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Time and again, we are shocked at how little doctors tell their patients about the psychiatric drugs that they so freely prescribe for them. Most people are fumbling in the dark when it comes to knowing about the actual effects and hazards of these mind-altering drugs.
In fact, physicians are encouraged not to tell their patients the known dangers of psychiatric drugs. Handbooks and textbooks that document serious adverse drug effects often recommend to doctors that their patients receive extremely limited renditions of the facts. Consider "Current Psychotherapeutic Drugs", a 1998 publication of the American Psychiatric Press (Quitkin et al., 1998 [313]). This handbook for doctors lists dozens of adverse effects caused by Ritalin, the stimulant drug used to treat ADHD in children and adults. For example, it states that the drug is "contraindicated" for (and thus should not be given to) children with "marked anxiety tension, agitation". It confirms that "frank psychotic episodes" can be caused by the drug itself and that withdrawal from it can lead to "severe depression". As the drug's "most common adverse effects", it lists "restlessness, overstimulation, insomnia, and anorexia".
After warning the physician about these and other potentially grave and confusing consequences of taking or withdrawing from Ritalin, what does "Current Psychotherapeutic Drugs" recommend telling parents? Here is the entirety of the "Patient Information" it provides:
"Use caution when driving or operating hazardous machinery. Patients or their parents should record the patient's weight two times a week and report any significant loss. Any changes in mood should be reported to the physician, as should any evidence of skin rashes, fever, or pain in the joints. The sustained-release tablets should not be crushed or chewed."
Does this "Patient Information" truly inform parents about the dangers of giving Ritalin to their child? Shouldn't it mention that the drug can cause "frank psychotic episodes" and "severe depression" upon withdrawal? Don't parents need to know that Ritalin can cause or worsen the very symptoms it is supposed to cure, including "restlessness" and "overstimulation"? Shouldn't parents be told that Ritalin is contraindicated for children with "marked anxiety, tension, agitation", since these are symptoms that parents might think the drug should cure?
Fortunately, since "Current Psychotherapeutic Drugs" first appeared in 1998, the availability of drug information on the Internet has vastly increased. Also, as consumers have become more demanding of information, some professional drug guides have urged doctors to provide patients with more detailed information. Unfortunately, these guides too often minimize the risks in order to avoid causing alarm in potential consumers. For example, the 15th edition of "The Clinical Handbook of Psychotropic Drugs" (2005), written for clinicians, includes Patient Information handouts about the various drug classes. Its recommended information sheet on stimulants lists considerably more side effects than the 1998 "Current Psychotherapeutic Drugs", but it downplays them, for example, by suggesting that they "are usually not serious and do not occur in all individuals". Although the patient handout identifies "energizing/agitated feeling, excitability" as "common" effects, it merely suggests taking the stimulant earlier in the day to lessen interference with falling asleep. In making this recommendation, it fails to take into account how the daytime occurrence of these stimulating drug effects can vastly disrupt the lives of the children, as well as their parents or caregivers. Headaches, dry mouth, loss of appetite and weight loss are also minimized as temporary effects, although weight loss in a developing child may have unforeseen consequences on development while causing psychological problems.
The Handbook does recommend that some effects should be reported "immediately" to the doctor, such as fast or irregular heartbeat, severe agitation or restlessness, and especially "a switch in mood to an unusual state of happiness or irritability, fluctuations in mood". Still, there is no mention of the risks of psychosis, depression, and suicidality that Peter Breggin discusses in his introduction to the book. Furthermore, there is no mention of withdrawal effects as common reactions and potentially dangerous reactions, including "crashing". Nor are patients given a sense of the relatively high frequency of most listed effects.
Under the question "How long should you take this medication?" the authors answer that "Psychostimulants are usually prescribed for a period of several years" (Bezchlibnyk-Butler and Jeffries, 2005 [38]). They do not warn the consumer that there is no scientific basis for prescribing these drugs long-term and that even the short-term effects are limited to the suppression of behavior and spontaneous mental activity.
Overall, we continue to detect professional attitudes in the field that encourage giving patients and their families limited information. These attitudes reflect a widespread ethical abuse in psychiatry and medicine - the failure to provide patients and their families with the necessary information to make informed decisions about taking psychiatric medications or giving them to family members. This lack of information also undoubtedly renders patients and their families unable to properly assess adverse effects when they do develop. As in the case of Ritalin, many of the drugs common side effects are likely to be mistaken for the patients own problems.
When psychiatric drugs turn out to be harmful, the victims often tell us, "I thought FDA approval meant a drug is safe. I never thought our doctor would prescribe something so dangerous". When a loved one dies from the effects of a psychiatric drug, grieving, outraged families often demand to know, "Did the FDA know it could be lethal? Should our doctor have known it could kill?"
