Over Dose: The Case Against the Drug Companies
Over Dose: The Case Against the Drug Companies
Part 1 of 2
Chapter 1: The Race To the Bottom
I was in my recliner, headset on, writing this book when the telephone rang.
"Dr. Cohen, my name is Alex. I'm sorry to bother you, but I need to speak to you about problems I'm having with my medication."
I don't get many calls. After twenty years in practice, I've been disabled for ten. I have no office or funding for my research, so I work at home. My telephone number is unlisted. Alex, a young man from the other end of the country, had obviously gone to considerable trouble to find me.
"I'm taking Prozac for panic attacks and depression," Alex told me. "I was nearly housebound by agoraphobia once. I was okay for three years, but things got stressful at work and the problems returned."
"Prozac is a reasonable choice for your disorder," I said. "What's the problem?"
[Karl Note: Even when a "medical doctor" speaks out against drugs, he often still has a "reasonable" attitude toward them, and there is zero time when Prozac can or should be prescribed -- ZERO!]
"I've gotten much worse since starting the drug. I get terribly agitated now, and my heart pounds and I can't sleep. I get so shaky sometimes, I'm afraid to go out. I'm withdrawing And depressed again. I think the Prozac is making me worse."
"What do your doctors say?"
"They say that the side effects from the Prozac -- the insomnia and palpitations -- show that it is working, and that I should wait it out."
I sighed quietly. This was awful advice, but not unusual. Although I already knew the answer, I asked, "What dose of Prozac are you taking?"
"Twenty milligrams a day."
Twenty mg -- that's what Lilly and Company, Prozac's manufacturer, recommends initially for otherwise healthy people ages eighteen to sixty-five, and that's what physicians prescribe. Unfortunately, neither Alex nor his physicians knew that early research had already shown that doses one half or even one quarter Lilly's recommended amount are all that some patients need (1, 2).
Anything greater commonly causes side effects including agitation, insomnia, rapid heart rate, and consequent depression and social withdrawal. These are signs that Alex was being over-dosed.
Alex isn't alone. In 1998 an extensive study published in the Journal of the American Medical Association (JAMA) showed that 106,000 people die annually in American hospitals from medication side effects (3).
Medication reactions are the fourth leading cause of death in the United States, dwarfing the number of deaths caused by automobile accidents, AIDS, alcohol and illicit drug abuse, infectious diseases, diabetes, and murder. In addition to the medication-related deaths, the JAMA study also tallied 2,216,000 severe medication reactions in U.S. hospitals annually.
Because of the especially rigorous methods the researchers applied, even these numbers may not present the full picture. The authors defined serious side effects narrowly, including only clearcut reactions causing permanent disability, hospitalization, or death. Thus, they excluded side effects that disable people for weeks or months, side effects such as dizziness or sedation that cause automobile accidents or falls and broken limbs, side effects that require emergency interventions, and side effects that prolong hospitalizations or force people to miss work.
And the authors didn't even try to count the largest category of all -- side effects occurring in outpatients. Overall, the authors excluded side effects that occur far more often than the ones they included.
Despite omitting so many side effects, the JAMA study still recorded numbers reaching epidemic proportions. And, as the authors noted, this side-effect epidemic wasn't new: "The incidence has remained stable over the last 30 years (4)."
Because it is sometimes difficult to place such statistics in everyday terms, consider this: 106,000 deaths a year averages out to nearly 300 deaths a day, every day. In comparison, about 85 people died from accidents linked to faulty Firestone tires. The Firestone deaths occurred over a period of several years -- medication reactions kill 300 people every day. Yet, it was the Firestone deaths that dominated the news for several weeks and drew Congressional hearings.
Deaths from all major airline crashes in the United States average less than 300 annually, but one airplane crash gets more media attention and governmental scrutiny than the 300 medication-related deaths that occurred not only the same day as the airline crash, but also every day before and after for decades.
Why has this epidemic of side effects gone unrecognized? Deaths from medication reactions rarely look any different than natural deaths. There's no visible wreckage to videotape, no crash sites to horrify and fascinate viewers. As media people say, "No film, no story."
Medication deaths often occur quietly in hospitals, emergency rooms, and homes. When medication-related deaths occur, it is often unclear at first whether the cause was the medication, the illness, or other factors. In other words, to much of the media, there's nothing sexy about side effects.
