Tag Archives: Roggli

Warnings on generics: Supreme Court rules against consumers

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I am outraged!

And more than a little scared.

This week, on Thursday, June 23, 2011, the US Supreme Court ruled 5-4 against two women who claimed that they were not properly warned about the risk of taking a generic equivalent drug, (http://www NULL.latimes NULL.com/health/boostershots/la-heb-generic-drugs-20110624,0,5484443 NULL.story)saying that consumers were not allowed to sue for side effects not listed on the label. The justices said the generics companies didn’t have the same responsibility as brand name pharmaceuticals to update their warning labels when new side effects were discovered.

Are you kidding me?

Those generic drugs, the ones pushed hard by insurance companies because they cost less, the only ones that some people can afford to take, are not even required to toe the same line for warning labels as Big Pharma?  Ridiculous. Absurd. And dangerous.

The two women, Gladys Mensing of Minnesota and Julie Demahy of Louisiana took a generic equivalent of Reglan (originally developed by Wyeth) to treat acid reflux for about four years and developed serious neurological symptoms (involuntary muscle movements). Although the Supreme Court did not dispute that the symptoms were side effects of the generic drug, it said that companies who manufacture generics should not be held to the same standards as research pharmaceutical firms to add new warnings to their labels. Their contention is that the original warning label is sufficient for a generic equivalent.

Justice Clarence Thomas wrote that the reason generics were granted special exemption was that "It is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing drugs more quickly and cheaply to the public."

But what about our safety and our right to full disclosure? Is the tradeoff for cheaper prescription prices an incomplete warning label about a potentially long-term, debilitating neurological condition? In this case, apparently so.

What does this mean for generic manufacturers? That they may skip merrily down the road producing medications that may or may not negatively impact the end user without telling us about newly-discovered problems.

What does this mean for ADD medications? It means "caveat emptor" – let the buyer beware. The drugs that are "off patent" may or may not have new, serious side effects. But if we take a generic we’ll never know, because there is no requirement that we be told about them. And now, no way to seek legal recourse against the company that produced the drug.

I am reminded of the severe warnings issued to cash-strapped consumers who ordered prescription drugs over the internet from foreign countries. There was no published warning of the purity or efficacy of the mail order drugs. Isn’t that exactly what is going on here? Granted, it is not a contamination or substitution problem, but we are buying (and taking) life-saving drugs without updated information about their potential for damage. So how can we know whether the generic we are taking is prone to cause problems that appeared after the original FDA approval? We can’t, thanks to the Supreme Court.

If Reglan was still under patent, Wyeth Pharmaceuticals (now part of Pfizer) would certainly be held responsible for warning the public about these serious side effects. But not the generic companies. This ruling allows generic drug manufacturers to hide the bad news from us. Until we experience them first hand.

Now I am even MORE outraged.

I will continue to request brand name prescriptions from my doctors. Thank goodness my health insurance still pays for them. My fingers are crossed that yours does, too. Which doesn’t mean those side effects on the label make me feel safer. But at least I know the possibilities.

Tell me about your prescriptions — do you take generics or not? Are you outraged too?

Neurotoxicity and meds

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Buried in the fine print of an article in Wikipedia, I found some rather disturbing information.

A number of releasing agents, notably many of those derived from amphetamine (http://en NULL.wikipedia NULL.org/wiki/Amphetamine), have been found to be neurotoxic (http://en NULL.wikipedia NULL.org/wiki/Neurotoxic) to serotonin (http://en NULL.wikipedia NULL.org/wiki/Serotonin) and/or dopamine (http://en NULL.wikipedia NULL.org/wiki/Dopamine)neurons (http://en NULL.wikipedia NULL.org/wiki/Neurons) via damage to axons (http://en NULL.wikipedia NULL.org/wiki/Axon) and dendrites (http://en NULL.wikipedia NULL.org/wiki/Dendrite), enzymes (http://en NULL.wikipedia NULL.org/wiki/Enzyme), mitochondria (http://en NULL.wikipedia NULL.org/wiki/Mitochondria), DNA (http://en NULL.wikipedia NULL.org/wiki/DNA), plasmalemmal (http://en NULL.wikipedia NULL.org/wiki/Membrane_transport_protein) and vesicular transporters (http://en NULL.wikipedia NULL.org/wiki/Vesicular_transport_protein), and the cell membrane (http://en NULL.wikipedia NULL.org/wiki/Cell_membrane), ultimately causing cell death (http://en NULL.wikipedia NULL.org/wiki/Cell_death) or apoptosis (http://en NULL.wikipedia NULL.org/wiki/Apoptosis) as a result. Examples include amphetamine, methamphetamine (http://en NULL.wikipedia NULL.org/wiki/Methamphetamine), MDMA (http://en NULL.wikipedia NULL.org/wiki/Methylenedioxymethamphetamine), fenfluramine (http://en NULL.wikipedia NULL.org/wiki/Fenfluramine), and PCA (http://en NULL.wikipedia NULL.org/wiki/Parachloroamphetamine), among others.

