The report, “Health, United State, 2004,” published by the
National Center for Health Statistics, claims that 44 percent of U.S. citizens
take at least one prescription drug; for the elderly, the number climbs to more
than 80 percent. In fact, an increasing dependence on prescription drugs
permeates much of the civilized world. In an article by Dr. Tony Vendryes, the Jamaican
Gleaner Online stated, “We warn our youngsters and athletes about the
danger of illegal drugs but turn a blind eye to the harsh reality that
legally-prescribed drugs kill and harm vast numbers of innocent victims every
day…Jamaican men, women and children are consuming more prescription drugs than
ever before.”
We’ve been trained to trust doctors – after all, they have
gone through rigorous training and must obtain and maintain a license to
practice medicine. And until recently, most people considered approval by the
Federal Drug Administration (FDA) a sign that a drug was safe and effective.
But many patients have abdicated their own responsibility to educate themselves,
and often critical information about prescription drugs is not made available.
The hard truth is, just because the FDA approves a drug, or a doctor prescribes
a drug, doesn’t mean it is safe.
Are prescription drugs really a problem?
The phrase “drug problem” usually conjures images of cocaine
addicts, meth labs, empty syringes in the gutter, and crime waves. But illegal
drugs are not the only “drug problem” this world faces – prescription drugs are
fast becoming an even bigger health problem than illegal drugs. Even the Journal
of the American Medical Association (JAMA) admits that the third
leading cause of death in the U.S. is doctor-induced disease. Yep – that’s
right. Except for heart disease and cancer, the thing that poses the most risk
to your health is doctors, with at least 225,000 deaths occurring per year –
just in hospitals![1]
Another study, published in 1998, rated adverse drug
reactions as between the fourth and sixth leading cause of death in the U.S,
saying reactions killed upwards of 100,000 people in 1994, and seriously
injured another 2.2 million. This study also restricted its data to hospitals,
and did not include prescription errors.[2]
Other sources, such as Dr. Gary Null and colleagues, who
published “Death by Medicine” in 2003, estimate that more than 700,000 people
die each year due to medical mistakes. (This number includes problems with
prescription drugs, but also includes unnecessary surgeries, bedsores, and
malnutrition, among other problems).
These are scary statistics, even if the exact number of
deaths due to prescription drugs is impossible to pinpoint. The numbers cited
above are almost certainly low, considering that most of the above data relates
only to hospital deaths (what about people who die at home or at work?), and
that many adverse drug reactions are not reported (either the patient fails to
report them, or the doctor does). Even scarier is that most people seem unaware
of the problem; and those who know about it try to keep it a secret.
This article explores the various facets that comprise the
prescription drug problem, citing examples, exploring causes, and offering some
possible directions for solutions.
What can go wrong?
First, why should people be concerned about prescription
drugs? The answer is because they pose a number of serious health risks that
are not properly explained to consumers by most doctors. These health risks
include the following:
adverse reactions (including death) to a single drug
adverse drug interactions in “drug cocktails”
nutritional depletion
prescription errors (from doctor, at pharmacy, or in
hospital)
off-label prescriptions
abuse.
Let’s look at some examples of how each of these risks
manifests itself.
Adverse reactions: Most people consider
antibiotics to be “safe.” But one, Floxin® (one of a group of
antibiotics called fluoroquinolones), has an overall 11
percent adverse reaction rate and is well-known for causing serious side
effects including tendon ruptures and neuropathy issues, seizures, anxiety,
cognitive changes, depression, dream abnormality, and hallucinations (among
others). Other fluoroquinolones include Cipro®,
Penetrex®, Maxaquin®, and Noroxin®. In August
2006, the FDA received a request for a black box warning for all fluoroquinolones.[3] According to an article by Dr. Jay S. Cohen in the Annals of Pharmacotherapy, “fluoroquinolone-associated demyelinating peripheral neuropathies
have not previously been appreciated or listed in the drug-prescribing
information.”[4] A recent check of the listed side effects of Floxin revealed that
tendonitis/tendon rupture was listed – but was buried in the “worldwide
post-marketing” section, which is much farther than most consumers would read.
