Furious Seasons

Glaxo Goes After British Blogger's Video

I learned yesterday that attorneys representing GlaxoSmithKline in the UK had sent a letter to Bob Fiddaman, who writes the Seroxat Sufferers blog. Seroxat is Paxil's brand name in the UK. As a result of the letter, Fiddy felt compelled to remove a video he created and posted to his website in February. It's not clear to me what specific legal action the lawyers threatened.

I linked to the video when it was originally posted in February since I felt it got at some of the issues that had just been aired in the British and American press concerning accusations that GSK had hidden suicidality data connected with the use of Paxil. The person making that accusation was none other than Harvard clinical psychiatry professor Joseph Glenmullen who had reviewed clinical trials data in connection with a California lawsuit. Fiddy's video presented statements made by Alistair Benbow, a GSK UK official and medical doctor, concerning the drug's suicidality profile and contrasted them with statements in the British press about Seroxat's suicidality profile as well as interspersing all of that with information about select patients who had experienced some of the drug's rotten side effects. There was even background music.

Fiddy, in essence, posed the question of whether Benbow was a liar.

The whole thing seemed innocent enough since Fiddy was working with known facts and seemed to be presenting them in a reasonable fashion. But GSK's attorneys, apparently writing to Fiddy on behalf of Benbow, objected to the fact that Fiddy had employed GSK's logo in his video. What's more, the video was posted to YouTube and in the comments section someone asked Fiddy a question and Fiddy compared Benbow with Hitler, as I understand it. The attorneys apparently complained to Fiddy that Benbow was feeling harassed as a result of the video. And they also took umbrage that Fiddy has implied that Benbow was a liar.

Fiddy explains his view of the situation here. He took the video off of YouTube recently and issued an apology to Benbow. Fiddy, most of you know, had some rotten experiences on Seroxat (Paxil).

Going after Fiddy for comparing Benbow to Hitler shows an incredibly thin skin on Benbow's behalf and how silly British press laws are (the subject for another day perhaps). It's also a move that Fiddy should regard as a backhanded compliment and a badge of honor. He's being targeted because he is one of the loudest voices on the Internet denouncing GSK and how it's handled Paxil/Seroxat and he's clearly gotten under Benbow's skin. Basically, GSK used lawyers to intimidate an activist into shutting up, especially in light of the fact that there are many, many others on the Internet who have talked serious trash about Benbow. Unless GSK plans to go after everyone who's said anything sharp about Benbow, then they have singled out Fiddy.

Beyond that, this kind of behavior on GSK's part chaps my hide, as the saying goes, because GSK has had run ins with academics before and attempted to stifle their views. I simply won't tolerate this sort of nonsense and since I have obtained a copy of the video thanks to the magic of the Internet, I am posting it here, unedited.

The video is also on YouTube here. You can comment on it here or on YouTube. I know that Paxil/Seroxat stirs passions like few other psych meds, so I'd simply ask that people who feel compelled to comment on this matter in any fashion keep their rhetoric reasonably decent.

Atypical Antipsychotics Again Fail To Outperform Old Antipsychotics

In a new study just out in The Lancet, Dutch researchers report that second generation antipsychotics (aka, atypicals) do not beat first generation antipsychotics in treating symptoms of schizophrenia in first-episode patients. And if they can't beat the old drugs in doing what they were primarily designed to do, then why are they worth upwards of 20 times the cost of the first generation antipsychotics? Why is that question not even being asked by Congress and government officials, given that the government pays for the cost of about two-thirds of these drugs?

Anyway, the study is so new that it's not on the journal's website yet. The brief rundown is that it involved 498 patients experiencing a first episode of psychosis. The drugs studied were Haldol (first generation) and Seroquel, Zyprexa, Geodon and Solian (all second generation drugs). Solian is not available in the US.

The study found that the drugs treated symptoms of schizophrenia equally between the two classes with around a 60 percent success rate. The differences that popped up were that there was generally a longer time to discontinuation of the drug (translation: the patient cannot stand the drug's side effects and goes off of it) for the second generation meds. Zyprexa appears to have been the winner in that regard, which strikes me as odd, given its side effect profile. But I haven't seen the full paper so it's difficult to judge. Then again, this study was underwritten by AstraZeneca, Pfizer and Sanofi--and I've learned to be skeptical of results from pharma-sponsored studies.

I am slightly suspicious that there was such a marked difference in time to discontinuation between Haldol and the newer drugs since the landmark 2005 CATIE study found that that time was roughly similar. But then CATIE studied schizophrenics whose first episode of schizophrenia had been roughly 20 years earlier and this study examined patients in their first episode. So there is a certain amount of apples to oranges here.

This now marks the third time in recent years that a large study has found that that first generation antipsychotics performed about as well as second generation antipsychotics in treating schizophrenia despite the vast cost difference. In 2005, it was the CATIE study in the US, followed in 2006 by the British CUTLASS study. At this point, I would say that most intelligent doctors should be leery of the newer drugs.

Even more broadly, what truly pisses me off about the collective evidence for the atypicals is that these drugs were supposed to be so much better than older drugs and so much safer than the older drugs that not only could they be "silver bullets" for schizophrenia treatment, they were good for darn near every emotional condition between heaven and earth. That hype has led to the atypicals being used as frontline treatments for bipolar disorder, ADHD, dementia, depression, anxiety, autism, conduct disorder and so on. Much of that use has been off label and medically unjustifiable and much of that use in my mind has been an immense rip off of patients and taxpayers.

When is someone in power going to get off their lazy butt and do something about this nonsense? Are there any doctors out there with a shred of decency left who might maybe think twice about prescribing these drugs to their patients?

Is America Really So Sick And Anxious?

That's the question posed by Christopher Lane, author of Shyness: How Normal Behavior Became A Sickness, in an op-ed in the New York Sun yesterday. (BTW, I interviewed Lane last fall on his new book and you can read that here.) It's a legitimate question given that some researchers believe that about 50 percent of Americans have some form of a mental disorder under the dictates of the DSM. So are we really that ill or is the DSM just that expansive?

"DSM-III grew out of meetings that many participants described as chaotic. One observer later remarked that the small amount of research drawn upon was "really a hodgepodge - scattered, inconsistent, and ambiguous." The interest and expertise of the task force was limited to one branch of psychiatry: neuropsychiatry. That group met for four years before it occurred to members that such one-sidedness might result in bias.

"Incredibly, the lists of symptoms for some disorders were knocked out in minutes. The field studies used to justify their inclusion sometimes involved a single patient evaluated by the person advocating the new disease. Experts pressed for the inclusion of illnesses as questionable as "chronic undifferentiated unhappiness disorder" and "chronic complaint disorder," whose traits included moaning about taxes, the weather, and even sports results.

Social phobia, later dubbed "social anxiety disorder," was one of seven new anxiety disorders created in 1980. At first it struck me as a serious condition. By the 1990s experts were calling it "the disorder of the decade," insisting that as many as one in five Americans suffers from it. Yet the complete story turned out to be rather more complicated. For starters, the specialist who in the 1960s originally recognized social anxiety - London-based Isaac Marks, a renowned expert on fear and panic - strongly resisted its inclusion in DSM-III as a separate disease category. The list of common behaviors associated with the disorder gave him pause: fear of eating alone in restaurants, avoidance of public toilets, and concern about trembling hands. By the time a revised task force added dislike of public speaking in 1987, the disorder seemed sufficiently elastic to include virtually everyone on the planet."

And as we know things have gotten freakier since DSM-III in 1980. Consider: the revision of manic depression into bipolar disorder 1 and bipolar disorder 2 in 1994 has led to a situation where some researchers and pharma companies now run around claiming that bipolar disorder affects 5 percent of the adult US population, whereas before the inclusion of the softer BP2 the prevalence of manic depression (aka, BP1) was pegged at 1 percent of the adult US population. I doubt that the rate of mania (needed for a BP1 diagnosis) has increased in our culture enough to justify that number, meaning the increased prevalence is largely due to BP2.

Consider as well: most cases of BP2 are commonly depression coupled with the occasional bout of agitation and insomnia. But with a bipolar 2 diagnosis, these same folks will be written off as crazies, as bad as people who are manic all the time, and pounded with meds until their symptoms don't exist and neither does the patient. All because they have depression and can't sleep?

That simply doesn't strike me as mental illness and it certainly strikes me as bad health care policy.

In other words, Lane is onto something and it's not just applicable to anxiety.

FDA Investigating Suicide Link To Singular

Just out is news that the FDA will review reports of suicides and suicidal ideation connected with use of the allergy drug Singular. The drug is made by Merck.

"FDA said it asked the Whitehouse, N.J.-based company to dig deeper into its data on Singulair for evidence of possible links to suicide. The agency said it has not established a ''causal relationship'' between Merck's drug and suicidal behavior. An agency spokeswoman said the review was prompted by three to four suicide reports it received since last October."

I am glad to see that the FDA is finally--after decades of people like me complaining to them--taking the issue of medications and suicide induction seriously.

Risperdal Kills Nursing Home Patient

An Illinois nursing home faces fines from the state after giving an unidentified patient the atypical antipsychotic Risperdal at 10 mgs. a day. I've been around mental health issues for years and I think the highest dose I've ever heard of anyone getting of Risperdal was 8 mgs. a day and that was for a severely psychotic person.

What may have happened in this case is that the pharmacy order was written for 5 mgs. of Risperdal twice a day, so you have to suspect that someone in the pharmacy missed a decimal point--as in .5 mgs. of Risperdal twice a day. Either way, a nurse or someone else should've caught the mistake since 10 mgs. of Risperdal makes no rational sense for anyone, especially a nursing home patient.

