The following suit has been brought in the State of California as a result of Dr. Peter Breggin’s work with attorney Don Farber in association with the law offices of Vince D. Nguyen. The suit is brought on behalf of the citizens of California and provides a model for fraud and class action suits in other states and on a national level. The primary focus of this suit is alleged fraud on the part of SmithKline Beecham in regard to the difficulties involved in withdrawing from their antidepressant Paxil.
The entire formal complaint follows:
Vince D. Nguyen, Esq. (SBN 171768)
Law Offices of Vince D. Nguyen
In Association:Donald J. Farber (SBN 168837)
2858 Stevens Creek Blvd., Suite 101
San Jose, CA 95128
Ph. (408) 296-1881/Fax 296-0474
Plaintiffs Pro Se
SUPERIOR COURT OF THE STATE OF CALIFORNIA
COUNTY OF SANTA CLARA
NGUYEN & FARBER
SMITHKLINE BEECHAM CORPORATION, and DOES 1 through 20,
Case No.: CV 791998
COMPLAINT FOR INJUNCTIVE RELIEF UNDER BUSINESS AND PROFESSIONS CODE; REQUEST FOR RESTITUTION
1.Plaintiffs are singularly and collectively persons doing business in Santa Clara County with a professional and personal interest in reducing addiction to legal and illegal drugs.In this complaint, plaintiffs protest the unlawful, unfair business practices and false and misleading statements of defendant SmithKline Beecham Corporation (“SKB”) in the marketing of the antidepressant drug “Paxil” to thousands of California patients and consumers since December 29, 1992, thus addicting such persons to Paxil without warning.Immediate and irreparable harm is occurring daily to these citizens.Plaintiffs thus seek the court’s injunctive powers to remedy the situation.
Parties and Subject Matter
2.Plaintiff “Nguyen” is Vince D. Nguyen, an attorney who has represented clients in drug products liability actions from his place of business in San Jose, California, including past actions against SmithKline Beecham Corporation on the drug "Paxil" and against Pfizer, Inc. on the drug "Zoloft."
3.Plaintiff "Farber" is Donald J. Farber, an attorney who has represented clients in drug products liability actions from his place of business in San Rafael, California, including past actions against SmithKline Beecham Corporation on the drug "Paxil" and against Pfizer, Inc. on the drug "Zoloft."
4.Defendant SKB is a corporation doing business in California and Santa Clara County, and has been marketing Paxil to patients and consumers in these locations since December 29, 1992.
5.Defendant SKB has conducted its own research and development of Paxil since approximately 1980, and is fully and singularly responsible to California patients and consumers for the drug’s efficacy, safety, and warnings to the public on the drug’s adverse effects.
6.Paxil is a prescription drug, requiring the prescription authority of a physician before it is dispensed to any patient/consumer.
Societal Problem–Drug Abuse and Drug Dependency
7.Drug abuse is society’s scourge.Such abuse often begins with legal, medicinal use of prescription drugs.The patient gets "hooked" on painkillers, for example, and is unable to stop taking the drug once the pain has passed.Antidepressant drugs, including selective serotonin reuptake inhibitors ("SSRI") such as Paxil, are similarly hazardous, even more so in many instances.Medical risk taking of this nature would be acceptable if the habit-forming nature of Paxil were fully divulged to physician and patient prior to selection of Paxil.But it is not.Serious habit forming characteristics are formed, and the Paxil patient is unable to wean himself/herself off the drug after therapeutic use is no longer needed.Physical and psychological dependency on Paxil is the result.Withdrawal problems of many varieties occur.When withdrawal problems arise, the patient often feels entrapped, in despair, and desolate.Hope fades.Addiction worsens.Even suicide occurs.
8.A person suffering from depression is compelled to overcome one of contemporary life’s major problems.If the person goes to the family physician to be treated for clinical depression, the last thing the person expects from Paxil is to have an additional malady inflicted upon him/her.It is a cruel hoax to be made to expect improvement from an antidepressant medication, and to then discover later that one is addicted to the medication because the known hazards of the drug were not communicated to the patient.Unfortunately, that has occurred with numerous Paxil users continuously since 1991.
9.From 1989 to the present, patients attempting to taper down or abruptly discontinue use of Paxil have suffered withdrawal symptoms as noted in the paragraph above.Physical symptoms occur:"hot flashes," dizziness, ataxia, paraesthesiae, gastrointestinal and flu-like symptoms, and related sensory and sleep disturbances.Psychiatric symptoms occur:anxiety, agitation, lability of mood, nervousness, hypersexuality, crying spells, irritability, sweating, lightheadedness, headache, weakness, and tremor.The result of these terrible symptoms is that many patients continue to take Paxil because they are entrapped by the drug.
10."Relapse" is not "withdrawal."Relapse occurs when a patient who has improved his/her depressive state, then reverts back to a more seriously depressed state.Symptoms exhibited during relapse are frequently comparable to symptoms exhibited during withdrawal.As indicated elsewhere in this complaint, it is alleged on information and belief that SKB over the years categorized numerous patients’ withdrawal symptoms as relapse symptoms.SKB did this in order to gain FDA approval for Paxil and avoid the harsh consequences of dealing with the drug’s withdrawal problems.
Informed Consent Always Required
11.The physician recommends the prescription drug for the patient.The physician is the key person in assessing the need to balance the therapeutic value of the drug with the anticipated adverse side effects of the drug.The physician chooses drug "A" over drug "B" for the patient based on the patient’s diagnosis and medical history.For depression, many mental health experts believe a combination of psychotropic drugs and communicative therapy is the most effective treatment.Others believe brain drugs are toxic and should never be used, and thus such practitioners rely on communicative therapy either alone or in conjunction with other type of drugs, such as minor tranquilizers.For a drug abuser, a treating physician may choose therapy to treat depression rather than Paxil for fear the patient is vulnerable to physical or psychological dependence on substances.
12.SSRI’s are particularly critical drugs because they directly douse the brain with man made chemicals.As an SSRI, Paxil purportedly corrects biochemical imbalances in the brain.Its preservation of serotonin in the brain path, it is said, enhances the "happiness" molecules.Conversely, as it were, the absence of serotonin induces depression.Paxil is the most potent of the SSRI’s.Paxil also has the shortest half-life of any of its competitors.Before a patient is prescribed an SSRI, the physician and that patient–ideally–have fully communicated with each other and be jointly committed to the drug.Otherwise, the results can be hazardous.SSRI’s can induce suicidality in patients.Family support is often necessary to work through problems associated with antidepressant therapy.Without such support, the patient’s personal situation can erupt into crisis.Without accurate information on the drug, the physician is unable to fulfill that professional role, and is effectively a bystander as his/her patient’s fate is decided by factors known only by the drug company.
13.The physician depends upon information contained in the "Physicians’ Desk Reference" ("PDR") to select a drug for the patient.The physician determines the "prescribing information" and "labeling" of a particular drug by perusing the PDR.Most physicians know very little about individual drug products.Reliance on information in the PDR is thus critical in determining whether a particular drug is appropriate for a particular patient.Drug manufacturers, such as defendant SKB, are fully responsible for the accuracy of information on their particular drugs listed in the PDR.While the prescribing information and labeling must be approved by the FDA before it is released to the PDR, regulatory approval does not mitigate the manufacturer’s legal responsibility for complete accuracy of content.Notwithstanding the physician’s key role, the patient through advice from the physician and the concept of informed consent has the right to make the decision to use or reject a particular drug.Even if Paxil happens to be efficacious in treating depression, the prospective Paxil taker has a right to know in advance that Paxil induces dependency.Paxil, in fact, induces dependency.However that fact has not been conveyed to physicians or patients.As a result, many patients have unwittingly developed dependency on Paxil.These patients have never given informed consent, and are addicted to Paxil involuntarily.
