Should psych drugs be avoided at ALL costs?

My brain isn’t functioning today quite honestly so my apologies if the following makes no sense whatsoever. It’s long and I ended up rambling.


Lately, I’ve been thinking about whether there are any benefits to using pharmaceutical drugs. I have blogger friends who are very much anti-pharmaceuticals anything, try to avoid drugs as much as possible but take them if necessary, or think pharmaceutical drugs are a Godsend.

I’m still trying to figure out where I stand.

Pharmaceutical companies are in the business of making money. It is not to their advantage to put out completely shoddy products that do not work. I’m sure many of them bury negative data and findings that do not shed a positive light on their drugs but if something works overall, they’ll put it out there. I don’t believe the doctors who are involved in these trials are all dirty, rotten sell-outs. Some of them are very well-meaning and honest who work to make these drugs as effective as possible. Call me naïve if you like but I just can’t bring myself to believe there are more greedy docs who skew results than there are those who are concerned with advancement.

I don’t think twice about popping Excedrin Migraine when I’ve got a painful, debilitating migraine; I have no problem taking naproxen (aka Aleve) when I’ve got menstrual cramps, and taking ibuprofen isn’t an issue if I have severe muscle pain. I don’t question the safety of these drugs. I’ve used them for so long, they’ve proven to be relatively safe for me (not everyone can tolerate those drugs) and efficacious. The safety risk of taking Excedrin Migraine sometimes outweighs the benefits of not taking it. (Note: I only speak of adults in terms of ingesting this kind of medication.I don’t believe developing bodies, such as youngsters, are able to handle medication that can significantly affect mood.)

When it comes to psych meds, I am not anti-medication. Psych meds should be taken on a case-by-case basis. There are some people who consider these meds to be a life-saver while others complain that it has made them miserable and worsened their lives. This is the gamble people take when choosing to ingest a psych med—most people don’t know that. Trouble is, most people don’t know when the stakes are high enough to take that risk.

I shouldn’t be in a position to judge anyone but when I hear people taking antidepressants based on circumstances—a job loss, failed relationship, loss of a life—I worry that it’s unnecessary. We are becoming a nation that is more reliant on “quick fixes” rather than developing coping mechanisms. It’s easier to pop a pill and dull your emotions than it is to face problems, tackle issues head on, and learn to work your way through it. Case in point: rising unemployment hasn’t slowed sales of antidepressants or sleeping pills.

  • I have an aunt who was a violent paranoid-schizophrenic. She was placed in a mental institution and drugged up the wazoo. Now, she’s basically existing; the lights are on but no one’s home. The drugs have killed her. She’s alive but not really.
  • My father was a non-violent paranoid-schizophrenic. It got to the point where we needed to medicate him to get him on track. The medication helped him to function “normally” but his thought processes and physical ability was significantly slowed. He once told me that he felt useless because my mother was busting her butt at work to pay for my college and he was basically an invalid because his mental illness had prevented him from being able to work. He died 4 months later. A few days after the funeral, my mom began to find his psych meds hidden all around the house. I often wonder if the drugs killed him.
  • Another aunt (this is all on the paternal side of the family) also became a paranoid-schizophrenic. She was a brilliant woman who was basically reduced to moving from place to place to the point where she eventually became homeless and could not hold down a job. She disappeared for a while but during one cold winter, was found and brought into a homeless shelter. She was placed on meds and her cognitive functions returned despite the fact that her speech was sometimes garbled. She traveled the world, went on cruises and various excursions. The change was remarkable. Psych meds improved her life and saved her—the benefits of the drugs outweighed the side effects.

As I withdraw from Lamictal, I am curious to see who I am without this drug. Will my creative juices flow freely once again or are they now somewhat hindered? Will my cognitive functioning correct itself or will I forever suffer from problems? Will my short-term memory loss issues smooth out or will I still suffer from intermittent forgetfulness? I have some side effects that may remain with me for a while or perhaps forever (though I hope not) but seeing others fully recover after taking drugs for 10 times longer than I have gives me hope.

I feel the majority of my progress has come from intensive counseling and being infused with the truths as laid out in the Bible. I’d say 90% of my progress has been due to counseling. I give the meds 10%. You can tell I don’t place much stock in them. But they’ve helped to cut down on the mixed episodes.

So far, I haven’t had any suicidal thoughts are behaviors that are out of the ordinary. (Thank GOD.) I’ve been dealing with a mild depression but that stems from basing my worth based off of my career rather than any biological imbalances. The last time I suffered a severe depression, I was on Lexapro (if that tells you anything).

I’ve gotten a lot of resistance and concern from family members who question my decision to come off of the medication. They’ve seen a miraculous change in me and attribute it to being on meds. Meds aren’t a cure-all. They don’t see the counseling and shifting of thought processes going on that has helped me to develop coping mechanisms. Meds may help people “cope” but they don’t develop the tools needed to cope.

I’ve decided that I’ll probably give that Christian psychiatrist a call. My counselor recommended him and she said that he’s very neutral on meds and doesn’t shove them on anyone. I mentioned that I wasn’t sure if anyone would accept me as a patient only to lose me in the end—she insisted he wouldn’t mind. The intake cost is hefty but since I was able to temp a few days for my job this week—I’m not permanently returning, I can swing it.

Which brings me back to my position on psych meds: I said it earlier but I think it’s a case-by-case basis. In my personal life, I’ve seen the benefits outweigh the side effects and I’ve seen the side effects outweigh the benefits. And I’ve seen benefits (not necessarily beneficial) as a result of side effects. Psychiatry is the biggest medical guessing game of all medical specialties. There are no certainties, and there’s no one medication that works best for everyone. Pharmaceutical companies make it a point to put the disclaimer on the patient information sheet that they’re not exactly sure HOW these drugs work. All that stuff about serotonin, dopamine, and neurotransmitters is pure speculation when it comes to depression. You’ll have me convinced about chemical imbalances once I can get a MRI and blood test done. Until then, it’s all trial-and-error.

So if I do suffer from relapses while withdrawing from this medication and it gets to the point where I may need to be hospitalized, I’m not averse to remaining on the drug. Better to be alive and on a psych drug than dead because I was determined not to use it at risk to my safety. If I end up having to stay on the drug, the future of giving birth to children will seem a bit more uncertain.

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Loose Screws Mental Health News

Portland, Oregon has been recently declared the most depressed city in the country. BusinessWeek determined this based on “antidepressant sales, suicide rates, unemployment, divorce, and crappy weather.” Philly didn’t make the top 20 list. That’s because we’re too busy enjoying the highest suicide rate in the country.


smokingA great way to avoid depression, however, is to simply stop breathing. Yes, that’s right. Just stop breathing. A new study presented at an American Psychological Society meeting shows people who are consistently exposed to secondhand smoke are twice as likely to suffer from depression. So that’s my recommendation to you: STOP BREATHING. I guarantee you won’t be depressed after a while. (By the way, that’s a joke so you can go ahead and take a deep breath now.)


Apparently all this talk of an economic depression is causing people to be depressed enough to buy more antidepressants. I don’t get how it works but it seems as though antidepressant prescriptions (along with sleeping aid prescriptions) are rising alongside the unemployment rate in this country. Big Pharma isn’t filing for bankruptcy anytime soon. And if they do, it’s their own freakin’ fault.


In what appears to be a landmark ruling (correct me if I’m wrong), the U.S. Supreme Court ruled that pharmaceutical companies are still liable for injuries cause by FDA-approved drugs and devices and juries can legitimately award damages. The buzzword I’ve learned for this case is preemption.

