Public Citizen, the FDA, and SSRI Safety

In 1965, in his book Unsafe at Any Speed, Ralph Nader revealed how the automobile industry was selling unsafe automobiles that were the cause of crashes, injuries, and deaths. He wrote how the car companies, to save money, were failing to include safety measures in their automobiles they knew were available.

Nader made his case on the basis of data, focusing his criticism of automobile safety on that era’s most popular car, the General Motors Chevy Corvair. He identified the problems that made these cars unsafe to drive, and how General Motors was betraying the trust of its customers.

His critique not only leveled very serious charges against the car companies, but by doing so, he also challenged the public’s affection for their cars and their trust in their car manufacturers.

Nader is a lawyer and the case he made was well-substantiated and it was alarming. The media, recognizing the truth and importance of his findings, carried the story, ensuring that Nader’s book got widespread attention.

As a direct result of his revelations, the Federal Trade Commission was reformed and automobile manufacturers are required to adhere to higher safety standards. Automobiles, Americans’ prime means of transportation and a frequent source of enjoyment, are safer to drive.

Nader’s success related to automobile safety led him to turn his attention to promoting the government’s efforts to protect public safety on a wider scale and, in 1971, he formed Public Citizen, a nonprofit public advocacy organization.

One of his goals was for Public Citizen to promote improvements in the safety of health care. To fulfill this aim, he sought the help of Dr. Sidney Wolfe, who was a medical scientist engaged in evaluating drug research at the National Institute of Health (NIH). Wolfe agreed to leave NIH to lead this effort and together they created Public Citizen’s Health Research Group.

For reasons that will soon become obvious, Public Citizen’s Health Research Group focuses its efforts on monitoring the safety of prescription drugs and informing the public of its findings. Prescription drugs are developed by America’s most powerful industry, the pharmaceutical industry. Doctors prescribe these drugs every day to treat a wide range of physical illnesses and mental disorders.

Wolfe knew from his research reviews at NIH that although many prescription drugs are essential to health care, these drugs also can be very harmful. He affirmed the need for the public to be informed about the harms associated with prescription drugs to enable people to better protect themselves.

Prescription drugs were responsible for more than 2.2 million drug-induced diseases each year. More than 1.5 million people were hospitalized each year as a result of the adverse effects of prescription drugs; 700,000 people per year developed adverse drug reactions after they had been hospitalized for other reasons. Between a quarter and a third of emergency room visits were due to adverse drug reactions; older patients were particularly at risk, with many patients over the age of 65 prescribed at least one drug inappropriately. More than 100,000 people died each year from largely preventable adverse reactions to drugs.

Wolfe also pointed to other studies which show that people who are active and well-informed about how to take care of themselves are healthier. He believed that informing people about the adverse effects of prescription drugs is an important way to promote good health.

To this end, in 1988, Dr. Wolfe created a guidebook, Worst Pills, Best Pills, which reported on the safety of about a hundred prescription drugs that were prescribed for physical illnesses and mental disorders. The guidebook’s drug coverage was expanded in 1993 and again in 2005.

The 2005 edition of the guidebook, 913 pages long, is still available and importantly informative. It evaluates 549 prescription drugs, of which 181 (about a third) are classified as “Do Not Use” drugs because they are found by Public Citizen’s Health Research Group to be unsafe, having violated one or more of four criteria they apply. Many other drugs are classified as “Limited Use” drugs because their safety depends on limitations to their use. They list four criteria they apply to make this decision. Limited Use drugs are drugs that Public Citizen’s Health Research Group determined to be safe only if taken with restrictions that Dr. Wolfe spells out in Worst Pills, Best Pills. Worst Pills, Best Pills is supplemented by Worst Pills, Best Pills News, which is published as a monthly newsletter.

To be clear, their special value is that they are based on rigorous scientific analyses by Public Citizen’s Health Research Group, informing people about drugs that have been approved by the FDA and prescribed by doctors but that pose unacceptable risks. The Health Research Group found the problem to be of considerable size. Dr. Wolfe reported that 228 million prescriptions were written for drugs that were not safe.

Public Citizen also routinely testifies at Congressional hearings about its findings during the process the FDA requires for a new drug to gain its approval. Congressional hearings are conducted to review the data from clinical trials of a drug that are submitted by a drug company. Public Citizen’s Health Research Group provides valuable testimony in these evaluations of the drug’s safety.

