Pharmaceuticals certainly have their place in health care. For example, drug therapy saves lives in cases of infections, certain cancers, and insulin-dependent diabetes, and it relieves suffering for those in acute and chronic pain. The fact is, we need pharmaceuticals for the proper treatment of a wide variety of illnesses. It is obvious, however, that we in the United States have put too much faith in drug therapy. The “pop a pill and everything will be fine” mentality has led many to an early death or suppressed the health and vitality of others. The fact is that few magic bullets exist in the drug  industry. Our health care system has gotten out of balance.We need a shift toward preventing and treating the root cause of illness with diet, lifestyle changes, stress reduction, and natural remedies. Pharmaceutical medications should complement this approach and be used judiciously.

Astoundingly,Americans spend close to $200 billion each year on prescription drugs. This number does not include over-the-counter medications. The United States is the world leader when it comes to popping pharmaceuticals. Did you know that in 1986 there were fewer than 900 prescription medications in existence, but that currently there are over 8,000? There is a drug for everything. Critics argue that new disease labels are being created under the influence of pharmaceutical companies so that pharmaceutical markets can expand.

The Journal of the American Medical Association published an eye-opening report stating that 106,000 patients die each year from adverse reactions caused by drugs administered by medical professionals. In addition, 5 percent of hospital admissions are due to adverse drug reactions.Many researchers believe the incidence is likely much higher.

Over-the-counter or nonprescription drugs are not without risk, either. Many people assume that an over-the-counter item is safe because it does not require a prescription.While there is truth to that perception, nonprescription medications still carry a risk of serious side effects. For example, approximately 16,000 people in the United States die each year from adverse reactions to over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin and ibuprofen, which can cause gastrointestinal bleeding and kidney and cardiovascular problems. Again, many researchers feel this number is conservative and could easily be two to three times higher.

How do the numbers of fatal adverse reactions compare for nutritional supplements? There simply is no comparison. The American Association of Poison Control Centers reports that dietary supplements lead to about 10 deaths yearly,most of which are iron overdoses. As you can see, the risk of serious harm from nutritional supplements out of the millions of doses taken daily is a drop in a lake compared to the risk from pharmaceuticals. Therefore, nutritional supplements should be used instead of pharmaceutical medications whenever possible.

Our children are also at risk from adverse reactions from pharmaceuticals. It makes logical sense that a child’s developing body can be more easily harmed by drugs.While you won’t see it in media headlines, the risk is very clear.A study published in the prestigious journal Pediatrics in 2002 concluded, “Adverse reactions to drug therapy are a significant cause of death and injury in infants and children under two years of age. ” It is outrageous, but the truth is that most drugs given to children have never undergone pediatric-related studies! In 2007, Food and Drug Administration (FDA) experts published a 365-page report showing that decongestants and antihistamines have been linked with 123 pediatric deaths since 1969. Pharmaceutical companies announced a voluntary withdrawal of oral cough and cold medicines marketed for use in infants. The FDA also announced that almost 200 unapproved prescription medicines containing hydrocodone, a narcotic that is used to ease pain and cough, must be taken off the market for children under age 6. Frighteningly, pharmaceutical companies had extrapolated data from adult studies to estimate dosages for children. These doses may or may not be accurate.

At the other end of the spectrum, there is concern about the vulnerability of seniors to the toxicity of pharmaceuticals. As people age, the kidneys and liver process pharmaceuticals less efficiently. This means the drugs’ effects are more potent, last longer, and are more likely to cause adverse or fatal reactions.

Many consider the FDA lax in its protection of the public against dangerous drugs.Ongoing congressional hearings on financial interests between FDA employees and drug companies continue to expose a flawed agency. Many drug company executives are former FDA employees, and the FDA gets much of its funding from drug company research fees. The November 2004 edition of the Journal of the American Medical Association disclosed that “an investigation of 18 FDA expert advisory panels revealed that more than half of the members of these panels had direct financial interests in the drug or topic they were evaluating and for which they were making recommendations.”  The same report also noted that in 2003 “the pharmaceutical industry earmarked $4.9 million to lobby the FDA.”

