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Drug Overdosing: How to Avoid Medication
Side Effects
The FDA's Role
As of November 2002, there were many scientists at the FDA concerned about
these dose issues, but also some who weren't. Overall, the FDA has not
pushed the drug industry to provide better dose studies or a range of
doses to match patients' differences.
The FDA's decisions about drug doses have been criticized even from
within the FDA itself. Based on his recent study showing that dozens of
drugs ultimately require dosage reductions years after approval, FDA officer
James Cross stated in September 2002, "We've seen a lot of situations
where drugs are approved by the FDA and subsequent important information
about their optimal dose is not determined until afterward" (Zuger
2002).
Even if the FDA wanted to push the matter, could it? The pharmaceutical
industry has the biggest lobby in Washington and is a top contributor
to elected officials. With Congress pressuring the FDA to approve drugs
faster and faster over the past decade, and the new commissioner vowing
to speed approvals even more, the FDA isn't likely to reject drugs for
better dose studies. "Making sure the dosages that are used best
serve the patients should be near the top of the agenda for regulators
and the prescribing community," Dr. Herxheimer insists. "Right
now this item seems to be nowhere on the agenda" (Herxheimer 2001).
Consequences of a Flawed System
The failure of the system is revealed by disaster after disaster. "Discovery
of new dangers of drugs after marketing is common," a 1998 study
in JAMA declared. "Overall, 51% of approved drugs have serious
adverse effects not detected prior to approval" (Moore et al. 1998).
Another study disclosed that 20% of all new drugs ultimately require
a new "black box" warning, indicating serious or fatal reactions.
The study noted: "Serious adverse drug reactions commonly emerge
after FDA approval. The safety of new agents cannot be known with certainty
until a drug has been on the market for many years" (Lasser et al.
2002).
How can long-term side effects be minimized? By using the lowest, safest
doses. For example, the jury is still out on the long-term safety of statin
drugs, but already serious nerve injuries are being reported. A 2002 study
found that "people who had taken statins were 4 to 14 times more
likely" to develop peripheral nerve injuries (tingling, numbness,
shooting or electrical pain, muscle weakness) (Gaist et al. 2002). These
reactions occur in one in 2,000 users of statin drugs per year. With 35
million Americans projected to take statins, that's 17,500 cases of peripheral
neuropathies each year. Discontinuation doesn't always bring reversal.
Most important, the risk is cumulative: the higher the dose, the greater
the risk.
Doctors and the Drug Industry
Some doctors are terrific. Some aren't. But even good doctors often don't
have all of the information you'd like in order to make good dose decisions.
Doctors ultimately decide which drugs are successful, so doctors are in
a position to demand better drug information, a wider range of drug doses
to fit patients and better information about nondrug alternatives. Doctors
can play a pivotal role, but so far they haven't demanded anything. Many
doctors aren't even aware that a problem exists.
"There is an informational void about pharmaceuticals in the training
of most doctors, despite the importance of the prescription in medical
care," stated Harvard physician Jerry Avorn. "Most of those
who have looked thoughtfully at this process have been appalled at its
inadequacy" (Avorn 1995).
The result is that doctors' knowledge of medications is less than ideal,
which is directly linked to the high rate of side effects. "Much
of the morbidity and mortality currently associated with drug therapy
is due to well-recognized adverse effects and reflects our inability as
health professionals to implement current knowledge fully," Dr. Alastair
Wood, Vice Chancellor of Medical Affairs at Vanderbilt, wrote in 1998
(Wood et al. 1998).
Experience shows that specialists are usually more knowledgeable about
drugs than general physicians, but many specialists don't even understand
the importance of precision prescribing. One heart specialist said, "Most
doctors don't think about dose-response. They think you either get side
effects or you don't." Dr. Herxheimer agrees: "Clinicians rarely
think critically about the dose-response relations of the drugs they use"
(Herxheimer 2001).
Marlene had a serious reaction to Lipitor, so her doctor switched her
to Zocor. When another reaction occurred, he switched her to Pravachol.