Objective assessments of drug safety became even more important after the drug companies successfully lobbied Congress to allow them to engage in direct-to-consumer advertising of prescription drugs on television. The United States is one of only two countries in the world (also New Zealand) that allows this. Drug companies invest heavily in television ads to persuade viewers to buy their drugs and these ads pay off. Studies show that when a patient asks a doctor about a particular drug the doctor is likely to prescribe it. The government’s monitoring of the truthfulness of these ads is very weak because it is underfunded. Public Citizen currently is supporting legislation to address false and misleading prescription promotions on television.

The profit motive of the drug companies parallels that of other industries and conflicts of interest (payments by drug companies) influence many researchers, contaminating their reporting in medical journals of drug safety and effectiveness. In addition, a large percentage of articles in medical journals are written by ghost writers working for the drug companies, not by the doctors whose names appear on the articles as the authors. Not surprisingly, the FDA, heavily pressured by the drug companies to approve their drugs, sometimes gets it wrong.

Psychiatry’s commitment to drug treatment is fairly recent. Although there have always been some psychiatrists who prescribed drugs, during most of the 1900s, the majority of psychiatrists were Freudians. Their treatments were variants of psychoanalysis, a psychological treatment. These treatments were safe but their effectiveness needed the improvements of behavior therapy.

In 1980, psychiatric leaders declared they had new scientific evidence that mental disorders are physical illnesses. They stated they had drugs to treat these “brain diseases.” Their claims for a medical basis for the disorders and for the value of the drug treatments were false but went unchallenged until 10 years later when reviewers gained access to the data by filing a Freedom of Information request. They discovered that there was no evidence of a physical basis for the great majority of mental disorders (depression and the anxiety disorders); only for Down syndrome, dementia, and the organic disorders of alcohol and drug abuse. There was no accompanying evidence the drugs they were prescribing were effective beyond a placebo effect (a psychological effect).

Despite the failure of these efforts to substantiate medical treatment, psychiatrists, primary care doctors, and the public favor prescription drug treatments for these diagnoses, rather than psychotherapy, believing their value has been confirmed. Rhetoric, not science, is determining mental health care.

Worst Pills, Best Pills reviews the rationale for diagnoses of depression and the empirical basis for the drugs being prescribed to treat depression. Wolfe begins this discussion by pointing to research results which show that depression is not a genetic/physiological condition, that it has psychological causation. An abundance of scientific evidence finds that depression results from negative experiences in life. Researchers have shown that social/psychological factors are the prime cause of depression.

Medical treatment (drug prescriptions) for psychological problems is inappropriate and more likely to be harmful than helpful. The safe and effective treatment for depression recommended by Worst Pills, Best Pills is psychotherapy and social support, not prescription drugs. Wolfe makes the same point in his summary related to the anxiety disorders: “No drug is useful for the stress of everyday living.”

Wolfe concludes that the treatment ordinarily recommended for depression, prescription of the SSRIs, “has little value.” Worst Pills, Best Pills classifies the SSRIs as Limited Use, Do Not Use drugs.

In Worst Pills, Best Pills, Wolfe goes on to identify drugs that cause depression. Some prescription drugs have side effects of causing depression. These are the barbiturates (phenobarbital), tranquilizers (Valium and Halcion), heart drugs containing reserpine, beta-blockers, high blood pressure drugs, drugs for treating abnormal heart rhythms, ulcer drugs (Tagamet and Zantac), anticonvulsants (Dilantin), antibiotics (Cipro), diet drugs (amphetamines), pain killers or arthritis drugs (Motrin, Advil), as well as alcohol and more.

He warns against prescribing an SSRI to treat these drug-induced depressions. Wolfe’s recommended remedy is to reduce the dose of the drug that is causing depression or to stop taking it altogether.

Worst Pills, Best Pills also condemns as unsafe the all-too-common practice, principally by primary care doctors, of prescribing the SSRIs as anti-anxiety drugs (tranquilizers) or sleeping pills, citing the adverse effects of the SSRI drugs as outweighing whatever benefits might accrue from their prescription.

