The United States of America – An Overmedicated Society

by Dr. Henry Sobo

Here are two important facts that you should know:
#1. Medication side effects are the 4th leading cause of death in the U.S. annually, and
#2. More than 100,000 deaths per year are related to taking medications correctly, as prescribed.

These two astonishing statistics must provide a wake up call to anyone concerned about the national trend toward our being a grossly overmedicated society.

John Abramson, M.D., a faculty member at Harvard Medical School, has written a book called Overdosed America. He discusses how the influence of the pharmaceutical industry has contributed to the decisions that doctors and their patients make which have resulted in the fact in 1993 there were seven prescriptions written for every person in the United States, and that number climbed to twelve per person in 2004. This number has continued to rise. Is it really possible that all of these prescriptions are really necessary?

As a society we have come to routinely accept that we take pills to help us sleep, pills to help us focus, pills for greater sex, pills to reduce stress, pills to change our children’s behaviors, pills to avoid future problems we may develop.

We have substituted anti-depressants and medications as a cure for stress and anxiety, while there are hosts of other natural and safer ways to manage the problem. Is it because the other methods require more time, and work, whereas popping a pill seems like an easy solution? The tendency to look for the easy quick fix has resulted in “legal” drug abuse that’s becoming a gigantic national problem. Law enforcement agencies tell us that legal prescription drug abuse causes many more deaths per year than illegal drug abuse!
The dollars spent on all forms of drugs to treat childhood and adolescent behavioral disorders rose by 77 per cent between 2000 and 2003, and that number has surely risen further.

At our colleges and universities, the percentage of students who sought help at campus health clinics and were prescribed “psych meds” went from seven per cent in 1992 to 18 per cent in 2000. And it continues to increase.

The role that the pharmaceutical industry has played has come under increased exposure.

Dr Abramson explains in his book the following important problematic areas of their influence.

Newer, more expensive treatments are aggressively promoted to doctors and directly to consumers because they are more profitable, even when the medication is a “copycat”-  It is very similar to an already existing drug which is a much less expensive.

The integrity of clinical drug trials is repeatidly compromised by the financial and political influence of the pharmaceutical industry. Experts who write clinical guidelines arising out of the drug research, influencing other physicians nationwide, are often paid by the drug companies whose products they recommend.

Doctors reading medical journals for the latest information, are not always seeing complete, unbiased reports. One important reason for this is called the “shelf” effect. This refers to the fact that a drug company can simply “put on the shelf” a drug study that does not show that the drug they have studied was effective. They can just leave that study unpublished, while the company publishes and publicizes a more favorable study. This happens simply because companies have no legal obligation to publish the result of their study. If a company conducts two studies on a medication and one shows that it works while the other shows that it doesn’t, the company is fully within its legal rights to publish the positive study and put the other on a shelf only to be forgotten.

The influential  New England Journal of Medicine has reported that one third of the studies done by the companies  that make the antidepressants Paxil and Prozac, were never published. It seems obvious that these unpublished studies, whose results are not as good as the published studies, would hinder the success of an application for approval of  a new drug, and these unpublished studies, out of sight and out of mind, don’t get in the way of the drug’s being approved by the FDA. Clearly this is misleading to both doctors and their patients who are not really fairly able to judge a drug’s true effectiveness.

In published studies, approximately 60 percent of patients reported improvement with depression after taking pharmaceutical agents. But it is also true that there is a positive effect from placebos ‘dummy’ pills that do not contain any active ingredient) with improvement in about 40 % of patients.  When the unpublished studies are factored in, the difference between the drug therapy and a placebo is much less. Obviously this brings  the effectiveness of the medication into question.

A similar skewing of results, toward reporting only positive results, exists for a variety of medications; one investigation found that  94 percent of the positive studies were published, whereas only 14 percent of those with disappointing or uncertain results were published. The Congress passed legislation that directed that certain studies  must be submitted to clinicaltrials.gov, a public database operated by the National Library of Medicine. This may help to alleviate the problem , but clearly it is not nearly enough to truly undo the damage being done for years  by the suppression of  unfavorable drug studies.

Greg Critser, the author of How Prescription Drugs are Altering American Lives, Minds and Bodies, provides an expose regarding the politics behind allowing direct advertising of prescription drugs to consumers. This type of advertising had for many years been restricted to doctor’s medical journals. Using the political tactic that allowing such advertising was a matter of consumer rights, and availability of information, drug companies were allowed to use direct consumer advertising. Now we see a constant stream of TV, radio and magazine ads promoting medications as any other consumer product, promising to benefit your life. It was argued that such advertising by drug companies directly to the public on TV and magazines allows the public more information upon which to base their decisions. The practical reality of what has occurred is that the sophisticated advertising campaigns by multibillion dollar corporations has so influenced society, that we seem to have accepted that medication should do everything from guarding us against our excesses of food , lack of exercise, excess drinking, and tobacco use, and improve our lives regardless of the way we live. We rely on them to increasing our children’s performance at school, to jump-starting our own productivity at work, and protect us from real and  imagined health risks.

