Big Pharma: Rx for Disaster

[This article was originally written in August 2006. At nearly 4,000 words, this is one of my longer articles. Apologies to those who don’t have the time….]


Supporting a worldwide pharmaceutical drug market valued at between $400 billion and $500 billion each year, North Americans are among the most medicated humans on the planet. On the surface—and employing the traditional definition of “medicine”—this can be interpreted as a good thing. More help for more people with physical, mental, and emotional ailments is a sign of a progressive and compassionate society.

Nice vision, eh? Too bad it’s so far from the reality of modern western medicine. Patients, both the truly sick and those simply led to believe they’re ill, are being misled and mistreated by pharmaceutical corporations and doctors in a deregulated wild west of medicine that’s becoming increasingly corrupt and intimidating.

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Lest we deceive ourselves, let’s not limit to adults our consideration of the dark side of this chemical gold rush, fueled by corporate greed and a gross lack of government oversight. Children are being targeted by drug companies in a manner like never before. While Ritalin is the drug most associated with childhood Attention Deficit Disorder (ADD), many adult medications are being prescribed to young people, but typically with little or no testing.

There’s also the topics of suicide and addiction. Anti-depressant drugs such as Prozac and Paxil have been linked to aggressive behavior and suicide in both adults and children by studies released on both sides of the Atlantic. Adding insult to injury, medical journals—traditionally a bastion of reputability and solid science—haven’t been immune to corruption on the part of big pharma. Within the past few years, reports have surfaced showing that a significant percentage of medical journal articles has been authored by ghostwriters hired by drug companies.

A Pharmaceutical Primer

Before delving into the often-harmful effects of pharmaceutical drugs themselves, it’s helpful to briefly examine the companies producing and marketing them. First, most drug companies are very profitable. From 1980 to 2000, industry profits tripled. The pharmaceutical business is consistently ranked as the most profitable industry of the 47 listed in the Fortune 500 (only in 2003 did it slip, and only to third place).

Much of the colossal growth of “big pharma” has resulted from the deregulation of the industry by the Reagan administration. Beginning in 1980 with Reagan’s election, a series of laws were passed that favored the growth of the pharmaceutical market and allowed drug companies to partner like never before with academia and other public institutions (such as the National Institutes of Health, or NIH).

In this manner, drug companies have been able to push much of the expense of research and development off on “partners” and other third parties. These alliances also help drug companies contain bad publicity because so many organizations have a financial stake in the health of their pharmaceutical sugar daddy. For example, the Massachusetts Institute of Technology lost a $1 million annual revenue stream when dexfenfluramine (marketed as Redux), for which it held a patent, was recalled in 1997.

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While many pharmaceutical company public relations spokespeople refer to the high costs of research and development when defending their steep drug prices, most drug research isn’t conducted by drug companies. According to Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine, pharmaceutical companies rely on academia, small biotech start-ups, and government bodies such as taxpayer-supported NIH to conduct research on their products.

As big pharma gained wealth and power, it began exerting more lobbying pressure on the U.S. Congress (there are now more drug company lobbyists in Washington, D.C. than there are elected officials). In the 1990s, Congress passed several laws that significantly helped fatten drug company revenues and, resultantly, profits. The patent life of brand-name drugs increased from eight years in 1980 to 14 years in 2000. While this may not seem overly significant, consider a “blockbuster” drug such as arthritis treatment Celebrex or the antidepressant Zoloft, each of which generates more than a billion dollars in sales per year. It’s simple math: Six additional years of exclusivity on such drugs equals about six billion dollars. That six billion dollars buys a lot of lawyers and lobbyists to pressure Congress and various policy makers into forming legislation that favors the pharmaceutical industry (but is often counter to the best interest of patients and consumers).

As ex-Minnesota governor Jesse Ventura used to say, “Follow the money.” Some of the numbers on big pharma’s financial side are mind boggling, but extremely educational in understanding the motives and power held by these firms. For example, in the late 1990s, just before losing its patent on Prilosec, AstraZeneca was raking in $6 billion per year for the popular heartburn medication that it marketed as the “purple pill.” Claritin, before owner Schering-Plough lost its patent in 2002, accounted for one-third of the company’s revenues. When the patent expired, the drug began selling over the counter for considerably less than prescription price. In response, Schering-Plough attempted to switch patients from Claritin to Clarinex, a nearly identical drug—except for the fact that Clarinex is still patented.

