A Matter of Perspective: Adverse Drug Reactions vs Supplement Dangers

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A Matter of Perspective: Adverse Drug Reactions vs Supplement Dangers

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A Matter of Perspective ...

by Dr. Michael Murray

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.

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.

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.

Table - Consumer Reports Dirty Dozen

Androstenedione (or andro)

Aristolochic acid

Bitter orange

Chaparral

Comfrey

Germander

Kava (or kava kava)

Lobelia

Organ/glandular extracts

Pennyroyal oil

Skullcap

Yohimbe

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:

Pomeranz B, Corey PN. Incidence of adverse drug reactions in

hospitalized patients: A meta-analysis of prospective studies. JAMA

1998;279:1200-1205.

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.

Johnson JA, Bootman JL. Drug-related morbidity and mortality. A cost-

of-illness model. Arch Intern Med 1995;155(18):1949-1956.

Jacubeit T, Drisch D, Weber E. Risk factors as reflected by an

intensive drug monitoring system. Agents Actions 1990;29: 117-125.

 

 

 

The above is taken from Dr. Murray's Natural Facts Newsletter,

2:8:2004.

 

 

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