After another reaction, she quit treatment. "If a medication doesn't
work or causes side effects," a pharmacist said years ago, "most
physicians just switch from one to another, then another, then another,
until they either find a drug that works, or they or the patient give
up. Very few physicians go to the trouble of adjusting drug dosages to
fit their patients. Most don't deviate from the drug companies' recommendations."
Marlene was 64 and obviously sensitive to statin drugs, but the doctor
never considered simply reducing the dose. Why? Dr. Woosley, who develops
medical training programs, said "Only about fifteen of the medical
schools today teach formal courses in clinical pharmacology, which is
the discipline that emphasizes individual variability in response to drugs.
This small effort will never counter the overwhelming message from the
drug industry that one dosage is all that is needed and everyone will
respond nicely without side effects."
The result is that most doctors accept drug company information uncritically.
They assume that the drug companies and the FDA have chosen doses carefully
and that the recommended doses are right for everyone. They accept incomplete
side-effect lists in the PDR as the final word, even when published studies
repeatedly say otherwise.
Most doctors get their drug information from the drug company-written
PDR, the 80,000 drug representatives dispatched to doctors' offices, the
drug advertising that fills medical journals, drug company-designed studies,
and drug company-underwritten conferences. Many doctors don't hesitate
to accept $500 stipends and fancy dinners to receive drug company-paid
presentations.
One concerned doctor wrote to the New England Journal of Medicine:
"The conflicts are obvious to everyone in the field. Who hasn't sat
through a company-sponsored presentation by a well-known colleague without
squirming a little at the obvious bias in the discussion?" (Young
2000). A doctor visiting from Germany, appalled at the overt willingness
of doctors to accept drug company goodies, wrote to JAMA, "In the
long run this behavior will undermine the respect and trust of physicians
and the standing of the entire medical profession" (Vollmann 2000).
Dr. Marcia Angell, former Editor-in-Chief of the New England Journal
of Medicine, chided doctors, "It is well to remember that the
costs of the industry-sponsored trips, meals, gifts, conferences, symposiums
and honorariums, consulting fees, and research grants are simply added
to the prices of drugs and devices" (Angell 2000). But many doctors
eagerly accept these freebies. As one doctor wrote, "Physicians as
a group have an amazing capacity to rationalize their own greed."
Some doctors are rightfully concerned, but not nearly enough. "Many
physicians have grown accustomed to industry-subsidized education and
now resist paying even modest amounts to attend classes" offered
by unbiased medical centers, the Wall Street Journal reported
in 2002 (Hensley 2002). Yet, if you bring your own ideas about drugs and
doses to your doctor, don't expect a warm reception. Many doctors get
defensive, even hostile, when patients question their methods. If there's
any area that defines doctors, it's their ability to prescribe drugs.
They are the experts, and too often they choose to defend their turf rather
than expand their minds.
"Doctors don't like to be challenged," a pharmacist wrote.
"One doctor was prescribing Paxil well above the highest recommended
dosage. When I asked him about it, he said, `Are you a doctor? Who are
you to be telling me what to do!' Indeed, some doctors have difficulty
admitting even common side effects listed in the PDR. Being defensive
doesn't strengthen doctor-patient relationships. More and more, doctors
are perceived as pill pushers and as defenders of the medical-pharmaceutical
machine instead of their own patients.
This perception is enhanced when drug companies can so easily convince
doctors to prescribe new drugs even when older, better-known drugs are
equally effective. For years, the FDA has warned doctors against using
new drugs unless a patient has a specific need. Dr. Janet Woodcock, Director
of the FDA Center for Drug Evaluation and Research, has stated, "The
sad truth is that, even after all the clinical development that occurs
with every drug and even after drugs have been approved for a time, we
only have a crude idea of what they do in people" (Cimons 1999).
With the FDA approving drugs faster than ever, the American public is
frequently the world's first population to try out new drugs.
