Warnings on generics: Supreme Court rules against consumers

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

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?

YOUR truth about stimulants

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.

Mood changes

Is it just me or is the world more moody these days?

Oh yeah. It's me.

I don't know what's going on with me and have been reluctant to share it with you since I try hard to stay upbeat. But darn it, I just can't seem to get it together right now. I forget things. I snap at people I love. I overreact.

I suppose you could point to my Adderall "vacation" as the cause, but it was happening even before that. In fact, that was one of the reasons I actually TOOK a vacation from stimulants (helped along by new information from Tracy Ware).

I just don't feel like "me" right now. Everything seems to bring out the worst in me. I am not happy with this person I have reverted to (yes there was a dark time that I was this person almost all the time – yuck).

In between, I managed to turn a big corner: I was in touch with my own wisdom. I could trust my intuition (and did). And now it's like a delicious dream from which I have awakened. I want to go back to sleep again. I want the "good Linda" back again (sigh).

Well, what's the lesson here? That life isn't all a bowl of cherries? That I don't have it all "together?" That it's pretty normal to ebb and flow with moods and wisdom and intuition and the rest of it? Probably.

What I do know is that it will return – that elusive sense of well being. I know it. I've tasted it, lived it, steeped in it. And I will again. But right now, I just wanna crawl into a little ball and cry. I might just do it. Tears are cathartic for me.

Oh, wait, I have to go to a birthday party in 10 minutes!. Maybe the storm can wait a bit,,, Pictures from the Big Birthday coming up next.

Stimulating everybody’s brain?

Recently, I heard a doctor tell a TV audience that stimulants like Ritalin and Adderall improve focus for ANYBODY, not just people with Attention Deficit Hyperactivity Disorder. His point was that a positive response to stimulant medication is not proof of an ADHD diagnosis.

Wait a minute. When I first tried stimulants they put me to sleep! It was the first thing that convinced me that I really had ADHD. I'd heard that people with ADHD have a "paradoxical response" to medication, so if I was sleepy after I took Dextrostat, I must have an ADD brain.

I later learned that I had misinterpreted that information. Stimulants don't really have an opposite effect on ADHD brains. Instead, they realign the dance of specific neurotransmitters so the neurotransmitters can hit their mark in the neuron network. I fell asleep when I took Dextrostat (100% dextroamphetamine) because it was the wrong medication for my particular brain chemistry. Adderall (a combination of four different amphetamine salts including dextroamphetamine) worked wonders for me – no midday naps, much more focus.

The TV doctor was reacting to news that some college students swallow stimulant tablets before exams to improve their competitive edge. No word on whether the stimulants actually boosted the students' test scores, but the doctor implied that the groundswell of adult ADHD diagnoses was based more on requests for stimulants than legitimate medical testing.

This kind of pseudo-medical nonsense makes me mad. It took me a long, long time to believe that my ADHD diagnosis was accurate. Now I realized I was deeply  influenced by the skepticism of the media, the public and even the medical community about the legitimacy of ADHD. There was the pharmaceutical conspiracy theory: Big Pharma had concocted ADHD to boost their profitability. Adult ADHD was trivialized: only children could suffer from this silly little disorder so if you "still" have ADHD you must be immature. There was stigma attached to having something "wrong" with your brain: ADHD people are to be shunned or at least marginalized. No wonder I wanted nothing to do with any of it.

But here I am, broadcasting my ADHD story to anyone who stumbles across this blog. Obviously, I've come to terms with my ADHD. I know it's legit, that I am not a hypochondriac and that I certainly would never choose to take powerful medication if it wasn't necessary.

It's my responsibility – and yours, if you or someone you love has been diagnosed with ADHD – to combat the misinformation that masquerades as truth.

Do some of today's college students take stimulants before exams? You bet. Just like some college students took No-Dose when I was in college in the 1970s. And just like mega doses of caffeine, stimulants send those little neurotransmitters into hyperdrive in "normal" brains, creating frenzy instead of focus

Does it mean that adult ADHD is over-diagnosed? Nope. In fact, it is dramatically under-diagnosed; estimates show that only 10% of adults with ADHD are actually diagnosed and treated. Mark my words: in the next few years, we will see dramatic increase in the number of adults who are newly diagnosed with ADHD.

There will be a tipping point, a place at which an ADHD diagnosis carries no emotional baggage. It will merely be a condition to be treated, much like Type 1 diabetes or kidney disease. And then we can get on with the rest of our amazing and extraordinary lives.

Stimulating everybody's brain?

Recently, I heard a doctor tell a TV audience that stimulants like Ritalin and Adderall improve focus for ANYBODY, not just people with Attention Deficit Hyperactivity Disorder. His point was that a positive response to stimulant medication is not proof of an ADHD diagnosis.

Wait a minute. When I first tried stimulants they put me to sleep! It was the first thing that convinced me that I really had ADHD. I'd heard that people with ADHD have a "paradoxical response" to medication, so if I was sleepy after I took Dextrostat, I must have an ADD brain.

I later learned that I had misinterpreted that information. Stimulants don't really have an opposite effect on ADHD brains. Instead, they realign the dance of specific neurotransmitters so the neurotransmitters can hit their mark in the neuron network. I fell asleep when I took Dextrostat (100% dextroamphetamine) because it was the wrong medication for my particular brain chemistry. Adderall (a combination of four different amphetamine salts including dextroamphetamine) worked wonders for me – no midday naps, much more focus.

The TV doctor was reacting to news that some college students swallow stimulant tablets before exams to improve their competitive edge. No word on whether the stimulants actually boosted the students' test scores, but the doctor implied that the groundswell of adult ADHD diagnoses was based more on requests for stimulants than legitimate medical testing.

This kind of pseudo-medical nonsense makes me mad. It took me a long, long time to believe that my ADHD diagnosis was accurate. Now I realized I was deeply  influenced by the skepticism of the media, the public and even the medical community about the legitimacy of ADHD. There was the pharmaceutical conspiracy theory: Big Pharma had concocted ADHD to boost their profitability. Adult ADHD was trivialized: only children could suffer from this silly little disorder so if you "still" have ADHD you must be immature. There was stigma attached to having something "wrong" with your brain: ADHD people are to be shunned or at least marginalized. No wonder I wanted nothing to do with any of it.

But here I am, broadcasting my ADHD story to anyone who stumbles across this blog. Obviously, I've come to terms with my ADHD. I know it's legit, that I am not a hypochondriac and that I certainly would never choose to take powerful medication if it wasn't necessary.

It's my responsibility – and yours, if you or someone you love has been diagnosed with ADHD – to combat the misinformation that masquerades as truth.

Do some of today's college students take stimulants before exams? You bet. Just like some college students took No-Dose when I was in college in the 1970s. And just like mega doses of caffeine, stimulants send those little neurotransmitters into hyperdrive in "normal" brains, creating frenzy instead of focus

Does it mean that adult ADHD is over-diagnosed? Nope. In fact, it is dramatically under-diagnosed; estimates show that only 10% of adults with ADHD are actually diagnosed and treated. Mark my words: in the next few years, we will see dramatic increase in the number of adults who are newly diagnosed with ADHD.

There will be a tipping point, a place at which an ADHD diagnosis carries no emotional baggage. It will merely be a condition to be treated, much like Type 1 diabetes or kidney disease. And then we can get on with the rest of our amazing and extraordinary lives.