November 1, 2009

Antipsychotic Drugs, Their Harmful Effects, and the Limits of Tort Reform

By Dr. Peter Breggin

There are many problems within our legal system that could benefit from reform. But within the area in which I have great experience as a psychiatric expert, so-called tort reform has already gone too far. It is already too difficult for injured patients or their surviving families to bring malpractice suits against physicians and health facilities, and product liability suits against drug companies, even when their cases have great merit. I believe in private health care and I believe in the free market, but liberty requires checks and balances. The right to sue medical practitioners and pharmaceutical companies provides a necessary control in our free market system, as well as a means for individuals to seek compensation and justice.

Harm Caused by Antipsychotic Drugs

For illustrative purposes, I’ll focus on the newer antipsychotic drugs, the so-called atypicals, including Zyprexa, Risperdal, Geodon, Seroquel, and Abilify. These drugs produce horrendous adverse effects that often lead the victims or their surviving families to consider bringing lawsuits against doctors, health care facilities, or drug companies.

First, the antipsychotic drugs produce tardive dyskinesia. Tardive dyskinesia involves drug-induced abnormal movements that commonly disfigure patients and in some cases result in lifelong pain and total disability. The disorder frequently begins with out-of-control movements of the face, eyes, tongue, and mouth, including grimacing, chewing and tongue protruding. The muscles of the neck, torso, limbs, and fingers and toes can be involved. The ability to walk is often impaired. Speech, breathing, and swallowing can be afflicted. One variant called tardive dystonia results in agonizing muscle spasms, often leading to gross distortions in posture and gait. Another, tardive akathisia, causes neurological sensations that are excruciating and drive the patient to move about in an effort to relieve them. Some have been driven to suicide.

Tardive dyskinesia and its related disorders commonly begin to occur after only a few months or less of drug exposure and the risk accumulates over time. Rates for the older antipsychotic drugs are well demonstrated and reach or exceed 5% a year, cumulative. Fifteen percent or more of patients will develop tardive dyskinesia after three years of taking antipsychotic drugs. In the elderly tardive dyskinesia rates exceed a shocking 20% a year. With the newer drugs, the rates for developing tardive dyskinesia are said (by drug advocates) to be lower, but they remain very significant. In addition to innumerable cases of tardive dyskinesia in adults, I have also personally evaluated dozens of cases in children caused by the newer antipsychotic agents like Risperdal, Zyprexa and Abilify.

There is no effective treatment for tardive dyskinesia. Most cases are permanent and some worsen over time.

Tardive dyskinesia is especially insidious in onset because the drugs that cause tardive dyskinesia also mask or suppress the initial symptoms while the disease is developing. If the doctor does not carefully monitor and periodically stop the drug to check for the early development of tardive dyskinesia, a full-blown disabling case can develop before anyone realizes what has happened.

Second, the newer antipsychotics frequently cause diabetes and pancreatitis.

I have been a medical expert in fatal cases. Eli Lilly has paid more than one billion dollars in order to settle hundreds of diabetes cases related to Zyprexa without admitting any wrongdoing and without releasing their in-house safety data for public and professional scrutiny.

Third, these drugs also produce a potentially disastrous “metabolic syndrome” that includes elevated blood sugar, elevated cholesterol, elevated blood pressure, and severe obesity. They can also cause direct harm to the function of the heart. Overall, it’s a prescription for cardiac disease and premature death. New studies in children have found astronomical rates of pathological obesity after only a few months exposure.

Fourth, these drugs cause gynecomastia—abnormal breast tissue growth and even milk secretion—in children and adults. A twelve-year-old boy can be devastated by the development of one or more large breasts. Sometimes these abnormal growths remain after the drug is stopped, and even recur after surgical removal. According to attorney Stephen Sheller, Risperdal and then Seroquel are the major offenders in his extensive experience with cases of gynecomastia.

Fifth, these drugs cause neuroleptic malignant syndrome, a potentially fatal disorder that mimics viral encephalitis.