Increased Influence of Pharmaceutical Industry in Health Care
14.Paxil’s eligible patient group is growing.After the 1992 FDA approval of Paxil for depression, SKB submitted applications to apply the drug to other disorders.Subsequently, in 1996, the FDA authorized Paxil’s treatment for obsessive compulsive disorder ("OCD") and panic disorder ("PD").Testing and research continues.It is SKB’s intent to expand Paxil into as many medical applications as it feasible for that type of drug.
15.Antidepressant drugs, including Paxil and other SSRI’s, have been prescribed in increasing numbers the past ten (10) years.Since the first SSRI, Prozac, was introduced in 1988, prescriptions for antidepressants have tripled.Sales of antidepressants, the most costly and fastest growing of the top four therapeutic drug categories, topped $7 billion in 1998, up from $2 billion in 1993.SKB’s Paxil sales last year were $1.7 billion, much of that in the U.S., California, and Santa Clara County.Sixty (60) percent of antidepressant drugs are prescribed not by psychiatrists, but by primary care physicians and family practitioners.Contrary to common notion, primary care physicians and family practitioners generally have no training in the selection of individual drugs for their patients.Indeed, in accredited medical schools throughout the United States, only 25% offer courses to prospective physicians on this subject.The number of prescription drugs approved for the U.S. market is high, and getting higher.The number is increasing rapidly due to technological advances and the public’s demand for new drugs to cure cancer, AIDS, and other serious diseases.The average physician cannot keep up with all the drug products entering the market.As a result, the great majority of physicians prescribing individual drugs for their patients are dependent on the drug companies for information on their drugs.Drug manufacturers aggressively target individual physicians.They do so through free samples and other techniques designed to corner the market with particular health care providers.Cost considerations in the national health care debate are thrown into the mix, as physicians are increasingly pressured to reduce costs.Pharmaceutical companies have seized on the times to be a major player in health care.This is a rightful and honorable capitalistic motive, but unfortunately the societal costs of a bad drug are often irremediable.Unlike a defective appliance, the patient whose brain is damaged by a bad drug can’t trade it in for a new one.Thus in this fast moving technical field, vulnerability to drug manufacturers’ false propaganda is infinitely greater for society than false claims by used car dealers.
16.This defendant and other drug manufacturers court health care providers through the "preferred drug."The SKB’s sales force visits health care providers, and attempts to persuade the providers to make Paxil their "preferred" antidepressant drug.If a provider agrees, a large volume discount is given to the provider.The financial incentives, however, do not accrue to the benefit of the patient. Secrecy often surrounds the process.Preferred drug arrangements are rarely posted in the doctor’s waiting lounge, and even more rarely discussed with the patient.The patient is unaware that his/her physician prescribes Paxil based primarily on financial incentives rather than merit.Another common scenario is that the discount continues only if the provider enlarges the patient group from 20% initially, for example, to 30% during the next annual cycle.The drug manufacturers then boast in their advertising literature of their recent health care provider "recruits."Little do most patients realize as they come across these flyers in the health care magazines, that they were the bargaining chips for the ads.
17.With such a competitive environment, it is not surprising that high politics pervades the FDA drug labeling process.Each little word and phrase in a drug label probably affects 2000 or 3000 drug picks by physicians over a year.While the exact numbers are speculative, it is certain that each word or phrase said about the drug will have a magnifying effect as they are read by thousands of physicians picking drugs for their patients.It is no accident that high corporate officials from the pharmaceutical manufacturers personally mull over the words and phrases that go in their drugs’ prescribing information and labeling.Pushing the envelope to its maximum is the name of the game on labeling.Though subtle and more polished than TV used car ads, the drug manufacturers’ promotional tactics are no less aggressive and manifest themselves in the drug labeling process administered by FDA.Pushing the envelop to its maximum is the game.SKB and other drug manufacturers conduct all out lobbying campaigns with influential FDA officials, targeting, usually, one particular official and getting that official on the applicant’s "side."With one FDA official on the company’s side, the remainder of the FDA bureaucracy, given that bureaucrats mostly like to follow precedence but not establish it–will likely roll over and agree to the plan originally recommended in writing by their fellow bureaucrat.SKB followed this model with Paxil’s labeling while drafting it and getting FDA to review and approve it.A high SKB vice president in charge of a Paxil division personally drafted up a "footnote" to Paxil’s proposed labeling scheme.Rather than attach his name to the footnote correspondence, which would create attention, he charged a subordinate to promote the "footnote" within FDA channels.However when representing the issue to senior FDA officials, the subordinate made sure that the FDA staff knew that the footnote was the VP’s personal creation and that it he wanted it approved.The FDA "approved" the footnote without further ado.
18.A prescription drug may not be marketed in the United States until first approved by the FDA.The FDA approved Paxil on December 29, 1992 for the treatment of depression.
19.Whether a drug technical matter is submitted to the FDA or passed on to a health care provider in the marketing process, the informational product is one produced by a monopoly.The drug manufacturer hides behind the protection of trade secrets and patients’ privacy data to justify a blackout of information on their research.It is common knowledge that cheating goes on in clinical trials.The FDA staff responsible for oversight of technical drug matters–including clinical trials–is very small.At best, the FDA staff spots a problem here or there on drug safety or efficacy, and then questions the applicant on it.But the FDA simply does not have the resources to monitor the technical research done by drug manufacturers, or the very lengthy clinical trials involving human patients where the drug’s safety and efficacy are supposedly put to the test.The FDA knows that, and spot checks are made by government regulators to halfway keep things in check.But effectively the integrity of the process depends primarily on the individual sponsors and their corporate culture.Besides the FDA, the only other check on pharmaceutical company’s monopoly of information on their drug are public interest and consumer groups who–though enthusiastic–invariably operate with limited funding and great disadvantage compared to the large pharmaceuticals.Articles are published and widely distributed and critiqued by the professionals in the field.However lurking beneath this seemingly open process are thousands of patient files accumulated during the clinical trials that receive no public scrutiny.All are exempt from outside review through the operation of the privacy laws.That process allows the physicians involved in the clinical trials, e.g. those paid by the drug manufacturers, to effectively control medical diagnosis and results, often so to the ignorance of the patients themselves.Unless the FDA asks for a particular patient’s file, which is rare, the drug manufacturer’s categorization of a patient’s symptoms and results from the drug experimentation stands unchallenged and–multiplied by thousands of patients–provides the basis for the drug’s evaluation on safety and efficacy.
Paxil’s Clinical Trials
20.From 1980-1991, approximately 5000 patients were tested on Paxil during SKB’s clinical trials.Eighty-three (83) different Paxil trials were conducted.Various time periods were involved in the individual trials.Many patients were tested for only a month or 6 weeks.Some were tested longer, including approximately 400 who were in trials longer than a year.SKB pulled out all the stops to ensure the trials were successful.Only two (2) positive trials are required for FDA market approval.By any reasonable person’s perspective, Paxil’s track record in the clinical trials was poor.After a decade of juggling data in the 83 different trials, SKB was finally able to cite four (4) "positive" trials and three (3) "supportive" trials to justify Paxil’s approval.Dropouts in most trials were rampant.Most of the dropouts occurred because Paxil caused adverse experiences, and the victims wanted nothing more to do with the drug.
21.Paxil’s clinical trials were a statistical sham.Rather than deal with real numbers, SKB created a fraudulent measuring standard called "patient years" (or "patient exposure years").The need for "patient years" became obvious in the 1980’s.It was obvious in the late 1980’s and into the 1990’s that Paxil clinical patients were attempting suicide and suffering "adverse experiences" at an alarmingly high rate.Moreover, as indicated above, hundreds of Paxil volunteers dropped out because they could not tolerate the drug.The dropout rate was 20%.Fifty-eight (58) patients alone attempted suicide after they were given Paxil.Hundreds of additional Paxil patients suffered adverse experiences caused by the drug.In 1991, SKB "ran the numbers" and discovered the absolutely horrible Paxil record.The 58 attempted suicides out of the patient base constituted a suicide rate of 0.77% in real numbers.Under clinical standards, a rate of 1% is considered a "frequent" occurrence.On those numbers, Paxil patients approached a "frequent" suicide rate.This was a far greater suicide rate than "placebo" or the other active drug being tested on the patient population.To avoid a company disaster on the Paxil project, SKB had to change the rules, and shift to the "patient years" sham.