The patient received 19 doses of 5 mgs. in January 2007 and died the next month of a heart attack.

Anti-Depressants Linked To Diabetes?

OK, this is all new to me, but a Canadian researcher has published a paper (which I cannot even find the abstract of) in Diabetes Research and Clinical Practice asserting that people taking anti-depressants have a 30 percent higher risk of developing diabetes. Would that be caused by the meds or something else?

"Brown said it's not entirely clear whether it's the medication itself or the more severe depression that's actually causing the Type 2 diabetes.

"She said a growing body of medical literature draws a link between mental illness and chronic physical conditions associated with Type 2 diabetes -- such as heart disease.

"'Depression can be so debilitating,' said Brown. 'There's decreased motivation, weight gain, some people can barely get out of bed in the morning, so you obviously don't take care of yourself (physically) the way you would if you weren't depressed.'"

Apparently, the study found the prevalence of diabetes to be highest among patients taking both an SSRI and tricyclic anti-depressant in combination. Patients taking either class of drug by itself didn't have such high rates, so there could be something about the combined effects of the drugs. Either way, I've never heard of a similar assertion before, so I'd like to see some more evidence.

For those of you who might read into this that I am an anti-depressant hater, please understand that I am just putting information out there on the risks associated with these drugs. Whether or not you take them is entirely your call.

The Zyprexa Chronicles: Thoughts On Alaska Settlement

I know more than a few readers are disappointed in the $15 million settlement reached between Alaska and Lilly on Tuesday. Yes, the settlement was a bit of a surprise, especially this late in the game as the New York Times notes, but Lilly's pattern is to settle these cases. It's cheaper than a jury verdict and allows sales reps to continue to spread the good word about the company's drug. It also allows Lilly's lead attorney, Nina Gussack, to say things like:

"The agreement included no admission of wrongdoing by Lilly, which is based in Indianapolis.

"Nina Gussack, who headed the Lilly trial team, called the settlement a 'very positive resolution.'

"'It certainly, in light of the state's initial views about what this case was valued at, represents an extraordinary resolution for Lilly,' Gussack said.

"Court-ordered mediation had been begun before jurors heard opening statements March 6 and culminated with the settlement Tuesday night. The company was confident in the defense it had presented so far, Gussack said, and the state likely recognized the value of Zyprexa and how it continues to be prescribed.

"'I think against that background, resolving cases for relatively modest amounts, given the history here, is always a good thing for litigants,' she said."

I don't know what pattern this will set for the other nine states currently suing Lilly or for the 25 or so states pondering a multistate lawsuit or for the feds. I'd assume that Lilly's lawyers would get back to negotiating very hard with the feds, but beyond that who knows. My hunch is they are going to settle as many of these claims as possible.

One thing is clear: there are simply too many lawsuits against Lilly for the Zyprexa story to go away any time soon.

Stay tuned.

The Zyprexa Chronicles: Lilly's Statement On Alaska Settlement

Here's Eli Lilly's statement regarding its last minute settlement with the State of Alaska in the Zyprexa case:

"The agreement resulted from ongoing mediation ordered by trial Judge Mark Rindner before the trial began. Presiding Judge Morgan Christen renewed mediation efforts with the parties last week.

"The settlement will include payment by Lilly of $15 million plus a term that will ensure that Alaska is treated as favorably as any other state that may settle with Lilly in the future over similar claims.

"'I am very pleased with the efforts by Assistant Attorney General Ed Sniffen and our team of trial attorneys,' Colberg said. 'We believe this is a good result for the State of Alaska and the Department of Health and Social Services,' he added.

"'We believe this settlement is in the best interest of the company, the State, and, importantly, of the patients, families and healthcare professionals for whom Zyprexa is an important treatment option,' said Robert A. Armitage, Lilly's senior vice president and general counsel.

"In addition, Lilly provided the following information:

"'While we had a strong defense, we agreed with the State that the best result for everyone is an amicable resolution,' Armitage said. 'A trial always involves significant time and resources, especially a two-phase trial like this one that posed additional legal hurdles. A settlement helps us get back to what we want to focus on as a company: developing important new medications through research and partnerships with doctors and patients.'

"'We appreciate all the time and energy the jury invested over more than three weeks in such a complex case,' Armitage added.

"The agreement involves no admission of wrongdoing on Lilly's part.

"The March, 2006 lawsuit claimed the State and healthcare providers were insufficiently warned about possible side effects relating to weight gain, high blood sugar and diabetes, causing harm to the State's Medicaid recipients and increased costs to the State. The lawsuit asked that Lilly pay the State for those costs and pay civil penalties under the Alaska Unfair Trade Practices and Consumer Protection Act (UTPCPA).

"Prescribed for more than 23 million people since its initial approval by the FDA in 1996, Zyprexa is regularly prescribed in the U.S. and in more than 80 other countries. One of a class of medications called 'atypical antipsychotics,' it is approved to treat schizophrenia and bipolar disorder.

"'Our decision to resolve this case does not change the fact that Zyprexa can continue to improve the lives of patients around the world who are suffering from schizophrenia and bipolar disorder,' Armitage said."

The State has not issued its own release yet.

The Zyprexa Chronicles: Breaking: Lilly Settles With Alaska For $15 Million

I am stunned to report that the Alaska v. Lilly trial settled yesterday for a mere $15 million. This move will be picked apart by many in the mental health and pharma worlds--and since I learned of it very early this morning, and after I'd been out for a few hours, I will refrain from comment for now. Except to note that the Zyprexa documents are that much more important than they were yesterday.

More later today.

The Zyprexa Chronicles: Two Answers For Psychosis, One Great Story

The New York Times' Alex Berenson, whom I hold in very high regard, stumbled onto an amazing real life paradox while in Alaska last week and turned it into a fascinating story. Brief summary: upstairs in the court house, Lilly was defending Zyprexa as good and safe and valuable for schizophrenics (the week before the drug had been declared unsafe and the company liable for all manner of problems according to the plaintiff's case) while downstairs a judge was conducting a commitment hearing for a man who seems to have been pretty much delusional and, ironically in the minds of many docs, an appropriate candidate for treatment with Zyprexa or a similar drug. But the judge was operating under the strictures of a fairly recent Alaska Supreme Court ruling (I wrote about this case 18 months ago. I now know that I was not exaggerating that the case, Myers v. Alaska, would have real world implications) that makes it illegal for the State of Alaska to commit people to the state hospital and give them medications that may be of harm to them, especially if less restrictive alternatives were available. The judge didn't commit the man.

The drug at the center of Myers was Zyprexa.

How could the judge commit the man with the evidence of harm caused by antipsychotics that had been laid out upstairs earlier this month? As a class, the atypical antipsychotics are not all as bad as Zyprexa (Clozaril is arguably worse), but they all have serious problems attached to their use and it appears to me that the man may suffer some of the consequences of being on these medications in the past. You read the story and tell me what you think.

If the judge had committed the man, then the man's lawyer would've had a writ up to the Alaska Supreme Court tout suite. That's simply a stunning sea change in jurisprudence and mental illness in American culture. It's also a huge experiment, practically speaking, and I hope it works out. I'm also sure that somewhere Back East Fuller Torrey is composing an op-ed.

Here's another irony: the case that resulted in the above state supreme court ruling was argued by Jim Gottstein. I'm sure most of you will recall that Gottstein is the Anchorage lawyer who passed off the Zyprexa documents to Berenson in late 2006, documents which Berenson used to detail all sorts of misbehavior by Lilly in the Times. The irony here is a bit much for me.

Anyhow, Berenson's piece is well done and you ought to read it. He does such a good job of handling the piece that I am professionally jealous. Oh, did I mention that it includes a photo of two attorneys representing Lilly?

The Alaska v. Lilly case should have its closing arguments today or tomorrow. The case would then be expected to go to the jury which is being asked to consider whether the company was liable or not of covering up risks associated with the use of Zyprexa. If the jury finds the company liable, then a separate jury will be asked to set a monetary award. More on that later.

The Zyprexa Chronicles: Zyprexa Documents Hit YouTube!

A UCLA PhD candidate in History who's a reader of this site came upon a genius idea: making a video of himself reading one of the Zyprexa documents on YouTube. His name is Brad Fidler (website) and the document he chose (ZY100175096 4.1 MB .pdf) had details of a little role playing game Lilly wanted Zyprexa reps to play in order to increase their knowledge of the drug. The document is quite large, so please use my bandwidth sparingly, and is the primary "Viva Zyprexa" campaign roll out in 2000. The game is called "Family Feud" and is on page 61 of the 67 page document.

Yes, the game sounds weird, but I recall from my own pharma company reppin' days that during sales training reps often acted out various roles--doctor, nurse, purchasing agent, etc.--with one another so we could sell our products better.

Here's the video:

Inventor Admits New Bipolar Gene Test Has Problems

There's been quite a rush of researchers lately proclaiming that they've developed a genetic test that will tell someone if they have bipolar disorder. The latest example comes straight out of my old stomping grounds of San Diego where John Kelsoe, a UCSD psych researcher, has developed an alleged home gene test for bipolar disorder and works with a company named Psynomics--the name is a riff on genomics--to market the test at $399 a pop.

Beyond my usual concerns about these tests, which I'll come to in a second, the researcher admits:

"Kelsoe, 52, acknowledges that bipolar disorder probably results from a combination of genetic factors and life experiences, and that the presence of these gene variations does not at all mean that someone will, in fact, develop the disease. He admits, too, that his findings about the genetic basis of the illness are far from complete.

But he said his test is a vital starting point toward moving away from the notoriously tricky practice of diagnosing bipolar disorder based purely on a person's behavior.

"'The goal of this is to try and help doctors make an accurate diagnosis more quickly so the patient can be treated appropriately,' Kelsoe said. 'Anything is going to help, even if it just helps a little bit.'"

