Charles Pixley, Sui Juris
4810 Saint Paul Boulevard
Rochester 14617
phone:  (716) 544-2288
In Propria Persona
All Rights Reserved
without Prejudice
UNITED STATES OF AMERICA [sic],)  Case Number:  95-CR-6067-T
          Plaintiffs,          )  MOTION TO EXONERATE
                               )  AND SEAL RECORD
     v.                        )
CHARLES PIXLEY [sic],          )
          Defendant.           )

COMES NOW, Charles Pixley, Sui Juris, kneeling before His Honor with a contrite heart, Defendant in the above captioned case, makes this Appearance, by Affidavit, requesting RELIEF In Propria Persona, At Law, in Common Law, with Assistance Special.


Defendant, hereby respectfully moves this Honorable Court to issue an ORDER TO EXONERATE, or VACATE, or PARDON, or REVERSE pursuant and all pertinent records sealed.


Further, defendant has new evidence and affirmations pertinent to the case and instant Motion, which must be addressed before this Court can rule in a timely manner.  Wherefore, Defendant upon affirmation, declares and evidences the following:


Your Honor, herein I present several reasons why I believe asking this final indulgence of the court to clear my name is justified.  I was compelled by the Spirit, not criminal intent, called into battle against falsehood as a necessity in a noble cause, with conscientious objection.  I committed no conspiracy especially not one to defraud the "United States".  It became clear these issues demanded a head-on offense to reveal the fiction, even if it meant jail time or, as President Lincoln said:  "giving the last full measure of devotion," for my country.


My concession to waive a jury, born under various pressures, still haunts me.  I take responsibility and hold no malice.  The decision evolved after a phone call from Christopher Taffe to my attorney, William H. Moore, one morning just before the trial.


At Schuylkill, with prayer to discover the Truth, I identified the real reason for my incarceration was PRIDE.  I surrendered to God's will, and chose to receive this Time as a gift of His Love, and to spend the time fruitfully as a PENANCE.


The office of the U.S. Attorney and FDA may claim a victory, but it will be remembered for blocking yet another cure for cancer.  To quote, in part, a 250‑year‑old American cell mate, Henry David Thoreau:


"But it is the fault of the government itself that the remedy is worse than the evil.


"Why does it always crucify Christ and excommunicate Copernicus and Luther, and pronounce Washington and Franklin rebels?  What I have to do is to see, at any rate, that I do not lend myself to the wrong which I condemn."


Perhaps someday I'll be called upon to act an administrator, or in some other capacity in the Healing Arts community, but I fear retaliation.  [See Exhibit 1.]


Concerning retaliation and on behalf of my friends, I beg this court to take Judicial NOTICE of the following:


One-sided FDA dominion and unbalanced allopathic AMA state medical boards have a history of retaliation.  One of America's greatest family practitioners and medical minds, my friend Dennis Meyers, M.D., was formally harrassed and forced to surrender his medical license, after 30 years of practice.  I have reason to believe this occurred primarily because he was a federal witness in my case.  See 18 U.S.C. 1512-1513.


Following my trial, the Pennsylvania's medical board reviewed his file and found Dr. Meyers had come to a hospital to visit a family member in labor.  Dr. Meyers had been drinking at a seasonal party, and was reprimanded.  This occurred in 1976 in San Francisco.  Now impoverished, he lives with his family in Littleton, Colorado, ph. (303) 797 7663.


In New York, the Office of Professional Medical Conduct ("OPMC"), out of control, does not follow the mandates of current law, and is currently retaliating against Rebecca Carley, M.D., Hicksville, ph. (516) 433-0774, Serafina Corsello, M.D., New York City, ph. (212) 246 6270, and Jennifer Daniels, M.D., Syracuse.  All are brilliant women, competent and successful, but due to the overwhelming evidence of harm they are outspoken critics of vaccinations.


Another example of AMA and retaliation, George Lundberg, M.D., was fired by the AMA.  He was editor of the Journal of the American Medical Association ("JAMA").


"In October of 1998, he outraged some AMA leaders by reiterating his charge on 60 Minutes that doctors were burying their mistakes by not performing autopsies, which had shrunk from 50% to less than 5%, seriously jeopardizing medical accountability.  A majority of physicians are ignorant of the contents of the Code of Medical Ethics.


"He charges that organized medicine has collapsed before an over‑built and over‑used political/industrial complex that under‑funds prevention, undermines scientific research, and overlooks patients' needs with disastrous results for doctors and patients alike."  [Severed Trust: Why American Medicine Hasn't Been Fixed, George Lundberg, M.D., Basic Books, 2000.  [See Exhibit 2:]

This week some may assess the price of freedom we have yet to pay in full.  I was reminded of the words of Gen. Omar Bradley, by Gen. Lee Butler (Ret.), hosted July 1, 2001, by my Pastor Robert H. Schuller:


"Man is stumbling blindly through a spiritual darkness while toying with the precarious secrets of life and death.  The world has achieved brilliance without wisdom, power without conscience.


"Ours is a world of nuclear giants and ethical infants.  We know more about war than we know about peace, more about killing than we know about living.  Our knowledge of science has already outstripped our capacity to control it.


"We have grasped the mystery of the atom and rejected the Sermon on the Mount.  We have many men of science, too few men of God."


