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 Courts 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 drugs addictive qualities. In 1992 Paxils 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 1990s 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 doctors 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. Lets 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. Paxils 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 Paxils 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 FDAs 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 dosageattempted 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 conductedas 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 mysteryphysicians 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 relapsedirected 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 physicians 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 patients 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 Paxils 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 Paxils 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 Paxils 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. (Qs are our (plaintiffs) questions, As are SmithKlines answers, and notes of ours that follow SmithKlines answers.
Q: How many complaints on Paxil withdrawal have you received since January 1, 1993?
A: We object to the question. We dont know what you mean by complaint and withdrawal but well 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 marketit 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 SmithKlines reliance on it for scientific application. SmithKlines 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 companys perspective. As to SmithKlines 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 FDAs committee hearing on October 5, 1992. The misrepresentation occurred just before committee members voted on Paxils market approval. Page 98 of the committees 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 Paxils 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 werent responsible for the warning anyway, but well produce paperwork showing the background of the labeling process if you agree to secrecy. (note: heres another case where SmithKline is trying to evade their responsibility. Plaintiffs are aware that certain class warnings were developed for SSRIs 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 FDAs 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 SSRIs. 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 authors 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 companys 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 successfuland 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. ABCs 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 theres 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 SSRIs 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 theyre 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 1990s. 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. Willmans articles did not specifically address the agencys 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. Willmans 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 FDAs 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 1990s 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 persons 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 Ive 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 SSRIs 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: email@example.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: firstname.lastname@example.org