Another commonly prescribed group of drugs are psychiatric
drugs – and they are increasingly being prescribed for children, with horrific
results. In well over half of the school shootings that have occurred since
1998 (and maybe in all of them), the child wielding the gun was on psychiatric
drugs.[5]
Great Britain's Department of
Health issued a report that said studies based on more than 1,000 children show
the rate of self harm and potentially suicidal behavior increases in those
under 18 taking Paxil®, one of several SSRI (selective serotonin
reuptake inhibitors) antidepressants (other SSRIs include Prozac®, Luvox®,
and Seroxat®). British health regulators recently issued a warning that
said “It has become clear that the benefits of Seroxat in children for the
treatment of depressive illness do not outweigh these risks.” The FDA and
Irish health officials have also issued a similar warning for Paxil.
According to a story on USA TODAY Online, some
antipsychotic drugs can also be dangerous when given to children. The article
stated that “[A] study of FDA data collected from 2000 to 2004 shows at least
45 deaths of children in which an atypical antipsychotic was listed in the FDA
database as the “primary suspect” for cause of death. No one seems to be taking
notice of such data, however. In fact, during the period from 1995 to 2002,
said the article, “outpatient prescriptions for kids ages 2 to 18 leaped
fivefold — from just under half a million to about 2.5 million,” which means
about 4 out of every 100 children are taking such drugs, despite the fact that
the drugs are not labeled for pediatric use.[6]
Painkillers are also commonly prescribed. Most people know
that NSAIDs such as ibuprofen can cause stomach bleeding. And in 2004, another
painkiller, Vioxx®, skyrocketed to the top of the media coverage. Vioxx
was taken off the market in 2004, because researchers discovered that long-term
users of Vioxx (25 mg/day) showed an increase in the incidence of heart attacks
and strokes. After Vioxx was pulled from the U.S. market, other countries, such
as New Zealand and Germany, restricted the use of Vioxx and similar drugs
(called COX-2 inhibitors). Dr. David Graham, an employee of the FDA and the
main “whistleblower” on the dangers of Vioxx, said in an interview that because
the FDA ignored data that pointed to increased risk of heart attack in users of
Vioxx, that “the FDA is responsible for 140,000 heart attacks and 60,000 dead
Americans. That’s as many people as were killed in the Vietnam War…[Americans]
should be screaming because this can happen again.” Estimates place worldwide deaths
caused by Vioxx at 150,000 to 200,000 – but these figures have not been
confirmed officially.
Indeed, it seems Dr. Graham was right in his warning that it
“could happen again.” An FDA advisory panel recently voted to approve Vioxx’s
return to the market, and Merck (the manufacturer of Vioxx) is seeking FDA
approval for a very similar drug, Arcoxia® (already available in 62
countries worldwide).
Another drug, Tysabri®, was recalled in 2005,
after only about a year of being on the market. Why? According to the warning
now required to be on the drug, which was reinstated in 2006, “TYSABRIincreases
the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic
viral infection of the brain that usually leads to death or severe disability.
Although the cases of PML were limited to patients with recent or concomitant
exposure to immunomodulators or immunosuppressants, there were too few cases to
rule out the possibility that PML may occur with TYSABRImonotherapy.”
Some people are now asking “is no drug too dangerous for FDA
approval?” and “Can doctors and patients competently weigh the risks versus the
benefits of such drugs?”
Drug cocktails: According to the National Center for Health Statistics, 16.5 percent of Americans take three or more
prescriptions at one time. This is often referred to as a “drug cocktail.” Each
of these drugs has its own effect on the body – but together, the potential for
danger is even greater, as many drugs interact negatively with one another. The
online reference, www.drugdigest.org, which lists known drug interactions, says
that there are at least 11,500 potential prescription drug interactions, then adds
this caution: “Not all drug interactions are known or reported in the
literature, and new drug interactions are continually being reported.” Some
drugs are worse than others in this regard. JAMA recently reported that
“there are probably more potential drug interactions between warfarin and other
prescription drugs than [with] any other prescription product.” Warfarin (aka
Coumadin®) is a blood thinner commonly prescribed for heart patients.