Moreover, the public likes to believe that our hospitals and medications are safe and that our doctors are taking every reasonable precaution.
Facing the failure of a major industry is never comfortable. How many decades did it take recognize the drunk driving problem? To bring the dangers of cigarettes to public awareness? To mandate seatbelts in cars? Maybe with medication side effects it's the same: We'd rather not know.
It might be different if the public received an accurate account of the scope of the side-effect epidemic. Alex' experience, for example, may have been severe enough to drive him to contact an unfamiliar doctor 2,500 miles away, but his case will never be counted in the side-effect statistics.
His doctors didn't recognize Alex' side effects, and even if they had, they probably wouldn't have reported them to the FDA. "Most physicians feel that detecting adverse reactions is a professional obligation, but relatively few actually report such reactions [to the FDA]," states Goodman and Gilman's The Pharmacological Basis of Therapeutics, one of medicine's most respected drug references (5).
Dr. Brian Strom, former chairman of the department of biostatistics and epidemiology at the University of Pennsylvania, told the New York Times in 1997: "Most doctors don't know the system [for reporting medication reactions to the FDA] exists (6)." When speaking to medical groups, Dr. Strom showed a slide of an FDA Medwatch form and asked: "How many of you have ever seen that?" Usually, less than a third raise their hands.
Yet, it is from voluntary reports from physicians that side-effect statistics are derived. Physicians, however, often feel that so-called minor side effects -- the ones that make millions of people like Alex feel merely miserable or unable to function normally -- aren't worth reporting.
Reporting more serious reactions may raise questions about treatment or lead to lawsuits. Another highly regarded drug reference, Melmon and Morrelli's Clinical Pharmacology: Basic Principles in Therapeutics, commented: "Drug-induced complications can mimic and therefore be attributed to disease-induced problems.
When therapy fails, we [physicians) frequently can attribute the failure to the disease and escape blame. Probably nowhere else in professional life are mistakes so easily hidden, even from ourselves (7)." The result is that only one in twenty side effects is reported to authorities (8, 9).
Drug companies and medical institutions have their own reasons for underestimating the full scope of the side-effect epidemic. Dr. David Bates, an associate professor of medicine at the Harvard Medical School, wrote in JAMA:
Hospitals have had strong incentives not to identify too many of these adverse drug events. Reporting large numbers of adverse events and any serious preventable event brings intense scrutiny from regulators and the public. Thus, most hospitals have relied on spontaneous reporting, which only identifies about 1 in 20 adverse reactions and leads to the perception that injuries from ADRs are less common than they really are (10).
Even the Food and Drug Administration acknowledges that adverse drug reactions are grossly underreported. In March, 2000, Dickinson's FDA Review reported on its interview with Jerry Phillips, associate director of the Office Of Post-Marketing Drug Risk Assessment at the FDA:
"These reports, however, are generally believed by experts to grossly understate the actual situation, Phillips said. In the broader area of adverse drug reaction data, the 250,000 reports received annually probably represent only 5% of the actual reactions that occur (11)."
A simple extrapolation from these numbers reveals a total of five million medication reactions each year -- and this is still probably an underestimate.
However, one by one, the public is learning about the perniciousness of the side-effect epidemic. Knowledgeable people have told me that their elderly parents died not from their illnesses, but from being prescribed too many too powerful medications. Dozens of websites now exist where patients can discuss medication reactions that have caused major reactions or disabilities that their physicians have ignored.
Many physicians dismiss anecdotal reports or cases posted on the Internet, but scientific discovery often begins with individual reports of an unrecognized or poorly understood problem. These reports, especially when hundreds of in-depth, medically credible descriptions are listed, should be taken seriously, because they represent another unrecognized aspect of the side-effect epidemic.
It might be different if the side-effect epidemic was caused by a few bad drugs. Every industry produces some lemons. Thus, the FDA has had to remove ten prescription drugs (plus a vaccine and an anesthetic) within the last four years. But, as this book will document, the problem extends well beyond these few. Instead, it involves hundreds of drugs including top-sellers like Viagra, Premarin, Prozac, Lipitor, Celebrex, and Motrin.