For all of these disorders, patients and their families need to be warned about the risks and educated about how to identify early signs. Patients needed to be monitored and the drugs must be stopped at the earliest sign of one of these disorders. The need for the drugs, a rational treatment plan, and patient consent should be documented in the medical record. Unfortunately, physicians too often fail to meet these standards while cavalierly prescribing these dangerous agents to adults and, at times, to small children.

And that’s only the beginning of the list of disastrous adverse effects caused by antipsychotic drugs. I believe these drugs would be outlawed in a rational society, especially for children. Instead, the FDA has recently been expanding their use in children.

Ironically, the FDA is approving these drugs for use in children at the same time that the Justice Department has been fining drug companies for illegally marketing these drugs to children. The illegal marketing corrupted and contaminated medical practice, encouraging physicians to prescribe off label, eventually leading the FDA to then approve off label prescribing. The studies used to justify this approval have been wholly developed and supervised by these same drugs companies using handpicked doctors who have often been involved in encouraging off label use. Drug companies commonly ghostwrite the research publications that appear under the names of these doctors.

The Difficulty of Bringing Lawsuits

Although many millions of people are seriously harmed each year by the so-called antipsychotic drugs, relatively few victims are able to bring malpractice or product liability suits. Since the drugs work by producing a chemical lobotomy, patients who remain medicated are too apathetic to complain or even to recognize their abnormal movements. Even when they stop taking the drugs, and become more aware of their impaired condition, most remain unable to find an attorney to take their case. On a weekly basis, I receive calls from injured individuals asking me to evaluate their cases or to refer them to attorneys. Often the news for them is discouraging.

Doctors, health facilities, and drug companies hire lawyers who make it very costly in time and money to bring lawsuits against their clients, regardless of how badly they have practiced medicine. Very few patients can finance the suits themselves. To make it worthwhile for attorneys to finance the suits, they must hope for settlements or jury awards in the hundreds of thousands of dollars—or more. With the economy in such bad shape, fewer patients or attorneys have the wherewithal to risk bringing malpractice or product liability suits. Even when the economy was humming, I often heard lawyers refuse to even look at cases unless the victim was dead or permanently disabled in an obvious way that a jury could see across the courtroom.

For example, I received a phone call from a lawyer who had tardive dyskinesia in the form of a disfiguring facial tick that compromised his ability to appear in court in front of juries. He could not find another lawyer to take a malpractice case against the doctor because the injury was not severe enough. In the case of patients with tardive akathisia, which feels like being tortured from the inside out, it’s almost impossible to find lawyers willing to take the cases because there is nothing obvious to show the jury.

In addition, once lawsuits have begun, it commonly takes many years for them to be resolved. During these intervening years, the legal process will abuse these victims all over again, often by subjecting them to hostile medical examinations by physicians hired by the defendants as well as by vicious legal examination under oath during pre-trial depositions.

A number of states already have “pain and suffering” caps. An agonizing, permanent neck spasm caused by antipsychotic drugs must be totally disabling as well as painful to earn a significant award.

Some states prohibit doctors from testifying in malpractice cases if they devote a substantial amount of their time testifying in court. Other states require that a doctor must have nearly identical credentials and practice as the doctor he is testifying against.

Doctors are very reluctant to testify against other doctors. It is almost uniformly impossible to get local physicians to testify in even the most horrendous cases, so that at best the victim must seek experts from out of town, risking the accusation that they are “hired guns.”

There are many reasons for doctors not to testify against their colleagues—even colleagues they do not know who live on the other side of the country. Neurologists, for example, are frequently requested to evaluate cases of drug-induced impairment like tardive dyskinesia. They will often make a general diagnosis of “movement disorder” but withhold the key diagnosis of drug-induced tardive dyskinesia. This way, they spare the doctors from getting blamed and protect them from lawsuits. As specialists, neurologists rely heavily on referrals from other doctors. They cannot afford to alienate doctors by making diagnoses that might cause or confirm malpractice suits.

