Prescription drugs constitute the major treatment modality of scientific medicine. With the discovery of the “germ theory,” medical scientists convinced the public that infectious organisms were the cause of illness. Finding the “cure” for these infections proved much harder than anyone imagined. From the beginning, chemical drugs promised much more than they delivered. But far beyond not working, the drugs also caused incalculable side effects. The drugs themselves, even when properly prescribed, have side effects that can be fatal, as Lazarou’s study160 showed. But human error can make the situation even worse.
On December 10, 2007, the headline read: “The Quaid Twins ‘Fighting for Their Lives’: Dennis and Kimberly Quaid Keep Vigil as Their Newborns Struggle to Survive a Devastating Hospital Error that Resulted in an Overdose of Blood Thinner”:
The twins were hospitalized at Cedars-Sinai [Medical Center in L.A.] due to staph infections. . . . At the hospital on Nov. 18, [2007,] they were allegedly among three patients given 1,000 times the recommended dose of heparin, a drug used to prevent IV catheters from clotting. The dosage was high enough to cause severe bleeding and death if left untreated. 161
Infant care, famous parents, renowned hospital. “How could such a thing happen?” you may ask. That is what the Patient Safety and Quality Improvement Act of 2005 is in place to discover.
Drug iatrogenesis may also include anesthesia. Fatal anesthesia errors still occur. Major complications of spinals and epidurals include damage to nerves or the spinal cord by infection (meningitis and abscess), bleeding and blood clots (hematoma), direct damage to the nerves (needle injury or chemical injury) and poor blood supply to the spinal cord (ischemia). All can cause permanent nerve injury including paralysis. A further complication occurs when a “drug switch” or “route switch” occurs: either the wrong drug is delivered as an epidural or spinal (drug switch) or a drug that should have been administered intravenously is used in as an epidural or spinal, or vice versa (route switch). The sensitivity of the nervous system and the type of drugs used means these mistakes can be fatal.162
Although anesthesia is considered very safe, it is not risk free. . . . Uncommon complications include chest infections and difficulty breathing, damage to teeth, lips or tongue, and awareness under general anesthesia. . . . The rare and very rare complications of anesthesia include damage to the eyes, serious allergic reactions to medications, nerve damage, equipment failure and death. . . .
Deaths caused solely by anesthesia are very rare, and are usually the result of several serious complications together [such as allergies], your previous medical conditions, your body size, your surgical procedure, and your habits like smoking, [all of which may] influence the risks of certain complications. . . . Risk cannot be completely avoided, but the combination of your anesthesia professional’s training, modern [sterilized] equipment used to deliver anesthesia and monitor your condition, and modern medications have made anesthesia a much safer procedure in recent years.163
A survey of a 1992 national pharmacy database found a total of 429,827 medication errors in 1,081 hospitals. Medication errors occurred in 5.22% of patients admitted to these hospitals each year. The authors concluded that at least 90,895 patients annually were harmed by medication errors in the US as a whole.164
A 2002 study shows that 20% of hospital medications for patients had dosage errors. Nearly 40% of these errors were considered potentially harmful to the patient. In a typical 300-bed hospital, the number of errors per day was 40.165
Problems involving patients’ medications were even higher the following year. The error rate intercepted by pharmacists in this study was 24%, making the potential minimum number of patients harmed by prescription drugs 417,908.166
The Lazarou study167 analyzed records for prescribed medications for 33 million US hospital admissions in 1994. It discovered 2.2 million serious injuries due to prescribed drugs; 2.1% of inpatients experienced a serious adverse drug reaction, 4.7% of all hospital admissions were due to a serious adverse drug reaction, and fatal adverse drug reactions occurred in 0.19% of inpatients and 0.13% of admissions. The authors estimated that 106,000 deaths occur annually due to adverse drug reactions.
Using a cost analysis from a 2000 study in which the increase in hospitalization costs per patient suffering an adverse drug reaction was $5,483, costs for the Lazarou study’s 2.2 million patients with serious drug reactions amounted to $12 billion.168, 169
Serious adverse drug reactions commonly emerge after FDA approval of the drugs involved. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.170
More recent studies on adverse drug reactions show that the figures may be increasing. A 2003 study followed 400 patients after discharge from a tertiary care hospital setting (requiring highly specialized skills, technology, or support services). Seventy-six patients (19%) had adverse events. Adverse drug events were the most common, at 66% of all events. The next most common event was procedure-related injuries, at 17%.171
In a New England Journal of Medicine study, an alarming one in four patients suffered observable side effects from the more than 3.34 billion prescription drugs filled in 2002.172 One of the doctors who produced the study was interviewed by Reuters and commented, “With these 10-minute appointments, it’s hard for the doctor to get into whether the symptoms are bothering the patients.”173
William Tierney, who editorialized on the New England Journal study, wrote, “Given the increasing number of powerful drugs available to care for the aging population, the problem will only get worse.” The drugs with the worst record of side effects were selective serotonin reuptake inhibitors (SSRIs), nonsteroidal anti-inflammatory drugs (NSAIDs), and calcium-channel blockers.
