4
Problems with Specific Classes of Drugs

Antibiotics

According to William Agger, MD, director of microbiology and chief of infectious disease at Gundersen Lutheran Medical Center in La Crosse, WI, 30 million pounds of antibiotics are used in America each year.204 Of this amount, 25 million pounds are used in animal husbandry and 23 million pounds are used to try to prevent disease and promote growth. Only 2 million pounds are given for specific animal infections. Dr. Agger reminds us that low concentrations of antibiotics are measurable in many of our foods and in various waterways around the world, much of it seeping in from animal farms.

Agger contends that overuse of antibiotics results in food-borne infections that are resistant to antibiotics. Salmonella is found in 20% of ground meat, but the constant exposure of cattle to antibiotics has made 84% of salmonella resistant to at least one antisalmonella antibiotic. Diseased animal food accounts for 80% of salmonellosis in humans, or 1.4 million cases per year. The conventional approach to countering this epidemic is to radiate food to try to kill all organisms while continuing to use the antibiotics that created the problem in the first place. Approximately 20% of chickens are contaminated with Campylobacter jejuni, an organism that causes 2.4 million cases of illness annually. Fifty-four percent of these organisms are resistant to at least one anti-Campylobacter antimicrobial agent.

Denmark banned growth-promoting antibiotics beginning in 1999, which cut their use by more than half within a year, from 453,200 to 195,800 pounds. A report from Scandinavia found that removing antibiotic growth promoters had no or minimal effect on food production costs. Agger warns that the current crowded, unsanitary methods of animal farming in the US support constant stress and infection, and are geared toward high antibiotic use.

In the US, over 3 million pounds of antibiotics are used every year on humans. With a population of 284 million Americans, this amount is enough to give every man, woman, and child 10 teaspoons of pure antibiotics per year. Agger says that exposure to a steady stream of antibiotics has altered pathogens such as Streptococcus pneumoniae, Staphylococcus aureus, and various Enterococci, to name a few.

Almost half of patients with upper respiratory tract infections in the US still receive antibiotics from their doctors,205 which is inappropriate in most cases. In Germany, the prevalence of systemic antibiotic use in children aged 0–6 years was 42.9%.206

Data obtained from nine US health insurers on antibiotic use in 25,000 children from 1996 to 2000 found that rates of antibiotic use decreased. Antibiotic use in children aged three months to under three years decreased 24%, from 2.46 to 1.89 antibiotic prescriptions per patient per year. For children aged three to under six years, there was a 25% reduction, from 1.47 to 1.09 antibiotic prescriptions per patient per year. And for children aged 6 to under 18 years, there was a 16% reduction, from 0.85 to 0.69 antibiotic prescriptions per patient per year.207 Despite these reductions, the data indicate that on average, every child in America receives 1.22 antibiotic prescriptions annually.

Group A beta-hemolytic streptococci is the only common cause of sore throat that requires antibiotics, with penicillin and erythromycin the only recommended treatment. Ninety percent of sore throat cases, however, are viral. Antibiotics were used in 73% of the estimated 6.7 million adult annual visits for sore throat in the US between 1989 and 1999. Furthermore, patients treated with antibiotics were prescribed non-recommended broad-spectrum antibiotics in 68% of visits. This period saw a significant increase in the use of newer, more expensive broad-spectrum antibiotics and a decrease in use of the recommended antibiotics penicillin and erythromycin.208 Antibiotics being prescribed in 73% of sore throat cases instead of the recommended 10% resulted in a total of 4.2 million unnecessary antibiotic prescriptions for sore throats alone from 1989 to 1999.

In September 2003, the CDC re-launched a program started in 1995 called “Get Smart: Know When Antibiotics Work.”209 This $1.6 million campaign is designed to educate patients about the overuse and inappropriate use of antibiotics. Most people involved with alternative medicine have known about the dangers of antibiotic overuse for decades. Finally, the government is focusing on the problem, yet it is spending only a miniscule amount of money on an iatrogenic epidemic that is costing billions of dollars and thousands of lives. The CDC warns that 90% of upper respiratory infections, including children’s ear infections, are viral and that antibiotics do not treat viral infection. More than 40% of prescriptions for antibiotics written each year in physicians’ offices are inappropriate.210, 211 Using antibiotics when not needed can lead to the development of deadly strains of bacteria that are resistant to drugs.212

The CDC, however, seems to be blaming patients for misusing antibiotics even though they are available only by prescription from physicians. According to Dr. Richard Besser, then head of the “Get Smart” program to educate patients about proper antibiotic use, “Programs that have just targeted physicians have not worked. Direct-to-consumer advertising of drugs is to blame in some cases.” Besser says the program “teaches patients and the general public that antibiotics are precious resources that must be used correctly if we want to have them around when we need them. Hopefully, as a result of this campaign, patients will feel more comfortable asking their doctors for the best care for their illnesses, rather than asking for antibiotics.”213

What constitutes the “best care”? The CDC does not elaborate and ignores the latest research on the dozens of nutraceuticals that have been scientifically proven to treat viral infections and boost immune-system function. Will doctors recommend garlic, vitamin C, lactoferrin, elderberry, vitamin A, zinc, or DHEA? Probably not. The CDC’s commonsense recommendations that most people follow anyway include getting proper rest, drinking plenty of fluids, and using a humidifier.

