Hijacked: US Healthcare

Care in Crisis, Physicians at the Center

by Ronald Stallings, MD Board Certified Emergency Physician

“A Babe in the Woods”

My patients that night, a group of young accident victims with head and neck fractures, had made my 24 hour ER shift especially exhausting. The early morning drive east along the Columbia River from the Oregon coast was lulling me to sleep. It is a beautiful drive, but the beauty is repetitive, and that morning it was blurring in and out of focus.

My eyelids lifted and fell like lead.

The endless forms that I’d had to fill out that night on each of the patients had taken their toll, too. The forms are designed to facilitate patient evaluation, but I think they are really designed to squeeze the maximum billing out of each patient visit.

As I drove along, the next choice I made changed my life forever. I decided to fight off sleep by listening to a medical education tape series that I subscribe to. Barely able to focus, I snapped the tape into the player. The voice said,

The former editor of the New England Journal of Medicine states that it is no longer possible to believe most of clinical research published, or rely upon the judgment of trusted physicians or authoritative medical guidelines. The FDA, as of twelve years ago, is entirely funded by the pharmaceutical companies.

My eyes popped wide open. The speaker had my full attention. I suddenly knew that what he was telling me was the real reason behind my sabbatical leave the year before. And I thought about my present work place. The one and only meeting that I was ever asked to attend at that hospital was a marketing session. How could  this be? How could the field of medicine I had dedicated 25 years of my life to have taken such a drastic wrong turn? How had the forces of self interest turned a once ethical institution into an establishment that places profits over people? Like a raging flood down the Columbia River, I felt a rush of memories—the irritants, the contradictions, the corruption I’d seen first-hand–it all poured over me.

American Medical Care has been hijacked by a variety of corporate, financial and pharma- ceutical interests in a way that few fully understand. For the most part, American Medical Care no longer serves the patient. And, most sickening of all, physicians are often the willing instruments of that system.

pharmaceutical companies to invest in antibiotic research, according to a London School of Economics report cited by Eben Harrell’s 2009 article in Time, “The Desperate Need for New Antibiotics.” Here are the reasons.

“The course of antibiotic treatment is typically short because the drug helps patients get better  quickly. “Doctors tend to write fewer prescriptions for  an  effec- tive antibiotic so that their patients will be less likely to develop resistance to the drug.

“And then, when resistance to a certain antibiotic inevitably develops, the drug becomes obsolete.”

And, as we know, if it is not profitable, industry won’t invest research dollars.

Underlying the criticisms is the understanding that prod- ucts like Clarinex, Crestor, and Botox  waste  resources, keep drug spending high, and distract the industry from doing really important work….all the brainpower that is devoted to tweaking Claritin (to keep  the  patent  going) or developing Botox and other “Lifestyle  drugs”  could have been used to cure cancer (and AIDS) (Hawthorne, 2005, p. 277).

Or, of course, developing new antibiotics.

How did we get to a point where drug companies are manipulating our healthcare system for their own profits? How did we get to a point where government agencies support the interests of Wall Street and Big Pharma and leave the rest of us with the world’s most costly (2.3 tril- lion dollar a year) sick-care system that rewards us with a life expectancy that ranks 42nd in the world and is, by all accounts, broken? I will relay to you what I have found.

The Problem: Pharmaceutical Companies

Our Expense and Their Profits

Americans now spend a staggering $420 billion a year on prescription drugs, and that figure is growing by about 12 percent a year. When considering Pharma profits, as Dr. Marcia Angell writes in her 2004 book, The Truth About the Drug Companies, it is useful  to  note  that “…the median net return for all other industries in the Fortune 500 is only 3.3 percent of sales, while Pharma has netted a whopping 18.5 percent. With the collapse of Lehman Brothers as well as many other commercial banks, the banks’ financial records have come under intense scrutiny. Evidence shows, according to Dr. Angell, that “…commercial banking, itself no slouch as a well-connected and aggressive industry, runs a distant second at 13.5 percent.” (Angell, 2004, p. 11) In Jacky Law’s Big Pharma, 2006, the author notes,

Consider the world’s top players. Just ten drugs earned no less than $48.3 billion in 2003. Each of these prod- ucts on its own represents more income than most com- panies see in a lifetime. Leading the table was Pfizer’s Lipitor which earned $10.3 billion, followed by another cholesterol reducing drug, Merck’s Zocor, which had sales of $6.1 billion (Law, 2006, p.8).

How did they do it? According to Dr. Angell,

Before its patent ran out…the price of Schering Plough’s top selling allergy pill, Claritin, was raised thirteen times over five years, for a cumulative increase of more that 50 percent, over four times the rate of general inflation (Angell, 2005, p. xii).

In 2001 the ten American drug companies in the Fortune 500 list… ranked far above all other American industries in average net return, whether as a percentage of sales (18.5%), of assets (16.3%), or of shareholders’ equity (33.2%). These are astonishing margins (Angell, 20005, p. 11).

Drug Industry’s Fiction that Research is their Biggest Expense

As Dr. Angell tell us,

Big Pharma often claims that it spends more money on research than on marketing, a claim that is easily shown to be untrue. According to the SEC and shareholder reports for 2001, the biggest drug companies spent, on the average, 35 percent of their revenues on marketing and administration. That is, approximately 19 billion dollars, but the figure leaves another 35 billion in expens- es unaccounted for by Research and Development or other costs (Angell, 2005, p. 136).

I imagine that the other 35 billion in expenses are used for the gray area marketing activities which drug compa- nies call “education,” which include seminars for physi- cians and presentations at medical conferences.

Ilaria Passarani, health policy officer at the European consumer organization BEUC, commented,

“These major drug companies should be focusing on innovative medicines, but this report says they actually spend 23% of turnover on marketing and promotional activities, a third more than the 17% they spend on research and development” (Cendrowicz,  Time,  Nov.  28, 2008).

As an example of the global reach of pharmaceutical advertising, when I was in east Africa in 1998, in a very remote area of Kenya, I was approached by two young men. They were the picture of health and they had only two questions for me. “Do you know Mike Tyson?” and “How can we get some Viagra?”


That day I also wondered if the medical use of marijua- na, which I had been ambivalent about, could possibly be part of the solution for medical care in the U.S. And I wondered if it also might save me from the guilt and out- rage I was feeling?

Two years have passed since that pivotal day. I have read books and articles, talked with people here and in other countries. In the U.S., it seems that the hijacking is just about complete. It will take persistent hard work over a long period of time to turn this situation around and I want to begin by telling you about what I have learned.

Not Your Parents’ History Lesson:

A Short History of Drugs and Supplements Many of the wonder drugs that transformed human health during the last hundred years are natural sub- stances that have been in use for centuries. Penicillin, for example, was used by South American indigenous physi- cians some 800 years ago. Greenwald, Blackman, Dowell, Pascual, and Woodbury in their 1998 Time arti- cle, “Herbal Healing,” reviewed some history,

Ephedra, the main ingredient of some over-the-counter asthma treatments, has relieved breathing problems in China for 5,000 years. An estimated 25% of all modern pharmaceutical drugs are derived from herbs, including aspirin (from white willow bark), the heart medication digitalis (foxglove), and the cancer treatment  Taxol (Pacific yew tree). There might have been no sexual rev- olution without the birth-control pill, derived from a Mexican yam.

Studies have shown that wine,  which  has been available  to many cultures throughout the centuries, is a major fac- tor in the reduction of cardiovascular disease and longevity.

U.S. Doctors more commonly prescribed medicinal herbs before World War II and before the advent of wonder drugs like penicillin (Greenwald, et. al., 1998).

Also, less parochial minded individuals are turning to cannabis, which has been shown to be scientifically effec- tive and has been used for thousands of years for a myr- iad of illnesses.

All of the alternative medications are popular, in part, because they are usually cheaper than prescription med- ications (Yan, 2009).

Linda Marsa, in her book Prescription for Profits notes that most of the reasons for the improved health of the world, in developed countries where infections had not been a major factor in morbidity and mortality, can be attributed to better sanitation of water and food as well as improved safety conditions at work and elsewhere.

It is, she says, “…impossible to overstate the importance of the discovery of penicillin…Common potentially deadly illnesses, after penicillin came on the scene, became relatively minor ailments. And the unprecedent- ed collaboration between government and industry to mass-produce penicillin was a spectacular demonstration of what a well-financed, cooperative research effort could accomplish.” (Marsa, 1997, p. 22)

Bacterial and parasitic diseases are the second leading cause of death worldwide. According to a report on antibiotic research released in 2009 by  the  London  School of Economics  and  Political  Science,  175,000 deaths are attributed to hospital-acquired infections each year in Europe alone (Harrell, 2009).

Despite the importance of effective antibiotics, the num- ber of different antibiotics available to treat infections when they do occur is dwindling because pharmaceutical companies have neglected to invest in the development of new types of drugs (Harrell, 2009).

It is true in general that the development of any new drugs is declining sharply because the big money is to be made in lifestyle drugs and making small changes in existing drugs to seek approval to market them for treat- ment of other conditions.

My own trips to Central and South America have helped me understand the reasons that microbes have mutated and why we are losing the battle against them, with little help from the pharmaceutical industry. In many coun- tries a person does not need a physician’s prescription to buy an antibiotic. Patients who are experiencing flu-like symptoms will, at the encouragement of their pharma- cist, self-medicate for a viral or other illness for which antibiotics are completely ineffective. This, of course, ruins the effectiveness of an antibiotic when it is needed to treat an infection. I contend that doctors and pharma- cists, almost single handedly, are responsible for an infec- tion epidemic that is sweeping the nation: MRSA [Methicillin-resistant Staphylococcus aureus]. MRSA is a potentially lethal disease caused by an over prescription of antibiotics, usually for viral illnesses for which there is no cure.

Laura Blue, in an October 17, 2008 Time Magazine arti- cle discussing MRSA, noted  that,  “The last two decades  of the 20th century saw nearly zero progress, and in those years several disease-causing bacteria evolved resistance to commonly used drugs. Researchers at the Centers for Disease Control and Prevention found that more than 40% of staph infections in the U.S in 2006 were MRSA– a bug that now kills more Americans  a  year than AIDS.”

There are several reasons why it’s not cost-effective for pharmaceutical companies to invest in antibiotic research, according to a London School of Economics report cited by Eben Harrell’s 2009 article in Time, “The Desperate Need for New Antibiotics.” Here are the reasons.

“The course of antibiotic treatment is typically short because the drug helps patients get better  quickly. “Doctors tend to write fewer prescriptions for  an  effec- tive antibiotic so that their patients will be less likely to develop resistance to the drug.

“And then, when resistance to a certain antibiotic inevitably develops, the drug becomes obsolete.”

And, as we know, if it is not profitable, industry won’t invest research dollars.

Underlying the criticisms is the understanding that prod- ucts like Clarinex, Crestor, and Botox  waste  resources, keep drug spending high, and distract the industry from doing really important work….all the brainpower that is devoted to tweaking Claritin (to keep  the  patent  going) or developing Botox and other “Lifestyle  drugs”  could have been used to cure cancer (and AIDS) (Hawthorne, 2005, p. 277).