[Gen. Omar Bradley, in an address in Boston, November 10, 1948, abbreviated here]


Albert Einstein is quoted as saying: "When you do the same thing over and over and expect a different result, it's the description of insanity."  The Cancer Industry maintains a redundant 70‑year‑old program.  Billions are collected for a cause, and therapies are repeatedly re-introduced as a new hope, and promise sometime in the distant future, to find a cure for cancer.  People with cancer become victims bombarded with overwhelming and expensive attacks on their vital systems.  Their wallets are emptied.  Then they die.


[ref. trial exhibits:  New England Journal of Medicine, "Progress Against Cancer," May 8, 1986 by John Bailar, III and Elaine M. Smith, and the ten year follow-up:  "The War on Cancer," The Lancet, May 18th, 1996, by Michael B. Spoorn.]


The FDA, AMA, National Institutes of Health ("NIH"), academic leaders in oncology and perhaps even the doctors who approve of these deadly anti-neoplastins are wise enough to stop further treatment at that point.


I maintain there is a conspiracy, and agencies of the "United States" are aiding and abetting a medical conspiracy which, no matter how noble the original intent, has inadvertently become a conscious and premeditated program of eugenics, and perhaps the outcome includes genocide.


At the very least, it is a criminal conspiracy by a medical cartel to take money under false pretenses, proclaiming that orthodox allopathic medicine is capable of curing cancer, which it clearly is not.


Therefore, this cartel perpetrates a fraud resulting in death, charging for therapies which are well known to be ineffective and representing them as cures, while at the same time preventing all other treatments known to be effective.


Further, NBC Channel 4 News and the Boston Herald reported a thwarted cover-up of the homeopathic 714X, found by Boston's Dana Farber clinical trials to be an effective cure for cancer, and they tried to bury it.  They were sued and lost.  Dana Farber is directly linked to, and funded by, the federal government.  [See Exhibit 3.]

It is no secret this "cartel" maintains an insidious influence over Congress;  we refer to this "lobbying" as a euphemism.  Along with their substantial financial influence comes the persons in power necessary to finesse favorable laws and regulations.  The cartel appears to obey those laws, but in fact holds sway over the FDA.  Thus, the Sovereignty of the American People is directly thwarted, while the cartel creates the regulations relied upon by federal agency and this Honorable Court.  Your honor, doesn't this make a mockery of Justice?  [See Exhibit 4.]


One particularly horrifying combination drug, Fen-Phen, was railroaded through FDA in 1996 by behemoths Wyeth Ayerst, Fison and Interneuron.  Their lobbyist board of directors included former Secretary of State Al Haig, and former FDA general counsel Peter Barton Hutt.  See Dispensing with the Truth:  The Victims, the Drug Companies and the Dramatic Story Behind the Battle over FEN-Phen, by Alicia Mundy, Washington Bureau Chief for Mediaweek, St. Martin's Press, 2001.  [See Exhibit 5.]

"In one of the largest mass tort lawsuits in American legal history, around 45,000 women ‑‑ epidemic by any person's standards ‑‑ were believed to have developed one of two different diseases linked to their lungs or to their heart from taking the drugs.


"Another 300,0000 women were prepared to sue Wyeth and American Home Products in order to get expensive tests to determine whether they also had heart disease ....  The FDA washed their hands of the issue and let the tort lawyers take over.  The company had begun a nearly $100 million public relations spin campaign that would put presidential consultants to shame."  [ibid. pg. 8]


"In January 1997 ... the companies scheduled a meeting to present their latest proposed study to the FDA ... by now with all the news about increasing risk ....  That's when the companies pulled out their ace:  Congressman Tom Lantos.  The California Democrat was friends with some people on the Interneuron board.  ... [Lantos] said he strongly disagreed with having an open advisory committee meeting ... arguing that ... he thinks we are being hypersensitive to the criticism of a few individuals."  [ibid. pg. 83-85]


Further, examples of deadly failure and pending epidemic are reported in the July 2001 edition of Penthouse magazine, entitled "Cancer Warrior," by Debbie Bookchin and Jim Schumacher.


"Between 1954 and 1963, in one of the biggest blunders in medical history, almost half the American population, or 98 million people were administered a polio vaccine contaminated with a cancer causing virus ....  As a consequence, federal health officials have been loath to acknowledge its presence in human tumors or, according to critics, to fund research that could prove it causes cancer."  [See Exhibit 6.]


Consider these excerpts from Trade Secrets:  A Moyers Report, in the chapter "The Evidence":


"Chemicals are among the most highly regulated products in commerce, the American Chemistry Council tells the public.  However, the industry's own private documents ‑‑ examined in Trade Secrets:  A Moyers Report reveals a decade long effort to limit the regulation of toxic chemicals.  ‘Gentlemen, this is a campaign that has the dimension and detail of a war,’ wrote one committee chairman of the Chemical Manufacturer's Association (now called the American Chemistry Council) in a 1979 report to the CMA board of directors.  The report lays out plans to moderate, change or stop government regulations in the pollution control arena, and urges more corporate financial support to fund, an effective army that would include lobbyists, lawyers and public relations specialists.  The dollars expended on offense, the committee chairman wrote, are a token compared to the future costs."  [See Exhibit 7.]

Ralph W. Moss, Ph.D., author of The Cancer Industry, writing for the German Society of Oncology, an article "The Grand Illusion of Chemotherapy," published in June 2001:


"It is five years since I wrote Questioning Chemotherapy.  In those five years, about 250,000 peer‑reviewed articles have appeared on Medline on the topic of cancer, including 25,000 on cancer chemotherapy.  An additional 10,000 abstracts have been presented at the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research annual meetings.  Out of this vast amount of research a total of 70 new approvals have been made by the U.S. FDA for drugs used in treatment of cancer patients.