What this says essentially is that amphetamines can damage neurons and cause cell death. But the piperidine compounds aren’t as  toxic – that’s Ritalin, Concerta and Daytrana:

In contrast, piperazine (http://en NULL.wikipedia NULL.org/wiki/Piperazine), aminoindane (http://en NULL.wikipedia NULL.org/wiki/Indane), and oxazoline (http://en NULL.wikipedia NULL.org/wiki/Oxazoline) releasing agents, as well as those from various other chemical families (http://en NULL.wikipedia NULL.org/wiki/Chemical_family), are considered to be either fully nontoxic (http://en NULL.wikipedia NULL.org/wiki/Toxicity), or significantly less toxic (http://en NULL.wikipedia NULL.org/wiki/Toxicity) in comparison.

Methylphenidate belongs to the piperidine (http://en NULL.wikipedia NULL.org/wiki/Piperidine) class of compounds and increases the levels of dopamine (http://en NULL.wikipedia NULL.org/wiki/Dopamine) and norepinephrine (http://en NULL.wikipedia NULL.org/wiki/Norepinephrine) in the brain through reuptake inhibition (http://en NULL.wikipedia NULL.org/wiki/Reuptake_inhibitor) of the monoamine transporters (http://en NULL.wikipedia NULL.org/wiki/Monoamine_transporter). It also increases the release of dopamine and norepinephrine. MPH possesses structural similarities to amphetamine (http://en NULL.wikipedia NULL.org/wiki/Amphetamine), and, though it is less potent, its pharmacological effects are even more closely related to those of cocaine (http://en NULL.wikipedia NULL.org/wiki/Cocaine).[1] (http://en NULL.wikipedia NULL.org/wiki/Methylphenidate#cite_note-0)[2] (http://en NULL.wikipedia NULL.org/wiki/Methylphenidate#cite_note-1)[3] (http://en NULL.wikipedia NULL.org/wiki/Methylphenidate#cite_note-2)

I’ve written here previously about Dr. Tracy Ware’s assertion that amphetamines aren’t such a good choice for our ADD brains, even if they do help our focus and concentration. And that Ritalin (methyphenadate) isn’t quite so bad. This article supports her opinion.

Darn it. Just when we found something that would at least wake up our brains a little, allow us to focus, the ultimate effect is negative. I sure don’t want cell death in my neurons. I think it’s back to caffeine for me. But in small doses so my heart doesn’t go pitty-pat in ways it shouldn’t.  (sigh)  Don’t you wish this was easier?

CogMed – Take 2

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About a year ago, in the interests of giving everything a try that purports to help ADHD, I plunked down my money (a lot of money actually – $1500) and set about trying CogMed, a computer-based memory training program. (http://cogmed NULL.com)

At the time, I was absolutely overwhelmed – more than usual overwhelm – and knew I wasn't going to be able to give the program the time and, um, attention, it needed. But I plunged in valiantly. The result was not so good. The exercises are difficult and get more difficult as the program progresses. That's by design – there is a computer somewhere in Europe that constantly monitors my efforts and scores. If I am doing well, it increases the difficulty. If I am floundering, it eases up a bit to let me get back in the groove.

But there's the rub – there IS no groove. Every time I start feeling confident, the doggone program ups the ante. It's maddening. And frustrating.