Or, of course, developing new antibiotics.

How did we get to a point where drug companies are manipulating our healthcare system for their own profits? How did we get to a point where government agencies support the interests of Wall Street and Big Pharma and leave the rest of us with the world’s most costly (2.3 tril- lion dollar a year) sick-care system that rewards us with a life expectancy that ranks 42nd in the world and is, by all accounts, broken? I will relay to you what I have found.

The Problem: Pharmaceutical Companies

Our Expense and Their Profits

Americans now spend a staggering $420 billion a year on prescription drugs, and that figure is growing by about 12 percent a year. When considering Pharma profits, as Dr. Marcia Angell writes in her 2004 book, The Truth About the Drug Companies, it is useful  to  note  that “…the median net return for all other industries in the Fortune 500 is only 3.3 percent of sales, while Pharma has netted a whopping 18.5 percent. With the collapse of Lehman Brothers as well as many other commercial banks, the banks’ financial records have come under intense scrutiny. Evidence shows, according to Dr. Angell, that “…commercial banking, itself no slouch as a well-connected and aggressive industry, runs a distant second at 13.5 percent.” (Angell, 2004, p. 11) In Jacky Law’s Big Pharma, 2006, the author notes,

Consider the world’s top players. Just ten drugs earned no less than $48.3 billion in 2003. Each of these prod- ucts on its own represents more income than most com- panies see in a lifetime. Leading the table was Pfizer’s Lipitor which earned $10.3 billion, followed by another cholesterol reducing drug, Merck’s Zocor, which had sales of $6.1 billion (Law, 2006, p.8).

How did they do it? According to Dr. Angell,

Before its patent ran out…the price of Schering Plough’s top selling allergy pill, Claritin, was raised thirteen times over five years, for a cumulative increase of more that 50 percent, over four times the rate of general inflation (Angell, 2005, p. xii).

In 2001 the ten American drug companies in the Fortune 500 list… ranked far above all other American industries in average net return, whether as a percentage of sales (18.5%), of assets (16.3%), or of shareholders’ equity (33.2%). These are astonishing margins (Angell, 20005, p. 11).

Drug Industry’s Fiction that Research is their Biggest Expense

As Dr. Angell tell us,

Big Pharma often claims that it spends more money on research than on marketing, a claim that is easily shown to be untrue. According to the SEC and shareholder reports for 2001, the biggest drug companies spent, on the average, 35 percent of their revenues on marketing and administration. That is, approximately 19 billion dollars, but the figure leaves another 35 billion in expens- es unaccounted for by Research and Development or other costs (Angell, 2005, p. 136).

I imagine that the other 35 billion in expenses are used for the gray area marketing activities which drug compa- nies call “education,” which include seminars for physi- cians and presentations at medical conferences.

Ilaria Passarani, health policy officer at the European consumer organization BEUC, commented,

“These major drug companies should be focusing on innovative medicines, but this report says they actually spend 23% of turnover on marketing and promotional activities, a third more than the 17% they spend on research and development” (Cendrowicz,  Time,  Nov.  28, 2008).

As an example of the global reach of pharmaceutical advertising, when I was in east Africa in 1998, in a very remote area of Kenya, I was approached by two young men. They were the picture of health and they had only two questions for me. “Do you know Mike Tyson?” and “How can we get some Viagra?”

The Inflated Cost of US Drugs

Because of the influence of the pharmaceutical industry on government, inflated drug prices have burdened U.S. patients and taxpayers with unnecessarily high costs for years. Although it is against the law, people have found a solution in buying drugs from Canada,

…where government regulation kept prices some 70 per- cent lower than in the United States (Hawthorne, 2005, p.163).

So how is the American consumer grappling with the cost? As Dr. Angell notes, “They (low-income patients) may trade off drugs against home heating or food. Some people try to string out their drugs by taking them less often than prescribed, or sharing with a spouse…Not only do these low-income patients go without needed treatment but their doctors sometimes wrongly conclude that the drugs they prescribed didn’t work and prescribe yet others.” (Angell, 2005, p xii)

Boosting Profits by Prescribing for Lifestyle Benefits

Cialis is the third of the highly  advertised  impotence drugs, approved in November 2003. When Pfizer launched Viagra in 1998 it insisted that the drug was aimed at older men suffering from a diagnosed medical condition called erectile dysfunction. But as the ads with beautiful blondes and hulking sports stars made  clear,  that strategy was quickly abandoned, and now all three brands are basically pitched to younger men like expen- sive sex toys. Indeed, the fastest-growing group of Viagra users from 1998 to 2002 were men aged 18 to 45 accord- ing to a survey by the pharmacy  benefits  manager Express Scripts, Inc. (Hawthorne, 2005, p.276).

Neglecting Urgent Human Needs to Pursue Profit

I and many of my colleagues believe that development of lifestyle drugs drains the resources of the industry when those same resources would be better suited to research on HIV/AIDS and other life threatening disorders.

In 2004, the total number of new active substances approved for use by the FDA had dwindled  to a new low  of just 23, down from 31 recorded in 2003, and  29  in 2002. Of those 23 new pharmaceuticals, says Ian Lloyd, Managing Editor of the Global Pharma Research Database, only four can be described as significant ther- apeutic advances (Law, 2006, p. 10).

The development of new antibiotics appears to take a back seat to high profits that pharmaceutical companies find in lifestyle drugs such as cholesterol-lowering drugs, Viagra, Propecia, etc. (Harrell, 2009).

Designing New Conditions and New Drugs to Treat Them

Jacky Law, in her 2006 book Big Pharma, described how Irritable Bowel Syndrome, as well as other diseases, was a disorder fostered by pharmaceutical companies to sell their drugs. “Their marketing machine is very methodi- cal: The first step of the strategy was to set up an adviso- ry board with one key opinion leader from each state of Australia. The job of this doctor would be to provide advice to the corporate sponsors of current opinion in gastroenterology and on ‘opportunities for shaping it’. Further work included developing ‘best practice guide- lines’ for diagnosing and managing IBS.” (Law, 2006, p. 58)

Law goes on to explain how osteoporosis [in addition to such conditions as Attention Deficit Hyperactivity Disorder (ADHD), Restless Leg Syndrome (RLS), and Fibromyalgia (FM)], is a classic example of how corpo- rations have changed the way populations think about disease, in this case about bone loss. In the case of osteo- porosis treatments, you have to take the costly drugs for several years to show the slightest drop in risk. Also the risk is not equal across racial lines. For instance black people are less like to develop osteoporosis than whites though it is marketed to African Americans equally (Law, 2006, p. 59).

The Invention of Pre-Hypertension and Pre-Diabetes

Disorders have been reclassified in order to develop a great number of patients. A good example of this redefi- nition has taken place with anti-hypertension medica- tions. According to Dr. Angell, “High blood pressure was defined for many years as BP above 140/90. An expert panel then introduced something called pre-hypertension in 2003, which is between 120/80 and 140/90. Overnight, people with blood pressures in this range found  they had a medical  condition.”  (Law,  2006, p. 48).

I have seen the same use of bogus science and playing fast and loose with diabetes. I have an aunt who is in her late 70’s. I told her that her blood sugar of 120, which with- out medication has never gone higher than 130, is not diabetes like her MD stated. Nevertheless, because she trusts her physician, in her mind it just has to be so, regardless of the textbooks and reference material that I sent her and my encouragement to get a second  opinion.

Corporate Strategies to Promote New Medical Conditions

In many cases, the formula is the same. Groups and/or organizations are orchestrated, funded, and facilitated by corporate interests, often via their PR and marketing infrastructure. A key strategy of the organizations is to target the news media with stories designed to create fears about the condition or disease and draw attention to the latest treatment. The media is a poster child for this use of the “stay tuned for the film or story at 11:00” style of journalism.

Company-sponsored advisory boards supply the “inde- pendent experts” for these stories, consumer groups pro- vide the “victims”, and PR companies supply media out- lets with the positive spin about the latest breakthrough medications (Law, 2006, p. 52).

The Unholy Partnership between Congress and Big Pharma–Good Intentions Gone Wild In 1980, Senators  Birch Bayh and  Bob Dole teamed  up  to sponsor a bill that would give companies exclusive licensing rights to discoveries arising from federally fund- ed research and would encourage academic scientists to seek commercial applications for their work. Although it accelerated the process of commercializing inventions developed within universities and government,  one effect of the bill was to decrease the crucial element of sharing information among scientists (Marshall, 1996, p. 1359).

The Bayh-Dole Act and, also in 1980, the Stevenson- Wydler Act allowed the NIH to specify that certain tax- payer-supported work in medical schools, teaching hos- pitals, and small biotech companies will not be patented but will remain in the public domain. Bayh-Dole makes the following requirements:

  • Work licensed to drug companies must be “available to the public on reasonable terms.”
  • Work patented and licensed under the terms of Bayh- Dole must be reported to the  National  Institutes  of Health (NIH) so that the NIH can keep  track  of  drugs that originate in that way.
  • If profits from the drugs are very large, Bayh-Dole also requires that some part of the royalties be returned to  the  government.  (This is a sound idea but profit-sharing has been ignored by the phar- maceutical companies and

the NIH has gone along

(Angell, 2005, p. 69.)

The result of the Bayh-Dole Act is that  drug  companies  no longer have to rely on their own research for new  drugs, and few of the large ones  do.  Increasingly,  they  rely on academia, small bio tech start-up companies, and the NIH, for the discovery  of new  drugs.  At least  a third of the drugs marketed by the major drug companies are now licensed from universities or small biotech compa- nies, and these tend to be the most innovative new dis- coveries (Angell, 2005, p. 8).

The HIV/AIDS drug AZT, for example, is a good illus- tration of Bayh-Dole in action. AZT (Zidovudine) was the first drug on the market to treat HIV/AIDS. Sold under the brand name Retrovirus, it was originally man- ufactured by the drug company Burroughs Wellcome, then by the much larger British firm GlaxoSmithKline. The profits went at first to Burroughs Wellcome and then to GlaxoSmithKline, but the research and most of the development was done in government and university laboratories (Angell, 2005, p. 24)

To benefit from taxpayer-funded scientific research, many international pharmaceutical companies are locat- ing their facilities near MIT (Angell, 2005, p. 13).

European companies, too, are now locating their research and development operations in the United States. They claim it is because we don’t regulate drug prices, but more likely it is because they want to feed on the research output of American universities and the NIH. In other words, it’s not private enterprise that draws them here but the very opposite—publicly spon- sored research enterprise (Angell, 2005, p.xvii).

Of the seven innovative drugs approved in 2002, only three came from members of the Pharmaceutical Research Manufacturers of America (PhRMA).

…Nothing from any major American drug company. (Angell, 2005, pp. 55-56).

And the research was all paid for by the taxpayer-funded NIH.

Now primarily a marketing machine to sell drugs of dubious benefit, the drug industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the Food and Drug Administration, academic medical centers, and the med- ical profession itself. Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions (Angell, 2005, p. xviii).

