The Durk Pearson & Sandy Shaw®
LIFE EXTENSION NEWS
VOLUME II - ISSUE #2 - MARCH 1999

Something very important has happened since our last newsletter. We are very happy to report that:

We Win Our First Amendment Suit Against FDA!!
Freedom of Speech Lives!!
On Jan. 15, 1999, in a landmark decision, a panel of the
U.S. Court of Appeals for the District of Columbia Circuit, ruled
3-0 in favor of plaintiffs (that's us!), deciding that the FDA's
health claim approval process was unconstitutional under the First Amendment and "arbitrary and capricious" under the Administrative Procedure Act. Winners of this case include us, our co-plaintiff the American Preventive Medical Association, and (added to our case from a separate appeal) Citizens for Health. Additional winners (who filed an amicus brief in support of our First Amendment challenge of FDA regulations) were: Direct AIDS Alternative Information Resources, People Against Cancer, and the Foundation for Advancement of Innovative Medicine. In addition to the Department of Health and Human Services, Food & Drug Administration, and the United States, other losers (who filed an amicus brief supporting the FDA information restrictions) were: American Cancer Society, American Heart Association, Center for Science in the Public Interest, Public Citizen, and Consumer Federation of America.

Special Thanks
We met constitutional attorney Jonathan Emord as a result of publishing our 1993 book, Freedom of Informed Choice: FDA vs. Nutrient Supplements (still available from Common Sense Press for $6.95, (800)542-3230) and of our reading his excellent paper, "The Doctrine of Commercial Speech in First Amendment Jurisprudence," Cato Institute Policy Analysis (Sept. 23, 1991). Jonathan has skillfully argued our FDA suit from its initial filing in 1994 through the legal mazes to this long-awaited victory. (The FDA may appeal, but we do not expect they will be able to reverse this decision.) We spent a lot of our own money in this case, but also got major help along the way in paying the legal bills from Julian Whitaker, M.D., and the American Preventive Medical Association. Some additional financial help came from the National Health Federation, Life Enhancement Products, Life Extension Foundation, Greg and Michelle Pryor of Life Priority, Inc., and a few others who wish to remain anonymous. An analysis of the decision, as well as our briefs and oral arguments, may be downloaded from www.emord.com.

Those of you who have followed our work know that we have been publicly critical of the FDA for many years, including a long section (Appendix E) in our #1 bestseller Life Extension, a Practical Scientific Approach. In Freedom of Informed Choice, we specifically focused on the deleterious consequences of FDA's regulations of "health claims" and why we thought these regulations violated the First Amendment's protections of speech and press. If you want to improve human performance and extend human lifespan, it is not enough to do research. You have to be able to turn research findings into practical products people can buy and use, and you have to be able to inform people of what those products do; the FDA has long stood as the major barrier to these ends.

Suiting Up
The suit started for us in 1993, when we began filing Public Comments in response to the FDA's proposed rules regulating what health claims they would permit for dietary supplements.2 As far as we were (and are) concerned, the Constitution's First Amendment makes it clear that the federal government has no authority to regulate truthful speech at all. It seemed to us that the idea that "commercial speech" (what you say when it accompanies a commercial transaction) is somehow less deserving of constitutional protection than other kinds of speech (though the First Amendment says nothing of the kind) makes those of us involved in commercial transactions - either as buyers or sellers - into second class citizens. We had already become aware of this "commercial speech" doctrine by 1986 and realized that it was allowing government agencies, such as the FDA, unprecedented control over the communication of truthful scientific information when it accompanied a product.