A woman who was injected with an antinausea drug (Phenergan, if you’re wondering) brought a damage suit against Wyeth after her arm had to be amputated. After a jury awarded her with $6.7 million, Wyeth took the case to the U.S. Supreme Court, expecting a cool victory after the court sided with Medtronic in last year’s Riegel v. Medtronic case. Wyeth, the defendant in the case, hoped the Supreme Court would rule in their favor since the FDA had already evaluated their product for safety—a preemptive act. However, this time the court ruled 6-3 in favor of allowing the woman to keep her award money. The decision also sets a precedent for pharmaceutical consumers to sue pharmaceutical companies for injuries despite FDA approval—striking down preemption. For further information, check out Doug Bremner’s and Philip Dawdy’s blogs that have already covered this. In the meantime, I leave you with this:

Ronald Rogers, a spokesman for Merck, said, “We believe state courts should not be second-guessing the doctors and scientists at the F.D.A.”Merck was hit with several huge damage awards over its painkiller Vioxx before agreeing to a $4.85 billion settlement in 2007. Allowing juries to make determinations about drug risks, Mr. Rogers said, would cause “mass confusion.”

Hm. Make of that what you will.

Loose Screws Mental Health News

As reported by The New York Times, people with bipolar disorder have a higher risk of suffering from fatal illness according to a study (that reviewed 17 other studies involving more than 331,000 people) reported in the February issue of Psychiatric Services.

In the larger studies, almost every cause of death was higher among bipolar patients: cardiovascular, respiratory, cerebrovascular (including strokes), and endocrine (like diabetes). In the smaller studies, mortality from cerebrovascular disease was higher among those with bipolar illness, but they showed inconsistent results, probably because they used smaller samples or less representative populations.

Gianna at Beyond Meds provides here take here.


Some crazy nurse in Minnesota convinced a Canadian college student to kill herself and walked her through the process of appropriately hanging herself. Ed Morrissey of Hot Air calls the nurse "the first serial suicide-inciter of the modern age." Couldn't have said it better myself.


Philip Dawdy at Furious Seasons is on a roll, holding AstraZeneca accountable for its actions regarding hidden information about Seroquel and now he hosts the Seroquel documents — alongside Lilly's Zyprexa documents — that indicate buried studies. Dawdy's also running a spring fundraiser and I suggest you get your butt in gear and donate to him if it's important to you that someone holds pharmaceutical companies accountable for their actions. I've already done my part.


Sorry this post isn't filled with my normal snark and cynicism. I'm behind on a lot personally — still trying to get the hang of this self-employment thing — and this is what I can throw out for now.

Done deal: Pfizer buys Wyeth for $68 billion

Pfizer-Wyeth merger

The New York Times puts it this way:

The deal, if completed, would not only create a pharmaceutical behemoth but would be a rarity in the current financial tumult: a big acquisition that is not a desperate merger of two banks orchestrated by the government. [emphasis mine]

Funny the writers decided to add that. A year ago, that clause would have never been considered yet alone thought of.

Pfizer isn’t doing badly; in fact, despite the credit crunch, they’ve been able to snag $22.5 billion in loans since they also have $26 billion cash on hand. The NYTimes also reports that this merger would be the biggest since AT&T and BellSouth merged back in March 2006. But of course, with mergers always come layoffs. And what a time to have layoffs. Pfizer today announced that they’ll be cutting 8,000 jobs.

But as I said in a previous post, Pfizer’s biggest challenge is get some pipeline products out to market soon since some of the patents on their big names (ie, Lipitor) are expiring soon. Don’t hold me to this but I think Wyeth has a bit more sitting in their pipeline, hence why the merger would make sense. But I hope Wyeth can produce a new blockbuster drug for Pfizer otherwise Pfizer’s really going to be hurting for money. Especially since Wyeth’s best-selling drug, Effexor, is now generic and Pristiq isn’t completely cutting it.

Pfizer may be buying Wyeth

Pfizer-Wyeth merger

Is Wyeth being hurt by the failing economy? I’m not so sure but Pfizer may be buying up Wyeth for up to $60 million. According to news reports, this could help the pharmaceutical giant by bringing in some of Wyeth’s brand name products while many of Pfizer’s own manufactures (think Lipitor) go generic. However, it could also be a drawback as one of Wyeth’s biggest sellers—our favorite antidepressant Effexor (venlafaxine)—has gone generic. Also, Pfizer doesn’t have the best track record of buying up other companies and turning them into blockbuster gold. Should be interesting to see what happens in the next few years if the deal does go through.

Pharma's "me-too" drugs face skeptical docs and health insurers

As patents expire on a variety of drugmakers’ moneymakers, pharma companies have gone to great lengths to structurally reinvent the successful drugs then tout the benefits that differ from their predecessors.

InvegaCase in point — Johnson & Johnson’s Invega. Invega is the successor to the popular antipsychotic drug, Risperdal, and competitor to AstraZeneca’s widely used antipsychotic Seroquel. Scott Hensley at The Wall Street Journal’s Health Blog (WSJ) reports that Risperdal is going generic in June. Gianna at Beyond Meds recently said it will not. According to the Dow Jones Newswires (DJN), these “junior” drugs face skepticism from health insurers and doctors. California-based Kaiser Permanente and Minneapolis-based UnitedHealth Group Inc. (UNH) are example of companies that have somewhat discouraged use of the drug. Kaiser doesn’t cover Invega at all, and members of UNH are required to pay higher copays for the brand name. The wire reports New York-based psychiatrist Jeffrey Lieberman wasn’t “buying it” the difference between Invega and Risperdal.

Invega is “basically a me-too drug, and the company hasn’t done the studies that would be required to really distinguish it,” Lieberman, chairman of the psychiatry department at Columbia University’s medical school told Peter Loftus of Dow Jones Newswires.

Ouch.

The blog also quotes Daniel Carlat from the The Carlat Psychiatry Report.

Dan Carlat, a psychiatrist and a tough critic of Invega, wrote that J&J’s “marketing team apparently missed the fact that the word in the English language that sounds most like “Invega” is “inveigle,” meaning “to entice, lure, or ensnare by flattery or artful talk or inducements.’ ” He asked doctors: “Will you be doing your patients a favor by taking the plunge? Or will you simply be giving them the same wine in a fancier bottle?”

Even J&J’s Group Chairman of Pharmaceuticals, David Norton, admitted that Invega is a tough sell.

“We need to do a better job at drawing a differentiation in a difficult-to-treat population.

So far, Invega sales have been incredibly disappointing compared to the Risperdal blockbuster.

Wyeth (antidepressant Effexor XR cum Pristiq) and Shire (ADHD drug Adderall XR cum Vyvanse) face the same uphill battle. Wyeth’s Effexor faces generic competition from Teva Pharmaceuticals despite efforts to halt generic sales of the drug and the patent on Shire’s Adderall is set to expire next year.

Hensley, in his analysis, raises a question in which the answer remains to be seen:

Cheap generics abound to treat a broad assortment of illnesses these days. What’s the point, the critics ask, of paying more for drugs that are at best only slight improvements over tried and true medicines available at bargain prices?

It’s something that I’ve questioned myself.

In an attempt to have the “me-too” drugs compete with its derivative, both Wyeth and Shire are slashing their prices, or as the DJN reported, “emphasizing improved dosing for the newer drugs.” Although Pristiq’s efficacy comes at higher doses, it’s being priced 20 percent lower than Effexor.

[Deutsche Bank pharmaceutical analyst Barbara Ryan] thinks the odds of
Pristiq’s success are slim because it appears to offer few benefits
beyond those of Effexor.

That remains to be seen. So far, a few patients have commented on my blog that Pristiq has already begun to help them. I haven’t seen any DTC ads for Pristiq so I can only assume that drug reps are doing a fine marketing job at selling the different benefits of the drug to doctors.

Vyvanse, on the other hand, is looking promising for Shire, already having 7 percent of U.S. ADHD drug prescriptions. Chief Executive Matthew Emmens says the drug is chemically different from Adderall (aren’t they all?) and has better pricing. Shire expects to beat Adderall’s 26 percent peak market share. Seems like a lofty goal to me.