Adding to the potential danger are possible interactions between
prescription drugs and “natural” substances like herbs. In countries where
treatment with herbal medicines is common, such as Ethiopia, these sorts of
interactions pose a significant threat. Fekadu Fullas, Rph, Phd, has written a
book, Interactions of Ethiopian Herbal Medicines and Spices with
Conventional Drugs: A Practical Guide. Other researchers should follow
Fallas’ example and publish similar guides for other countries.
Nutritional depletion: Some prescription
drugs pose a different kind of danger. Instead of directly killing you, or
directly causing behavioral anomalies, they interfere with the natural levels
of various nutrients or other substances in your body. This depletion, over
time, may make it more likely that you will succumb to other ailments besides
the one the prescription drug was supposed to fix. The simplest and possibly
most common depletion is the effect of antibiotics on the digestive system.
Most antibiotics can cause diarrhea, but many people don’t know why that
is. In most cases, it is because the antibiotics are doing their job – only too
well. They kill off not only the harmful bacteria that is making you sick, but
also the beneficial “flora and fauna” that naturally inhabit your digestive
tract; this lack of normal digestive bacteria, in turn, causes diarrhea (it can
also cause women to be prone to yeast infections). The simple precaution of
taking a “probiotic” – usually acidophilus bacteria, and sometimes others as
well – along with the antibiotic can generally prevent diarrhea. But a great
many people are never advised to do this by their doctors.
Antibiotics are generally taken for a short time, and
digestive bacteria can usually repopulate themselves without aid – but there
are other, more long-term and dangerous depletions caused by prescription
drugs. Statins, used to lower cholesterol, deplete or interfere with the
absorption of several chemicals necessary for continued health. In particular,
statins are well-known for causing severe muscle damage (rhabdomyolysis), extreme
weakness, muscle pain, severe memory loss, liver and kidney problems, and
depletion of CoQ10.[7]
Some blood pressure medicines can also significantly reduce
the levels of CoQ10, which helps maintain cellular energy and is an important
antioxidant. Many drugs, including some blood pressure medicines, estrogen
replacement therapy, and antibiotics can deplete various B vitamins (e.g., B-2,
B-6, and B-12).
Because doctors are not highly aware of these side-effects
of the drugs they prescribe (after all, the pharmaceutical companies do not
trumpet the information from the rooftops), many patients assume that the hair
loss, memory impairment, weakness, depression, and a host of other symptoms are
part of what the doctor is treating – not an effect of the treatment itself!
Prescription errors: According to the
Nov. 14, 2006 issue of the Jamaican Gleaner Online, the president of the
Nurses Association of Jamaica (NAJ), Edith Allwood-Anderson, said “Medication
errors by local doctors are a cause for concern.” She also stated that “The
standard of prescription orders is insufficient and needs to be monitored.”
A 2004 study in Norwich, England revealed that 24 critical-care units, over
a four-week period, wrote an average of approximately 15 prescriptions per
patient. Fifteen percent of those prescriptions contained at least one error; 19.6
percent of those errors were considered “significant, serious or potentially
life threatening.”[8]
Even if the doctor writes the correct
prescription, things can still go wrong at the pharmacy.
One tragic example is the death of five-year-old Brendan
Ward, who died in 2004 due to a “typo” in his prescription for imipramine, a
medication that helps with bedwetting. The technician typed “250
milligrams/teaspoon” instead of “50 milligrams/teaspoon.” Imagine the horror
and grief when Brendan’s mother found him stone-cold dead in his (dry) bed the
next morning.
The National Association of Boards of Pharmacy estimates
that in 2004, incorrect prescriptions caused as many as 7,000 deaths in the United States. Of the more than 4 billion prescriptions filled each year, as many as 5
percent are incorrect. Exacerbating the problem is a trend toward a decreasing
number of pharmacists – a recipe for more errors than ever.
Off-label prescriptions: It is common
practice for doctors to prescribe medications for conditions for which the
medication is not approved by the FDA. Sometimes, this is a good idea – if
clinical observation and scientific studies indicate such a use poses concrete
benefits and little risk to the patient. The problem is, according to a study
from the Stanford University School of Medicine, doctors don’t always use such
criteria to prescribe a drug “off label.”
The study looked at prescriptions for 160 drugs during 2001.