Comedian Chris Rock has a great standup routine about the constant TV ads we see.

“…they keep naming symptoms until they get one that you’re convinced you got.”

As Chris Rock points out , the advertisements don’t even inform you about  precisely what the pill supposedly does. “You see this lovely lady sitting on a beautiful, dappled grey horse or a hefty he-man reclining in a bathtub,” says Rock, “and the voice-over just keeps naming symptoms: “Are you depressed?” “Are you lonely?” “Do you have performance anxiety?” “Do your teeth hurt?”

Then he makes mention of that one commercial which might ask: “Do you go to bed at night and wake up in the morning?”

“They got that one?” asks Rock. “I got that. … I’m sick. I need that pill!”

Chris Rock’s routine hits home because we have become the most medicated generation in history. We are constant and devoted consumers of pharmaceutical products from the cradle to the grave.

Two other books that discuss this problem are Marcia Angell’s The Truth About the Drug Companies and  Jerry Avorn’s Powerful Medicines.

As these problems have been exposed there has been a corresponding push for disclosures of the relationships that exist between the drug companies and their paid consultants who are prominent , trusted doctors whose opinions influence other medical doctors. But disclosures often come long after the undue influence of the drug companies has already made crucial inroads into the prescribing practices of the medical profession itself. Only years after the use of psychiatric drugs in children rose dramatically, was it exposed that a prominent Harvard child psychologist, who promoted the practice of increasingly using drugs with children, was found to have been paid 1.3 million dollars in consultant fees by drug companies. Despite this disclosure, the damage had already been done, as his influence on the prescription writing habits of pediatricians nationwide had already had its impact.

As cholesterol lowering medications have become increasingly prominent it is important not to allow the problems associated with them to be swept under the rug. These medications are among the most aggressively marketed medications. And they are taken by millions of people who may not be treating a current problem as much as accepting that statistically it is best for them to take them for a possible future benefit.They have never been exposed to the statistics related to the drug’s health benefits other than those very briefly quoted in drug company advertising.

Many people, if they understood the statistics involved, might very well opt not to take statin medication.

Crestor Study Results – And What They Really Mean
The authors of the Crestor-CRP study reported that over the 1.9 years of the study, there was a 44% reduction in cardiac events (defined as heart attack, stroke, severe angina, or cardiac death) among the subjects taking Crestor versus those taking a placebo. A 44% reduction sounds very impressive, but it is misleading.

Here are the actual numbers from the study. Over 2 years, 1.36% of subjects in the placebo group experienced a cardiac event; 0.77% of subjects in the Crestor group experienced an event. The difference was 0.59%. That is, less than 1%, a tiny difference.

The difference was so tiny that it will require 120 individuals with elevated CRP to take Crestor every day for two years for just one person to obtain benefit.2  Meanwhile, the other 119 individuals taking and paying for Crestor for two years will obtain no protection from a cardiovascular event.

Why would the results of the Crestor-CRP study be proclaimed so loudly nationwide despite being so tiny? The Crestor-CRP study was underwritten by AstraZeneca, the manufacturer of Crestor. We have seen previously that the marketing departments of drug companies are masters at obtaining maximum media coverage for their studies even if the results are unimpressive. Wide exposure means increased sales and big profits.

One media outlet took a critical stance. ABCNEWS.com boldly offered a dissenting opinion. In “Doctor Urges Caution in Interpreting New Findings on Cholesterol Drug,” Dr. Nortin Hadler wrote, “The benefit shown in this study is tiny, and if [the Crestor-CRP study] were repeated, there might be no benefit at all. I never leap to act on the basis of such small effects.”3

Serious Side Effects Downplayed
In Crestor-CRP, the drug displayed many of the common adverse effects of other statin medications (Lipitor, Zocor, Pravachol, Mevacor, Lescol). Typical side effects include abdominal pain, muscle pain, serious muscle breakdown (rhabdomyolysis), renal disorders, and liver disorders. More subjects in the Crestor group experienced these side effects than subjects in the placebo group. A far more serious adverse effect occurred with Crestor: 270 cases of newly diagnosed diabetes were reported among Crestor users, and 216 cases were reported among placebo users. The 54 more cases of diabetes in the Crestor group was a significant and worrisome finding. Diabetes is one of the most destructive, life-shortening disorders of our time. It also is a leading cause of heart attacks and strokes. Imagine, taking Crestor to prevent a heart attack and getting diabetes instead.

