ANTIDEPRESSANT: Psychiatrist Goes Nuts: Diagnosed Bipolar as They All Are!

Paragraphs 6 through 9 read: “Munn lost his license to practice psychiatry in Montana in 2003, after having an ongoing sexual relationship with one of his patients. His marriage dissolved around the same time. Already being treated for depression, Munn’s condition was rediagnosed, and with the help of counseling and medicine, he rebuilt his life into one where he’s succeeding while living with a mental illness.”

“Anti-depressants didn’t help the manic side of Munn’s bipolar disorder. At times his thoughts raced. He didn’t sleep. He had grandiose ideas ­ like how to fix the entire mental health system in the state of Montana.”

“And he believed he could do anything he wanted.”

“’I felt rules didn’t apply to me. That would be grandiosity,’ he said. ‘But they do. And that’s accepting that you have a mental illness’.”

http://www.helenair.com/articles/2009/08/02/top/55lo_090802_mh2.txt

Psychiatrist brings himself back from the brink of suicide

By JOHN HARRINGTON – Independent Record – 08/02/09

Eliza Wiley Independent Record – Nathan Munn has fought back from some very low places. Rather than ending his life, the psychiatrist chose to seek treatment for his bipolar disorder and began a new career teaching psychology courses and developing a mental health direct care program at University of Montana-Helena.
In 2003, with his career and home in very public shambles, Nathan Munn nearly committed suicide.

But rather than end his life, the psychiatrist chose not to pull the trigger one fateful night. He subsequently got treatment, including psychotherapy and medications, for his bipolar mood disorder.

Now, Munn is an instructor at the University of Montana-Helena, teaching psychology courses and developing a mental health direct care program that trains students how to be direct caregivers, counselors and other types of mental health professionals.

“I’m really thankful for my job at UM-Helena,” said Munn, 49, in a candid interview last week. “And I hope that my story can be of some inspiration along with my teaching. It’s my intention that I’m still helping in the community, but now with education as opposed to direct providing of psychiatric care.”

Munn admits somewhat nervously that his past is still “hard to talk about.” He chooses his words carefully, often pausing between sentences. He’s told his humbling story before, and maybe it’s getting a little easier ­ but not much. Remorse hangs deep in his eyes.

Munn lost his license to practice psychiatry in Montana in 2003, after having an ongoing sexual relationship with one of his patients. His marriage dissolved around the same time. Already being treated for depression, Munn’s condition was rediagnosed, and with the help of counseling and medicine, he rebuilt his life into one where he’s succeeding while living with a mental illness.

Anti-depressants didn’t help the manic side of Munn’s bipolar disorder. At times his thoughts raced. He didn’t sleep. He had grandiose ideas ­ like how to fix the entire mental health system in the state of Montana.

And he believed he could do anything he wanted.

“I felt rules didn’t apply to me. That would be grandiosity,” he said. “But they do. And that’s accepting that you have a mental illness.”

Mental illnesses are by no means limited to those on the fringes of society. Millions of Americans of all walks of life ­ blue collar and white, laborers and professionals ­ live daily with schizophrenia, depression, bipolar mood disorder and other diagnosable and treatable conditions.

Mike Larson of Dillon is director of the State Bar of Montana’s Lawyer Assistance Program, which was created in 2006 after several attorneys committed suicide in Missoula.

“Lawyers, from the first call in the morning to the last e-mail at night, are busy dealing with everyone else’s problems,” Larson said. “So what do they do when their own problems kick in?”

Larson said that from a population of 2,800 members of the bar in Montana, he takes calls from eight to 10 new clients a month, around a third of which are related to mental illness, with another third dealing with chemical dependency. He said many lawyers are reticent to call the program, either out of fear that others will learn of their treatment and their careers will suffer, or from simple denial.

“There are a lot of stereotypes out there about what mental illness is, and there’s that whole component of not wanting to be under the stigma of mental illness,” Larson said.

For Munn, day-to-day life means a regimen of a mood-stabilizing drug and an anti-depressant, acknowledgement of and taking responsibility for the mistakes he made and a resolve to move forward knowing the illness will likely be with him for the rest of his life.

“It’s not like there’s one day that you no longer have a mental illness,” he said. “On appropriate treatment, it can be in remission. And you stay on your meds and you do the psychological work necessary, and you move forward.

“I hate to say it because it sounds like it’s bragging, but it takes courage. You have to face this, you face what you did, you face having a mental illness, and you accept other aspects of your life.”

Munn doesn’t hide from his condition, and hopes that sharing his story will comfort others who find themselves in similar positions.

“One of the main things I want to say is when you have a mental illness, you have to acknowledge that that’s there, and that you have it,” he said. “I have a bipolar disorder, I am not bipolar. It is something that I have, it is not something that I am. A lot of people say, ‘I am bipolar.’ Well, what does that mean? You don’t say, ‘I am congestive heart failure. I am sinusitis.’ It’s not who you are, it’s what you have.”

Just as there are ways to characterize people living with mental illness, there are productive ways to discuss the illnesses themselves, Munn said.

“(People) talked about the dark recesses of the mind. That’s not the way to talk about it,” he said. “The term ‘dark recess’ has such a negative connotation, Dr. Jekyll and Mr. Hyde, that’s not it. They’re not dark recesses. It’s neuropathology. It’s limbic system disregulation. And it’s the cognitions, the thinking that goes along with it.

“That’s a tough thing for people to get, but I think it’s crucial for people to get that as they’re recovering from a mental illness, that our brains and our minds are the same thing. So when I have negative cognitions, when I’m thinking that people would be better off without me, that’s the psychological part.

“And that’s a key point for people, is that what you’re thinking psychologically and what your brain is doing physically, we don’t know how it’s the same function, but it is the same function. The subjective psychology that you’re feeling as a person with a mental illness, is the psychological aspect of the biological process, and yes, it is a real illness. The idea that a psychological illness is somehow not real is just absurd. That’s crazy.”

Many mental illnesses can be directly traced to chemical imbalances or other physical abnormalities in the brain. But having a mental illness can’t by itself be an excuse for any actions, good bad or otherwise.

“You don’t want to use it as an excuse to justify behaviors. You have to take accountability. Personal accountability is necessary for recovery, it just is,” he said. “It takes humility, it takes a lot of work, it takes compliance.

“I made huge mistakes. My choices were horrible. Despicable, really, is the term to use. I hurt a lot of people. I hurt patients that I had, the person herself and her family, and of course my family. I feel sorry and apologetic about that every day. Especially for my children, I feel horrible and always will.

“One of the points I would like to make is, yes, I have this bipolar disorder. To deny I do would be to deny I have a mental illness. But I also completely accept responsibility and accountability for my actions. And that’s a very important point: recovery requires personal accountability. Yes, I have a major mental illness, and yes, I am responsible for my actions. Those aren’t mutually exclusive.”

Treating a mental illness isn’t a guarantee of happiness. Life still presents challenges, and treatment gives those suffering from mental illness a better chance at facing those challenges head-on and coming out ahead.

“Life has struggles, with or without a mental illness,” Munn said. “Having your mental illness treated doesn’t mean your life is wonderful. You’re still going to have the struggles that everyone has. But you’ll also have wonderful things. I’m a grandfather. And that’s wonderful. If I had killed myself, I wouldn’t have known this joy of having a granddaughter.

“You have to accept mental health care of various types, and you need to know that it’s worth it, that treatments are available, the science is there, people do recover, illnesses do go into remission. Of all chronic illnesses to have, having a mental illness is not bad. Treatments are available, and you can live a long, good life having your mental illness treated.”

Larson of the Lawyer Assistance Program acknowledged that people need to want to treat their illnesses.

“There are a lot of people out there that still need the help that haven’t come forward or recognized they need the help,” Larson said. “Not only are they in denial that they have a problem, they’re in denial that everyone knows they have a problem.”

And even if the disease goes into remission or becomes manageable, a person must be diligent, even when things are going well.

