Thursday, May 24, 2012

False Advertising - a New Low!!

"FTC V. POM You be the judge" is the headline in an advertisement on page A13 in today's New York Times.  The ad goes on to "inform" the consumer that an "FTC judge agreed that POM Wonderful 100% Pomegranate Juice and POMx do provide significant health benefits.  Here is what the judge said in his own words."

The ad goes on to quote out-of-context statements contained in the decision of the administrative judge in a suit brought by the Federal Trade Commission accusing the POM Wonderful Co. of false and misleading advertising vis-a-vis its claims to significantly affect matters such as prostate health and erectile dysfunction.

The ad quotes the judge's ruling:

"Competent and reliable scientific evidence supports the conclusion that the consumption of pomegranate juice and pomegranate extract supports prostate health, including by prolonging PSA doubling time in men with rising PSA after primary treatment for prostate cancer." (page 282.)

Here is the quote in context from page 282 of the decision:


As discussed above, the expert testimony regarding the studies relied upon by Respondents is conflicting. The greater weight of the persuasive expert testimony demonstrates the following: The basic research, the Pantuck Study, and the Carducci Study, relied on by Respondents, support the conclusion that pomegranate juice has a beneficial effect on prostate health. F. 1142. Competent and reliable scientific evidence supports the conclusion that the consumption of pomegranate juice and pomegranate extract supports prostate health, including by prolonging PSA doubling time in men with rising PSA after primary treatment for prostate cancer. F. 1142. However, the greater weight of the persuasive expert testimony shows that the evidence relied upon by Respondents is not adequate to substantiate claims that the POM Products treat, prevent, or reduce the risk of prostate cancer or that they are clinically proven to do so. F. 1143. Indeed, the authors of the Pantuck Study and the Carducci Study each testified that their study did not conclude that POM Juice treats, prevents, or reduces the risk of prostate cancer. F. 1055, 1056, 1084, 1085. And, as Respondents’ expert conceded, no clinical studies, research and/or trials show definitively that the POM Products treat, prevent, or reduce the risk of prostate cancer. F. 1135-1138.

Having fully considered and weighed all the evidence and the conflicting expert testimony on Respondents’ basic research and clinical trials, the greater weight of the persuasive expert testimony demonstrates that there is insufficient competent and reliable scientific evidence to substantiate a claim that the POM Products treat, prevent, or reduce the risk of prostate cancer or that clinical studies, research, and/or trials prove that the POM products treat, prevent, or reduce the risk of prostate cancer. F. 1143. Accordingly, Complaint Counsel has met its burden of proving that Respondents’ substantiation was inadequate to make the implied prostate cancer claims found to have been made in this case, and that, therefore, such claims were false or misleading.

The ad concludes with the following cited "claim" from the judge's decision:

"Competent and reliable scientific evidence shows that pomegranate juice provides a beneft to promoting erectile health and erectile function." (page 188)

In fact, page 188 cites various studies that are being examined by the court, including the one above and the one I cite below, also on page 188.

There is insufficient competent and reliable scientific evidence to show that pomegranate juice treats erectile dysfunction in a clinical sense or has been clinically proven to do so. (Burnett Tr. 2285, 2300; Goldstein, Tr. 2611; CX1289 (Melman Expert Report at 0018). See also Burnett, Tr. 2261-64).

And here is part of the court's final conclusion:

The weight of the persuasive expert testimony demonstrates that there was insufficient competent and reliable scientific evidence to support the implied claims, made in advertisements disseminated by Respondents, that the POM Products treat, prevent or reduce the risk of heart disease, prostate cancer, or erectile dysfunction, or are clinically proven to do so. Therefore, such claims were false or misleading within the meaning of Section 12 of the FTC Act, and Complaint Counsel met its burden of proving the second element of a false advertising claim.

Once again - If it seems too easy to be true - best check it out!!