As for Invega, J&J is currently seeking FDA approval to use the drug for bipolar disorder and not just treatment for schizophrenia. It is also l0oking to get approval for an injectable Invega XR.

(Invega logo from Janssen.com)

My official position on pharmaceutical companies and psychotropic meds

In previous posts, perhaps I’ve come off a little bit as “I hate Big Pharma.” I did. For a while.

I’m not in love with pharmaceutical companies either. I’ve quoted it before but “to whom much is given, much is required.” As a result of accumulating knowledge through reading and research, I know a whole lot more about pharmaceutical companies, the treatment options they put out there, and what lengths they go to get those treatments out there. Most of the things I read are negative. Much of what I’ve said is negative. Perhaps “ignorance is bliss.” My husband said this recently:

“The Internet is the great bitching ground. No one’s going to talk about how great medication is. Everyone’s going to go on and just bitch about side effects and bad experiences.”

I agree. “Effexor really helped me feel better today” doesn’t make for an interesting blog post. No one pays attention to medication when it’s working, however, everyone will complain if something is going wrong. The most “positive” drug comments I’ve seen are on my seemingly “negative” posts from people who are being helped by a drug.

Take, for instance, the following comment from Suffering:

Read the rest of this entry »

Response to "Mental Health Blogs Going Bye-Bye?"

From one of Furious Seasons’s latest posts:

Mental Health Blogs Going Bye-Bye?

As I noted earlier, there’s a spate of mental health blogs that are going on hiatus of some kind. Now, it’s my sad duty to report that Gianna Kali’s Bipolar Blast blog is going on an indefinite hiatus as well. You can read her post "Quitting?" for the details. Bottom line: all those years of very high doses of psych meds seem to have injured her body. I cannot even begin to send her enough good wishes. I cannot even begin to express my disgust with some of the bad doctors she ran into over the years.

Also, the Psych Survivor blog, written by a man I only know as Mark, was taken down a few weeks ago, and from what I gather he is in the hospital with heart problems. His was/is a good and strident voice on these issues we all care about and his work is missed.

All of this kind of makes me feel glum, since the two people above had been at the blogging game for well over a year and I sensed that they’d both be around long-term. These are people I care about and it sucks that they won’t be the presence they once were.

Why is it that mental health blogs are so difficult to do and keep going? Why is it so hard for them to find the substantial audiences they deserve? The Internet is crowded with blogs about politics, technology, gadgets, gossip and parenting and many of these seem to do quite well and have huge audiences and long lives, despite the fact that many of them are merely echoes of one another. Are readers of blogs that simple-minded that all they need is the latest news and opinion on Apple’s or Microsoft’s latest bit of software or Obama’s or Hillary’s latest gaffe?

You’d think in a country where 10 percent of the population is on anti-depressants and another 5 percent to 10 percent is likely on some other psych med that there would be a substantial audience for these issues (regardless of what one makes of the dominant mental health paradigm), especially given how wildly popular neuroscience is on the Net. It makes me wonder if we all–and here I include myself–have done something wrong in how we analyze these issues (are we too contrarian?) or if we all simply haven’t been crowded out of the big search engines (that’s how most people find mental health information online) because the Net is so over-populated with pharma sites and allied pro-pharma health websites. I can certainly say that the mainstream media–which usually loves writing about characters on the Net who push against life’s many intellectual tides–has given very little attention to sites like this one, despite the fact that sites like mine have been a very real service to many in the media.

Or maybe the mainstream approach to mental health care is right and the public is just trying to tell us something.

What do you think?

I’ll tell you what I think.

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Freelance writing, editing, and proofreading

I’m thankful that I’ve been able to obtain a part-time job at an ad/marketing agency where I can do some freelance editing and proofreading. I charge them $10 more than what I made at my last job right now, but in retrospect, I think I underestimated my value. However, I cut the company some slack because I haven’t been editing or proofreading in quite a while. I figure I’m a good deal considering my kick-butt skills at the rate that I’m charging. (Woo-hoo! Confidence!)

This leaves me with two free days to do some writing. I’ve mentioned in the past that I haven’t done any form of reporting since 2005, which scares me. In the past, I’ve had editors tell me what stories they think are important or relevant to the locals and I just went out, covered the story, wrote up my assignment, turned it in, then basked in the glow of seeing my name glistening in print. Now, it’s up to me to be up on what’s important and relevant to the community that I live in and decide what I think editors will want to publish. It’s a tricky game and I’m bound for rejection. Considering my history of rejection from my peers, I don’t know if I’m particularly apt for constant rejection from editors. I know I’m not supposed to take it personally but I’m Ms. Overly Sensitive. My recent experience with Joe (here and here) from the magazine I interviewed for has actually taught me a lot. It’s been an annoyance to endure but it’s been a valuable lesson. I’m learning not to take his treatment of me personally. Perhaps I read him all wrong and he’s not the jerk that I think he is. Regardless, he at least sent me a copy of the  issue my work was published in — wouldn’t you know — sans that elusive $75 check. I’m particularly angry with him, mainly because I feel like I got played for the fool. Part of me wants to pursue my writing career even more now to show him that he lost out by not hiring me. The other part of me knows that I’m so unmotivated to do anything that I won’t get anywhere with anything. Better to have low expectations and be pleasantly surprised than to have high expectations and be significantly disappointed.

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Are Big Pharma murderers?

An book review in the NYTimes today focuses on Melody Petersen, a former reporter of the Times, who has written a book against  Big Pharma's marketing tactics called Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves Into Slick Marketing Machines and Hooked the Nation on Prescription Drugs. In the book, she asks:

“Could drugs be killing people but escaping all blame, leaving them to harm even more Americans until someone, finally, catches on?” Ms. Petersen asks.

Few of us have. Most of America hasn't. Petersen outlines in great detail – the point of repetition according to Janet Maslin's review – Big Pharma's propensity for skewing clinical trial results so that their drugs perform better than placebo, the increased and ubiquitous DTC marketing, and the "payola-dispensing drug company representatives."

(“Hotel too cold inside,” one said, in an evaluation of a June 1998
drug company program, adding, “Resort places preferred.” From a
different doctor, miffed at the lack of a chauffeur at another event:
“Hired car would have been much preferable.”

Petersen also covers Big Pharma's tactic of fixing side effects of medications by creating medications to fix the side effects leading to medication on medication.

And when the side effects of sleeping pills or antidepressants mean
more elderly people fall down, the solution is not likely to be the
scaling back of such prescriptions. “Instead,” she writes, “the
companies have used the statistics on falls to create a new blockbuster
pharmaceutical market for drugs they claim will reduce the chances of
breaking a bone.”

According to the Maslin's review, the book calls for non-government watchdog agencies and closer oversight on published studies, which Petersen says are ghostwritten by pharma spokespeople. Overall, Petersen's book sounds like a must-read for anyone who is skeptical of Big Pharma's activities. However, I doubt her book will get much press or coverage considering that you can't read any major publication without turning the page and seeing a drug ad then the required 2-page side effect warning that everyone skips over. If anyone reads the book, I'd like to know your thoughts about it.

Sorry if this post sounds hastily written. I'm off to an interview to freelance for a company.

Blood test for efficacy of antidepressants in the future?

Scientists have found that a biomarker for depression could show whether a person's antidepressant is working. The discovery could lead to something everyone in the psych world has been waiting for: a blood test of some kind.

The researchers looked at the interaction of neurotransmitters and a protein called Gs alpha. In brain cells, the protein acts like a kind of butler, passing messages from neurotransmitters on the outside and amplifying their messages, [study co-author Mark] Rasenick explained.

