Philip Morris
Book Burning
Fields
- Author
- Oliver, S.
- Type
- MAGA, MAGAZINE ARTICLE
- Area
- NICOLI,DAVID/OFFICE
- Attachment
- 2046936814/2046936816
- Site
- W6
- Request
- Stmn/R1-072
- Stmn/R1-079
- Named Person
- Bush
- Clinton
- Goodman, J.C.
- Gramm, P.
- Kazuhiko, A.
- Kessler, D.
- Levine, S.
- Matthews, M.
- Novack, J.
- Reich, W.
- Scott, K.
- Wright, J.
- Document File
- 2046936725/2046937271/Missing
- Named Organization
- FDA, Food and Drug Administration
- G Men
- Highland Lab
- Life Extension Foundation
- Market Forces
- Natl Center for Policy Analysis
- Nutricology
- Omni Magazine
- Centers for Disease Control + Prevention
- Author (Organization)
- Forbes
- Litigation
- Stmn/Produced
- Master ID
- 2046936726/6992
- 2046936726 Table of Contents
- 2046936727 A
- 2046936728-6731 FDA's Legally Suspect Actions Invite Challenge
- 2046936732-6735 FDA Paralysis Raises Health Care Costs
- 2046936736-6739 the Real Problem with Health Care in America: While Dr. David Kessler's FDA Fiddles, Medical Approvals Lag and Americans Die
- 2046936740-6743 What the FDA Doesn't Want You to Know Could Kill You
- 2046936744-6751
- 2046936752-6759
- 2046936760-6762 Guide to Medical Device Regulation FDA Issues First Warning Letter Citing Gmp Problems Under New Cpg
- 2046936763-6766 the Vitamin Uprising
- 2046936767-6780 Losing the Edge Overseas Patients Reap the Benefits of U.S.Research While Those Here Wait
- 2046936781-6783 Losing the Edge
- 2046936784 Feds: Toughen Regulation, Promote Research Improvements Needed, and They Are on the Way
- 2046936785-6786
- 2046936787-6789 Challenging FDA Authority
- 2046936790-6793 Speakeasies in A New Age of Prohibition
- 2046936794-6798 Who Is Happiest Politician in Washington Over Whitewater? Alfonse D'amato - Newt Gingrich - David Kessler?
- 2046936799-6800 Pro-Free Enterprise Group Challenges FDA's Authority to Regulate Drug Companies' Speech
- 2046936801-6802 Wlf Off-Label Use Suit Heats Up
- 2046936803-6805 Just Call Me 'doc'
- 2046936806-6810 Food and Drugs and Politics
- 2046936811-6813 Science and Technology Getting the Lead Out
- 2046936814 Forbes Fear of Falling 5 Ways to Protect Yourself in Scary Times
- 2046936817 If A Murderer Kills You, It's Homicide If A Drunk Driver Kills You, It's Manslaughter If the FDA Kills You, It's Just Being Cautious
- 2046936818-6820 Frustration for Medical Innovators
- 2046936821 Block That Innovation
- 2046936822-6823 Getting Even
- 2046936824-6826 Biotech Pipeline: Bottleneck Ahead
- 2046936827-6829 Consuming Interest Are We Safe From the FDA?
- 2046936830-6839 Saying Yes to Drugs Policy Analysis
- 2046936840-6858 Deadly Overcaution: FDA's Drug Approval Process
- 2046936859 B
- 2046936860-6861 Litigation Update Wlf Wins Suit Against FDA to Stop Overregulation of Heart Valves (Washington Legal Foundation V. Shalala)
- 2046936862-6863 Litigation Update Wlf Opposes FDA Efforts to Dismiss First Amendment Lawsuit (Washington Legal Foundation V. Kessler)
- 2046936864-6867 Dickinson's FDA Review
- 2046936868-6869 Wlf Urges Appeals Court to Enjoin Federal Policy Restricting Human Heart Valve Transplant (Washington Legal Foundation V. Shalala)
- 2046936870-6871 FDA Problems Slow US Andas
- 2046936872-6873 Taking the Heat An Aids Patient Champions A Risky Blood Treatment Banned in the U.S.