22.The "patient years" standard is a sham by anyone’s common sense.It works like this.Assume 366 patients are selected at random to test Paxil.Three hundred and sixty five (365) patients take Paxil and suffer horribly the first day–immediately quitting the test.These patients are called, not surprisingly, "losers."The 366th patient, however, tolerates Paxil quite well, and even improves on the drug, staying in one or more trials for a full year.This patient is a "winner" by SKB standards.Like a champion race horse, this "winner" is entered in all the sweepstake trials for Paxil–and these trials are intentionally programmed to be long.Knowing they have a champion race horse, SKB racks up "points."By anyone’s common sense standards, 365 failures out of 366 attempts would render the drug a dismal failure.But not so under "patient years."Under patient years, the one Paxil patient who tolerated the drug for one year counts the same as the 365 patients who couldn’t tolerate the drug and dropped out the first day.The "score" in this example is "one patient year" for each side.Not surprisingly, the mathematicians who go along with this voodoo math are subordinate to the physicians and clinicians in the corporate chain of command, and the physicians at the top of the FDA chain of command.
23.In Paxil’s clinical trials, SKB ultimately achieved positive results–as it were–because of emphasis on "subjective" testing data.Objective data is very scientific.Subjective data is less scientific.The latter requires more stringent controls to be applied scientifically.Subjective data is subject to the biases, opinions, and prejudices of the person(s) collecting the data.SKB’s subjective data to justify Paxil’s approval was obtained both from physicians, principal investigators ("PI") (most of whom were physicians) and from patients.The physicians and PI’s were compensated handsomely by SKB for their participation in the trials.On information and belief, plaintiffs allege these individuals were hired only after appropriate screening to ensure they were friendly to the drug industry and SKB.
24.In the seven (7) clinical trials "supporting" Paxil, SKB used subjective data and evaluation to attempt to demonstrate Paxil reduced suicidality.SKB’s methods, however, were "softball" and not a true test of Paxil’s efficacy.Even members of the FDA committee later voting to approval Paxil questioned the easy criteria on which they were compelled to vote.Two members questioned the validity of using outpatients (rather than inpatients) and outpatients, at that, who were not severely depressed.Two such subjective methods to determine a patient’s suicidal tendencies included the "Hamilton" testing method and the "MADRS" testing method.It takes an experienced physician working patiently and deliberately to obtain accurate "Hamilton" and "MADRS" readings.Physicians interview patients thoroughly to determine accurate "Hamilton" and "MADRS" readings.To determine a patient’s suicidality over a six (6) week clinical trial, the patient has to be interviewed and observed weekly.Patients, like poll responders in general, often respond to the poll taker according to expectations.If the patient believes the doctor wants to hear that the patient is feeling better today, the patient will answer “yes” to the question “Are you feeling better today?”The patient knows what the doctor expects to hear.Patients are recruited for clinical trials by a variety of methods, including the inducement of “free” medication.To a depressed person who often has had expensive medical bills over several years, the inducement of “free” medication is often akin to the enticement awarded alcoholics for selling blood to a blood bank for hard cash.Given the psychologically dominant position of the physician over the patient, rare is the patient who will openly challenge the physician and depart from the physician’s expectation.Clinical trials are supposed to be conducted under rules which minimize biases and prejudices of the PI’s and patients.While “blind” and “double blind” techniques are the vehicles used to enhance the integrity of randomization, biases and prejudices of the sponsor and clinician still come in to play.Trained physicians observe patients and can make intelligent assessments on whether the patient is randomized on the placebo sugar coated pill–or is on an active drug.If a patient relatively normal at the start of a placebo trial (placebo vs Paxil) is "jumping" around the physician’s office and "hyper" after the trial begins, it is evident the patient is on Paxil.Good results are then documented.Suicidality indices decrease.An "active" trial (placebo vs Paxil vs active drug "imipramine") is not quite so simple, but almost so.The "jumping/hyper" patient in this instance is known to be on Paxil or imipramine.Statistically, the clinician biased for the sponsor’s success will do the same as in the previous example.S/he finds improvement in the patient.This is so for two (2) reasons.First, there is a 50% chance the patient is on Paxil.Thus, the odds favor Paxil over placebo on a 2:1 probability.Secondly, before the test even starts, an SKB designed test will not create a favorable protocol for imipramine.Doses for imipramine will be doubled–or halved–or otherwise varied from the most effective imipramine dosage in order that Paxil will be sure to out-perform imipramine.As with the above patient population issue, a member of the FDA commission ultimately voting on Paxil expressed concern on the record that SKB’s imipramine doses were not well formulated.While in these subjective testing programs, most outpatients checked in with the PI’s on a weekly basis.This pleading is not intended to document the full range of "subjective" testing to obtain Paxil’s FDA approval.Rather plaintiff alleges testing methods were jockeyed back and forth, e.g. subjective vs objective, always with the goal of achieving the most favorable results for Paxil–and casting the most unfavorable results for placebo and the "other" drug.
25.Paxil’s addictive traits, central to this lawsuit, played a secondary role in the clinical trials leading up to Paxil’s approval by FDA in 1992.In 1988, a clinical trial potentially addressing the withdrawal issue commenced.In that trial SKB sponsored a Paxil "relapse" trial in Yugoslavia (the "Yugoslavia trial" or "relapse trial").SKB knew that a positive FDA vote for Paxil would be more likely if they could prove that patients taking the drug not only experienced improvement from their depressive state, but that Paxil also prevented "relapse."To be eligible for participation, patients had to have suffered a major depressive disorder and experienced a history of recurring depression.All patients took Paxil in "Phase I" of the trial.For "Phase II," the patients were randomized into two separate groups.One group remained on Paxil.The second group shifted to placebo, the sugar coated pill.Given the randomization assignments, the placebo patients–having just completed active Paxil ingestion in Phase I–would be vulnerable to withdrawal symptoms given the imposed "cold turkey" circumstances in which they were placed.If SKB had been sincere in detecting any Paxil inducement of physical and/or psychological dependency, SKB would have set up a systematic monitoring program for the placebo group.Phase II was an ideal test bed for that purpose.But SKB knew of their drug’s propensity to addict and, therefore, had no such intention of falling into that trap.SKB’s objective was to prove Paxil’s efficacy, not to give the regulators ammunition to scuttle the project.SKB intended to prove that Paxil patients do not "relapse."SKB thus cleverly set the relapse bar very high (the "relapse criteria") in order to make relapse extremely rare.Their relapse criteria were as follows.Relapse was defined as:(a) a condition requiring additional treatment for the patient, (b) a worsening of the severity of illness index by a factor of "2" since the last outpatient visit, (c) an overall severity of illness score of at least "4," a deterioration in depressive condition for a minimum of seven (7) days, and (d) an admission by the patient that his/her own criteria for a major depressive episode existed.
26.After Phase II of the Yugoslavia trial commenced, it is alleged on information and belief that the placebo patients began experiencing massive Paxil withdrawal symptoms.This occurred in 1989 and 1990.The SKB agents in Yugoslavia conducting the trial, however, were not looking for "withdrawal" symptoms.They were looking for relapse criteria.When a patient goes to the doctor’s office, scientifically validated medical procedures should be followed by the physician in order to attain an accurate diagnosis.In the case of ongoing clinical trials, however, as with the "Hamilton" suicidality indices, the physicians as well as the patients are on a pre-planned glide path in accordance with the trial protocol.Given this was a relapse study, medical ethics require the responsible clinician to abandon the trial for patient emergencies and safety, and to always follow sound medical procedures.Nevertheless, the high stakes nature of the clinical trials likely prevailed in the PI’s mind.This does not necessarily suggest that the PI is intentionally cheating.What is does suggest are that test objectives taint the prism through which the PI observes patient symptoms.In the Yugoslavia trial, when the placebo patients walked into the doctor’s office suffering withdrawal symptoms, the SKB agents saw relapse criteria, not symptoms of withdrawal.Alternatively, it is alleged on information and belief that many physicians in Phase II of the Yugoslavia study indeed detected and reported Paxil withdrawal symptoms for what they were.They did this in written patient summaries submitted to SKB headquarters.However, because of SKB’s study design and desire to avoid the "withdrawal" issue at all costs, SKB chose to interpret the withdrawal data as "relapse" data and reported it as such to the FDA.
