Drug Companies Fined
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.79 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.
Unnecessary Surgical Procedures
In 1974, 2.4 million unnecessary surgeries were performed, resulting in 11,900 deaths at a cost of $3.9 billion.80,81 In 2001, 7.5 million unnecessary surgical procedures were performed, resulting in 37,136 deaths at a cost of $122 billion (using 1974 dollars).9,10
It is very difficult to obtain accurate statistics when studying unnecessary surgery. In 1989, Leape wrote that perhaps 30% of controversial surgeries—which include cesarean section, tonsillectomy, appendectomy, hysterectomy, gastrectomy for obesity, breast implants, and elective breast implants81— are unnecessary. In 1974, the Congressional Committee on Interstate and Foreign Commerce held hearings on unnecessary surgery. It found that 17.6% of recommendations for surgery were not confirmed by a second opinion. The House Subcommittee on Oversight and Investigations extrapolated these figures and estimated that, on a nationwide basis, there were 2.4 million unnecessary surgeries performed annually, resulting in 11,900 deaths at an annual cost of $3.9 billion.80
According to the Healthcare Cost and Utilization Project within the Agency for Healthcare Research and Quality,22 in 2001 the 50 most common medical and surgical procedures were performed approximately 41.8 million times in the US. Using the 1974 House Subcommittee on Oversight and Investigations’ figure of 17.6% as the percentage of unnecessary surgical procedures, and extrapolating from the death rate in 1974, produces nearly 7.5 million (7,489,718) unnecessary procedures and a death rate of 37,136, at a cost of $122 billion (using 1974 dollars).
In 1995, researchers conducted a similar analysis of back surgery procedures, using the 1974 “unnecessary surgery percentage” of 17.6%. Testifying before the Department of Veterans Affairs, they estimated that of the 250,000 back surgeries performed annually in the US at a hospital cost of $11,000 per patient, the total number of unnecessary back surgeries approaches 44,000, costing as much as $484 million.82
Like prescription drug use driven by television advertising, unnecessary surgeries are escalating. Media-driven surgery such as gastric bypass for obesity “modeled” by Hollywood celebrities seduces obese people into thinking this route is safe and sexy. Unnecessary surgeries have even been marketed on the Internet.83 A study in Spain declares that 20-25% of total surgical practice represents unnecessary operations.84
According to data from the National Center for Health Statistics for 1979 to 1984, the total number of surgical procedures increased 9% while the number of surgeons grew 20%. The study notes that the large increase in the number of surgeons was not accompanied by a parallel increase in the number of surgeries performed, and expressed concern about an excess of surgeons to handle the surgical caseload.85
From 1983 to 1994, however, the incidence of the 10 most commonly performed surgical procedures jumped 38%, to 7,929,000 from 5,731,000 cases. By 1994, cataract surgery was the most common procedure, with more than 2 million operations, followed by cesarean section (858,000 procedures) and inguinal hernia operations (689,000 procedures). Knee arthroscopy procedures increased 153% while prostate surgery declined 29%.86
The list of iatrogenic complications from surgery is as long as the list of procedures themselves. One study examined catheters that were inserted to deliver anesthetic into the epidural space around the spinal nerves for lower cesarean section, abdominal surgery, or prostate surgery. In some cases, non-sterile technique during catheter insertion resulted in serious infections, even leading to limb paralysis.87
In one review of the literature, the authors found “a significant rate of overutilization of coronary angiography, coronary artery surgery, cardiac pacemaker insertion, upper gastrointestinal endoscopies, carotid endarterectomies, back surgery, and pain-relieving procedures.”88
A 1987 JAMA study found the following significant levels of inappropriate surgery: 17% of coronary angiography procedures, 32% of carotid endarterectomy procedures, and 17% of upper gastrointestinal tract endoscopy procedures.89 Based on the Healthcare Cost and Utilization Project (HCUP) statistics provided by the government for 2001, 697,675 upper gastrointestinal endoscopies (usually entailing biopsy) were performed, as were 142,401 endarterectomies and 719,949 coronary angiographies.22 Extrapolating the JAMA study’s inappropriate surgery rates to 2001 produces 118,604 unnecessary endoscopy procedures, 45,568 unnecessary endarterectomies, and 122,391 unnecessary coronary angiographies. These are all forms of medical iatrogenesis.
Medical and Surgical Procedures
It is instructive to know the mortality rates associated with various medical and surgical procedures. Although we must sign release forms when we undergo any procedure, many of us are in denial about the true risks involved; because medical and surgical procedures are so commonplace, they often are seen as both necessary and safe. Unfortunately, allopathic medicine itself is a leading cause of death, as well as the most expensive way to die.
Perhaps the words “health care” confer the illusion that medicine is about health. Allopathic medicine is not a purveyor of health care but of disease care. The HCUP figures are instructive,22 but the computer program that calculates annual mortality statistics for all US hospital discharges is only as good as the codes entered into the system. In email correspondence, HCUP indicated that the mortality rates for each procedure indicated only that someone undergoing that procedure died either from the procedure or from some other cause.
