Whole Body Health Sale

Life Extension Magazine

LE Magazine March 2005
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Death by Regulation

FDA’s Myth of Consumer Protection

The public has been deceived into believing that government “regulations” protect consumers against dangerous and ineffective products. The media, the government, academia, and even large drug companies perpetuate this myth.

For those who believe that government regulations provide a benefit, one only has to look at the cost and dangers of heavily regulated drugs and compare them to those of deregulated dietary supplements.

DRUG PRICE INCREASES NEARLY TRIPLE INFLATION RATE

On May 25, 2004, the American Association of Retired Persons (AARP) released a study showing that prices for the brand-name prescription drugs used most frequently by older Americans and available in January 2000 increased, on average, a cumulative 27.6% over the four-year period from 2000 to 2003.29

In 2003 alone, the average annual manufacturer price increase for the most widely used drugs was 6.9%, or triple the general inflation rate of 2.2%.29 Price increases that exceed the inflation rate are especially hard on retired people, whose incomes are often fixed. These steep price hikes are forcing increasing numbers of Americans to buy their prescription drugs from other countries at dramatically reduced costs.

In 1994, Congress weakened the FDA’s authority to regulate dietary supplements. Critics predicted that this would expose Americans to all kinds of dangerous and bogus products because the FDA would not be able to “protect” the consumer. Since 1994, whenever a hint of concern arises about a dietary supplement, the media and FDA blame the fact that natural products are not “regulated” and therefore pose inherent dangers.

When looking past the FDA and media’s charade about the need for regulation, an interesting pattern of truth emerges. After dietary supplements were deregulated, prices plummeted, more effective nutrients became available, and, most important, virtually no side effects occurred despite the government not overseeing content or potency.22,23

Compare what has happened with deregulated dietary supplements to heavily regulated prescription drugs. Since 1994, drug prices have spiraled so far out of control that the nation’s health care system is facing insolvency; overpriced new drugs are often no better than older drugs; no major disease has been cured; and a record-breaking number of adverse drug reactions and deaths have occurred.24-27

Those who believe they need FDA regulations to protect them are ignoring historical reality. Regulations are the underlying cause of dangerous drugs, ineffective drugs, and overpriced drugs. Regulations enable incompetent FDA officials to declare a drug “safe.” Regulations enable drug companies to exaggerate the purported benefits of drugs approved by the FDA. Regulations protect drug companies against lower-cost competition.28

The most devastating effect of regulations is that they suffocate medical innovation. The FDA has made it so complicated and expensive to get a drug approved that drug companies spend inordinate amounts of their resources just bringing out different versions of existing drugs, instead of investing in novel technologies needed to find cures for the killer diseases of aging. Getting another “statin” drug approved is easy compared to getting the FDA to understand how a new therapy might work by an unprecedented mechanism. Small companies that have innovative ideas but not a lot of money stand little chance of getting their products to market.

TABLE 1: DIETARY SUPPLEMENT PRICE REDUCTIONS FROM YEAR INTRODUCED TO DATE

Product

Year Intro-duced

Original
Strength

Original Count

Original
Lowest Member Volume
Price

Original Cost
Per Mg

Current Strength

Current Count

Current
Lowest
Member
Volume
Price

Current Cost
Per Mg

Price Reduction
to Date

Acetyl-L-
Carnitine
capsules

1993

500 mg

100 caps

$93.00

0.0018600

500 mg

100 caps

$35.00

0.0007000

62.4%

Alpha-
Lipoic Acid
capsules

1996

100 mg

100 caps

$30.94

0.0030940

250 mg

60 caps

$24.00

0.0016000

48.3%

Bilberry
capsules

1995

30 mg

100 caps

$14.96

0.0049867

100 mg

100 caps

$18.75

0.0018750

62.4%

Boswella
capsules

1992

300 mg

100 caps

$30.00

0.0010000

300 mg

100 caps

$22.50

0.0007500

25.0%

NGH powder

2000

6000 mg

325 g

$32.37

0.0000996

6000 mg

325 g

$23.25

0.0000715

28.2%

DHEA
capsules

1996

25 mg

100 caps

$20.00

0.0080000

25 mg

100 caps

$9.38

0.0037520

53.1%

Ginkgo
Extract
capsules

1994

120 mg

100 caps

$27.00

0.0022500

120 mg

365 caps

$32.63

0.0007450

66.9%

Huperzine
capsules

2000

50 mcg

60 caps

$28.13

0.9376667

50 mcg

60 caps

$18.00

0.6000000

36.0%

Methyl-
cobalamin
tablets

1998

1 mg

60 tablets

$8.63

0.1438333

1 mg

60 tablets

$6.75

0.1125000

21.8%

Methyl-
cobalamin
tablets

1998

5 mg

60 tablets

$29.63

0.0987667

5 mg

60 tablets

$17.25

0.0575000

41.8%

Modified
Citrus Pectin
powder

1995

15 g

454 g

$130.00

0.0002863

15 g

454 g

$71.06

0.0001565

45.3%

NADH
tablets

1995

2.5 mg

30 tablets

$44.00

0.5866667

5 mg

30 tablets

$18.63

0.1242000

78.8%

SAMe
tablets

1997

200 mg

20 tablets

$25.00

0.0062500

400 mg

20 tablets

$21.00

0.0026250

58.0%

Saw Palmetto
capsules

1992

160 mg

60 caps

$23.00

0.0023958

320 mg

30 caps

$9.00

0.0009375

60.9%

TMG tablets

1997

750 mg

90 tablets

$18.75

0.0002778

500 mg

180 tablets

$11.63

0.0001292

53.5%

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