Not only are revenues high for drug companies, but profit margins are far beyond the expectations of all other industries. In 2001, the top ten American drug companies basked in profits equaling nearly 20 percent of sales. However, the median net return for all other industries in the Fortune 500 was only 3.3 percent of sales (less than one-sixth of big pharma’s numbers). Consider also that, in 2002, total profits for the top ten drug companies equaled $36 billion. This exceeded the combined profits of the other 490 corporations in the Fortune 500 by more than $2 billion!

Prescribing Death

Some of the numbers regarding the use of pharmaceutical drugs in the United States are alarming. Each year, more than 2.2 million hospital admissions result from adverse reactions to prescribed medications. But hold onto your seats, boys and girls: Nearly one in ten of these admissions results in…death.

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In 1999, after suffering a minor urinary tract infection and taking a pharmaceutical drug to treat it, author Stephen Fried’s wife suffered side effects that included delirium, visual distortions, insomnia, and bipolar disorder. Documented in his book Bitter Pill, Fried describes how the adverse reactions of his wife—and millions of others like her—are considered to be statistically insignificant by both drug companies and their government regulators.

In the U.S. alone, between 45,000 and 200,000 people die annually of reactions to legal drugs (this is two to nine percent of the 2.3 million Americans who die each year). Compare this to the 5,000 to 10,000 who die of illegal hard drug use. In 1998, the Journal of the American Medical Association released a study entitled “Incidence of Adverse Drug Reactions in Hospitalized Patients.” The article reviewed thirty-nine studies regarding adverse drug reactions occurring in American hospitals during the previous 30 years. By very conservative analysis, the study determined that in 1994 more than 2.2 million people were hospitalized due to negative reactions to pharmaceutical drugs. Moreover, 106,000 of these hospital admissions resulted in death. All of these cases involved properly prescribed and administered drugs.

The number one killer in the U.S. is heart disease (about 750,000 deaths annually). Number two is cancer at about 530,000 deaths. Third place belongs to strokes, with approximately 150,000 deaths. But, according to Dr. Ray Strand, America’s number four killer isn’t auto accidents, AIDS, or suicide bombers in Baghdad. Instead, it’s the 100,000 deaths each year resulting from adverse reactions to properly prescribed medication. “If you add the 80,000 deaths caused by improperly prescribed or administered medication, adverse drug events become the number three leading cause of death in this country,” said Strand.

Overall, the mass media has done a poor job of reporting the reality of adverse drug reactions within the population, but many stories have been too big to ignore. Vioxx, the pain reliever developed by Merck that used to rake in $2.5 billion annually, in the fall of 2004 was found to cause heart problems that could—and did—result in death. This fact somehow eluded the U.S. Food and Drug Administration (FDA) when it approved the drug in 1999.

In 2000, through a subsequent study, Merck learned that Vioxx resulted in twice as many heart attacks than when patients were using an older painkiller called naproxen. Drug company spin meisters said this was due to the protective effects of naproxin. In other words, Merck said Vioxx wasn’t causing heart attacks, but instead naproxin was preventing them. However, a long-term follow-up study comparing Vioxx to a sugar pill placebo proved that it actually was the cause of the heart attacks.

Off-label Prescriptions

One practice within the U.S. medical profession that’s fully legal and accepted is the off-label prescribing of drugs. This involves taking a drug intended for a particular ailment and prescribing it for another condition. Potential complications arising from this practice only increase when the drugs being prescribed off-label are intended for—and tested on—adults, but given to children.

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If doctors are having a difficult enough time avoiding death and suffering in their patients when prescribing drugs for their intended efficacy, one can imagine the problems that have arisen from off-label prescribing. And no group of doctors writes more off-label prescriptions than child psychiatrists.