Monday, May 21, 2012

Amend Our Constitution

How should our Constitution be regarded.  Aside from its organizational function, was it primarily intended to serve as a set of principles or as a set of laws.  A set of principles is forever open to interpretation and re-interpretation.  A law establishes a "rule" which, if not adhered to, results in some form of sanction.  Granting a person the right to privacy is a principle, not a law.  It does not define privacy or private acts.  Barring the sale of alcoholic beverages is a law.   Non-adherence to this law results in punishment.

Principles may be regarded differently by different people.  Since justices of the Supreme Court are people, it follows that they, too, will have a variance in opinions.  It is expected and understood.  Judgements are easier if there is legal clarity.  Basing opinions on undefined general principles will always be open to criticism.  Constitutional clarity can be achieved with constitutional amending.

Our Constitution can be amended - very difficult, but possible.  There have been only 27 amendments since 1787 (225 years), and only 17 of them since the Bill of Rights, and only 12 since those immediately following the Civil War!  It has been 20 years since the most recent amendment, the 27th, was ratified.  None of the more recent amendments deal with anything substantial, unless you consider lowering the voting age to 18, or restricting the method of determining congressional salaries as such.

We often criticize the decisions of the Supreme Court in its constitutional rulings and accuse it of legislative rather than judicial activity - of being an "activist" Court.  But it is seen as an activist Court only when it has no legislation to direct it.  There is nothing in the Constitution about abortion or about gay marriage.  The Constitution gives absolutely no guidance on such "social" or "moral" issues.  To use this document as a basis for such social decision-making is truly a stretch - no matter what side of the issues one is on.

State courts have no problems in dealing with social issues.  Quite a number of states have passed amendments to their constitutions dealing with gay marriage and abortion.  Why should it be so difficult for our legislators to do the same for our federal Constitution.  So long as the Constitution does not include specific amendments addressing these social issues, resolutions and rulings may never be permanently achieved.  It is nonsensical for gay marriage to be acceptable in New York, but not in New Jersey.  It is just wrong for the federal advantages of marriage to not apply to legal same-sex marriage because it is not recognized by the federal government.

These controversies will continue to be argued on constitutional grounds though, in fact, such grounds are non-existant - and will remain so until appropriate amendments clarifying these important social matters are added.  If we have a "living Constitution," then it deserves to "live" in modern times.  It should be re-evaluated and amended on some recurrent basis.



Tuesday, May 8, 2012

Putting a Value on Human Life


The philosopher Peter Singer has cited the following syllogism:

It is wrong to kill an innocent human being.
A human fetus is an innocent human being.
Therefore it is wrong to kill a human fetus.

The conclusions of the pro-life movement in this country are based on the second portion of this argument; that  a fetus is an "innocent human being."

Singer and others do not disagree with the second premise, but with the first; that it is wrong to kill an innocent human being.  His disagreement with the conclusion, therefore, is based on the idea that it is not always wrong to kill an innocent human being.

Arguments that a fetus, at any stage of development, is not a human life will forever remain a challenge, especially as the ability of salvage a fetus of almost any age, will eventually reach reality.  If one  accepts the second premise in the above syllogism, then the only way to endorse abortion is to agree to the first premise, as does Singer.

The only way I can place a value on human life is to measure its value when related to another human life, or human lives.  It is acceptable, at least philosophically, to sacrifice the life of one innocent person  in order to save the lives of many - the old argument of who to toss out of a lifeboat, or whether or not to avoid running over a child, when avoiding the child would result in the destruction of a busload of innocent human beings.

The life of a fetus, at any stage of development, comes into question when its life can impact negatively on the life or health of its mother.  Singer bases such decisions on "preferences."  What is the preference of the mother compared to the preference of the fetus?  A "preference" he defines as something sought to "be obtained or avoided," and to have any preference at all requires the ability to suffer or feel satisfaction.  It falls to reason that a very immature fetus could not possibly express a preference, whereas a mother certainly could.  This, in Singer's philosophy, would deem the life of the mother more valuable than the life of the fetus, in the difficult situations where a choice must be made between the two.

This argument does not apply to questions of choice in multiple gestations.  What should be done if it is deemed necessary to destroy one (or more than one) fetus in order to assure the survival of the others?  Which fetus should be sacrificed if all are equally vulnerable?  How could this decision be made?  Should it be left to the physician to decide?