Because the problem is so large and so many drugs are involved, blame is difficult to assess. In addition, these same drugs help millions of people, which further obscures the many problems they cause, why they cause them, and how easily many of these side effects, like Alex', could be avoided.
Consider, for example, one class of medications: women's hormones. When I was a medical intern in 1971, I treated a young woman with a blood clot in her lower leg (thrombophlebitis). She required hospitalization and bed rest for nearly two weeks. She was lucky: Hundreds of women like her died each year when such clots broke free and coursed to their lungs.
These clots were caused by birth control pills -- pills that in the 1960s and 1970s contained three to eight times more estrogen and progesterone than actually needed (12, 12A). That's 300 to 800 percent more of these powerful hormones than today's pills -- doses that exposed millions of women to greatly increased risks of blood clots, strokes, and death.
The death rate from thromboembolism alone was 600 percent higher with the original high-dose pills. I don't know where my patient is today, but she probably is now worrying about the increased risks of breast cancer that have been reported with these high-dose pills (13-16). How many women have been harmed by these excessive doses that were prescribed in the United States for twenty-eight years? Some data exist, but the full extent of the damage has never been defined.
Perhaps my patient, after entering menopause, received hormone therapy for hot flashes. If she was prescribed Premarin for hot flashes at the dosage recommended by its manufacturer, Wyeth-Ayerst, she might have received double or even quadruple the amount she actually needed. Wyeth-Ayerst recommended 1.25 mg of Premarin as its initial dose for hot flashes from 1964 through 1999, long after medical experts had shown that 0.625 mg and even as little as 0.3 mg were sufficient for many women (17-19).
Premarin is perhaps the most prescribed drug ever; in 1999 alone, women purchased more than 47 million prescriptions in the United States. Yet even in 2000, after Wyeth-Ayerst finally reduced its recommended starting dose for hot flashes to 0.625 mg, this amount remains excessive for some women (20-22). Similarly, the recommended doses of Premarin for preventing osteoporosis have been unnecessarily high for many women (23, 24).
Meanwhile, estrogens like Premarin have been linked to increased rates of breast cancer (25, 26) -- and it is likely that the higher the dose of estrogen, the greater the risk. Has my patient been affected? How many thousands of women have been harmed over the years? We'll never know, and the side-effect statistics will never reflect them.
Why weren't lower, safer, effective doses of these hormones, as used today, developed decades earlier? The technology existed in the 1960s to determine the lowest, safest doses of these potent drugs. But the intense, fast-paced competition of the medication marketplace frequently spurs drug companies to conduct small, brief, insufficiently extensive studies on the dosages of new drugs (27) -- dosages that will be taken by millions of people.
The result is that only belatedly, years or even decades later, do we discover that lower doses are not only effective, but avoid many side effects. Of course, by this time, tremendous damage has been done to people and their families.
The story is the same with many drugs -- not just obscure drugs, but many top-selling drugs. The problem encompasses the entire field of medication therapy, as recognized experts have attested:
Carl Peck, M.D., former director of the FDA's Center for Drug Evaluation and Research: "There are noteworthy examples in drug development of failing to get the dose right when a drug is first marketed (28)."
Dr. Raymond Woosley, the chairman of the department of pharmacology at Georgetown: "The US society has invested in developing wondrous new pharmacologic therapies but has failed to invest adequately in their safe use (29)."
Dr. Norman Sussman, editor of Primary Psychiatry: "There are lots of problems with the current system of drug testing. Often it fails to detect efficacy and, more often than would be desired, misses significant side effects (30)."
Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine: "To rely on the drug companies for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism (31)."
The result of these shortcomings? Dr. Thomas J. Moore of Georgetown University, Dr. Bruce Psaty of the University of Washington, and Dr. Curt Furberg of Wake Forest University determined that "51% of approved drugs have serious adverse effects not detected prior to approval (32)."
Think about this -- more than half of our drugs, after being deemed "safe" by the FDA and then prescribed to millions of people, are subsequently detected to have previously unrecognized, medically serious side effects. No wonder we have a side-effect epidemic.
When the majority of our drugs are approved with serious risks, the threat isn't small. Forty-six percent of Americans take at least one prescription drug dally (33). That's more than 128 million people. Most of these people are taking medications long-term, so their exposures aren't brief. Twenty-five percent of Americans take multiple prescription drugs every day.