Embarrassingly, of all the people Dr. Tracy Ware has coached through CogMed, I was the ONLY person who didn't finish. A sad distinction, especially since I had a year to finish the program. I even stopped taking my Adderall, in part, because I'd heard that people did better on CogMed without meds.

To be fair to myself, CogMed is a PC program. I am a Mac person. I had a really old PC laptop that died this year. So it was a major headache to load the program and DO it. Tried to install Windows on my Mac and never did get it figured out (I am sure it's possible, I was just too overwhelmed with other stuff to make it work).  Then there was the question of time. My sessions lasted 90 minutes – sometimes longer. It took me a long time to buckle down my brain and force it to work in the way that CogMed demands. My head hurts remembering it.

So why in the world would I try it again? Because apparently it really makes a difference for ADDivas like me. Some of my best friends have had remarkable success with CogMed. They say the old patterns still had to be changed but thanks to the results of CogMed, new patterns were POSSIBLE.

I've always said that most of the advice given to ADHD folks is just the same old advice given to linear people. The only problem is that linear people can IMPLEMENT that advice. I recently was disheartened to hear a noted psychologist tell someone to "just DO it" – like we haven't tried that already! But if CogMed can help my brain actually conform to those linear standards a little better, then it might be worth another shot.

A few weeks ago, I plunked down more money (not quite as much, thankfully) and decided to give CogMed another try, especially in light of the buzz at CHADD this year that working memory is the key to ADHD problems and perhaps treatment.

I still had the disk from last year so I could start any time. Tracy sent me the new login but I let it languish for two weeks. I was at CHADD, the ADDA board retreat and I knew I wouldn't be able to start or sustain training in the midst of travel. So….this weekend, I blew the dust off the CD cover and popped it into my new PC laptop (I actually bought a laptop for CogMed  … and my Quickbooks files which suck on a Mac).

I was guardedly optimistic – I had some experience with this, after all, so perhaps it would be easier. Nope. The program still kicks my butt. I have no idea what my baseline working memory showed when I started yesterday but it couldn't have been good. I still stumbled, mostly on the spatial tasks that require chasing a series of lighted dots and reproducing the same pattern with my mouse. Ha. Good luck with that one.

This time, I have scheduled CogMed into my life five days a week. I am going to finish it, I swear. The research is too compelling NOT to jump into this again. And I will keep you posted right here. Deal? OK then. I'm going to talk about Day Two in a separate post.

Great apps for iPad and iPhone

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My iPad (http://www NULL.apple NULL.com/ipad/)has become my best friend – I take it everywhere I go (although I am a bit leery of the grocery store – afraid I might leave it in the cart). And since I was an "early adopter," there weren't millions of apps available when I received my iPad via FedEx back in May. That meant I could actually sort through the ones I'd like to try.

"Taska" (http://www NULL.bitalpha NULL.com/index NULL.html) is one of my favorites – it's a To Do list and project management app that has a simple, beautiful interface that I actually USE. Based on "Getting Things Done" or GTD principles, it has  "Inbox," "Action List,"  "Next," "Someday," and "Projects" lists. But it also has a Shopping List (sorely missing from apps like THINGS for Mac), which I love.

Even better, using my iPad's GPS (I have the 3G version which lets me roam and use the internet), it uses "Context" to show me where I am located in relation to the errands I am running. For instance, if I am supposed to go to the bank which is across town and to Lowe's (I spend a lot of time at Lowe's) which is two blocks away, Taska will tell me that, so I can be more efficient with time and gas. Cool, huh?

It syncs with the popular Toodledo app (http://www NULL.toodledo NULL.com/index NULL.php?ref=td495d4c8865423)when you use it on the iPhone. But for me, the iPhone is just too darned small to be practical. I can't see it well, my big fingers always hit the wrong keys on the keyboard and it's not as pretty (granted, I have an ancient iPhone…shockingly it's two years old!!!).

Anyway, wanted to let you know about Taska. I do a lot of research about this stuff and might as well pass along my findings to you, too!