The pharmaceutical industry claims it supports limiting the use of antibiotics. The drug company Bayer sponsors a program called “Operation Clean Hands” through an organization called LIBRA.214 The CDC also is involved in trying to minimize antibiotic resistance, but nowhere in its publications is there any reference to the role of nutraceuticals in boosting the immune system, or to the thousands of journal articles that support this approach. This tunnel vision and refusal to recommend the available non-drug alternatives is unfortunate when the CDC is desperately trying to curb the overuse of antibiotics.

The AHRQ reports that currently, “The most common HAI [healthcare-associated infection] agent is methicillin-resistant Staphylococcus aureus (MRSA).”215

NSAIDS

It is not only the US that is plagued by iatrogenesis. A survey of more than 1,000 French general practitioners (GPs) tested their basic pharmacological knowledge and practice in prescribing NSAIDs, which rank first among commonly prescribed drugs for serious adverse reactions. The study results suggest that GPs do not have adequate knowledge of these drugs and are unable to effectively manage adverse reactions.216

A cross-sectional survey of 125 patients attending specialty pain clinics in South London found that possible iatrogenic factors such as “over-investigation, inappropriate information, and advice given to patients as well as misdiagnosis, over-treatment, and inappropriate prescription of medication were common.”217

In 2003, J.S. Hochman, MD, Executive Director of the National Foundation for the Treatment of Pain, referring to NSAID-related deaths as a “silent epidemic,” wrote:

It has been estimated conservatively that 16,500 NSAID-related deaths occur among patients with rheumatoid arthritis or osteoarthritis every year in the United States. This figure is similar to the number of deaths from the acquired immunodeficiency syndrome and considerably greater than the number of deaths from multiple myeloma, asthma, cervical cancer, or Hodgkin’s disease.218

Over 66,000 people were killed over a 10-year period during the Vietnam War. More people are killed by NSAIDs in one year (16,500 deaths) than were killed in any two years of the Vietnam War. In ten years, NSAIDS kills 165,000 people. NSAIDS kills 2.5 times as many people in a ten-year period as were killed in the ten years of the Vietnam War.

In 2003, the British Medical Journal warned that women who took NSAIDs—“painkillers like Advil®, Motrin®, and Naprosyn®—had an 80 percent higher risk of miscarriage than women who avoided these medications.”219 “The risk increased if such painkillers were taken shortly before or after conception, or for longer than one week.”220

On September 30, 2004, Merck announced “a voluntary worldwide withdrawal of Vioxx® (Rofecoxib), its arthritis and acute pain medication.” Merck announces voluntary worldwide withdrawal of Vioxx®221 “due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on rofecoxib. Rofecoxib is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the FDA in May 1999.”222 “It was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.”223 This means that children were exposed to this dangerous drug.

The Lancet carried the following article in its first issue of December 2004, “Risk of cardiovascular events and rofecoxib: cumulative meta-analysis,” which finds that “rofecoxib should have been withdrawn several years earlier. The reasons why manufacturer and drug licensing authorities did not continuously monitor and summarize the accumulating evidence need to be clarified.”224

The NSAID “Vioxx® was withdrawn after evidence came to light that it almost doubled the risk of heart attacks and stroke in people who had been taking it for 18 months.”225 FDA researcher Dr. David Graham, testifying before the US Senate, estimated 88,000 to 138,000 Americans had heart attacks or strokes as a side effect from Vioxx®. “Of these,” Graham said, “30–40% probably died.”226 “That would be an estimated 27,000 to 55,000 preventable deaths attributed to Vioxx®.”227

Dr. Graham continues his Senate testimony, “If there were an average of 150 to 200 people on an aircraft, this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky. This translates to 2–4 aircraft every week, week in and week out, for the past 5 years.”228

Cancer Chemotherapy

In 1989, German biostatistician Ulrich Abel, PhD, wrote a monograph entitled “Chemotherapy of Advanced Epithelial Cancer.” It was later published in shorter form in a peer-reviewed medical journal.229 Abel presented a comprehensive analysis of clinical trials and publications representing over 3,000 articles examining the value of cytotoxic chemotherapy on advanced epithelial cancer.

