All updated patient reports throughout the year have
previously been forwarded to the FDA under separate cover.”
Commissioner Goyan considered this alleged misreporting extremely serious in
view of the fact that it was the eye toxicity that the FDA was most concerned
about. Under the IND regulations that govern this human experimental work, it is
mandatory that the sponsor shall promptly investigate and report to the FDA and toall investigators any findings associated with the use of the drug that may suggest
significant hazards, contraindications, side effects, and precautions pertinent to the
safety of DMSO. Eye changes in the scleroderma patients clearly fall within this
definition. It is possible that lens changes are a complication of the disease, but there is
nothing reported in the medical literature indicating that eye symptoms are present
in scleroderma. From the correspondence found three years later in the Research Industries
corporate files, it appears that Scherbel’s letter is the first DMSO report of human
eye toxicity ever, and that the pharmaceutical company had furnished the report to
Dr. Pani at the FDA. Commissioner Goyan said that if Pani had possessed this
information and not provided it to the FDA, it would be grounds for his dismissal
from the agency. It looked like the FDA had a real health problem with DMSO—specifically,
eye toxicity in humans. Also, the agency learned that the odor-free DMSO, 87-2,
and another DMSO derivative called Satori, had no IND and no animal testing, but
were being distributed in interstate commerce and being used by the general
public. We saw at the start of this chapter that Jean Puccio almost daily paints on
87-2, which she acquired from Dr. Jacob. Use of this unapproved drug is illegal. Dispensing it is a violation of the Federal Food, Drug, and Cosmetic Act. Dr. Hensley brought all this information to the Inspector General of the United
States. “The Office of Inspector General went to the United States attorney in
Baltimore, because it is the judicial district, and briefed them on what they knew
of it,” said Dr. Hensley. “They interviewed a great many people during that week
[May 12, 1980] and had some very definite impressions as to what they ought to
do.”
The incident with which we opened 
Chapter 2
, where FDA officials 
holding a
Federal warrant entered Dr. Jacob’s office on November 10, 1980, looking for
documents on eye toxicity, is a direct outgrowth of this discovery and its eventual
public disclosure in the Congressional Record. In fact, one of the investigators
visiting Dr. Jacob’s office was Dr. Alan B. Lisook, who is Dr. Hensley’s
supervisor at the Division of Scientific Investigations, Bureau of Drugs, FDA. Lisook flew to Portland, Oregon, from Washington, D.C., to grab what reports on
eye toxicity he could out of Jacob’s files. You’ll recall that Lisook wasn’t allowed
access to the files. Meantime, the Inspector General, in consultation with the Baltimore United
States attorney, investigated possible malfeasance on the part of some employeesof the agency. “The allegations have to do with the question of whether the
sponsor and the investigators were investigated promptly enough and in a proper
fashion,” explained Nancy L. Buc, Chief Counsel of the FDA, “and also may have
to do with questions that pertain to the sponsor and to the investigators.”
Dr. Pani, the medical officer with the primary responsibility for DMSO, who
was assigned to the drug in 1968, was transferred from the DMSO project. And
then he was forced to retire from the FDA under threat of outright dismissal. The
policy management staff at the FDA conducted an investigation of Dr. Pani and his
relationship with the sponsors, the clinical researchers, and the physician-monitor. This physician-monitor was responsible for making sure the protocols of
investigations were being followed, the product being employed was pure, and the
records being kept were accurate. The FDA staff’s findings have not been made
public, but I have found out that the physician-monitor was Stanley Jacob. Dr.
Pani and Dr. Jacob were indicted by the Justice Department on criminal charges
rising from the FDA investigations. A BUSINESSMAN PROTECTS HIS INVESTMENT
Henry Moyle and Louis Haynie created Research Industries Corporation (RIC) in
1968 out of an amalgamation of a land development firm and the Deseret Drug
Company. Early in the 1970s they expanded by purchasing three DMSO clinics in
Juarez, Tecate, and Nogales, Mexico, where patients were treated under the
direction of Mexican doctors. Not quite satisfied that DMSO was safe, the
businessmen called in Dr. Jacob to tour the clinics and coach them on suggested
changes in their therapeutic procedures. After persuading Americans, for a time, to cross the border for DMSO
treatment, the partners decided to manufacture, market, and legitimize DMSO in
the United States. First they had to work with the FDA in trying to get approval of
the drug. This became Moyle’s almost full-time responsibility. Dr. Jacob became
associated with the company and put Moyle in touch with Dr. K.C. Pani for
discussions about INDs for DMSO. The two indications that seemed most promising for INDs were scleroderma
and interstitial cystitis. American physicians treating these conditions with DMSO
were Dr. Scherbel and Bruce H. Stewart, M.D., respectively, both of the
Cleveland Clinic Foundation. Later, Dr. Stewart brought in Sheridan Shirley, M.D.,
of the University of Alabama, and these two doctors administered DMSO to
patients suffering from interstitial cystitis. Their patient experimentation was doneunder an IND initiated in 1974. RIC acquired a wholly owned subsidiary known as Terra Pharmaceuticals,
Buena Park, California, to manufacture DMSO. It had once been owned by Nutri-
Lite, a subsidiary of the Amway Corporation. Twenty to thirty workers now
manufacture DMSO at the Terra Pharmaceuticals plant. Data submitted by Dr. Shirley was a fifty-one-patient study; the data submitted
by Dr. Stewart was a fifteen-patient study. The research had gone on for more than
a year. Research Industries Corporation was the sponsor who submitted the
clinical trial reports to the FDA. The Shirley and Stewart studies sent along for
approval of DMSO in the treatment of interstitial cystitis were accepted, and the
drug came into legal use for this condition. About a year later, RIC was inspected
by the FDA to see what kind of monitoring the company was doing at the time. Then the FDA checked with the two clinical investigators, randomly chosen, to see
how the monitoring that had been conducted actually stood up. Their visit to Dr. Shirley’s research facilities was disturbing to the FDA
inspectors. Although the researcher had been given ten days’ notice, he had
difficulty producing the background information and other raw data that would
support the safety claims he had made. This led to another inspection the FDA
labeled “for cause.” The “for cause” inspection was designed to compare case
report forms—fifteen were chosen at random—to the patient records. The
inspectors wanted to learn if the underlying data that had previously been missing
were still missing. Dr. Hensley said, “The intent was also to pursue beyond that; to
go, in fact, to the laboratories that had allegedly done that data and, if necessary, to
the patients.”