How the Industry Addresses Drug Safety Problems

The Problem with Avandia

For the 200 million diabetics worldwide, the past few years have brought some disturbing findings about risks that may be associated with certain  diabetes  drugs. Recent concerns that Avandia might  cause  cardiovascu- lar problems, for example, have led some  experts  to call for it to be pulled from the market, although it remains available today (Payne, 2009).

Some studies link Avandia to increased cardiovascular risks such as heart attack and death, a serious concern considering that people with diabetes face two to four times the risk of cardiovascular disease compared with the general public. A 2007 meta-analysis published in the The New England Journal of Medicine found that peo- ple taking Avandia had a higher risk of heart attack and death from cardiovascular causes. More recently, a study published in the Archives of Internal Medicine, found that the risk of death and heart failure for older people with diabetes seems to be greater in those taking Avandia than those taking Actos, another medication in the same class. Nevertheless, the study funded by GlaxoSmithKline, nicknamed the RECORD trial, found that taking Avandia did not seem to increase the risk of heart attack or death (Payne, 2009).

The FDA says that it will require GlaxoSmithKline to conduct a cardiovascular outcome trial on Avandia to provide a definitive answer to the question of Avandia and an unacceptable risk of cardiovascular disease (Payne, 2009).

Speaking on the subject of Avandia, Sidney Wolfe, editor of worstpills.org and Director of Health Research Group at the nonprofit Public Citizen reminds us, “Any drug that is worth anything needs to decrease the risk of car- diovascular disease.” (Payne, 2009)

As a physician, my distrust of studies sponsored by the manufacturer of the product being studied is well found- ed. Again and again the industry has manipulated stud- ies. The evidence is clear.

How the Industry Ignores Cheap but Effective Drugs

High Blood Pressure Treatments

A major study, the ALLHAT Antihypertensive Trial, reported in the Journal of the American Medical Association 2002, demonstrated that a common water pill was just as effective for lowering blood pressure and actually better for preventing some of the devastating complications of high blood pressure, mainly heart dis- ease and strokes, than blood pressure medications pro- moted by the drug companies. The Director of the National Heart, Lung, and Blood Institute was unequiv- ocal in his conclusion. “ALLHAT shows that  diuretics are the best choice to treat hypertension, both medically and economically.” (Angell, 2005, p. 96)

At that time, Norvasc, a product of Pfizer, Inc., was the

most heavily advertised drug in  The  New  England  Journal of Medicine. Not surprisingly, there were no advertisements for the common water pill. As a result, of the top fifty drugs used by  senior  citizens  in  2001, Norvasc was the second most commonly used  and  diuretics like the one that proved superior in ALLHAT appeared nowhere on that list (Angell, 2005, p. 97).

How the Industry Tests the Effectiveness of New Drugs

Drug companies can’t market a new drug until they have carried out a clinical trial to show that the drug is safe and effective compared to a sugar pill. That, however, raises another problem. Can we believe in the accuracy of those trials? After all, that crucial last stage of research and development is usually sponsored by the company that makes the drug, even if the early research was done elsewhere. Is there some way that companies are able to rig clinical trials to make their drugs look better than they are? Unfortunately, the answer is yes. Trials can be rigged in dozens of ways, and it happens all the time (Angell, 2005, p. 95).

Doctors rely for their information on medical journals, textbooks, seminars, medical education courses, and, unfortunately, drug company marketing. Textbooks and the beliefs of so-called “Thought Leaders” are no better than the evidence on which they are based, and that evi- dence, in most cases, comes from research reports in medical journals, so it is crucial that those reports be unbiased. Increasingly, clinical research on drugs is spon- sored by the companies that manufacture them.

The Industry’s Efforts to Build New Markets for Existing Drugs

The drug industry works in various ways to raise profits without making any useful scientific contribution. They test uses of existing drugs to be used for other conditions so that they can expand the market for approved drugs. And they package new disease “conditions” that can be treated with existing drugs.

For example, most young women experience some pre- menstrual tension from time to time . Lilly’s launch of the prescription drug Sarafem made premenstrual symp- toms a disease—now called “premenstrual dysphoric dis- order” (PMDD). Sarafem, the treatment for PMDD, is the same as Prozac, a commonly prescribed antidepres- sant, but marketed at a higher price (Angell, 2005, p. 86).

Lax controls coupled with huge potential financial gain from lifestyle diseases led US attorney Richard Scruggs to take on Swiss drug company Novartis a few years ago for allegedly inventing the condition ADD. This was a seri- ous charge, alleging the manufacturer of the their top selling ADD drug, Ritalin, had conspired with the APA to package up common behavioral traits – such as being unable to concentrate for long on everyday tasks- and define them as a single disorder.…..(Hawthorne, 2005, p. 254).

How the Industry Skirts the Question of Effectiveness The Emergence of Biased Research

Dr. Angell comments on the increasing control exercised by the pharmaceutical industry.

Drugs companies have considerable control over the way the research is carried out and reported. That  is  new. Until the 1980s, researchers were largely independent of the companies that sponsored their work. Drug compa- nies would give a grant to an academic medical center then step back and wait for the faculty researchers to report the results. Now, however, companies are  involved in the details of research from  design  of  the study through analysis of the data  to  the  decision whether to publish the results. This has made bias extremely likely. Researchers don’t control clinical trials any more; sponsors do (Angell, 2005, p. 100).

“I saw companies begin to exercise a level of control over the way research is done that was unheard of when I first came to the journal, and the aim was clearly to load the dice to make sure their drugs looked good.” The decep- tive methods include comparing new drugs to sugar pill instead of testing their effectiveness in comparison to drugs currently in use.” Angell says that these are tactics that are difficult to spot when reviewing research. Angell notes that in her tenure as editor of the New England Journal of Medicine, they would reject such studies, but

38 • Treating Yourself, Issue 32 – 2011

later would see them published in other journals (Angell, 2005, page xviii).

Beginning in the 1980s, when drug companies became richer, more powerful, and more profit-driven, they became less willing to sit back and wait for academic researchers to produce research results. Instead of relying on academic centers, companies turned to the new for- profit research industry that grew up to serve them (Angell, 2005, p. 100).

The doctors are not themselves trained researchers,  so  they do what they are told or risk losing their lucrative deals with the for-profit research contractors. The con- tract research organizations, in turn, answer only to big pharma (Angell, 2005, p. 101).

Many researchers have lost their independence but have profited greatly in doing so. This was the case when I worked at a “Doc in the Box” in Vancouver, Washington where an investigational study involving asthma was being conducted. As clinic staff, we were given no guide- lines except to refer anyone with a wheeze to the study. Of course the owner of the clinic was paid very well for each person inducted into the study. In hindsight, I see why the owner of the clinic, a very wealthy doctor who was involved in a number of money-making projects, devoted so much of his time and attention to this aspect of his empire.

They [doctors] have lucrative financial arrangements with drug company sponsors that would have been impossible twenty years ago. Researchers serve as con- sultants to companies whose products they are studying, become paid members of advisory boards and speakers’ bureaus, enter into patent and royalty arrangements together with their institutions, promote drugs and devices at company-sponsored symposiums, and allow themselves to be supplied with expensive gifts and luxu- ry trips (Angell, 2005, p. 103).

At the same time, many research studies sponsored by drug companies exclude the researcher from having any knowledge of the outcome or giving them access to com- plete data (Angell, 2005, p. 103).

I heard an emergency medicine device presentation deliv- ered by a Harvard researcher who addressed an audience of physicians. He proclaimed loudly that he had no financial connection to the product and at the same time told his audience that they were “backward  idiots”  if they were not using the product. In the course of the pres- entation, the speaker did disclose that he had been hired by a law firm to give expert testimony in defense of another product line that the same manufacturer had produced. I would also guess that he had not come to speak to us without compensation. He was listed as a

member of a speakers’ bureau, a bureau no doubt fund- ed by a pharmaceutical manufacturer.

A recent survey found that industry-sponsored research was nearly four times as likely to be favorable to the company’s product as NIH-sponsored research. That is in accord with a large body of evidence showing that researchers with industry connections are far more likely to favor company products (Angell, 2005, p. 106).

In the case of the calcium channel blockers  to  control  high blood pressure, for instance, one survey of seventy articles about their safety found that 96% of the authors who were supportive of the drugs had financial ties to the companies that manufactured them, while only 37 per- cent of authors who were critical had such ties (Angell, 2005, p. 107)

Research Tricks

Big Pharma spends an enormous amount of its immense resources to circumvent and manipulate the system of drug evaluation. They are masterful at this, mind-

ful of the enormous rewards. Here are some of the research tricks.

Compare the new drug’s     effectiveness to that of a placebo. Research bias can be built into a study of effectiveness if the new

drug is   compared   to   a sugar pill  rather  than an older effective drug that treats the same condition. Using the

sugar pill comparison, the drug may appear to be more effective than it is (Angell, 2005, p. xxvi).

When this method is used, even serious readers may automatically conclude that it

is better than older drugs already in use. Other practices noted by Dr. Angell include comparing the new drug’s effectiveness with an effective older drug but lowering the dose of the older drug in the trial so it will appear ineffective or, giving too high a dose of the older  drug so it will have side effects. Researchers may test the drug’s safety by enrolling only young subjects in a trial of a drug intended for use by older people. Because young people generally experience fewer side effects, the drug will look safer in these trials than it would in practice. Also, the trial can be designed to be too brief to be meaningful, they may present only part of the data—the part that makes the product look good—and ignore the rest. (Angell, 2005, pp. 107-108).

Also, the researchers or the drug company may choose to

suppress negative results. An empirical survey of article publishers demonstrated that they are more likely to pub- lish positive results. The journal editors’ rationale is that people want to read positive and useful information rather than negative information.

Companies Aggressively Seek FDA Approval for New Drugs

The Pharmaceutical Company’s first task in getting approval is to build a clinical case by  designing  trials  both pre and post approval to show their product in the best possible light. These are the publishing tricks:

  • Report your trial’s results only at the point when they come out well. Publish the helpful 6-month results, but bury the weak 12-month results.
  • Test it against a small group of rivals, to show it is as good.
  • Conduct your trial across a number of countries, publishing each result separately to suggest that a very large number of trials back your drug.
  • Keep republishing “positive trials.” Negative results         can be buried in an obscure journal.
  • Let the journals know that you will buy millions of         dollars worth of

reprints if they review your product favorably (Law, 2006, pp. 45-46.)

The FDA may approve the drug on the basis of minimal evidence. If the  drug  shows  positive  results  in  only   two

studies, it may be approved even if a majority of other studies show negative results (Angell, 2005, p.

112).

How the Industry Extends the Life of Its Patents

In a Time Magazine article, November 28, 2008, Leo Cendrowicz described charges brought against European drug makers for artificially inflated prices.

By using patent lawsuits and other delaying tactics to prevent cheaper generic medications from entering the market, the drug manufacturers cost European con- sumers up to $4 billion over an eight-year period ending in 2007. European Union Competition commissioner Neelie Kroes contends, “Market entry of generic compa- nies and the development of new and more affordable medicines is sometimes blocked or delayed at significant cost to healthcare systems, consumers, and taxpayers.”