- 2046936874-6876 New Study Says Breast Implants Are Not A Health Risk
- 2046936877-6878 Wlf Sues FDA to Overturn Policy Restricting Information on Off-Labels Uses of Approved Drugs and Devices (Washington Legal Foundation V. Shalala)
- 2046936879 Ex-Inspector of F.D.A. Is Convicted of Bribery
- 2046936879A FDA Has No Position Yet
- 2046936880-6881 M-D-D-I Reports - 'the Gray Sheet'
- 2046936882 FDA Halts Test on Device That Shows Promise for the Victims of Cardiac Arrest
- 2046936883 Law Concerning Medical Devices Is Often Ignored
- 2046936884 Dairies, Drugs and Accusations
- 2046936884A FDA to Launch Campaign on New Labels for Food
- 2046936885 Probe of Three FDA Officials Sought Industry Ties Before Approval of Bovine Growth Hormone Are at Issue
- 2046936886-6889 Safety First How A Device to Aid in Breast Self-Exams If Kept Off the Market Other Nations Approved It But U.S. Demands Proof Simple Pad Isn't Risky Nine Year Battle with the FDA
- 2046936890-6892 Who Will Regulate the Regulators? If You Make A Mistake, Shouldn't You Own Up? Not If You're the FDA, Epa, or Ftc
- 2046936893-6894 None - A - Day Is the FDA Out to Take Your Vitamin?
- 2046936895 Will A New Government Program Net the Bad Fish?
- 2046936896-6897 FDA Responds to Wlf Petition Regarding Off-Label Drug Use by Indefinitely Postponing Issuance of Regulatory Guidelines
- 2046936898-6905 FDA Research: Overview
- 2046936906-6910 Government Report Finds Levels Safe Pesticide Residues in Your Children's Food
- 2046936911-6912 Wlf Urges FDA to Rescind Policy Restricting Information Flow on Off-Label Uses of Approved Drugs and Devices
- 2046936913 Regulatory Chokehold FDA Red Tape Dooms Transplant Drug
- 2046936914 FDA Called Lax in Overseeing Medical Sterilizers, Disinfectants
- 2046936915 FDA Sets Labeling Rules for Dietary Supplements Nutritional Data, Support for Health Claims Required
- 2046936916 Chemicals That Taint Seafood Concerns Continue Over Safety of Methylmercury Inspection Processes
- 2046936917 Lifesaving Devices Languish at the FDA
- 2046936918-6919 Wlf Sues FDA to Enjoin Federal Policy Restricting Human Heart Valve Transplants (Washington Legal Foundation V. Shalala)
- 2046936920 What's in Food? Answers Differ at 2 Agencies Manufacturers Fight to Keep FDA Label Rules From Encroaching on Ftc Ad Rules
- 2046936921 Reform the FDA
- 2046936922 Legal Beat FDA Approval Shield Firms in Injury Suits
- 2046936923 Water From A Bottle
- 2046936924 Commentary FDA and Our Split Medical Persona
- 2046936925-6926 FDA Assailed for Slow Testing of New Drugs
- 2046936927 Andrews Office Products Capitol Heights, Md (K)
- 2046936928-6947 Statement by David A. Kessler, M.D. Commissioner of Food and Drugs Before the Committee on Energy and Commerce Subcommittee on Health and the Environment U.S. House of Representatives
- 2046936948-6961 Filthy Food,Dubious Drugs, and Defective Devices: the Legacy of FDA's Antiquated Statute A Staff Report
- 2046936962-6968 Gao Reports on FDA-Related Topics 860000 to Present
- 2046936969 D
- 2046936970-6985 Statement by Louis W. Sullivan, M.D. Secretary of Health and Human Services Before the Committee on Labor and Human Resources U.S. Senate on the Final Report of the Advisory Committee on the FDA
- 2046936986-6992 Proposed Remarks of Dr. Charles Edwards Before the Senate Committee on Labor and Human Resources
Related Documents:
Document Images
5K
5rsce/et
,3i Crystai
n IYunlth
If the Food & Drug Administration doesn't like a vitamin, should it
be allowed to control literature about that vitamin?