“It’s not something you mess around with. And that’s OK,” Munn said. “Mental illnesses are chronic illnesses. People have the idea that, ‘Oh no, I’m going to be on medications for life.’ Well yeah, you are. And that’s all right, you have a chronic illness. There are a lot of chronic illnesses, not just psychiatric ones. And people who have those, like type 1 diabetes, will be on insulin. It’s accepted. So it’s a chronic illness, you accept that.”

And the more acceptance there is, across a broader swath of Montana at large, the easier it will be for people to summon the strength to get the help they need, to confront the illness, and to assume the places so many of them deserve as productive members of society.

To view the complete series on mental health care services in Montana, click here.

John Harrington: 447-4080 or john.harrington@helenair.com.

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Nguyen & Farber v SmithKline Beecham Corporation

Second Update: Paxil Lawsuit

Donald J. (“Don”) Farber Attorney at Law

Our objective in the lawsuit is to compel SmithKline to place an accurate warning label on Paxil regarding the drug’s addictive qualities. In 1992 Paxil’s watered down label was approved by the Food & Drug Administration (“FDA”), and has been remain unchanged ever since-this despite numerous medical articles published in the 1990’s outlining the seriousness of the problem.

Nguyen & Farber v SmithKline Beecham Corporation

2/24/2001

Second Update: Paxil Lawsuit

Donald J. (“Don”) Farber Attorney at Law

This is our 2nd update (“sitrep” or “situation report”) in our Paxil withdrawal lawsuit (“Nguyen & Farber v SmithKline Beecham Corporation”). We filed the case August 18, 2000 against SmithKline (now “GlaxoSmithKline) in Superior Court, Santa Clara County, San Jose, California. You are on our e-mail address group because of past communications on the Paxil issue. If you do not wish to be kept informed on the progress of the lawsuit-please advise, and you will be deleted from distribution.

Discussed below are:

(1) Chronological events in the lawsuit; (2) a review of the lawsuit and why it was necessary; (3) evidence now being sought in discovery; (4) settlement proposal of plaintiffs; (5) media interest in the lawsuit; (6) this lawsuit and FDA oversight; (7) solicitation of additional witnesses. (8) our expert consultant, Peter R. Breggin, MD.

1. CHRONOLOGICAL EVENTS IN THE LAWSUIT

August 18, 2000 Plaintiffs file “unfair competition” consumer lawsuit in San Jose, California October 4, 2000 Plaintiffs amend complaint (with “first amended complaint”) October 5, 2000 SmithKline answers original complaint with 26 affirmative defenses October 12, 2000: Plaintiffs submit Set One discovery demands to SmithKline November 16, 2000 SmithKline answers first amended complaint with 25 affirmative defenses November 22, 2000 Plaintiffs submit Set Two discovery demands to SmithKline December 18, 2000 SmithKline responds to Set One discovery demands January 2, 2001 Court’s first “case management conference” held in Department 2, Superior Court January 2, 2001 Plaintiffs make settlement demand on SmithKline February 2, 2001 SmithKline responds to Set Two discovery demands February 20, 2001 (expected) Plaintiffs file Motion to Compel discovery responses Next official event: April 10, 2001 Case Management Conference #2

2. A REVIEW OF THE LAWSUIT AND WHY IT WAS NECESSARY.

Our objective in the lawsuit is to compel SmithKline to place an accurate warning label on Paxil regarding the drug’s addictive qualities. In 1992 Paxil’s watered down label was approved by the Food & Drug Administration (“FDA”), and has been remain unchanged ever since-this despite numerous medical articles published in the 1990’s outlining the seriousness of the problem. The woefully inadequate label does not alert physicians and patients to the addiction problem and the serious and prolonged withdrawal it causes when Paxil dosage is reduced or stopped. Technically speaking, the whole of the FDA labeling is written for the physician, and not for a lay reader. This works its way into the doctor’s office by way of a medical publication called the “PDR” (Physicians’ Desk Reference). The lawsuit was the result of complaints from numerous Paxil victims. Over the past (8) years since Paxil has been on the market-as anti-depressant sales have soared-Paxil patients have been victimized to addiction in increasing numbers. More patients have started taking Paxil and more, for varying reasons, have attempted to wean off the drug. A significant number, however, have been unable to do so-and feel entrapped. Most patients we have talked to are angry, and feel they were deceived into taking the drug under false pretenses. Most do not hold their physicians responsible, and instead focus their ire on SmithKline. Let’s make one point clear. Antidepressant drugs are also controversial because some believe they cause manic stimulation in a certain category of patients, leading to suicide and other forms of violence. We believe that to be true-but this lawsuit is not about the suicide issue, nor other forms of adverse Paxil side effects that are frequently the subject of complaint. This lawsuit is narrowly tailored to the Paxil addiction and withdrawal issue. Paxil’s 24 hour half life, a half life much lower than the selective serotonin reuptake inhibitors (“SSRI”) Prozac and Zoloft-is a special bio-chemical factor of the SmithKline drug that distinguishes it from the respective Eli Lilly and Pfizer drugs just mentioned and-according to many experts-is the reason Paxil is particularly troublesome on the addiction front. Since Paxil’s FDA approval on December 29, 1992, many patients initially prescribed Paxil were led to believe by their physicians that the drug had few if any side effects. Indeed, in an internal document dated June 19, 1991, the FDA’s Martin Brecher, MD, wrote “the sponsor (SmithKline) represents that paroxetine..(Paxil)causes fewer side effects than other available antidepressants.” It is noteworthy this comment was submitted notwithstanding 21% of all Paxil patients quit clinical trials because they could not tolerate the drug. In any case after the drug was on the open market, Paxil patients-weeks, months, or years later after beginning dosage—attempted to reduce or quit dosage, they found themselves in the throes of withdrawal beyond their comprehension. Ignorant of the hazard from the beginning, patients came on to this suffering through seemingly mysterious illnesses. “Electric zaps” and other adverse physical and psychological symptoms appeared out of the blue. Patients went to their physicians. Diagnostic medical tests were conducted—as doctors do in the course of isolating illness. In most cases neither physician nor patient suspected at the outset that Paxil withdrawal was the problem.

Notwithstanding our earlier comment that most patients are forgiving of their family physicians, unfortunately in too many of these cases, the physician turned out to be an obstacle in solving this problem. Often the patient or family member, mindful of when dosages were taken and stopped, was the creative one to deduce that the painful symptoms were associated with Paxil withdrawal. In other cases-while the mysterious illness was still a mystery—physicians became frustrated, telling patients they were imagining their symptoms. It goes without saying that this was very frustrating, and disheartening to the patient who knew what s/he was experiencing. But that was not the most serious problem. The greatest pitfall was misdiagnoses in the opposite direction. The diagnosis of relapse was such an example, and not an uncommon one. At a time when the patient desired to come off the drug because it was thought the underlying depression had improved, or perhaps because of an adverse side effect-and attempted to do so-the relapse diagnosis had exactly the opposite effect from what the patient desired. In one instance we were told by a patient that her physician thinking “relapse”—directed the patient to up the 10mg Paxil dosage to 60 mg daily. By that time the patient, fortunately, had enough sense to realize that her physician did not have the slightest notion of the problem, but was willing to pump his patient full of even a greater dosage of habit-forming drugs. The patient, fortunately, had the good sense to get a new physician. Another young lady, very frustrated by her physician’s reluctance to believe Paxil withdrawal was the problem after a reduction in dosage, challenged her physician that a return to full dosage would cure the bad symptoms. The physician agreed to the experiment. Within a day after return to full dosage, the patient’s bad symptoms disappeared. The physician was honorable enough to admit he had been wrong, that Paxil withdrawal had indeed been the problem. When gauging that there are hundreds and thousands of Paxil patients involved, one realizes there is tremendous pain and suffering because of Paxil’s mislabeling. One can only imagine the tragedies that have occurred because Paxil withdrawal was not anticipated, and thus not properly diagnosed when it appeared. In selecting these stories, we are not “picking” on the physicians. On the contrary-we think we are proving our point. If the physicians are unaware of Paxil’s addictive hazards, the responsibility for that problem lies squarely with SmithKline and the FDA. For that reason, corrective action must be initiated. If neither SmithKline nor the FDA is willing to step up to the plate and fulfill their responsibility to the American consumer-as is the case-Vince Nguyen, Skip Murgatroyd, and I as “persons” with standing under California “unfair competition” statutes will do so. Let justice begin in the Golden State-and with assistance of consumers throughout the nation-and indeed also in the UK, Canada, and Australia (as we have witness statements from citizens of those countries), let us commence the task-and let us complete it with resolve.