Out of a total of 725 million prescriptions, 21 percent were off-label. What’s
worse, 73 percent of these off-label prescriptions had little or no evidence
that the off-label use would be of benefit. For example, 83 percent of the
prescriptions for a drug called gabapentin (also known as Neurontin®)
were off-label; but in 66 percent of these cases, the scientific evidence (such
as that published in DRUGDEX) did not support gabapentin’s use.[9]
Sometimes
off-label prescriptions don’t just not work, they are downright dangerous. With
regard to prescribing psychiatric drugs for children, John March, chief of
child and adolescent psychiatry at Duke University School of Medicine, says “We
have no evidence about the safety of these agents or their effectiveness in controlling
aggression. Why are we doing this?”[10]
As another example, Gabitril® is a drug that is used successfully to treat some forms of epilepsy.
But this drug is also commonly prescribed for other conditions, such as
psychiatric illnesses – with an unexpected effect: at least 30 patients for
whom Gabitril was prescribed, but who did not have epilepsy, suffered seizures.[11] Now, these patients’ doctors
were probably as dismayed as their patients at the negative effect of the
prescription – and who would have thought a medicine used to treat seizures would cause them? But this just underscores how unsafe and/or
untested many prescription drugs are, and illustrates the dangers of off-label
prescriptions.
Abuse: Prescription drugs are also
becoming the drug of choice for teenagers seeking a quick buzz, according to
the 2003 Monitoring the Future survey, conducted by the University of Michigan Institute for Social Research. The survey revealed that one in ten high school seniors
had used Vicodin® (without a prescription). Similar usage numbers
were revealed for Ritalin®, while 6 percent had used tranquilizers
(such as Valium®). Four and a half percent had used OxyContin®,
a powerful painkiller. “These drugs can be highly addictive if they’re used on
an ongoing basis, and the person can become physically, psychologically and
behaviorally addicted to them,” said Maher Karam-Hage, M.D., who is medical
director of the Chelsea Arbor Treatment Center (operated by Univ. of MI).
As more and more parents fall into the trap of listening to
the pharmaceutical companies’ and doctors’ mantra of “you need more drugs!”
they are unwittingly putting their children at risk by storing these
theoretically “safe” medications in their homes.
Where to lay the blame?
It is tempting to lay the blame for this whole mess at the
feet of one or other of the players – the pharmaceutical companies, the FDA, or
the doctors. And each of these definitely deserves some of the blame.
Big Pharma: Pharmaceutical companies often downplay
research trials that do not show the drug in question in a positive light. Statin
drugs, for example, are marketed as lowering cholesterol which in turn is
supposed to lead to better cardiovascular health. But in September 2004, JAMA published a study that showed that high doses (80-mg/d) of one statin drug
(simvastatin, better known as Zocor®) not only failed to lower risk
of cardiac events (heart attack, stroke, or cardiac death), it also caused an
unacceptable high rate of myopathy. And in the analysis of the study, it was
stated that
[I]n1997 the manufacturer undertook a development program
to study2 higher doses of simvastatin (80 mg/d and 160 mg/d).Although a favorable report appeared in the medical literature,development of the 160-mg/d dose was abandoned due to high muscletoxicity. Although never reported in the scientific literature,the
financial community was informed that the rate of muscle-relatedsymptoms
was 5.7% for the 160 mg/d dose…
There are
several lessons to be learned from these events. Thefailure of the
160-mg/d dose of simvastatin and the enhancedtoxicity … should
probably haveserved as a warning that the 80-mg/d dose of
simvastatin mightborder on a toxic threshold. Relatively minor
differences inthe rate of elimination, a low body mass index, mild
renal insufficiency,or other unknown factors appear capable of
pushing simvastatinblood levels into the toxic range. The
failure to publish theactual results of studies using the
160-mg/d dose (negativepublication bias) arguably prevented the
medical and scientificcommunity from fully appreciating the
myopathic potential ofhigh-dose simvastatin.[12]
(emphasis added)
Of course, you can’t single out cholesterol drugs. According
to Dr. Julian Whitaker,
A minimum of
five studies on the use of [Paxil, an antidepressant] for children and
adolescents have been conducted, and four of them showed that not only did it
not work but also suggested increased risk of suicide. However, just one study
– the only one that showed partially favorable result – was published.[13]
Dr. Richard Friedman, director of the psychopharmacology
clinic at Weill Medical College of Cornell University, wrote in the New York
Times, “For too long, drug companies have been allowed to tell us only the
good news about their products. Now we're ready for the whole story.”[14]
In late October 2006, GlaxoSmithKline PLC (based in London) agreed to a $63.8 million settlement for claims that it allegedly promoted its
antidepressant drug Paxil for use by children and adolescents while withholding
negative information about the medication's safety and effectiveness. Although
GlaxoSmithKline denies the lawsuit’s claims, they settled to avoid any further
litigation costs.[15]
A British newspaper, The Independent, reported in June
2005 that “vital data on prescription medication found in millions of British
homes has been suppressed by the powerful U.S. drug regulators, even though the
information could potentially save lives.” The paper said 28 pages of data had
been removed from the FDA files.