Book
burning
By Suzanne Oliver
IN THE U.S. you can legally open a
health food store and sell capsules of
coenzyme Q10, a nutritional supple-
ment that supposedly boosts heart
performance. You can also open a
newsstand to sell magazines with arti-
cles touting the supposed medical
benefits of coenzyme Q10.
But don't try to open the news-
stand in vour health food store. If you
do, the Food & Drug Administration
can confiscate both coenzvmes and
magazines and maybe have you
thrown in the cooler.
In 1989 the FDA told Kenneth
Scott, owner of nutritional supple-
ment maker Highland Laboratories,
in Mount Angel, Ore., he couldn't
send out article reprints with his prod-
ucts. According to the FDA, a reprint
Forbes June 21, 1993
constitutes a health claim if it's dis-
tributed with the product. Make a
health claim about a vitamin and it
becomes subject to FDA approval.
So Scott set up his daughter, Kim,
in the business of mailing out reprints.
Scott's vitamin customers were sent
order forms for article reprints, in-
cluding a reprint of an article extolling
coenzyme Q10 from the February
1987 issue of Osnni magazine. Scott's
daughter mailed the reprints free to
customers who requested them.
In October 1990 FDA agents and an
armed U.S. marshal entered Kim
Scott's home and seized the Ornni
reprints. Other contraband seized by
the G-men included newspaper and
journal articles.
Under Dr. David Kessler, a Bush
= LEFT: Stephen Levine,
owner of NutrlCology
' BELOW. Dr. Jonathan Wright
at his Tahoma Clinic
in Kent, Wash.
The FDA doesn't just police
their nutritional supplements;
it polices their journal
reprints.
®
Administration appointee retained by
President Clinton, the FDAis one very
busy beehive. Its 8,500 employees
certify food colors, supervise drug
manufacturing practices, review pre-
scription drugs-the list of duties
goes on and on. The FDA's mandate
also includes confiscating literature
the agency doesn't approve of, if the
literature is too closely connected to
the sale of food, drugs or devices.
The FDA has cut out a lot ofwork for
itself. Medical journals are full of stud
ies connecting nutrition to disease
prevention, the recent discoveries on
vitamin E and heart disease being a
telling instance. But there is only one
health claim about nutritional supple
ments the FDA has approved, and that
is that extra calcium may help protect
the elderly against osteoporosis.
What about the well-documente.i
fact that folic acid supplements redu:c
a woman's chance of giving birth tc, a
babv with severe nen,ous svstem dc
formities: This one hasn't vet been
formally approved by the tortot+r
FDA, notwithstanding that a sister
government agency, the Centen tor
Disease Control & Prevention, has
recommended folic acid supplemcnts
to voung women in its Alorbsdin~
Tjlortcrlitv Weeklv Report. In theorv,
then, if you were to sell folic acid
capsules and at the same time hand
out copies of the CDC's newsletter, the
FDA could seize both the capsules and
the newsletter. (The FDA tells us a
formal policy is in the works and not
to worrv. )
The FDA has burned books before.
In the 1950s, for example, psychia-
trist Wilhelm Reich sold an "orgone
box"-a device made from phwood,
fiberglass and steel that supposedly
65

FDA
accumulated energy from the atmo-
sphere and revitalized a patient. The
FDA in 1956 destroyed the boxes and
burned Reich's books and papers.
Reich died in prison.