There have been other studies which have had disturbing results.

“Zetia and Vytorin don’t work!” “This shocking headline came about as a result of a story  reported on the New York Times  front page on Tuesday January 15, 2008. A clinical trial of Zetia, a widely used cholesterol drug, raised doubts about both the medicine’s effectiveness and the behavior of the pharmaceutical companies that conducted the study.  Zetia, and a pill that contains Vytorin, failed to benefit patients in a two-year trial that ended in April 2006.

Merck and Schering, the company that markets the medication, repeatedly missed their own deadlines for reporting the studies results.  Thus, cardiologists around the world were waiting and wondering what the study would show and why it was not reported.  At the same time millions of patients had continued taking Zetia and Vytorin.  Finally a month after news articles reported the delay and Congress pressured the companies to disclose the study’s findings, the results came out.

Not only did Zetia fail to slow the accumulation of fatty plaque in the arteries, it actually seemed to contribute to plaque formation.

Dr. Steven E. Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were shocking.  “This is as bad a result for the drug as anybody could have feared,” said Dr. Nissen, an editor of the Journal of the American College of Cardiology.  “Millions of patients may be taking a drug that does not benefit them, raising their risk of heart attacks and exposing them to potential side effects.  Patients should not be given prescriptions for Zetia unless all other cholesterol drugs have failed,” he said.

During the two years of the study, patients who took Zocor alone reduced their LDL (bad cholesterol) by 41 percent on average, while patients who took Vytorin reduced their LDL cholesterol by 58 percent.  Yet despite the larger cholesterol reduction, patients taking Vytorin actually had more growth of fatty plaque in their carotid arteries than those on Zocor.

It is important to understand that Zetia does “work” to lower cholesterol and it did so in this study.  This means that lowering Cholesterol may not be all that it’s cracked up to be. This study brings into question the “Cholesterol hypothesis”- the idea that elevated cholesterol leads directly to heart disease.  Although this scientific hypothesis has never been clearly proven it has become the holy grail of modern cardiology.  Despite appearances to the contrary conveyed by TV commercials, the  link between cholesterol and heart disease, although seemingly no longer a debatable subject, is indeed still a subject of fierce debate in the scientific community. 

The Cholesterol hypothesis- Does lowering cholesterol really prevent heart disease?

Just two days after the results of the study showing the failure of Zetia and Vytorin, another article appears in the NY Times, which revisits the whole notion of a clear connection between elevated cholesterol and heart disease.  It was entitled, New Questions on Treating Cholesterol.

For many years, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology.  It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol.

But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — “The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,” said a leading cardiologist.

For patients and drug companies, the stakes are enormous Cholesterol-lowering medicines, taken by tens of millions of patients daily, are the largest drug category worldwide, with annual sales of $40 billion.  Because the link between excessive LDL cholesterol and cardiovascular disease has been so widely accepted, the Food and Drug Administration generally has not required drug companies to prove that cholesterol medicines actually reduce heart attacks before approval.

Cholesterol lowering medications therefore, have not had to conduct “events” trials beforehand.  These studies would show whether episodes like heart attacks are reduced.

So far, proof that a  drug lowers LDL cholesterol has generally been enough to lead to approval.  Only then does the drug’s maker begin an events trial.  And until the results of that trial are available, a process that can take several years, doctors and patients must accept the medicine’s benefits largely on faith.

If you listen carefully to the TV commercials you will hear in the disclaimer in the commercial, that the medication has not been proven to prevent heart disease in a healthy person- even though the message of the commercial seems to be that it does do just  that.

Doctors generally believe that the amount by which cholesterol is lowered, not the method of lowering it, is what matters.  That continues to be the assumption.  Recent scientific research regarding the failures of two important clinical trials has thrown that hypothesis into question.

In December 2006 Pfizer stopped development of a new experimental cholesterol drug torcetrapib, when a trial involving 15,000 patients showed that the medicine caused heart attacks and strokes.  An essential point to be clear about is that the drug torcetrapib did lowered LDL (bad) cholesterol while raising HDL, or good cholesterol.  Torcetrapib’s failure shows that lowering cholesterol alone does not prove a drug will benefit patients.

Then, the drug makers announced that Vytorin, which combines Zetia with Zocor, had failed to reduce the growth of fatty arterial plaque in a trial of 720 patients.  In fact, patients taking Vytorin actually had more plaque growth than those who took Zocor alone.  This happened even though Vytorin and it’s component Zetia did lower cholesterol. 

For the second time in just over a year, a clinical trial found that LDL reduction did not translate into measurable medical benefits.