3. EVIDENCE NOW BEING SOUGHT IN DISCOVERY.

Discovery has commenced in the lawsuit. Plaintiffs are seeking evidence: (a) that illustrates Paxil in fact causes the serious withdrawal problems we allege, and (b) that SmithKline is well aware of Paxil’s hazards. To avoid legalese, we will paraphrase and use ordinary English to convey some of the exchanges that have occurred in our discovery process to date. You will get an idea of how large corporate defendants stymie the discovery process, and effectively throw up a firewall to ward off plaintiffs. (“Q’s” are our (plaintiffs’) questions, “A’s” are SmithKline’s answers, and “notes” of ours that follow SmithKline’s answers.

Q: How many complaints on Paxil withdrawal have you received since January 1, 1993?

A: We object to the question. We don’t know what you mean by “complaint” and “withdrawal” but we’ll turnover over our adverse complaint file on Paxil. (note: they have not turned over the file yet)

Q: What efforts have you made since 1993 to find out about the Paxil withdrawal problem?

A: We object to the question. We have, however, performed numerous analyses of symptoms that were reported following cessation of Paxil therapy. We will provide you documents on these entries if you agree to keep them secret. (note: we have strong reason to believe the “analyses” SmithKline claims are not scientific in any manner, shape, or form-and what SmithKline is claiming is nothing more than a retrospective analysis of computer reports generated by the adverse event reporting system imposed by the FDA. There is nothing wrong with FDA adverse event reporting system, except that-after a drug is one the market—it is a voluntary reporting system for physicians and pharmacists. After an FDA approved drug is distributed into the general population, only a small percentage of adverse events ever get reported. Notwithstanding the limited sample, it is not the limited reporting that is the problem, but SmithKline’s reliance on it for scientific application. SmithKline’s misplaced reliance on the adverse event reporting system to discern addiction/withdrawal is a “garbage in garbage out” technique represented as scientific analysis. This is the same ploy used to justify the drug companies’ refusal to design a forward looking study on the SSRI suicide problem. We believe SmithKline refuses to conduct such studies because they are rightfully dubious of the unsatisfactory results that would ensue from the company’s perspective. As to SmithKline’s “secrecy” requirement, plaintiffs will not agree. That is yet another ploy to keep the public excluded from knowing the hazards of a particular product that is on the market. Plaintiffs will not agree to a secret process without compelling justification. To date, we have not seen anything justifying such secrecy.

Q: What were the symptoms of the 18 Yugoslav patients you claim were suffering “relapse” (and we claim may have been suffering withdrawal)?

A: We object to the question, but we will turn over the case report forms on those patients if you agree to keep them secret. (note: we have refused to agree to secrecy on the forms, but out of respect for the privacy of the patients, we have agreed that SmithKline can delete all identifying data on the patients involved (name, address, etc.) This issue is still unresolved).

Q: Identify by names the physicians who administered the Yugoslav trial.

A: We object, but will turn over the names of all officials authorized to make medical entries on that trial if you agree to secrecy. (note: Here is where pharmaceutical companies conducting clinical trials often skew the results. We do not know SmithKline has cheated, but we cannot presume they have not. As President Reagan once said: “Trust, but verify.” Yes, we must verify. What frequently happens during a clinical trial is that the physician on the scene is perfectly candid, and writes down accurate information. However when this information gets to company headquarters, e.g., a higher up will modify the finding to make the results appear more favorable. Rarely does a “smoking gun” appear to prove out and out cheating, but through massaging data “here” and “there,” statistics can often be molded to portray a much more favorable result than otherwise warranted. It appears in this instance that SmithKline is attempting to keep a lid on the identity of the particular Yugoslav physicians who ran the trials at the clinics. Company executives simply do not leave to chance the details of clinical data collection at the various test sites. We are also naturally skeptical on the Yugoslav venue. With the difficulty of regulatory agencies in the U.S. and U.K. to effectively monitor medical personnel in a country where political instability has been present, the results of such a trial must be viewed with even greater skepticism. We will scrutinize this carefully, and persist until we are confident of how “PAR 08-03” (the Yugoslav trial) was conducted and how the results were tabulated and reported.

Q: (we cited a known source who telephonically called in a withdrawal complaint to SmithKline, and, with the authorization from the patient, asked SmithKline to see all the paperwork that was generated on the patient. We then asked for the identity of the senior SmithKline official who acted on the complaint. Our reason for doing so was our suspicion that SmithKline has been downplaying customer complaints on withdrawal for years. In the next few weeks we will selectively verify known withdrawal complaints to determine if SmithKline was forthright in accepting the patients’ complaints and forwarding the complaints accurately to the FDA.)

A: (SmithKline again objected, but said they would provide the package they prepared on the complaining patient. Large entities, government or private, often have low level people sign reports, even though senior officials review the reports and effectively make the decision on disposition (i.e. the concept of “plausible denial”). In this interrogatory, SmithKline said their “clinical safety physician” regularly reviews adverse reports. This is a typically evasive answer, offering generalities but avoiding the requested specifics.

Q: (we asked whether SmithKline “systematically assessed” the withdrawal issue in the Yugoslav trial?

A: (Interestingly, SmithKline admitted they did not systematically assess withdrawal in the Yugoslav trial. We actually knew that they had not. However plaintiffs maintain SmithKline misrepresented that issue during the FDA’s committee hearing on October 5, 1992. The misrepresentation occurred just before committee members voted on Paxil’s market approval. Page 98 of the committee’s transcript recorded the FDA representative, David Wheadon, MD, saying “As you can see here, few numbers of patients experienced any adverse event after being randomized off(Paxil)into the placebo group and the percentages are certainly very small. But these were the common adverse events seen in that small population IN OUR ATTEMPT TO SYSTEMATICALLY ASSESS A DISCONTINUATION SYNDROME.” ) (Note: As one learns, no SmithKline person publicly utters the word “withdrawal.” Company spokespeople order SmithKline employees to say “discontinuation.” This is quite silly, but propagandists always operate with rigidity of the spoken and written word. In any event, it is readily discernible that exaggeration and stretching of the truth transpires to get a drug approved before FDA committees. The above quote is manifestly clear that SmithKline conveyed the idea they “systematically” assessed withdrawal in the Yugoslav study. They subsequently got caught in a false representation, and now are attempting to recast their deception. We did note their word “attempt” in the above quote-so, to be technically and rhetorically fair, we further asked SmithKline if they “attempted” to systematically study the withdrawal issue, but somehow failed in their objective. We felt we knew the answer to that question, but wanted to hear it from SmithKline nonetheless. The answer was “no” to both. Despite being forced to acknowledge there was nothing “systematic” at all about their withdrawal inquiry, SmithKline continues to be evasive on the issue).

Q: In Paxil’s labeling, why did you warn patients that those with a “history of drug abuse” should worry about tolerance for the drug when other patients were not so warned?

A: We object to the definition of “history of drug abuse” and weren’t responsible for the warning anyway, but we’ll produce paperwork showing the background of the labeling process if you agree to secrecy. (note: here’s another case where SmithKline is trying to evade their responsibility. Plaintiffs are aware that certain “class” warnings were developed for SSRI’s as a class of drug. This phrase (“history of drug abuse”) was one of them, and SmithKline simply adopted it. The problem, however, is that the warning is very deceptive in the case of Paxil. The wording implies that regular patients do not have to worry about developing tolerance of Paxil; only patients with a “history of drug abuse” do. SmithKline is trying to hide behind the FDA’s class warning while at the same time they are aware that Paxil has a 24 hour half life and is much worse on that front than the other SSRI’s. Interestingly, SmithKline did admit in discovery that they have no scientific basis to claim that those with a “history of drug abuse” are at a greater risk to suffer withdrawal (or as they say “discontinuation syndrome”) than other patients.