"Has all this activity resulted in more effective treatments for cancer?


"... The brief answer is: No!  If anything, the value of chemotherapy is less documented today than it was five years ago."  [See Exhibit 8.]


Adding injury to insult, there are numerous instances of harm caused by approved pharmaceuticals, or chemicals.  The FDA is known for its "revolving door," as corporate scientists are employed by the FDA to obtain drug approval and then return to their company.  When it's revealed the drug is deadly or harmful, little is done to censure, fine or bring to justice the agency, company, or individuals.  This cycle is repeated ad nauseam.


Is there any life left in the notion the government obtains its just powers from the consent of the governed?


The FDA and U.S. Attorney's Office are hungry for convictions.  I respectfully suggest an investigation into probable cause to charge the private and federal actors with conspiracy to engage in a pattern of racketeering activity, see 18 U.S.C. 1961, et seq., and/or violations of 18 U.S.C. 241-242.  Now federal employees may be tried in state courts in the 9th Circuit (11 western States).


Allopathic business has shown its limits and now we are on the brink of a major and massive national health crisis.  California Healthcare Association reports 64% of all in that State are running in the red and nationwide too many to list.


"Nearly all of the hospitals are suffering financially,” said Monica Mahaffrey, spokeswoman for the Healthcare Association of New York State.  The Genesee Hospital’s closing is symptomatic of the entire industry.  These aren't flukes.


"Batavia's United Memorial and Syracuse's Crouse filed chapter 11, in February.  Hospitals in Bethpage, Nassau County, Ellenville, Ulster County and Flushing have also filed bankruptcy.  Last fall, Massapequa General, Our Lady of Victory in Lackawanna and Union Hospital in the Bronx did also.  In 1999, New York State hospitals lost $539,000,000 and, though statistics are still being evaluated, 60 percent of New York hospitals now operate in the red."  [See Exhibit 9.]



Betrayal of Trust:  The Collapse of Global Public Health, by Laurie Garrett, Hyperion Books, Pulitzer Prize winning author of The Coming Plague states:


"Tens of millions are dying of new, untreatable forms of TB, malaria, strep, staph, and other organisms.  Millions more are dying of AIDS.  Measles and other vaccine-preventable diseases still kill hundreds of thousands more children every year.  Hospitals have become primary vehicles for the spread of disease and not of their cure.  These are not the result of mysterious malicious microbes.  These are public health failures.  The system we trust to ensure safe water, food, hospitals and communities can no longer in this globalized world rise to the challenge."  [See Exhibit 10.]

Further, I invoked the APA against the United States Department of Justice by submitting a formal petition for issuance of rules promulgating the statutes I was charged with violating:  they did NOT exist at the time of the trial.  "[A]n administrative agency may not create a criminal offense or any liability not sanctioned by the lawmaking authority ...."  2 Am Jur 2d, pg. 129.


There is a recent court decision which nullifies the FDA's position that our book Do No Harm must be banned from sale on the basis it is advertising, though we acted in accordance with the laws of Congress for an Institutional Review Board ("IRB"), established under 21 U.S.C. Part 56, to provide for "Informed Consent".  To this day, FDA still sends mail addressed to Charles Pixley, IRB manager.


In consideration of this point, please review the following comments prepared by Jonathan W. Emord, Esq., for his clients ‑‑ Durk Pearson and Sandy Shaw.  "In Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g denied en banc, 172 F. 3d 72 (D.C. Cir. 1999), the questions are thus res judicata:  they have been judicially acted upon and decided, they are settled by the judgment of the court.  The United States Court of Appeals held unconstitutional, under the First Amendment, four FDA rules that suppressed four separate health claims.  The Court's decision invalidated the agency's rules.  As a matter of law, the rules are of no further legal force or effect, yet the FDA continues to enforce them.


"The Supreme Court has held violations of a First Amendment right, even for a very short period of time, an irreparable injury.  See Elrod v. Burns, 427 U.S. 347, 373 (1976) (plurality opinion).  ("The loss of a First Amendment freedom, for even minimal periods of time, unquestionably constitutes irreparable injury.")


"When the First Amendment rights are violated, the Supreme Court expects Government to eliminate the violation without delay.  It considers delay intolerable."  See Riley v. National Federation of the Blind, 784 U.S. 781, 793-94 (1988) (internal quotes omitted).   ("Speakers ... cannot be made to wait for years before being able to speak with a measure of security.")


"The Pearson Court held that the FDA may not suppress health claims on the basis that they do not satisfy its ‘significant scientific agreement’ standard regardless of how FDA defines that standard."  164 F.3d at 654.


Thus, separate from FDA's health claims review standard, by which FDA officially authorize and approves claims under 21 U.S.C. § 343(r), is the First Amendment, by which it must allow even claims it does not authorize and approve, if those claims can be rendered non-misleading through the addition of a disclaimer ....


"FDA may not substitute a new scientific validity test for the First Amendment standard articulated in the Court's decision.  The Constitution is Supreme Law, and the agency must ensure protection for all lawful commercial speech, not just a subset of that universe.  The FDA must do so in strict accordance with the standards articulated in the Pearson decision itself.  Pearson tells this agency that its legacy of suppression must come to an end;  that it must henceforth favor disclosure over suppression as the rule, not the exception ...."  [See Exhibit 11, at end.]