FDA Censorship of Truthful Information Kills
In our Freedom of Informed Choice: FDA vs. Nutrient Supplements, we discussed the constitutional and scientific issues of FDA's regulation of the dissemination of scientific information. We explained what a disastrous effect upon the public health the FDA was having by drastically slowing the flow of truthful health information concerning dietary supplements, such as antioxidant vitamins. (We also included several diabolically nasty cartoons aimed at the FDA.) One of our examples was low-dose aspirin. In the "Physician's Health Study" published in 19891, it was reported that in previously healthy men over 50, an aspirin every other day reduced the risk of a first heart attack by about 44%. Ten years later, the FDA still unconstitutionally prohibits aspirin companies from communicating this information to the general public. (It only decided a few months ago to allow the information to be communicated to doctors!) During this period, hundreds of thousands of people have died from heart attacks unnecessarily because they did not know about and were not taking low-dose aspirin (the latest evidence places the most protective dose for most people over 50 in the range of 1/4 to 1/2 aspirin a day - we take 1/4).

"Commercial Speech" in the Courts
We began reading the entire text of U.S. Supreme Court decisions in "commercial speech" cases in 1993 to learn how the Court and how individual Justices viewed the constitutional limits on government regulation of advertisements and of product labels. We found a well developed jurisprudence that provided for an awkward (and, to our minds, unsatisfactory) "balancing test" (of free speech vs. government interests in regulating speech) that attempted to allow yet provide limits to government regulations of truthful speech accompanying the sale of a product. We considered FDA's regulations on truthful health claims to have gone beyond the bounds set by the Court and by Congressional statutes and far beyond the bounds set by the clear language of the First Amendment ("Congress shall make no law . . .abridging the freedom of speech or of the press") and filed suit against the FDA in 1994. We thought, in doing so, we might push the envelope on freedom of speech to help restore constitutional restraints on government regulation of "commercial speech."

The D.C. Appeals Court in our case logically developed the consequences of prior U.S. Supreme Court decisions concerning First Amendment limitations on governmental censorship, with particular focus on the communication of scientific information as part of "commercial speech." As we had hoped, this decision has enlarged the boundaries of freedom of speech recognized by the Courts as being clearly beyond constitutional federal government regulatory power.

Courts Do Not Usually Consider Constitutional Arguments
In fact, the Court did something very unusual. Courts generally examine constitutional challenges to laws after they have considered procedural challenges. If a law can be thrown out on a procedural basis, a Court will almost always do that in preference to taking on a constitutional challenge. Rarely do the constitutional questions get a review. In our case, however, the Court stated, "Normally we would discuss the non-constitutional argument first, particularly because we believe it [that an undefined standard is no standard] has merit. We invert the normal order here to discuss first appellants' most powerful constitutional claim, that the government has violated the First Amendment by declining to employ a less draconian method - the use of disclaimers--to serve the government's interests [of protecting the public from misleading information]" Thus, the Court said, "even if 'significant scientific agreement' were given a more concrete meaning, appellants might be entitled to make health claims that do not meet that standard - with proper disclaimers." (The Court decided this, though it was not one of the issues we raised in this case because we didn't think the courts were ready for it! it looks to us as if they are pointing the way for the FDA -- how, if they take the decision seriously, they can thereby avoid both violating the First Amendment's constitutional prohibitions and the otherwise inevitable next FDA First Amendment suit!)

The Court's discussion of the First Amendment implications of the FDA's not permitting disclaimers was a response to our complaint that the FDA refused to permit four claims that we wished to make. They prohibited all four proposed claims (such as "antioxidant vitamins may reduce the risk of certain cancers" and "omega-3 fatty acids may reduce the risk of cardiovascular disease") by claiming that there was not "significant scientific agreement" (which they would not define) and would not permit us to qualify the claim by including, for example, information about the limits of the current evidence of cancer risk reduction by antioxidant vitamins and what types of evidence exist (cell cultures, animal, clinical studies, epidemiological studies, etc.). The Court established that there is a clear First Amendment preference for more information rather than less, and the use of disclaimers to correct potentially (but not inherently) misleading information must be considered by the agency.