One such case is that of ten-year-old Shaina Dunkle of Smithtown, Pennsylvania. Dunkle had been taking the drug desipramine (Norpramin) for her ADHD. Desipramine is a drug typically prescribed for adult depression, but is commonly given to children for a variety of behavioral problems. In 2001, after taking the drug for about a year, Dunkle collapsed due to a grand mal seizure. She died minutes later in the arms of her mother. An autopsy revealed there could be no cause of death other than the desipramine.

Dunkle should never have been prescribed desipramine. In the mid-1990s, reports began to surface within the medical community regarding sudden deaths within children taking the drug (all within appropriate doses). Seven such cases of sudden death among children prescribed desipramine were published. Most doctors abandoned the drug for safer medications, such as Ritalin. Although her parents were given no indication whatsoever that use of the drug carried potential complications or any increased risk of sudden death, Dunkle was prescribed desipramine by her doctor five years after these reports surfaced.

Serious SSRI Side Effects

Since the late 1980s, a category of drugs called Selective Serotonin Reuptake Inhibitors, or SSRIs—including Prozac, Paxil, Zoloft, Celexa, Luvox, and Lexapro—has been commonly prescribed for depression in both adults and children. Replacing tranquilizers such as Valium, SSRIs were hailed as wonder drugs, supposedly causing no addiction and conveniently taken only once per day. Beginning in the 1990s, however, reports began to surface that linked the use of SSRI drugs to agitation, strange behavior, and even suicide.

If only a very small percentage of those consuming SSRI drugs are affected in an adverse manner, it still results in big numbers. Between 1988 and 2002, 27 million people were prescribed Prozac. Between 1993 and 2002, 18.5 million people took Paxil. And between 1992 and 2002, 22 million people were prescribed Zoloft. If only 1/100th of 1% of these patients (one in 10,000) experienced adverse symptoms, it would equal 6,700 innocent people who had engaged in aggressive or suicidal behavior (many of whom surely succeeded in harming themselves or others).

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But percentages of adverse manic reactions to antidepressant drugs is likely considerably higher than 1/100th of 1 percent. Some studies have reported that “some degree of clinically significant over-stimulation and mania” results in five to 10 percent of patients taking antidepressants. If only two percent of patients experienced these negative side effects, it would equal more than 1.3 million people!

In January 2006, mainstream media reported the story of retired baseball star Jeff Reardon. Reardon, a former star pitcher with career earnings of $11 million, had little reason to rob a jewelry store. But that’s exactly what the ex-slinger, who had been consuming several antidepressants following the death of his son, did. “I completely lost my mind,” Reardon told police after turning himself in, adding, “I flipped on my medications.”

Dr. Peter Breggin, a medical expert and psychiatric consultant, says this isn’t an isolated story. “I’ve seen dozens of similar cases,” he reported. Breggin described a man who was taking Prozac and the tranquilizer Xanax at the time that he robbed his wife’s bank, another bank near his mother’s residence, and his local drug store. Wearing no disguise and carrying only an empty air pistol, the man engaged in friendly small talk while patiently standing in line at his last robbery. When police surrounded the building with guns drawn, he nonchalantly walked through the flabbergasted officers, got into his car, and drove away. Amazingly, among a flurry of bullets, the man was captured unharmed. A judge later found him not guilty due to temporary insanity caused by psychiatric drug “intoxication.”

In a similar case, Breggin described how a college student robbed several gas stations. Like the drug intoxicated bank thief, the student was strangely unconcerned with his chances of getting caught in the act, driving the same car his family used to regularly visit the same gas stations. Like others, he too wore no disguise. “Both of these individuals were suffering from antidepressant-induced manic reactions that completely obliterated their judgment and led them to take actions that were wholly out of character for them…they were upstanding people with no criminal records,” said Breggin.

Breggin reported how another man became suicidal after taking Paxil. The man, who had no history of violence or criminal activity, drove his car into a policeman. Not satisfied with hitting the man, he got out of his car and began jumping on his victim, attempting to obtain the officer’s gun with the goal of shooting himself.