In my own case, nothing was held back from the FDA!  So, where was the deception?  In fact, they procured a sample of 714X, and they received all available data.


FDA could have said:  "Mr. Pixley, we see you are running into a bureaucratic boondoggle here.  714X is a homeopathic remedy;  it needs a specific label for importation.  Here is what you need to do to obtain an import permit.  Keep up the good job.  You're saving lives."


What did they do instead?


It was announced, 30 June 2001, that NY Senator Clinton and Congressman Lafalce suggest FHA funds will raise our Lazurus hospital system.  Billions have already been gifted, and wasted, maintaining the present systemic failure.  [Exhibit 12:  Local Gannett News clipping, July 1, 2001.]


Your Honor, I don't pretend to have all the answers;  I do know who does, and I was providing a solution.


I do have a vision of how to solve this crisis.  Perchance, this Honorable Court will order a grant from the "United States" to be used in part to payoff Genesee Hospital's debts, and in part to afford me the time required to synthesize an answer to the looming health crisis.  I would be honored to set an example of health care leadership.  We have already seen what the current system can do;  I believe we can do better.



I'll close with a quote from Marianne Williamson, the author of The Miracle of Love.


"Our deepest fear is not that we are inadequate.  Our deepest fear is that we are powerful beyond measure.


"It is our light, not our darkness, that most frightens us.  We ask ourselves, who am I to be brilliant, gorgeous, talented and  fabulous?  Actually, who are you not to be?  You are a child of God.  Your playing small doesn't serve the world.  There is nothing enlightened about shrinking so that other people won't feel insecure around you.


"We are born to make manifest the Glory of God that is within us.  It is not just in some of us.  It's in everyone, and as we let our own light shine, we unconsciously give other people permission to do the same.   As we are liberated from our own fear, our presence automatically liberates others."


Your Honor, the prescience of this court is legendary.  Excuse my allusion, but granting this Motion will not reverse the spin of earth on its axis, anymore than final hour presidential pardons, by William Jefferson Clinton upon his departure, of men far more dubious that I could ever be.


It is my understanding that the role of the Prosecuting Attorneys is to be advocate for both servant of the people and the government.  They must also ensure that individuals are not wrongfully convicted.  They must strive to preserve the public welfare and safety of all citizens.


I therefore humbly ask, based upon that criterion, that the necessary, reasonable and sound decision is to dismiss this case.  If this sapient Court does so Order the instant Motion, I, Charles Pixley, agree not to sell the physical product 714X, nor any other unapproved substance, in the "United States".


Before the Greatest Counselor and Our Father, I ask The One Almighty to bless this Honorable Court.  I humbly pray this Court to hereby Order, Exonerate, Reverse, Vacate and Seal these records.  Vires Vitalis Sustinete ‑‑ Truth Sustains Life.


Further, this Affiant sayeth not.


I, Charles Pixley, Sui Juris, hereby certify, under penalty of perjury, under the laws of the United States of America, without the "United States," that I am at least 18 years of age, a Citizen of one of the United States of America, and that I personally served the following document(s):


or placed one true and correct copy of said document(s) in first class U.S. Mail, with postage prepaid and properly addressed to:

Michael A. Telesca                  Linda Metz U.S.P.O.
United States District Court        United States Probation
100 State Street                    100 State Street
Rochester [zip code exempt]         Rochester, [zip code exempt]
NEW YORK STATE                      NEW YORK STATE
Christopher Taffe                   William H. Moore, Jr., Esq.
United States Attorney              Attorney to Defendant
620 Federal Building                910 East Victory Drive
Rochester [zip code exempt]         Savannah {zip code exempt]
NEW YORK STATE                      GEORGIA STATE
[See USPS Publication #221 for addressing instructions.]
Dated:  2 July 2001
/s/ Charles Pixley
Charles Pixley, Sui Juris
Citizen of New York state, federal witness
(expressly not a citizen of the United States)
All Rights Reserved without Prejudice
Exhibit 1:
Copyright 2001
Charles Pixley
Executive Director
Association of Eclectic Physicians

A small, powerful group of citizens has been brought together by Time and has committed itself to working to benefit all mankind.  It includes enlightened professionals trained in all facets of the healing arts, lawyers trained in representation, socially advantaged members of society, entrepreneurs, business professionals and scholars.


This group is has been alarmed by the closing of Genesee Hospital and the dramatic rise in hospital closings in major cities like Stanford in Palo Alto, Yale in New Haven, Washington D.C.'s D.C. General and, of course, our own Genesee in Rochester, to name a few.  Each of these cultural centers boasts the greatest medical schools, hospitals, business and law schools which mold our children into the best minds of the time.  They represent the shining light of Liberty at the doorway to our nation, and their academic acumen has always been an example to the world.


Vision plus action equals manifestation.  Therefore, we have decided to avert the pending national Healthcare crisis by setting an example for all.  The following will give you a glimpse into the new paradigm in wellness academia.


We await your willing response and generous support.


It is a beautiful day with a cool dry breeze and clear skies as you arrive;  your driver pulls under the expansive canopy.  You're greeted by a uniformed door person who opens your door and greets you with a smile;  another assistant is collecting your luggage while the door person puts their arm around your shoulder and escorts you to your room, which is ready and prearranged.