Talmudic scholars have assessed a mother's life as more valuable than that of her fetus.  Violence directed at a pregnant woman that results in the demise of her fetus does not carry a death penalty, but a monetary one.  The value of a fetus becomes equal of that of the mother only when one-half of the baby has been delivered.

When a decision as to who obtains a heart transplant has to be made between two individuals, both of whom have equal abilities to suffer or feel satisfaction, it is the one who is most medically needy.  If both are equally needy, it is the one who is first on the list.

Difficult decisions or choice will remain difficult decisions of choice - but there are clearly instances where they must be made.  Onerous, yes - but necessary, absolutely!






Tuesday, April 24, 2012

Is the Fetus, In Fact, a "Child?" Yes, Says Nebraska!

An editorial in todays New York Times provides a fascinating story concerning "the strange road" taken by the Legislature of the State of Nebraska.  The Legislature has deemed a fetus eligible for the State Children's Health Insurance Program!  And, even more unusual, is the fact that this bill is supported not only by Nebraska Right to Life and the Nebraska Catholic Conference, but by Planned Parenthood!

How did this strange partnership occur?  Turns out the Governor of Nebraska had vetoed a bill intended to provide free pre-natal care to undocumented immigrants.  The Governor considered the bill a violation of extant immigration laws and referred to the law as "misguided, misplaced and inappropriate."  The Legislature subsequently ruled that "unborn children do not have immigration status and therefore are not within the scope" of laws affecting "illegal" immigrants, and consequently have the same rights to medical care (pre-natal) as do "born" children (post-natal).  The program is expected to cost Nebraskans $2.5 million a year

Nebraska has, in effect, now officially declared a fetus eligible for medical insurance coverage, extending all the rights of "born" children to "unborn children."  This brings the status of abortion into question in Nebraska.  Nebraska's abortion laws allow abortions only "before viability or if woman is victim of abuse or neglect or if the M.D. has certification in writing that the continued pregnancy is a threat to woman's life, health."

Will a fetus "before viability" be entitled to medical coverage in Nebraska?  If so, the "non-viable" fetus clearly has a new legal status granting him certain rights,  raising the even larger issue as to whether an abortion on such a fetus could ever be considered.  If, on the other hand, the "before viability" fetus is not eligible for this medical entitlement, then may his "illegal" mother still be provided with free pre-natal care, or must she wait until her fetus attains viability?

Thursday, April 5, 2012

The Supreme Court Justices - Are They "Hacks"?

President Obama comments on a case presently before the Supreme Court, feeling confident that the Court will do the right thing and duly confirm an act of Congress, not setting a precedent for unconstitutionality in such a situation.  Columnist Maureen Dowd has written that the Court "has squandered even the semi-illusion that it is the unbiased, honest guardian of the Constitution. It is run by hacks dressed up in black robes."

Of course the President's comments are clearly incorrect.  As a matter of fact, the duty of the Court to establish constitutionality was set as precedent way back in 1803 when it ruled an act of Congress unconstitutional in Marbury v. Madison.

There is some truth in Maureen Dowd's assessment that the Court is "unbiased" and "run by hacks," though I would refrain from using such an obviously negative term.  It is, after all, composed of political appointees.  The President is a politician ("hack?") and has, in recent history, always appointed justices that he predicts will share his view of what is constitutional and what is not.  Occasionally there may be a surprise, e.g.  Eisenhower's appointment of Earl Warren, Kennedy's appointment of Byron White, Ford's appointment of John Paul Stevens, and George H.W. Bush's appointment of David Souter.

Our Constitution is open to interpretation.  Even in cases of unanimity, the justices have offered varying interpretations of the law in explaining their opinions.  Why should it be unusual to expect politically appointed justices to follow the principles that determined their appointment in the first place?  An article so vague as is the one describing the federal government's rights vis-a-vis commerce - the word "commerce" itself being undefined - would especially be open to such critical evaluation.