When the protein is working properly, it's like a butler whose "hands are just flying, cooking and cleaning at the same time," he said. But when the brain is depressed, "it just sits there in the corner."

That's an interesting observation. This might finally explain the difference between "depressed" brain activity and normal brain activity on an MRI. (By the way, has anyone had an MRI performed for depression?)

Researchers compared the proteins in the brains of people who committed suicide as a result of depression to those who did not. "They found the protein would have worked less effectively in the brain cells of the suicide victims."

Dr. Gregory Simon conceded that doctors cannot determine which antidepressant will work for which person.

"There's a long history of research using patterns of symptoms or biological measures — chemicals measured in blood or spinal fluid — to predict response to a particular antidepressant. None of those hoped-for predictors have significant value.

[Genetic tests] would not eliminate trial-and-error, but it would reduce the waiting time with each trial. But it's a long way from a study like this one to a test that's useful to patients and doctors."

Good news for the skeptics about this research study: It was funded by the U.S. Public Health Service and the American Foundation for Suicide Prevention. But a test simply to see if an antidepressant is working has the smell of pharma somewhere on it.

(Hat tip: Ephphatha)

Blogs around the way

I’m catching up on reading my fellow bloggers’ posts (see Blogroll to the right), so if you’re not reading their site already, I’d encourage you to do so. Below  are some posts that caught my attention. Some might be a little dated.

Gianna at Bipolar Blast: Has a video up of Gwen Olsen, an ex-pharma rep who says that pharmaceutical companies aren’t in the  business of curing but in the business of "disease maintenance and symptom management." It’s nothing new but here are two quotes that caught my attention:

"And what I’m saying is provable is that the pharmaceutical industry doesn’t want to cure people. You need to understand specifically when we’re talking about psychiatric drugs in particular that these are drugs that encourage people to remain customers of the pharmaceutical industry. In fact, you will be told if you’re given a drug such as an anxiolytic, or an antidepressant, or an antipsychotic drug, that you may be on the drug for the rest of your life. And very frequently, people find that they are on the drug for a very long period of time, if not permanently, because they’re almost impossible to get off of. Some of them can have very serious withdrawal symptoms – most of them can have extremely serious withdrawal symptoms if they’re stopped cold turkey – but some people experience even withdrawal symptoms when they try to titrate or they try to eliminate the drug little by little, day after day."

"We have got to start making the pharmaceutical industry accountable for their actions and for the defective products they’re putting on the market. It won’t be long before every American is affected by this disaster and we need to be aware of what the differences are between diseases between disorders and between syndromes. Because if it doesn’t have to be scientifically proven, if there are no tests, if there are no blood tests, CAT scans, urine tests, MRIs – if there is nothing to document that you have disease, then you in fact, do not have a disease, you have a disorder and it has been given and has been diagnosed pretentiously and you need to get yourself educated and understand that there are options and those options are much more effective than drugs."

I’ve always wondered why doctors don’t run tests to diagnose any psychiatric disorders. From NIMH:

Research indicates that depressive illnesses are disorders of the brain. Brain-imaging technologies, such as magnetic resonance imaging (MRI), have shown that the brains of people who have depression look different than those of people without depression. The parts of the brain responsible for regulating mood, thinking, sleep, appetite and behavior appear to function abnormally. In addition, important neurotransmitters–chemicals that brain cells use to communicate–appear to be out of balance. But these images do not reveal why the depression has occurred.

If MRIs have shown that the people with depression have a part of the brain that functions abnormally then why isn’t it standard for all people diagnosed with depression to have an MRI done to confirm this? I have one of two hypotheses:  it’s too expensive to get an MRI done for each person and that insurance won’t pay for it or the abnormal functioning cannot be detected in the brain of every depressed person.  Therefore, is major depressive disorder really a made-up diagnosis?

Read the rest of this entry »

Pristiq receives approval from FDA

PristiqMore than a year ago, I promised to keep tabs on Wyeth’s new (renamed, rather) drug Pristiq. So I’m living up to it.

On February 29, 2008, the FDA granted Wyeth approval to move forward with putting the drug out on the market.

Wyeth said the company planned a big sales effort to introduce the product to psychiatrists and primary care doctors.

There’s a problem with that sentence. I’ll give you a second to figure out what’s wrong with it. Haven’t got it yet?

Primary care doctors. PCP should not be in the business of prescribing or providing psych meds. I’ve gone on and on about it at length before, but I’ll mention it again. PCPs are trained to treat overall conditions that have no need of referral to specialists. Think about it this way: If your psychiatrist prescribed anti-inflammatory medication because you mentioned that you’ve been having problems with your foot, you’d be taken aback, right? If a dermatologist prescribed heartburn medication after a patient mentioned he’d been having heartburn trouble, that would seem almost illogical, wouldn’t it?

(Pristiq logo from Pristiq.com)

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Selective publication on antidepressant efficacy and data

After the release of the U of Hull study on Tuesday, the AFP has written an article about doctors who are urging patients on antidepressants to continue taking them.

Louis Appleby, national clinical director for Mental Health, told the Press Association: "… the message to patients and doctors remains the same — anti-depressants are an appropriate treatment for moderate or severe depression."

I agree that patients on antid's should not cease medication cold turkey. (Trust me on this one. Even with proper tapering, the side effects are not pretty.) I waver on the idea that antid's are "appropriate treatment" for moderate-to-severe depression rather than a "form of treatment." Antidepressants can help, but I'm not sure I like the term "appropriate." But I likely am arguing semantics.

Since the results of the study originate from Britain (despite the fact that it also includes data from the FDA), I can only assume that news reports on this are more widespread over there. In my Philadelphia, USA-world, it seems a little bit off the radar to me. Let me know if I'm wrong.

To Mr. Appleby's credit, he has acknowledged that the British government plans to rigorously pursue routes of alternative treatment in light of the study.

The government has plans to expand the availability of psychological therapies as an alternative to drugs, Appleby explained, with extra investment and more psychological therapists.

"The evidence shows that these therapies are effective and often preferred by patients."

WebMD also covered the recent study.  Dr. Nada Stotland of the American Psychiatric Association insists that the study is not reflective of real psychiatry.

"We know that many people who are depressed do not respond to the first antidepressant they try," she says. "It can take up to an average of three different antidepressants until we find the one that works for a particular individual. Therefore, testing any single antidepressant on a group of depressed individuals will show that many of them do not improve."

Stotland has a point. Patients usually do not respond to the first antidepressant that is prescribed to them. About 30 percent of patients do not respond to antidepressants or experience no improvement until several weeks later.  Even then, patients who are on antidepressants for long-term maintenance, experience the return of depressive symptoms. An article from The New England Journal of Medicine evaluated the selective publishing of antidepressant trials with a positive efficacy:

Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive.

The authors' conclusion: "Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients." It's an obvious statement; so obvious, it can be easily overlooked.

While it's important to shed light on the issue of treating depression with antidepressants, it seems as though many authors are cherry-picking favorable results to publish. Considering that much of these research studies are backed by drug companies, it's no surprise. Also, I can't fault the authors only. I recently freelanced for a medical publication and learned that many of the submitted articles are heavily rewritten by the editors. Editors are hard-pressed (and probably loath) to publish a piece that criticizes antidepressants when their biggest advertisers include such big names as Wyeth, Eli Lilly, and GlaxoSmithKline. Run enough of those pieces and a publication is quickly on its way to folding.

That's why it's stunning to read the U of Hull study that has somewhat of a negative slant toward antidepressants' effectiveness. While doctors are wisely advising patients to continue any antidepressants they may be on, currently drug makers have launched into damage-control mode.

In a statement, GlaxoSmithKline (GSK) representatives express "disappointment" at how the study was being reported by the media, suggesting that news reports may have caused "unnecessary alarm and concern for patients."