As you stroll through the massive colorful hallways, you smell exquisite fragrance of flowers wafting through the air and the sound of waterfalls and birds echoing from the nearby solarium gardens.  There is music in the air as students from the Eastman and Hochstein practice their sonatas.  Suddenly you are deeply moved and silently aware you have been overcome with a deep sense of well being.


This is not like any other Five Star Hotel you have ever visited;  this is GENESEE INTEGRATED HOSPITAL, SPA and ACADEMY.  In your private room you notice space rearranging your mental images as the colors, fragrances, the placing of furniture merge;  and it feels so comfortable you don't want to leave.  All modern conveniences are provided and within easy reach.  You freshen up and change into your bathing attire and terry cloth robe, as your personal attendant arrives precisely on cue to take you to your first session at the Mineral Hot Springs.


At the baths your immerse in the 108 degree mineral rejuvenating waters and drift off into a state of physical ecstasy;  and your thoughts, business concerns, cares and troubles melt away.  Leaving your feeling of illness behind, again on cue your attendant arrives, escorts you to a room with a massage table, silent except for the gentle airy sounds of a Japanese wooden flute, where aroma therapy, deep tissue massage, Reiki and Acupuncture moxibuxction begins;  you leave your body and drift into another dimension.


Upon awakening it seems days have passed as you realize your body is not the same body you came in with;  it is now reminiscent of the one you had when you were a teenager and you are ravenous.  Your personal escort arrives and takes you, robe and all, into the dining room and you select from a gourmet Five Star menu color‑coded to your personal needs and prepared under the watchful direction of a renowned Executive Chef.  In the corner by the window, sun is streaming in near the trio playing an energetic selection of music.


You are escorted back to your room where a folder of information awaits you for your review and approval.  The information is on the several therapies which have been recommended for your review and informed consent.


Your suggested therapies include Music Therapy upon rising and  retiring, offerings from acupuncture to stimulate the immune system and restore organ and nerve function, Homeopathic dentistry, a brief but specific regimen of very specific low‑intensity antibiotics, and Reiki sessions three times per day for several days.  These all to permanently eliminate the causes of your chronic condition.


On day two, after room service delivers a perfectly arranged array of exotic fruit and flowers, your escort takes you to the Whispering Gardens and Arboretum.  Overhead in trees near the water falls there is an aviary where multi‑colored birds sing in their nests joyously saved from extinction from the disappearing rain forest.


You and the rest of your classmates are met by Spirit Guides representing all faiths, and a Yoga class for some and Tai Chi for others.  After your group exercise session, your Spirit guides give lessons on uniting and maintaining the Spirit, the Mental Being and the Body as one.


In the evening there is a required introductory session where your family and friends are trained how to create positive support systems for you and themselves, and illness prevention methods for the rest of your days.  After their session of Light, your family arrives at your private room to listen to your jubilance, and witness your transformation.  On your floor near the family dining and visiting center, your family are assisted by one of our chefs in meal preparation at the large, well stocked kitchen nearby, which is open 24 hours a day, so you can have anything you desire within your healing program.


Three days have passed and your realize your crisis is over.  After several intense training sessions, quiet and private time with a Spiritual advisor, hours of prayer and positive thinking seminars, you regret having to prepare to leave in the morning;  but now, you are armed with a new awareness, knowledge and commitment to remain healthy.  Reservations are pre-arranged by appointment and a visit by a professional member of the wellness staff, who spends four hours with you in your home, taking expansive medical history dating from your childhood and advancing though simple blood work.


The Genesee Wellness Cooperative offers all healing modalities  available worldwide, and confidentiality and anonymity are guaranteed, whether you are a local member, or you arrive by private referral and pay for your stay as a private guest.



By entering:

[Exhibit 9]

"hospital closings" into a few Internet search engines, the following results came back.  I spent about 30 minutes.



Operation Save America - Rochester - Genesee Hospital is March 29,  2001. Genesee Hospital is Closing. The Genesee Hospital of Rochester, a 114-year-old institution,  announced that it would be closing and padlocking its

Alameda Hospital Closes Maternity Ward -- 27 Jobs Affected Financial losses, few deliveries,competition force shutdown George Raine, Chronicle Staff Writer Tuesday, January 2, 2001


Alameda -- One-hundred and six years after it opened as a six-bed sanatorium for women bearing children, Alameda Hospital, seeing money drain in its costly maternity ward, will stop delivering babies on Jan. 31.  The number of deliveries at the hospital is small -- about one a day. But the symbolism of the decision by the hospital's board is considerable, and typical in a health care industry buffeted by ever-rising costs.


Alameda Hospital, while losing money, is financially stable, said O'Neill, who since he began his career in health care in California in 1970 has followed the industry's wild economic ride.


In fact, the California Office of Statewide Health Planning and Development reports that 64 percent of the state's hospitals are operating in the red. "It's a very challenging time for our industry," O'Neill said.


NEWS: Mount Zion Hospital prepares for closing Friday, October 29, 1999. UCSF-Stanford merger dissolves - Casper says UCSF-Stanford failure symptom of greater problems for academic... URL:

Wylie hospital closing is ‘shock to community’ - 1999-03-29 - Dallas BusinessWeek of March 29, 1999 URL:

DC General Hospital Closing Is National Catastrophe This ... Interview: Kenneth Lyons. DC General Hospital Closing Is National Catastrophe. Kenneth ...