Especially during the drug approval process, the FDA is largely dependent on information that it receives from drug companies. Consider the following circumstances, however. The fact that a person experienced an "adverse event" (e.g., a headache or a fall) while taking a drug does not mean that this event was caused by the drug. Scientists or doctors employed by a drug company make the initial judgment that an adverse effect may or may not have been caused by a drug during testing; but management at the company headquarters makes the final decision about how to handle the data submitted to it by its paid researchers. If management decides that there's no possible connection between the company's drug and the patients negative reaction, the data may never find its way to the FDA. Or the data may be presented to the FDA in such a disguised fashion that it fails to draw attention at the agency. For example, a drug withdrawal reaction may be recorded as "two days in duration" when in reality the patient was placed back on the drug after two days in order to stop the withdrawal reaction98.
At a training seminar tailored to drug company staff99, a drug company executive gave the following example of a death that, in his opinion, did not have to be reported to the FDA as even possibly drug-related: "While a subject in a clinical drug trial, a man stepped off a curb, was hit by a car, and died". According to the executive, there was no reason even to consider reporting this as a possible adverse drug effect.
Drug company executives are not usually scientifically qualified or sufficiently objective to play so crucial a role in regard to the safety of the drugs that their company manufactures and sells. Yet this particular executive not only played such a role in his own company but, at the seminar, trained others how to do so as well. And his assessment in this case was wrong. A drug most certainly could have contributed to or caused the death under discussion.
Many drugs impair awareness, judgment, reflexes, and balance - thus increasing the likelihood that a user will be injured or killed in an accident. Drugs can also cause a seizure or even a heart attack, either of which could have caused the drug-trial subject to fall off the curb. A more remote possibility is that the drug he was taking could have interfered with blood clotting, causing him to die from injuries that ordinarily would not have been fatal.
Looking even more deeply at the "accidental" death in this example, we might surmise that it could have been a suicide. People do intentionally kill themselves by stepping in front of cars, trucks, buses, and trains. Moreover, some drugs are associated with an increased suicide-attempt rate. Yet despite all these possibilities, the company executive was willing - on the basis of a one-line report - to dismiss this man's death as having no possible connection to an experimental drug.
If even the FDA often lacks sufficient information to get an accurate picture of a drug's dangers, individual practitioners and the public must be even less well-informed. Regularly serious questions are raised about most drugs that occupy the coveted place of latest "miracle drug". Over the last decade, these have included Prozac, Viagra, Zyprexa, Bextra, Vioxx, Meridia, and others. Some people who have taken these drugs for their approved indications have died. Typically, the FDA acknowledges that deaths were reported during the post-marketing testing of the drugs, but it argues - as do the drug manufacturers - that the fatalities were not necessarily caused by the drug itself. How can practitioners and the public make up their own minds on this issue?
Through the Freedom of Information Act (FOIA), and increasingly through the FDA's own website, any citizen can obtain a summary of pre-marketing drug testing results for any of the recently introduced medications approved by the FDA. This material is called a Summary New Drug Application (Summary NDA). But the basic underlying data about adverse drug reactions and their interpretation are considered "proprietary"; they are the secret property of the drug company that manufactures the drug under exclusive patent. Only a product liability suit against that manufacturer would open access to the company's own research records. Even then, it would be hard for a small team of attorneys and experts (often only two or three people with limited experience) to effectively evaluate the hundreds of cartons of boxed data in the two or three days they would be allotted. And if important data were discovered, even this information would probably be kept under wraps by the courts so that the general public could not obtain it. Some drug companies actually settle product liability suits against them in order to avoid making damaging disclosures in a public trial.
This point is worth underscoring. Physicians and even key health policy planners do not have access to all the necessary data required to make an independent evaluation of a drugs safety. They must instead rely on very general information provided by the FDA, which in turn relies largely on the drug companies themselves.
FDA records contain thousands of reports of severe and life-threatening reactions to almost every psychiatric drug in current use. With respect to each of these drugs, the agency has attempted to determine if, on balance, the drug is sufficiently useful to outweigh its potential dangers. But this evaluation does not necessarily mean that the drug is safe. Indeed, determination of whether the drugs potential benefits outweigh its potential risks is, of necessity, highly subjective. Hence FDA approval should not be interpreted as indicating that a given drug is without serious and potentially fatal adverse reactions. On the contrary, all psychiatric drugs approved by the FDA can pose enormous risks even in routine use.