We have demanded that SmithKline produce the following documents for plaintiffs’ review: (a) documents on withdrawal sent to SmithKline from the FDA; (b) documents on withdrawal sent to the FDA from SmithKline; (c) document establishing the rules for the Yugoslav clinical trial; (d) documents on the 18 patients who suffered “relapse” during the Yugoslav clinical trial; (e) documents explaining the FDA imposed “post marketing” label for Paxil that ordered SmithKline to print on the label: “There have been spontaneous reports that abrupt discontinuation may lead to symptoms such as dizziness, sensory disturbances, agitation or anxiety, nausea and sweating: these events are generally self-limiting.” (f) documents addressing any medical author’s writings on the possible relationship between Paxil and withdrawal; (g) documents that came into your possession depicting new information on Paxil withdrawal that you were not previously aware of;

Document response: In virtually every document request, SmithKline has conditioned their willingness to turn over the documents on the issuance of a “protective order.” As stated, plaintiffs will not agree to secrecy.

All of the above discovery disputes are being worked as this sitrep is written. It is very likely that the judge will have to resolve most of them.

4. PLAINTIFFS’ SETTLEMENT PROPOSAL.

On the occasion of the “case management conference” January 2, 2001, upon invitation by SmithKline, plaintiffs made a written settlement demand. Essentially, plaintiffs demanded that the Paxil withdrawal problem be fully acknowledged, and that SmithKline take steps to divulge what they know about the problem and commit to modifying the deficient Paxil warning. The proposal did not specify the exact wording on any revised Paxil warning, but merely put forward a framework by which settlement could occur. No response has been forthcoming. It must be borne in mind that lawsuits do not, except in rare instances, dictate a company’s policy. The “bottom line” profit factor is usually the decisive factor in corporate conduct. Only if SmithKline deems their “bottom line” at risk do we expect action to resolve this dispute. We have a feeling that the high corporate executives at SmithKline have limited their agenda to sales-which have been very successful—and have a tin ear on the withdrawal subject. Given the public interest nature of this lawsuit, we have made it clear to SmithKline there will be no “secret” settlement of this lawsuit. The final result-settlement or trial-will be a matter of public record.

5. MEDIA INTEREST IN THE LAWSUIT.

Since we filed the lawsuit, several national media organizations, print and TV/radio, have requested that we keep them abreast of developments. The media has followed and reported on the SSRI suicide issue since Prozac first entered the market a dozen years ago. The addition/withdrawal issue, however, has only recently taken hold in the press. ABC’s “20/20,” with Connie Chung and Nancy Snyderman, did an excellent show on Paxil withdrawal on August 25, 2000. Very recently I got a call from another major network producer. That major network executive was of the same mind as we are, that there’s several people in the bowels of the pharmaceutical industry who are probably aware of the “smoking gun” on anti-depressants. With the tobacco industry, it took 30 years for the “smoking gun” to come to the surface. But SSRI’s and antidepressants as an issue are infinitely more complicated than tobacco-and that of course is exactly why the clinical data surrounding such clinical trials can be manipulated, massaged, and juggled to make it appear the drugs are safe and efficacious.

6. THIS LAWSUIT AND FDA OVERSIGHT.

If the FDA were doing its job properly, would this lawsuit be necessary? No! In reviewing records and events, we are utterly astounded by the lack of mission focus at FDA. When we look where former FDA officials are employed and/or where they’re doing their high price consulting, the big picture becomes pretty clear. The average FDA official is not about burn bridges with the pharmaceutical companies when s/he is on the job-and risk future career harm. However in the case of the FDA, the issue is slightly more complicated than with other government agencies. Bureaucracies get their marching orders, and once established, procedures are virtually on autopilot. Plaintiffs call attention to what we believe is the most outstanding journalistic reporting we have seen on the issue. On December 20, 2000, the Los Angeles Times devoted half their front page section to the problem at FDA. David Willman of the Times, and two assistants, did Pulitzer quality investigative reporting on how the FDA got off track in the 1990’s. Early in the Clinton administration, the FDA was directed to cooperate with private industry in developing drugs for diseases such as AIDS and cancer, and to make them available as a faster pace than the FDA had been accustomed to. This was a worthy goal. As with much in government and law, however, unintended consequences often follow. Several drugs were rushed on the market under the hastened FDA approval process-and then subsequently banned because usage in the general population proved them unsafe. When government cuts corners, abuses pop up in a variety of fashions. Mr. Willman pointed out the widespread conflicts of interest at play in the drug approval process at FDA as these events unfolded. Willman’s articles did not specifically address the agency’s psychopharmacological drugs section, but frankly we think that section is “worse” than the FDA in general. FDA psychiatrists in that section have gone out of their way to run interference for the drug companies and for approval of psychotropic drug applications, when their primary concern should be safety for the American consumer. Much of the correspondence coming out of the FDA that we have reviewed on Paxil sounded like SmithKline sales literature. This dynamic is difficult to describe without reading it yourself-but frankly we were shaking our heads as we read the cheerleader tone of the rhetoric. These FDA commentators would accentuate a supposed attribute of Paxil-but when a drawback had to be addressed, an FDA commentator downplayed it. In one clinical trial, “PAR 08-01.” eight (8) medical students, signing up to be guinea pigs for a Paxil dosage experiment, reported they suffered severe adverse symptoms. The FDA categorized the trial as “unexpected difficulty” for SmithKline in the Paxil application. Adverse reactions ranged from 52-90% of the entire patient group. After these questionable results, the commentator grossly spun the results in favor of SmithKline. The FDA blamed the principal investigator (“PI”) hired by SmithKline, alleging he was “conducting his first tolerance study.” . This was remarkably strange given that the protocol for the dosage was written by SmithKline. Not content with that, the FDA commentator then stated the adverse symptoms were the result of an excessively high dosage “and perhaps also to increased sensitivity rising from the medical background of some of the subjects and the inexperience of the investigator.” In other words, the 8 medical students were probably imagining their ills, and the PI was incompetent. Such a thrust by the FDA commentator was without any scientific basis and was nothing but sheer speculation slanted in favor of the Paxil application. Unfortunately this is the FDA pattern as we have observed it. Moreover, the FDA stacks their voting committees with drug industry advocates. Willman’s statistics, carefully gathered over a decade, clearly illustrate that. Half the people who sit on FDA voting boards have a conflict of interest. Incidentally, while Paxil was not highlighted in the Times’ series , we pointed out in our August 18, 2000, complaint that all six (6) members of the FDA’s “Psychopharmacological Drugs Advisory Committee” (“PDAC”) who voted to approve Paxil were issued a waiver to sit on the board because each had a conflict of interest. We have no reason to believe our civil servants at the FDA or physicians sitting on the PDAC are personally corrupt. But the system is corrupt when it circumvents checks and balances and allows individuals with a vested interest in the outcome to represent the public in voting on the outcome of a particular drug application. The standard FDA and industry excuse heard to justify this is that these individuals are uniquely qualified, and without them these committees could not function. That, of course, is absurd and smacks of elitism. These are the same folks that voted for the seven (7) drugs that David Willman reported had to be taken off the market in the 1990’s because they were found to be unsafe. We are not criticizing the FDA for occasional errors of judgment. We are criticizing them for pro-industry bias and abandonment of the consumer as their primary focus. The FDA needs shaking up-and now!

7. SOLICITATION OF ADDITIONAL WITNESSES.

The three (3) attorneys prosecuting this lawsuit continue to solicit witnesses. So please, join us. If you have knowledge of anyone suffering Paxil withdrawal, please instruct that individual to contact one of us. Do not assume what you know is commonly known or that we attorneys know it. We are anxious to hear from anybody who has information on Paxil withdrawal. Each person’s experiences are unique, and we would like to learn of them. Also, if you know anyone who has sensitive information on any related issue in the lawsuit, please advise them to call us collect.

