- It amazes me that adverse reactions to prescription drugs
are estimated to kill over 106,000 Americans every year, yet all it seems
that the media is interested in is inaccurately portraying the dietary
supplement industry as dangerous and "unregulated." I think a
little perspective is in order.
-
- Consumer Reports "Dirty Dozen"
-
- Recently, Consumer Reports came up with what they referred
to as the "Dirty Dozen." Actually, this report is actually the
stimulus of this editorial. While I agree that some of the compounds listed
are potentially harmful, when you take a look at the list as a whole it
is laughable compared to the dangers of even as something as simple as
aspirin. What am I talking about? It is a well established fact that each
year the use of aspirin and other NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs) accounts for an estimated 7,600 deaths and 76,000 hospitalizations
in the United States." NSAIDs include aspirin, ibuprofen, naproxen,
diclofenac, ketoprofen, and tiaprofenic acid.
-
- While I agree that androstenedione (or andro, for short)
is certainly not a dietary supplement and that aristolochic acid and pennyroyal
oil are definitely hazardous, most of the health food stores that I have
been in do not carry these products or others on the Consumer Reports list.
For example, the natural product industry has been aware of the dangers
of the pyrrolizidine alkaloids found in comfrey for almost 20 years. In
fact, I haven't seen a comfrey product designed for oral use containing
these compounds in a health food store in the last 15 years or so. Now,
I could be wrong and there could be some loose comfrey being sold as a
tea out there, but my point is that is comfrey really a public health hazard?
My point here is if you really take a look at some of the other members
of the 'dirty dozen', you will see that they pose little risk simply because
they are not widely available.
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- The media keeps harping on the dangers of ephedra, but
was ephedra really all that bad? My feeling is that it was the abuse of
ephedra that was the primary issue. Used responsibly at appropriate dosages
there is no question that ephedra is a safe and effective natural product.
Granted, there was the tendency of abuse because of the typical American
belief that if a little is good, a lot is even better. But, again let's
try to keep things in perspective. In the worst case scenario, over the
last 20 years ephedra was linked to approximately 150 deaths (virtually
all of which were related to excessive dosage or abuse). In contrast, approximately
2,000,000 people in the United States died from adverse drug reactions
including over 140,000 deaths caused by aspirin and other NSAIDs.
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- Taking anything by mouth, whether it is a food, drug,
or supplement requires some personal responsibility. But, the relative
risk of danger from taking a nutritional supplement or herbal product is
substantially less than that seen with prescription and over-the-counter
drugs. That fact is very clear.
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- Table - Consumer Reports Dirty Dozen Androstenedione
(or andro, for short) Aristolochic acid Bitter orange Chaparral Comfrey
Germander Kava (or kava kava) Lobelia Organ/glandular extracts Pennyroyal
oil Skullcap Yohimbe
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- Adverse Drug Reactions (ADRs)
-
- It has been difficult to get a true accounting of the
scope of the problem with adverse drug reactions. Why? It is because fewer
than 10% of all such effects are ever reported. Reporting ADRs to the FDA
is a voluntary system even if the drug caused significant harm or even
death. The data that does exist on the scope of the problem with ADRs is
staggering. For example, based upon detailed analysis and projections presented
in the most respected medical journals including the Journal of the American
Medical Association it is estimated that 6.7% of hospitalized patients
have a serious adverse drug reaction with a fatality rate of 0.32%. This
translates to more than 2,216,000 serious ADRs in hospitalized patients,
causing over 106,000 deaths annually.[1] These sobering statistics do not
include the number of ADRs that occur outside the hospital or the estimated
350,000 ADRs that occur in U.S. nursing homes each year.[2]
-
- If we put these statistics into monetary figures it is
estimated that the cost of drug-related illness and mortality is likely
now over $200 billion annually.[3] To put this dollar amount into perspective
this amount is more than the total cost of treating diabetes or heart disease
in the United States.
-
- The obvious question is "Why are there so many ADRs?"
There are many reasons. Here are just a few.
-
- * First, more people are being placed on drugs than ever
before. For example, roughly 4 billion prescriptions were filled last year.
That is about 12 prescriptions for every person in the United States.
-
- * Second, more and more people are being placed on a
combination of drugs - many times to deal with side effects caused by some
of the other drugs. The rate of ADRs increases exponentially after a patient
is on 4 or more medications.[4]
-
- * Third, many of the newer drugs are more dangerous than
older drugs. The FDA has approved many of these drugs without complete
safety data. Drug companies can now pay a fee to speed up approval. Of
the 548 new drugs approved by the FDA from 1975-1999, 56 of these (10%)
were given a new black box warning because of severe ADRs or were withdrawn
from the market because of reports of deaths.