Reuters also reported that prior research has suggested that nearly 5% of hospital admissions (over 1 million per year) are the result of drug side effects. But most of the cases are not documented as such. The study found that one of the reasons for this failure is that in nearly two thirds of the cases, doctors could not diagnose drug side effects or the side effects persisted because the doctor failed to heed the warning signs.
In 2004, the world pharmaceutical market did $550 billion in sales; the US market accounted for 48% of that total, which was $248 billion. The US sold nearly half of the world’s total of prescription drugs.174
Standard medical pharmacology texts admit that relatively few doctors ever report adverse drug reactions to the FDA.175 The reasons range from not knowing such a reporting system exists to fear of being sued.176 Yet the public depends on this tremendously flawed system of voluntary reporting by doctors to know whether a drug or a medical intervention is harmful.
Pharmacology texts also will tell doctors how hard it is to separate drug side effects from disease symptoms. Treatment failure is most often attributed to the disease and not the drug or doctor. Doctors are warned, “Probably nowhere else in professional life are mistakes so easily hidden, even from ourselves.”177
It may be hard to accept, but it is not difficult to understand why only one in twenty side effects is reported to either hospital administrators or the FDA.178
If hospitals admitted to the actual number of errors for which they are responsible, which is about twenty times what is reported, they would come under intense scrutiny.179
Jerry Phillips, associate director of the FDA’s Office of Post Marketing Drug Risk Assessment, confirms this number. “In the broader area of adverse drug reaction data, the 250,000 reports received annually probably represent only 5% of the actual reactions that occur.”180 Dr. Jay Cohen, who has extensively researched adverse drug reactions, notes that because only 5% of adverse drug reactions are reported, there are in fact 5 million medication reactions each year.181
Patients seeking a more joyful existence and relief from worry, stress, and anxiety are frequently swayed by the messages endlessly displayed on TV and billboards. Often, instead of gaining relief, they fall victim to the myriad iatrogenic side effects of antidepressant medication.
Moreover, a whole generation of antidepressant users has been created from young people growing up on Ritalin®. Medicating young people and modifying their emotions must have some impact on how they learn to deal with their feelings. They learn to equate coping with drugs rather than with their inner resources. As adults, these medicated youth reach for alcohol, drugs, or even street drugs to cope.
According to JAMA, “Ritalin® acts much like cocaine.”182 Today’s marketing of mood-modifying drugs such as Prozac® and Zoloft® makes them not only socially acceptable, but almost a necessity in today’s stressful world.
You cannot turn on TV without hearing a pitch for drugs for social anxiety, depression, or lethargy. Note that when they tell you the side effects, they often show a pastoral scene of beauty, or a joyful activity, at the same time, so you will equate the obligatory warning of danger with a pleasant memory.
Doctors (not just consumers) are bombarded with psychoactive pharmaceutical propaganda, so they will prescribe certain drug products:
In 2006 money from the pharmaceutical industry accounted for about 30 percent of the [American Psychiatric] Association’s $62.5 million in financing. About half of that money went to drug advertisements in psychiatric journals and exhibits at the annual meeting, and the other half to sponsor fellowships, conferences and industry symposiums at the annual meeting.183
To reach the widest audience possible, drug companies no longer simply target medical doctors with their marketing of antidepressants. By 1995, drug companies had tripled the amount of money allotted to direct advertising of prescription drugs to consumers. The majority of this money is spent on seductive television ads. From 1996 to 2000, spending rose from $791 million to nearly $2.5 billion.184 This $2.5 billion represents only 15% of the total pharmaceutical advertising budget.
While the drug companies maintain that direct-to-consumer advertising is educational, Dr. Sidney M. Wolfe of the Public Citizen Health Research Group in Washington, DC, argues that the public often is misinformed about these ads.185 People want what they see on television and are told to go to their doctors for a prescription. Doctors in private practice either acquiesce to their patients’ demands for these drugs or spend valuable time trying to talk patients out of unnecessary drugs.