Of course these news reports are "unnecessary" to GSK. Letting patients know that their antidepressants might not work better than sugar pills isn't good for business. However, GSK's reps were kind enough to balance out their statement, adding "counseling and lifestyle changes" also are important aspects of treating depression. Then, the company accuses the researchers of selectively reporting their data:

"GSK fully endorses public disclosure of clinical trial results for its medicines and is actively committed to communicating data relevant to patient care," the statement reads. "All the data related to GSK's clinical trial results of [Paxil], regardless of study outcome, are available at the company's clinical trials register at 20 www.gsk.com."

Tell that to the estimated 5,000 Americans who have filed a lawsuit against GSK regarding Paxil. Still, Kirsch, who has received consulting fees from Squibb and Pfizer, insists "the [drug companies] certainly do publish selectively."

I'm inclined to agree.

Loose Screws Mental Health News

"Can an antipsychotic drug from the 1950s be paired with a 1980s antibiotic to shrink 21st-century tumors?"

That's the first line from the NYT's recent article on biotech companies mixing two unrelated generic drugs to treat medical problems. Alexis Borisy, the executive of CombinatoRx, is spearheading the movement to mix and match two different generic drugs in the hopes that the combo will cure or effectively treat a disease that may be unrelated to the drugs' initial purposes.

"Orexigen, in creating its obesity drug Contrave, took a treatment used for drug and alcohol addiction and combined it with an antidepressant sometimes used to help people quit smoking." (My guess is that the antid was Zyban.)

It's a nice concept, but I'd hate to see risk of side effects doubled. One med can be a doozy; coupled with another could turn out to be problematic.


More from the NYT: Pharmaceutical companies pay psychiatrists (to push their products) more than doctors in any other specialty.

"For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved."

The bipolar child paradigm.

Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program.

Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said.

The number most likely represents a small fraction of drug makers’ total marketing expenditures to doctors since it does not include the costs of free drug samples or the salaries of sales representatives and their staff members. According to their income statements, drug makers generally spend twice as much to market drugs as they do to research them.

Doesn't the last sentence make you feel all warm and fuzzy inside? It's great to know that getting people to use drugs are more important to these companies than making sure these drugs are safe to use. Yeah, yeah, I know, it's a company and companies are only out to make profits. Whatever kind of optimist is in me wants to believe that maybe there's one doctor out there who is more motivated by helping others than by pharma-backing money. But I'm only a slight optimist.

YouTube vs. Big Pharma: Round 1

We seem to have a lot of contenders today. Kevin M.D. has a post (linking to PharmaGossip which links to Advertising Age) about the video "exposés" on pharmaceutical companies that have been popping up.

GlaxoSmithKline now has its own one minute, 43-second video on YouTube for Restless Legs Syndrome. Ms. Wetzel said she believes more drug companies and ad agencies will adopt such an approach. "The conversation about health care goes on," she said, "and we're going to have to deal with it."

My job blocks YouTube so I can't see the video, let alone link to the one I'd like to reference, but the other day, I saw (at least) a minute-long TV ad for Celebrex, but oh man, was it awful. See the craptasticness of it at celebrex.com. While I'm all for pharmaceutical companies being upfront and honest about their products, from a marketing standpoint, this commercial is an unbelievable disappointment. (Who agreed to this?) It's one of the most boring commercials I've ever seen and goes on and on for – oh say, a minute – about all the side effects of Celebrex before getting to the positive aspects about the drug. Has the FDA changed the rules on advertising NSAIDS that I'm not aware of? Here's your sampling:

"Lately, there has been some confusion about arthritis pain treatments. It is important to know that there are risks with all pain medicines, including the 3 most common NSAIDs: CELEBREX, naproxen, and ibuprofen. In fact,the FDA requires all these NSAID pain relievers, including CELEBREX, to have the same cardiovascular warning. Understanding the risks and benefits of different NSAIDs is important. All NSAIDs, including CELEBREX, help relieve arthritis pain, but only you and your doctor can decide which one is right for you. An NSAID like CELEBREX might be an option."

* I just timed it: It was 2½ minutes long.

Get prescription medication without a prescription

I went to retrieve a printed document at the main office copier/printer/fax yesterday and noticed two unsolicited faxes sitting on the upper tray. The first one was the generic tropical vacation deal; the second was from myfirstpharma.com encouraging whomever to order “prescription medication without a prescription.”

You can go on the site and order the prescription medication they offer:

“Just fill out our online questioner [sic] and one of our doctors will write your prescription. Our pharmacy will then fill your order and ship it overnight to your Door.”

First, let’s address the online “questioner.” It doesn’t ask for your symptoms or why you want the drug. The only exception is purchasing a weight-loss drug. You fill in your height, weight, and BMI to verify obesity. So of course, you can’t lie and say you’re 5′ 4″ and 210 lbs when you’re really 5′ 4″ and 110 lbs. [sarcasm] Click the “Buy now” button and all of the shipping and billing information pops up with the “questionnaire” at the end. You must agree or disagree with the questionnaire that consists of the following:

  1. I agree not to take any over-the-counter medicines without approval from my pharmacist. If you disagree, please explain why.
  2. I agree not to take medication if I am pregnant, breast-feeding, or trying to get pregnant. If you disagree, please explain why.
  3. Please list all current medical conditions.
  4. Is there anything in your medical history that you consider to be relevant?
  5. Please list all over-the-counter and prescription medications that you are currently taking and the length of time for each.
  6. Please list all medication that you plan to take while on this program.
  7. Please list all past or present allergies including allergies to any medications.
  8. Please list all past surgeries and provide details including the condition that was treated with each surgery.
  9. Please explain the specific medical reason for ordering this medication. The physician must know the exact nature of your medical problem in order to prescribe this medication. This cannot be left blank.
  10. Are you currently taking this medication? If yes. How frequent do you take the medication in one day?

If you disagree with any of the above, you need to specify why. (Not sure if you get denied, but it’s what the site requires.) Need an anxiety medication? You can buy Buspar. Want to try different antidepressants without having to go through the hassle of seeing your doctor and dealing with insurance? You can choose from Bupropion, Fluoxetine, Wellbutrin, Paxil, Effexor, and Lexapro.

I highly getting recommend Effexor on your own. [sarcasm]

Pharma AdNeedless to say – but I’ll say it anyway – this is ridiculously dangerous. It’s cheaper to go through your doctor ($15 copay, most likely) and insurance (probably a $20 copay), but if you can’t afford that and can somehow afford prescription medication on your own, you’d better cough up some serious dough. Here’s the going rate for effexor on the site:

30 pills at 37.5 mg – $191.00
30 pills at 75 mg – $209.00
30 pills at 150 mg – $217.00
90 pills at 37.5 mg – $361.00
90 pills at 75 mg – $447.00
90 pills at 150 mg – $427.00

In KBTX.com’s article about the subject, Dr. Garth Morgan of University Family Medicine makes a few good points:

“It’s actually very scary for this type of website to actually exist. You have no way of knowing the physician that is prescribing this to you, or if they’re actually a physician,” [Morgan] said. “Looking at the website there is nothing on there that tells you who the doctors are that are prescribing it.”

“Medicines on the site are addictive, medicines on there have a black market value, and people could sell them on the black market,” said Morgan. “If people get on these sites and start ordering these medications and taking them incorrectly they’re going to be coming to the emergency rooms or my office and I won’t have an idea what they’re taking.”

“The medicines that are meant for prescriptions mean you have to have someone follow over you, look over your shoulder, work with you,” said Morgan. “It doesn’t mean it’s just an inconvenience that you have to have a piece of paper to get the medication.”