Actually, having lived through 20 years of the anything-will-help paradigm, I am going to have to shake my head at all of this. Would you buy a test from a company that admits that the test is incomplete? I wouldn't. I also cannto figure out who would invest in the company in the first place.

There is no legitimate basis upon which researchers can claim any longer that bipolar disorder is a strictly genetic disorder, and it's really time for them to stop hyping it as such. Such talk creates a set of false expectations for patients with bipolar disorder (gene therapy will cure me!) and encourages them to not do the psychological grunt work they must do in order to live productive lives. I especially worry about this test being used on children and the results being employed by parents, doctors, schools and so on to determine how the child will lead the rest of their lives. And that's even assuming that bipolar disorder exists in children, which I think doesn't exist in kids.

Even more, these tests, as I have noted before, could wind up being sources of profound discrimination for patients, or potential patients, and could lead to an epidemic of misdiagnosis.

In the above article, Kelsoe says that this test will create an objective standard for diagnosing bipolar disorder. I heartily disagree. There isn't even anything approaching consensus for what genes are involved in, or predictive of, bipolar disorder, so I'm not sure where Kelsoe is coming from.

"Among hundreds of families Kelsoe has studied, one of the gene variations in the Psynomics test showed up in 1 percent of those unaffected by the disorder versus 3 percent who are affected. The other variation appeared in 7 percent of those without bipolar compared to 15 percent who have the disease."

That's not a particularly impressive correlation between gene variants and the disorder. Yes, let's all go make people take this test and medicate them on the basis of an incomplete test for a disorder that is poorly understood. Makes perfect sense.

South Africa Runs Out Of Psych Meds

Here's one of the weirdest stories I've run across in a while: mental health patients in South Africa are running out of their meds, reportedly because there is a lack of raw materials to make them and pharmacies don't have the drugs in stock. I'm not sure that I buy that explanation (if it's true, then what's going on in China where many raw materials are created?), but it sure does make the hair stand up on my neck to consider what would happen if there were a shortage of anti-depressants, antipsychotics or mood stabilizers in the US or Britain, for example. And whether you like or hate meds, you ought to be a bit concerned about what's going on in South Africa because there must be a bunch of cold turkey withdrawal going on there, and there are likely more than a few patients who will wind up in deep trouble as a result.

It's not clear how this situation will be resolved, but it sure speaks to problems in the international pharma market that this is going on. For all we know, this is the tip of the iceberg.

The Zyprexa Chronicles: Judge Says FDA Can't Police Drug Safety

There's been spotty coverage of the Alaska v. Lilly trial ever since Lilly began to mount its defense last week. That's apparently because Lilly's lawyers are taking the tactic of putting an expert on as a witness, who claims that there is no link between Zyprexa and diabetes, and then claiming it properly warned the FDA about any risks associated with the drug and that, thus, its butt was covered. In other words, a very simple argument that will play out over the next day or so before jurors hear closing arguments possibly as early as tomorrow.

The trial judge isn't necessarily buying all of Lilly's arguments.

"Without lawsuits like the one the State of Alaska brought against Lilly, claims that drugs cause health problems 'might well go unaddressed,' Anchorage Superior Court Judge Mark Rindner said from the bench this week.

"The jury was out of the room. The state had just rested. Lilly asked the judge to issue an immediate verdict in its favor, a routine step at that point in a trial.

"Rindner was reacting to an assertion by Lilly lawyer George Lehner that drug regulation is a matter for the federal Food and Drug Administration, not any state. Alaska's Unfair Trade Practices and Consumer Protection Act shouldn't apply to drugs, Lehner told the judge.

"Rindner disagreed. Evidence presented by the state over the past two weeks established that the FDA 'isn't capable of policing this matter,' he said."

I think the judge is right on both counts, especially in his assertion that the FDA can't police the drug marketplace completely. The FDA is wildly understaffed and the rules they operate under are essentially written by Big Pharma's lobbyists--you all do remember the Medicare Plan D business right?--and that makes it hard for the FDA to do much. As much as some wonks might not care for state court trials over drugs, the sad fact is that this is the only way to hold companies accountable when they misbehave.

I'm Back

I decided to take the end of last week off, but I am back in the saddle now, so to speak, and will be playing catch up today. Stay tuned.

I hope you all had a nice Easter/Spring Break.

Atypical Nation: Seroquel Described As "Heroin Substitute"

I am not making this up: An account in the Patriot Ledger of a drug bust in Massachusetts describes the atypical antipsychotic Seroquel thusly:

"Detectives found numerous prescription pills--the heroin substitutes Suboxone and Seroquel--as well as heroin, cash and plastic bags, police said."

I'm not sure if that was an awkward bit of writing or if Seroquel has truly entered the underworld as a sociocultural variant on OxyContin, aka "hillbilly heroin." Either way, Seroquel is a known drug of abuse in prison systems and on the streets (it's also one of the leading recreational drugs amongst our troops in Iraq) and there are numerous reports of patients who developed a tolerance to the drug when taking it as instructed by a doctor.

It's also the subject of three separate applications to the FDA to have the drug approved as a treatment for depression.

Ain't America grand?

The Zyprexa Chronicles: $2 Billion May Hinge On Alaska Case

The stakes could hardly be any higher for Eli Lilly as it defends itself against the State of Alaska's allegations that the company failed to warn doctors and patients about problems with its drug Zyprexa. According to Bloomberg, losing in Alaska could have huge implications for other outstanding lawsuits against the company and stalled negotiations with the feds and about 25 states. A loss in Alaska could set the stage for another $2 billion or so in payouts to states and the feds.

"A defeat would weaken Indianapolis-based Lilly's position in nine other states' suits and separate consumer-protection investigations in about 30 states. The company resolved about 31,000 patients' claims for $1.2 billion. Total exposure in the rest may reach $2 billion, said David Stallard, a lawyer for Utah, which sued last year. That's equivalent to $1.83 a share.

"'We'll feel like we have a stronger hand if Lilly loses,' Stallard, 55, said from Salt Lake City. 'Even if Lilly was willing to pay $1 billion, it isn't enough to satisfy all the parties at the table.'"

Earlier reports indicated that Lilly was seeking to settle claims with the feds and some of the states for about $1 billion.

No news yet from Anchorage on how the trial has gone the last two days.

BTW, I'll mostly be offline today. Traffic is slow due to spring break/Easter break and I'm catching up on some other things.

The Zyprexa Chronicles: Lilly Opens Defense Today

I hear through the grapevine that the State of Alaska wrapped up presenting its case against Eli Lilly yesterday over allegations of its handling of the drug Zyprexa. I'll have more on how the case wrapped as soon as I read some news accounts of the proceedings. The plaintiff's case has gone largely without fireworks: patients who took the drug developed diabetes, Lilly knew as early as 1998 that its drug could cause diabetes, the company didn't inform doctors of any differential risk of diabetes and other problems with its drug until 2007 (as opposed to the antipsychotic class wide warning in 2003/4), even though it had a duty to warn doctors and patients earlier.

Accusations of off-label marketing were kicked out of the case by a judge pre-trial, likely due to the dubious federal preemption standard.

I also understand that Lilly is expected to open its defense of how it handled Zyprexa sometime on Tuesday. I'll have more on that when I know more, but I expect Lilly's attorneys to argue that the company provided all relevant safety data to the FDA and that since the agency didn't ask it to warn anyone, it didn't have to warn anyone. Putting the FDA on trial, in essence, ought to be an interesting trick. We'll see what a jury makes of that.

Tibet Protests Hit YouTube

I admire the courage of the many Tibetans who are rising up against the Chinese government. There are conflicting reports of how much violence is taking place, but you should have no doubt that the Chinese will do whatever is necessary to crush the revolt and that the world will not hold it against them in the run up to this summer's Olympic Games in Bejing.

Politics is a bit out of my usual realm on this site, but I've met many Tibetans over the years and I respect these folks more than I can tell you.

The Chinese government should grant these people their independence and get the hell out of Tibet.

Northern Illinois Shooter's Toxicology Report Released

Officials released the toxicology report for NIU shooter Steven Kazmierczak on Friday. His blood contained trace amounts of nicotine, Xanax and two cold medicines. There were no traces of an anti-depressant.

None of that does much to prove or disprove various arguments around what drove the shooter to kill five others and himself at the university last month. His former girlfriend was variously quoted as saying he had stopped taking Prozac cold turkey--always a bad move--a few weeks before the shooting.

The Zyprexa Chronicles: Alaska Jurors Hear Of 2002 Japanese Label Changes

I've paid attention before on this site to the fact of Japanese label changes concerning hyperglycemia and diabetes that the Japanese government imposed on Zyprexa in early 2002. On Thursday, jurors in the Alaska v. Lilly case heard from plaintiff's attorneys about how Zyprexa sales tanked by 75 percent in Japan after the warning. It hurt the company elsewhere:

"'Market research shows we have also lost quite a bit of credibility with prescribers and opinion leaders, basically because they felt left in the dark with what they perceived as the late sharing of safety information,' two Lilly executives wrote that year in a memo to John Lechleiter, the company's chief operating officer and president."

That's the same Lechleiter who apparently wanted to press Zyprexa on kids in 2003, according to a report in the New York Times on Friday.

"Lilly didn't agree with the health ministry's ruling, and said so, arguing against the warning on the drug label, Lechleiter said in his video deposition, played in the courtroom. That might explain why one of the executives thought the company 'lost substantial ground and trust' with the government in Japan, he said."

Lilly has argued in its own documents that the safety warning in Japan had no relevance to the safety of the drug in the US.