The Court's decisions are certainly open to criticism, but only after rendered.  It is not fair to inveigh against the Court based on what one expects an outcome to be, and without having read the opinions once submitted.  I have read the majority and minority positions on a number of cases.   Though I may disagree with a verdict of the Court, it is my committed belief that the justices arrive at decisions based on an intelligent, as well as a "reasonable and proper" reading of the Constitution - a reading which may, at times, result in the rejection of an otherwise good and well-meaning act of Congress.


Saturday, March 31, 2012

The Constitutionality (Or Lack Thereof) of the Affordable Care Act

The Supreme Court must now decide whether individuals can be constitutionally mandated to purchase a basic form of health insurance.  I think there is little disagreement that such a plan would be important in providing health care coverage for most every American.   For insurance companies to offer  customers having major medical conditions a reasonable rate, a pool that includes the very healthy seems necessary to mitigate what would otherwise be a weighty financial burden.

The Court must now decide whether a good bill - a bill that potentially offers major benefits to almost everyone, should be deemed constitutional.  But the constitutionality of a legislative act should not depend on its worth or lack thereof.  Constitutionality should rest solely on proper reading and interpretation of the various articles, clauses, and amendments of which the Constitution is comprised, and the stare decisis factors involved.

The Affordable Care Act, at best, treads the thinnest of constitutional lines.  Never in U.S. history has a citizen been required to participate in a business - in this case the medical insurance business.  No one over 26 years of age can choose to opt out, no matter how rich, no matter how healthy - with rare exceptions.  Constitutionality primarily resides in interpretation of the "commerce clause" contained in
Article 1, Section 8, Clause 3, of the Constitution which empowers Congress and "to regulate commerce with foreign nations, and among several states, and with the Indian tribes." The term commerce as used in the Constitution means business or commercial exchanges in any and all of its forms between citizens of different states, including purely social communications between citizens of different states by telegraph, telephone, or radio, and the mere passage of persons from one state to another for either business or pleasure.

Interpretation has always been directed at parties actively involved in some form of commercial activity.  There has never been a legal compulsion for citizens to participate in a commercial activity should they choose not to do so.  Though the argument can be made that all citizens participate in the "business of health" - if not on an active basis, on a passive basis - by the mere virtue of being alive, the case is hardly dispositive.  To add to the interpretive complexity, citizens are not actually required to participate in the "business of health," but in the "business of insurance."

My feeling is that a federal requirement to buy health insurance, though advantageous to the general welfare on its face, does not pass constitutional muster.  Matters that the government feels are proper for the general health and welfare of its citizens, should be supported by the citizenry via a properly applied tax or tax credit.    The taxing power of the federal government remains unquestioned and without challenge.

It appears that the legislative process, finding itself unable to provide needed health care to the citizenry via a "Medicare for all" system, passed an act that compels purchase of a commercial product - an act that stretches the interpretation of the Constitutional commerce clause too far.



Wednesday, March 21, 2012

Health Care Rationing - What Is a Death Panel


Health care rationing is discussed by Professor Alan B. Cohen in a Letter-to-the-Editor in today's NY Times (March 21, 2012).  In his letter, Professor Cohen beclouds the true issue that "rationing" implies.  The term is understood to apply to the so-called "death panels," an unfortunate euphemism for limiting health care in certain situations.  Americans must come to understand the enormous percent of the medical dollar consumed during the last years of life (estimated at 33% in some studies), most often without significant life-extension, and the prodigious sum expended on those with terminal illnesses, often on procedures and pharmaceuticals that are at best of questionable value.  The health care dollar is best applied where it is clearly shown to be of significant benefit. We need "panels" to perform well-constructed "outcome studies" to properly evaluate how the shrinking health-care dollar is best applied, and to consider restricting re-imbursement to those applications.

Except for the unlikely discovery of some future inexpensive panacea, Americans must come to accept the fact that the existential advances in medical research and technology (also very expensive) - their intent being to eliminate disease and extend life - are associated with massive increases in cost.  This is the true "reality" that "life-panels" will need to address.