A lot has been made about more doctors choosing to practice in Texas because of the protection afforded them by recent tort reform. Good for substandard doctors, but bad for the patients. Legitimate malpractice suits are now too hard to bring in Texas and in several other states. Many ethical attorneys have sought other areas of practice and patients no longer have much hope of justice or compensation after being injured by negligent medical and psychiatric practice.

Drug Company Malfeasance and FDA Negligence

Earlier I mentioned that Eli Lilly has paid out more than a billion dollars in settlement of cases of diabetes allegedly induced by Zyprexa. In addition, Eli Lilly has been subjected to criminal and civil fines of $1.4 billion by the U. S. Justice Department for promoting Zyprexa for unapproved uses. In the process, Eli Lilly pled guilty to illegally marketing Zyprexa. In addition, Pfizer has recently pled guilty and paid fines and penalties of $2.3 billion for illegally marketing four drugs, including the pain medication Lyrica and the antipsychotic drug Geodon. And this past Friday, October 30, 2009, it was announced that AstraZeneca will pay $520 million in fines for illegally marketing its blockbuster drug Seroquel in part by promoting it for children and the elderly.

Attorney Stephen Sheller has been involved in representing whistleblowers in the $1.4 billion Lilly case and $2.3 billion Pfizer case. He explained to me, “The contamination of science and the misrepresentation of adverse event risks have made it nearly impossible to know if the information provided to physicians can be believed.” Sheller would like the FDA to stop expanding the approved uses for these drugs and instead to re-evaluate whether or not they should remain on the market. He points out that the so-called scientific studies used for their approval have once again been called into question.

Since the drug companies make many billions of dollars a year on drugs like Zyprexa, Geodon, and Seroquel, they are able to weather seemingly huge one-time fines and large settlements as the cost of doing business. Often they get away without being forced to disclose their proprietary data that pertains to public safety. Genuine reform would require drug companies to reveal all data pertinent to public safety without first being forced to go to trial. Meanwhile, the real cost in terms of damage to the patients and their families falls upon the taxpayer who must pick up the bill for the medical care and support of these disabled individuals.

Despite continued evidence and even open admissions by drug companies that they have misrepresented data and marketed illegally, the FDA increasingly panders to the same drug companies by expanding the approved use of antipsychotic drugs for children. Instead of tort reform, we need an investigation of the psychiatric drug approval process within the FDA.

Of course, dreadful outcomes in medical care can occur without any wrongdoing on the part of doctors, health facilities, or drug companies. In regard to product liability suits against the drug companies, in my experience the great majority of suits are brought only after the drug companies have spent years hiding and denying the harmful effects of their products, for example, in causing diabetes or in causing suicidal behavior. Before judges will allow the cases to go forward, they must determine that there is merit to the case, including a scientifically demonstrated cause and effect relationship between the drug and the adverse effect. Often these judges strongly favor the drug company viewpoint and naively accept drug-company sponsored research as valid.

In regard to malpractice suits brought against physicians and health care facilities, in nearly all the cases in which I have been involved as an expert, the patients or their surviving family members have decided to bring a suit only in the face of systematic and severe negligence. Even then, the injured parties are usually reluctant to sue unless the doctor has added insult to injury by denying any responsibility and showing no sympathy. In my experience, doctors who genuinely care about their patients, and who practice with their well being uppermost in their minds, are seldom sued.

More tort reform will mean less protection for patients and an increasing disregard for people who have been injured by medical and corporate negligence. It will also unleash even more drug company malfeasance. Instead of tort reform, my colleagues need to do a better job of policing themselves, medical researchers should refuse to sell out to the drug companies, medical journals should stop catering to drug companies, and organized psychiatry and medicine should stop acting like partners of the pharmaceutical industry. Finally, the FDA should do its job of protecting the consumer instead of approving toxic agents and overlooking their harmful effects, thereby sacrificing millions of patients to powerful interest groups in the medical and the pharmaceutical industry.

Originally published on The Huffington Post