Breggin reports that nearly every case of this type that he’s investigated has involved a patient who recently began treatment or had their dosage adjusted. In such cases, patients experience impaired judgment, a lack of an understanding of the consequences of their actions, feelings of invulnerability, and impulsivity. Their impulsivity is especially alarming, making their behavior nearly impossible to predict or prevent. Beginning in 2004, the FDA began requiring antidepressant manufacturers to use labels indicating the potential side effects of their drugs to include “aggression, hostility, impulsivity, agitation, and mania.”

If taking SSRI drugs wasn’t risky enough, there’s also the issue of withdrawal, which can cause violent impulses, including suicide. Again, because this behavior is impulsive, it’s difficult or impossible to predict or prevent. In one case, a man with no prior history of violence assaulted a friend after missing only two doses of Paxil. The longer the drug has been consumed, the more severe the withdrawal symptoms. 

Biased Research

Most information regarding drug efficacy and side effects is produced by clinical trials and laboratory research, resulting in articles appearing in medical journals. Publications such as The New England Journal of Medicine and the Journal of the American Medical Association ring with an air of refined academic prestige. Medical journals, probably the most relied upon channel of information regarding new research and drug information by doctors and the medical profession, have carried a solid reputation for dependability and objectively hard science.

Medical-Research

Until recently, that is. With the pharmaceutical industry’s heightened profits came heightened influence. Today, most clinical research and drug trials are sponsored by the company that makes the drug. This is more than a slight conflict of interest, and one that government regulators and the mass media have allowed to exist almost unchecked.

According to Angell, drug researchers worked very independently of drug companies until the 1980s. “Drug companies would give a grant to an academic medical center, then step back and wait for faculty researchers to produce the results,” wrote Angell in her book The Truth About the Drug Companies. She describes how, today, drug companies and their long financial tentacles are involved in every aspect of research, “…from design of the study through analysis of the data to the decision whether to publish the results.” Thus, if research to which it is financially connected produces results that executives think will be less than impressive to investors, a pharma company can simply bury the data, never allowing it to see the light of day—or put a ding in its stock price.

Proof of the industry’s far reaching influence lies in the fact that the highly-respected New England Journal of Medicine dropped its policy prohibiting authors of medical study review articles to have financial ties to the drug companies making the medicines being analyzed. On the surface, this makes the journal seem as bad as the pharmaceutical corporations. However, it justified its action as a pragmatic one, stating it could no longer locate enough independent experts who had not been paid in some way by the pharmaceutical industry.

Industry-Paid Ghost Writers

Also involving medical journals and carrying equal ethical implications is the practice of pharmaceutical companies employing unattributed ghostwriters to develop articles for medical journals. One case involved Adriene Fugh-Berman, an associate professor at the Georgetown University School of Medicine, who received requests from AstraZeneca to contribute to and peer-review the same article (a blatant conflict of interest). Another involved Dr. David Healy, an esteemed British psychiatrist, who was approached by a drug company and e-mailed a 12-page paper, fully edited and bearing his name. The only problem was the fact that Healy had never before seen the article.

THE GHOST WRITER

One British newspaper estimates that half of all articles appearing in medical journals are written by ghostwriters. “With one half of journal articles being ghostwritten, where is the FDA? Why are we putting up with all this? These lies kill and they are killing more by the minute,” said Dr. Ann Blake Tracy, Executive Director of the International Coalition for Drug Awareness. The Canadian Broadcast Company featured an episode of Marketplace in which a ghostwriter admitted that he was paid to write favorable reports. “Bad side effects that could affect patient safety are sometimes completely ignored,” he admitted.

Thankfully, several prominent voices within the medical community, fearful that doctors have been receiving biased and inaccurate information, have stepped forward to criticize the practice of medical journal ghostwriters. “Scientific research is not public relations. If you’re a firm hired by a company trying to sell a product, it’s an entirely different thing than having an open mind for scientific inquiry,” said Robert Aliff, vice chancellor of clinical research at Duke University Medical Center. Dr. Richard Smith, editor of the British Medical Journal, said, “When we find out, we reject the paper, but it is very difficult. In a sense, we have brought it on ourselves by insisting that any involvement by a drug company should be made explicit. They have just found ways to get round this and go undercover.”