-
- * Lastly, the majority of health complaints patients
see doctors for owe their origin to dietary and lifestyle factors. Trying
to treat the symptoms with a drug (a biochemical band-aid) fails to address
the underlying cause and leads to side effects as a result.
-
- One of the big reasons why more people are relying on
drugs more than ever before is direct to consumer advertising by drug companies.
Prior to 1997 drug companies were prohibited from marketing their product
directly to consumers. If you watch the evening news or soap operas, or
read magazines like Time and Newsweek or read newspapers, it is clear that
ads for prescription and over-the-counter drugs dominate advertising. In
fact, the marketing budget alone of the drug companies is 50% greater than
the total retail sales for every vitamin, mineral, or herbal product sold
in the United States through any channel of trade. Direct to consumer advertising
is estimated to have increased the number of prescriptions last year by
nearly 30 million. As an example of the power of direct to consumer advertising,
the sexual potency drug, Viagra, can probably serve as the poster child.
Within a few months of its introduction, several million men began taking
Viagra, and many serious side effects, including fatalities, suddenly appeared.
-
- The FDA has no idea on how deep the problem with ADRs
runs relying on their current reporting system. For example, the FDA receives
an average of 80 reports each year about adverse reactions caused by the
drug digoxin. This relatively small number of reports seems to indicate
that digoxin was not a big problem. However a systematic survey of Medicare
records revealed 202,211 hospitalizations for adverse reactions to digoxin
during a seven-year period.
-
- The Power of the Drug Companies
-
- Two years ago an entire issue of the Journal of the American
Medical Association (JAMA 2002 vol. 287 #21) was devoted to looking at
some major problems with the relationship between drug companies, physicians,
the FDA, and medical journals. Here are just of few of the findings:
-
- * More than half of the experts hired to advise the government
on the safety and effectiveness of drugs have financial relationships with
drug companies that will be helped or hurt by their decisions.
-
- * Federal law generally prohibits the FDA from using
experts with financial conflicts of interest, but the FDA has waived the
restriction more than 800 times from January 1998 to June 2000.
-
- * Approximately 85% of authors of "Clinical Practice
Guidelines" are financially dependent upon drug companies.
-
- * Of 359 studies from JAMA, NEJM, BMJ, AIM, & Lancet
only 26 did not contain misleading statistics.
-
- * Of new releases on studies receiving drug company financing
only 22% reported the source of funding.
-
- * Negative findings are suppressed.
-
- One of the conclusions of the editors was that the issues
presented "underscore that the findings presented in the press and
medical journals are not always facts." I think these issues have
far greater social significance than some of the "non-issues"
that the media have tried to create over the last few years in regards
to natural products. Wouldn't you agree?
-
- The Bottom Line
-
- It seems that the FDA seems intent on trying to create
a shroud of doubt on the safety of natural products. The media feeds on
this attempted frenzy and repeatedly states that the dietary supplement
industry is "unregulated." I don't understand how that statement
can continually pop up in the media when there are well-established federal
regulations governed and enforced by the FDA regarding the safety and manufacture
of dietary supplements. I hope that the media is not being swayed into
a bias against the supplement industry just because a major portion of
its advertising revenue is coming from the drug companies.
-
- My suggestion to the FDA is that instead of focusing
energy on trying to create issues with the supplement industry, it would
serve us better by developing programs and procedures to better protect
us all from a much more significant danger - adverse drug reactions. In
addition, it seems that the FDA should attempt to do a better job of separating
itself from the interests of drug companies and instead better serve the
public's interest. If that were the case, I think there would be a dramatic
move towards the promotion of the use of natural products to promote health.
-
- Key References:
-
- [1] Pomeranz B, Corey PN. Incidence of adverse drug reactions
in hospitalized patients: A meta-analysis of prospective studies. JAMA
1998;279:1200-1205. [2] Avorn J, McCormick D, Jain S, Eckler M, et al.
Incidence and preventability of adverse drug events in nursing homes. Am
J Med 2000;109(2):87-94. [3] Johnson JA, Bootman JL. Drug-related morbidity
and mortality. A cost-of-illness model. Arch Intern Med 1995;155(18):1949-1956.
[4] Jacubeit T, Drisch D, Weber E. Risk factors as reflected by an intensive
drug monitoring system. Agents Actions 1990;29:117-125.
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- © 2004 www.doctormurray.com http://www.doctormurray.com/newsletter/2-8-2004.htm
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