Hugs

LInda

 

YOUR truth about stimulants

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Should you stop taking your Adderall or Vyvanse or Dexadrine now that you've heard Dr. Tracy Ware's presentation (http://store NULL.lindaroggli NULL.com/product_p/d-the%20truth%20about%20stimulants NULL.htm) about the potential dangers of amphetamines? Maybe yes. Maybe no.

I just got off the phone with a woman (let's call her "Maggie") who recently started taking Vyvanse with great success. No side effects and improved attention, etc. After she listened to Tracy's presentation, she was unnerved by the possibility of brain damage with amphetamines so she switched medications (to a second tier ADHD drug). Maggie's been in a downward spiral ever since. Missed appointments, foggy brain, battered self esteem. Nothing we aspire to, right?

So why didn't she immediately stop the new meds and go back to Vyvanse? I suspect she called me for a reality check on whether I believed amphetamines really killed off brain cells. And I do. I told Maggie that many medications have potentially serious consequences: high blood pressure medication can cause sexual problems (http://www NULL.mayoclinic NULL.com/health/high-blood-pressure-and-sex/HI00091) for men. The FDA reported today that taking a malaria drug could cause severe kidney damage (http://drugstorenews NULL.com/story NULL.aspx?id=146043&menuid=335)and heart failure. There are unintended consequences to almost every choice we make.

But also I told her that returning to Vyvanse sounded like a good idea. I'm not a medical doctor so my opinion is worth about what you pay for it – $0. But it makes eminent sense to me to stick with something that works versus flailing around trying to save your brain cells. And yes, I DO understand that salvaging brain cells is an important goal, but the jury is still out on whether those cells will regenerate or not. There is a LOT we don't know yet about the brain and how it repairs itself.

Even more important, there is a quality of life issue here.  We ADD women have been through a lot of stuff (OK, sh**t) in our lives. Finding a medication that actually works to bolster our time management, organization, sense of well being, is a godsend.

We shouldn't stop exercising because we might pull a hamstring or sprain an ankle. And we shouldn't stop taking our amphetamine medication because someone told us there is potential for cell death. For heavens sake do NOT stop taking medication without telling your doctor! Those consequences could be even more dire than continuing the meds!

Anyway, Dr. Ware doesn't shun amphetamines; she prescribes them for her patients who need them. That includes those of us who don't see much improvement with Ritalin-family meds (like Tracy's own husband!).

The fact that I stopped taking my Adderall was more about looking at the factors that were causing me to feel out of control and a bit crazed. Sure there is a lot going on in my life. There is ALWAYS a lot going on in my life. And changing one thing at a time, to see the effects, is the way I can narrow down the cause of the problem, and then find my way back to a solution.

I don't know about you, but I want to feel alive every day. I want to feel good about myself and productive. I want to feel proud of myself and I'd like the people I love to be proud of me, too. It's not too much to ask of an ADD life. I know. I've lived it. And I'm going back there.

That means I will probably go back to Adderall. Not sure yet. Working on it. But if I do return to amphetamine medication, it will be MY truth about stimulants. Not Tracy's. Not Maggie's (Vyvanse is awful for me, BTW). Not Susan's or Ellen's or Mary's. Mine.

You need to find YOUR truth about stimulant medication. Yes. No. Maybe. Sometimes. Alternatives. Rotating. It's all part of the mix. If there is one thing I have learned about ADHD it's that it is literally a different experience for everyone. Personalized treatment..that's where we're headed, according to another psychiatrist who visited our Meetup group last night.

Work with your doctor, monitor your symptoms, get reaction from your loved ones. Find your OWN truth and then, make peace with it. None of us are gonna get out of this alive. Something, somewhere, sometime when we least expect it and probably don't want it, will cause our bodies to shut down and we'll bid farewell to the mortal coil.

So how do you want to live your life in the meantime? At my retreats I always read a poem by Mary Oliver (http://www NULL.loc NULL.gov/poetry/180/133 NULL.html)that ends with this line: "Tell me, what is you plan to do with your one wild and precious life?"

You alone have the answer. For all of it.