WFAA.COM - Hospital Closing Concerns Medical Community Hospital Closing Concerns Medical Community Reporter: Anna Martinez Updated: Nov 08, 2000,1002,16006,00.html

GRAND PRAIRIE   Plans to close Grand Prairie's only hospital by Friday continue amid growing concern from the area's doctors about what will happen to their patients.  Dallas-Fort Worth Medical Center announced Tuesday its lender is foreclosing on the property after the hospital lost $6-million this year.


Press Release -- Congressman Dennis J. Kucinich -- St. ...  ... Edgell. Monday, March 6, 2000, (202) 225-5871. Bulletin: St. Michael Hospital Closing Blocked for Now Common Pleas Court Judge Issues Temporary Restraining Order ...

Lakewood, Ohio.


Hospital closing means job loss 10/15/98 Web posted Thursday, October 15, 1998 7:27 am CT Hospital closing means job loss. By MICHAEL ...

Ironton South Eastern Ohio, hospital closing soon ... Ironton hospital closing soon -- January 17, 2001 Efforts to save a hospital in Ironton proved unsuccessful Wednesday. River Valley Health Systems announced

PALM SPRINGS, CA, Desert Sun Online - Hospital closing its home-care program - Hospital closing its home-care program Eisenhower program not paying its way; other firms can absorb patients, workers, official says. ...

The Desert Sun December 6th, 1999 RANCHO MIRAGE ‑‑ Financial troubles have pushed Eisenhower Medical Center out of the home-health-care business.  Beginning Saturday, Eisenhower Home Care Services will not accept new patients and is shutting down its home-health-care services permanently.  By the end of January, future patients will be referred to the Visiting Nurse Association of the Inland Counties.


LOCAL NEWS COVERAGE. Friday, July 14, 2000 Dayton Ohio’s oldest hospital closing ...

Mercy Hospital closing in Hamilton (Cinncinnati Ohio area ) in June March 21, 2001 Mercy Hospital closing in Hamilton in June By Earnest Winston

Ypsilanti Michigan Hospital closing YPSI ON THE NET. WHAT.S HAPPENING IN YPSILANTI.... URL:

The New Jersey Hospital Association - What's New President's Advertorial. Minds and Emotions Collide When A Hospital Must Close. Hospitals are important community resources, a source of security... URL:

Hospital closing impacting area office market - 2000-06-05 - Atlanta Business sponsored by: sponsored by: Home : Atlanta : Archive : 2000 : June : Week of June 5, 2000 URL:

Closing of Deaconess/Waltham Hospital Waltham, MA.

Van Wert County Hospital in central Ohio, serves as the access point for high quality health care for over 70,000 people in Van Wert and surrounding counties. It is a... URL:

NurseWeek|HealthWeek:  Closing Time:  California leads the nation in hospital closings URL:

Hospital Closing Neo Natal ICU to Punish Nurses,  April 6, 2000. Hospital Closing Neo Natal ICU to Punish Nurses, URL:

Wheels of change turn slowly-in many directions at once Are the doors of the county hospital closing for some USC physicians and health care professionals? The clock keeps on ticking, but it's not certain... URL:

Hospital closing means job loss 10/15/98 Web posted Thursday, October 15, 1998. The demise of Palo Duro Hospital in Canyon, Texas leaves meany of its 78 employees without jobs.  URL:

Tampa bay: Hospital's closing worries advocates. The shutting down of  G. Pierce Wood next ...

Hurricane Bonnie:  Hospital closing upsets officials Wilmington, N.C.

ONTARIO UPDATE:  Hospital closing would ‘ignore francophone rights’ VOLUME 35, NO. 42, December 21, 1999.

Symposium to review effects of state hospital closing in Winfield, KS

Hospital closing! Why???  DISTRICT OF MISSION, B.C. Sunday, 1/16/2000

Study recommends closing some VA hospital buildings The Front Page. National. URL:

Activists protest over Mercy Hospital Detroit, MI closing - 3/19/00 Not far from shuttered Mercy Hospital Detroit, and waits to...URL:

Tears and hope for Tattnall Memorial Small rural facility closes, By Mary Landers Savannah Morning News   Editor's note: A little over a month ago, health reporter Mary Landers and photographer Scott Bryant began making regular visits to Tattnall Memorial Hospital to chronicle the daily workings of this rural facility. They followed patients, doctors, nurses, janitors and administrators through Friday, when the doors closed.  Tattnall Memorial was built in 1974 in centrally located Reidsville, the county seat.


Greater Cincinnati Health Watch ‑‑ August 23, 2000 for Some Kentucky Residents 5. ACCESS TO CARE:  Ohio Hospital Closings Raise Concern about Care Quality,


The Daily Ardmoreite, Ardmore, Okla. USA Report warns of ... Story last updated at 11:44 am on Friday, March 31, 2000 Report warns of hospital closings, urges federal aid ...


Medicare plan may force hospital layoffs, closings The Detroit News  Home Page October 13, 1995 Medicare plan may force hospital layoffs, closings. ...


Baltimore  New law may spur hospital closings, new ERs ‑‑ 2000-07-03 ‑‑ Exclusive Reports.  From the June 30, 2000 print edition. New law may spur hospital closings, new ERs.  ...


March 8, 2000. Cuyahoga County (Ohio) Commissioners urge action, communication on spate of hospital closings; changes in healthcare. ...



Committee approves hospital closings ‑ The Richmond Times ‑ Committee approves hospital closings.  by TAMMIE SMITH, TIMES‑DISPATCH STAFF WRITER, Feb 02, 2001. ... Not waiting for health-care legislation from the U.S. Congress, Illinois and its health services providers have put market forces to work.