8. EXPERT CONSULTANT.

Peter R. Breggin, MD, nationally known psychiatrist and author, is plaintiffs’ expert consultant in the lawsuit(“www.breggin.com”) Dr. Breggin, National Director of the Center for the Study of Psychiatry and Psychology, Bethesda, MD, is a former faculty member of the Johns Hopkins University Department of Counseling. Dr. Breggin is a consummate professional with unsurpassed integrity and courage. When one observes the degree to which the “bio psychiatric” establishment attacks Dr. Breggin and his views, one begins to appreciate what is at stake in this issue. Dr. Breggin has testified many times before congressional committees. Most recently in September, 2000, Dr. Breggin testified before a House subcommittee on the forced drugging of children. Even more recently an experienced psychiatrist in Southern California told me in regard to our consultant: “I used to think Breggin was exaggerating the danger of psychiatric drugs but I’ve come to realize he was actually understating the problem.” After the lawsuit was filed, the same psychiatrist told me flat out: “ For your information, ALL SSRI’s are addictive!!!”

NEXT SITREP..More later. We will issue the next sitrep after the next case management conference in April.

Regards Donald J. (“Don”) Farber Attorney at Law (and co-plaintiff) (Commander, U.S. Navy (Retired)) 1907 Las Gallinas Avenue San Rafael, CA 94903 ph (415) 491-0674 fax (415) 491-0829 e-mail: “n3dgt@AOL.com”

Co-Plaintiff and Co-counsel Vince D. Nguyen, Esq. c/o Law Offices of Vince D. Nguyen 2858 Stevens Creek Blvd, Suite 101 San Jose, CA 95129 Ph (408) 296-1881 Fax (408) 296-0474 e-mail: “lawvdn@accesscom.com”

In Association with Plaintiffs George W. (“Skip”) Murgatroyd, Esq. Of Counsel c/o Baum, Hedlund, Aristei Guilford & Downey 12100 Wilshire Blvd, Suite 950 Los Angeles, CA 90025 Ph (310) 207-3233 Fax (310) 820-7444 e-mail: “skip-tracy@att.net”

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Jefferson Co., Wisconsin vs. David Throm (Criminal Trial)

Trial starts for Palmyra man accused of killing

By Steve Sharp
Daily Times staff

The defense said today it plans to argue that Throm did not intend to kill Wilke and that his personality was affected by the mood-altering drug Paxil.
Jefferson Co., Wisconsin vs. David Throm (Criminal Trial)

2/24/2003

Trial starts for Palmyra man accused of killing

By Steve Sharp
Daily Times staff

JEFFERSON – A Jefferson County judge began hearing the opening statements of attorneys this morning in the case of a Palmyra man who is charged with first-degree intentional homicide for the killing of his girlfriend last summer.

Prior to the opening statements, Branch II Circuit Court Judge William Hue worked out details of the bench trial with attorneys for defendant David Throm, 41, of Palmyra and the state of Wisconsin. The trial is expected to last through the end of this week with Hue returning a verdict as early as Friday afternoon or as late as next Monday morning, March 3.

Throm is charged with killing his live-in girlfriend, Colleen Ann Wilke, 39, of Palmyra, last summer. He remains held on a $1 million cash bond.

Throm fled to Minnesota following the death of the woman and had apparently failed in an apparent attempt to commit suicide by hanging himself from a tree at a rest stop along Interstate 90 near Faribault, Minn. Throm was also found with a suicide note that stated where Wilke’s body could be found in a marshy area of Palmyra. The body was then recovered by Jefferson County authorities.

At Daily Times press time this morning, Jefferson County District Attorney David Wambach was making his opening statement to the court. Wambach said that the case before the court this week “proves the old addage that themore things change, the more they stay the same.”

“We’re in an era of lap-top computers, automobiles, and high-techweaponry,” Wambach said, but he noted that Throm’s alleged crime harkens to man’s more primitive period, when physical size and strength were more important.

Wambach explained, using a visual presentation including photos of Wilke’s dead body, just how Throm went about killing her. Wambach noted that she sustained a cerebral hematoma, or fatal injury to her skull.

“She died at the hands of David Throm,” Wambach said, adding thatThrom had stated in days prior to the homicide that Wilke “should fear” him.

Wilke and Throm were not living together at the time of the murder because they had recently broken off their relationship.

The defense said today it plans to argue that Throm did not intend to kill Wilke and that his personality was affected by the mood-altering drug Paxil.

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Patients vs. Bayer

BayerPatients vs. Bayer
Bayer Official Offers Defense in Texas Trial of Drug Suit

By MELODY PETERSEN
The New York Times

Melody Peterson of the New York Times reports that in the first case brought against Bayer involving its anticholesterol drug, Baycol, a senior official of Bayer AG testified in court in Corpus Cristi, Texas. He acknowledged that company officials in Germany proceeded with the marketing of Baycol despite the reluctance of US company officials to do so.

Patients vs. Bayer

3/1/2003

Bayer Official Offers Defense in Texas Trial of Drug Suit

http://www.nytimes.com/2003/03/01/business/01DRUG.html?ex=1047531517&ei=1&en =2c00117efe2c31f7

By MELODY PETERSEN
The New York Times

Melody Peterson of the New York Times reports that in the first case brought against Bayer involving its anticholesterol drug, Baycol, a senior official of Bayer AG testified in court in Corpus Cristi, Texas. He acknowledged that company officials in Germany proceeded with the marketing of Baycol despite the reluctance of US company officials to do so.

More than 30 people who took the drug died in the US of rhabdomyolysis (rhabdo) before it was withdrawn from the market in 2001.

Internal Bayer company documents reveal a corporate culture among its executives that puts sales above patient safety. The documents reveal that the company was „overwhelmed‰ by the avalanche of spontaneous adverse drug reports from doctors: “The steadily increasing numbers of spontaneous reports of rhabdomyolysis associated with Baycol, along with the additional telephone activity, has overwhelmed the available safety assurance resources.”

Bayer‚s vice president of scientific affairs wrote in an e-mail: „Many of the cases are ugly,” including reports of “dialysis, long hospitalization, disability and two potentially related deaths.”

However, the Times reports, even after numerous reports of rhabdo were mounting “there is not a real push to find out about statins and rhabdo.”

Of greater interest to Bayer officials were its sales. The Times reports that the minutes of a Bayer meeting indicate that Dr. Wolfgang Plischke, president of Bayer’s North American pharmaceutical division, “reiterated the need to drive future sales and his belief that we can achieve blockbuster status.”

Inexplicably The FDA obliged Bayer with its marketing strategy that increased fatalities by approving a higher dose formula of Baycol in July 2000: The Times reports that Bayer „executives said their goal with the higher dose was to capture 15 percent of the market. At that time, the minutes said, Baycol had 5 percent.‰

FDA did nothing to protect the public from a lethal drug until Bayer pulled Baycol off the market in 2001 after more than 30 deaths were linked to the drug.

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) http://www.ahrp.org Contact: Vera Hassner Sharav 212-595-8974 e-mail: veracare@ahrp.org

A senior executive at Bayer testified in court yesterday that company officials in the United States recommended against selling the anticholesterol drug Baycol several years before it was introduced in 1997 because they thought its sales potential was limited.

But Baycol was introduced because officials in Germany, where Bayer is based, decided to push ahead when market conditions improved and the potential for profit looked promising for many years.

Sales of Baycol increased rapidly until Bayer pulled Baycol off the market in 2001 after more than 30 deaths were linked to the drug. The company has been dealing with the aftermath since.

The Bayer executive, Dr. Lawrence Posner, senior vice president for pharmaceutical development, was testifying in county court in Corpus Christi, Tex., in a case brought by a patient who contracted a muscle disorder called rhabdomyolysis after taking Baycol.

It is the first case involving Baycol to go to trial. More than 10,000 patients or the families of those who died after taking Baycol have filed lawsuits against Bayer.

Dr. Posner defended the company for several hours yesterday as lawyers for the plaintiff, Hollis Haltom, 82, introduced dozens of internal company documents into evidence.

He said Bayer had monitored reports of rhabdomyolysis, known as rhabdo, in patients taking Baycol and had properly informed doctors about the risks of the medicine as it learned of them.

But several memos from Bayer’s safety officials in 1999, made public earlier in the trial, describe how its staff was struggling to respond to an increasing number of reports of patients who had become ill with rhabdo while taking Baycol.