I found some more information on panicdisorder.about.com (of all places) about the risks involving the purchase of non-prescribed medications:

What is dangerous about buying medications online?
You may find yourself facing the following dangers if you purchase drugs online without a prescription:

  • Web sites offering medications without prescriptions are illegal and are not regulated in any way. The medication you purchase may be contaminated. It may not be the correct product or it may not even be a medication. You may be given the wrong dose.
  • Wrong medications and dosages put you at risk for drug interactions and other health consequences.
  • Both the FDA and the American Medical Association agree that it is unsafe to take prescription medication without seeing a doctor for a prescription. These illegal Web sites often will provide you with medication after you have filled out a questionnaire. A questionnaire cannot determine if a treatment is appropriate for you nor can it figure out if you have any underlying medical conditions that may be complicated by the medication.
  • If you purchase medications without a prescription from a foreign Web site, you are at risk for being ripped off financially and there will be little you can do about it. It is generally illegal to import most drugs purchased from these kinds of sites.

I’d like some illegal Percocet, but I’d be too much of a scaredy-cat to give any of my credit card info online.

Here’s the lesson, kiddies: Don’t purchase meds online, even if your PCP is clueless to the risks of psych drugs. It’s worth adding that you shouldn’t even purchase psych meds if your PCP is prescribing them.

(photo from The Red State)

Women & Antidepressants

Pink, a magazine for business women, has an article in its April/May 2007 issue titled, “The Magic Pill.” (The only way to read this article is to get a hard-copy of the mag.) No, this isn’t about birth control. The subhead: “Antidepressants are now used for everything from migraines to menopause. But are women getting an overdose?”

Good question. The article, well-written by Mary Anne Dunkin, does a nice job of trying to present both sides of the coin. One subject, Pam Gilchrist, takes tricyclic antidepressants to relieve her fibromyalgia symptoms. “One of the [antidepressants] that allows her to keep going” is Effexor (venlafaxine). God forbid the woman should ever have to come off of that one. (It works well when you’re on it, but withdrawal is sheer hell.)

The other subject mentioned in the article, Billie Wickstrom, suffers from bipolar disorder, but had a therapist who diagnosed her with obsessive-compulsive disorder. The psychiatrist she was referred to promptly put her on Anafranil (clomipramine). We all know what antidepressants tend to do for those with bipolar disorder. Wickstrom blanked out at an interview that she says she normally would have aced. In another incident, she veered off-course after leaving town and spent the night on the side of the road with her daughter. “Search parties in three states” were out looking for them.

“Three years and three hospitalizations later, Wickstrom is finally free of clomipramine and has a job she loves as PR director for a $300 million family of companies. She says she’s happy, she’s focused and she feels great – consistently.”

Dunkin’s article uncovers a large, problematic use – by my standards, anyway – of off-label usage by doctors.

“Gilchrist… is one of the estimated one in 10 American women taking some type of antidepressant medication. And a considerable percentage of these prescriptions, particularly those for tricyclic antidepressants, are not used to treat depression at all.

A growing number of doctors today prescribe antidepressants for a wide range of problems, including anxiety, chronic pain, insomnia, migraines, high blood pressure, irritable bowel syndrome, premenstrual syndrome, menopausal hot flashes and smoking cessation.”

I’m sure the list goes on, but magazines have but oh so much space.

Melissa McNeilDr. Melissa McNeil at the University of Pittsburgh points out three things:

  1. Since depression is a prevalent (see common) condition, doctors are better detecting it.
  2. Since antidepressants have proven their safety and efficacy, primary care physicians have no reservations prescribing them.
  3. Clinical studies are finding that antidepressants can aid a number of medical issues apart from depression.

My take on McNeil’s points (I’ll try to keep them brief):

  • Depression is way too common to be abnormal. If a woman has a rough patch in life for 2 weeks or more, she’s got depression. As for doctors being better at detecting depression? Studies consistently show that doctors are great at overlooking depression in men.
  • Antidepressants haven’t proven jack squat. Placebos have proven more safety and efficacy than antidepressants. PCPs have no reservations prescribing them because they only know about the positive facts that pharma reps tell them instead of researching the potential side effects.
  • Clinical studies aren’t finding all those things out. Seroquel has FDA-approval to treat psychiatric symptoms (psychosis, for one). As far as I know, Seroquel is not FDA-approved to treat insomnia or crappy sleeping patterns. There are no specific clinical studies to see if Seroquel can treat insomnia. Seroquel is prescribed to treat insomnia/restless sleep because doctors have found that a major side effect of the drug is somnolence. If this is the case, Effexor should be prescribed for weight loss. It’d be the new Fen-Phen.

Dunkin cites two widely used antidepressants for nonpsychiatric uses: Wellbutrin (bupropion) and Prozac (fluoxetine). Zyban, used for smoking cessation is, well, bupropion. Sarafem, used to treat PMS symptoms is – you guessed it – fluoxetine.

Viktor BouquetteDr. Viktor Bouquette of Progressive Medical Group thankfully takes a more cautious approach:

“The widespread use – mostly misuse – by physicians of antidepressants to treat women for far-ranging symptoms from insomnia, chronic fatigue and irritability to PMS and menopause is merely another unfortunate example of the pharmaceutical industry’s tremendous influence on the practice of modern medicine. Take enough antidepressants and you may likely still have the symptoms, but you won’t care.”

Kudos to Dunkin for landing that quote. Since Bouquette is part of an alternative medicine group, he’s got a good motive for slamming pharma companies.

McNeil goes on to sound anti-d happy in the article. Not that it matters, but she is also a section editor for the Journal of Women’s Health, which has several corporate associates representing pharmaceutical companies. (She is also the only source in the article who sings anti-d’s praises.) Dunkin tracked down Dr. Scott Haltzman, a clinical professor at the Brown University Department of Psychiatry, who advocated patient responsibility.

“Just because antidepressants work for depression does not mean they should always be used. People need to learn skills to manage their depressive symptoms instead of depending on medication. When you take medicine for every complaint, you lose the opportunity to learn how to regulate your mood on your own.”

Oh, for more doctors like Haltzman and Bouquette.

UPDATE: Uh, alleged fraud suit pending against Progressive Medical Group. Bouquette is now part of Progressive Medical Centers of America.

Hirschfeld developed MDQ for GSK

“GlaxoSmithKline, one of the world’s leading research-based pharmaceutical healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better, and live longer.”

Quetiapine articleOK, I’ll be honest. I can’t keep up with my own posts and have no idea whether or not I’ve posted on this yet. Judging from the fact that I still have this bp booklet, I’m going to guess not. If I have, then there’s more.

When my psychiatrist diagnosed me with bipolar disorder in November, he handed me a bunch of material: a mood tracker (PDF), an article touting the benefits of Seroquel, and a booklet titled, “Bipolar Disorder,” which refers the reader to www.1on1.health.com.

The booklet seems pretty harmless to a patient newly diagnosed with bipolar disorder:

“Highs and lows can be part of life. But, with bipolar disorder, they can be severe. You may feel too depressed to get out of bed one day. Soon after, you may feel full of energy. You may have normal times between the highs and lows. When people have mood symptoms, it’s more likely to be depression.

Mood swings can be hard to predict. But you may have warning signs. You may even learn what can trigger your symptoms. You’ll read about this and more in this booklet.

Bipolar disorder is complex. Doctors docn’t know what causes it. They know that genes play a role. The illness may be linked to brain chemicals. These chemicals can get out of balance.

There are treatments to help control the symptoms. Learn about your condition. Get help for it. This booklet is a good first step.”

Thank you, GlaxoSmithKline.

GSK, the provider of such psych drugs as Lamictal, Paxil, and Wellbutrin, issues a series of booklets for patients referring them to 1on1health.com. The topics include depression, anxiety disorders, epilepsy, type 2 diabetes mellitus, high cholesterol, among others. The tips seems pretty simple and straightforward:

“Health and lifestyle chances may trigger your symptoms. Some common changes are:

Not having a sleep schedule
Misusing alcohol or drugs
Stopping your medicine, or starting medicine for depression or another illness
Having thyroid or other health problems”

Then it gets into the general stuff about the difference between mania, depression and further clarifies what hypomania and mixed moods are. Then, the kicker follows:

“If you think you may have bipolar disorder, fill out the checklist on the next two pages. Share it with your doctor. He or she can use it to help diagnose you.”