The FDA drug approval system is far from where it needs to be. This is evident from the numerous recalls of popular drugs. You may wonder how the drugs we list below could have been on the market if the testing procedures are so stringent. Two (sometimes one) Phase 3 clinical human trials are required for drug approval by the FDA. This involves a few hundred to a few thousand patients. The trials allow researchers to identify the most common but not always the most serious side effects a drug may have. The problem is that less than 50 percent of all serious adverse reactions to a new drug are identified before it enters the marketplace. This means at least half of the serious adverse reactions are discovered by you—the public.

Following is a brief summary of drugs that were either withdrawn from the market or given new warnings in recent years.Although not an exhaustive list, it demonstrates the point that FDA-approved drugs can be dangerous.

Erectile dysfunction drugs, including:

1. Sildenafil (Viagra)
2. Vardenafil (Levitra)
3. Tadalafil (Cialis)

Use: Treatment of erectile dysfunction (ED).

In 2007, the FDA informed doctors of reports of sudden decreases or loss of hearing following the use of these drugs.

Thiazolidinedione class of antidiabetic drugs, including:

1. Rosiglitazone maleate (Avandia)
2. Pioglitazone hydrochloride (Actos)
3. Rosiglitazone maleate and glimepiride (Avandaryl)
4. Rosiglitazone maleate and metformin hydrochloride (Avandamet)
5. Pioglitazone hydrochloride and glimepride (Duetact)

Use: Type 2 diabetes.

In 2007, the FDA requested an updated label with a boxed warning on the risks of heart failure.

Tegaserod maleate (Zelnorm)

Use: Irritable bowel syndrome and constipation.

In 2007, this drug was removed from the market due to serious cardiovascular problems, including myocardial infarction (heart attack), unstable angina (chest pain), and stroke.

Antidepressant medications

Use: Treatment of depression.

In 2007, the FDA noti?ed the makers of all antidepressant medications to update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years during the first one to two months of treatment.

Amphetamine with dextroamphetamine (Adderall), methylphenidate (Ritalin, Concerta)

Use: Pediatric and adult attention deficit/hyperactivity disorder treatment.

In 2006, a black box warning was given for cardiovascular risk.

Pimecrolimus (Elidel) and tacrolimus (Protopic)

Use: Topical eczema treatments.

In 2006, these were given a black box warning after researchers found a link between these drugs and increased risk of lymphoma and skin cancer.

Celecoxib (Celebrex)

Use: Anti-inflammatory.

In 2005, a boxed warning was required regarding potentially serious adverse cardiovascular events and possibly life-threatening gastrointestinal events.

Valdecoxib (Bextra)

Use: Anti-inflammatory.

In 2005, this was withdrawn due to lack of data on the cardiovascular safety of long-term use of Bextra, along with increased risk of adverse cardiovascular events, possibly associated with chronic Bextra use. There also were reports of rare, but serious, potentially life-threatening skin reactions.

Rofecoxib (Vioxx)

Use: Nonsteroidal anti-inflammatory.

In 2004, this drug was withdrawn due to increased risk of serious cardiovascular events, including heart attacks and strokes.

Cerivastatin (Baycol)

Use: Cholesterol-lowering.

In 2001, it was withdrawn due to reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction.

Phenylpropanolamine (PPA) and phenylpropanolamine hydrochloride
(the active ingredient in PPA)

Use: Ingredients in cold and cough medicines, nasal decongestants, and over-the-counter appetite suppressants and weight-loss products.

In 2000, they were withdrawn due to risk of hemorrhagic stroke.

Troglitazone (Rezulin)

Use: Treatment of type 2 diabetes.

In 2000, it was withdrawn due to severe liver toxicity.

Cisapride (Propulsid)

Use: Treatment of acid reflux.

Serious cardiac arrhythmias (irregular heart rhythms) and cardiac arrest. In 2000, it was withdrawn from the market.

Reference:

• Prescription for Drug Alternatives: All-Natural Options for Better Health without the Side Effects (James Balch, Mark Stengler, Robin Young-Balch, 2008)