In addition to “negative publication bias,” the
pharmaceutical companies also seed governmental and research groups with panel
members who have financial ties with the pharmaceutical companies themselves.
Talk about conflict of interest! Is it surprising, for instance, that an
“expert” panel voted for new, lower cholesterol guidelines (thereby creating a
new pool of cholesterol-lowering drug users), when eight out of the nine
members of the panel were involved financially with the statin drug-producing
companies?
Dr. Whitaker claims that “three quarters of the clinical studies in the top
medical journals such as The Lancet, The New England Journal of
Medicine, and JAMA are commercially funded.”[16]
Pharmaceutical companies also market their drugs aggressively. Now, there’s
nothing illicit about marketing, per se. But two marketing techniques used by
the drug companies are of questionable ethics. One is their direct-to-consumer
ads, such as on TV. These ads clearly portray certain drugs’ benefits, while
downplaying risks. The list of side effects is often read at “auctioneer” speed
right at the end of the commercial, making it hard to hear and understand.
Prior to 1997, direct-to-consumer advertising by drug companies was illegal.
Drug companies also target doctors specifically, using a variety of
techniques ranging from free samples to “continuing education” classes that
push certain drugs to flying doctors to exotic locations for “conferences”
about a particular drug. Doctors, of course, claim they are unaffected by all
the attention paid to them by the drug companies – that they prescribe based on
science not advertising. However, in 2005, a small study published in JAMA showed an interesting result: people who specifically named a drug (by
referring to a TV commercial for Paxil) during a doctor’s visit were five times
as likely to be given a prescription for antidepressants than those who did not
name the drug.[17] One could infer from this study that drug ads affect consumers, who in turn
affect doctors’ decisions – possibly leading to
over-prescription of the advertised drugs.
Matthew Hollon, an internist at the University of Washington, called direct-to-consumer advertising by drug companies a “haphazard
approach to health promotion that is driven primarily by the pharmaceutical
industry’s interest in turning a profit.” Hollon also claimed that 80% of
physicians believe that direct-to-consumer drug ads cause patients to request
medications they do not need.
A study conducted at Brandeis University and published in Psychiatric
Services claims that after direct-to-consumer advertising was legalized in
1997, pharmaceutical companies increased their TV advertising budget 600
percent, reaching a total of $1.5 billion in 2000.[18] During a similar time frame, the
incidence of prescriptions of psychotropic drugs (such as those used to treat
ADHD and depression) increased significantly. By 2001, said the study, ten
percent of doctor’s office visits by adolescent boys resulted in a prescription
for such a drug.[19] According to a June 2006 article in The Guardian (a British
publication), the marketing budget for drug companies worldwide in 2005 was $60
billion – twice as much as they spent on research.[20]
Pointing to the fact that
misconduct on the part of drug companies is not just a U.S. issue, the world
federation of consumer organizations, called Consumers International, wrote in
its report, “Branding the Cure: A consumer perspective on Corporate Social Responsibility,
Drug Promotion and the Pharmaceutical Industry in Europe,” that “irresponsible
marketing practices form a serious, persistent and widespread problem among the
entire pharmaceutical industry.”[21]
Federal Drug Administration: The FDA takes its share of
the blame, as well. Dr. Graham said flatly that the FDA is “serving industry
rather than the public.” In other words, it is a
common opinion that the FDA is in the pocket of the drug companies, and no
longer considers the American people its primary client or concern. Writing for
NewsTarget.com, columnist Mike Adams wrote in June, 2006 that the FDA had
passed a Final Rule that states “consumers can no longer sue drug companies for
the harm caused by any FDA-approved drug, even if the drug’s manufacturer
intentionally misled the FDA by hiding or fabricating clinical trial data.”