Undefined Standard is No Standard At All
One specific rule the new decision throws out is the FDA's purported "significant scientific agreement" standard for health claims. The Court agreed with our argument that the FDA has established no standard since the FDA has refused to define what "significant scientific agreement" means. This is a statutory violation because Congress required in the DSHEA that the FDA establish a procedure and standard for accepting health claims.3
The FDA will now have to proceed with new rulemakings in which it attempts to decide what "significant scientific agreement" might mean when they cannot define it simply as whatever the FDA says it is on a case by case basis. We think it likely that the FDA will first attempt to propose the same old unconstitutional rules dressed up in new verbiage. You can be sure we will be filing Public Comments!

The Court appears to have found some of the government's arguments a bit ridiculous. For example, on page 10 of the decision, the Court notes, "As best we understand the government, its first argument runs along the following lines: that health claims lacking 'significant scientific agreement' are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale. (emphasis in original) It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous." Both of us got a good laugh out of that. See the excerpts from the oral arguments below (ADDENDUM) for even more laughs.

The FDA Does Not Approve This Claim
The Court also said, "The government's general concern that, given the extensiveness of government regulation of the sale of drugs, consumers might assume that a claim or a supplement's label is approved by the government, suggests an obvious answer. The agency could require the label to state that 'The FDA does not approve this claim.'" We had suggested such an approach, which we called a "split label," in our early Public Comments to the FDA, but the FDA rejected it. Perhaps they were concerned that people might see 'The FDA does not approve this claim' everywhere and wonder why they needed the FDA in the first place. In fact, the FDA has approved only two health claims for dietary supplements during the entire eight year period since the Nutrition Labeling and Education Act required the FDA to review and approve health claims for dietary supplements and foods.

Consequences of this Court Decision
This decision has made us feel great (as a friend of ours put it, we feel "like the 'minutemen' did!") It is possible, with enough conviction, careful choices of case, court and attorney, plus time and money, to bind the federal government down with the chains of the Constitution. The result of this decision is going to be immense, though there seems to be almost no notice yet in the mainstream press. Greater freedom of speech is going to dramatically increase the market potential of the dietary supplement industry, with much more information about products being supplied to consumers. As consumers learn more about the effects of dietary supplements, they will become more sophisticated in evaluating available products and far less likely to believe lies (whether from private or government sources). As with any new technology, it will take consumers a while to sort things out and locate and stick with reliable sources of information. Fly by night outfits may do well in the short run but suppliers of truthful and nonmisleading information about dietary supplements, as well as those who receive the information, will come out the long-term winners.

Because of extensive and burdensome government regulations of medicine and medical insurance, alternative medicine (for example, dietary supplements) is one of the few areas of medical practice that is still in a free market in which consumers pay with their own money and get what they pay for. We hope that those alternative medical practitioners and their patients who want to require taxpayer coverage of alternative medicine under Medicare and other government programs are not successful in getting their wish because the result would be to help the government take over and destroy the freedom we currently enjoy in alternative medicine. He who pays the piper calls the tune . . . .

Speaking of Government Takeover of Medical Practice:
The Federal Government Has No Constitutional Authority to Regulate Intrastate Use of Medical Marijuana
We also have a suit filed with the U.S. District Court for the District of Columbia (97CV00462(WBB)) challenging the federal government's authority under the Constitution to take action against the intrastate prescription and use of medical marijuana in states where that is legal, on the basis of the First, Ninth, and Tenth Amendments, and the limits of the Commerce Clause4. This case is not about whether medical marijuana is a good medication or not; it is about whether the federal government has constitutional authority to regulate the intrastate practice of medicine and whether Congress and the "drug czar" can grant the federal government general police powers (which the constitution does not do) over medicine or anything else by the simple expedient of decreeing all commerce to be interstate.