In a memo written on Dec. 30, 1999, and addressed to Dr. Posner, safety officials said they had received reports of 60 cases of rhabdo in the United States in the previous two months. Doctors and others observing people becoming ill or dying while taking a medicine voluntarily file the reports in question, known as adverse event reports, with regulators and the drug’s manufacturer.

“The steadily increasing numbers of spontaneous reports of rhabdomyolysis associated with Baycol, along with the additional telephone activity, has overwhelmed the available safety assurance resources,” the officials, who were not individually identified, wrote.

Philip S. Beck, an outside lawyer for Bayer, said in an interview yesterday that he disagreed that safety officials were ever overwhelmed. “The company provided all the manpower that was needed,” he said.

One document that lawyers for the plaintiff have mentioned at least twice is an agenda for a meeting of Bayer’s scientific relations department staff in January 2000. It is covered with handwritten notes, some describing Bayer’s willingness to study reports of rhabdo before introducing a new higher dose of the drug, which is an anticholesterol medicine known as a statin.

The notes on the agenda say that because Bayer had described the risk of rhabdo in Baycol’s label, “there is not a real push to find out about statins and rhabdo.”

The note – by a person not yet identified in court – also says that a safety database has been developed. “Some are scared to uncover such data (bad data) because of the launch of 0.8 mg,” it says about the higher dose. “If F.D.A. asks for bad news, we have to give, but if we don’t have it, then we can’t give it to them.”

Bayer did undertake an internal analysis of the reports of rhabdo cases around that time. In March 2000, Steve Niemcryk, an epidemiologist at Bayer, and Paul Cislo, a database analyst, reviewed the reports of rhabdo that regulators received through June 1999. They said Baycol “substantially elevates” the risk of rhabdo, compared with similar drugs on the market.

But the analysts also said the magnitude of the problem could not be determined with the available data. The report said the company was talking to health insurers and other organizations with large numbers of patients taking Baycol about doing a better analysis.

Mr. Beck said the study was not scientific. The adverse event reports, he said, say only that a drug may be associated with the side effect, not that it actually caused it.

About that time, Dr. Richard Goodstein, vice president for scientific relations at Bayer, wrote an e-mail message to two dozen Bayer executives working on Baycol in the United States. He said that “alleged cases” of rhabdo caused by Baycol were coming into his office at a rate of about one a day.

„Many of the cases are ugly,” he wrote, including reports of “dialysis, long hospitalization, disability and two potentially related deaths.”

Dr. Goodstein continued, “To me, it has never been an issue of, should-if-will we need to respond, but rather to whom, how, what?”

“It will be too long a time until the potentially helpful results of new epidemiologic/scientific studies envisioned by Bayer World-Wide are completed,” he wrote.

In videotaped testimony played for the Corpus Christi jury, Dr. Goodstein said he recalled being worried about the rising reports and said he had discussed with his boss and other Bayer executives whether the analysis by Mr. Niemcryk and Mr. Cislo should be disclosed to doctors. “We decided that it was not substantive data,” Dr. Goodstein said. “We can’t have anybody making decisions based on unreliable data.”

The documents also indicate that Bayer executives decided to limit the spread of studies with unfavorable findings on Baycol’s effectiveness.

For example, at a July 1997 meeting of Bayer’s Baycol publications committee, executives discussed a study comparing cerivastatin, the chemical name for Baycol, to simvastatin, a competing drug. “The U.S. did not want to publish this data, since simvastatin did better than cerivastatin” and included doses that were lower than those in another study, the minutes said.

Bayer has been largely silent about how important the higher dose of Baycol was to the company. But company documents indicate that Bayer was counting on the stronger pill to increase sales.

According to minutes of a meeting of the U.S. Baycol Project team in July 2000, just before the Food and Drug Administration approved the higher dose of the drug, executives said their goal with the higher dose was to capture 15 percent of the market. At that time, the minutes said, Baycol had 5 percent.

The minutes also say that Dr. Wolfgang Plischke, president of Bayer’s North American pharmaceutical division, attended the meeting and “reiterated the need to drive future sales and his belief that we can achieve blockbuster status.”

Pharmaceutical companies often refer to a blockbuster drug as one that reaches sales of $1 billion a year.

When Bayer pulled the drug from the market in August 2001, the F.D.A. said some of the 31 deaths reported had been linked to the stronger pill. Mr. Beck has said that Bayer knew that side effects increased with the higher dose, but that the company began selling it to help people with severe heart problems who needed a stronger medicine.

Another document that lawyers for the plaintiffs have raised repeatedly was created after Baycol was pulled from the market in August 2001. The document is a slide that was presented to top Bayer executives at a global planning meeting in December 2001 that says, “DIG; THROW (The Corpse); COVER (With sand).”

Lawyers for the plaintiffs say the document is one of many supporting their allegation that Bayer covered up information about the serious risks of Baycol.

But Mr. Beck told the jury that the document – one slide in a set presented to top global Bayer executives – should be disregarded. It refers, he said, to a plan by people at the company who wanted Baycol put back on the market. The author of the slide wished to make the point that putting Baycol back on the market was a bad idea that should be buried, Mr. Beck told the jury.

Copyright 2002 The New York Times Company

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Jefferson Co., Wisconsin vs. David Throm (Criminal Trial)

Throm is found guilty in death of girlfriend

By Steve Sharp
Daily Times staff

A 42-year-old Palmyra man was found guilty this morning of first-degree homicide and a charge of hiding a corpse by a Jefferson County judge.
Jefferson Co., Wisconsin vs. David Throm (Criminal Trial)

2/28/2003

Throm is found guilty in death of girlfriend

http://www.wdtimes.com/articles/2003/02/28/news/news2.txt

By Steve Sharp
Daily Times staff

A 42-year-old Palmyra man was found guilty this morning of first-degree homicide and a charge of hiding a corpse by a Jefferson County judge.

David W. Throm was found guilty of killing his live-in girlfriend and hiding her body by Judge William Hue.

Hue convicted Throm of the two charges after listening to testimony throughout the week. Opening arguments got under way Monday morning and approximately 28 witnesses testified during the bench trial.

Following the conviction this morning, Throm’s bond was revoked and he was returned to the Jefferson County Jail to await sentencing.

No date for his sentencing has been set.

If a request is filed for a pre-sentence investigation, the sentencing date will be 45 to 60 days from now. If no request is filed, a sentencing date will be held within 30 days.

Throm faces life imprisonment for the death of Colleen Ann Wilke, 39, of Palmyra, whose body was found July 2, 2002, in a remote area about one mile west of County Trunk H on Marsh Road in the town of Palmyra.

Throm was later arrested in Minnesota when deputies responded to an emergency call at a wayside near Blue Earth, Minn. Throm apparently attempted to commit suicide as deputies found a suicide note in his car stating his girlfriend, Wilke, was dead. The note also indicated where Wilke’s body could be found.

Wilke and Throm were not living together at the time of the incident because they had recently broken off their relationship. Both were on the rebound from recent divorces.

Throm’s attorney, Maura McMahon of the state public defender’s office, pursued an involuntary intoxication defense relating to Throm’s prescription to Paxil, an antidepressant drug.

Prior to Paxil, walking away from a situation was Throm’s defense mechanism, McMahon told the judge. Dr. Andrew Schroetner, a psychiatrist form Watertown, testified by video that he had increased Throm’s dose of Paxil on June 7, 2002. Two weeks before Wilke’s body was found and Throm arrested, Schroetner decreased the dosage of Paxil and added a dose of Seroquel.

District Attorney David Wambach presented testimony in which Throm’s care provider described him as angry, wounded and ready to explode. During his opening argument, Wambach referred to a statement Throm had made to Wilke that she “should fear him.”

A Madison pathologist testified Wilke sustained a bruised heart, nine rib fractures, lacerated liver, fractured voice box cartilage and four separate areas of neck hemorrhage.

Several neighbors, friends and family members of Wilke’s testified, including her 14-year-old daughter.

Throm did not take the stand during the trial.

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Taylor vs. Solvay Pharmacueticals

Taylor vs. Solvay Pharmacueticals

Drug firm settles with Columbine victim

By Howard Pankratz hpankratz@denverpost.com
Denver Post Legal Affairs Writer

Columbine survivor Mark Taylor today dropped his lawsuit against the manufacturer of a drug he claimed made Eric Harris homicidal and suicidal in return for the company contributing $10,000 to the American Cancer Society.

