Obection! Objection! Objection!
Just answer the damn question will you!
Donald J. Farber Attorney at Law
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