Managed care systems have expanded dramatically, some community hospitals have closed and Illinois Medicaid is shifting to an HMO-based delivery system.  The shakeout has forced changes at all levels of Chicago health care, from community clinics and Cook County Hospital to corporate HMOs and university teaching hospitals.  At center of issue:  money.  State's Medicaid program, worth $1 billion per year, is being divvied up among HMOs that actively solicit public aid recipients in state offices and on street.  Clinics and community hospitals must fight to retain patient base as managed-care firms add partners, siphon off patients.  Even teaching hospitals are on defensive, adding primary care programs and developing their patient bases.


The toughest problem is how to cut costs while maintaining quality care and safety net for poor and uninsured.  As in other states, HMOs have shifted away from inpatient care in favor of "drive‑through births" and outpatient programs.  Hospitals and clinics that use Medicaid and private-patient revenues to subsidize care for uninsured face tough choices.  Some join managed care networks to maintain revenue/patient flow; others, like St. Cabrini Hospital, closed their doors.  Even Cook County Hospital, longtime provider to poor, has maneuvered for survival, negotiating with state to lock in 110,000 Medicaid patients.


The industry employs 101,744 health care professionals in the area, but distribution is uneven.  In 1993, nearly 80 percent of the city's 1.07 million African Americans lived in federally designated "doctor shortage areas."


Investigation by the Chicago Sun-Times (5/26/96) found some Medicaid recipients received conflicting information about costs of services;  others encountered hard-sell tactics.  Marketers go door-to-door in poor areas and meet prospects in front of nonprofit clinics dependent on Medicaid revenue.  Two employees were dismissed after state investigations.


A join-or-die atmosphere has prevailed, with most previously  independent small hospitals partnering up.  Grant, LaGrange, Chicago Osteopathic and Olympia Fields Hospitals, among others, all became part of Columbia/HCA, whose Chicago Division president Nick Hilger, 708-990-0690, can comment on savings reaped through consolidation; also Jeff Prescott in media relations, 615-320-2000.


Columbus Cabrini Health Systems closed St. Cabrini Hospital, then  merged with St. Joseph's Hospital to create Catholic Health Partners;Laurie Stevens, 773-665-3967, of Catholic Health Partners was with Cabrini. Mark J. Valentino, lifelong resident of Cabrini Hospital neighborhood,  publisher of Near West Gazette, 312-243-4288, led futile effort to save hospital.


Cook County Hospital and state's largest private hospital, Rush-Presbyterian-St. Luke's, created partnership on outpatient and research facility to treat HIV/AIDs and other communicable diseases.  The $25 million facility will be first of kind in nation; has 79% of funding with recent $9.8 million grant from U.S. Dept. of Health and Human Services, $1 million from Illinois. Project chair is Christie Hefner, Playboy Enterprises, 312-751-8000.  Rush also formed 10-year pact to train residents in primary care at County satellite facilities; Dr. Erich Brueschke, Rush Medical College, 312-942-3237.


Illinois Region Humana Healthcare serves 375,000 people in metro Chicago;  parent firm has 2.2 million members nationally, Barry Averill, 312-441-9111.  Advocate Health Care was born by merger of Lutheran General Health Care System and Evangelical Health System;  has 20,000 employees, 180 metro sites, eight hospitals;  Richard Risk/Daniel Parker, 708-990-5606

Exhibit 12

Emord & Associates, P.C., Burke Professional Center, 5282 Lyngate Court Burke, Virginia 22015;  1050 Seventeenth Street, N.W. Suite 600, Washington, D.C. 20036;  Phone: (202) 466-6937  e-Fax: (202) 466-6938;  Web Site:;  E-mail:


FDA PUBLIC MEETING ON IMPLEMENTING THE PEARSON COURT DECISION AND OTHER HEALTH CLAIM ISSUES PANEL I:  "Should health claims be allowed on dietary supplements on a basis other than significant scientific agreement?  If so, what should that basis be and what are appropriate criteria for making decisions about such claims?"


The questions posed to the panel are in fact legal issues that have already been resolved in a final and binding order of an authority higher than this agency, the United States Court of Appeals for the D.C. Circuit in the case of Pearson v.  Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g denied en banc, 172 F.3d 72 (D.C. Cir. 1999).  The questions are thus res judicata:  they have been judicially acted upon and decided;  they are settled by the judgment of the court.  It is thus not the time to ask these questions.  It is, rather, long past the time for this agency to comply with the Court's order.


In Pearson v. Shalala, the United States Court of Appeals held unconstitutional under the First Amendment four FDA rules that suppressed four separate health claims my clients wish to make.  The Court's decision invalidated the agency's rules.  As a matter of law the rules are of no further legal force or effect, yet FDA continues to enforce them.


The Court's mandate to implement its decision issued to this agency on April 20, 1999.  Upon receipt of the mandate, FDA's duty was clear.  It had to discontinue enforcement of the invalidated rules immediately, and it had to allow my clients' claims to be made with dispatch.  In flagrant defiance of the Court's order, this agency, over eleven months later, still enforces all four of the constitutionally invalid rules.


Moreover, it has adopted a cumbersome, extensive, and protracted series of regulatory steps that it intends to take before finally addressing the Court's constitutional mandate.  Those steps appear calculated to postpone FDA compliance with the Court's order for years.  FDA is thus engaged in a pattern of delay and denial of its constitutional duties.  This past Friday, my firm filed an application for preliminary injunction with the United States Court of Appeals to stop this agency from continuing to enforce the four invalid rules.


