Thursday, July 12, 2007

Vyvanse Watch

Vyvanse (lisdexamfetamine dimesylate) was approved by the FDA in February for the treatment of ADHD in children, and is finally available in pharmacies. Tonight, Shire is presenting its official introduction of Vyvanse to physicians in a live webcast called "ADHD Thursday Night Live."

I don't know a huge amount about Vyvanse yet. I do know that Vyvanse is the molecule dextroamphetamine (trade names Dexedrine and Dextrostat) attached to the amino acid lysine. Shire cleverly calls it "lisdexamfetamine," presumably on the theory that using an "f" instead of "ph" in the chemical name will make it less obvious that Vyvanse is simply a fancified version of good old Dexedrine, a mainstay of ADHD treatment of decades.

At any rate, Vyvanse is an inactive
“pro-drug” which has no pharmacologic effect until after it is absorbed through the GI tract into the bloodstream, when liver and gut enzymes cleave off the lysine portion and produce the active drug d-amphetamine. The requirement that lysine be lopped off delays the peak concentration of d-amphetamine, but not by very much. To give you a sense of the scale that we are talking about, Dexedrine, which is pure dexamfetamine (I'm using Shire's Newspell here) reaches its peak concentration at 3 hours after administration (see Dexedrine prescribing information, accessed at http://www.fda.gov/cder/foi/label/2006/ 017078s040lbl.pdf). Vyvanse reaches its peak concentration at 3.5 hours, a delay of 30 minutes. While classified as a Schedule II controlled substance like existing stimulants, Vyvanse produces no high if snorted, and a 100 mg dose made drug abusers less buzzed than a 40 mg dose of Dexedrine. However, at 150 mg of Vyvanse there were no differences between the two on the “drug likeability scale.” (See the manufacturer’s Web site at http://www.vyvanse.com/.)

Over the past 2 weeks in my private practice office I have received 9 different mailings from Shire about Vyvanse, an average of about one every other day, but I expect the pace to pick up significantly. Today, my Vyvanse mailing invited me to a "virtual roundtable series" to "provide feedback on various support materials that Shire provides physicians to help them better understand...Vyvanse." In other words, Shire has invited me and thousands of other physicians to be marketing consultants. No compensation was mentioned, but I was provided with the following number to register: 1-800-635-8730, program 2595. Readers are invited to do their own research on this opportunity.

I'll keep you updated on future promotionals as they flood into my office. This should be interesting, as Shire is the most aggressive pharmaceutical marketer I've ever seen, and they are not shy about using CME programs to promote their products.

6 comments:

scattered said...

I have been taking 30mg Vyvanse for a couple of weeks after a 50 year life of frustrated inability to concentrate on any one thing for very long. It's effect was almost immediate. The downside is that I miss the comic nature of my bouncing brain...my friends and family do not. if nothing else, the mess that is my life now has become painfully apparent. I don't feel completely overwhelmed, but close. i don't understand the medical communities willingness to prescribe speed and not opiods. from my memories of my parents medicine cabinet...not much has really changed since the sixties. It's all just an educated guess with usually inconsistant or worse results, at least for me.

Anonymous said...

I really do not care what marketing the companies do as long as the medication does what it says it can do. I have been fighting my insurance company for 9mo to get Vyvanse approved as it was the only medication the worked for me for the short time I was on it.

I was on Concerta, Ritiln, and Adderall XR - They all gave me major side effects like serious cramping and abdominal pain, panic attacks & anxiety, to crashes around 3-4pm when I need to be alert with 3 little kids coming home from school.

Because of my fight to try to get the medication covered, I lost custody of my children temproarily as my ex hisband if saying that my "mental health" is not well managed.

So can you please explain to me that the ONLY medication that worked for me, I can not even get? And not to mention that Ido not have to worry about it's addictive qualities.

Gina Pera said...

That's really a shame, anonymous. A medication that could help you to be healthier in mind and body, not to mention keep your family intact, and you can't get it.

Yet, our religion-infused Bush administration is doling out millions and millions of dollars to "faith-based" marriage initiatives carried out by lay people. Yet how many "marriage problems" are caused by brain disorders that remain untreated because community mental health clinics have gone the way of the dodo bird. My guess is, a huge percentage of them.

Leave it up to the grandstanding Grassley and his ilk--so blindly supported by comments elsewhere on this blog--and your insurance will never cover any modern delivery method for your stimulant medication. (Besides, they make so much more money when the insured pay a premium for the higher-cost meds.)

It's just amazing to me. White House staffers are some of the most powerful members of Congress, though they work behind the scenes with their own undisclosed interests. Yet no one questions Grassley's staffers and their motives. Talk about naive!

No one can convince me that Grassley's big insurance-company campaign donor has nothing to do with his crusade against psychiatric researchers and the medications they show to be effective.

Anyone who swallows his office's hype without question probably believed the "smoking gun" in Iraq, too. And look where that got us.

Yes, some pharma reps spook me, too. I've observed docs shortly after reps have gotten to them, and they look like they're fresh out of an an Amway marathon. Scary!

But for people like you and many others, Vyvanse (or Concerta or Daytrana or....) will be the only thing that works. So, we have to remember that behind the reps and the icky marketing moves are scientists who really do care and who've devoted their lives to helping people improve their lives.