Three decades later, the FDA is still
valiantly fighting quack medicine. On
May 6, 1992 FDA agents and ten
police officers, one with gun drawn,
burst into the Kent, Wash. clinic of
Jonathan Wright, a medical doctor
specializing in nutritional treatments
for illness. During a 14-hour raid the
officials seized injectable vitamins,
. minerals and glandular extracts, as
well as newsletters published by
Wright containing articles on presen-
ing health through diet.
The FDA has also seized newsletters
published by the 10,000-member
Life Extension Foundation.
In 1987 the FDA asked NutriCol-
ogy, a San Leandro, Calif. nutritional
supplement maker, to stop selling the
book Miracle Cure: Organic Germa-
nium, bv Kazuhiko Asai. The firm's
owner is Stephen Levine, who holds a
Ph.D. in molecular genetics from
Berkeley. Levine took the book ot}-
the market, but he's still trying to sell
his germanium, linseed oil, borage
seed oil and coenzvme Q 10 (all avail-
able at health food stores) to a mail-
order clientele of doctors. The FDA is
pursuing a case against him.
Okav, maybe Levinc's theories are
bunk. But maybe they aren't. Do we
rcallv want Dr. Kessler dcciding the
matter? ~
Wilhelm Reich, orgone energy theorist
In 1956 the FDA burned his books.
The Clinton Administration wants to reform
the health care system by giving Big Brother
more power. Two think-tankers-and a leading
Republican senator-want to revolutionize
the system by giving individuals the ultimate say in
how their health care dollars are spent.
All power to
the patients
An interview with John C. Goodman
and Merrill Matthews by Janet Novack
IkiAGIhE AN OLD MAN dying from in-
operable lung cancer. At a cost of
$50,000 his doctor can keep him alive
for another two months, at best. Eco-
nomic and moral question: Who's to
say whether prolonging the patient's
life is a sensible use of S50,000?
One answer to that question is big
government. Most proposals to re-
form U.S. health care spending as-
sume that market forces cannot ratio-
nalhy allocate health care dollars;
therefore politicians and/or health
care bureaucrats have to step in. This
is the logic behind so-called managed
Competition reform proposals.
But there is another answer. John
C. Goodman and Merrill Matthews,
of the National Center for Policy
Analysis, in Dallas, want to give health
care decision making power to indi-
vidual patients and their tamilies.
How? A plan based on their ideas
that Senator Phil Gramm (R-Tex.)
intends to sponsor is still evolving. As
it now stands, it would allow 54,500 a
year to be put into a family's medical
t2~,-a savings account designed to
pay for routine medical expenses like
checkups, diagnostic tests and minor
surgery. The contribution to the
medical itt.a would qualif<, for a tax
break, either a deduction or a tixed
credit against taxes; the credit might
be structured to provide more dollars
of tax savings to the lower income. If
an employer paid the $4,500, it
would be treated as taxable income to
the employee, who would then re-
ceive a tax break.
What about really big medical bills?
Part ofthe annual $4,500-$1,000 to
52,000-would be used to buy a
catastrophic care insurance policy, to
cover expenses arising from, say, a
heart attack. The unused money in
the account would compound tax
free. If the account got large enough,
some of the cash could be used for
nonmedical expenses such as educa-
tion. For people below a certain in-
come level, the government would
put cash in their medical ims, with the
amount depending on their income.
Alternativelv, the whole $4,500
could be used to buy an insurance
policy with low deductibles. Or to
join a group health plan. The essential
point: Only if individuals are spend-
ing their own money will health care
decisions be rationally made and the
market given a chance to work.
FoitBEs recently spoke to Good-
man and Matthews about health care
reform and medical tttAs.
Goodman: We have far and away the
best health care available in the world,
and it would be terrible if reform lost
that. There's nothing wrong with ~
spending 14% of our national income p
on health care if we're getting our ~
money's worth. But we're not. [The C'~
third party payment system encour- ~
ages] both patients and doctors to W
waste a lot of money. On average, ~
only 20 cents of each dollar comes ~
directly out of patients' own pockets; N'+
the rest is paid by employers, insur- ~
66 Forbes June 21, 1993