Epithelial cancer is the type of cancer with which we are most familiar, arising from epithelium found in the lining of body organs such as the breast, prostate, lung, stomach, and bowel. From these sites, cancer usually infiltrates adjacent tissue and spreads to the bone, liver, lung, or brain. With his exhaustive review, Abel concluded there is no direct evidence that chemotherapy prolongs survival in most patients with advanced carcinoma.

According to Abel, “Many oncologists take it for granted that response to therapy prolongs survival, an opinion which is based on a fallacy and which is not supported by clinical studies.” Over a decade after Abel’s exhaustive review of chemotherapy, there seems no decrease in its use for advanced carcinoma. For example, when conventional chemotherapy and radiation have not worked to prevent metastases in breast cancer, high-dose chemotherapy (HDC) along with stem-cell transplant (SCT) is the treatment of choice. In March 2000, however, results from the largest multi-center randomized controlled trial conducted thus far showed that, compared to a prolonged course of monthly conventional-dose chemotherapy, HDC and SCT were of no benefit,230 with even a slightly lower survival rate for the HDC/SCT group.

Serious adverse effects occurred more often in the HDC group than in the standard-dose group. One treatment-related death (within 100 days of therapy) was recorded in the HDC group, but none was recorded in the conventional chemotherapy group. The women in this trial were highly selected as having the best chance to respond.

Unfortunately, no all-encompassing follow-up study such as Dr. Abel’s exists to indicate whether there has been any improvement in cancer-survival statistics since 1989. In fact, research should be conducted to determine whether chemotherapy itself is responsible for secondary cancers instead of progression of the original disease. We continue to question why well-researched alternative cancer treatments are not used.

Until now, the extent to which chemotherapy tortures young patients, formerly thought to be strong enough to withstand the toxicity, was unknown.

On August 16, 2006, Harvard Medical School-affiliated Drs. Michael J. Hassett, A. James O’Malley, Juliana R. Pakes, Joseph P. Newhouse, and Craig C. Earle published, “Frequency and Cost of Chemotherapy-Related Serious Adverse Effects in a Population Sample of Women With Breast Cancer” in the Journal of the National Cancer Institute.231 The authors acknowledge that “breast cancer is the most common indication for chemotherapy among women in the United States, and chemotherapy drugs are the leading cause of serious drug-related adverse effects among women with breast cancer,” but the authors suggest that studies in older women cannot be extrapolated to the general population. This, therefore, is the first study of chemotherapy-related serious adverse effects in a population-based sample of younger women with breast cancer. 12,239 women 63 years of age or younger with newly diagnosed breast cancer participated in the study. (“A drug-related serious adverse effect has been defined as any untoward medical occurrence that is related to drug use and results in death or significant disability/incapacity, requires hospital admission or prolongation of existing hospital stay, or is life threatening.”) Several of the adverse effects are:

Prior to this study, it was believed that women over age 65 could be expected to have comorbid conditions that would make them more susceptible to adverse side effects of chemotherapy, but that the younger population could survive the toxicity. The authors conclude that “breast cancer chemotherapy may cause more patient suffering and higher healthcare costs than previously estimated.”232

They emphasize that clinical trials of new drugs are often inadequate to accurately show experiences of the general population. They warn:

Although clinical trials of new drug therapies provide some information regarding the number and nature of serious adverse effects, reports of these complications are frequently inadequate and may not accurately reflect the experiences of the general population. Indeed, recent and widely publicized cases have demonstrated that serious adverse effects that are not fully appreciated during early clinical trials can appear after a drug is approved by the US Food and Drug Administration (FDA) and used by the public. In fact, one study of serious adverse effects identified after FDA approval found that 22 cancer drugs had been linked with 25 serious adverse effects between 2000 and 2002.233

The authors conclude that their findings “have important implications for quality of life and could affect decisions regarding [risks of] therapy.”

A 2004 pioneer overview study, “The Contribution of Cytotoxic Chemotherapy to 5-year Survival in Adult Malignancies,” by Drs. Graeme Morgan, Robyn Ward, and Michael Barton in Clinical Oncology reports that “The overall contribution of curative and adjuvant cytotoxic chemotherapy to 5-year survival in adults was estimated to be . . . 2.1% in the USA.”234 That is, only 2.1% of patients treated with cytotoxic chemotherapy for various malignancies survive for 5 years as a result of chemotherapy. They note that their estimate of benefit is statistically generous, using the “upper limit of effectiveness,” and “the benefit of cytotoxic chemotherapy may have been overestimated for cancers of esophagus, stomach, rectum, and brain.” The authors refer to “the minimal impact of cytotoxic chemotherapy on 5-year survival, and the lack of any major progress over the last 20 years.”