In 1999, Americans purchased 2,587,575,000 prescriptions -- that's nine prescription drugs (as well as several over-the-counter drugs) for every person in America.
Americans paid $125 billion for these prescriptions -- $50 per prescription on average. One would think that with so much cost and utilization, medications would be our most carefully manufactured and safest products. Yet, as Dr. Bates wrote: "Only after drugs leave the trial setting and are used in sicker patients do their true risks become apparent (34)."
It doesn't have to be this way. As Dr. Bates also wrote, "Although some risks are inevitable, they can be significantly reduced (35)." I agree -- side effects can be significantly reduced, but they aren't. The inadequate methods by which drugs are developed and prescribed are why.
Weary of seeing avoidable side effects affect patient after patient, I began investigating the origins of this problem. With a background in general medicine, pain research, general pharmacology and psychopharmacology, and experience as a staff member at UCLA, UCSD (the University of California, San Diego), and at the world's largest naval medical center at Balboa Hospital in San Diego, I began voicing my concerns publicly in 1988.
First I wrote letters to medical journals and authored health columns in a local newspaper. Beginning in 1996, I began publishing lengthy articles describing my findings in respected medical journals such as the Archives of Internal Medicine (36-38), Postgraduate Medicine (39), Geriatrics (40), The Annals of Pharmacotherapy (41, 42), and Drug Safety (43).
After more than a decade of research conducted without any influences, I found that the drug companies dominate the entire process of medication therapy -- from early research to ultimate usage -- as few other industries control their products today. Drug company research and development often serves marketing strategies more than sound science or patients' safety.
The many ways that drug companies accomplish this is discussed in depth in Chapter 9, but here is a glimpse -- derived from numerous medical journal articles including JAMA (44), the New England Journal of Medicine (45), and Lancet (46) -- of the methods that drug companies use in accomplishing their goals:
Drug companies can choose research study designs that are more likely to produce favorable results rather than designs that might provide more accurate results.
Drug companies can conduct multiple studies on new drugs, and then select and publish the most favorable ones while suppressing the rest.
Drug company studies can measure a drug's effectiveness in multiple ways, then select and publish only the best results. Sometimes these favorable results have little to do with whether the drugs will help patients.
Drug companies hire professional writers to prepare articles according to company guidelines, using favorable phrases and terms selected by the companies.
Drug companies hire high-profile experts to place their names on drug company-generated articles, although the experts have not participated in the studies and their financial connections with the drug companies are not disclosed.
These excesses might be unimportant if drug company research represented a small portion of all medication research. However, the drug companies underwrite 70 percent of all medication research today (47). This gives the pharmaceutical industry tremendous power over the entire medication research effort, including the threat of lawsuits or loss of future funding for physicians wanting to publish unfavorable findings (48).
More and more, drug companies are requiring researchers to sign confidential agreements before receiving any funding, giving the companies the power to suppress findings they don't like.
The pharmaceutical industry's ability to amass wealth while hospitals and medical centers struggle financially has allowed the drug companies to intrude into the arena of independent academic medicine (49). This intrusion is so great that in 2000, Dr. Angell issued an astonishing article -- "Is Academic Medicine for Sale?" -- in the New England Journal of Medicine:
Academic medical institutions are themselves growing increasingly beholden to industry.... Some academic institutions have entered into partnerships with drug companies to set up research centers and teaching programs in which students and faculty members essentially carry out industry research....
When the boundaries between industry and academic medicine become as blurred as they now are, the business goals of industry influence the mission of the medical schools in multiple ways.... The influences of the marketplace should not become woven into the fabric of academic medicine. We need to remember that for-profit businesses are pledged to increase the value of their investors' stock. That is a very different goal from the mission of medical schools (50).
Despite the concerns of Dr. Angell and other experts, drastic reductions in insurance and Medicare payments have placed great pressure on medical institutions and research physicians to accept the money -- and terms -- of the drug companies.
At the same time, the drug companies spend billions targeting office physicians, as well as new interns and residents, with gifts, free meals, travel subsidies, and subsidized symposia presenting the drug companies' spin on their medications (51, 52).