The Alaska Daily News is putting selected Zyprexa documents on its website. You can find them on a small sidebar on the story link above.

NOTE: I know this trial is stirring up some strong emotions in some readers because of what happened to friends or family who took Zyprexa. I am going to continue to put out updates on this trial and I just hope readers will be restrained in their comments.

The Zyprexa Chronicles: Incoming Lilly CEO Allegedly Pushed For Off-Label Marketing Of Zyprexa For Kids In 2003

Alex Berenson at the New York Times has a piece that just hit the paper's website detailing an email that was presented in the Alaska v. Lilly Zyprexa trial earlier this week. In the email, according to the Times, John Lechleiter, a then Lilly VP who's soon to become the company's CEO, did the following:

"In the message, Dr. Lechleiter, who was then the company’s executive vice president for pharmaceutical products, noted to other Lilly officials that company representatives were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, he said.

"'The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,' Dr. Lechleiter wrote in the message. He also encouraged Lilly to get data on the use of Zyprexa in treating 'disruptive kids' in order to increase the drug’s sales."

The drug is not approved for use in children. It's not approved for use among "disruptive" adults even. To think that a high company official would press for Zyprexa's use in children with ADHD (meaning mostly boys) is simply disgusting, given what the company knew about this drug in 2003.

Lilly responded to the paper:

"A spokesman for Eli Lilly said Dr. Lechleiter, an organic chemist, was not advocating off-label promotion in his note but simply wanted the company to respond to physicians’ requests for information. The company declined to make Dr. Lechleiter available for comment."

Interestingly, the trial jury did not get to hear about the email since the off-label marketing portion of Alaska's lawsuit was thrown out recently. But there it was being discussed in open court (with the jury excused) and Berenson seized upon it. I'm sure the Drug Wonks crowd will deem that a reportorial breach somehow.

Lechleiter is scheduled to become Lilly's new CEO on April 1.

03-14-2008 Media Madness

I know a good number of readers are on spring break this week and next, so I am just going to offer a few links to things and take the rest of the day off. Too bad it's not exactly spring in Seattle.

First, I wanted to let you all know that the winter fundraiser brought in $2,479 in reader contributions. I cannot even thank you enough for your generosity.

I finished reading Charles Barber's book Comfortably Numb last night and will have a full review of it on Monday. I'll give you my short review now, however: buy this book. I think it's the most important general interest book on mental health in America in years, possibly since Listening to Prozac itself, and was written by someone in the mental health field who clearly "gets it." You should support Barber's work.

CL Psych muses upon the media attention being lavished on the Spitzer case and wonders why the media has completely ignored the Connecticut lawsuit against Eli Lilly, especially since it's accusing the company of things like payoffs and bribes. Beyond whatever anyone makes of New York's former governor and prostitution, it's one of those times when I am a bit embarrassed by the lack of taste shown by some news organizations in covering this scandal right down to every detail of the alleged prostitute's life. It's all gotten to be a bit much.

Liz Spikol uses the new House version of the federal mental health parity bill to smartly question the medical model model of mental illness.

Here's a review of what looks to be an interesting book on mental health and women in Western culture.

Have a nice weekend and/or spring break.

The Zyprexa Chronicles: In Alaska Trial, Lilly Witness Argues Against Lilly

There was an interesting turn of events in the trial of Alaska v. Eli Lilly in Anchorage yesterday: Duane Hopson, a psychiatrist at Alaska's state hospital, was originally supposed to be a witness for Lilly but instead testified on behalf of the plaintiffs. He told the court that the company had implied its drug was safe when in fact it had problems.

"'Do you believe patients who were placed on Zyprexa developed diabetes who otherwise would not have developed diabetes if you knew then what you've been told now?' asked attorney Scott Allen, a lawyer from Houston, Texas, who is part of the team representing the state.

"'I think there are,' Hopson answered."

Under cross examination, Hopson said the state sometimes still uses the drug on some patients, but that it's not as a first line agent. The company didn't note that its drug caused blood sugar changes in some patients until last year, more than 10 years after the drug was approved.

In another odd moment, a juror collapsed on the floor before court began. On the basis of that incident, Lilly moved for a mistrial. Motion denied.

The Zyprexa Chronicles: Lilly Fires Back At Connecticut AG

I noted yesterday that the State of Connecticut had become the tenth state to sue Eli Lilly over various accusations surrounding the company's alleged handling of the drug Zyprexa and that the state AG's office had issued a nuclear weapon of a press release describing the lawsuit and some of the details of its accusations against Lilly. Some of those accusations included payoffs to state officials and bogus educational campaigns in addition to the usual round of illegal off-label marketing and downplaying of risks associated with the drug's use. You can more of those here.

Yesterday, Lilly put out a press release attacking the AG's press release. Lilly must be pissed off because I have never before seen them issue a press release in response to a lawsuit being filed. I can also tell that Lilly's PR folks must've been pissed because they simply cannot have been thinking clearly when choosing their words.

"Eli Lilly and Company (NYSE: LLY), strongly disagrees with the characterization of company practices as alleged by the Connecticut Attorney General Richard Blumenthal in a news release issued March 11, 2008."

OK, so it disagrees with the characterization, but what about the facts?

"The tone and content of the release is a disservice to patients who may currently be taking Zyprexa to treat a life-threatening disease. Specifically, the news release contained no acknowledgement of the seriousness of schizophrenia or bipolar disorder, no reference to the importance of treatment stability, and provided no guidance to patients who may now have questions about their treatment."

If the AG's press release is a disservice to patients, then what would Lilly's behavior towards patients amount to? Also, last time I checked, the AG isn't a medical authority or a medical officer, so why would it be incumbent upon him or his office to characterize the "seriousness" of schizophrenia and bipolar disorder? Don't these disorders speak for themselves and wouldn't patients taking Zyprexa already be aware of that? Why would Lilly be crazy enough to think that it's the AG's job to offer any "guidance" whatsoever to patients?

"Given the lack of complete information in the news release, Lilly offers the following:

-- Patients should continue with medications that have been prescribed and discuss their concerns with their doctor.

-- Patients can get information about Zyprexa by contacting the LillyAnswers Center at 1-800-LillyRx (1-800-545-5979) or going to the Zyprexa website at www.zyprexa.com."

Here, we have Lilly handing out medical advice to patients, which strikes me as a serious breach of ethics. Telling patients what to do with their medications is a no-no. I don't do it. Neither should Lilly. BTW has anyone ever called that 800 number before with concerns about Zyprexa? I'd like to hear from you if you have.

"Zyprexa is a lifesaving medication that has been taken by more than 23 million people worldwide. We remain confident in the safety and efficacy of Zyprexa based on the depth and breadth of scientific research conducted around the world."

Oh, would that be like the findings of the CATIE study? As for the lifesaving claim, yes, it's true that Zyprexa has been a boon to some patients, but if Lilly really, really thinks it can offer that as a blanket statement, then perhaps its PR officials ought to take a few weeks worth of Zyprexa at 10 mgs. a day and get back to me.

"Lilly is committed to the highest ethical standards and to promoting our medications only for approved uses. We have clear guidelines and extensive training for our sales representatives to help assure that they provide appropriate promotional information that is within the scope of prescribing information approved by the FDA."

Ah, yes, the Donna and Martha campaigns and the PCP campaign of 2002 clearly prove the company's adherence to those principles.

"We believe these claims are without merit and we will vigorously defend against them."

Nah, I bet Lilly folds like a house of cards and settles sometime in the next year.

One blogger in the corporate communications world has criticized Lilly's PR efforts on the Zyprexa front. My hunch is someday a communications prof is going to have a field day with the company's PR work.

The Zyprexa Chronicles: Connecticut Sues Lilly Over Zyprexa

The state now becomes the tenth in a string of states suing the maker of Zyprexa. It's the usual set of allegations, as WSJ's Health Blog notes, and then there is some eye-popping detail:

"Connecticut is looking to recover more than $190 million the state spent on Zyprexa over many years, on the grounds that Lilly illegally marked the drug for unapproved uses and concealed risks associated with the drug.

"'The illegal marketing campaign exploited children and senior citizens — causing severe weight gain, diabetes and cardiovascular problems,' Blumenthal said in a statement. 'This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies.'"

The state AG's office put it a lot more aggressively in a press release:

"Eli Lilly allegedly corrupted physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children."

That sounds tasty. Then there's this:

"'The illegal marketing campaign exploited children and senior citizens - causing severe weight gain, diabetes and cardiovascular problems,' Blumenthal said. 'This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression and Attention Deficit Disorder in children when it was never approved for any use in children and caused serious side effects.

"'Through a complex series of illegal rackets and lies, Eli Lilly built a multi-billion dollar drug enterprise at the expense of taxpayers, consumers and patient lives. Today's action seeks millions for Connecticut taxpayers and consumers who continue to suffer the financial and physical ruin resulting from the improper prescribing of Zyprexa.

"'Eli Lilly adopted a sick marketing mindset: profits over patients, sales over safety. Driven by fierce greed, Eli Lilly corrupted doctors, pharmacies and public officials nationwide who easily abandoned integrity and decency for self-enrichment. My office will fight aggressively on behalf of Connecticut citizens who continue to pay the price of Eli Lilly's illegal, senseless schemes.'"

Payoffs? Ghostwritten articles? Marketed for indications for which the drug was not approved? The state is suing partially under the federal RICO Act (Racketeering Influenced and Corrupt Organizations Act), which was a law originally designed to prosecute criminal organizations such as the Mafia.

These are the words and deeds of Connecticut's AG Richard Blumenthal, who I assume has the evidence to back these allegations. I point this out because I know if I posted this entry over on Daily Kos, then some concern trolls would swing by and accuse me of murder for suggesting that there's anything wrong with Zyprexa or other psych meds. Well, guess what? I am not the one making these allegations. An elected official is. Just as in the cases of Arkansas with Risperdal and Montana and Utah with Zyprexa.