The damning indictment was part of a 400-page, interim Commission report based on evidence collected during

January raids at the headquarters of some of the world’s biggest drug companies, including US companies Pfizer and Johnson and Johnson, Britain’s GlaxoSmithKline, Anglo-Swedish giant AstraZeneca, and Sanofi-aventis of France. The other companies known to be raided were Wyeth, Merck, Bayer Schering Pharma, and Roche, as well as generic firms Teva and Sandoz.

The most common tactic allegedly involves filing multi- ple patent applications often for the same medicine—so- called patent clusters—that stake out an extremely broad claim for a drug’s intended use and physical form. This may include use as a liquid, a capsule or a pill. In one case, the E.U. found 1,300 patents for a single medicine.

…..generic medicines can cost as much as 90% less than branded drugs: total savings gained by copycat drugs [cheaper   forms   marketed   after   the   patent   expires]

…amounted to at least $17 billion over the 2000-2007 period examined by the Commission.

How the Industry Promotes the Effectiveness and Safety of their New Drug For years any change in my practice was based on jour- nal articles and seminars. Most of the time, the new treat- ments were just old pills in new bottles, usually at a high- er price.

Editor of the British medical journal, Lancet, Dr. Richard Horton, quoted in Big Pharma, describes the industry’s methods.

“A pharmaceutical company will sponsor a scientific meeting. Speakers will be invited to talk about a product, and they will be paid a hefty fee… for doing so. They are chosen for their known view about a particular drug or because they have a reputation for being adaptable in attitude towards the needs of the company paying their fee.”

The meeting takes place and the speaker delivers a talk. A pharmaceutic communications company will record this lecture and convert it into an article for publication, usually as part of a collection of papers emanating from the symposium. This collection will be offered to a med- ical publisher for an amount that can run into hundreds of thousands of pounds. The publisher will then seek a reputable journal to publish the papers based on the sym- posium, commonly as a supplement to the main journal.

The important point is that there is very little peer review in a whole raft of journals that pose as science journals. Their process of publication has been reduced to market- ing dressed up as legitimate science…” says Horton (Law, 2006, p. 47).

What is disturbing is that I, along with probably a major-

ity of physicians, put an enormous amount of credence into these studies which are of dubious quality. These studies result in changes to our practice, unneeded extra healthcare costs, and, in some cases, death and disability for our patients.

How the Industry Advertises its Drugs Television advertisement of drugs, sanctioned by the FDA, has increased in frequency and sophistication in recent years.

To pharmaceutical industry executives, some doctors, some consumer groups, and FDA officialdom, this is just an example of the government doing its job and trying to educate the public. But to most doctors, many consumer groups, and other critics, this is salesmanship, not educa- tion, and something as serious as medicine–something that can have horrible side effects, that can save lives if used properly or kill people if something goes wrong – should not be pitched like toothpaste (Hawthorne, 2005, p. 254)

Often advertising is designed to educate about newly dis- covered disorders for which the pharmaceutical industry has found a drug treatment. However glitzy and sexy the advertisements and movies may be (see the film Love and Other Drugs, 2011), they are nothing more than promo- tions along with loopholes and subliminal maneuvers that enable pharmaceutical companies to influence patients, influence lawmakers, and reap huge profits.

The pharmaceutical industry is everywhere in Washington, all but writing  the  Medicare  prescription drug bill, fielding more lobbyists  than there are members  of Congress, flinging gifts and  trips  at doctors  and  trying to prevent double-blind drug trials that pit one  drug against another, instead of against  a  placebo  (Angell, 2005, p.106)

Drug Companies Defend their Higher Priced Drugs Against All Challengers

in cases of heart attack, the control group would receive  a placebo and that patients would have to pay their own costs. (Marsa, 1997, p. 211) Doctors, after hearing word of this deception, refused to refer their patients to the study.

Despite evidence to the contrary, Genentech still con- tends that its drug t-PA, a very costly medication, is more beneficial than Streptokinase, a less expensive alterna- tive.

The studies comparing t-PA and the less expensive strep- tokinase, titled TIMI and GISSA-2, showed that while streptokinase was linked to greater numbers of bleeding problems and allergic reactions, t-PA was linked to high- er incidences of strokes and re-occlusion (Marsa, 1997,

p. 204). Another very large study, the International Study of Infarct Survival, ISSI-3…showed that t-PA was not more effective than less expensive medications, and that t PA had a higher risk of strokes. Marsa reported that “Oxford’s Rory Collins, one of the British ISIS-3 researchers, said that if U.S. doctors used streptokinase, ‘it would save more than $100 million each year.’” (Marsa, 1997, p. 213)

Myocardial infarctions can be caused  by a combination of events, i.e. vessel narrowing or spasms, plaques, and blood clots, to name a few; though the majority of them may include or be solely caused by vasospasms which inexpensive beta blockers can control. Attention is diverted away from that important cause because beta blockers are cheap to make and have slimmer profit mar- gins.

I am not convinced that t-PA is our end point drug and that it is the most effective drug to treat most MIs, espe- cially given a more cost-effective, equally effective, and less-promoted alternative. After all, in most post mortem heart samples of diagnosed heart attacks, no blood clots or arterial blockage can be found. This raises the ques- tion of hype versus scientific clarity.

What I find most disturbing is that as an emergency physician I am a front-line physician for t-PA use and it appears that I and my colleagues are, through our igno- rance, being manipulated and pressured into using t-PA instead of an equally effective and less expensive medica- tion. My personal survey of in-hospital pharmacies revealed that Streptokinase, once at a cost of $800, is no longer available. t-PA is now the only choice  available and it has doubled in price to a whopping $4,000 a dose. What was once obscure to me is now clear. My sabbati- cal leaves were a reflection of the lunacy and corruption in my field.

Academic Researchers Face Growing Conflicts of Interest

University research facilities, once the setting for disinter- ested scientific study have, since the 1990’s, formed pub- lic-private partnerships with pharmaceutical companies. The public universities’ historic need for funding made them vulnerable to infusions of cash from the pharma- ceutical giants once the government put laws in place to encourage that relationship.

A 1996 Harvard survey of 210 U.S. companies that fund academic scientists reached some disturbing conclusions. The study revealed that the ethical dilemmas and practi- cal problems sparked by industrial intrusions on cam- pus…were now endemic and magnified a thousand fold.

…the evidence was overwhelming that companies did, in fact, dictate what research was conducted by government supported scientists (Marsa, 1997, p. 253).

Drug Company Sponsorship of Patient Advocacy Groups

Another form of marketing disguised as education is the sponsorship of patient advocacy groups. Many of these groups are simply fronts for drug companies. Dr. Angell notes, “People who suffer from a certain disease are looking for a support network devoted to expanding awareness of the disease and they are pleased to find one.” (Angell, 2005, p. 151-152). The groups they find, however, may be just another marketing tool for a drug company.

Drug companies also set up patient advocacy groups as magnets for people with specific diseases. These groups can be rich sources of patients for clinical trials. Most human subjects are now recruited through these kinds of efforts, not referred by their doctors. They are usually paid from a few hundred to a few thousand dollars for participation in a trial (Angell, 2005, p. 30).

The Problem: The FDA

For almost a century, the FDA has been the Good Housekeeping seal of approval, the Nobel Prize, and Ivory soap combined. American

12-year span, FDA stats showed that one-fourth rup- tured, on average (Hawthorne, 2005, p. 182).

Pharma’s influences on the FDA were also highlighted in the fight over re-importation of prescription medication from Canada.

The FDA’s supposed safety concerns seemed like a red herring. After all, the various bills in congress would sub- ject re-imported drugs to FDA oversight, and the FDA already inspected manufacturing plants throughout the world and was clamping down on counterfeiting. This was Canada, for heaven’s sake–you didn’t see Canadians dropping dead by the dozens from poisoned hyperten- sion pills (Hawthorne, 2005, p. 164).

The Gradual Erosion of the FDA’s Independence and Influence

Letters and phone calls from members of congress direct- ly to FDA officials became more common  after  2000.  The pressure that drug companies were able to exert on the congress resulted in pressure on the FDA to speed up the approval process.

Lester Crawford, the veteran FDA official and acting commissioner in the early 2000s, estimated that the agency gets 200 to 300 letters a year from members of congress (Hawthorne, 2005, p. 144).

FDA officials, too, applied pressure down the line to researchers based on requests they received from congress.

Jay Siegel was not so blasé the one time it happened to him, when he was director of CBER’s Office of Therapeutics Research and Review. In fact, he was shocked. A high-level FDA official said to him, almost offhandedly, “Things would go well on a certain legislative issue if this approval happened.” (Hawthorne, 2005, p. 156)

When the consumer group Public Citizen surveyed med- ical officers…in 1998, 34 of the 53 who responded said that the pressure to approve new drugs was “much greater,” or “somewhat greater” than it had been before the user fee law. Nineteen (reviewers) said there were more than two dozen new drugs that they had reviewed and that had been given a go-ahead that they felt should not have been allowed on the market. Nine also reported what they considered “inappropriate” phone calls about a drug under review, usually from the manufacturer (Hawthorne, 2005, p. 160).To appreciate the full significance of these calls and letters, you have to remember that Congress controls the FDA s budget…. For a reviewer to get a phone call from a mem- ber of Congress inquiring as to why a drug has not been approved yet is more or less like a mechanic in a company’s auto pool getting a query from the chairman of the board as to whether his car is ready. You bet it is (Hawthorne, 2005, p. 144).

The G.W. Bush Administration Accelerated the Role of Drug Companies in Driving Drug Policy

Heavy as the politics has been over the years…things took a leap into another dimension when George W. Bush came to Washington D.C. in 2001 (Hawthorne, 2005, p. 211).

The industry used their position of favor in the Bush administration to influence the Medicare prescription drug bill.

For years the industry used its clout to keep Congress from adding prescription drug coverage to Medicare, the health insurance plan for the elderly, because the manu- facturers feared that would mean government price con- trols, When public outrage finally forced the drug mak- ers to give in on the basic principle of Medicare coverage, in the early 2000s , they still managed to persuade the Republican-controlled congress to ban any government- negotiated price caps (Hawthorne, 2005, p. 145).

After the Republicans also took control of the White House in 2001, Big Pharma’s muscle grew stronger yet. Several ex-pharmaceutical executives and allies were appointed to key federal posts (Hawthorne, 2005, p.218).

Problems Within the FDA

The FDA Holds Back Study Results that Indicate a Drug is Dangerous

A June 3, 2009 editorial column in the New York Times, “FDA’s Secret Files,” noted that, “At the insistence of industry, and its claims of proprietary information, the FDA often sits on data that raise questions about a drug’s safety or therapeutic value. The consequences for some patients can be severe. Quoting an article of the previous day by Gardiner Harris, the editorial said, “In recent years, the FDA failed to inform the public that a widely-prescribed heartburn drug was especially toxic to babies, that a diabetes drug and a painkiller increased heart attack risks and that antidepressants increased sui- cidal thoughts and behavior in youngsters.”

The FDA Cites Federal Law that Restricts the Release of Trade Secrets

Federal law that restricts the release of trade secrets and other internal records backs up the FDA’s failure to fully report the results of research to the public.