Beyond these direct influences, drug companies exert broad influence over the drug information received by doctors and consumers. The vast majority of everything physicians and consumers read and know about medications comes from the drug companies. Medication package inserts, drug advertising toward physicians and consumers, and the information in the ubiquitous Physicians' Desk Reference (PDR) (53) come directly from the drug companies.
Where do most doctors turn for medication and dosage information? To the PDR, to drug company representatives who make the rounds of doctors' offices, and to advertising in medical journals. Yet, the medication information offered by these drug company-supported sources is often biased, incomplete, and sometimes inaccurate.
Please see the continuation of this article, below, in the next issue of my newsletter.
Over Dose: The Case Against the Drug Companies
By Jay Cohen, M.D.
Part 2 of 2 (Part 1)
The PDR is not only the leading drug reference among physicians, but it is also purchased by thousands of consumers each year. Moreover, the PDR is the source for the bulk of information contained in other consumer drug references. Yet, as I have written in multiple professional publications, because the PDR is mainly a collection of drug-company written package inserts, it omits a great deal of important information.
The PDR omits or underreports many serious side effects. It frequently omits information about proven-effective medication dosages that are lower and safer than the doses recommended by drug companies or usually prescribed by doctors (54-58). Many new, important uses of medications are not even mentioned in the PDR.
Nor does the PDR provide any guidance whatsoever in selecting between the many drugs that might be used for medical conditions. And, although a new PDR is published each year, many drug descriptions are not updated. Some of these descriptions contain information that is decades old.
A glaring example was provided in a 1997 article in the Annals of Emergency Medicine (59). This article examined drug company guidelines in the PDR for handling overdoses of 20 drugs commonly seen in overdose situations in emergency rooms.
The study found that for 80% of the drugs studied, the PDR guidelines for handling overdoses were inadequate. For overdoses with nearly half of these drugs, the PDR recommended "ineffective or frankly contraindicated" treatments that could worsen the situations or cause unnecessary deaths.
The drug companies'
influence even extends to the FDA, which we will
explore in Chapter 11. The FDA is required to ensure
the effectiveness and safety of medications, but
changes in the law and political pressure from
Congress, as well as a massive shortfall in funding,
has led to weakened FDA standards. Furthermore, some of
the FDA's own policies make matters worse (60).
Funding for the FDA's monitoring of newly approved
drugs is so limited that some drug toxicities weren't
identified by the agency, but by investigations
conducted by newspapers or health interest groups.
Limited funding also hampers the ongoing monitoring of
important drugs with recognized risks.
After Viagra was on the
market for seven months, the FDA reported receiving 230
cases of deaths associated with the drug (61). The FDA
responded, as usual, with required changes in Viagra's
labeling -- yet, the agency hasn't provided any
follow-up reports on Viagra-related deaths or any
analysis of whether the labeling changes have helped.
Experts with drug company ties fill many important
advisory positions at the FDA. An investigation by USA
Today found that more than half of the experts on FDA
advisory committees "have financial relationships with
the pharmaceutical companies that will be helped or
hurt by their decisions (62)."
Today, the FDA approves drugs much faster, and sometimes on fewer studies, than required ten years ago (63-65), and FDA oversight wasn't exactly robust then, as multiple drug withdrawals in the 1980s demonstrated. Since 1997, more drugs have proven toxic and been withdrawn than ever before.
Some of these withdrawn drugs - Redux, Seldane, Propulsid, Rezulin -- were prescribed millions of times. According to Dr. Alastair J.J. Wood, Assistant Vice Chancellor for Research at the Vanderbilt University Medical Center (66), "a staggering 19.8 million patients (almost 10% of the U.S. population) were estimated to have been exposed" to just five of the ten drugs withdrawn in this period.
Dr. Wood added, "None of the drugs was indicated for a life-threatening condition nor, in many cases, were they the only drugs available for that indication (67)." Safer alternatives to these drugs existed, but intense marketing convinced physicians to prescribe them anyway -- and to continue prescribing them even as the FDA prepared to withdraw them.
Drug companies can profit handsomely on such drugs. Seldane, the top-selling antihistamine in the world for more than a decade, was on the market for thirteen years until the FDA removed it in 1997, seven years after the drug's cardiac toxicities were identified in 1990 (68).