It is, of course, impossible to predict how this will come out. We believe our constitutional arguments are very strong and there has been some movement in recent U.S. Supreme Court and lower court decisions to limit the intrastate reach of the Commerce Clause (eg., U.S. vs. Lopez, 1995; U.S. vs. Pappadopoulos, 1995). Still, there are those in the judiciary who care much more about maintaining the federal government's usurped powers than of restoring constitutional limits to federal actions. (This is called "outcome based" jurisprudence.) It will demand considerably more courage on the part of the courts to decide in our favor than the FDA First Amendment suit did. If we win, it will vastly increase freedom of choice in medical practice by jettisoning the "one size fits all" federal government approach (the whole point of the constitutional design of federalism) to allow 50 different competing intrastate regulatory approaches. We will, however, have to raise more money for the appeal (whether it is the government or ourselves who file it) after the District Court decision on our medical marijuana/federalism suit comes down. You can download the briefs and oral arguments for our medical marijuana suit from www.emord.com.

Is this fun or what? Yes, but only when you win.

References

    1 "Final Report on the Aspirin Component of the Ongoing Physicians' Health Study," New England Journal of Medicine 321(3):131-135 (July 20, 1989)

    2 The reason for filing comments during the Public Comment period after an agency has published a proposed rule in the Federal
    Register is not because you expect the agency to care what you
    have to say, but because it gives you standing to sue. If you do
    not file comments on a proposed rule and are later injured by it,
    you cannot go directly to the federal courts to challenge the
    rule; you have to first "exhaust your Administrative remedies,"
    which means spending a lot of money in the agency's internal
    Administrative court where you cannot hope to win.

    3 It is also unconstitutional because the Constitution authorizes
    only one federal institution to make laws, the Congress. See
    U.S. Constitution, Article I, Section 1. The federal agencies
    can carry out the will of Congress pursuant to Congressionally
    created law, but cannot make rules in the absence of statutory
    authorization. This is a constitutional principle that is widely
    flouted by federal agencies. (For one thing, why limit your
    rulemaking to that authorized by Congressional statute when
    nobody in a regulatory agency has ever been thrown in jail or
    lost their job or even been disciplined by the Congress for
    making law that went beyond or even defied the explicit will of
    Congress as expressed in statute?) A time is rapidly approaching
    when a properly chosen regulatory agency rule or rules should be
    challenged on the basis of Article I, Section 1 of the
    constitution; however, we didn't judge that this case was the
    right one for such a challenge or that the courts were ready for
    it.

    4 Our co-plaintiffs include Julian M. Whitaker, M.D., Jeffrey A.
    Singer, M.D., Richard D. Fisher, M.D., Henry N. Blansfield, M.D.,
    William Regelson, M.D., American Preventive Medical Association,
    and Life Extension Foundation. Our thanks to these brave people!

ADDENDUM: Oral Arguments in Pearson & Shaw et al v. Shalala et al.
You can learn a lot about a court and its judges by
listening to oral arguments, in which there is usually a lively interaction between each side's attorney and the judges, who interrupt frequently to ask questions and make comments, sometimes pointed and humorous. Unfortunately, we were not able to travel to Washington, D.C. to hear oral arguments, so we did the next best thing by getting and reading the transcript of the
oral arguments. The following short excerpt shows how dubious
the judges were of the FDA's position that unapproved health
claims are inherently misleading.

THE COURT: . . . Do you seriously argue that these statements
are inherently misleading?

MS. KOHL [Christine N. Kohl, representing the FDA]: In the
FDA's judgment, Your Honor, yes, they are. There is such power
over the consumer in the market place at the point of sale . . .

THE COURT: . . . what if the proposed statement were exactly
what your FDA's parent Agency [HHS] said, quote, "Fatty acid
omega-3 is under study because of a possible association with a
reduced risk of heart disease in certain people." That was the
only thing they wanted to put on the label, and it was word for
word what HHS put out. Is your position that is inherently
deceptive?

MS. KOHL: Yes, Your Honor, that's the scientific judgement
of the FDA that there is not -

THE COURT: So HHS, FDA's position is that HHS is making
inherently deceptive statements.

MS. KOHL: . . . These regulations that are being challenged
apply only to labeling on the dietary supplement.