Many people have been harmed over the decade because the FDA has treated clinical trial results of drugs and devices as trade secrets,” said Dr. Stephen Nissen, a car- diologist at the Cleveland Clinic who has campaigned for

44 • Treating Yourself, Issue 32 – 2011

the release of such information…In 2007, Dr. Nissen published a study showing that Avandia, a popular dia- betes medicine made by GlaxoSmith Kline, increased the risk of heart attack by 42 percent, The data [obtained from the FDA] Dr Nissen used was made public because of a lawsuit, but the agency had known of the possible risk for nearly two years (Harris, 2009).

If Test Results are Unflattering, Drug Companies Ignore Data Supplied to the FDA and Publish Misleading Information

“The Journal of the American Medical Association pub- lished a study of Celebrex, a painkiller made by Pfizer, suggesting that it helped guard against ulcers”  (New  York Times, 2009). However when more complete data was supplied to the FDA, which demonstrated that it did not guard against ulcers, “…sales representatives contin- ued to give the original study to doctors’ offices…The journal published an author’s clarification after learning that Pfizer had given the FDA a more complete set  of data suggesting that the drug did not protect against ulcers. Even so, Pfizer sales representatives continued to give the original study to doctor’s offices (New York Times, 2009).

The FDA Fails to Remove Fraudulent Researchers from its Ranks

In October 22, 2009, writing in the New York Times, Gardiner Harris described the failure of the FDA to remove fraudulent researchers.

Defina Hernandez helped to carry out one of the most audacious drug research frauds in American history, but because federal drug regulators sent a legal notice years late and to the wrong address, she can legally continue to conduct research. She worked for Dr Rober Fiddes, and he helped conduct more than 170 drug studies for near- ly every major drug maker in the world and routinely fal- sified data and patient records while doing so.

Ms Hernandez pled guilty to fraud and federal  law required the FDA to ban her from participating in  fur- ther drug research. The agency had five years after her conviction in which to act.

In a review of 18 proceedings, investigators for the Government Accountability Office found that the FDA took from 1 to 11 years to complete its process to ban researchers. This means many who were convicted of fraud remained eligible to conduct experiments for years (Harris, 2009).

The Deep Pockets of the Drug Industry Assures Their Power over the FDA

…the pharmaceutical industry that the FDA regulates…carries outsized clout. It has enough  lobbyists to put a shadow on each member of Congress. Its trade organization, the Pharmaceutical Research and Manufacturers of America, or PhRMA, spends some

$150 million a year in lobbying, including nearly $5 mil- lion just to lobby the FDA. In most years that total has been the biggest political wallop of any American indus- try, according to the consumer group Public Citizen (Hawthorne, 2005, p. 145).

And, for the industry, the investment is well worth it.

Drug companies, after all, claim they spend more than

$800 million, on average, to develop a drug. If the FDA gives its imprimatur, the most successful products could bring in over $500 million in sales apiece each year (Hawthorne, 2005, p. 145).

The End of the Historical Firewall that Separated Drug Companies and the FDA Until the 1970s, the FDA and the drug companies bare- ly spoke to each other. The FDA did not give any guid- ance on organizing clinical trials or compiling an appli- cation. As Bob Temple , the associate director of medical policy, wrote in a textbook he co-authored in 1995, “There was , in fact , an explicit concern that too much participation by FDA staff in the development process would leave the Agency unable to be appropriately neu- tral and analytical when the resulting data were submit- ted as part of a NDA.” By the same token, the agency did not get all those phone calls from Congress. Bill Vodra (a former FDA lawyer) said that when he was associate chief counsel in the late 1970s “a drug compa- ny wouldn’t have a congressional strategy as part of drug development.” (Hawthorne, 2005, p. 147)

In the years that followed, the concept of conflict of interest between researchers and drug companies was swept away by the lure of well-paid research positions in industry. Concerns for future employment made drug reviewers think twice before criticizing a new drug. As Fran Hawthorne tells us in her 2005 book Inside  the FDA, conflict of interest rules, “can only really kick in when the job negotiations are solid enough that the employee feels comfortable telling the FDA brass. The problem is that the potential for conflict may start years earlier while a reviewer is mulling over taking a job in industry sometime in the future. Members are afraid to be too hard on the companies where they soon hope to be sending their resumes.” (Hawthorne, 2005, pp. 150- 151).

Influences that Lead to Faster Drug Approval A 1994 study by David Dranove, Northwestern University and David Meltzer,  Brigham and Women’s Hospital, looked at 700 breakthrough drugs approved over the previous 40 years.

They determined that the FDA seemed to approve drugs with big potential sales faster than it approved those that were major scientific innovations. The pair measured approval times against sales figures and also, as a proxy for scientific importance, against the number of times a drug was cited in medical journals, medical textbooks, and subsequent patent applications. “This suggested that the companies were able to do quite a good job of influencing the approval process. We were surprised that the FDA was as responsive to the needs of the market over the needs of science.” (Hawthorne, 2005, p. 158)

A long time industry insider notes:

The most that Bill Vodra,  former  FDA lawyer,  will  admit is that “White House or congressional  pressure  makes them (the reviewers) move faster.”  The pressure  will not,  he asserted, persuade the FDA to approve a bad drug, but that begs the question of whether moving faster causes reviewers to miss danger signals in trial results (Hawthorne. 2005, p. 157).

According to Daniel P. Carpenter, a professor of govern- ment at Harvard University in regard to the speed  of FDA’s approval of a drug, “The biggest  influences  were the number of times a disease was mentioned in the Washington Post (but not on TV news broadcasts), the budget of the Center for Drugs, and the budgets of patient advocacy groups.” These factors could decrease approval time by 10 to 22 months (Hawthorne, 2005, p. 157).

I think that controlling the purse strings and otherwise allowing drug companies to breathe down the necks of reviewers give the industry too much influence in setting those deadlines.

FDA Enforcement of Standards Began to Plummet in 2001

By virtually all accounts, there were far more clashes between industry and the FDA in the early years. Starting in 2001, the number of warning letters began to plummet. Congressman Henry Waxman of California issued a report in October 2002 noting that “FDA enforcement actions for false and misleading drug advertising dropped significantly in the first two years of the (Bush) administration”—that is, 2001 and 2002. Waxman gave the new commissioner, Mark McClellan, a year to settle in, then produced a follow-up report in January2004. The findings: Even fewer warning letters were going out now. While the average number of new promotional pieces reviewed by the FDA each month increased by about six percent from 2002 to 2003, the number of enforcement letters fell 13 percent. In 1999 and 2000, the FDA had sent an average of 95 enforce- ment letters annually: by 2003, that was down to just 24 (Hawthorne, 2005, p. 267).

Dr. Angell reports, “I once heard another high official in the agency (FDA) say publicly that the job of the FDA’s Center for Evaluation and Research is to ‘facilitate’ drug development–something quite different from regulating it.” She writes, “It would seem that the industry, not the public has become the FDA’s client.” (Angell, 2005, p.  243)

FDA Lacks the Resources to Do the Job

The FDA, in spite of the huge infusion of cash from PDUFA, doesn’t have the staff to fulfill its major  func- tions and, I might add, lacks the courage to fulfill its his- torical mission.

For one thing, the FDA just doesn’t have the resources to  do the job. In 2001, the agency had only thirty people to review 34,000 advertisements. Additionally, the FDA is charged with ensuring safe manufacturing standards, but here again, it is woefully understaffed for  that  task (Angell, 2005, p. 33).

The Drug Industry Sidesteps the FDA by Going Straight to the Doctors

The pharmaceutical industry has learned to customize its method of influence to fit the particular target. In their manipulation of the FDA, they have fine-tuned their approaches to side stepping FDA regulations, often at public expense, in order to sell more drugs. For example,

…simply market the drug for unapproved “off-label” uses—despite the fact that doing so is illegal. You do that by carrying out “research” that falls way below the stan- dard required for FDA approval, then “educating”  doc-  tors about any favorable results. That way, you could cir- cumvent the law. You could say you were not marketing  for unapproved uses: you were merely disseminating the results of research to doctors who can legally prescribe a drug for any use (Angell, 2005, p. 157).

And, “… in the summer of 2004, the FDA’s chief coun- sel, Dan Troy, came under fire for inviting drug compa- nies to inform him of lawsuits against them so the FDA could help in their defense” (Law, 2006, p. 16)

The Problem: Doctors

The AMA and their Membership

Time Magazine, July 25, 1969, reported an outbreak of resistance to the American Medical Association by the student AMA during the AMA’s annual meeting.

“…just after the predominantly white, middle-aged doc- tors had joined in a 30 minute tribute to the flag, a stri- dent group of young medical students, doctors, and nurs- es burst into the hall, chanting “Hip, hip Hippocrates, up with service down with fees!”

Still remembered are the association’s relentless fights of yesteryear against Medicare and Medicaid. Opponents also recall its past opposition to group practice and its efforts to limit medical school enrollment. The AMA has made itself a visible villain, and is blamed, somewhat unfairly, for the soaring cost of medical care which is ris- ing at a rate more than double that of the cost of living. In 1968, “AMPAC (American Medical Political Action Committee) doled out an estimated $2.6 million in polit- ical contributions to candidates who mirrored its conser- vative views.”

Within the emergency medicine field there exists a ten- sion that is pitting doctor against doctor. With a shortage of thousands of emergency physicians for the some 8,000 hospitals in this country, two of the three boards, the American Board of Emergency Medicine, and the American Organization of Osteopathic Emergency Medicine, are fighting for sole recognition at the exclu- sion of the third, the American Board of Physician Specialties. Of course, just as the AMA tried to do with limiting the number of medical students, the attempt is to keep the supply low, the salaries high, and the political power firmly in their hands.

AMA lobbyists often team with other pressure groups, especially the Pharmaceutical Manufactures’ Association, whose member drug firms help support AMPAC and spend huge sums on advertising in the med- ical journals. By law, the AMA ‘s political funding com- mittee must be separated from its lobbying operation; in practice, however, the division is strictly a bookkeeping procedure (Time Magazine, 1969)

This MD’s Experience of Drug Company Recruitment for Drug Trials

My experience with Contract Research Organizations, (CROs), as mentioned above, are along these exact same lines.

To get human subjects, drug companies or contract research organizations routinely offer doctors large bounties (averaging about $7000 per patient  in  2001)  and sometimes bonuses for paid enrollment. For  exam-  ple, according to a 2000 Department of Health  and  human services Inspector General’s Report, physicians in one trial were paid $12,000 for  each  patient  enrolled,  plus another $30,000 on the enrollment of the sixth  patient. One risk of this bounty  and bonus  system  in that it can induce doctors to enroll patients  who are not real-  ly eligible, for instance, if it means an extra $ 30,000  to  you to enroll a patient in an asthma study,  you  might  very well be tempted decide your next patient has  asth- ma, whether he does or not (Angell, 2005, p. 30).

Other Influences that Mislead  Doctors Medical Journals devote most of their pages not to scien- tific studies but to pharmaceutical ads. Also, the Physician’s Desk Reference which is the physician’s drug handbook has omitted some of the most important and time-tested medications so they can emphasize more expensive, newer drugs. To me it has become useless.