Depression delights

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Maybe it was my husband’s near-fatal heart condition (http://lindaroggli NULL.blogspot NULL.com/2007/03/nailing-down-cloud NULL.html ) three years ago. Maybe it was the cease-and-desist order for GardenSpirit (my dream come true retreat house) (http://gardenspirit NULL.com) last year, which is forcing me to jump through extremely bureaucratic hoops (can you spell R-E-D T-A-P-E?). Maybe it was my parents moving into assisted living this week with virtually no notice. Maybe it was the failed project to redirect water away from my front yard that culminated in an ugly gash 4 feet wide and 200 feet long. Maybe was my dear Sheltie painfully hobbling toward an inevitable end. Maybe.
 
Or maybe, under a constant attack of stress, my brain reverted to its genetic predisposition. Depression.
 
Ugh. I really hate that word. And it seems to have descended on me despite my best efforts to 1) ignore it 2) pretend I was far too ‘healthy’ to fall victim to it and 3) work like a madwoman to outrun it. But thanks to my new psychiatrist, I am starting to view depression in a different light.
 
“It is really unfortunate that we use the word ‘depression’ because it sounds like you are sad. That’s not what depression is,” Dr. Ware (http://www NULL.chapelhillpa NULL.com/providers NULL.htm) told me yesterday. “It’s more like the frontal lobe of the brain goes dark.”
 
Frontal lobe? Hey, isn’t that an ADHD issue? Isn’t that all about executive function and planning and impulse control? Hmmm, could they possibly be related? Well yes. And no.
 
Depression isn’t ADHD. I was pretty angry when I found out I had ADHD because depression and ADHD in women are often confused. Even after I learned that ADHD often has a sidecar disorder along for the ride (like depression, bipolar, obsessive-compulsive), I was mad at all those doctors who had misdiagnosed me. I decided I’d probably never been depressed at all. It had been the ADHD all along, right?
 
Uh, probably not. Dr. Ware reminded me that signs of depression include lack of concentration, distractibility, trouble with focus. Huh. Sounds a lot like my good friends Inattention and Distraction, who pop up in a diagnosis of ADHD.
 
I suspect that for me, depression and ADHD take turns at the helm. One is in the driver’s seat while the other rides in the sidecar, then they switch places. Since it has been years since I was really depressed, I blithely decided that it would never return. Ever. WRONG.
 
Many of you wondered why I chose to stop taking my Adderall, especially when it had served me so well in the past. What I now realize is that the Adderall was keeping me afloat, squishing that depression into a corner so I could get something DONE (my favorite four letter word, remember?).
 
It was actually a miracle/stroke of genius/blessing that I stopped taking my Adderall because it peeled back the covers to reveal a more basic issue that I probably wouldn't have noticed otherwise. When Dr. Ware told me that  depression actually causes cell death in the brain (which is repairable, thank goodness) I suddenly understood why I’ve been struggling with even basic tasks (but embarrassed to admit it).
 
I have lots more to say about this but I know the ADD brain prefers short, sweet articles, so I’ll stop here for today. Stay tuned …
 
Oh, and my treatment plan includes being consistent with my antidepressant, fish oil, exercise and folic acid….tantalized???? Come back tomorrow for more….
 
(But first, tell me about your experience with depression…were you ever diagnosed with depression before your ADHD diagnosis? After? Talk to me!)

Lilly is ONE YEAR OLD?

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Can I actually have a granddaughter that will be one year old on Tuesday? How did I get this old? How did SHE get this old? And so quickly, too. We leave in the morning for Ohio. Taking along the puppy I am fostering for Triangle Sheltie Rescue.

The puppy has been a little ray of sunshine in my life, except for the erratic accidents on my throw rugs. I have never washed so many rugs in my life!

It's been 15 years since I have raised a puppy. And it's been 30 years since I had a baby in my house. It's different. Maybe serendipitous that both happened about the same time.

Lilly is such a happy little girl. Her smiles light up the world.

The puppy (whom we temporarily names Milli because she is so tiny like a millimeter or a millisecond) lights up other people's worlds. They adore how sweet she is when I take her out on a walk or to PetSmart.

A bit nervous about heading into my ex-husband's "territory." It was after we moved to Ohio (yeah, like two days after we moved!) that he asked for a divorce. It wasn't pretty. And it wasn't the first time he'd done it either. Yep, we got married and divorced twice. The second time worked. We found better matches elsewhere.