But there's more:

"Under the façade of independence, doctors at "educational" forums urged peers to prescribe Zyprexa; ghostwriters published articles that promoted off-label prescribing, while omitting details about serious side effects; and public officials in various states promoted Zyprexa for unapproved uses in adolescents at detention centers and nursing homes.

"In reality, Eli Lilly paid these "independent" physicians and authors generously and concealed the financial arrangements by funneling compensation through its illegal enterprises and third parties.

"In some cases, Eli Lilly provided physicians and other participants tens of thousands of dollars in payments, grants and other compensation.

"Eli Lilly also illegally promoted Zyprexa for the treatment of children suffering from depression, anxiety, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, sleep disorders and generally as a mood stabilizer. Zyprexa has never been approved by the FDA for any use in children, not even for children with schizophrenia or bipolar disorder."

And:

"PEER-SELLING ENTERPRISE: Lilly compensated medical marketing firms and several physicians who routinely promoted Zyprexa to peer physicians in venues nationwide. Physicians who attended "educational" events were deceived into thinking that the events were independent of Eli Lilly. Conspiring physicians concealed information about the efficacy of Zyprexa in off-label uses and dangerous side effects, as well as the doctors' financial ties with Eli Lilly.

"THE ROLE OF PHARMACIES: Eli Lilly targeted pharmacies, particularly those that serviced long-term care facilities. Typically, an Eli Lilly sales representative and a pharmacy would agree that the pharmacy formally request funding from Eli Lilly in order to present an "educational program" - for example, a program on the treatment of dementia.

"Both the pharmacy and the Eli Lilly representative would agree that the program include a presentation by a doctor - hand picked by Eli Lilly - who would promote off-label use of Zyprexa for dementia. The Eli Lilly sales representative would file a formal request funds from Eli Lilly for an educational grant. Eli Lilly would issue a check to the pharmacy and the pharmacy would issue a check to the doctor, concealing compensation from Lilly to the physician.

"PUBLICATION ENTERPRISE: Eli Lilly created a "Publication Enterprise" that hired writers to create articles, and then paid specialists to "author" the articles. The articles only included favorable results of Eli Lilly's own internal trials, and suppressed unfavorable results, including a clinical trial that failed to show Zyprexa's efficacy for bipolar disorder.

"PUBLIC PAYER ENTERPRISE: Eli Lilly captured the Medicaid and Medicare markets by paying officials in various states, paying them substantial sums of money to spread falsehoods regarding the efficacy, safety and side effects of Zyprexa and to promote off-label use. Eli Lilly targeted those who oversaw treatment for people with serious mental illness, including patients in mental hospitals and clinics who are on Medicaid - among the largest users of antipsychotic drugs. Lilly also influenced prescribing physicians to over-medicate senior citizens in nursing homes and adolescents in detention centers with antipsychotics."

I cannot wait to see a copy of the complaint itself. Some these accusations involving Zyprexa, kids and ADHD can be little else but allegations involving Big Pharma's end of the bipolar child paradigm. Keep in mind that since the alleged bipolar child diagnosis doesn't officially exist in the DSM (yet) that many of these kids with alleged childhood bipolar disorder (which is to say many of the boys with alleged childhood bipolar disorder) are being carried on states' Medicaid books as having an ADHD diagnosis (or ODD or conduct disorder).

So, yeah, this will be a fun trial.

Interestingly, someone at Lilly told the AP:

"A spokeswoman for Eli Lilly says that the claims in the lawsuit are without merit and the company is committed to high ethical standards and to promoting medications only for approved uses."

Oh, please. I wonder how much Big Pharma's spinmeisters get paid. See these posts to get a sense of the merits of Lilly's response and its promotion of the drug only for approved uses.

Meanwhile, trial continues in Alaska in that state's case against Lilly. There's not much to report there so far, except an expert witness for the state is getting $600 an hour and a juror dropped out of the case due to a dental emergency. Expect more interesting news when Lilly puts on its defense, likely beginning sometime next week, and its witnesses face cross examination by lawyers who stand to make tens of millions of dollars if they win the case for the state. That ought to be interesting.

No word on the previously rumored settlement between Lilly and the feds and a combine of others states considering similar lawsuits against Lilly over Zyprexa. I bet everyone is sitting back and watching how Alaska plays out.

Depression Blood Test: Time For Skepticism

Researchers in Illinois announced yesterday that they have determined a possible biomarker for depression, which could then lead to a possible blood test. The findings were announced in the Journal of Neuroscience, which for some reason doesn't have a copy of the paper or its abstract online. Nonetheless, it's been getting all kinds of news coverage.

"'This test could serve to predict the efficacy of antidepressant therapy quickly, within four to five days, sparing patients the agony of waiting a month or more to find out if they are on the correct therapeutic regimen,' said lead author Mark Rasenick of the University of Illinois at Chicago College of Medicine.

"Rasenick and his colleagues studied the brains of 16 clinically depressed people who committed suicide and compared them to the brains of cadavers with no history of psychiatric disorders.

"They found that a larger proportion of the key signaling protein Gs alpha was trapped in a part of the brain cells called lipid rafts, confirming earlier studies in rats and brain cell cultures.

"'These "rafts" are thick, viscous, almost gluey areas, that either facilitate or impede communication between membrane molecules,' Rasenick said.

"When this protein becomes trapped in the rafts its ability to activate neurotransmitters is reduced.

"'Antidepressants help to move the Gs alpha out of these rafts and facilitate the action of certain neurotransmitters.'"

This is interesting, of course, and there is an obvious need for such a test. But now it's time for a bucket of cold water. Sixteen sample subjects is a very small study and the findings assume that their depression caused their suicides (which might or might not be true), so this is work that will have to be replicated many more times before it can be accepted as sound science. What's more, I cannot find research linking the Gs alphas to depression, so it's possible that they may be a protein several steps removed from the source of depression--a proxy, in short, for a different mechanism behind depression.

So no one should be holding their breaths for this methodology to prove out just yet, nor should they expect a doctor to spring such a test on them anytime soon. As I noted in connection with the recently-announce bipolar biomarker blood test, there are many, many reasons to be leery of the introduction of such tests.

One other curious note: I can find no linkage between Gs alphas and serotonin. So if this biomarker business pans out, what does that mean for ye olde serotonin theory of depression?

Bipolar Blood Test Inventor Speaks

In late February, news trickled out that biomarkers had been established for bipolar disorder that could lead to a blood test. Now, Alexander Niculescu, an assistant professor of psychiatry, medical neurobiology and neuroscience at the Indiana University School of Medicine, does a Q&A with the Indianapolis Star. Here's some of the exchange.

"Q: Is this test ready now?

A: There's still a lot of work to be done. The exciting thing is that there's something there at all. This is the beginning of having a lab test that can measure mood states. In psychiatry we currently rely on patients' reports, and patients sometimes aren't sure how ill they are. As a practicing psychiatrist, I face that dilemma often, so having an objective test for disease severity would be a big step forward.

Q: How might it be used?

A: A blood test for mood state will be able to objectively reflect early whether a medication such as an anti-depressant is moving things in the right direction. If someone who's bipolar is diagnosed as depressed, the person may be started on an antidepressant. But that could flip them into a manic state. With markers, patients could be monitored and a dangerous episode for a patient might be averted. Having these markers can also be useful to drug companies for developing medications.

Q: What's next?

A: We need to do more extensive studies. We need to take this early-stage work into larger trials and establish which markers are best. But this is a big step in the right direction. Having a lab test would put psychiatry on par with other specialties."

Apparently, the good doctor still has a case of cardiology envy.

What's interesting is that the reporter who did the Q&A didn't ask about Eli Lilly's funding of the researcher's work and didn't ask about the ethical ramifications of such a test for people with bipolar disorder. I covered some of those concerns two weeks ago. Even more, I find it amusing that the reporter didn't ask about some of the diagnostic shifting that's going on in psychiatry around bipolar disorder. So a good follow-up question would've been: "So would this test be used to measure bipolar disorder type 1, bipolar disorder type 2, the proposed bipolar disorder type 3 (aka SBD) or the alleged child bipolar disorder?"

I would love to see the doctor handle that one.

Eliot Spitzer: Stress Made Him Do It

That's the view of Patricia A. Farrell, a New Jersey psychologist, who put out a vaguely interesting press release in the wake of revelations around New York's governor. You know like money laundering, high priced hookers and things governors do each and every day.

"How, people are asking, can such a successful, powerful and extremely wealthy man come to such a sorry point in his life? If we look at all the incredible blunders involved in this encounter, it would seem a trained attorney, former prosecutor and now governor, would never have been so inept. But men in his position aren’t thinking rationally and I believe that’s what happened to Mr. Spitzer.

"Consider the number of setbacks Mr. Spitzer had recently in his short tenure as governor. The newspapers will carry them in full detail and it’s not the news, but the psychological rationale that I’m seeking. I believe the Governor was incredibly stressed and in that type of situation people often do irrational, uncharacteristic things. Certainly, registering at a D.C. hotel name in the name of a friend and using your own New York City address doesn’t make sense. Neither does moving money to banks when you know that banks alert the IRS to such movements. Spitzer knows the legal system intimately and yet he acted as a neophyte might. I can only think, as a psychologist looking at the situation, that he wasn’t thinking rationally.

"We’ve seen this before as in the case of a highly respected jurist whose career came to a sorry end when he began stalking a woman. He did a number of unthinkable things that could only have resulted in his being caught. This was a man who everyone regarded as brilliant and a possible candidate for the Supreme Court. It was later learned that he suffered from depression and was on medication at the time he became involved in this irrational activity.