Perennial top-seller Propulsid, for heartburn, remained on the market for seven years, despite reports of hundreds of heart arrhythmias and scores of deaths before the FDA finally withdrew it (69).
Rezulin, a diabetes drug withdrawn by Britain in 1997, wasn't withdrawn by the FDA until 2000, during which hiatus Warner-Lambert earned $1.8 billion (70).
Drug company influence on regulatory agencies isn't solely an American affair. "Some medicines are out on the market too early, without giving practitioners sufficient time to evaluate them," Dr. Thiery Buclin, a Swiss health official, told Dimanche, a leading French newspaper, in April 2000.
"We have proof of too much hastiness and sometimes lack of prudence. In 1998 alone, out of thirty medicines launched in the Swiss market, five had to be removed. This is a significant number of rejects, revealing a counter-productive mechanism. The pharmaceutical industry plays the first role in this dangerous game. With aggressive marketing, it uses heavy infantry to convince health personnel (71)."
Aggressive marketing, slanting research, unethical publishing of results, pressuring medical centers, intimidating researchers, influencing physicians, limiting information, manipulating the FDA, marketing drugs with inaccurate safety information and inappropriate doses -- all of these have created an environment in which medication development has become, in Dr. Angell's fitting term, a "race to the bottom (72)."
The side-effect epidemic arises from the very methods by which drugs are produced, and thus it involves hundreds of medications. That's why warnings like this partial sampling from January 1998 to January 2000 continue to appear in medical journals and the news media:
"Correctly Prescribed Drugs Take Heavy Toll: Millions Affected by Toxic Reactions." Washington Post (73)
"Lawmakers Ask FDA Why Rezulin Was Kept on Market Despite Deaths." Los Angeles Times (74)
"Hepatotoxicity Associated with Antiretroviral Therapy in Adults Infected with HIV." Journal of the American Medical Association (75)
"Some AIDS Patients Are Hit by Disfiguring Fat Deposits; Protease Inhibitor Drugs Suspected." Philadelphia Inquirer (76)
"Sudden Deaths Reported with Orap." Worst Pills, Best Pills News (77)
"Alcohol-Acetaminophen [Tylenol] Syndrome: Even Moderate Social Drinkers Are at Risk." Postgraduate Medicine (78)
"Psychosis Due to Abrupt Discontinuation of Oral Contraceptive." Primary Psychiatry (79)
"Antibiotic Linked to Stomach Disorder in Infants." San Diego Union-Tribune (80)
"Study Links Breast Cancer, Hormone Use." Los Angeles Times (81)
"Maker of Fen-Phen Paid for Articles: Lawsuit Says Wyeth Hid Dangers Linked to Weigh-Loss Drugs." Associated Press (82)
"Liver Toxicity with Prostate Cancer Drug Eulexin." Worst Pills, Best Pills News (83)
"Trovan Associated with Liver Injury and Death." FDA (84)
Shocking? Knowing how the drug companies operate, it is no shock when new dangers are revealed with drugs we've been using for decades. It is no shock when:
In 2000, the Archives of Internal Medicine reports that anti-inflammatory drugs have been linked with congestive heart disease (85).
In 1999, the British Medical Journal (BMJ) reported that SSRI antidepressants (e.g., Prozac, Zoloft, Paxil) have been linked with increased risks of gastrointestinal bleeding (86).
A 2000 Los Angeles Times headline announced that frequently prescribed drugs for high blood pressure (beta blockers) have been linked with diabetes (87).
In 2000, the Annals of Internal Medicine reported that drugs relaxing the muscles of the lower esophagus have been linked with increased risks of esophageal cancer (88).
Unfortunately,
revelations like these aren't new. These and many more
surfaced each of the thirty years since I earned my
medical degree.
Of course, these incidents represent only reported
adverse effects -- the tip of the iceberg. Consider
digoxin, the best-selling heart drug. According to an
article in JAMA, the FDA receives about eighty-two
reports annually involving digoxin, yet "a systematic
study of Medicare records disclose 202,211
hospitalizations for digoxin adverse effects in a
7-year period (89)."
That's more than 28,000 reactions per year -- of which the FDA receives eighty-two.