27.SKB had a heyday in running up positive statistics for Paxil in Phase II of the Yugoslavia trial.In many of the eighty-three (83) trials comprising the entire clinical testing program over a decade, placebo, the sugar coated pill, "beat" Paxil in the statistics.That means Paxil was worse than no treatment at all (a conclusion, not surprisingly, that critics of SSRI’s insist is the true scientific result).Even in the seven (7) tests ultimately claimed to be positive for Paxil before the FDA, Paxil’s superiority over placebo was very marginal and required statistical fine tuning–as in "patient years"–to reach that result.In Phase II of the Yugoslavia trial, however, SKB’s statistics resulted in Paxil shellacking the daylights out of placebo.At the six (6) month mark in Phase II, SKB reported placebo patients suffered 450% more relapse incidents than did the Paxil patients.Eighteen (18) placebo patients suffered "relapse," SKB so reported, but only four (4) Paxil patients.This published result was to show that patients staying on Paxil continued to enjoy a normal, "depression free" life, but that those abandoning the drug would suffer relapse back into a depressive state.It is alleged on information and belief that most of these placebo patients were suffering withdrawal–not relapse–and that these trial results were a massive and cruel hoax.
28. In the meantime, SKB knew they had to keep a lid on the Yugoslavia trial to avoid detailed scrutiny by the FDA.SKB further knew that government regulators and mental health professionals were aware of the withdrawal issue and would look long and hard at any assertions SKB might claim in this area.SKB further knew that any claim connecting the "relapse" and "withdrawal" issues would be reviewed before the FDA committee that would vote on Paxil.Aware of this dilemma, SKB decided to massage the problem through back channel communications with Thomas Laughren, MD, a high official in the FDA.SKB felt if they could convince Dr. Laughren of the good "relapse" statistics in the Yugoslavia trial, they could avert the hard questioning of the FDA committee members on the withdrawal issue.Having "FDA" on your side before the FDA committee, it was felt, was good politics and a way to subtly shift responsibility for the issue away from SKB.To implement their tactic, SKB emphasized to Dr. Laughren that the Yugoslavia trial protocol was designed to detect relapse.At the same time, SKB told Laughren, they would do their best to detect and report on Paxil’s withdrawal issues during Phase II.Given that "withdrawal" at that moment was not a front burner issue, that explanation satisfied the FDA official.
Suicide Issue Delay’s Consideration–but FDA Finally Approves Paxil
29.Paxil’s fate before the FDA was to be decided on October 5, 1992.This date was much later than originally anticipated.The delay was caused by public pressure.There had been press reports that Prozac, originally appearing on the market in 1988, had caused many suicides.FDA was thus compelled to review Prozac and–obviously–considered it in their own interest to tread softly before approving additional SSRI’s for the market.Condemning Prozac and acknowledging the suicide issue, however, would suggest in many quarters that FDA was to blame for allowing a dangerous drug on the market in the first place.Few bureaucracies admit they are wrong, and all have a tendency to herald the status quo.Thus while assuring Congress and the media that they would thoroughly investigate the recent Prozac allegations, the FDA was actually in cahoots with the SSRI manufacturers on the suicide issue.On October 3, 1990, an FDA official, the Director of Neuropharmacological Drug Products, telephoned SKB headquarters.He asked to speak to SKB’s Regulatory Affairs director, a Ph.D.The call was made at a location that could not be traced back to the FDA official’s office.This person making the call was the senior FDA official responsible for Paxil’s application.The official made clear to SKB his purpose.It was not to "lay down the law" and ensure SSRI testing was refined.It was to tell SKB how to get around the suicide problem for Paxil’s upcoming application–and further not to worry.At the time of this telephone call, October, 1990, the FDA was still a year away from the ultimate September 20, 1991 hearing that would determine FDA’s position on SSRI’s and suicide.But the issue had already decided in the eyes of the FDA.Getting to the point in this October 3, 1990 telephone call, the FDA official assured SmithKline that "the Division does not see it as a real issue, but rather as a public relations problem."The "it" was the relationship between Prozac and violence-ideation and suicide-ideation.The FDA official made clear that for Paxil–his agency would short cut the process and not require scientific precision for evaluating the drug’s connection to suicide.He told the SKB agent that FDA did not desire a "voluminous" submission of Paxil suicide data.The FDA official told SKB to keep the submission brief, that FDA "…(did)…not want to review something that large."The FDA official offered tips to the Ph.D. on how SKB could get around the suicide issue.He told him SKB "should" key in on Dr. Teicher’s article regarding suicide ideation (note:it was Teicher’s article in a national medical journal that first gave credence to Prozac’s suicide connection).The FDA official revealed the test standards Eli Lilly used in order to get Prozac approved, effectively saying that SKB should copy the Lilly standards and that all would be OK.Feeling elated that FDA’s top regulator was advising them on how to get around the suicide issue, the Ph.D. seized the moment.He asked the FDA official whether SKB’s point person on the suicide issue could work with him (FDA official) to ensure that SKB’s submitting document was correctly prepared.The FDA official "said that would be fine."Thus, instead of being a critical watchdog for the public welfare, the FDA simply went into the applicant’s camp and acted as SKB’s intermediary to maneuver Paxil’s application into safe waters for the drug company.Before hanging up the telephone, the FDA official once again reassured SKB they were all just playing the PR game on suicide, emphasizing "that the Division does not think…(suicide and SSRI’s)…is an issue, but…(that)…it needs to be addressed."Paxil’s application eventually came to the fore.As with many new drug applications, the FDA convened a panel of non-governmental experts to determine Paxil’s fate.It was on October 5, 1992, that the FDA convened the "Psychopharmacological Drugs Advisory Committee" (or "committee") to consider Paxil’s safety and efficacy and fitness for market.All six (6) members of the committee were affiliated with the pharmaceutical industry, and required "conflict of interest" waivers in order to sit on the panel.
30.It was in mid 1992 that Dr. Laughren was directed by the FDA to be the staff point person for the October 5, 1992 Paxil committee hearing.Dr. Laughren had earlier concluded he would recommend Paxil’s approval.Dr. Laughren was also getting promoted and had only recently assumed the higher position.He was being assigned to take over the position occupied by the FDA official who had telephoned SKB on the PR nature of the Prozac problem.Dr. Laughren was taking over the higher position very late in the game insofar as Paxil’s application was concerned.The earlier incumbent–as described–had already taken a position favoring Paxil’s approval, and was not modest in voicing full support for SSRI’s.It would have been highly unusual for the FDA to place in that position an individual who would upset the apple cart and refute what his/her predecessor had committed to on the Paxil decision–and of course that didn’t happen.Dr. Laughren fell in line with his predecessor and validated all of his predecessor’s findings.In preparation for the upcoming October 5, 1992 committee proceedings, Dr. Laughren wished to be "hands on" before committee members.His wished to make it appear that the FDA staff was totally in command of their domain.Here, however, is where the FDA regulatory system breaks down–and was broken in this instance.It is where, essentially, the government bureaucrat depended on the "regulated" in order to look good in the job and get through a particular project–and that’s what happened here.Both players–FDA staff and SKB–recognized they were dependent on each other to look good before the committee.Like the telephone tipoff on the suicide issue, this was a poor environment for checks and balances, or fostering effective FDA regulation on behalf of public safety.For several weeks leading up to October 5, 1992, Dr. Laughren depended on SKB to get up to speed for his expected presentation before the committee.This was notwithstanding that FDA had been provided all of Paxil’s trial documentation as the clinical trials had progressed throughout the previous decade.As Dr. Laughren was preparing for the committee hearing, he made several urgent fax appeals to SKB headquarters to help him prepare his presentation.He was not modest.He asked numerous questions.He asked for numerous, individualized research scenarios.Some were provided immediately from SKB’s computer.Others had to be specially gathered by SKB and forwarded later.To facilitate Dr. Laughren’s support for their product, SKB promptly and fully complied with all of his requests.These SKB and FDA principals operated on a "first name" basis in their fax exchanges.SKB officials were so friendly with Dr. Laughren, they addressed him as "Tom" in front of the committee podium.