But when you have kids, divorce doesn't mean "I'll never see you again." It may mean "I don't WANT to see you," but the first grandbaby … well, all that old stuff  disappears temporarily. At least I hope so.

Anyway, I am sitting here letting my hair get back to its original color (OK I know I am not supposed to say that out loud) while the puppy sleeps and I catch up on a few blog posts.

Back on Wednesday – wish me luck with the puppy, the ex, the baby and the rest of the relatives!

Million dollar ideas

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I read somewhere that all of us come up with million-dollar ideas every week, perhaps even every day (for ADDivas like us, it might be as often as hourly!).

But we seldom ACT on those ideas, for a variety of reasons: lack of time, self doubt, fear of failure.

When I have those ideas (quite often), I am sure I will remember them later but — my ADD brain conveniently forgets them almost instantly. I usually have some growling hint that I had a brilliant idea but no memory as to the substance of the idea itself!

So…I propose that we use this space as a catch-all for our million dollar ideas. Even if we don't have time to work on them right now, at least they are captured and we can go back to see them again.

One caveat: if you see a Million Dollar Idea that speaks to you, please check with the person who submitted it. In other words, no stealing THEIR good idea and making it your own unless the originator gives you permission. This will be a place of creativity and ideas, not a mudfight, OK?

I am creating a separate category for Million Dollar Ideas (under ADDiva Entrepreneurs); and I will kick off the parade with my first idea….check it out!

Three weeks without Adderall

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OK, it's been three weeks since my last Adderall and I am reporting on the effects (or lack of them).

For the first few days, I found myself on autopilot, reaching for the pill case that contained my little blue "energy pills." But I steeled myself against taking them and let the ride wind down. I thought after a week, I'd evaluate my energy and focus, then decide whether to resume my meds…or not.

Well, Tracy Ware, the psychiatrist who spoke at the Meetup group (http://www NULL.meetup NULL.com/Triangle-Adult-ADHD/)two days after I stopped taking Adderall, scared the beejeezus out of me – her warnings about neurotoxicity seemed to be based in science. And I don't want fewer Dopamine receptor sites – I want MORE. Now the jury is still out on the overall effects of amphetamines, but why tempt fate?

Tracy told me privately that the Adderall would stay in my system for at least a month. A MONTH? She said that the second week would likely be worse than the first week. Hmmm .. this sounded a lot like detox, right? I didn't think of myself as an addict. Not ever. This was prescription medication. And I took only a tiny amount (max 2-3 pills a day of short acting 10 mg brand name Adderall).

But sure enough, the second week, I was draggy and had a hard time staying alert. Mostly, I was sleepy.

I found that if I got enough sleep at night (or with naps during the day), I was OK. But if I stayed up too late, got up too early or shorted my required 8 hours of sleep in some other way, I was blah. Just blah.

Couldn't get things done. Couldn't get motivated. Couldn't get going.

But here's the strange thing: I have been living in a mess in my bonus room/guest room for two years now. I am not proud of it. I am terribly embarrassed by it. But it's true.

Last week (third week off Adderall), I got the darned room cleaned up. Granted, I had motivation (my kids were coming to spend the weekend with darling little Lilly). And I had help (Erica the super organizer (http://www NULL.getalifeinc NULL.net/) came on Thursday morning and Janine the super housekeeper cleaned the rest of the house).

But I've had help before.
I've had motivation before.
But this is the first time I actually DID something about it.

Not only did we get the room cleaned, I bought a new bed, new curtains, new lamps and redecorated the room with a new duvet cover, pillows, mirrors and ceiling fan before they arrived! (Yes I had someone install the fan and hang the mirrors – is that cheating? Nope).

Point is that I am still tired/sleepy, but I seem to be getting things done anyway.
I am clearer about what I want and need done.
And I am pretty happy about it.

Is this an aberration?
Is it related to the absent Adderall?

Not a clue, have I.

But we're gonna find out.
In 10 days, I am going to go back on Adderall and monitor myself closely to see how I feel, what I accomplish and how my loved ones respond to the difference (if there is a difference).

In the meantime, I am taking more naps, trying to get to bed on time (what IS on time anyway?) and working in my garden for the first time in months.