The great tragedy of it all is that so many side effects are avoidable. Prozac, perhaps the most famous breakthrough drug since penicillin and insulin, serves as a perfect example. Prescribed 24,742,000 times in 1999, Prozac causes side effects in a large proportion of the people started on it. Sexual dysfunctions alone occur in 33 to 50 percent or more of Prozac users (90-92).
Plus, the drug has
repeatedly been linked to incidents of psychosis,
suicide, and violent behavior. I saw some of this
myself. Yet, when I began individualizing my use of
Prozac to fit the needs and tolerances of patients,
side effects dropped dramatically, and the percentage
of my patients obtaining good responses far exceeded
Lilly and Company's own claims.
Pfizer developed Lipitor to be extremely powerful in
lowering blood cholesterol levels, so that with
aggressive marketing, Lipitor could surpass better
established, more proven competitors. With 48,791,000
prescriptions filled in 2000, Lipitor has accomplished
this, but it has also triggered more reports to me
about side effects than the other five drugs in its
class combined.
Perhaps this is because the standard dosage of Lipitor is so strong, it is far stronger than many patients actually need or can tolerate.
Similar problems exist in the way drug companies research and market many other top-selling drugs today. There is no doubt that popular drugs such as Zocor, Vasotec, Norvasc, Viagra, Motrin, Voltaren, Premarin, Prozac, Lipitor, Celebrex, Zestril, Allegra, etc., are very effective -- I want to emphasize this -- but today's methods of producing and prescribing these drugs do not include minimizing their risks.
Of course, pharmaceutical companies cannot study everything, but as subsequent chapters will show, current research is woefully deficient in anticipating and avoiding foreseeable problems -- problems that could be avoided by producing and prescribing medications to fit people.
The drug companies reject the assertion that their medications are not safe. "Do unsafe drugs enter and remain in the marketplace? Absolutely not," stated Bert Spilker, a senior vice president for the Pharmaceutical Research and Manufacturers of America (PhRMA), according to the Los Angeles Times (93).
The drug companies also claim that they need large earnings -- $124,835,595,000 in 1999 -- to conduct their research. They have a point -- to a point. Aggressive research is indeed essential. The medications produced by the pharmaceutical industry have greatly improved the quality and length of life of millions of people. But this explanation loses credibility when:
1. Just one of every five dollars the drug industry collects goes to drug research:
2. Some drug companies spend almost twice as much money for marketing and advertising than for research;
3. Drug industry profit-taking is so large it outstrips every other industry by far (94).
As Dr. Angell stated in a second astonishing 2000 article in the New England Journal of Medicine ("The Pharmaceutical Industry: To Whom Is It Accountable?"): "An industry so important to public health and so heavily subsidized and protected by the government has social responsibilities that should not be totally overshadowed by its drive for profits.
There needs to be a better balance between the interest of the shareholders and those of the public (95)." Indeed, and this balance should begin with improving drug research and development in order to ensure drug safety and to end the side-effect epidemic.
The sad irony is that not only would patients, physicians, insurers, and health care organizations benefit from reducing the high incidence of medication side effects, but so would the drug companies. When 50 percent or more of patients quit treatment for conditions such as high blood pressure (96, 97), high cholesterol (98, 99), and osteoporosis (100, 101, 101A), no one wins.
These patients become exposed to markedly increased risks of premature disease and death, and the healthcare system is burdened with billions in extra costs. Yet, if the priority in producing medications wasn't expediency but maximizing the benefits while minimizing the risks of medication treatment, many of these problems could be avoided. And keeping patients satisfied and in treatment would increase drug sales.
Just because side effects are all too common, this doesn't mean they must be. In a 1999 article in JAMA, Dr. Wood stated, "Drug safety will improve only when it is viewed as a cooperative venture between regulator, industry, and prescriber, when all parties are prepared to engage in open dialogue so they may learn from the past with a view toward improving the future (102)."
This dialogue should have begun long ago, because ending the side-effect epidemic doesn't require some new insight or discovery: It simply requires restoring sound, practical, scientific principles to the ways we research, develop, regulate, and prescribe medications.
As Over Dose will demonstrate in detail, we already have all of the information we need to do this -- to drastically reduce the occurrence of medication side effects and to end the side-effect epidemic today.
We have so much information that, by using it in the manner I will describe in subsequent chapters, patients can have great influence on how medications are prescribed to them. In doing so, they can greatly increase their chances of a positive response to medication treatment while greatly reducing their risks.