…whether the public benefits from taking more and more medicines for increasingly badly defined  diseases  is open to serious question. One could make a strong argument that Americans with minor ailments suffer more from overmedication and all the side effects and drug interac- tions that go with it, than from undermedication (Angell, 2005, p. 128).

It has been reported that Americans consume ( and Doctor’s prescribe) 95% of the world’s Vicodin, and 60% of the world’s opiates. How sweet it is, or, as Bob Dylan would say “Everybody must get stoned.”

I have found that a significant number of speakers in the subscription medical seminar tapes I listen to are paid mouthpieces for the drug companies. “Come on in, the water’s…..” or “ Mi Casa es Su Casa”:

Drug companies pay doctors several hundred dollars a day to allow sales reps to shadow them as they see patients, a practice called a “proprietorship”. One Schering-Plough rep explains “it’s another way to build a relationship with the doctor and hopefully build busi- ness.” (Angell, 2005, p. 127).

Drug reps are allowed to attend medical conferences, may be invited into operating rooms, and sometimes are even present when physicians examine patients in clinics or at the bedside (Angell, 2005, p. 128).

As an anesthesia resident I witnessed such practices often while at UMDNJ. I often wondered why they were there, these non-medical personnel, viewing sometimes full unclothed individuals. I don’t recall a single time that a rep or doctor talked about the procedure or the manufac- turer’s item being used. It was mostly idle chat about golf or some recreational subject. In later years I spoke with an orthopedic rep who was a brother of a close friend who confirmed that it was the practice of “endearment”. Over prescribing antibiotics and narcotics, doctors are often the willing accomplices of the drug companies because doctors feel and are trained that they must “do something” and “meet the expectations of the patient.”

The outcome is that doctors have been taught too well to reach for a prescription pad instead of talking to patients (Angell, 2005, p. 169).

In 2003, the Office of the Inspector General of the US Department of Health and Human Services warned that excessive gift giving to doctors could be prosecuted under anti-kickback laws. These guidelines and the inspector general’s warning may have discouraged the most extreme

practices, but the guidelines are voluntary and even the warning is filled with loopholes (Angell, 2005, p. 129).

This “food,  flattery,  and  friendship,”  as  it  has  been called, creates a sense of reciprocity in  young  doctors  with long prescribing lives  ahead  of them  (Angell,  2005, p. 127).

In my years of residency training I witnessed this finely tuned courting ritual. Drug reps come to residency pro- grams, hospitals, and doctor’s offices loaded with “free- bies”. In an atmosphere of good food, drinks, and small gifts, young residents who are eager to learn, and attend- ing physicians, can be seduced and highly influenced by these softly authoritative figures who are often attractive and often female.

This may be why the Student AMA has chosen to speak out against Universities in general taking drug company- sponsored monies.

The Medical Seminar Business

Most states mandate that doctors have a certain number of continuing medical education credits yearly. This is fortunate for the drug companies.

It has been estimated that the industry hosted over 300,000 pseudo-educational events in 2000, about a quarter of which offered continuing medical educations credits (Angell, 2005, p. 142).

One such course offered by the American Heart Association (AHA), regarding Advanced Cardiac Life Support, brought multi-millions of dollars to that organ- ization. In addition, the drug companies profit greatly from drugs set up as the ACLS standard  of  care. However research has consistently throughout the years shown that these very expensive drugs and procedures touted by the AHA are ineffective  compared  to  a “cheap” electric shock treatment during cardiac arrest.

The Fate of Professionals Who Do Play the Game

A cardiovascular journalist recalls one  eminent  doctor who was not on stage to announce the results of an important clinical trial he had led. When she asked him later why he had not announced the results, himself,  he said he hadn’t been prepared to give them the company spin (Law, 2006, p. 36).

Larger Sales Forces and Increased Visits to Doctors Boost Profits

James Brewer, head of sales force strategy at Lilly, said in 2003 that there were  88,000  reps  in  the US calling on some 950, 000 doctors.  This compares with 55,000  in  1995,  a  time  when there were also more drugs for  them  to  sell. “…The average sales call is only two min-

utes, so the complexity of our business revolves around deriving the most value from these two  minutes.” (Law, 2006, p. 54).

Prescription-tracking companies buy information from big phar- macy chains about doctors’ prescribing habits and sell it

to drug companies. Using these physician  profiles, drug reps know  exactly what a doctor prescribes before  each visit,  so   he can tailor their sales pitch and undermine drugs used by the physician and make every minute count (Angell, 2005, p. 130).

A group researching the prescribing behavior of doctors who receive sales visits showed a strong relationship between number of visits and doctors prescribing

rep may also have promoted two or three other drugs in that same visit, and for these three drugs in the study, each visit increased their market share with the doctor by 6-7%.” (Law, 2006, p. 55).

As I have mentioned before, doctors are not researchers, nor are they very well trained to evaluate scientific stud- ies. By and large, they, like I, rely to a great degree on sales reps and the self-serving documents they provide. Doctors tend to be overstretched and too busy to critical- ly read studies or even focus on the bottom line in the practices. Few are even good business people. Their ineptness in certain areas is clear. Sixty percent of all doc- tors retire poor, a fact that most would find incredible (Medical Economics , circa  1990),  and the  main reason is staffing, coupled with poor management practices by the doctor.

Doctors, because of their heavy demands on their time and their desire to keep patients happy, contribute to pre- scription drug abuse. To cite an example, one of many I’ve experienced, I worked at a hospital where there was a “Candy Man,” that is, a doctor who liberally overpre- scribed narcotics and antibiotics. The nurses told me they always knew when this individual had gone to a lecture or heard a medical tape touting a new drug because he would change his practice, sometimes daily, based

on that information and he could be counted on to mouth the study to them.

Doctors Overprescribe Instead of Talking to Their Patients

I have a motto which I say to myself at least once a day: “Sitting down with a patient will save my ass.” I have found repeatedly that a patient’s first desire is to be heard, not necessarily to get a new kind of pill or have a proce- dure performed on them. Many needless prescriptions can be avoided by following this practice.

In my own practice, fortuitously, I have avoided legal pitfalls and I have had few complaints from my patients. I say unabashedly that this is not the result of great intellect. In part  it  does  have  everything to

do with sitting down, with a smile, in front of my patient. The practice of  sitting  down  with  a patient,  even  when I’m not yet fully focused, forces me to actively listen or at least appear to, every single time, even in a busy emergency department. I learned this inadvertently from working very long hours in an emergency department and just wanting to sit down to rest for a minute. Nurses in my early years of practice would come to me and say, “That patient really liked you because you sat down and listened to him.” Studies have shown that doctors who sit down with their patients are perceived to have spent more time with them than a doc- tor who stands for the same amount of time. Another effect that has been demonstrated again and again, no matter how bad the physician, is that nice doctors don’t get sued. But do many doctors follow that rule?  No.  It can be more common to hear a doctor say, “I’m here to save asses, not kiss them.”

As an example of the power of effective communication, for the first years of my practice one of my biggest chal- lenges was drugs seekers– a very very clever bunch. Learning in medical school that the placebo effect was well documented, I would routinely instruct the nurses to give suspected drug seekers saltwater injections before which I would inform them that I was ordering a power- ful endorphin stimulator, similar to morphine. I never gave it much thought until one very early morning when  I had gone back to my call room, half asleep, I heard one of these patients stumbling down the hallway and as she passed my door she said, “I don’t know what that doc-  tor gave me, but it was strong!”

Cash Payments for Accepting a Drug Rep’s Visit

Dr Neal Moser, a pulmonary and critical care physician with a 13 doctor group practice in Edgewood, Kentucky has made it known he sees nothing wrong in accepting

$50 for listening to a short sales pitch from a drug rep in his office, This is the deal offered  by  Time-Concepts LLC, one of several companies that have moved in to ease the strain on that two minute window (Law, 2006, p. 56).

According to Big Pharma author Jacky Law,  “The American Medical Association, like its British counter- part, the BMA, prevents doctors from accepting cash payments on the grounds that it is likely to destroy their best medical judgment. Gifts are fine, if they cost under

$100 and help in some professional capacity.” (Law, 2006, p. 56).

I would note that the AMA has no meaningful enforce- ment power over doctors in or out of their organization short of denying AMA membership to an individual.

Efforts to “educate” the physician, however, would be hard for a doctor to avoid, because, as Moynihan, Heath and Henry say, quoted from their book Selling Sickness, “Drug companies have sponsored meetings where the dis- ease was being defined, funded studies of therapies, and developed extensive financial ties with leading researchers. They have funded patient groups, disease foundations, and advertising campaigns (on both drugs and diseases) targeted at doctors.” (Law, 2006,  p. 59) Law notes that in this context of biased education, sales visits, and profit over all, “Old, natural  and  obvious things, such as safe drugs that have been sold for years, broccoli, walking sticks, or vitamins, for  example,  don’t  get patented and there is therefore little incentive to deep- en our understanding of their benefits, except in the dwin- dling public health sector. (Law, 2006, p. 74).

New Burdens on Emergency Physicians

Some hospitals, as members of The Joint Commission (TJC), formerly the Joint  Commission  on  Accreditation  of Healthcare Organizations, are now requiring emer- gency physicians, who spend an average of five to seven minutes with a patient in the emergency room, to vouch for the safety and effectiveness of all the patients’ medica- tions. This is unreasonable and no easy task since many elderly patients are sometimes on 15 to 25 different med- ications.

I am amazed at the number of patients who come to the ER expecting an antibiotic for viral infection and who, after I have sat down with them for mere minutes and explained the risk and the inappropriateness of antibiotics in their case, accept and are in agreement with my expla- nation. In my 25 years of practice I would be hard pressed to think of even two patients who demanded antibiotics.

And it does not stop at antibiotics. When I was an anes- thesia resident, our star resident and I were told that our next patient was a frightened, screaming young child. The resident, without seeing the patient, went to get Versed, a powerful sedative. I stepped into the patient’s room and almost immediately exclaimed how pretty her braids were for about two minutes. She immediately calmed down. The senior resident returned with the Versed to find a smiling child. I became well-known for this ability and, I might add, only for this ability, which was not heroic at all. After 15 years of screaming kids in the ER,    I had learned that talking to the patient first pays  off. And, after 25 years of practice when I have not seen the inside of a court room, I am convinced that it is para- mount.

How the Drug Industry Has Corrupted Medical Education

Jeffrey Kluger, in a March 6, 2009 Time Magazine arti- cle, “Is Drug-Company Money Tainting Medical Education?” gives an account of the pressures on educa- tional institutions and on doctors.

The American Medical Student Association (AMSA) decided to grade 150 med schools on just how much money and gifts they are collecting from drug compa- nies—the more goodies a school is vacuuming up from the industry, the worse its grade. Harvard received an “F.”

And while Harvard might be the highest-profile name that was posted on AMSA’s grade list, it was hardly the only one that flunked. 40 out of the 150 schools surveyed received F’s; only 22 got an A or B.