Bipolar questionnaireFurious Seasons posted a link about a fake drug named Havidol (which I totally got suckered into because I skimmed the post and missed the “OK, it’s a gag” part), but the hilarity stems from similarly stupid (and vague) questions. I’ve put a screenshot of the PDF GSK provides on their Web site to the right. My issue is not so much with the questions necessarily, but with the lead-in to them:

Has there been a time when...” [emphasis mine]

It doesn’t matter whether you were 3 years old or 46 years old, if you answered “yes” to more than one “there’s ever been a time when” question, guess what? You MAY qualify for bipolar disorder! A sampling:

Has there ever been a time when…

  • You were easily angered that you shouted at people or started fights?
  • You felt much more sure of yourself than usual?
  • You talked or spoke much faster than usual?
  • You were so easily distracted that you couldn’t focus?
  • You had much more energy than usual?
  • You were much more active or did many more things than usual?
  • You were much more social than usual?
  • You were much more interested in sex than usual?

Guaranteed everyone reading this said “yes” to at least TWO questions. If not, I question whether you’re breathing. (Sadly enough, this makes me realize how easy it was for me to get fooled by the phony Havidol quiz.)

The follow-up to the questions above asks, “If you checked YES to more than one of the questions above, have several of these things happened during the same period of time?” Then, “How much of a problem did any of these things cause you (like not being able to work, or having money or legal troubles)? Choose one[:]

  1. No problem
  2. Minor problem
  3. Moderate problem
  4. Serious problem”

The multiple choice question above may not matter. Answering some of the lead-in questions in the affirmative may qualify you for the disorder.

Here’s a nice little tidbit. The questionnaire was “adapted with permission from Robert M.A. Hirschfeld, M.D.” So as an uninformed patient reading this (which I was at the time), I’m thinking, “Oh, this must be legit since they got permission from a doctor to use this checklist.” There’s more than meets the eye here.

On the surface, Dr. Hirschfeld seems like an awesome doctor – and he very well may be. Dr Hirschfeld’s bio from the University of Texas Medical Branch at Galveston (UTMB) extols the “Professor and Chair” of its psychiatry deparment. He has history of working with various national organizations such as the National Depressive and Manic-Depressive Association,  National Institute of Mental Health (NIMH), and National Alliance for Research on Schizophrenia and Depression (NARSAD). He’s written all kinds of articles and blah blah blah. He’s considered a leader in his research of bipolar disorder.

In fact, because Dr. Hirschfeld is so great, he’s a member of pharmaceutical boards and has acted as a consultant for pharmaceutical companies, according to ISI Highly Cited.com. Some of our favorite guys appear here: Pfizer, Wyeth, Abbott Labs., Bristol-Myers Squibb, Eli Lilly, Forest Labs, Janssen, and – lookee here! – GSK.

The duration of Dr. Hirschfeld’s affiliations with these pharmaceutical companies are unspecified. All other “appointments/affiliations” have assigned years, i.e. 1972-1977, 2001-Present. His consulting affiliations follow his internship in 1968-1969. It looks a bit misleading to follow the consulting jobs after, oh say, 1969, and not provide dates of when he became a consultant for all of these pharma companies. Toward the end of the document that I found, his affiliations from 1986-Present are listed with various boards, associations, journals, and a slew of pharmaceutical companies.

Hello, hello, hello. He is a MEMBER of the Zyprexa U.S. Bipolar Academic Advisory Board, the Celexa/Excitalopram [sic] Executive Advisory Board, the Lamictal National Advisory Board, and the Zoloft Advisory Board.

Humor me here. His clinical trials include:

  • 1994 Paroxetine for Dysthymia (SmithKline Beecham)
  • 1995-97 Several (I found five) double-blind studies on sertraline and imipramine in patients qualifying for the DSM-III definition of major depressive disorder
  • 1996-98 Gabapentin therapy for bipolar patients

And the list, including mirtazapine, fluoxetine, venlafaxine, lamotrigine, goes on. You can also find the “grants” pharma companies gave to fund these clinical trials.

From 1997-2000, Hirschfeld received a $100K grant from Abbott Labs to develop “a new checklist for bipolar symptoms.” (I’m not sure what the old one was.) In 2001, he received a $142K grant for the “Bipolar Prevalence and Impact MDQ Project.”

I don’t even need to look MDQ up. It’s Mood Disorder Questionnaire. The grant came from GSK, who “adapted” the questionnaire with Hirschfeld’s “permission.” That sounds simply gravy.

To understand more about bipolar disorder, you can listen to the stories of Greg, Stuart and Leslie – all your classic bipolar cases and how medication and/or therapy has helped them so much. You can also watch the bipolar
disorder animation
that regurgitates all the things that we’ve become skeptical about.

In the meantime, remember the instructions included in Seroquel’s safety information that no one reads (excuse the crappy “Paint” job):

Seroquel warnings

Catching up: Furious Seasons

I’ve been out of it. Really out of it.

In my backlog of reading, Furious Seasons has posted the results of what he’s entitled, "The Zyprexa Chronicles."

The judge ruled in favor of Lilly.

Holy crap. I knew this would happen, but hoped it wouldn’t.

This all occurred on Feb. 13, so I’m really behind the times here. (Did Punxsawtawney Phil see his shadow yet?) But it’s a reminder to, not just the blogosphere, but also to the media that, well, pharma companies are more powerful and have more sway in court.

After reading a bit more on the situation (ok – I’m getting all my info from ONE blog), it seems that the judge hasn’t really ruled against blogs using or disseminating these documents (MindFreedom.org being the exception apparently) but these leaked documents could cause Lilly "irreparable harm." What? Documents that need to be made public would harm Lilly? It’s David against Goliath. Mainstream media — CBS, ABC, NBC, AP — haven’t picked up on this story. The majority of Americans – I’d venture to say the majority of Zyprexa consumers – don’t know about the proven side effects of this drug. I highly doubt it would cause "irreparable harm."

Classic quote:

"The way reporters work is a good deal for the public. We get paid like school teachers, think like lawyers and detectives, fight like Marines when necessary and write like… oh, nevermind."

Man, ain’t it the truth. Especially the schoolteacher pay. Except in Brooklyn, NY where they’ll pay a starting teacher at $40K because they need teachers in the inner city. But I digress.

"So, Ms. [Marni] Lemons (Eli Lilly spokeswoman), what I reported on yesterday — that your company was talking about potentially downplaying glucose increases noted in studies used to approve Zyprexa for long-term use in bipolar disorder — was based on these documents and it sure looks to me like your employees were strategizing all over the Lilly email system. I contacted your press office on Monday and asked them to respond to several questions about that document. Your people never responded….

The same goes for you people at the FDA. Stop telling me to file FOIAs in order to get basic public information that affects millions of people that should already be freely available on your website."

For those who don’t know, FOIA stands for Freedom of Information Act, in which anyone can write to a governmental agency and appeal for documents that have been made public. The nice part about this? The agency can black out information that don’t want you to know. They can deny your request, block out some data, or block out so much that the document ends up being useless. Oh, and FOIAs take forever and freaking day to arrive because the gov’t sends them when it’s convenient for them.

Furious Seasons has also been following the NYT’s coverage about a child diagnosed with ADHD and bipolar, who was killed and supposedly overdosed on medication. Riiight. Unfortunately, from what I can see – perhaps I’ll find a bit more – the NYT is extensively covering mental health issues. Perhaps they’re getting a ton of hits on the Zyprexa series and have figured out that people actually care about mental health topics. Whatever the reasoning, I’m glad they’re doing it.