Yet doctors repeatedly make new drugs bestsellers within months. Drug
reps fill doctors' cabinets with "free" samples, knowing that
if patients do well on them, they won't want to switch. Drug advertising
seizes upon any difference, no matter how trivial, to sway doctors to
prescribe expensive new drugs with no track records, and doctors readily
oblige. You'd think that after recent disasters with Baycol, Rezulin,
Lotronex, Duract, Redux and Fen-Phen, doctors would learn, but they keep
prescribing new drugs like Clarinex, Nexium, and Bextra at greater risk
and cost. These repeated problems compelled Drs. Marcia Angell and Arnold
Relman, another former editor of the New England Journal of Medicine,
to warn, "Few Americans appreciate the full scope and consequences
of the pharmaceutical industry's hold on our health care system"
(Angell et al. 2001).
One healthcare observer wrote, "The root cause is the physician,
his lack of knowledge or intellectual curiosity. The pharmaceutical companies
are trying to make a buck any way they can, and it is up to the physician
to have the fortitude to resist." He has a point. Doctors can't have
it both ways. They can't be objective advisors to patients while being
so reliant on drug company data and accepting of drug company influences.
Such reliance explains why people today make more visits to alternative
practitioners than to mainstream doctors. It explains why mainstream doctors
remain largely unaware of proven-effective alternatives like omega-3 oils
for reducing inflammation and sudden cardiac death, policosanol and inositol
hexanicotinate for reducing cholesterol, or the importance of coenzyme
Q10 for people taking statins. It explains why mainstream doctors continued
to make Premarin, with its conjugated horse estrogens, a top-seller for
decades although many types of human estrogens (estradiol, estriol) were
available.
It explains why, despite hundreds of studies in medical journals, most
doctors don't know anything about magnesium's essential role for normal
blood vessel functioning, or that 80% of westerners are deficient in magnesium.
By balancing calcium, magnesium is a safer, natural, much less expensive
way to help reduce blood pressure than the prescription calcium blockers
for which doctors write $4 billion in prescriptions each year, yet few
mainstream doctors know about it.
Without drug-company backing, vital information about lower drug doses
and nondrug alternatives can take years or decades to permeate mainstream
medicine. That's why Over Dose: The Case Against The Drug Companies
was written to expose the problems in the medical-pharmaceutical complex,
while providing low-dose and other important self-help information to
patients and doctors. That's why, despite its revelations about the drug
industry and mainstream medicine, the Journal of the American Medical
Association, Publishers Weekly, Booklist, Mensa
Bulletin, and everyone else have strongly recommended the book (see
reviews at www.amazon.com).
To begin bridging the information gap in mainstream medicine, a free
electronic newsletter and a series of inexpensive booklets with evidence-based
information for patients and their doctors are being made available. You
can sign up for the newsletter or obtain the first booklets (Magnesium
for High Blood Pressure and Magnesium for Migraine Headaches) at www.MedAlternatives.com.
If we are to improve our medical care and end the side effect epidemic,
we have to make all doctors integrative practitioners. To do so, we have
to develop new mechanisms for getting good drug and nondrug information
to mainstream doctors.
What You Can Do
If you are doing well on a medication, that's good. That's the goal: receiving
benefit without side effects. But if medications are causing problems,
or if the next time you need a medication you want to minimize the risk,
you need to inform yourself about the lowest, safest doses. Do not reduce
doses without your doctor's guidance. Undertreatment can have serious
medical consequences.
Hopefully, you have a doctor who recognizes the importance of precision
prescribing. Some do. Following a 1999 article in Newsweek (Cohen
1999), one doctor wrote, "I have always found that patients do well
on low, 'subtherapeutic' doses, which are not just placebos." Another
wrote, "As a physician who is a patient with a chronic illness, I
can tell you from my vast experience that the doses in the PDR are often
way off."
If your doctor, like most doctors, isn't aware of the low-dose alternatives,
what can you do? Inform yourself. The day when you could rely on doctors
to provide all of the important drug information is long gone. Doctors
have less time than ever to read medical journals or to search the medical
literature. You can access it yourself at www.PubMed.org, established
by the National Institutes of Health. People spend a lot of time researching
an auto or stereo purchase; they need to do the same for their own bodies.