When doctors are being lavished with meals and speak-  ing fees by the likes of Pfizer and Merck, can you trust them when they later write prescriptions for those com- panies’ drugs? Medical schools were  long  considered above such vulgar stuff.

The facts, argued AMSA, justify their outrage. Of Harvard’s 8,900 professors and lecturers, 1,600 admit that either they or a family member have had some kind of business link to drug companies—sometimes worth hundreds of thousands of dollars—that could bias their teaching or research. Additionally, pharma contributed more than $11.5 million to the school last year for research and continuing-education classes.

As we move into the post-Bush era, Kluger sees some signs that the federal government is beginning to restrict the industry’s influence on doctors. “Recently, the Pharmaceutical Research and Manufacturer Association prohibited salespeople from treating doctors to meals and golf excursions and even banned the ubiquitous company-branded pens, mugs and notepads that clutter waiting rooms and reception desks…(and recently) fed- eral officials revealed a newly aggressive plan to begin pursuing civil and criminal charges against doctors who accept kickbacks or demand speaking or consulting fees for prescribing drugs or medical devices.” However, as recently as July 2011, this practice remains.

Even Idealistic Doctors Succumb to Pharma’s Strategies

“Pushing Drugs,” a July 30,  2005  Science  News  article by Ben Harder, reviews the pressure medical marketing places on doctors and how effective it is. In regard to giv- ing free drug samples, Harder says,

listen to Dr. John D. Abramson of Hamilton, MA–“I thought I was being Robin Hood,” Abramson says. Before long, however, he grew so familiar with adminis- tering the free drug samples that he found himself writ- ing prescriptions for insured patients whose coverage would pay for the medications. For pharmaceutical com- panies, Abramson’s behavior meant new customers. That’s what they wanted,” he says, “They were playing me like a violin.”

Harder notes inventive strategies used by the drug com- panies.

At least two pharmaceutical marketing strategies con- verge to alter doctor’s prescribing habits. On one hand, detailer representatives target physicians with visits and samples, and ads tout drugs in journals. On the  other,  mass media advertisements urge people to ask their doc- tors about specific brand-name medications.  This  direct- to -consumer (DTC) advertising, which  is  not  permitted in Europe and strictly limited in Canada, has in the past decade grown into a multi-billion dollar industry in the United States.

Consider these results reported by Harder from a fact finding study by Richard L. Kravitz of the University of California, Davis campus on the consequences of drug promotions. “He found while using physician actors in doctor’s offices in San Francisco, Sacramento, Calif, or Rochester, that…When standardized patients faking major depression didn’t specifically request an antide- pressant, 31 percent received a drug prescription. However, when others claimed that a television show about depression had encouraged them to seek drug treatment, 76 percent received a prescription of some kind…Also, when members of a third group reporting identical symptoms asked specifically for Paxil, saying that they had seen it advertised on television, more that half resulting prescriptions were for that drug.”

In standardized patients who reported symptoms of adjustment disorder (temporary condition typically treat- ed without medication) and didn’t raise the subject of antidepressant drugs, just 1 in 10 got medication. But nearly half of the actors who asked for medication got it. Most who asked for Paxil walked out with a prescription for the drug while most who made a nonspecific request were prescribed some other anitdepressant.

Some doctors say that DTC marketing may have done some good by informing patients about the diseases, the drugs, and increasing the conversation. Others say ads encourage patients to seek unnecessary treatment and don’t fully convey the therapies’ risks (Harder, 2005).

Fran Hawthorne, in Inside the FDA, quotes doctors’ beliefs about drug advertising. “In light of the commer- cials’ powers of persuasion, it is simply wrong as a poli- cy, critics say, to peddle prescription drugs so cavalierly. “Medicines aren’t like shampoo or perfume. They’re things people need to maintain health, not discretionary products a person can use or throw away on a whim,” wrote Dr. Erin N. Marcus, an internist and professor  at the University of Miami School of Medicine, in an op-ed article in the New York Times in January 2003 (Hawthorne, 2005, p. 264). A New York Times opinion piece, “Countering the Drug Salesmen,” March 20, 2008 talks about a possible cor- rective policy under consideration by congress in which government-funded healthcare professionals would call on physicians to provide a counterweight to the drug companies and other one-sided influences that doctors are exposed to. How well might it work? Harvard University prepared educational materials and sent their trained medical professionals–pharmacists and nurses– to doctors’ offices and reported a saving of more than $500,000 on gastrointestinal drugs alone.

Doctors Do Bear Some of the Responsibility When it comes to conventional U.S.  medicine,  doctors are not great at health-care, but they are great at sick- care. Patients, too, bear part of the responsibility for this problem. When I take the time to counsel my patients about eating a healthy diet and exercising, their eyes  glaze over. And, judging by their girth and by the por- tions and types of foods physicians are plating, they by and large are little more qualified to address this issue than their patients.

There is also a problem of doctors believing in their own infallibility. When Dr. Atul Gawande,  a  Harvard  sur- geon, developed a brief pre-surgical checklist that was demonstrated to eliminate many surgical errors, his col- leagues were not anxious to adopt it. Gawande testified that his technique got “massively better results.” Nevertheless, the checklist has not been widely accepted and Gawande believes that is because doctors don’t want to admit that they make simple errors. Curiously, a majority of those same physicians would want the check done by their surgeon (National Public Radio  News, 2010, Jan 5).

This lack of admission of infallibility manifests itself in poor communication between doctors, which adds to health-care cost in the way of poor patient care, duplica- tion of services, and a greater risk of injury to patients from repeated tests.

Personally, I was surprised by the one doctor who thanked me for calling him regarding a patient’s medica- tion and other issues. You might think that doctors want to do the right thing and communicate, in spite of the time pressure and owning up to fallibility it implies. In my experience, the number of physicians who have called to talk about a patient at the clinic or the emergency department is negligible. Does sheer arrogance play a part? Most of Dr. Gawande’s checklist revolves around good communications, so it seems we are willing to accept a higher morbidity and mortality rate because of our unwillingness to communicate.

The Acceptance of Advanced Cardiac Life Support With No Evidence of Effectiveness Advanced Cardiac Life Support (ACLS), that is, the array of drugs, machines, and techniques commonly used in emergency rooms in the case of heart attack, is the treat- ment approach sponsored by the American Heart Association (AHA). There are many health care profes- sionals who are convinced that ACLS has become a cottage industry for the AHA and the pharmaceutical indus- try that offers little more than show and lacks any evi- dence of effectiveness. In reality, the only proven modal- ity is defibrillation which is most effective within the first few minutes, usually outside the hospital, and can be per- formed by the lay public with little training.

The Problem: Doctors

As a member of this honorable profession which also has its full complement of flawed people who harbor a whole rainbow of big- otries, I still feel that it includes the most dedicated, the most diligent, the most ethi- cal people I have been associated with. I believe the public, rightly so, has placed physicians at the top of the list of most trusted professions. Over the years, howev- er, this hard-earned medallion has been tar- nished. The reasons are many, as I will explain, but the answer always comes down to “the bottom line.”

Doctors Bear Responsibility

When it comes to conventional U.S. medicine,  doctors are not great at health-care, but they are great at sick- care. Patients, too, bear part of the responsibility for this problem. In light of the fact that study after study shows the diet and exercise is most important factor for good health, when I take the time to counsel my patients about eating a healthy diet and exercising, their eyes glaze over.  And, judging by their lack of nutritional knowledge, abdominal girth, portions and  types  of foods physicians are plating, they by and large have lit- tle more credibility to address this issue than their patients.

There is also a problem of doctors believing in their own infallibility. When Dr. Atul Gawande, a  Harvard  sur- geon, developed a brief pre-surgical checklist that was demonstrated to eliminate many surgical errors, his col- leagues were not anxious to adopt it. Gawande testified that his technique got “massively better results.” Nevertheless, the checklist has not been widely accepted and Gawande believes that is because doctors don’t  want to admit that they make simple errors. Curiously,    a majority of those same physicians would want the check done by their surgeon (National Public Radio News, 2010, Jan 5).

This lack of admission of infallibility manifests itself in poor communication between doctors, which adds to health-care cost in the way of poor patient care, dupli- cation of services, and a greater risk of injury to patients from repeated tests.

Personally, I was surprised by the one doctor who thanked me for calling him regarding a patient’s medication and other issues. You might think that doctors want to do the right thing and communicate, in spite of the time pressure and owning up to fallibility it implies. In my experience, the number of physicians who have called to talk about a patient at the clinic or the emergency department is negligible. Does sheer arrogance play a part? Most of Dr. Gawande’s checklist revolves around good communications, so it seems we are willing to accept a higher morbidity and mortality rate because of our unwillingness to communicate.

Doctors’ Role in the Over Prescription Problem

As touched on elsewhere, doctors are contributing to the epidemic prescription problem, whether it is the appar- ently cavalier practice of the physicians for Elvis, Rush Limbaugh, and Michael Jackson, the  “Docs  in  the  Box” in the office on the corner, or the local emergency depart- ment with its Candy Man.

The US consumer receives 95% of the world supply of Vicodin, and 60% of the world nar- cotic, according to one research. A study funded by the CDC and the National Center for Injury Prevention and Control showed in 1999 to 2005 the annual incident of unintentional drug overdoses increased from 11,155 to 22, 448. It now rank only sec- ond to motor vehicle accidents as a leading cause of death. This represent an increase of more than 100%. This increase was found to be due to physician backed prescriptions, and not attributed to illicit drugs such as heroin and cocaine. So the question begs: Why are physi- cians writing prescription for these powerful drugs when studies have shown them to not be as efficacious as non narcotics for some of the most common conditions? It pays! Doctors want to keep patients happy and maintain their revenue stream. They want to meet or exceed patient expectations, or frankly “get rid of” demanding, and or sometime drug seeking patients. Backed by dubi- ous beneficial marketing studies generated by the Big Pharma marketing apparatus they feel compeled to offer these most powerful analgesics. Also, for emergency physicians, there is the phenomenon of the Press Ganey Scores. This is an analysis of patient satisfaction that administrators are watching closely in emergency depart- ments across the country. Although I am a big  fan  of it, as well as a student of judicious marketing, it is held over the heads of physicians to the exclusion of good medical care.

In remote rural areas, Critical Care Access hospitals are particularly affected by prescription abuse. There are many reasons ie. shifting demographic, depressed local economies. These hospitals are often strapped for cash. Of late, many have closed there doors. Federal reim- bursement to there facilities are dependent on “the num-

bers” for the indigent, and self-pay patients who often can’t or don’t pay. Administrators are keenly concerned with keeping the numbers up. In light of the extreme over prescription by some doctors, I have been asked to write prescription narcotic pain policies for emergency depart- ments. To my amazement, they have largely been ignored. Why? It doesn’ t pay. Drug seekers frequent emergency departments multiple times per week and sometimes several times a day and this practice is one of mutual financial benefit.

Not only narcotics but antibiotics and other prescription medications are often over prescribed. A doctor I know was denied employment for stating and practicing non- antibiotic prescription treatments for cold-like symp- toms. He was asked not to write in the chart “homemade chicken soup” and other more natural, scientifically sup- ported treatments.