Astute observation from Furious Seasons:

"This whole diagnose-medicate-blame-the-"illness"-for-bad-outcomes nonsense has got to stop. It’s bad enough in adults and teens, but in kids it is a complete outrage. It is interesting to me, though, that when a child dies, the skeptical questions are asked. When an adult has awful results from taking Zyprexa, say, or Paxil, the media is largely silent."

More to come on other blogs…

Pristiq gains ground with FDA

FDA approval for Pristiq (I'll refer to it as Pq occasionally) is contingent upon Wyeth's handling of "quality control problems… made to the satisfaction of federal inspectors." As I'd previously mentioned before, Wyeth has built an amazingly similar medication based on Effexor. Wyeth is trying to market Pristiq as an antidepressant and treatment for vasomotor symptoms (hot flashes during menopause). Wyeth is significantly banking on Pristiq since their $3.5 billion Effexor XR will lose its patent in a few years, allowing other companies to make venlafaxine generics.

Some of the "quality control" problems Wyeth is experiencing:

  • unclear whether Pq keeps depressive episodes at bay
  • efficacy at low doses and in young kids
  • severe nausea in 50 percent of patients in the clinical trials

Reuters' article notes this, though:

"But the studies do not need to be completed prior to approval of the new depression pill."

While Wyeth has admitted that Pq is "structurally related" to Effexor, it "has not yet disclosed if Pristiq has any advantages over Effexor XR, other than to say it would be an alternative to existing treatments."

But it has acknowledged the newer drug caused nausea in about one-half of patients in clinical trials.

Wyeth is banking on patients sticking out the nausea for one week (it supposedly subsides after that) or a 50 mg pill that would be more effective than the whopping 400 mg they used in earlier phases of the clinical trials.

"The company said it will not launch Pristiq until it obtains results from the low-dose trials. Moreover, Wyeth said the timing of the launch also will depend on progress of the FDA's ongoing review of Pristiq as a possible non-hormonal treatment for hot flashes. The FDA is scheduled to decide on the hot flashes indication in April."

Wyeth wants to be absolutely sure they can cover all of their bases in an effort not to lose a single portion on their market share — from those who can tolerate low doses at 50 mg to those who need to go 400 mg and up.

"A G Edwards analyst Joseph Tooley has predicted Pristiq will garner annual sales of $1.4 billion by 2011 — about $1 billion from use against depression and the remainder for menopausal symptoms."

Getting not only psychiatrists to prescribe the drug, but also OB/GYNs is a clever move on their part.

Loose Screws Mental Health News

Wow. I learned something new – “Women are over-represented in all cases of” depression, anxiety, dysthymia and panic attacks. Read more here.


An interesting observation from Gretchen Rubin, blogger of The Happiness Project.

“Studies showed that depressed people have as many nice experiences as non-depressed people, but they remember them less well.”


Graham’s Blog has linked to interesting fashion jewelry: Made with Molecules. For only $20, you can:

“Display your favorite neurotransmitters close to your brain!”

Erhm. The very thought of this disturbs me. Also feel free to purchase a serotonin-happiness card or a dopamine-heart card – just in time for Valentine’s Day.

dopamine heart card

Pfizer is cutting 10,000 from its workforce citing nothing other than loss of profits:

“The drug giant Pfizer said Monday that it would lay off 10,000 workers and close several manufacturing and research sites in an effort to bolster earnings hurt by the loss of patent protection on certain drugs and by setbacks in developing new products.”

I’ve mentioned patent protection before but it seems that Pfizer isn’t generating enough “structurally related” drugs to prevent the loss of its profits to generics. The two biggest losses: Zoloft and Zithromax.

“Pfizer said the moves would save $1.5 billion to $2 billion a year in pretax expenses.

Pharmaceutical industry analysts have generally been welcoming cutbacks by Pfizer but have said that while cost-cutting is beneficial, the company needs to resume growth by bringing new products to market.”

Pfizer’s a big company; I’m sure they’ll have no problems rebounding. However, I have no doubt that the failed torcetrapib factored into Pfizer’s decision to cut staffers.


A Philly plaintiff in the Vioxx suit against Merck has willingly withdrawn her suit. She cannot refile against Merck.

“Merck has consistently said it will fight each case on a one by one basis rather than submit to a large settlement.

In trials that have reached a jury verdict so far, Merck has won nine and lost four, including one Merck victory that since has been thrown out.”

The legal fees surrounding the Merck case must be astounding, but is it really worth it for Merck to drag these cases out against 27,000 other plaintiffs? I would assume on Merck’s part that it would be cheaper to settle. But then again, maybe it’s the whole “we need to clear our name” thing. That’s a fast way to lose profits for a pharma company.

Eli Lilly: Zyprexa causes diabetes; Byetta can help

I found this Bloomberg chart in the Metro Philly newspaper and thought it showed an interesting paradox. I tried to find a link for it on the Internet but as of yesterday, there was none.

Eli Lilly's Byetta

An Interesting Observation

Time’s Quote of the Year:
“Actually, I thought we were going to do fine yesterday – shows what I know.” – President Bush on the midterm elections

CLASSIC.


An interesting observation I don’t know if anyone has already made or if anyone will pay attention to – Time‘s 2006 POTY issue carried 14 medically- or pharmaceutically-related ads. Two of those ads were full-color spreads related to two major pharma companies: AstraZeneca (an ad letting you know they can help/care) and Eli Lilly (touting the benefits of Cymbalta). I couldn’t help but stop and stare at Ambien CR’s ad pages. Ambien CR, a version of the popular sleep aid developed sanofi aventis has a WHOPPING 3.5 pages. Three-quarters of the first page is the Ambien CR color ad and the bottom quarted is  “Important Safety Information” in a blue box. Turn the page and there is nothing but fine print black text streaming across TWO pages. As if a quarter-page of safety information and a FULL two pages weren’t enough, flip the page again, and more “information for patients” continues for a half-page. I’d like to  know someone that’s actually read ALL those warning/safety information things. How many people actually READ all two and three-quarters (2 3/4) of safety information? I’ll be honest with you; I sure don’t. I skip all that stuff. But it’s there so when people suffer side effects, the company can say, “Hey! We  included this in our advertisement! It’s everywhere; you have no basis to sue.”

AstraZeneca, the maker of antipsychotic drug, Seroquel, writes in its ad (click on the thumbnail to see the modified scanned version):

AZ“A pharmaceutical company saving you the money on the medicines it makes.Imagine that. [larger font]

If you take any AstraZeneca medicines, you may be surprised that there’s someone you can turn to for help if you can’t afford them: Us. A family of four without prescription covrage making up to $60,000 per year may qualify for patient assistance. The AstraZeneca Personal Assistants can assist you in signing up for programs that can provide you free medicines or significant savings IF you qualify. [emphasis mine]
We’ll be the first to admit we don’t have all the answers. But as a pharmaceutical company, we recognize that when you trust us to help you, we feel we owe you the same trust in return. That’s what AZ&Me is all about. A place we’re creating to put the personal touch back into healthcare.

Please visit AZandMe.com or call 1-800-AZandMe.”

AstraZeneca Personal Assistants??? What is this? A department store? I can hear it over the loudspeaker now: “Now, calling all patients who use AstraZeneca medicines, we have personal assistants who can help you select the right care and plan to help you get the medicines you need.” And the cute slogan AZ&Me slogan. How adorable. It just makes you want to cuddle right up to Big Pharma! Because remember, they’re putting the “care” back in “healthcare.”  (sarcasm)

If anyone has used AZ&Me to get Seroquel for free or at a discount, e-mail me ASAP at suicidal.recovery AT gmail.com. I’d love to communicate with you.