Thus, there is no way of knowing exactly how many people die from a particular procedure. While codes for “poisoning & toxic effects of drugs” and “complications of treatment” do exist, the mortality figures registered in these categories are very low and do not correlate with what is known from research such as the 1998 JAMA study6 that estimated an average of 106,000 prescription medication deaths per year. No codes exist for adverse drug side effects, surgical mishaps, or other types of medical error. Until such codes exist, the true mortality rates tied to medical error will remain buried in the general statistics.
An Honest Look at US Health Care
In 1978, the US Office of Technology Assessment (OTA) reported, “Only 10-20% of all procedures currently used in medical practice have been shown to be efficacious by controlled trial.”90 In 1995, the OTA compared medical technology in eight countries (Australia, Canada, France, Germany, the Netherlands, Sweden, the UK, and the US ) and again noted that few medical procedures in the US have been subjected to clinical trial. It also reported that US infant mortality was high and life expectancy low compared to other developed countries.91
Surgical Errors Finally Reported
An October 2003 JAMA study from the US government’s Agency for Healthcare Research and Quality (AHRQ) documented 32,000 mostly surgery-related deaths costing $9 billion and accounting for 2.4 million extra hospital days in 2000.92 Data from 20% of the nation’s hospitals were analyzed for 18 different surgical complications, including post-operative infections, foreign objects left in wounds, surgical wounds reopening, and post-operative bleeding.
In a press release accompanying the study, AHRQ director Carolyn M. Clancy, MD, noted, “This study gives us the first direct evidence that medical injuries pose a real threat to the American public and increase the costs of health care.”23 According to the study’s authors, “The findings greatly underestimate the problem, since many other complications happen that are not listed in hospital administrative data.” They added, “The message here is that medical injuries can have a devastating impact on the health care system. We need more research to identify why these injuries occur and find ways to prevent them from happening.” The study authors said that improved medical practices, including an emphasis on better hand washing, might help reduce morbidity and mortality rates. In an accompanying JAMA editorial, health-risk research-er Dr. Saul Weingart of Harvard’s Beth Israel-Deaconess Medical Center wrote, “Given their staggering magnitude, these estimates are clearly sobering.”93
When x-rays were discovered, no one knew the long-term effects of ionizing radiation. In the 1950s, monthly fluoroscopic exams at the doctor’s office were routine, and you could even walk into most shoe stores and see x-rays of your foot bones. We still do not know the ultimate outcome of our initial fascination with x-rays.
In those days, it was common practice to x-ray pregnant women to measure their pelvises and make a diagnosis of twins. Finally, a study of 700,000 children born between 1947 and 1964 in 37 major maternity hospitals compared the children of mothers who had received pelvic x-rays during pregnancy to those of mothers who did not. It found that cancer mortality was 40% higher among children whose mothers had been x-rayed.94
In present-day medicine, coronary angiography is an invasive surgical procedure that involves snaking a tube through a blood vessel in the groin up to the heart. To obtain useful information, x-rays are taken almost continuously, with minimum dosages ranging from 460 to 1,580 mrem. The minimum radiation from a routine chest x-ray is 2 mrem. X-ray radiation accumulates in the body, and ionizing radiation used in x-ray procedures has been shown to cause gene mutation. The health impact of this high level of radiation is unknown, and often obscured in statistical jargon such as, “The risk for lifetime fatal cancer due to radiation exposure is estimated to be 4 in 1 million per 1,000 mrem.”95
Dr. John Gofman has studied the effects of radiation on human health for 45 years. A medical doctor with a PhD in nuclear and physical chemistry, Dr. Gofman worked on the Manhattan Project, discovered uranium-233, and was the first person to isolate plutonium. In five scientifically documented books, Dr. Gofman provides strong evidence that medical technology—specifically x-rays, CT scans, and mammography and fluoroscopy devices—are a contributing factor to 75% of new cancers. In a nearly 700-page report updated in 2000, “Radiation from Medical Procedures in the Pathogenesis of Cancer and Ischemic Heart Disease: Dose-Response Studies with Physicians per 100,000 Population,”96 Gofman shows that as the number of physicians increases in a geographical area along with an increase in the number of x-ray diagnostic tests performed, the rate of cancer and ischemic heart disease also increases. Gofman elaborates that it is not x-rays alone that cause the damage but a combination of health risk factors that include poor diet, smoking, abortions, and the use of birth control pills. Dr. Gofman predicts that ionizing radiation will be responsible for 100 million premature deaths over the next decade.
In his book, “Preventing Breast Cancer,” Dr. Gofman notes that breast cancer is the leading cause of death among American women between the ages of 44 and 55. Because breast tissue is highly sensitive to radiation, mammograms can cause cancer. The danger can be heightened by other factors, including a woman’s genetic makeup, preexisting benign breast disease, artificial menopause, obesity, and hormone imbalance.97
Even x-rays for back pain can lead someone into crippling surgery. Dr. John E. Sarno, a well-known New York orthopedic surgeon, found that there is not necessarily any association between back pain and spinal x-ray abnormality. He cites studies of normal people without a trace of back pain whose x-rays indicate spinal abnormalities and of people with back pain whose spines appear to be normal on x-ray.98 People who happen to have back pain and show an abnormality on x-ray may be treated surgically, sometimes with no change in back pain, worsening of back pain, or even permanent disability. Moreover, doctors often order x-rays as protection against malpractice claims, to give the impression of leaving no stone unturned. It appears that doctors are putting their own fears before the interests of their patients.