tells you with 100% certainty that it will work, they're lying to you or just plain wrong." I have been through about sixteen different psychotropic drugs since 1991, and the last time I had to adjust was over ten years ago because I started taking lower doses of two antidepressants at once and it's prevented my annual fall-off. I'll never be "normal" but this helps me get closer.

Moose said...

About ten years ago, when I was dirt poor, I used to get my health care from a free clinic. If you went to the twice-weekly clinic, you never knew what kind of doctor you'd see. They were all volunteers, friendly folks who understood that when you're poor, you can't always be choosy about how you live.

Of those that stuck in my head, I saw a psychiatrist (who was retired from regular practice, but kept his license current), a variety of internists, a urologist, and a neurologist.

While going through my medication list the neurologist asked why I was taking two blood pressure medicines. I told him that one, lisinopril, was for mildly elevated blood pressure, and the other, verapamil, was started long before I had blood pressure issues, as migraine prevention.

He told me that, from his perspective, people with migraines fell into four categories: About a fourth got prevention from beta blockers. Another fourth got prevention from calcium channel blockers (like verapamil). The third group were helped by ACE inhibitors (like lisinopril). And the final fourth were boned and could only take reactive drugs like Imitrix.

Although I found that fascinating, I admit that I never looked into whether there was science behind this or just perception bias. (Doctors, as you probably know, are prone to "In My Practice I See" bias. Somewhere I have a link to an article by a doctor saying that those words drive him bonkers!)

[/end blather]

John Woolman said...

“There is no therapeutic rose without its thorns” , Sir John Gaddum (1900 - 1965).

Anonymous said...

looking at the data for aimovig, while statistically significant, it isn't all that miraculous. their 6 month study, depending on dose, showed a decrease of 3.2 to 3.7 days of migraine days per month (in months 4 to 6 after starting therapy) compared to a change of 1.8 days with placebo in people who had 8 migraine days per month. at the end of their 3 month study on people who also averaged 8 migraines days per month, the change in headache days was 2.9 vs 1.8 with placebo. better than nothing and probably worth a shot based on the safety profile but people are certainly still having headaches. i wonder what long term data will look like.

Brian said...

As someone who gets multiple cluster headaches (migraines) a month I have never found a miracle preventer and thus wouldn't bet on any such thing (as the triggers can be so very varied) in the future.

What I consider my "miracle" drug is what I take when I am getting one Sumavel DosePro (which was suddenly yanked off the market). I'm going to have to live with self injecting sumatripitan I guess.

Packer said...

Dudes and dudettes get on board there is but one miracle is weed. Or so I am told 50 times per day in my little autoimmune affinity group . In my state they have designated prescribers and I knew the local MD , who was a person with pretty advanced case of not knowing where she was at any given moment, so I decided against.

Tam said...

In Australia the Government have just started subsidising Fycompa for epilepsy and are touting it as a miracle drug that will help hundreds of epilepsy sufferrs. My husband was on it for about 6 months last year and the only miracle was that we survived. It did nothing to stop his seizures, but it turned my sweet, loving husband into a monster. We also constantly get told to stop all other drugs and just yse CBD oil (by non-medical staff of course) There is no miracle drug. There is no magic wand. CBD oil, Fycompa, botox or anything else may or may not work. Great for you if it does, but don't be offended and take it as a personal slight when it doesn't work for us!

Anonymous said...

I have to admit it, Dr G. To begin with, I thought you were making up the bit about a drug named aimovig. How do you even pronounce the word?

Anonymous said...

Let me hope for a miracle! I've just been prescribed Aimovig, am waiting to get my first dose, and am clinging hard to my bottle of Imitrex in the meantime. I've failed four different meds plus Botox injections and still have daily migraines.... Okay, if not a miracle, at least some effect?

Anonymous said...

This should be required reading for medical students. In medical school we are taught the molecular structure of a medication, the mechanism of action, what receptors it works on and other basic science minutiae, but they never actually discuss the clinical trials that got the medication approved. COmmonly, the benefits are in secondary endpoints that barely meet statistical significance. But they have made the connection that drug A is good for condition B. then when you go out in practice and start prescribing drug A you wonder why it doesn't seem to work.

Ms. Donna said...

Well, the stroke fixed the migraines. But I do recall the pain was terrible and I could not be my best self with one. I WANTED to hide in a dark room and close my eyes, plug my ears, pinch my nose, etc., but life had other plans.
Sooooo -- doctor and I tried this, that and something else. A combination of things caged (not tamed) the beast, and that was the best to be done.
Of course, I had to move, and the doctor saw the "cocktail" Doc 1 had me on and had a cow. So back to one drug, with all the symptoms.
So, if these drugs even help 10 per cent of migraine sufferers, great. I hope all docs know to try them.
Hope and being taken seriously is important.

Anonymous said...

I think it was Sir William Osler who said (paraphrased) You should use a new drug before it has time to develop side effects or Lose it’s efficacy.

Rita said...

I would just be happy if doctors would pay as close attention as they should to the drugs they prescribe. In my almost 70 years I have had a doctor tell be that my ear pain was due to congenital absence of ear wax about two months after he had washed out excess wax, which even if he didn't remember me would have been in my chart; another doctor told me that severe headaches were not a side effect of my asthma medication although they were clearly listed on the insert sheet (admittedly they were not a common side effect, but they were listed); another doctor started to prescribe a sulfa drug for a bladder infection despite the fact that I was holding my newborn in my lap, which should have been a clue to ask whether I was breastfeeding. And no one seems able to explain why a doctor would prescribe a statin that increases the risk of diabetes to someone who already has diabetes--isn't this sort of oil on the flames?

Done venting. I love your column and do respect good, thoughtful physicians and realize that current conditions mean that many front line doctors are rushed and overbooked.

Migraineur said...

Pronunciation: am-o-vig (vig rhymes with pig)

Biggest reported side effect, constipation.

Does it help me? Jury's still out, but trying to talk to the mail order pharmacy about the delivery I was supposed to get is giving me a migraine, so....

Anonymous said...

Taltz (ixekizumab) absolutely was a miracle drug for my psoriasis. I went from having ~90% BSA coverage to basically complete remission in under a year. It absolutely stomps Humira and Enbrel, in both the studies and in my own body; at the cost of producing a (not statstically significant) higher (~1%) risk of infection.

That said, nothing is ever guaranteed when it comes to pharmaceuticals, and any physician that makes such a claim should lose their damn license.

Anonymous said...

Wasn't this the side plot in The Fugitive? Better make sure no samples were switched...

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