The Ethics of Profiting from Medicine Everywhere in the world of what was once pure scientific research, we see a rush for the gold and the influence of the business interests.

In the past, medical investigators felt it was unseemly to profit from people’s ills. When Jonas  Salk,  for  example,  who was funded by grants from the March  of Dimes, developed the polio vaccine, legendary newscaster Edward

R. Murrow asked him why he never patented his inven- tion. “How can you patent the sun?” Salk replied.  For Salk and his contemporaries, commercialism cast a shad- ow, tainting the integrity of pure research (Marsa, 1997, p. 50).

These days scientists are quicker to protect their own turf and less able to collaborate. In Linda Marsa’s 1997 Prescription for Profits, she describes a famous conference.

The collegial relationship famously broke down at the 1975 Asylomar Conference when 150 prominent scientif- ic leaders converged on Monterey California where Recombinant DNA safety guidelines were to be devel- oped. It quickly degenerated into esoteric schoolyard squabbling among a bunch of men who were accustomed to being the smartest kids in the class (Marsa, 1997, p. 65).

As Linda Marsa notes, “Secrecy replaced the openness that was once the hallmark of good science.” Molecular biolo- gist Russell Doolittle of University of California San Diego and the Salk Institute commented on the effects on the sci- entific community.

In a letter to the University of California’s Patents Board, Doolittle wrote, “There used to be a good healthy exchange of ideas and information among researchers at UCSD, the Salk Institute, and Scripps. Now they are locking our doors. The threat to scholarship is serious, indeed.” (Marsa, 1997, p. 137).

The Problem: Supreme Court Overturns the Citizens United Case and Unleashes a River of Money

A Supreme Court decision in January 2010 overturned a 20-year precedent that prevents corporations from buy- ing campaign ads from their general treasuries. This deci- sion also struck down a law saying corporations could- n’t buy “issue ads” which can be thinly veiled opposition ads for specific candidates–flooding the airways in the closing days of campaigns.

The result? Corporations can unleash multi-million-dol- lar ad barrages against candidates who try to curb spe- cial interest power, or they can devote millions to prop- ping up elected officials who back their schemes. With no limits on their spending, big oil, Wall Street banks, and health insurance companies will try to drown out the voices of everyday Americans.

The Problem: Patients and Societal Problems Increase the Costs of Healthcare

Emergency departments, which represent 50% of admis- sion into hospitals, are now the scene of societal woes. A significant reason for the skyrocketing cost of healthcare lies with patients who use healthcare to treat social issues. Patients range from pregnant teens (or teens who just want to know if they are pregnant) faking abdomi- nal pain and seeking medical care to obtain a picture of the unborn child, to drug seekers and frequent flyers.

Chronic and unnecessary visits are responsible for 80% of cost. For example, in the popular case of young girls feigning abdominal pain, this results in ER visits that often cost thousands of dollars. I personally am respon- sible for millions of dollars of unnecessary tests for fear of medical liability and I have been accused of being the “conservative doctor”.

In a hospital in California, I knew of one frequent flyer who was estimated to have cost the state $200,000.  Make no mistake about it, we have a public option and   it is called the Emergency Room.

Losing faith in Western Medicine or Just Supplementing It?

American consumers seem to be discovering new ways to maintain their health as John Greenwald et. al. explained in a 1998 Time article, “Herbal Healing.”

Consumers spent more than $12 million on natural sup- plements last year (1997), nearly double the amount spent in 1994, and sales continued to grow at better than 10 % a year.

Among the eye-opening findings: Americans today make more visits to nontraditional physicians, including natu- ralists who claim expertise in herbs and other natural therapies, than to their family doctors. And they spend almost as much out of pocket (not reimbursed by health insurance) on alternative medicine ($27 billion) as on all un-reimbursed physician services ($29 billion).

The frantic expansion of the market for herbs and other supplements, though, comes at some risk to consumers. These products are not regulated in the U.S nearly as strictly as over-the-counter drugs or even foods–in sharp contrast to countries like Germany, where the govern- ment holds companies to strict standards for ingredients and manufacturing.

Perhaps a third of Americans have tried an herbal reme- dy, and that number is expected  to  grow  sharply  now that giant pharmaceutical companies with huge ad budg- ets and vast distribution channels are charging into the field (Greenwald et. al., 1998).

One major factor that will hasten the exodus to holistic medicine can be found in the remarks of an industry insider. A former Vice President of GlaxoSmithKline, an eminent academic geneticist from Duke University, announced that most of the company’s products were ineffective in most patients. He was acknowledging that most drugs, because of genetic differences or other rea- sons, are only effective for 30% or 50% of the people who take them (The Independent, 12/8/2003). News like this is not good for the pharmaceutical industry which has staked its future on marketing specific drugs for more and more uses to ever wider groups of people.

Did Someone say “Herb”? or,

“Put that in your pipe and smoke it.”

Cannabis needs to be researched with a healthy sense of skepticism. My own research has come up with startling preliminary results. If history is correct, and the results I am seeing from current international and national research, government and non-government, are correct, it is the one of the most useful medications known. Research confirms that cannabis shows promise in treat- ing severe pain, muscle spasms, glaucoma, asthma, refractory nausea and vomiting, seizures, Alzheimer’s, and a host of other disorders (Grotenhermen, et. al., 2002).

It is interesting to note that the same U.S. government which claims that cannabis is a dangerous drug, has no medicinal value, and prohibits its use, has registered a patent on a cannabinoid, the active medicinal chemical of marijuana, for its ability to protect the brain after a stroke (April 1999, #6630507: , United States of America/Department of Health and Human Services).

No other substance even comes close to its effectiveness. It poses virtually no serious health risk, especially when filtered inhalation and topical and oral ingestion are con- sidered.

  • Then why is it classified with dangerous drugs like heroin, when cigarettes and alcohol combined are responsible for well over 60% of hospital admissions and have little or no medicinal value?
  • Why is it illegal for researchers to even study it in the laboratory?

I have practiced emergency medicine all over the world, from Native American villages to the inner city of

Newark, New Jersey to war torn Bosnia and Albania. I have treated many overdoses of heroin and other pre- scription drugs. Never once in my career have I ever had to treat a marijuana overdose. Textbooks barely describe marijuana overdoses. When they do, they say that it is harmless. The medically judicious use of cannabis must be further studied (Tintinalli et. al., 2004).

The primary reason for the public outcry against medical marijuana and its demise was a massive propaganda campaign against it. Note that it used to be stocked in pharmacies and was used in mainstream medicine both in the U.S. and Europe.

Then, pharmaceutical companies, in league with the gov- ernment, and at the encouragement of the Hearst Corporation, convinced the public that marijuana was a threat to society. They had their reasons. The pharma- ceutical companies understood that it was an effective treatment for many different ailments and it was cutting into their profits. The Hearst Corporation wanted to suppress competition from hemp pulp manufacturers to protect their stake in the paper industry (Herer, 2000).

From the point of view of the drug industry, because the cannabis plant could not be patented, it posed a real threat to their product lines. The anti-cannabis propa- ganda included films such as Reefer Madness which depicted drug-crazed, sex hungry wild teens. The films tried to link marijuana in the public mind with the threat- ening image of a promiscuous white woman and a black jazz musician.

Yale University drug historian, Dr. David Musto,  explains in his 2000 video series Hooked:  Illegal  Drugs and How They Got That Way, that marijuana scare tac- tics were similar to the way cocaine was outlawed, by promoting the fear that cocaine would induce black peo- ple to attack whites. Musto asserts that all of the drug laws were developed because of racism against people of color.

The Epilogue

Because of all that I have learned, I would like to think that hope is still not lost, even in the face of what appear to be insurmountable odds in favor of the business of medicine. Consider that the business interests would love nothing more than for their subjects to roll over in the mire of hopeless. This we cannot do!

If Medicine Continues on its Present Course, What will Result?

  • Increasing healthcare costs.
  • A greater number of drugs inadequately studied  and approved for sale, bolstered up by unsupported, supposedly peer reviewed and persuasive articles that will govern the way patients are treated.
  • Biased scientific research resulting in an increase in patient illness and death.
  • A dwindling middle  class  and  further  polarization of the US population where the best medicine goes to the wealthy. This will result in 3rd world medicine for most of us and first class medicine for the small group that can afford it. This may be why a recent Time Magazine  headline  reads,  “Your  next  doctor  may  be a nurse.”

What the Medical Establishment Won’t Tell You

  • Many of the drugs that we prescribe for hypertension, heart disease, high cholesterol, etc. have little effect on overall morbidity and mortality.

They are expensive and many doctors don’t have a clue what they cost.

  • There is a worldwide infectious disease crisis which the medical establishment created and for which we have no cure.
  • Shockingly, few new antibiotics are in development.
  • Most heart attacks are not caused by blood clots, but are probably spasmodic, so the clot buster at

$4,000 a dose that Genentech recommends may not help the majority of victims.

  • Advanced Cardiac Life Support (ACLS) and CPR

have little to no benefit over an electrical shock. ACLS and CPR have a dismal record of patients leaving the hospital alive.

  • Aspirin and, potentially, cannabis are the true wonder drugs of human kind.
  • Cannabis may be rediscovered as a true and, possibly, one of the only wonder drugs known to man, which has minimal side effects and no directly reported deaths.

The Solutions I Propose to You

  • National Health Care with a Public Option. Remember, as I have said, we already have a much more costly public option. It’s called the Emergency Room.
  • The American public must become more politically active and hold elected officials accountable. Find out who is funded by what special interest and vote them out if their voting record reflects a loyalty to someone other than us. Remember that we get the government we deserve.
  • Work with those few politicians, both democrats and republicans, who need us to, as Lyndon Johnson said, “Make me do it” This is done to create a groundswell of support for the progressive minded politicians who will serve the American people’s true interest. A New York Times opinion piece written June 3, 2009 asserts that, “If some laws and regulations need to be rewritten, that is a small price to pay for greater transparency.”
  • Demand more from your physicians by being a partner in your own healthcare. Don’t demand healthcare without basis. Follow the recommendations of nurses and access nurse practictioners and physician’s assistants who are less likely to be bought.
  • MDs should resist the influence of pharmaceutical companies and critically question research. Seek out the financial source of the research you read.

Dr Angell recommends that, as a patient, when your doctor prescribes a new drug, ask these questions,

  • What is the evidence that this drug is better than an alternative drug or some other approach to treatment?
  • Has evidence been published in a peer-reviewed medical journal or are you relying on information from drug company representatives?

She also advises, “Ask your senators and representatives if they receive campaign contributions from pharma, and how much.” And, “Pay no attention to direct to con- sumer ads for prescription drugs (Angell, 2005, p. 61).

These are hard questions for some, though for me, as a doctor, it would inspire me to know more about the drugs than I feel doctors typically know. And remember,

nurses can be some of your best healthcare friends.

To paraphrase a reader who responded to Dr. Angell’s article “Is Academic Medicine for Sale?” An alert reader wrote, NO! The current owners are very happy with it (Angell, 2005, p. 61).

References

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