"Stress can result in the most unthinkable actions and we have to consider this in the case of Eliot Spitzer."

I'm not sure I buy that stress made him do it. I think Spitzer is one of those classic Elmer Gantry or Jim Bakker types--moral and mighty in public, sleazy and law-breaking in private. Megalomaniacs, in other words.

Anyway, I'm sure at some point the press will have loads of fun with Spitzer's fall from grace. Let the psychoanalysis begin.

Where It's At, Part 2

As I noted on Friday, I did a lot of thinking over the weekend and have decided to keep charging ahead with the work I do here. For one, it appears that the winter fundraiser may have exceeded its $2,000 goal, although I won't know that for sure until a couple of promised checks come in over the next couple of days. I'll update you then.

Second, the issues that I--and we, really--take on here are too substantial to ever back away from. Third, psych meds are in various water systems in our country now and that's just too indicative of how big and weird America's mental health problems are. In the face of that, I simply cannot go quiet.

Fourth, quite a few of you have emailed me personally to let me know that you find my work "essential" and important to your lives. That sort of clinched things for me.

I am not quite sure what posting schedule I'll adhere to this week, as I am a bit off due to the return to daylight savings time which always throws my sleep patterns off for a couple of days. What's more, I am working on a small freelance piece that I've got to finish over the next few days. I won't get paid for it until sometime in June (I told you the freelance market was like weird post-modern slavery), but whatever.

My hunch is that I will try and make some adjustments to how much I write, so that I can make some gratuitous attempt at having a social life and that I will--finally--try and locate a decent bit of software that will allow me to not be caught up in moderating reader comments but that will still block spam. I hope to pull that off later this week.

Despite all of that, this may be a busy week given that the state is presenting its case in the Zyprexa trial in Alaska and I'll offer updates and context as the week chugs along.

Thanks to all of you for your support and for the many, many kind emails and comments in recent days. It all means a great deal to me.

Take The Big Pharma In The Water Supply Poll

This connects with today's other piece on psych meds and other pharmaceuticals being detected in America's water supply.

Psych Meds In The Water Supply

A very interesting piece by the AP came out over the weekend, revealing that numerous metropolitan drinking water systems have trace amounts of pharmaceuticals and other psych meds in them. For example:

"Officials in Philadelphia said testing there discovered 56 pharmaceuticals or byproducts in treated drinking water, including medicines for pain, infection, high cholesterol, asthma, epilepsy, mental illness and heart problems. Sixty-three pharmaceuticals or byproducts were found in the city's watersheds.

"Anti-epileptic and anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.

"Researchers at the U.S. Geological Survey analyzed a Passaic Valley Water Commission drinking water treatment plant, which serves 850,000 people in Northern New Jersey, and found a metabolized angina medicine and the mood-stabilizing carbamazepine in drinking water."

I'm not citing the above as evidence for or against the use of these medications, but am merely pointing to how obviously saturated American culture is with these drugs. The AP claims that since these are in trace amounts they pose no danger to the public. Not long ago, researchers found traces of Prozac in creek bed mud in Portland, Ore. And, in Britain, Prozac was found to be in the water supply in 2004.

I think we all have a good intuitive grasp on how anti-depressants and anti-seizure meds ended up in the water supply. What do you all make of this phenomenon? I'll run a separate poll on this today.

For my part, I bet companies such as Eli Lilly and AstraZeneca will not rest until trace amounts of antipsychotics are found in America's water systems as well. Then, they will know they have really captured the American mind and can get to work on capturing its soul.

Interestingly, the AP slugged its copy "Pharmawater." I'm just saying.

The Zyprexa Chronicles: Lilly's Legal Hypocrisy

Some of you may have noted that in recent coverage of the Zyprexa trial in Alaska that Lilly's outside attorney, Nina Gussack, has pointed out what she considers a discrepancy in Alaska's case. Namely, that the state alleges that Lilly failed to warn about risks inherent to the use of the drug while at the same time the state continues to use the drug. While one assumes a lawyer on the state's side will beat down that argument by countering that the drug is only risky for a certain percentage of patients, as it has later turned out, but that Lilly knew it was risky back before it properly warned users in the US.

Which brings me to a bit of hypocrisy in Gussack's approach. In April 2002, Japanese regulators ordered the company to slap warnings on its drugs in Japan, which the company did. Soon after, however, it argued in its own internal documents that the Japanese warning--with which they did not agree--had no affect on the safety of Zyprexa in America. (Yes, like the American and Japanese endocrine systems are so different.) In June of that year, the company rolled out an epic marketing program in which it sent its sales reps off to visit thousands of PCPs in America and convince them that in their practices they were regularly encountering women with agitation and mild depression and that these women showed the signs of bipolar disorder and would that doctor consider starting a patient such as that on Zyprexa today because Zyprexa, like, totally worked for that condition--the complex "mood patient." That sounds like the same kind of conflicted thinking they are accusing Alaska of.

Even weirder: At the time of the American PCP roll out, Zyprexa was only approved for acute mania use in bipolar disorder, and that would be bipolar disorder type 1 since bipolar disorder type 2 doesn't have mania as one of its dimensions. The women described in Lilly's campaign might have been bipolar disorder type 2, if that, but they were bipolar disorder type 1 and Lilly was using its bipolar disorder type 1 indication to roll on up on PCPs and get their patients knocked out on antipsychotics. One wonders how many of these women later developed diabetes and other maladies.

If that isn't ignoring its duty to warn given what had come down from Japan, then I don't know what would be. Kinda smells like off-label marketing to me as well.

Zyprexa documents relevant to this post:

April 15, 2002 Lilly memo on Japanese label changes

June 2002 Lilly Primary Care Sales Force Resource Guide

Zyprexa Frequent Areas of Concern from the Donna campaign

The Zyprexa Chronicles: Lilly Does A Drive By

No single entity has accessed the leaked Zyprexa documents more than Eli Lilly & Company itself. I've seen instances where single employees have gone to particular documents where they were named. I'll read nothing into that behavior!

Today, perhaps for old time's sake, someone from Lilly came through briefly.

Pfizer, J&J and Lilly all hitting on the Zyprexa documents within an hour of one another. I'm so humbled by the attention from Big Pharma today.

Pfizer Visits Furious Seasons

To download the Zyprexa documents. Here's a screenshot of their second visit today. During the first visit they downloaded about 200 documents. So they returned for Round Two. Always happy to help out my good friends from Big Pharma with free resources and another fine public service.

Today's Music: Hot Snakes

I've long loved this band since its members harken back to my punk rock days in San Diego and they just kick ass in general. The band is Hot Snakes--they broke up three years ago--and the song is "Automatic Midnight."

I'll give major props to the first reader who can tell me what two other bands the two guitarists in this band were in together before this one.

Sorry for the low-tech filming and recording, but that's low-budget punk for ya.

UPDATED: Where It's At

Hilarious update at the bottom.

So I'm sure most of you have surmised by now that the fundraiser has not met its goal. Sadly, this is the case and I will be scaling back my work here in the near future. A couple of people have already written to ask me if I would be taking the Zyprexa documents offline. The answer is "No." I would not do that to the public while there is an ongoing trial against Lilly with other legal proceedings to come.

While I appreciate each and every contribution and the many kind emails I've gotten recently telling me about the importance of my work, I want to share two of my frustrations with you. Six percent of the readers of this site each month--so about 1,300 readers--are from Seattle. I have gotten one contribution from a reader in Seattle. I live in Seattle and it's more than a little discouraging to see such a lack of response in my own town. In fact, it hurts me considerably and is certainly central in my current thinking about where I am going to take my life in the near future. This city is simply too passive-aggressive for its own good. If Seattleites wish to address this by taking a nasty little pill about which they and their doctors have incomplete information, then I wish them luck. Don't come crying to me when Effexor or Paxil fucks you up.

Second, dozens of law firms, news outlets and insurance companies have downloaded the Zyprexa documents in preparation for whatever action they might be taking against Lilly. I have not seen one plug nickel in contributions from any of these lawyers, news outlets or insurance companies. That is just disgusting and heartless, especially in light of the legal risk I took in putting the documents online and the amount of time it took me to get them online (about 40 hours when everything is counted). It's sad to me that none of these outfits chose to throw me even a bone. I guess honorable behavior in this country of ours is looked upon as the public act of a fool these days.

I don't know quite yet what my scaled back activity will look like. The failure of this fundraiser comes at a time when I am being hassled and openly fucked with by three different editors of my freelance work--none of whom are paying me enough to fuck with me--and that's just something I won't tolerate. In other words, I won't be working with these editors in the future and that will effectively kill my ability to do freelance work in Seattle. It also comes at a time when the journalism business is in complete free fall--reporters who've won actual Pulitzer Prizes are walking out the door at the LA Times--and there are zero prospects for me to be employed in a business into which I have poured so much of my adult life.

That's a long way of letting you all know that I will be taking several days off to think through my future. I can assure you that it is not a pleasant exercise. Am I thinking of leaving journalism altogether? The answer is "Yes." I know when I am not wanted or needed.

UPDATE: Just after I posted this item a bit ago, I went to check my site stats and there was Pfizer--yes, that Pfizer, makers of Geodon, Zoloft, etc.--downloading the entire set of Zyprexa documents. Will Pfizer be making a contribution to this site for the public service I've provided them? I won't be holding my breath. But I sure do love the irony of the timing.

The Zyprexa Chronicles: Opening Arguments In Alaska

I have little to offer today since I am far too tired from some outside work I've been doing to keep myself alive while I try to keep this site going to even think much less write.