Drug advocates are fond of discussing risk/benefit ratios - specifically the relationship between the hazards and the usefulness of a drug. But who determines these ratios? Even under the best of conditions, they are rarely left up to the patient who will suffer the consequences. The patient simply doesn't have sufficient information or background knowledge to make such evaluations.
Risk/benefit analyses are initially calculated by the drug company itself, using research studies designed and carried out by doctors on its payroll. Using data prepared by the drug company, the FDA then makes its own risk/benefit analysis. In doing so, the FDA is dependent upon the drug company's analyses of the masses of data in its possession. Moreover, the FDA almost always ends up making compromises in order to accommodate industry. This process is called "negotiating" with the drug companies. It is kept entirely secret from doctors and consumers alike. Over the last several years, leaks by whistleblowers, litigation, and special investigations by reporters or lawmakers have begun to reveal some of its features - all of which lean toward concealing or distorting information from doctors and patients to present a more favorable portrait of drugs100.
After a drug is approved, the final risk/benefit analysis is made by individual doctors, who prescribe it to patients. For almost any drug, these prescribing physicians have almost no access to the original information generated for the approval of the drug. Increasingly the FDA is making available on its website many of its own evaluations of the studies submitted by manufacturers to gain approval of their drugs, and this is a welcome development. However, it may take several months or more after a drug is approved for these FDA evaluations to be available. During this time, when the media, doctors, and patients first hear about the new product, the manufacturer is the only source of information about the drug. The FDA evaluations frequently add up to a few hundred pages, and most practicing physicians will never comb through them. For most practitioners, information about drugs will come from drug-industry sponsored continuing education seminars and from the glossy brochures of well-trained pharmaceutical representatives who push their wares using every possible maneuver. Moreover, FDA evaluations regularly blank out some significant information that the manufacturer believes constitutes "proprietary information". This may include, for example, the list of adverse effects observed in studies where the drug was being tested for another indication, for which the rate of adverse effects was so high that the manufacturer decided to halt the studies.
In this connection, consider again some of the facts discussed in previous chapters:
Prozac, Zoloft, Paxil, Celexa, Luvox, Remeron, and others - the so-called selective serotonin reuptake inhibitors (SSRIs) - built their popularity as antidepressants on the mistaken belief among doctors and patients that they have fewer serious adverse effects than other antidepressants. From the very beginning, we knew this was false marketing hype created by the drug company Eli Lilly (Breggin and Breggin, 1994 [53]). But most psychiatrists seemingly fell for it. Even now many psychiatrists and other physicians are not aware of the increasing catalog of dangers from these drugs.
To illustrate, over 10 years after Prozac was on the market, a headline in the May 1998 edition of "Clinical Psychiatric News" reported that: "Long-Term Side Effects Surface with SSRIs". The article described serious sleep and sexual dysfunctions, as well as abnormal weight gain, associated with use of SSRIs. During their disturbed sleep, patients may also suffer from periods of insomnia, nightmares, teeth grinding, sweating, and abnormal movements of their bodies.
The report mentioned a drug, Prozac, that supposedly benefits depressed people but can end up making them more depressed and even suicidal! According to the report, "With ongoing treatment [with Prozac], increasing numbers of patients report lethargy and fatigue". Lethargy and fatigue, of course, can lead to or worsen depression. Furthermore, with respect to the insomnia caused by Prozac, "there are a lot of data showing that people who sleep poorly are more likely to relapse and that suicide risk is higher"101.
Many people have decided to use Prozac in the hope that it will help them lose weight. Eli Lilly itself tried unsuccessfully to get the drug approved by the FDA for weight control. Then it turned out that, over the long term, many patients on Prozac are gaining too much weight. They are becoming obese.
How did Eli Lilly respond to these newly recognized dangers of Prozac? In a full-page multicolor ad in the same issue of "Clinical Psychiatry News", the drug company promoted Prozac as producing "both restful nights and productive days". But "restful nights" are a remarkable claim for a drug that was already known to produce insomnia in 20 percent of patients in the four-to-six-week studies used for FDA approval. (Because of this insomnia, many of the patients were prescribed addictive sleeping pills). Unfortunately, the ad makes no mention of the risks of obesity, worsening depression, or suicide associated with Prozac. As required by law, however, a sentence in very fine print toward the bottom of the back page notes that there have been post-marketing reports of "suicidal ideation" as well as "violent behaviors". Though forced by the FDA to mention these possible adverse drug effects, the drug company also stated that they "may have no causal relationship with the drug". Of course, the "unexpected" weight gain issue is not limited to Prozac. One clinician writing to the British Medical Journal in 2003 noted: "I have observed frequent, rapid weight gain in clients using Paxil. When asking questions about the alleged anorexic effects of the drug back in 1995, I was met with skepticism. This is the first year that live heard anything about the drugs causing weight gain. However, it's no surprise to me in my role as a therapist" (Green, 2003 [188]).