31.When the FDA committee convened in Rockville, Maryland, on October 5, 1992, the FDA staff made their presentation first.SKB’s presentation followed.Dr. Laughren’s presentation was lengthy, and essentially constituted the FDA staff’s position on Paxil.In his overview to the committee, Dr. Laughren addressed many Paxil issues.Knowing the six (6) voting members would be interested in the "withdrawal" issue, Dr. Laughren felt obligated to explain to the committee FDA’s understanding on the Yugoslavia trial.That was that the Paxil withdrawal issue was not formally studied during the tests.Laughren told the committee in regard to the Yugoslavia trial:"There was no systematic effort really to look at the withdrawal syndrome, but in looking at the patients coming off of…(Paxil)…in the clinical trials, there was no strong suggestion of a withdrawal syndrome."That was strange language coming from a top FDA official commenting on clinical trials.Proper science and clinical analysis do not permit a "strong suggestion" of anything without scientifically imposed controls to justify such a conclusion.
32.At that juncture, SKB’s plan for the committee was proceeding smoothly.The FDA was in their corner, and the FDA staff had told the committee exactly what SKB had hoped they would.Then in the afternoon it was SKB’s turn to address the committee.SKB was not content to rest on Dr. Laughren’s commentary regarding the Yugoslavia study.SKB boldly went to the next level.SKB asserted to the committee that SKB had studied "whether or not there is a discontinuation syndrome in patients who are abruptly discontinued from Paxil."The SKB representative continued:"To end with a brief discussion of whether or not there is a clear withdrawal syndrome, we have pulled upon the …(Yugoslavia trial)…"Then, SKB made an outrageous and categorical falsehood.The SKB representative told the committee SKB in the Yugoslavia trial attempted to "systematically assess a discontinuation syndrome."This statement was in direct contradiction of Dr. Laughren’s earlier statement in the day that "There was no systematic effort really to look at the withdrawal syndrome."Having refuted the FDA representation that there were no "systematic" tests on Paxil withdrawal, SKB then further claimed the tests were successful in that regard.The SKB representative told the committee they examined the data on the Phase II placebo group and that "few numbers of patients experienced any adverse event after being randomized off…(Paxil)…into the placebo group and the percentages are certainly very small."What SKB failed to add was that no "adverse events" were reported on the placebo group because the eighteen (18) placebo victims’ symptoms were reported by SKB to have been "relapse" symptoms.Given the high bar established by SKB for relapse, the 18 placebo victims constituted a staggeringly high 45% of the placebo group.Had a reasonable clinical standard for "relapse" been set, it is quite possible 75% or 90% an or even higher casualty rate would have been recorded.
33.Then a most startling and telling exchange occurred before the committee.The SKB proclamation that "systematic" withdrawal testing had been accomplished in the Yugoslavia trial caught the FDA staff representative, Dr. Laughren, completely off guard.Hearing the SKB representative directly contradict him on "systematic" withdrawal testing, and further hearing that placebo patients suffered no adverse effects after being taken off Paxil, Dr. Laughren interrupted the SKB speaker.From his perspective sitting in the audience, Dr. Laughren understood there were "crossed signals" before the committee between the FDA staff and SKB, and that the discrepancy required immediate correction.Dr. Laughren additionally understood there was now a gap in the testimony.Dr. Laughren understood the placebo group’s statistics meant nothing without comparison to the Paxil group.He then yelled up to the podium to the SKB representative, and the following exchange occurred:
Laughren:"Unfortunately you did not contrast…(the placebo group)…with the rates…(of adverse experiences)…in the patients who continued on…(Paxil)…"
SKB:"Right.I know the point you are going to raise, that it really does not look that different…"
Laughren:"That was my impression."
SKB:"…from what you saw in the…(Paxil)…group, and that is a well founded point.So we very much agree with your earlier conclusion that there is no clear withdrawal syndrome but this was our attempt to try and investigate it in somewhat of a controlled fashion."
In effect, SKB had just pulled off a coup.SKB had successfully and deceitfully maneuvered Dr. Laughren into making the case before the committee that withdrawal tests were conducted, and they proved Paxil "clean" on the withdrawal issue.SKB got Dr. Laughren to do their heavy lifting before the committee on a subject the FDA official had no personal knowledge of.SKB simply stepped aside and put icing on the cake with a polite "we very much agree with…(Dr. Laughren’s)…earlier conclusion that there is no clear…(Paxil)…withdrawal syndrome."
34.SKB’s tactic to skirt the withdrawal issue at the committee hearing was thus successful.After representation to them that Paxil had been systematically tested for withdrawal and that the tests were successful, the committee voted to approve Paxil.
About Face on Labeling
35.After the committee voted on October 5, 1992 that Paxil was safe and efficacious for treating depression in the U.S., the other details of Paxil’s "prescribing information" and "labeling" had to be formulated by SKB and approved within the FDA bureaucracy before Paxil could be marketed.
36.Having obtained committee approval by attesting that Paxil had been "systematically" tested and determined not to cause withdrawal symptoms–SKB was now in another quandary.Knowing what SKB then knew about Paxil’s withdrawal problems, SKB knew they would be in very serious and immediate trouble if Paxil hit the market with "prescribing information" and "labeling" that reflected what was represented to the committee.Should that materialize, SKB realized that "prescribing information" and "labeling" to that effect would blow up in their face.SKB would stand convicted of a public lie based on their own written words.
37.Now the politics in the drug labeling process kicked in full bore.On or about October 6, 1992, recognizing the new quandary, SKB made another 180 degree turn.SKB decided to go back to their original position.They decided they better disavow any testing on the withdrawal issue.So, SKB kept "systematic" in their vocabulary but added the qualifier "not" before it.The following is what SKB published in regard to Paxil’s withdrawal issue.
"DRUG ABUSE AND DEPENDENCE.Physical and Psychologic Dependence:"Paxil has not been systematically studied in animals or human for its potential for abuse, tolerance, or physical dependence.While the clinical trials did not reveal any tendency for any drug seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a…(central nervous system)…active drug will be misused, diverted and/or abused once marketed.Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of Paxil misuse or abuse (e.g., development of tolerance, incrementations of dose, drug seeking behavior).
The FDA did not object to SKB’s labeling scheme, and the above notation was approved for inclusion in the PDR.It was made available to all physicians beginning December 29, 1992.The same notation remains in effect today.
Withdrawal Warning for Drug Abusers Only
38.With the above notation in Paxil’s prescribing information and labeling, SKB took deception to the next level in deceiving American consumers.The above prescribing information and labeling is false and misleading on its face.Not satisfied to merely tell the public the opposite of what they told the committee on "systematic" testing; not satisfied to merely falsify the results to make it appear that Paxil was not habit forming when it was–SKB went to the third level of deception by exploiting decent, honorable citizens who, through perhaps depressed, would never dream of using illegal drugs.SKB did this by focusing attention on "patients…with a history of drug abuse."The notation implies that patients with a "history of drug abuse" may be vulnerable to "physical and psychologic dependence" with Paxil’s use.But SKB effectively instructs citizens who have never abused drugs that there is no risk of dependency.They do this through identification of a single risk group who–even if they didn’t take Paxil–would be given the same admonition.SKB knows that most law abiding citizens with no history of illicit drug use would, after reading the notation, say to themselves "Me–a history of drug abuse?…No!…that certainly does not apply to me!"It is alleged on information and belief that that is exactly the reaction that SKB intended law abiding citizens suffering depression to conclude.In effect, the notation is a green light to entice patients who have never had history of drug abuse to conclude that they will not suffer withdrawal symptoms from Paxil.