In addition, the guidebook warns of other very serious adverse effects induced by the SSRIs. The SSRIs induce hypomanic and manic reactions. The SSRIs are associated with increased suicidal thoughts and actions. The SSRIs cause sexual dysfunction in men and women. Going off an SSRI is highly problematic because withdrawal reactions often are severe and prolonged.

Twenty years after the publication of Worst Pills, Best Pills, Dr. Robert Steinbrook, who is now director of Public Citizen’s Health Research Group, came to the same conclusion, reiterating Wolfe’s recommendation of psychotherapy and his classification of the SSRIs as Limited Use, Do Not Use drugs.

The July, 2025 issue of Worst Pills, Best Pills News reviews a new antidepressant drug approved by the FDA, a ketamine-based nasal spray, which Worst Pills, Best Pills News classifies as a Do Not Use drug based on Public Citizen’s Health Research Group’s evaluation of the poor outcome research results. Steinbrook’s advice is to choose “psychotherapy and work with your clinician to identify and address the factors responsible for your condition.” He advises “taking a walk or calling a loved one,” “improve your diet and sleep pattern,” and “get social support and to exercise regularly.” He concludes that “such interventions are known to be effective” ways to combat depression.

The value of Public Citizen’s greater concerns about the safety of the SSRIs versus those of the FDA is illustrated by what happened regarding informing the public of the danger of the SSRIs inducing suicidal thoughts and actions. Public Citizen’s Health Research Group learned that the FDA had received more than 14,000 reports of adverse effects of these drugs and that the FDA knew the drug companies were withholding information that the SSRIs were associated with increased suicidality but was not taking action to warn the public. Public Citizen petitioned the FDA to require a black box warning concerning SSRI-induced suicides. Their petition was denied. It took better than 10 years for the FDA to issue this public health advisory.

The FDA, in deciding whether to approve a drug or to issue warnings about its safety once a drug is approved, evaluates the drug according to two standards: The drug’s safety and the drug’s effectiveness.

The most publicized results of a drug’s testing are the results of randomized, placebo-controlled, double-blind studies. The focus in the reporting of these studies is more on effectiveness than on safety. The focus of the results reported in Worst Pills, Best Pills is more on safety than on effectiveness. These are generalizations, but they describe a recognizable difference in the emphasis of published evaluations of a drug, including the effectiveness and safety of the millions of SSRIs prescribed for depression. Obviously both standards need to be met and public knowledge of how well both of these standards have been met is critically important.

The findings of Worst Pills, Best Pills are especially relevant because diagnoses of depression have failed tests of their reliability and validity. Many people experiencing sadness, which is a normal, natural response to losses in life, are misdiagnosed as depressed and prescribed these drugs. There is no medical basis for these prescriptions which are even more likely to be harmful with misdiagnosed patients.

With regard to drug effectiveness, NIMH’s most ambitious drug treatment outcome study is the 2006 STAR*D study, which was designed to determine the effectiveness of the SSRIs as drug treatments for depression. Measured after several months on the drug, the SSRIs are shown to be no more effective than placebo (25-35%). Measured after taking an SSRI for a year, the more important measure, the SSRIs are much less effective than placebo (3%). These are the results has been well-documented in several medical journal publications—and they closely mirror the results of previous NIMH findings for drug treatments of depression, both short-term and long-term: The SSRIs provide a modest placebo effect at first but with continued use, this limited value is reversed.

However, by various statistical manipulations, psychiatrists have misrepresented the results of the STAR*D study to claim the drugs to be almost 70% effective. Doctors, the media, and the public have not been told the truth about these drugs and the media has repeated the falsified results.

Although Worst Pills, Best Pills is now 20 years old, the research reviews in Worst Pills, Best Pills News have confirmed that the 2005 guidebook is still an excellent source of information about the safety of the SSRIs. In 2008, Public Citizen’s Health Research Group warned of serotonin toxicity because of the large number of prescription drugs that have serotonergic effects. The SSRIs Celexa, Lexapro, Prozac, Luvox, Paxil, and Zoloft are cited, along with other antidepressants: Anafranil, Cymbalta, Tofranil, Remeron, Serzone, and Effexor. In 2022, Worst Pills, Best Pills News carried updated research reports on Prozac (fluoxetine) and Celexa (citalopram), confirming the negative findings reported in 2005 in Worst Pills, Best Pills. Both drugs continue to be classified as Limited Use, Do Not Use drugs because they have “clinically important and potentially dangerous interactions with many prescription drugs and over the counter medications.”