The fundraiser brought in another $75 yesterday, but I fear it will fall short of its modest goal. If you want to do something about it, you know what to do. Otherwise, fine, whatever.

Oh, yes, opening arguments in the case of Alaska v. Eli Lilly were heard yesterday. Pretty much predictable blather from the state and Lilly so far. You can read a summary here. One thing is clear: the Zyprexa documents that are hosted on this site are at the heart of this case and of the evidence in the case. Knowing the documents as well as I do, I wish Eli Lilly all the luck in the world.

Oh, did I mention that this site is the only one in the US that houses the documents? Did I mention that I put them online last year at substantial legal risk to myself? Did I mention that Eli Lilly's legal team has read them and so have the legal staffs of several states AGs' office? I guess I just did.

Big Ad Dollars Spent On Abilify

Decision Resources, a market analyst firm, is out with a report on the market for atypical antipsychotics, which the company estimates at $15.9 billion in 2007 with growth projected to $17.8 billion in 2011. That's a lot of doped up people, and you know that's not going to be in schizophrenia. Where do you think the growth market is for these drugs? Depression perhaps? Kids? The company doesn't say in the report's snippet it's made public.

What it does say is that the Bristol Myers-Squibb/Otsuka partnership spends about twice as much on advertising Abilify as dod makers of other atypicals. It doesn't say how much money the company spends however, although since it's been a heavy advertiser on national TV, you know it's a lot. What's interesting is that DR claims that such ads sure haven't positioned Abilify as the go-to drug in the mind of doctors. Meanwhile, Lilly and AstraZeneca send doctors the most promotional literature for atypicals. One assumes AZ will increase its literature carpet bombing of docs if Seroquel gets approved for depression.

I miss the bad old days when antipsychotics didn't need to be advertised to either physicians or the general public because no doc in his or her right mind would use an antipsychotic on anyone but people with psychotic disorders. Not depression, not anxiety, not alleged child bipolar disorder, not mild forms of bipolar disorder. How times change.

The Zyprexa Chronicles: Alaska V. Lilly Trial Opens

Trial began Monday in the case of the State of Alaska v. Eli Lilly over the latter's handling of Zyprexa. The first day and Tuesday involved jury selection and today Lilly's bigshot outside lawyer, Nina Gussack of Pepper Hamilton, is expected to make opening statements for Lilly. Lilly's legal team and corporate folks have taken over part of two floors in an Anchorage hotel.

The State is also represented by outside lawyers.

In addition, a firm specializing in broadcasting such proceedings to interested litigators around the country has set up shop in the court room. To watch a streaming Internet feed of the trial will cost $300 a day.

It's not clear how long trial will last, but there are no reports of either side trying to negotiate a last minute agreement.

More details as they become available.

Winter Fundraiser, Day 10

Another $270 came in yesterday which brings the total for the fundraiser to $1,439.26. The goal is $2,000 by the end of Friday, so there is still $560 to go. As I've mentioned before, if the fundraiser doesn't hit $2,000 by then, I'll need to scale back my work on this site significantly. How much work do I do here? In February, I wrote over 30,000 words on this site. Obviously there was a lot of news last month, but that output is about half of the average book and probably about half of the average annual output of a lot of people who make a living writing for magazines and newspapers. Just offering some perspective.

So with $560 to go, I'd really appreciate it if readers who have not contributed to day would step with contributions of $10, $15 or $25. A lot of small contributions can go a long way very quickly. Those of you who've contacted me for my mailing address, please send in your checks as soon as possible. It'd be a big help in determining where the heck this fundraiser stands.

Thanks to all of you who've contributed already.

For those of you who'd like to contribute, there's a PayPal button on the right or contact me by email for a snail mail address.

Thanks for your support.

03-05-2008 Media Madness

Yesterday was a remarkably quiet day in the frequently noisy mental health world. Conveniently, my back went into muscles spasms and I spent most of yesterday laying flat on my back. As a result, I'll be playing catch up on some bits later today, but for now wanted to pass along some interesting things I've run into the last day or so.

Danny Carlat bangs on a stealth advertising campaign for an antipsychotic that apparently won't be approved in the US. The campaign is in the form of a "survey" about treatment problems faced by people diagnosed with schizophrenia. What's also weird about the campaign is the involvement of Mental Health America, the former National Mental Health Association. This is the second time in recent months that it's essentially gone to bat for Wyeth. Last time out was a "report" on depression. Classically, MHA has gotten about half of its monies for its main national organization from Big Pharma (so has NAMI National only with a larger budget), but has been fairly circumspect about attaching its name to such campaigns (NAMI National hasn't been as virginal). It looks like that is over and it's simply discouraging to see.

Speaking of Wyeth, CL Psych has done an awesome job of defanging a study of Effexor's efficacy in which the authors--and main journal editor--were crazy enough to claim that a teensy bit difference in efficacy in treating depression had important public health implications. That's simply out of bounds. Besides, wouldn't patients' difficult experiences withdrawing from Effexor count as a public health problem, or do public health opinionators only care about certain kinds of addiction?

Charles Barber, author of Comfortably Numb, hosts a conversation concerning his book on washingtonpost.com and defends himself against a reviewer in the main paper who apparently thought that psychological treatments Barber enthused about in his book were unresearched. That's just silly, since there is a fairly strong evidence base for CBT, for example, at this point, while the evidence base for anti-depressants is among the most corrupted evidence bases I can think of in all of medicine. I would defend Barber's work a bit more aggressively but his publisher has still not sent me a review copy of the book. Proving once again what a nobody I am in the media game these days.

Speaking of the media game, yet another "memoir" author has been busted over publishing a fake account of their "life." I'm sure she got a nice advance, too. It just disgusts me that in a media world where many decent, honest sorts have been driven out of their jobs in recent years (myself included), people somehow get paying gigs by committing lies to paper. All I can do is cry, as the song goes.

I'll be back with more later, assuming my back cooperates.

Winter Fundraiser, Day Nine

Another $76.26 came in yesterday bringing the fundraiser's total to $1,169.26. The goal is $2,000 by the end of Friday. So right now, it's $830 short, so let me remind readers of what I wrote once before:

If this fundraiser doesn't bring in at least $2,000 by the end of this week, then I will significantly scale back my work here. I'll have little choice. I have put my professional life on hold for over a year now in order to make sure that readers who are interested in mental health issues had a place to go every day instead of relying on the when-they-get-around-to-it coverage of the mainstream media and the delusional opinions of the likes of Judith Warner, Fuller Torrey and NAMI National.

If you aren't down with Warner's nonsense, then please consider contributing $10, $15 or $25 to my work here. I know intimately that the economy is very weird out there right now and that times are tight, but small contributions from the many thousands of readers this site has (February was a record hits month for this site) can add up very quickly. I need you all to pull together and give what you can to make this happen.

Unless you think Judith Warner's vision of an America where every child is medicated simply for being a child and every adult is pressed to take medications that we know don't work well and have untoward side effects is what you want. I don't want to live in Warner's world. I bet you don't either.

So please give what you can. Large, small and in-between. The PayPal button is on the right. Or you can email me for a snail mail address.

Thanks for your support.

"One More Nail In The Coffin Of Antidepressant Use In Bipolar Disorder"

That headline quotes an editorial in this month's American Journal of Psychiatry by Nassir Ghaemi, an associate professor of psychiatry at Emory University and one of the thought leaders in psychiatry on bipolar disorder. I'm beginning to like his thinking a whole lot. In recent years, he's described bipolar disorder as an existential problem and he's urged his colleagues to take the alleged child bipolar disorder with a grain of salt and proceed with due caution.

Ghaemi's editorial comes in response to a small paper in the AJP which looks at results of the STEP-BD study for bipolars with rapid cycling, generally understood as four or more episodes in a year. In other words, the nasty, gnarly crap that I see way too many people put up with, the kind of crap that four and five meds--your psychopolypharmacy from Hell--doesn't seem to cut through either. You know the story: people who are taking Lithium, Lamictal, Celexa, Prozac and Abilify all at once and don't seem to get a lot better, if at all.

The upshot of the paper is that a high percentage of patients in the STEP-BD study who had rapid cycling were also taking an anti-depressant. From the study's abstract:

"Patients who entered the study with earlier illness onset and greater severity were more likely to have one or more episodes in the prospective study year. Antidepressant use during follow-up was associated with more frequent mood episodes."

I've not been able to review the entire paper because AJP pulled my free press access recently and hasn't reinstated it yet, so if anyone has the full paper, feel free to shoot it my way. But Ghaemi basically reviewed it for all of us in his editorial, so I'm just going to quote liberally.

"In this issue of the Journal, Schneck and colleagues report new data from the NIMH-sponsored Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study, in which about one-third of the patients with bipolar disorder had rapid cycling; these patients also had more recurrences in the 1-year follow up. Only 5 percent of these rapid-cycling patients continued to meet that definition (four or more episodes in a year) at the 1-year follow up, either because of appropriate treatment in STEP-BD or because of natural history. The major predictor of worse outcome was antidepressant use, which about 60 percent of the patients received, most often accompanied by mood stabilizers.

"By focusing on the relationship between antidepressant use and rapid cycling, the STEP-BD study fills an important void. Not only is the study far larger (N=1,742) than any prior investigation, it is also prospective, unlike all but one prior observational study. Moreover, unlike that study, this STEP-BD study shows that antidepressants are associated with worsened course of illness even after adjustment for severity of baseline depression."