FDA's continued enforcement of those rules is an act of contempt in the face of a final and binding order.  It is an act that challenges the Supremacy of the Constitution over contrary agency laws.  It is an act taken by officers of this agency who have sworn oaths to support and defend the Constitution.  It violates those oaths.


To be sure, FDA is not above the law.  It is certainly not above the Constitution.  The Constitution is the Supreme law, and FDA must obey it.  FDA should take heed and immediately, this very day, discontinue enforcement of the invalidated rules.  It should authorize all four of the Plaintiffs' health claims with the  disclaimers specified by the Court.  It may thereafter proceed with its rulemaking to determine precisely how, if it all, it should tailor those disclaimers.  But it may not, consistent with the First Amendment, continue to suppress my clients' protected speech, their health claims, for a moment longer.


The Supreme Court has held violation of a First Amendment right, even for a very short period of time, an irreparable injury. See Elrod v. Burns, 427 U.S.  347, 373 (1976) (plurality opinion) ("The loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.")


When First Amendment rights are violated, the Supreme Court expects Government to eliminate the violation without delay. It considers delay intolerable. See Riley v. National Federation of the Blind, 784 U.S. 781, 793-94 (1988) (internal quotes omitted) ("Speakers ... cannot be made to wait for years before being able to speak with a measure of security.")


So, then, what are the Court of Appeals' legally binding answers to the questions you pose?  The Pearson Court held that FDA may not suppress health claims on the basis that they do not satisfy its "significant scientific agreement" standard regardless of how FDA defines that standard. 164 F.3d at 654.  In letters to me of October 5, 1999, and February 17, 2000, Director Levitt accepts this legal requirement.


Thus, separate from FDA's health claims review standard, by which FDA officially authorizes and approves claims under 21 U.S.C. 343(r), is the First Amendment, by which it must allow even claims it does not authorize and approve if those claims can be rendered non-misleading through the addition of a disclaimer.  FDA may not substitute a new scientific validity test for the First Amendment standard articulated in the Court's decision.  The Constitution is Supreme law, and the agency must ensure protection for all lawful commercial speech, not just a subset of that universe.  The FDA must do so in strict accordance with the standards articulated in the Pearson decision itself.


Consistent with rules of statutory construction, FDA may not construe its statutory obligation under 21 U.S.C. 343(r) (to establish a procedure and standard for the authorization of dietary supplement health claims) as in conflict with the First Amendment.  See generally DeBartolo Corp. v. Florida Guild Coast  Building & Construction Trades Council, 485 U.S. 568, 573 (1988).


Rather, as the Pearson Court explained, 164 F.3d at 652; 659, under the statute FDA must define a procedure and standard for authorization and approval of health claims but under the First Amendment, even if a claim is not authorized and approved by the agency, it must nevertheless be allowed to be made so long as the addition of a disclaimer can render the claim non-misleading.


The purpose of the disclaimer is to inform consumers of the lack of conclusive evidence for a claim and of such other information as is necessary, on a case‑by‑case basis, to avoid consumer misperception.  In light of the infinite variety of potential nutrient-disease claims, case‑by‑case evaluation is unavoidable.


The Pearson Court held that inconclusive health claims may not be suppressed by FDA unless they convey no scientific information or unless they otherwise cannot be rendered non‑misleading through the addition of a disclaimer.  164 F.3d at 659.  Rather, FDA's remedy for inconclusive claims is the addition of a disclaimer, making the inconclusiveness clear to consumers.


The Pearson Court squarely placed the burden upon FDA to favor disclosure over suppression in every instance where a disclaimer can eliminate a misleading connotation.  Thus, for example, if a claim accurately conveys a nutrient-disease association, FDA must allow it even if the agency believes the evidence preliminary, unless FDA also reasonably finds no disclaimer capable of eliminating a misleading connotation.


The First Amendment makes FDA, like every other government agency that censors speech, meet a high threshold burden of proof to justify claim suppression:  proof that a claim cannot be rendered non‑misleading through use of a disclaimer.  The general rule is disclosure of information.  That is the constitutionally preferred means for overcoming misperceptions in the market.


Turning to the four claims at issue in Pearson, this agency should note well that the Court found all of the claims, at worst, only potentially misleading.  The Court wrote specific disclaimers for each of the claims to cure that potential.


The Court explained that FDA could avoid the erroneous public view that the agency had authorized the claims by including an additional disclaimer, to wit:  "The FDA does not approve this claim."  164 F.3d at 659.



Given the Pearson Court's constitutional order to this agency, FDA must immediately discontinue enforcement of the four invalidated rules and must, until it ultimately decides the precise language it prefers for the disclaimers, authorize on an interim basis all four Pearson claims with the disclaimers the Court has recommended.


Pearson tells this agency that its legacy of suppression must come to an end;  that it must henceforth favor disclosure over suppression as the rule, not the exception;  that it may not use its health claims review standard as a barrier to the communication of any claim that can be rendered non-misleading through the addition of a disclaimer;  and that the Court will view as dubious any agency justification for suppression that is based on alleged "benefits" of public ignorance.


Consumers can make choices they perceive in their own best interests if well enough informed.  It is the constitutional duty of this agency to ensure that they are so informed, and to favor disclosure over suppression as its standard practice.


Thank you.