How statins work:

Cholesterol production involves a number of steps in the body. The energy producing  substance acetyl-CoA is   an essential molecule to living systems that been called to “building block of life”.  Three coA molecules combine to form HMG (hydroxymethyl glutaric acid).  It is the next step in the process toward cholesterol production that statins inhibit. The enzyme HMG-CoA reductase is inhibited by statins so that the rest of the biochemical pathway is interrupted at this step and cholesterol is not manufactured. The problem with statins that make them  associated with so  many side effects is that interrupting this biochemical process not only inhibits the production of cholesterol, but another of intermediary substances  which have important and necessary  biochemical functions in the body.  And many potential effects of interrupting this pathway in the body are not completely understood.  As an example of how interrupting the cholesterol pathway may have deleterious side effects, pediatricians at University of California, San Diego published a report of a child with a hereditary defect of mevalonic kinase, which is the enzyme that facilitates the next step beyond the HMG-CoA which statins inhibit. The child with this abnormality was mentally retarded, microcephalic(very small head) and he died at 24 months. And not surprisingly, he had very low cholesterol.

Cholesterol is not the only end product of the biochemical process that produces it. The other major compound I called ubiquinone or CoQ10.

CoQ10 is an energy producing substance produced in the mitochondria of all of our cells. Side effects of CoQ10 deficiency include muscle weakness and wasting, heart failure (remember, the heart is a muscle) and neuropathy. CoQ10 deficiency because of taking a statin medication will attempt to be prevented by Integrative Medicine doctors who will recommend that CoQ10 be taken if a patient also takes a statin medication.

Jay S. Cohen M.D. is a nationally recognized expert on medications and side effects. He is the author of What You Need to Know about Statin Drugs and Their Natural Alternatives. Anyone who has discussed taking a statin medication with their doctor would do well to read it.

Natural Approaches

A natural supplement with properties similar to prescription statins is red yeast rice. This fermentation product contains small amounts of several statin-like compounds. It works like a mild statin and, like prescription statins, reduces vascular inflammation and elevated CRP. Red yeast rice can also reduce cholesterol levels.

The Indian herb guggullipid, Omega 3 fatty acids as found in fish oils, niacin, and garlic are among a variety of natural substances widely used by Integrative Medicine specialists to help their patients when improving cholesterol and general cardiovascular prevention is the goal.

Integrative doctors recommend a variety of natural approaches to reduce elevated CRP. Because smoking increases CRP, the first step for any smoker is to stop smoking. Being overweight increases CRP, so weight loss is also important. Healthy eating and exercise can also reduce CRP levels.

Studies Prove the Effectiveness of Omega-3 Oils (Fish Oils) in Preventing Sudden Cardiac Death 

Study after study has proven the benefit of fish oils in preventing cardiac deaths. A study published in the New England Journal of Medicine in 2002 demonstrated that “omega-3 fatty acids found in fish are associated with a reduced risk of sudden death among men3.” In this study, those with the highest levels of omega-3 fatty acids had an 81% lower risk of sudden cardiac death than men with the lowest levels. A study published in JAMA, also in 2002, found similar benefits of fish oils in reducing cardiac deaths in women4. Another 2002 study confirmed the reduced incidence of sudden cardiac death in people taking omega-3 fatty acids5.

A landmark study was published in Lancet in 1999. It was conducted in Italy for 4 years and involved 11,000 people with recent heart attacks. These high-risk patients received 1 gram per day of fish oils or placebo. The study demonstrated that the patients receiving fish oils had significantly fewer heart attacks and strokes, and 45% fewer cardiac deaths, than those receiving placebo6. These and many other studies have proven the benefits of fish oils in preventing sudden cardiac death. Although many American cardiologists now recommend  fish oils, many doctors have still not gotten the word.

There are several natural supplements that have anti-inflammatory qualities. Alternative Medicine doctors often include  curcumin , in their  treatment for elevated CRP. Perhaps Vitamin C should also be included in the treatment of elevated CRP. A study in the Journal of the American College of Nutrition demonstrated that vitamin C reduced CRP 24%.

It’s worth repeating that eating well and exercising, the two most basic ways that people can properly care for themselves, may be the very best ways of all to prevent cardiovascular disease.

Clearly, everyone in health care who is concerned about the overuse of medication in society recognizes the need for pharmaceutical drugs when medically necessary. At the same time an intelligent decision about whether to take medication should be made with information above and beyond what is provided by drug company advertising.

Dr. Sobo is a Medical Doctor practicing Holistic/ Nutritional Medicine in Stamford, CT. More information about natural hormones and about Dr. Sobo’s practice can be found on the Internet at http://www.drsobo.com. Dr. Sobo’s office phone number is 203-348-8805.

*DISCLAIMER:*The information provided is for educational purposes only. It is not intended to replace the advice of your physician or health care provider.You are encouraged to seek the advice of a competent health care provider before making any decisions that could affect your health.