Another Instance of Changing Withdrawal Data to Relapse Data
39.The Yugoslavia trial, heralded at the committee hearing, was not the only clinical trial in which SKB manipulated withdrawal data into relapse data.The same situation occurred in a U.S. trial.Conveniently, this was not presented to the committee at all either by SKB or the FDA staff.It was presented a year earlier by SKB to Martin Brecher, MD, of FDA.In that report to Dr. Brecher, subjective reporting gathered from patients by the PI’s told SKB management that Paxil was dangerously addictive.Dr. Brecher cited this report in his FDA internal written summary on June 19, 1991, but it was withheld from committee discussions on October 5, 1992.The result on Paxil’s addictive qualities was stunning, but SKB chose to ignore it.A group of 108 patients ending their participation in a trial told SKB that Paxil had caused them to suffer “withdrawal” problems (or the "Group of 108 Complaining Patients’ Study").Out of the 1293 patients in that trial, the 108 complaining patients constituted a staggeringly high 8.3 of the participants.Rather than take note of this alarming finding and report the red flag to the FDA, SKB chose the worst option.They chose to disbelieve the 108 participants, and put a self serving "spin" on the data.SKB reported that these patients dropped out of the clinical trials, and at the time of termination, dosage had not been abruptly discontinued or tapered down.On information and belief, it is alleged this was false for most patients.That is because most patients quitting testing do so well before they actually walk in to the clinic and say "I’m quitting."They quit days or even a week or two before they walk in to say "I’m quitting,"On information and belief, it is alleged most of these patients had in fact had their dosage abruptly discontinued or tapered down, and were actually suffering "withdrawal" symptoms as they claimed.But SKB categorized these patients’ "withdrawal" problems as "relapse" problems.This convenient transformation from "withdrawal" to "relapse" data staved off another potential crisis for SKB.Unlike the Yugoslavia trial wherein no patient inputs were recorded for history, these 108 patients specifically came forward to complain of "withdrawal."It was totally illogical for SKB to cite relapse.If anyone reports they are suffering "withdrawal," unless they are out and out lying (most unlikely for a patient desiring to get better), the only logical conclusion is that such a person acted upon his/her knowledge that the symptoms appeared after they had missed a day or two or three of taking the pill.It is the height of arrogance and self serving manipulation that SKB should summarily dismiss a person who insists s/he is suffering withdrawal from their drug.The 108 patients did not report "nervousness."They did not report "tremor."They did not report a whole host of nouns and adjectives that would have passed for "relapse" data.Instead they insisted they were suffering from "withdrawal."Worse than merely disbelieving the 108 patients, SKB changed the results to "relapse" without going back to interview those patients.SKB’s motive in the "withdrawal vs relapse" issue during clinical trials is one thing.However a compelling question is why–with all the facts on the table–did SKB choose to ignore problem for several years.The data in the "Group of 108 Complaining Patients’ Study" should have alerted SKB to immediately place a high priority on the "withdrawal" issue–to study it thoroughly, and update their warnings as appropriate in due time.SKB has done nothing to date on the problem.
Paxil’s Short "Half Life" Induces Dependency
40.Paxil’s "half life" is 24 hours, a factor critical in establishing dependency.In pharmacology, half life is the period over which the concentration of a specified chemical or drug takes to fall to half its original concentration in the specified fluid or blood composition.Since its introduction on the world’s stage, SKB has heralded Paxil as a breakthrough drug because of its short half-life.In media promotion and advertising, SKB invariably emphasizes Paxil’s short half-life and its attendant advantages over its SSRI competitors, Eli Lilly’s "Prozac" and Pfizer’s "Zoloft."In Paxil’s first sales flyer, under the headline "Fewer Concerns," SKB boasted of the drug’s "Minimal agitation…short half life and no potentially problematic metabolites.”Prozac and Zoloft both have considerably longer half-lives than Paxil; hence SKB uses the distinction to exploit what they view as Paxil’s advantage in that area.
41.Notwithstanding the Yugoslavia trial and the "Group of 108 Complaining Patients’ Study," Paxil’s short half life should have alerted SKB that Paxil would likely induce physical and psychological dependence, and create withdrawal problems for patients discontinuing or reducing its use.It is established scientific principle that short half-life substances are more likely to cause such dependency and withdrawal problems than substances with a long half-life.But SKB appeared oblivious to such a common scientific fact.SKB was and remains indifferent to Paxil’s causal relationship to physical and psychological dependency, addiction, and withdrawal problems for Paxil patients desiring to discontinue or reduce dosage.
42.Paxil’s labeling and prescribing information on "drug abuse and dependence" reported above deceived physicians and patients after December 29, 1992, similarly deceived from 1993 to 1999, and similarly deceives today.The deception rests with the fact that Paxil "hooks" many, many patients who have never had a "history of drug abuse."On information and belief, currently thousands of patients throughout the U.S. and hundreds of patients throughout California and Santa Clara County are "hooked" on Paxil because the labeling and prescribing information originated by SKB deceives physicians into believing the drug is not habit forming for most people when in fact it is.When the physicians and patients discover that Paxil does induce dependency, it is too late.Even though daily dosages for these Paxil patients are reduced incrementally from 30 mg or 40 mg down to 5 mg or 10 mg, the patient can go no further and must get his/her daily dosage or suffer major withdrawal symptoms as noted earlier in this complaint.The result of these terrible symptoms is for many patients to go back on Paxil.This terrible plight is no less than drug addiction induced by misleading information promulgated by SKB.
If SKB Didn’t Know in 1992, They’ve Had 7 1/2 years to Find Out
43.Notwithstanding the "relapse" versus "withdrawal" issue in the original clinical trials, and the misleading labeling and prescribing information originally promulgated with Paxil’s approval on December 29, 1992 (supra), SKB now has had seven and a half (7 1/2) years of Paxil experience with the general patient population.For these seven and a half (7 1/2) years, SKB has known about Paxil’s drug addiction problems, but–as indicated above–has done nothing about it.SKB has been consciously indifferent to the problem in order to preserve its profits, and even increase its market share.Current Paxil sales are approaching $2 billion annually, while SKB eagerly attempts to overcome Eli Lilly and Pfizer and be king of the roost in the SSRI world.
44.SKB’s continuing sales advertising on print, radio, and TV on Paxil’s short "half life" induces both physicians and patients to believe that Paxil has no withdrawal symptoms.In public promotion programs, SKB boasts that Paxil’s short half life does not affect the therapeutic process and reduces side effects.The implication is that the short half is all good, and has no down sides.As a result, more and more patients are being prescribed Paxil, and are getting "hooked" on the drug.The physicians are as vulnerable as anyone.They are intellectual leaders in the community, but after they’ve been duped on such a basic issue and find their patient is "hooked" on Paxil, they remain silent out of embarrassment.They are also fearful of being sued for malpractice for their role; thus they remain silent as a group.
45.Paxil was, is, and will continue to be addictive and habit forming for a great percentage of patients using the drug.Most such patients, however, are ignorant of this fact when they are initially prescribed Paxil by their physicians.As a result, all such patients are "hooked" on Paxil.As a result, they continue to buy Paxil in great quantities, reaping great profits on SKB on this basis alone.
46.Thousands of patients nationwide and hundreds in California and Santa Clara County are alleged to be addicted to Paxil because SKB refuses to warn them of this hazard.