Taylor vs. Solvay Pharmacueticals

2/6/2003

Drug firm settles with Columbine victim

http://www.denverpost.com/Stories/0,1413,36%257E53%257E1162902%257E,00.html

By Howard Pankratz hpankratz@denverpost.com
Denver Post Legal Affairs Writer

Columbine survivor Mark Taylor today dropped his lawsuit against the manufacturer of a drug he claimed made Eric Harris homicidal and suicidal in return for the company contributing $10,000 to the American Cancer Society.

Under the terms of the settlement, Belgium-based Solvay Pharmacueticals won’t pay Taylor or his lawyers any money.

Taylor and Solvay executives agreed that dismissal of the lawsuit doesn’t mean either has waived from their contentions about the merits of Luvox. Taylor alleges Luvox is dangerous while Solvay says it has helped millions cope with depression.

“Mr. Taylor believes his claims had merit, but Solvay has always denied, and continues to deny, each of Taylor’s claims about Luvox,” said the agreement read in Denver federal court by U.S. District Judge Clarence Brimmer.

In accepting the settlement, Brimmer said he thought the case was one that needed to be settled and noted that a couple of years ago a Wyoming jury had issued an The $10,000 being given to the American Cancer Society is described as a “charitable donation” in the settlement.

“Both parties are pleased with the amicable resolution and dismissal of this case without the need of subjecting the Denver community and the victims of Columbine to a public trial of this case,” said the settlement.

Taylor just barely survived the April 20, 1999, Columbine rampage in which Harris and fellow student Dylan Klebold embarked on the nation’s deadliest school shooting.

Taylor was critically injured when Harris threw two pipebombs at him and unleashed a volley of shots that wounded Taylor at least six times.

Taylor was a sophomore at the time and saw Harris out of the corner of his eyes a fraction of a second before he was gunned down. Harris and Klebold fatally shot 12 students and a teacher before killing themselves.

One of Taylor’s experts, Dr. Peter Breggin, wrote in a report filed in U.S. District Court that he believed Luvox triggered Harris’ participation in the rampage.

“On April 20, 1999, at the time he committed multiple homicides and suicide, Eric Harris was suffering from a substance induced (Luvox-induced) mood disorder with depressive and manic features that had reached a psychotic level of violence and suicide,” Breggin wrote. “Absent persistent exposure to Luvox, Eric Harris probably would not have committed violence and suicide.”

Breggin contends that Luvox is one of a family of depressants called selective serotonin reuptake inhibitors (SSRIs) that cause people to become violent. The SSRIs include Luvox, Prozac, Zoloft and Paxil.

But the drug manufacturers deny that the drugs cause such adverse affects and say they have been very helpful to those who use the medications.

Solvay believes that Harris was exhibiting violent tendencies long before he started taking Luvox.

The settlement came after a marathon, after-hours negotiating session Wednesday night presided over by U.S. Magistrate Patricia Coan. Present were Taylor, his mother Donna, Taylor’s lawyer Ron Miller and a legal team representing Solvay Pharmaceuticals, the Belgium-based company that makes Luvox.

The terms of the settlement were announced at what was to have been two days of pre-trial motions in front of U.S. District Judge Clarence Brimmer.

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Taylor vs. Solvay Pharmacueticals

Taylor vs. Solvay Pharmacueticals

Columbine survivor, Wash. teen team up
Suit over antidepressants unites an unlikely pair

By Howard Pankratz
Denver Post Legal Affairs Writer

The common bond that brought them together is their crusade against pharmaceutical companies.

Taylor vs. Solvay Pharmacueticals

1/17/2003

Columbine survivor, Wash. teen team up
Suit over antidepressants unites an unlikely pair

http://www.denverpost.com/Stories/0,1413,36%257E53%257E1116943,00.html

By Howard Pankratz
Denver Post Legal Affairs Writer

One was a victim of the April 20, 1999, Columbine massacre.

Cory Baadsgaard, left, sits with Columbine High School survivor Mark Taylor on Thursday during an interview for a television documentary. Baadsgaard was on antidepressants when he took an English class hostage at a high school in Washington state in April 2001. He blames the drugs for his actions, for which he spent 14 months in a correctional facility. Mark Taylor is suing the manufacturer of the antidepressant Luvox, which killer Eric Harris was taking at the time of the Columbine rampage. Gary Null & Associates of New York is filming the documentary, which could air in the summer, about the drugging of children and outcomes such as school shootings.

The other was a rifle-toting student who terrified his high school classmates in Washington state on April 15, 2001.

On Thursday, Columbine victim Mark Taylor and Cory Baadsgaard, the Mattawa, Wash., student who held a high school English class hostage, spent hours with each other.

Taylor was shot at least six times by Columbine killer Eric Harris.

Taylor wasn’t sure he wanted to meet the 18-year-old Baadsgaard, who was flown to Denver for the filming of a documentary by Gary Null & Associates of New York.

“I was a little bit afraid. I just didn’t know what kind of person he would be,” said Taylor, 19.

But when Taylor met Baadsgaard on Wednesday night, he shook Baadsgaard’s hand and said, “It’s nice to meet you.”

Then they talked for hours.

“He is a very sweet kid,” Taylor said.

Baadsgaard, a tall, athletic-looking young man who was the starting center on his basketball team, was completely surprised by Taylor’s reception.

“I thought, ‘Wow, this kid (Taylor) went through all this and he has forgiven everybody,”‘ Baadsgaard said. “I think it is kind of ironic to have a friend who has been highly affected. It’s cool to know he doesn’t have a problem with me.”

The common bond that brought them together is their crusade against pharmaceutical companies.

Taylor has a lawsuit against Solvay Pharmaceuticals, which manufactured the antidepressant Eric Harris was taking at the time of the rampage.

Baadsgaard, who was being treated for depression at the time he walked into Michelle Hansen’s honors English class with a loaded big-game hunting rifle, blames the antidepressants he had been on for 10 months.

He says he can’t remember a thing about the incident, something he directly attributes to the drugs, including one that was in the same family of antidepressants that Harris took. He stopped taking that drug, Paxil, three weeks before he invaded the classroom and was on a different drug at that time.

Baadsgaard, who spent 14 months in a correctional facility, hasn’t filed a lawsuit against the antidepressant manufacturers. But his father, Jay, said Thursday that they are looking into it.

The companies that make the antidepressants say the drugs help people and don’t cause people to become violent or suicidal, as claimed by Taylor.

In fact, Solvay Pharmaceuticals, which manufactured Luvox, the antidepressant Harris was taking, has accused Taylor of presenting “pseudo-scientific” theories to bolster his claims against the company.

Solvay has portrayed Taylor as lawsuit crazy and relying on unscientific gibberish to back his assertions that Luvox caused Harris to kill.

Gary Null, who says he is one of the country’s leading health and fitness advocates, has also been attacked as a conspiracy theorist who particularly targets the pharmaceutical industry.

Manette Loudon, who is producing the documentary in Denver, said the company hopes to complete its work in June on the two-hour film, called “The Drugging of Our Children.”

Baadsgaard, who has been banned for five years from Mattawa and can’t come within 25 miles of the tiny town of 1,800, said he never drank or did illegal drugs before he burst into the classroom.

He said he is convinced the prescription medication made him do it. “I’ve been there. I know what it’s like,” Baadsgaard said. “It’s horrible; it’s terrible. I blame everything on the drugs. Obviously, I didn’t know what I was doing.”

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Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

LA judge denies class action for Glaxo Paxil suit

Reuters

A U.S. judge in Los Angeles on Monday denied a request to certify as a class action a lawsuit claiming that GlaxoSmithKline Plc’s (GSK) anti-depressant Paxil is habit-forming. U.S. District Judge Mariana Pfaelzer said in her ruling that attorneys for a group of Paxil users failed to present a manageable trial plan.

Baum, Hedlund, Aristei, Guilford & Schiavo vs. Glaxo Smithkline Corporation

1/13/2003

LA judge denies class action for Glaxo Paxil suit

Reuters

To learn more, go to http://www.baumhedlundlaw.com.