Price Gouging

In 2000, heartburn reliever Prilosec was the world’s best selling pharmaceutical drug, costing Americans in Buffalo, New York $3.30 per pill. A 10-minute drive north of the Canadian border and the same pill could be had for $1.47. Another good example is the popular allergy medication Claritin, which costs five times as much in the United States than in Great Britain ($2.00 vs. $0.41).

But one can’t put all the blame on pharmaceutical corporations. The United States is the only industrialized nation to impose no price controls on pharmaceutical drugs. Ironically, drug companies say this is precisely why they must charge Americans so much. “The industry admits that it charges Americans, particularly those without insurance, far more than it does people in other countries, but it insists it needs to do so in order to make up for the fact that other countries regulate prices,” said Angell. If you’re American and angry with drug companies, logically you should be equally frustrated with Congress and it’s lack of price control oversight.

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In 2001, the pharmaceutical industry distributed $11 billion worth of free drug samples to doctors via 88,000 sales reps. Drug company reps handed out not only samples, but also personal gifts and perks (which sometimes included golf vacations and similar luxuries for those doctors who move the most product). This situation brings to mind the stereotypical scenario of the back alley drug dealer who, desiring to “hook” a new customer, gives away the first dose on the house.

$11 billion worth of free samples to doctors becomes truly pathetic when one considers that many senior citizens each month must decide which item they will do without: food, heat, or their prescription medications. In 2001, almost one in four seniors citizens reported skipping meds or simply leaving prescriptions unfilled because they couldn’t afford their drugs. Ironically, those without insurance—and who are typically the most financially challenged—pay the most for drugs. Members of HMOs are favored because their healthcare companies negotiate bulk deals for them. Senior citizens with nothing but Medicare typically pay more than anyone else for their prescriptions.

Direct Advertising

In 1998, the U.S. Food and Drug Administration (FDA) began allowing drug companies to market directly to consumers. While this may not seem like an overly dramatic change on the surface, it resulted in the current flood of television and print ads for drugs treating everything from toe nail fungus to erectile dysfunction. The drug industry currently spends about $1.5 billion per year on television ads. According to Competitive Media Reporting, this is about twice the amount spent by the beer industry on TV spots.

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In 1998, 55 million people in the United States talked with their doctors about pharmaceutical products they saw advertised on television. According to Prevention Magazine, in 84 percent of these cases, doctors wrote prescriptions. Knowing that the U.S. is the only industrialized nation that imposes no price controls on prescription medication, it may come as no surprise that America is the only modernized nation that allows prescription drugs to be directly marketed to consumers via television and print ads.

If the sheer volume of drug ads isn’t alarming, one should find disturbing the fact that drug companies are now targeting the healthy and purposefully stigmatizing common ailments and conditions as if they were dramatic life-threatening diseases. In the mid-1970s, in an interview with Fortune magazine, Merck CEO Henry Gadsden said he wanted to make his company more like Wrigley’s, the chewing gum manufacturer. Like Wrigley’s, Gadsden said he wanted to “sell to everyone” and admitted that he desired to make drugs for healthy people.

“Mild problems are redefined as serious illness and common complaints are labeled as medical conditions requiring drug treatments,” report Ray Moynihan and Alan Cassels in their book Selling Sickness. “Runny noses are now allergic rhinitis, PMS has become a psychiatric disorder, and hyperactive children have ADD,” they wrote.

An End In Sight?

Until pharmaceutical companies become more concerned with the fate of their customers than their stock valuations and profit margins, spiraling costs, uncertainty and fear among consumers, and unnecessary suffering will continue. Patients, including children, will continue to die due to a lack of thorough and objective research. As long as higher education is receiving money from pharmaceuticals and medical journals are provided with research results that are acutely skewed in a drug maker’s favor, the current crisis in western medicine will persist.


HBK11RenderGooey Rabinski is a technical writer and instructional designer who has contributed to magazines such as High Times, SKUNK, Heads, Weed World, Cannabis Health Journal, Green Thumb, and Treating Yourself. He is the author of Understanding Medical Marijuana, available on Amazon Kindle, and a contributing writer at Whaxy.com.

His marijuana-related freelance photos, spanning back more than a decade, are available on Instagram and Flickr. He tweets from @GooeyRabinski.

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