Dr. Wolfe remarks that one important study found that people mistakenly believe that the “FDA reviews all ads before they are released and allows only the safest and most effective drugs to be promoted directly to the public.”186
In 2004, pharmaceutical manufacturers spent an estimated $4.15 billion on direct-to-consumer advertising, according to IMS Health.187 There are those who surmise that consumers are paying for these expensive ads when they buy medications that cost much more than they are worth.
A finding of a national survey of 643 physicians by Harvard’s Dr. Joel Weissman, et al., found that “direct-to-consumer advertising (DTCA) led patients to seek unnecessary treatments.” 188
In 2004, Americans spent $188.5 billion on prescription medications, which was more than 4½ times the $40.3 billion spent in 1990.189
Dr. David Graham of the FDA’s Center for Drug Evaluation and Research warns:
Direct-to-consumer advertising in general is a great disservice to the American people. We see wonderful ads of people demonstrating their health, whether they’re skating across the ice or doing their Tai Chi. Madison Avenue knows that a picture is worth a thousand words, so they convey an image, a message, and it makes an impression on patients and on physicians. It creates needs or desires where there really isn’t a need or a desire.
There was a recent study in the Journal of The American Medical Association that showed that if patients mentioned a drug that they’ve seen on television to their physician they were much more likely to be prescribed that drug by the doctor. Drug companies know this. That’s why they do it. . . . Clearly, direct-to-consumer advertising does not serve the American people well.190
Another aspect of scientific medicine that the public takes for granted is the testing of new drugs. Drugs generally are tested on individuals who are fairly healthy and not on other medications that could interfere with findings. But when these new drugs are declared “safe” and enter the drug prescription books, they are naturally going to be used by people who are on a variety of other medications and have a lot of other health problems. Then a new phase of drug testing called “post-approval” comes into play, which is the documentation of side effects once drugs hit the market.
In one very telling report, the federal government’s General Accountability Office “found that of the 198 drugs approved by the FDA between 1976 and 1985 . . . 102 (or 51.5%) had serious post-approval risks. . . . The serious post-approval risks [included] heart failure, myocardial infarction, anaphylaxis, respiratory depression and arrest, seizures, kidney and liver failure, severe blood disorders, birth defects and fetal toxicity, and blindness.”191
NBC News’s investigative show Dateline wondered if your doctor is moonlighting as a drug company representative. After a year-long investigation, NBC reported that because doctors can legally prescribe any drug to any patient for any condition, drug companies heavily promote “off-label”—that is, frequently inappropriate and untested uses of these medications—even though these drugs are approved only for the specific indications for which they have been tested.192
The leading causes of adverse drug reactions are antibiotics (17%), cardiovascular drugs (17%), chemotherapy (15%), and analgesics and anti-inflammatory agents (15%).193
We have reached the point of saturation with prescription drugs. Every body of water tested contains measurable drug residues. The tons of antibiotics used in animal farming, which run off into the water table and surrounding bodies of water, are conferring antibiotic resistance to germs in sewage, and these germs also are found in our water supply. Flushed down our toilets are tons of drugs and drug metabolites that also find their way into our water supply. We have no way to know the long-term health consequences of ingesting a mixture of drugs and drug-breakdown products. These drugs represent another level of iatrogenic disease that we are unable to completely measure.194–202
Periodically, the FDA fines a drug manufacturer when its abuses are too glaring and impossible to cover up. In May 2002, the Washington Post reported that Schering–Plough Corp., the maker of Claritin®, was to pay a $500 million fine to the FDA for quality-control problems at four of its factories.203 The indictment came after the Public Citizen Health Research Group, led by Dr. Sidney Wolfe, called for a criminal investigation of Schering–Plough, charging that the company distributed albuterol asthma inhalers even though it knew the units were missing the active ingredient.
The FDA tabulated infractions involving 125 products, or 90% of the drugs made by Schering-Plough since 1998. Besides paying the fine, the company was forced to halt the manufacture of 73 drugs or suffer another $175 million fine. Schering–Plough’s news releases told another story, assuring consumers that they should still feel confident in the company’s products.
This large settlement served as a warning to the drug industry about maintaining strict manufacturing practices and has given the FDA more clout in dealing with drug company compliance. According to the Washington Post article, a federal appeals court ruled in 1999 that the FDA could seize the profits of companies that violate “good manufacturing practices.” Since that time, Abbott Laboratories has paid a $100 million fine for failing to meet quality standards in the production of medical test kits, while Wyeth Laboratories paid $30 million in 2000 to settle accusations of poor manufacturing practices.