A U.S. judge in Los Angeles on Monday denied a request to certify as a class action a lawsuit claiming that GlaxoSmithKline Plc’s (GSK) anti-depressant Paxil is habit-forming.

U.S. District Judge Mariana Pfaelzer said in her ruling that attorneys for a group of Paxil users failed to present a manageable trial plan.

Glaxo, Europe’s biggest drug maker, argued that it would be difficult for the court to determine if each member of a large class experienced the alleged withdrawal symptoms, including nausea and dizziness.

In October, Pfaelzer rejected a request from the same attorneys that advertisements stating that Paxil is “non-habit forming” be permanently barred.

The company was supported in court by the U.S. Food and Drug Administration, which said it had previously reviewed in-depth Paxil’s side effects and concluded that the drug is not habit forming and, as a result, the ads did not mislead.

The Paxil users are suing the British-based drug maker in federal court in Los Angeles, claiming that it deliberately played down the severity of withdrawal symptoms associated with abruptly stopping the drug.

Paxil, Glaxo’s top-selling product, reached sales of $2.7 billion last year.

©2002 Reuters Limited.

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Cassidy vs. Eli Lilly

Cassidy vs. Eli Lilly

Lilly settles Prozac lawsuit Terms of the deal not disclosed; new litigation in Georgia is targeting metabolization issue.

By Jeff Swiatek

The Cassidys’ lawsuit, filed in federal court in Pittsburgh, charged that Diane Cassidy’s doctor prescribed the antidepressant Prozac to her for weight loss and that the drug caused suicidal thoughts that led her to slash her wrists and overdose on a painkiller. She suffered intracranial bleeding from the painkiller, which left her paralyzed on one side and mentally impaired, according to the lawsuit, which sought $4.84 million in tangible damages.

Cassidy vs. Eli Lilly

11/30/2002

Lilly settles Prozac lawsuit Terms of the deal not disclosed; new litigation in Georgia is targeting metabolization issue.

http://www.indystar.com/print/articles/3/004678-4923-092.html

By Jeff Swiatek

A two-year-old Prozac negligence lawsuit, set for trial Tuesday, has been settled out of court by defendant Eli Lilly and Co. and the Pennsylvania plaintiffs.

The case was brought by Diane and Melvin Cassidy, of Monroeville, who in July 2000 picketed outside Lilly’s corporate headquarters in Indianapolis, handing out fliers proclaiming, “Lilly, how many people are maimed or dead on your drug today?”

The Cassidys’ lawsuit, filed in federal court in Pittsburgh, charged that Diane Cassidy’s doctor prescribed the antidepressant Prozac to her for weight loss and that the drug caused suicidal thoughts that led her to slash her wrists and overdose on a painkiller. She suffered intracranial bleeding from the painkiller, which left her paralyzed on one side and mentally impaired, according to the lawsuit, which sought $4.84 million in tangible damages.

The Cassidys were represented by Houston trial lawyer Andy Vickery, who has negotiated settlements of several Prozac cases against Lilly.

Terms of the settlement, reached this week, were not disclosed.

The Indianapolis drugmaker said in a statement that it “made a business decision to settle . . . for factors completely unrelated to the safety and efficacy of Prozac. Such factors included the extensive time demands that litigation would have placed upon our scientists, keeping them away from their primary objective of discovering lifesaving medicines. In no way was our decision to settle in any way motivated by concerns over the safety and efficacy of Prozac.”

The settlement comes the same week that a fresh Prozac lawsuit was filed against Lilly, in U.S. District Court in Georgia. It raises a new charge in the more than decade long litigation over Prozac: that Lilly has failed to publicize research showing some people are “poor metabolizers of Prozac” and a test can reveal if a patient might be affected.

The Georgia product-liability and wrongful-death suit, in which Vickery is assisting the plaintiff, was brought by William H. Shell, the widower of LaVerne M. Shell. She shot herself to death at age 63 in November 2000, 11days after starting on a prescription of Prozac to treat migraine headaches.

The lawsuit charges that a human enzyme dubbed CYP2D6 normally metabolizes or breaks down Prozac and similar drugs in the body, but fails to do so in a minority of people. In their bodies, the active ingredient in Prozac builds up to high levels, putting them at risk of violence and suicide, the lawsuit says.

“Lilly is negligent in failing to make this information public, to convey it to doctors, or otherwise to take reasonable measures to implement appropriate patient screening techniques,” the lawsuit says.

Lilly spokesman Blair Austin said that company officials hadn’t seen the lawsuit and couldn’t comment on the new charge.

The metabolization issue is gaining currency among some activists who publicize side effects from the Prozac class of antidepressants and other drugs.

Self-employed businessman Jim Harper of Glendale, Calif., who runs a Web site called Prozactruth.com, said he hopes to soon offer a DNA test through his site that can tell if a person is a poor metabolizer of Prozac and related drugs.

“I should not have to be the one” to publicize the test, Harper said Friday. “I’d rather be doing other things on my nights and weekends.” But drug companies and doctors aren’t doing enough to warn users of serious side effects from antidepressants, said Harper, who noted he receives hundreds of e-mails a week from people who read his Web site.

Harper said he hopes to arrange to sell the test for about $245 through Genelex Corp. of Redmond, Wash., a direct-to-consumer DNA testing firm

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Holcombe and Gollin vs. GlaxoSmithKline

Holcombe and Gollin vs. GlaxoSmithKline

2 Wisconsin women sue anti-depressant maker

By TOM HELD
theld@journalsentinel.co
Journal Sentinel

Suits here and elsewhere claim Paxil addictive, consumers not warned.
Holcombe and Gollin vs. GlaxoSmithKline

11/3/2002

2 Wisconsin women sue anti-depressant maker

http://www.jsonline.com/news/metro/nov02/93028.asp

By TOM HELD
theld@journalsentinel.co
Journal Sentinel

Two Wisconsin women have filed a class-action lawsuit against the makers of the anti-depressant Paxil, joining hundreds of others in alleging that the drug left them with severe withdrawal.

The suit filed in Milwaukee County accuses GlaxoSmithKline of failing to warn consumers that the popular drug can be addictive and that patients may suffer nausea, sweating, agitation and tremors when they discontinue its use. Similar lawsuits have been filed in 14 states, and a national class-action suit is pending in California.

The local plaintiffs, Christen Holcombe of Milwaukee and Linda Gollin of Pewaukee, are seeking to join hundreds and possibly thousands of other Wisconsin residents who sought help from Paxil, their attorney James Murphy said.

A decision on certification of the national lawsuit in California is expected Nov. 18. If it is certified, the suits in Wisconsin and other states probably will be set aside, Murphy said.

The suit by Holcombe and Gollin brings to Wisconsin the ongoing battle over Paxil and its alleged addictive downside. Hundreds of users across the country have complained that they had crying spells, dizziness and electric shock sensations when they stopped taking the drug.

GlaxoSmithKline maintains that Paxil is not addictive and its users may experience “discontinuation symptoms” that dissipate after one to two weeks.

“Any claims that Paxil is addictive are without foundation,” said Mary Anne Rhyne, a spokeswoman for the Pennsylvania-based drug maker. “There is no reliable scientific evidence to that effect.”

Reviews from the medical community have been split on the drug.

Last month, GlaxoSmithKline gained a legal victory in its defense of Paxil when the judge in the California case rescinded an order that had barred the company from claiming the drug was non-addictive in its advertising campaign. The ruling followed a U.S. Food and Drug Administration finding that the company’s ads for Paxil were not misleading.

The drug, introduced in 1992, is similar to Prozac and Zoloft, two other anti-depressants.

Paxil is GlaxoSmithKline’s bestselling drug, reaching nearly $3 billion in sales in 2001, according to the company.

Murphy said the drug’s value to GlaxoSmithKline sales explains why the company has resisted honest disclosure about its danger of addiction and withdrawal symptoms.

“They don’t want to discourage people from using it or from having doctors stop prescribing it,” he said.

Rhyne said Paxil had helped millions of people who suffer from depression.

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