47.SKB knows about this addiction problem.Since 1993, it is alleged on information and belief, that SKB has turned a blind eye to the problem.There are several websites nationally where Paxil sufferers check in and complain bitterly about their dilemma.It is alleged on information and belief that SKB assigns their agents to check out these websites.While there are always a few crackpots on the Internet, any sane and reasonable person would know that a vast majority of those individuals checking in on the website have legitimate withdrawal problems associated with Paxil.Virtually all of them attribute their problem to SKB’s inadequate warning in the "prescribing information" and "labeling."Plaintiffs have been informed, and allege on information and belief, that many patients have complained to SKB headquarters in Pennsylvania on this problem.However the complaining patient always get the run-around by low-level SKB employees who are instructed to stall.SKB is too clever to directly chastise the complainant.Rather, SKB will ask the complainant for the complainant to send in their medical record so that SKB can review it.This effectively diffuses the situation for a few days, sufficient to discourage the patient from following up.Like the "Group of 108 Complaining Patients," the chorus of Paxil withdrawal sufferers who complain of that problem are ignored.
48.The list of patients addicted to Paxil grows daily.
49.In addition to literally hundreds and thousands of known Paxil victims on an individual basis, SKB has also known for years that outside clinical studies conducted by prominent scientists have proven that Paxil causes withdrawal problems.
50.In 1993, CSM & MCA published a study indicating there were 78 reports of withdrawal symptoms on Paxil patients, that reactions tended to start 1-4 days after stopping the drug;
51.In 1994, Barr published a study on a 12-week double blind study indicating that several Paxil patients experienced withdrawal symptoms after abrupt discontinuation.It was further documented that in spite of dose tapering over 7-10 days, 3 out of 6 patients experienced withdrawal problems.
52.In 1994, Keithen reported that in spite of gradual dose reductions, 5 of 13 Paxil patients experienced withdrawal problems;
53.In 1994, Ellison reported 5% of SSRI patients reported peculiar and distinctive withdrawal phenomena.Ellison called it a "withdrawal buzz."It was further indicated in this study that SSRI’s with longer half-lives would likely produce fewer and milder withdrawal symptoms.
54.In 1995, Block reported severe psychiatric symptoms associated with Paxil withdrawal in two middle-aged men.Neither had previously had a history of major psychiatric disorders.
55.In 1995, Debattista & Schatzberg reported Paxil patients stabilized on low dosages (10 mg daily) were abruptly withdrawn, whereupon the two (2) patients experienced symptoms including severe fatigue, dizziness, nausea and vomiting, headache, tremulousness and malaise.
56.In 1995, Fava & Grandi reported three (3) Paxil cases where depressed patients experienced withdrawal symptoms.
57.In 1995, Frost & Lall reported two (2) Paxil patients suffering withdrawal problems like severe "electric shock" like those cases previously reported by Ellison.
58.In 1995, Koopowitz and Berk reported a Paxil patient suffered severe dizziness and vertigo after abruptly stopping Paxil at 4 months.After four (4) days the patient was able to return to work, but brief episodes of the withdrawal symptoms persisted for one month.In another patient, severe and intolerable akathisia resulted after the patient had been taking Paxil for two (2) months, whereupon a severe withdrawal reaction followed, including vertigo, dizziness, ataxia, nausea, diplopia, heaviness in head, and feelings of dissociation.In a third case, a patient asked to stop medication after 6 months, in which the daily dosage for 20 mg daily.Dosage was then reduced to 10 mg daily for one month, and then to 10 mg on alternate days for two weeks.On alternate non-drug days the patient experienced severe headache, very severe nausea, dizziness and vertigo, dry mouth, and lethargy.The dose was then changed to 5 mg per day, but the patient felt gradual withdrawal prolonged her agony.She therefore stopped abruptly.She experienced two weeks of further withdrawal symptoms, but then fortunately recovered.
59.In 1995, Oerhberg published an article indicating that 19 patients out of 55 in a SKB sponsored study suffered withdrawal symptoms, much higher than the placebo portion of the clinical population.One SKB agent, when noting these statistics, commented that "only" 34.5% (19 of 55) reported withdrawal symptoms, but that such cases were only "of mild or moderate severity."
60.In 1995, Pyke reported a Paxil patient experienced flu like symptoms after discontinuing abruptly.Pyke reported deficiencies in SKB’s prescribing information (as herein reported), but SKB did nothing about it.
61.In 1996, Bhuamilk Wildgust reported Paxil patients with learning disabilities were treated for depression either with Paxil (average 30 mg per day) or with Prozac (20 mg per day) on average for months.Withdrawal symptoms of agitation and restlessness were reported in 42% of the Paxil patients, but in no Prozac patients.
62.In 1996 Arya reported withdrawal symptoms in a female Paxil patient who had been treated with 20 mg daily for one year.On discontinuation, she reported headache, extreme tiredness, fatigue, emotional lability, a "floaty feeling" in her head and an inability to concentrate.She restarted Paxil at 10 mg daily and the symptoms disappeared.After one week, dosage was reduced to 5 mg daily for one week, and then Paxil was again stopped.Symptoms of tiredness, fatigue and "floaty feeling" returned and persisted for three days.
63.In 1996, Coupland reported a study involving 158 patients on SSRI’s.In addition to Paxil–the SSRI’s Prozac, Zoloft, and Luvox were studied.Severe withdrawal symptoms were noted for all.Symtpoms persisted for up to three (3) weeks.Symptoms occurred much more frequently with Paxil and Luvox than with the others.
64.In 1996, Mathew reported from Australia that severe withdrawal symptoms were noted in a study done there.Fifty one (51) different symptoms were observed, including "vivid dreams" and "lowered mood."The most common symptom, "dizziness," was variously described as having a "swimming, spaced-out, drunken or buzzing quality and was markedly exacerbated by movement."
65.In 1996, Pacheco reported five Paxil patients experienced withdrawal problems after treatment of 20 mg daily for 12-14 months, and the problems occurred notwithstanding a conservative tapering regimen.In two (2) of these cases, symptoms demanded urgent treatment.
66.In 1996 Reeves & Pinkofsky reported a 39 year old woman was being treated for depression.She took Paxil at 20 mg daily for one year.One day after abrupt withdrawal, she experienced nausea, hot and cold flashes, headaches, and lightheadedness, plus what she described as electric shocks running through her back and limbs, precipitated by movement.Symptoms worsened markedly over the next two days; electric shock sensations became so severe she began sitting as still as possible.At this point, the patient went to the hospital emergency room; withdrawal symptoms were reversed within three (3) hours of taking 20 mg of Paxil by the mouth.Later, she attempted gradual withdrawal (10 mg daily for one week), but the withdrawal symptoms re-appeared.Symptoms again abated when she resumed Paxil at 10 mg daily.The patient was subsequently withdrawn, with only minor and short lived symptoms, on 10 mg Paxil every other day for ten (10) days.
67.In 1997, nationally prominent psychiatrist Peter R. Breggin, in his "Brain Disabling Treatments in Psychiatry" published by Springer Publishing Co., reported withdrawal problems from Paxil and cited a 1995 Schatzberg report and 1994 Louie, Lannon, & Ajari report as bases for his conclusion.
68.In 1997, Dahl reported a suspected case of Paxil withdrawal in a neonate, following maternal exposure during the last trimester of pregnancy.The newborn initially appeared alert.At 12 hours, however, he was referred for observation of increased respiratory rate, jitteriness, increased muscle tone and tremor.Except for sustained jitteriness, symptoms decreased during the 3rd and 4th days, when close observation ceased.
69.In 1997, Landry and Roy, reported a 30 year old man on Paxil experienced withdrawal symptoms upon stopping Paxil a second time.He had stopped treatment earlier without ill effects, but the second time suffered severe withdrawal problems that lasted two (2) weeks.
70.In 1998, Huffstutler published an article reporting "discontinuation of antidepressant medications has received minimal attention" in the medical literature.
71.In 1998, McDonald reported 26 patients experienced withdrawal problems.These reactions were reported to the Canadian Adverse Drug Reactions Monitoring Programme for the four available SSRI’s.Paxil was by far the worst, 17 of the 26 cases.Three (3) of the twenty six (26) cases (drug not specified), resulted in hospitalization or prolonged hospitalization; and in one case, "electric shock like" symptoms (paresthesia) persisted for four (4) years after discontinuation of Paxil.