Although this blatant power grab by the FDA is unlikely to go unchallenged – it
has little or no basis in law – it certainly clearly delineates the FDA’s
position of being a cozy bedfellow of “big pharma.”
Physicians: Doctors, too, can be at fault
for inculating or exacerbating some of the problems with prescription drugs. For
example, GlaxoSmithKline (which is Great Britain’s largest drug company, and
the second-largest in the world) is being investigated by authorities in Germany and Italy for allegedly corrupting doctors by distributing illegal gifts worth up to E228
million during the years 1999 to 2002. Now, while you could make the case that
this is a drug company problem, you can just as easily make the case that it is
a doctor problem – they didn’t HAVE to accept those gifts!
What’s a patient to do?
But laying the blame at others’ doors is not the whole
answer. Citizens – whether of the U.S., Britain, or other countries, have a
responsibility to educate themselves and to demand changes in the obviously
faulty prescription drug system. Here are some positive steps citizens can take
to safeguard their own health and the health of others:
Work with government and advocacy groups to untangle the
regulatory aspect of drugs from the research and marketing aspects.
Support legislation that requires drug companies to
publish the results from all studies in a public database.
Push for more user-friendly drug documentation that
clearly lists the side-effects of drugs (in something larger than 4-point
type); encourage doctors to discuss these possible health threats with
their patients so that patients can make an informed benefit vs risk
decision.
Similarly, work to separate the prescribing process
(doctors) from the marketing tentacles of the pharmaceutical companies.
Work to change from a “fix the symptoms” health
perspective to a “find the causes” perspective.
Protect yourself from prescription errors by reviewing the
prescription with your doctor, and comparing the prescription to the
bottle of medication you receive from your pharmacist.
Educate yourself about your condition and all possible
treatments – prescription drugs and otherwise.
Learn to ask your doctor for supporting evidence when he
or she prescribes a drug for a specific condition, especially if it is an
off-label prescription.
One way to educate yourself about the dangers of
prescription drugs and the relationship between Big Pharma, doctors, and the
FDA, is to read books. There are a number out there; here are just a few to get you
started:
Overdosed America by Dr. John Abramson, M.D.
The Drug-Induced Nutrient Depletion Handbook by
Ross Pelton et al.
Bitter Pills: Inside the Hazardous World of Legal Drugs by Stephen Fried.
The Truth about the Drug Companies: How They Deceive Us
and What to Do about It by Dr. Marcia Angell
Note: None of the information in this article is intended
to be or should be construed as medical advice.
Reprint of web pages are only allowed with explicit permission. Please request our permission by emailing us with a complete description of the intended use.
Notes
[1] Starfield, Barbara. “Is US Health
Really the Best in the World?” Journal of the American
Medical Association (JAMA) 284 (July 26, 2000): 483-485.
[2]Lazarou , Jason; Pomeranz, Bruce H.; and Corey, Paul N. “Incidence of Adverse Drug Reactions in
Hospitalized Patients: A Meta-analysis of Prospective Studies.” JAMA. 279
(April 15, 1998): 1200-1205.
[9] Radley, David C.; Finkelstein, Stan N.; Stafford, Randall S. “Off-label
Prescribing Among Office-Based Physicians.” Archives of Internal Medicine 166 (May 8, 2006): 1021-1026.
[16] Whitaker, Julian. Health & Healing, 16 (June 2006): 2.
[17] Kravitz, Richard L.“ Influence of Patients’ Requests for Direct-to-Consumer
Advertised Antidepressants: A Randomized Controlled Trial.” JAMA.293
(April 27, 2005):1995-2002.
[18] Parks Thomas, Cindy; Conrad, Peter; Casler, Rosemary; and Goodman, Elizabeth. “Trends in the Use of Psychotropic Medications Among Adolescents, 1994 to
2001.” Psychiatric Services 57 (Jan. 2006): 63-69.