To its credit, the FDA itself has recognized and publicized that FDA approval does not rule out the danger of serious and even life-threatening adverse reactions that may surface later. Since the studies used for FDA approval of psychiatric drugs typically last only about six weeks, the FDA usually requires a warning that the drugs have not been proven safe or effective for longer use. Very few consumers appreciate this severe limitation on FDA approval. Most doctors seem to pay little or no attention to it.
Even short-term efficacy sometimes remains in doubt at the time a drug is approved. For example, internal documents from the FDA raised questions about the effectiveness of the antidepressant Zoloft right up to the moment it was approved. A high-ranking FDA official noted that the drug had been rejected by some European agencies and lamented that the FDA was loosening its approval standards to favor the drug industry102.
Another example concerns Prozac, which, in many of the studies used for FDA approval, turned out to be no better than a sugar pill. Making it look effective required selecting from among the studies and then doctoring them statistically to include patients who had also been treated with tranquilizers103. Prozac is now marketed as a generic drug and has lost popularity to other SSRIs. Predictably interest in its effects and history has faded - which allows many of the errors and deceptions in its approval and marketing to be repeated with impunity for the drugs that follow.
The many shortcomings of the FDA approval process place a great burden on the follow-up procedures that go into place after a drug is marketed. At that point, the FDA begins to rely heavily on voluntary reports sent in spontaneously; mostly by doctors and pharmacists. A pattern of reports that indicates a causal connection between a drug and serious adverse effects has often led to increased warnings in the drug's label or to removal of the drug from the market104. In 1990, the Government Accounting Office (GAO) [167] reported that more than 50 percent of drugs approved by the FDA between 1976 and 1985 were found, during or after marketing, to have previously undetected "serious" negative effects, or the fifteen psychiatric drugs approved during this period, nine were found to have additional serious risks and one was removed from the market by the FDA105. One antidepressant, nomifensine, was found to cause a potentially fatal blood disorder - but only after it had been marketed worldwide for eight to nine years (Leber, 1992, p. 6).
Spontaneous reports to the FDA have played a key role in the agency's decisions concerning these drugs. But how many serious adverse effects come to the attention of doctors, and how conscientious are the doctors about sending them in to the FDA?
Once a drug is on the market, thousands of patients may experience unpleasant or dangerous withdrawal reactions. However, only a few of them will realize that their problems were caused by the drug106, and even fewer will mention it to their doctors. In turn, only a fraction of doctors who become aware of even serious and unusual adverse drug reactions will actually report them to an appropriate authority such as the FDA.
In his 1998 book, Thomas Moore [287] documents how infrequently U.S. physicians report adverse reactions. Even in the most optimistic scenario, it appears that only a tiny fraction of adverse reactions are actually reported, including cases so serious they result in hospitalization or death, let the FDA relies heavily on these reports to monitor drugs, to update their labels, and, if necessary; to withdraw them from the market.
In a 1998 Canadian study fifteen hospital-affiliated primary care practitioners were queried about their personal observations of serious adverse effects of benzodiazepine tranquilizers during the previous two years (Cohen and Karsenty, 1998 [111]). Seven of these doctors described serious effects, including a fall resulting in a broken hip, a fatal overdose or suicide, a delirium requiring nine days of hospitalization, and a case of severe apathy lasting several days that disrupted all work and family activities. Yet none of the doctors had written up or reported these adverse reactions to any authority or journal.
In failing to report these admittedly serious and even life-threatening reactions, any or all of which could have resulted directly from the use of tranquilizers, the doctors withheld recognition of these dangers from the government, the public, and the medical profession. Their behavior perpetuated the unrealistic attitudes of doctors and patients alike toward the supposed safety of these drugs.
No psychiatric drug has been shown to be consistently safe and effective for more than a few weeks or months of use. Even after many years on the market, psychiatric drugs are rarely studied to the degree necessary to determine their long-term hazards or usefulness. In February 2007, the FDA indicated that from October 2005 through September 2006, pharmaceutical companies had yet to start 71 percent of outstanding "post-market" safety evaluations that these companies had committed to begin for approved products already on the market (Chen, 2007 [86]). Thus, people should be very cautious about staying on any psychiatric drug for months or years at a time.