72.In 1998, Rosenbaum and Fava published evidence about significant withdrawal problems associated with Paxil and Zoloft.
73.In 1999, Breggin again sounded the alarm on Paxil’s withdrawal problems, joining with David Cohen in their book "Your Drug May Be Your Problem–How and Why to Stop Taking Psychiatric Medications."
74.In 1999, Bakker, published a letter in Dutch entitled "Severe withdrawal symptoms with fever upon stopping paroxetine…("Paxil" et al)…"
75.In 1999, Peeters & Zandbergen published a case history of a 30 year old man, who was treated for depression, and who experienced "violent withdrawal symptoms with fever upon stopping paroxetine…("Paxil" et al)…"
76.In 2000, "Psychiatry On-Line" reported two (2) patients who all suffered prolonged neurological symptoms for months after stopping Paxil."Mrs. F" continued to suffer from tardive dystonia, 8 months after stopping Paxil, and one (1) year after stopping Paxil, "Mr. B" still suffered intermittent episodes, lasting hours to days at a time, comprising paresthesiae, dizziness, unsteadiness and slurred speech.
77.On August 6, 2000, "Psychiatry Drug Alerts" published by M.J. Powers & Co., reported a controlled study of 107 patients in which Paxil patients suffered serious and many withdrawal problems, as opposed to Prozac and Zoloft patients who suffered little.It was stated "patients withdrawn from …(Paxil)…reported deterioration in overall functioning and in functioning at work, relationships, and social activities.Patients withdrawn from…(Zoloft)…and…(Prozac)…reported lesser and no impairment, respectively."Powers hit the nail on the head on the seriousness of the "relapse vs withdrawal" issue.Powers added "a previous report has suggested that antidepressant withdrawal syndromes resolve within 1-2 weeks.Recognition and management of discontinuation symptoms is important, because these symptoms could be attributed to a depressive relapse or a physical illness (e.g. influenza) rather than to a specific drug interruption effect and may lead to pre-mature reinstitution of treatment."Whether Powers knew it or not, their study validates plaintiffs’ allegations that SKB’s Yugoslavia trial lead exactly to SKB’s and FDA’s wrong conclusions.Instead of providing validation on Paxil’s addictive qualities, the Yugoslavia trial was improperly used as a vehicle to convince patients they needed continuous does of Paxil to cope with their depression.This was and is tragic, and must be stopped.
78.On information and belief, it is alleged hundreds, possibly thousands, of patients have suffered severe withdrawal symptoms because their physicians do not know that Paxil is the worst SSRI in terms of addicting patients.Physicians do not know because SKB intentionally has withheld this information from them, and has withheld submitting this information to the proper federal and state authorities, and as a result this critical information is not contained in the "prescribing information" and "labeling" upon which physicians rely.
FIRST CAUSE OF ACTION
(VIOLATION BUSINESS & PROFESSIONS CODE § 17200)
79.The preceding is incorporated.
80.SKB has, since approximately, January 1, 1995, engaged in unfair competition, unlawful, unfair, and fraudulent business practices, and unfair, deceptive, untrue or misleading advertising by acts in violation of Chapter 1 (commencing with § 17500) of Part 3 of Division 7 of the Business & Professions Code.
81.SKB falsely advertises, through its Paxil labeling and otherwise, that only drug abusers are at risk of physical and psychological dependence, and withdrawal problems when tapering back or abruptly discontinuing Paxil usage.SKB knows such representations are false, and that all patients, including patients not having a history of drug abuse, are susceptible to withdrawal problems after tapering back or abruptly discontinuing Paxil.
82.SKB either knows or intentionally does not gather facts showing that massive numbers of Paxil patients are being addicted to Paxil.
83.SKB boasts to the public in advertising that Paxil’s "half life" is good for the patient, that a short half life specifically refines brain chemistry and reduces side effects–but they fail to tell the public that Paxil’s half life is bad for the patient in terms of addiction and withdrawal problems.
84.SKB has a duty to report to state and federal regulatory authorities and all physicians, consumers, and the public all the hazards associated with tapering off and abruptly discontinuing Paxil, but they have not done this, thus keeping all these parties in the dark on this terrible problem.
85.SKB’s violations in this cause of action are causing great profits for this defendant.Thousands of patients are buying Paxil, not because they require it therapeutically, but because they are addicted.
86.SKB has intentionally suppressed the adverse information pertaining to Paxil withdrawal.
87.SKB has failed to warn all of the aforesaid of the information pertaining to Paxil withdrawal, notwithstanding they have had a continuing duty to do so.
SECOND CAUSE OF ACTION
(VIOLATION OF BUSINESS & PROFESSIONS CODE § 17500)
88.The preceding is incorporated.
89.SKB through false and misleading statements in the public sector, including statements provided to regulatory authorities, statements caused to be published in the "Physicians’ Desk Reference ("PDR")," statements in newspapers, radio, and television, and sales pamphlets distributed to health care providers, have induced and are inducing citizens of California and this county, through physicians and otherwise, into purchasing and consuming Paxil under the guise that the drug does not cause physical and psychological dependence for patients tapering off and/or abruptly discontinuing Paxil usage.Such false inducement constitutes scienter, an improper motive, in that Paxil does cause all categories of patients to suffer such problems.When that happens, life becomes unexpectedly miserable for these patients.On information and belief, it is likely that suicidality develops in many such patients, and it is quite possible that actual suicides have occurred for this reason.
90.SKB has violated reasonable care by not studying this public health problem associated with Paxil, by not documenting the problem, and by not promulgating proper advisory information that would allow physicians and patients to cope with the problem.
91.SKB promotes Paxil by advertising its short half-life in the body, while emphasizing specific serotonergic pathways are affected in the brain.This and related advertising gimmicks are designed to entice the patient into believing that Paxil is a precise drug for their brain paths, perfectly hones to treat that patient’s depression, obsessive compulsive disorder, or panic disorder.Whatever merit such claims have, the "other side of the coin" on the short half life is that it creates miserable withdrawal problems for the patient tapering off treatment or abruptly discontinuing the drug.SKB knows this, but intentionally and/or negligently withholds this information from physicians and patients.
92.As a result of the above, California citizens are in great danger, and require immediate protection by this court.
THIRD CAUSE OF ACTION
93.The preceding is incorporated.
94.It shall be caused that each patient suffering objectively unexpected withdrawal symptoms from Paxil commencing from the time their therapeutic need for Paxil has ended shall receive restitution for all value, both medical and pharmaceutical and otherwise, during such time as said unexpected withdrawal has continued and is expected to continue in the future.
PRAYER FOR RELIEF:
Plaintiffs hereby pray for relief that:
a.That this court hereby direct affirmative actions and enjoin other actions currently in place or being practiced by SKB as the evidence so requires for the public safety;
b.That SKB take immediate steps to report to this court all information this defendant knows about Paxil’s withdrawal problems as outlined in this complaint;
c.That SKB take steps to immediately gather all information that is reasonably obtainable about Paxil’s withdrawal problems whether or not they relate to specific types of withdrawal issues outlined in this complaint;
d.That SKB immediately cease false and misleading advertising and public statements as pertains to Paxil’s half life, augmenting such statements, as necessary, with known information on how Paxil’s half life creates or exacerbates withdrawal problems in patients;
e.That SKB pay restitution to qualified individuals per the Third Cause of Action under a plan approved by the court;
f.That it be stipulated in remedy that no such action in relief shall be effective if it directly or indirectly opposes or is inconsistent with laws or regulations enforced by the federal Food and Drug Administration, and if such be the case, that said defendant provide detailed documentation to this court to justify each and every finding.
g.That plaintiffs be granted costs of this action;
h.That as a matter of public interest under Code of Civil Procedure § 1021.5, plaintiffs be granted reasonable attorney fees;
i.That the court grant other legal and equitable relief as the court deems appropriate.
Vince D. NguyenDonald J. Farber
Attorney at Law Attorney at Law