YOU HAVE A RIGHT TO BE INFORMED
The American Medical Association's Code of Medical Ethics
states: "The patient's right of self-decision can be effectively
exercised only if the patient possesses enough information to enable an
intelligent choice" (American Medical Association 1999).
What is "enough information?" Surely, if a lower dose is effective,
you have a right to know about it. If you are prescribed a standard dose
of a drug without being told about an effective lower dose, you haven't
received informed consent. If the standard dose has done major harm, you
may have grounds to sue.
Higher doses are certainly appropriate sometimes. Emergencies and acute
situations demand immediate relief. However, 90% of office visits aren't
for acute problems, but for minor or chronic conditions. There's time
to match doses to individuals. There's time to start with a lower, safer
dose and then to adjust upward, if necessary. You are paying the bill
and taking the risk, so you have a right to be fully informed about the
options.
The low-dose method is especially fitting for:
- Older people
- Small people
- People with multiple medical conditions
- People taking multiple medications
- People with histories of medication sensitivities
- People wanting to minimize costs
- People wanting to minimize risks
The "start low, go slow" approach may take a little more time
initially, but it saves a lot of time (and money) in the long run. Some
people will get surprisingly good results with a low dose and never need
higher doses. Some won't, and the dose will need to be increased. Even
then, they are assured that they are getting exactly what their bodies
need.
Not everyone opts for the low-dose approach. Some people know that they
aren't sensitive to medications. With such people, starting with standard
doses is valid. Indeed, some people seem resistant to drugs and require
very high doses. The key is to match the dose with the person. Ultimately
it doesn't matter whether you need a low dose or a high dose--what matters
is that you get the right dose for you.
Doing so requires good dose information and a range of drug doses. If
anything, the drug industry is providing less of each. The irony is that
other industries not only recognize the differences among people, they
capitalize on it. They produce cars, clothes, cosmetics, and all kinds
of commodities in vast arrays to match individual sizes and needs. But
with its monopolistic patents and sway over doctors, the drug industry
can do what it likes and charge what it wants.
In 2001, 3.2 billion prescriptions were filled in America--12 prescriptions
for each man, woman, and child. Forty-six percent of adult Americans take
a prescription drug every day. Each year, drug sales increase 25% (Pharmacy
Times 2002), and medication side effects remain a top killer. How can
we restore sanity to this system? It will have to begin with you.
You are paying the bill and taking the risk, so you have a right to
ask questions and to request better information. You have a right to ask
your doctor why he's selecting a specific drug at a specific dose. Are
there lower doses that work? What is his source of information? We must
require doctors to explain their decisions, to think about their choices,
and to consider other sources of information.
Most people don't like taking medication. If they must take it, they
want to use as little as possible. When the low-dose approach has been
offered to patients, most have opted for it, side effects have dropped
dramatically, success rates have climbed, patients are pleased, and so
is the doctor. Most side effects are avoidable. The side effect epidemic
can be halted, and everybody wins. But the current system is entrenched,
so change is going to have to begin with us.
FOR
MORE INFORMATION
Much of the information contained in this chapter was excerpted from
an article written for Life Extension magazine by Jay Cohen,
M.D. The following books and booklets by Dr. Cohen are available and highly
recommended:
- Over Dose: The Case Against The Drug Companies. Prescription
Drugs, Side Effects, and Your Health. Tarcher/Putnam, New York:
October 2001.
- Magnesium For High Blood Pressure (Hypertension): The Complete
Guide To Using Magnesium To Help Prevent and Treat High Blood Pressure
Naturally. Del Mar, CA: 2002. Books available at: www.medalternatives.com
- Magnesium for Migraine and Cluster Headaches: The Complete Guide
To Using Magnesium To Prevent and Treat Migraines and Cluster Headaches
Naturally. Del Mar, CA: 2002.
These books can be ordered by calling 1-800-544-4440. |