Good luck,
Gina

Anonymous said...

my psychiatrist seemed to want me to switch to vyvanse. I should have seen through this. I was on Adderall XR and it was pretty damn good. 2 20mg's a day (i should have been on 2 30s because I have a tolerance and am 250 lbs but whatever...screw docs charging like specialists but prescribing likes gp's lil punks, happy to field the easy money grounders and max profits...) anyways, apparently my insur co wanted a prior auth for vyvanse. apparently my doc threw adderall xr under the bus in that form (unbeknownst to me). docs always slying pushign the vyvanse, "oh, studies show its superior in every way...). Except this doc doesn't go outside the pdr, even though he's a specialist. and the pdr for vyvanse is stuck at 70mg, compared to 60 mg for Adderall xr. 70 mg vyvanse, however, translates, in its power, to about 25 or 30 mg of Adderall XR...so, I am getting less of the active ingredient with vyvanse at its max pdr dose compared to adderall xr at its max pdr dose of 60 mg (2 30 mg a day). Now my doc is saying I can't go back on adderall xr and the prior auth for xr was denied. doc says we said xr was not good when we applied for an auth for vyvanse. doc and the ins co are being kind of shifty about letting me see these damn prior auths. i sent in records requests. i want to know is it legal for shire to influence doc to switch me to vyvanse? i got a month free of vyvanse with that card...does he get free cme credits? 12 of those can costs like $500 a year or so (i think)...does he get free classes for switching patients? bcbshield in michigan or something gave docs $100 for every patient they switched over the generics, prompting the ama to issue a legality opinion on that and damning it...also the drug company said they previously appr'd my xr prior auth because it listed only mdd, major depressive disorder, not both mdd and add and said I should tell the doc to resubmit with just mdd, but the doc refused, said that would be wrong...i'm like, you did that before according to the insur co...let me do a document request to prove it and then explain why you are coming up with reasons now to keep me on vyvanse and off xr? ratface punks!

Anonymous said...

I was diagnosed with ADHD about half a year ago and was prescribed 50mg Vyvanse as a first course of treatment. I shudder when I remember the one month I was on that drug. Basically, it made me insane. I was beyond irritable and was so jumpy and anxious that I couldn't concentrate on anything. It almost cost me the loving relationship I was in with my boyfriend. He would point out to me things he noticed when I was on the drug such as twitching and dilated pupils. He had fallen into recreational drug use that got out of control when he was a teenager and had to go through a treatment program. He said many of the side effects he saw in me reminded him of people on hard drugs. I would get so focused on one thing that I shut out everything else in the world, including paying bills, being on time to work, or anything else. I would focus on one thing and everything else would be shut out. I played a computer game for two days straight and ignored everything else including my ringing phone, which was my boyfriend trying to find out if I was still alive. I have never done anything like this before or since.

The drug also caused me insomnia and severe constipation. Because of the insomnia my sleep deficit grew over the course of the month. I need at least six hours of sleep a night to function properly and if I don't get that much my mood is more volatile and I am disoriented and depressed, even when I am not on a stimulant med. When Vyvanse was added on top of that I experienced a daily melt-down because I was so sleep-deprived, unhappy, and tense.

I'm a bartender and I found myself arguing with customers for the first time ever and even cursed out two people in my bar. I am usually a very easy going person and love to joke around but this drug changed my whole personality. When on Vyvanse I had zero sense of humor and everything pissed me off. Customers I have known for years would approach me very subtly and ask with great concern in their voice what was wrong. I had no idea what they were talking about and after this happened several times I got very defensive. I must have acted like Michael Douglas in the movie "Falling Down." One of my coworkers described me as having rabies. My driving habits were completely crazy. I would drive as fast as I could everywhere I went, weaving in and out of traffic like a lunatic. If a passenger in my car pointed out the way I was driving I would get angry.

After a few weeks I started taking only a portion of each capsule by cutting it open and dissolving a fraction of its contents in a beverage. This helped a bit but once I had reduced the dose enough to where the side effects started to drop off I also felt no effect from the drug in reducing symptoms of ADHD.

When I next saw my doctor I told him what was going on and he was shocked by what he was hearing. I was his first patient to be prescribed this drug and he told me he had no indication from what he had read about Vyvanse that it would have side effects that were so severe. He prescribed me generic Adderall instead. It treats my ADHD effectively with fewer and much less noticeable side effects. After being off Vyvanse for a few days I realized what had happened to me because I felt so much better. Other people noticed, too. Strangely, while all this was going on I was unaware that I was acting unusually. I had three Vyvanse tablets left over and about a month ago I consumed a third of the powder in one tablet. I had a paper I needed to do for school and I thought the Vyvanse might help me keep going all day. Big mistake! I yelled at my boyfriend a few times that day and was belligerent and confrontational with everyone else. I was so wound up I got very little done on my assignment and basically wasted a whole day. That evening I threw the other two Vyvanse tablets in the garbage.

Not everyone will experience the same side effects but I would recommend to anyone who is prescribed this drug that they be very careful and give their doctor lots of feedback about what’s going on.

Andrew Kinsella said...

The data re the minimal difference between Vyanse and dexamphetamine are interesting.

I was actually on dexamphetamine for my ADHD for 20 months. It was an excellent treatment- and stabilised my attention so well that I learned to meditate-( and that is now the mainstay of my ADHD treatment.I have not needed medication now for 16 months).

However dexamphetamine is a dirt cheap drug. There is no profit in it for the likes of Shire. No wonder that they want a glossy new drug to market- Vyanse is a much better cash cow.