THE COURT: But why does that matter? . . . Why is it
inherently deceptive in the label, and not in the brochure.

THE COURT: Is this [that the statements are inherently misleading in a label] some impression the FDA has? Or maybe they have some study in the back. But I mean, I've got to tell
you, I walk to the grocery store all the time. . . . I just don't
get the impression that people are absolutely terrorized when
they approach a dietary supplement.

THE COURT: It's not like approaching a lawyer.

THE COURT: Yes. Label, as opposed to reading an article in a
magazine. I mean, is this something that you think it really
rises to the, you have to have a qualitatively different standard
when they go into the grocery store?

THE COURT (a few lines later): . . . But I find the argument
that this is inherently misleading is absurd . . . .

MS. KOHL: Well, Your Honor, again, it is the Agency's scientific judgment based on their -

THE COURT: Well, that's not a scientific judgment. That's a
legal judgment, isn't it?

THE COURT: . . . in order to win your case, you have to
establish that this is inherently misleading. That's basically what you are arguing, isn't it?

MS. KOHL: . . . If the Court doesn't agree with the FDA's
conclusion that these claims have so much potential for abuse
that they are inherently misleading --

THE COURT: Potential? Wait a minute counsel. You are
switching between inherent and potential. I'm trying to take out
of the case, obviously, and I think Judge Garland is too, this
inherently misleading notion.

MS. KOHL: And my response to that is, if you --

THE COURT: Is, you hate like hell to give it up, but --

THE COURT: You can't legally. They're in trouble if they
give it up.

THE COURT: I know, because the Agency said inherently misleading.


Too Early to Recommend Vitamin E Supplements
Says American Heart Association

One of the losing amici in the above case was the American Heart Association, which supported the FDA's information-restricting policies. In the Feb. 1, 1999 "Yahoo! News," there was a report on the AHA's view (from Circulation 1999;99) on the possible health benefits of taking antioxidant supplements. The AHA says, according to the report, that, although there is some evidence suggesting that diets rich in antioxidants such as
vitamins A, C, and E can reduce heart disease risk, it is still
too early to recommend the use of antioxidant supplements to the
general public. Moreover, "[a]lthough diets alone may not
provide the levels of vitamin E intake that have been associated
with the lowest risk in a few observational studies," we should
wait for more studies before making public recommendations to
take vitamin E supplements.

Why would the AHA make "wait and see" recommendations about
vitamin E supplements in the face of the astronomically high
medical and human costs of heart disease (the #1 killer in
industrialized countries and already the #2 killer in most Third
World countries), the large and growing body of evidence
supporting the protective effects of vitamin E (including both
large epidemiological and intervention studies, such as CHAOS),
as well as the low potential risk of supplemental vitamin E at
the dose levels found to be protective in prospective and
intervention studies? We don't know, but we have to wonder if someone in the AHA fears that, if people think they can substantially reduce their own risk of heart disease by taking vitamin E, they may be less likely to donate money to the AHA. As Nobel Prize winning James Buchanan's "Public Choice" theory has shown, those running large bureaucratic organizations tend to do whatever will keep money flowing into their organization.


Balloon Payment
Government is the ultimate "fly by night" organization.
Current officeholders benefit from what they do today (such as
lying and spending a lot of other people's money) and then
somebody else has to fix the resulting disaster later. This is
particularly bad for life extenders, as we intend to (or at least we are trying to) be around later.
                                     --Sandy Shaw


© Copyright 1999 by Durk Pearson & Sandy Shaw

NOTICE: The "Durk Pearson & Sandy Shaw Life Extension News" is for informational purposes only. Its contents are not intended as advice for the diagnosis, treatment, or cure of any medical condition. Pearson & Shaw are scientists, not doctors. If you have a medical condition, see a physician. Durk Pearson & Sandy Shaw® do not own any part of any dietary supplement company. They license their formulations and receive royalties on sales. The formulations they design and use are those which contain their names on the label.

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