Very significant hazards may go undetected even long after a drug is marketed. As noted, the studies used for approval are very short in duration. They are also limited in scope, often excluding patients who have severe or complicated emotional problems, as well as patients who are physically ill, actively suicidal, or taking other drugs. In addition, many prodrug biases are built into the research by pharmaceutical companies that are entirely responsible for financing, planning, monitoring, and interpreting all of the studies. Drug companies typically hire doctors from whom they have learned to expect positive results. Except under unusual circumstances, the FDA relies wholly on data that the drug companies have gathered, organized, pruned, and interpreted.
Adverse drug reactions are underestimated or minimized in many different ways. During drug testing, for example, symptoms such as depression or anxiety - which can be caused by many psychiatric drugs - are often mistakenly blamed on the "mental illness" of the patient. More specifically, a worsening of depression was listed in Prozac's official label as a commonly reported possible adverse effect of Prozac until it was edited out on the very last day or two107. Who edited it out? The FDA itself. What was the explanation? The agency wanted to shorten the distracting "laundry list" of adverse reactions indicated by the drug company. Yet depression as a common result of taking antidepressants surely warrants emphasis rather than complete deletion from the drug label. Because of the deletion, the profession and the public remain unaware of the frequent reports by Eli Lilly's own investigators that Prozac can worsen depression.
The media have become very protective of psychiatry - especially of psychiatric drugs. Except for occasional exposes, the media tend to publish testimonials to drugs while omitting their hazards. Books critical of psychiatric drugs are rarely reviewed in major newspapers or magazines and rarely discussed on television.
In the past year, the FDA has loosened the requirements for drug company advertisements directed to the public. As a result, there has been an explosion of such ads in newspapers and magazines, and on television, accounting for a 40 percent increase in print-media ad revenues since 1997. In 1998 alone, the U.S. pharmaceutical industry spent over $1.3 billion for direct-to-consumer advertising in television, magazines, and newspapers. We anticipate that the total will continue to increase and that the media will become increasingly protective of their benefactors. Eli Lilly has clearly led the way with a mammoth campaign for Prozac, spending over $41 million in advertising this product directly to the public in 1998 (an 82 percent increase over the previous year's spending)108.
Doctors fail to inform patients about the dangers of medications in part because they themselves are not fully informed. Many doctors rely too heavily on biased drug company advertising and sales representatives, and even the more skeptical among them are bombarded with information skewed in favor of drugs. Furthermore, medical educational and scientific programs are almost always funded by drug companies and, not surprisingly tend to promote their drug products. Psychiatrists, for example, often get phone calls from marketers asking them to accept $100 for listening on the phone to an "educational" program put on by a drug company or for attending a free dinner that includes a seminar about new drugs. In addition to the small fee or the free meal, the psychiatrists earn Continuing Medical Education (CME) credits toward maintaining their medical credentials.
Most psychiatric journals are totally dependent on drug company advertising - a relationship that influences their editorial policies. The specialty journals published by the American Medical Association (AMA), such as the Archives of General Psychiatry and the Archives of Internal Medicine, are sent free of charge to doctors in their respective specialties. How can the AMA afford this? Distribution of the journals is paid for by drug company advertising. Indeed, by offering the journals free to so many doctors, the AMA guarantees a hefty advertising investment from the companies themselves. Similarly the American Psychiatric Association, wholly dependent on massive infusions of drug company money is unwilling to take a critical look at either corporate practices or drug products. Ultimately, even medical and psychiatric textbooks are written by drug advocates who often minimize or ignore important and even dangerous adverse drug reactions. Only a few professionals become expert on the subject of medications without working with and for drug companies.
The failure of doctors to impart information stems partly from ignorance and partly from their attitudes toward their patients. Many doctors do not feel obliged to "tell patients everything". Instead, they control the flow of information in order to achieve certain ends, such as encouraging the acceptance of treatment. Medical education instills and reinforces this authoritarianism in young physicians. From the earliest stages of their clinical work, they must make life and death decisions, many of which are beyond their level of maturity, experience, or knowledge. If only to hide their personal insecurities about shouldering so much responsibility doctors can become arrogant. Further encouraging their paternalistic attitudes is the almost priestly role they play within society.
Doctors also lack the time to describe the full range of adverse drug effects to each of their patients. And rather than relying on written summaries of these effects, they tend to use their unaided memory and "clinical judgment" when informing their patients. As a result, they often leave out important information about potential adverse drug effects. Doctors in managed care are especially pressed for time and probably more likely than others to skim over or omit critical facts.
Finally some doctors purposely withhold information about the dangers of drugs for fear that their patients will refuse to take them. Because they believe that the patients need the medication, they prescribe it without providing sufficient information for the patients to make an independent decision. This unethical and potentially illegal practice is especially common among psychiatrists, many of whom harbor a patronizing attitude toward patients.