And:

"In my own clinical experience, most cases of refractory bipolar disorder, usually of the rapid-cycling variety, are due to the mood-destabilizing effects of antidepressants. Such patients often receive antidepressants for years, with or without mood stabilizers. They rarely receive mood stabilizers in the absence of antidepressants. If antidepressants are seen as mood destabilizers, then an adequate therapeutic trial of mood stabilizers for rapid cycling can occur only in the absence of antidepressants. Frequently, in patients with refractory rapid-cycling bipolar disorder, multiple trials of mood stabilizers appear to fail, as the data of Schneck et al. suggest, because they are evaluated with antidepressants. When antidepressants are stopped, those same mood-stabilizing agents can then be effective. Stopping antidepressants thus is the sine qua non of treating rapid-cycling bipolar disorder. Sometimes, in a minority of cases, usually with highly suicidal patients during depressive episodes, short-term antidepressant treatment may be warranted. But in most patients with rapid cycling, these mood destabilizers are best avoided." (Emphases in the original text)

And, Ghaemi points out that this isn't the classic manic switch, or mania induction from anti-depressants, that he's talking about:

"Mood destabilization with antidepressants should be distinguished from an acute manic "switch." Antidepressant-induced mania, or switch, is a short-term phenomenon; one might define it as happening within 2 months of the beginning of antidepressant treatment. Mood destabilization is a long-term phenomenon, reflecting more mood episodes over time than would have occurred by natural history. Antidepressants may cause long-term mood destabilization without a short-term manic switch, and vice versa. Although some agents may have low rates of acute manic switch, especially when used with mood stabilizers, the data from STEP-BD suggest that even the new generation of antidepressants can produce long-term mood destabilization."

And, then the bit that's got me smiling:

"In sum, like other results from STEP-BD, this study may be one more nail in the coffin of antidepressant use in bipolar disorder. It would seem rational to turn our attention from antidepressants toward better proven interventions, particularly psychotherapies, for the depressive morbidity of bipolar disorder."

Why am I smiling? Not only because I've been pointing out for about a year that in an earlier round of STEP-BD it was established that placebo beat anti-depressants in treating bipolar depression, but because I figured out in 2003 that anti-depressants simply didn't do squat for me in treating depression and seemed to agitate the heck out of me. It was about that time that I finally developed the nerve to stand up to a doc and say, "No way, Jose" to a suggestion that I take Wellbutrin. I'd just had a bad go with Lexapro and in previous years I'd had bad experiences with Prozac, Paxil and Zoloft (all in the early to mid-1990s) and lame experiences with Wellbutrin, which I took on and off from 1998 to 2002. And, I'd simply had enough of anti-depressants and told my then-doc that I didn't think they did much for bipolar disorder except cause trouble.

I'm also smiling because Ghaemi stressed the use of psychotherapy in treating bipolar depression, especially for rapid cyclers whom I am sick and tired of seeing jammed up on five meds and getting no relief.

I enjoy being right and having thoughts leaders in the field say that I was by implication. Sorta makes my day. And I'm sure it sorta doesn't make the day of the marketing departments at numerous pharmaceutical companies which make anti-depressants. And that makes me grin.

If any of you with bipolar disorder have questions about your use of anti-depressants, do one real smart thing: don't go off them without consulting with a doctor first. Then do something even smarter: when you go to see him or her, take along a copy of Ghaemi's editorial (it's linked above) and wave it at your doctor. Ask them if they have eyes and can read. Then ask for an appropriate tapering schedule for the anti-depressant you are taking.

That said, if you are diagnosed with bipolar disorder and you think anti-depressants work just fine for you in combination with a mood stabilizer, then rock on with your current meds mix.

The Long Road Off Paxil

A young lady named Summer Beretsky, a journalism student no less at the time, had a bit of a problem a ways back, which she describes in this piece in yesterday's Los Angeles Times:

"My panic attacks began in college. They would occur during situations in which escape proved either difficult or embarrassing: in class, in my cellblock of a dorm room, on the highway. They became a daily event and interfered with my daily activities, so I did what countless direct-to-consumer television ads told me to do: I went to my doctor.

"He gave me a script for Paxil, mumbled something about how half the population takes this sort of stuff and told me to take it easy.

"After a week or two, the panic attacks just stopped. For this, I was thankful. I could drive, go to class and spend time in my dorm room. But Paxil had one pretty undesirable effect on me: I started to lose interest in just about everything. I stopped initiating social activities (who needs that sort of thing?) and was no longer motivated to perform well academically."

She, then, went through several rounds of withdrawal hell, but eventually got in the clear.

"After my motivation and emotions returned, I started doing what I should have done when my panic attacks began: I became an information-seeking machine. I read books. I sought out alternative therapies. I took an anxiety-management class, tried acupuncture and learned about mindfulness meditation.

"Things started to improve, and the good news is this: Things are still, miraculously, improving. I'm now aware of how my freshly Paxil-free body reacts to anxiety-producing stimuli -- my heart races and my muscles tighten -- and because of this, I know when to start calming myself down.

"We live in a quick-fix world. You want a burger? Go to the drive-thru and you'll have one in less than a minute. You want to change the channel on the TV? Don't bother getting up; just use the remote.

"And likewise, for our panic attacks, we expect to find instant solutions behind the pharmacy counter. But quick fixes aren't always the best long-term solutions. Paxil was a merely a bank loan that I had to eventually repay with interest."

I congratulate the LAT for running her piece. It wasn't long ago that you would've never seen such an article in the mainstream media, but that seems to have changed in the past year. I wonder why.

BTW, as I have noted before, I know psychiatrists who won't prescribe Paxil for the very reasons Beretsky ran into and they wonder why it's still on the market.

Here's Beretsky's YouTube vid describing Paxil Hell. I've not been able to watch it since YouTube was misbehavin' yesterday, so I'll just assume it's dandy YouTubery and suggest you watch it.

The Zyprexa Chronicles: Alaska V. Lilly Trial Begins This Week

A civil trial brought by the State of Alaska against Eli Lilly over accusations involving its atypical antipsychotic Zyprexa is expected to begin in Anchorage tomorrow with jury selection. Last week, the trial judge tossed out a portion of the state's case when he ruled that its claim that Lilly had marketed the drug off-label for use in dementia and other unapproved indications could not be heard. It's not clear to me what the basis was for that move by the judge, as media coverage of the pre-trial moves is pretty scant.

The remaining accusation that the judge is allowing to go to trial is whether Lilly failed to warn doctors, consumers and the state about dangers associated with the drug. I would say that, based upon the leaked Zyprexa documents I've reviewed, Lilly is going to have an uphill fight in court on that front. All the same, the company claims it properly warned involved parties. That's for a jury to decide, of course.

This case is the first Zyprexa lawsuit to go to trial in the US and, excepting a last minute deal, will be closely watched by legal observers. Reportedly, Lilly was working to settle other states' and federal claims involving Zyprexa for $1 billion before the Alaska suit went to trial, but it's been all quiet on that front in recent weeks. The company is already being sued by eight other states over Zyprexa, and another 25 or so states and the feds are contemplating legal action still. What's more, there are about 1,200 lawsuits by individuals still outstanding against Lilly and those are expected to go to trial in June. To date, Lilly has settled about 30,000 cases for about $1.3 billion.

The outcome of this case could be crucial for the company's negotiations with the feds and others states.

It will be interesting to see if Lilly tries to settle the Alaska case right before trial begins, or if it wants to risk even more evidence of its alleged misbehavior from entering the public realm by way of evidence in the case and court testimony.

Late last week, Lilly filed an appeal with the Alaska State Supreme Court asking that trial be delayed until the Supreme Court could hear its appeal of the judge's ruling letting the trial proceed on the failure to warn claim. The Supreme Court declined to take up Lilly's appeal over the weekend.

On Wall Street, financial analysts could reportedly care less about the trial's outcome:

"Analysts say these trials don't raise a lot of concern on Wall Street, where many view them as a normal part of business for drug companies.

"'We've seen multiple drug companies in the past year or two paying big chunks to states to reimburse them,' said Dr. Jon LeCroy, an analyst who follows Lilly for Natixis Bleichroeder Inc. 'It's just expected.'"

We've sure come to a pretty pass in this country when drug companies are expected to payoff plaintiffs as a normal course of the life cycle of a drug. That attitude is beyond sad and reflects an odd sloth in our thinking and behavior as a culture that was simply unimaginable 10 years ago.

Obviously, I plan to be watching this trial as closely as possible and letting readers know what I know as soon as I can. Stay tuned.

Winter Fundraiser, Day Eight

Another $80 came in yesterday, which brings the total for this site's winter fundraiser to $1,093. That's over halfway to the goal of $2,000 by the end of Friday. I cannot even begin to thank you enough for your contributions. There's a ways to go, however, so from those of you who haven't contributed yet, I'd sure appreciate any contributions of $10, $15 or $25 you can toss my way. There's a PayPal button on the right, or if you prefer snail mail, send me an email and I'll shoot you a mailing address.

I'll be back a bit later this morning with some thoughts on the Zyprexa trial expected to begin later today in Anchorage, Alaska.

Peaking On Prozac? Or Peaking On Placebo?

The reaction in the British press to last week's bombshell study on the weakness of anti-depressants continues. For a study that supposedly told us something we already knew, it's getting a lot of attention. One doctor has even written a bit about the placebo effect and that got me to thinking about two things: the virtual silence in response to the study on these shores in the mainstream media continues to be deafening (ironic when you consider that the study was based on data submitted to the FDA and most of the patients in these trials were likely Americans), and a conversation I had with an acquaintance a few months ago.

He'd been living and working in New York City during the dotcom boom of the late-1990s and was still in Manhattan on 9/11. He'd been taking Prozac for a year or so and told me flatout, "I should be the poster child for Prozac. They should use me in an advertisement."

"Why?" I expected the usual "Prozac saved my life" testimony. Which would've been fine since I respect all the many different experiences people have had on anti-depressants. Those experiences are sure all over the map which is what makes it