The side effects Alex endured should never had occurred. Once they did occur, they should have been promptly curtailed. Alex' disorder should have been easily and quickly controlled. This book will explain how -- and how other patients and their physicians can do the same with their own medications.
Ten Medications Withdrawn From The Market Since 1997
Because Of Serious, Often Lethal Side Effects
Rezulin: Given fast-track approval by the FDA, Rezulin was linked to sixty-three confirmed deaths and probably hundreds more. "We have real trouble," an FDA physician wrote in 1997, just a few months after Rezulin's approval (103). The drug wasn't withdrawn until 2000.
Lotronex: Against concerns of one of its own officers, the FDA approved Lotronex in February 2000. By the time it was withdrawn nine months later, the FDA had received reports of ninety-three hospitalizations, multiple emergency bowel surgeries, and five deaths (104).
Propulsid: A top-selling drug many years, the drug was linked to hundreds of cases of heart arrhythmias and one hundred deaths.
Redux: Taken by millions for weight loss after its approval in April 1996, Redux was soon linked to heart valve damage and a disabling, often lethal pulmonary disorder. Withdrawn in September 1997.
Pondimin: A component of Fen-Phen, the diet fad drug. Approved in 1973, Pondimin's link to heart valve damage an a lethal pulmonary disorder wasn't recognized until shortly before its withdrawal in 1997.
Duract: The painkiller was withdrawn when it was linked to severe, sometimes fatal liver failure.
Seldane: America's and the world's top-selling antihistamine for a decade, it took the FDA five years to recognize that Seldane was causing cardiac arrhythmias, blackouts, hospitalizations, and deaths -- and another eight years to withdraw it.
Hismanal: Approved in 1988 and soon known to cause cardiac arrhythmias, the drug was finally withdrawn in 1999.
Posicor: For treating hypertension, the drug was linked to life-threatening drug interactions and more than one hundred deaths. An expert on the advisory committee said, "Posicor should not have been approved (105)."
Raxar: Linked to cardiac toxicities and deaths.
Subsequent Chapters of "Over Dose: The Case Against The Drug Companies"
Chapter 2: How Drug Company Policies Harm People
Chapter 3: How Drug Company Policies Cause Problems For 50-75% Of Patients Taking Prozac
Chapter 4: When New Drugs Are Approved, The Experiment Is Just Beginning, And You May Be Part Of It -- Viagra
Chapter 5: How The Drug Companies' Policies Harm Women
Chapter 6: Why 50-75% Of People Quit Taking Their Cholesterol-Lowering Medications
Chapter 7: Why 50-75% Of People Quit Taking Their Medications for High Blood Pressure
Chapter 8: Why Seniors Are At The Greatest Risk
Chapter 9: How The Drug Companies Slant Drug Research Limit Information To Doctors And Consumers, And Secure High Profits
Chapter 10: What The Drug Companies Need To Do To End The Side-Effect Epidemic -- But Will They?
Chapter 11: What's Wrong With The FDA? And What Can Be Done About It?
Chapter 12: What The FDA Shouldn't Do -- Why We Need An Independent Medication Safety Monitoring System
Chapter 13: Doctors, Drugs, And Patients
Chapter 14: How You Can Avoid Side Effects And Use Medications Safely
Jay S. Cohen, M.D., is an Associate Professor of Family and Preventive Medicine (voluntary) at the University of California, San Diego.
PUBLISHERS WEEKLY: "Replete with information supported by recognized and reliable sources, this expose` and health guide should be read by anyone taking prescription medication.... Clear, easy narrative ... an invaluable resource for doctors and patients alike."
BOOKLIST: "A thorough, solidly based book that deserves to be widely read by medical professionals and the lay public."
KIRKUS REVIEWS: "A call for action and a plan for it as well. Though not intended as a comprehensive reference, Over Dose is a source of useful drug information, much of it tabulated at chapter ends for easy consultation."
LOS ANGELES TIMES: "The central message of Over Dose is that people are overmedicated. Cohen believes that the only way for consumers to circumvent these problems is to become informed about lower, safer drug doses. To this end, the book includes practical advice on dozens of common prescription medications for those who are most at-risk: the elderly, women, and children."
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