Worst Pills, Best Pills is far from being alone in issuing warnings about the harmful effects of the SSRIs. Science journalist Robert Whitaker, in his 2010 award-winning book “Anatomy of an Epidemic,” reviews the scientific evidence indicating the SSRIs are associated with an increase in diagnoses of disability, exacerbating mental disorder rather than alleviating it. In 2022, Dr. Joanna Moncrieff, a British research psychiatrist, published research which refutes the chemical imbalance theory, psychiatry’s rationale for prescribing the SSRIs, and Harvard Medical School psychiatrist Dr. Joseph Glenmullen has described the debilitating physical effects commonly caused by the SSRIs, which indicates these drugs are creating brain disturbances, not correcting them. Dr. Giovanni Fava, editor of the medical journal Psychotherapy and Psychosomatics, has concluded that the SSRIs increase the likelihood of depressed patients relapsing and increase the likelihood of their never recovering. He confirms Wolfe’s reporting that continued use of these drugs can lead to bipolar disorder.

Dr. Steven Hyman, a former NIMH Director, concluded from his review of brain research that the SSRIs “create perturbances in neurotransmitter functions (that are) qualitatively as well as quantitatively different from the normal state.” In 2017, Dr. Peter Gotzsche, one of the founders of the Cochrane Collaboration, the volunteer organization that reviews the effectiveness and safety of prescription drugs, after reviewing 70 drug trials, reported that the SSRIs double the risk of suicide and violence, confirming Wolfe’s warning. And in 2018, an article published in the Journal of the American Medical Association (JAMA) confirmed Wolfe’s reporting of the many prescription drugs that have side effects that cause depression. Moreover, the JAMA article added another drug class to the list: the SSRIs.

One of the SSRIs identified in the JAMA article as causing depression is Celexa, the prime drug prescribed in the STAR*D study, a plausible explanation for the negative long-term results found for the SSRIs.

Nevertheless, these findings against the safety and effectiveness of the SSRIs have had no impact on the prescription of these drugs by psychiatrists and primary care doctors as the prime treatment for depression.

Research results have revealed what happens to patients when they are prescribed an SSRI to treat depression. An initial placebo effect (a positive psychological effect) is followed by the depressive side effects induced by the drug. The doctor misinterprets this worsening as a recurrence of depression, increasing the dosage of drug or prescribing a different SSRI.

Prior to psychiatry’s medicalization with reliance on drug prescriptions, depression was identified by NIMH as a rare disorder and as having an excellent prognosis. It is now the most frequent mental disorder, a recurring disorder with a poor prognosis. Psychological science and medical science tell us that problems in living are being addressed inappropriately by the prescription of drugs that are unsafe and ineffective rather than providing treatments that address the psychological/environmental cause of the distress.

The data showing that the SSRIs, one of America’s favorite drugs, are unsafe drugs certainly is as compelling as the data was against the safety of the Chevy Corvair, which was America’s favorite automobile. But whereas the damning evidence against this car became widely known, no such understanding has been fostered for the negative side effects of the SSRIs.

There is no mystery why Public Citizen and other responsible reporters have failed in their aim to educate the public that the SSRIs are unsafe and ineffective drugs. Their efforts, fully science-based, are sabotaged by doctors and the media who have succumbed to psychiatry’s fictitious claims, well-funded by the deep pockets of the drug companies, which promote a false belief in these drugs.

Cognitive Behavior Therapy (CBT), a form of psychotherapy, is verified as the safe and effective treatment for depression (as well as for the anxiety disorders), but it is infrequently recommended by doctors. Tens of millions of people (mainly women) diagnosed as depressed, often wrongly, are prescribed SSRIs, likely harming many more people than were harmed by unsafe automobiles.

Far more than is true of physical illnesses, mental health care is determined by economic interests, not by science, profoundly worsening mental health care.

Sidney Wolfe’s belief in the power of truthful information remains the best route to safe health care, including mental health care. Quality mental health care depends upon the public taking initiative to educate itself. Trustworthy information about the safety of the SSRIs and many other prescription drugs is available via Public Citizen’s Worst Pills, Best Pills. You can look it up.