The FDA uncovered virtually every possible deficiency in the Shirley studies,
according to Dr. Hensley. For example, there were no records of informed consent
by the patients. There was no institutional review board approval where it was
appropriate and necessary. The University of Alabama seemed not to have been
consulted at all about this patient experimentation under its jurisdiction. More important from the FDA’s viewpoint were problems with the safety and
efficacy data, which tended to invalidate all prior approval of DMSO for the
treatment of interstitial cystitis. In the safety data, the eye examinations that were
supposed to have been done before the study began and every three months during
its course and after its completion appeared not to have been done at all. The
laboratory work, a battery of patient tests to be accomplished before the study,
then on a monthly basis during its course and after its conclusion, could not be
verified because the underlying records were not to be found.The FDA inspectors diligently pursued these failings and were unable to
confirm that the testing had been performed. They interviewed patients and learned
that neither the laboratory work nor the eye examinations had taken place. The
reports of such laboratory and eye tests were allegedly false, even though the case
report forms held in house by the FDA showed that all of this work had been done
and that the results were normal. Hensley told Senator Kennedy that the efficacy data were also disturbing. The
agency had received two sets of case reports from RIC on Shirley’s study—one
near the end of 1975. It showed generally good to excellent results with treating
interstitial cystitis. The second arrived in early 1976 on a resubmission of the
NDA, which showed some of these patients deteriorating. When the FDA did its “for cause” inspection, the review of Shirley’s records
looked a good deal worse; people treated had more than just minor deterioration. The patients, although they might initially have had a very good response,
generally did seriously deteriorate and often required other medication or bladder
surgery. The Division of Scientific Investigations then declared that the Shirley data
simply could not be used. It was unsatisfactory, to say the least, said Dr. Goyan. Dr. Shirley came under FDA investigation; as a consequence his certification as an
FDA inspector was rescinded. The FDA also turned its attention to the study done by Dr. Stewart and, after
completing its review, a decision was made as to whether or not a hearing would
be held and further action taken. Furthermore, at 
least three other interstitial
cystitis studies came into question. Withdrawing approval of interstitial cystitis as
the only legal human use of DMSO was considered. A general pattern of
disinclination on the part of the investigating physicians to do the drug safety work
—the eye examinations and the laboratory tests—seemed to be developing. Dr. Scherbel explained the reasons for not burdening patients, institutions, and
researchers with this drug safety work. He told the House Select Committee on
Aging: “For those patients who could indeed profit from the use of a very simple
drug, we cannot use it unless we carry out a very strict protocol. If I wanted to
give this drug to a patient today, I must obtain sophisticated eye examinations
every six months. This patient must have blood studies every three months. If this
patient lives 150 miles from Cleveland, he or she must come back at a determined
time and the studies must be carried out according to FDA regulations. “Long ago we realized that toxicity was not a problem but we do not dare to
give this drug without carrying out a battery of very sophisticated laboratorystudies. Who pays for this?” asked Dr. Scherbel. “The patient might not have
funds to pay. Will the Cleveland Clinic? They will if I ask them to, but it is not
fair to the Cleveland Clinic to do this because it is the FDA request. “If we obtain funds from a pharmaceutical firm and eventually they sense this
drug is not going to be approved, where do the funds come from to continue
treatment for this group of patients?”
These are valid questions; they require answers if drug safety is to be assured. Unfortunately, Dr. Hensley disclosed another reason for the FDA’s
disinclination to accept DMSO studies strictly on the face value of researchers’
opinions. The investigating doctors tended to overlook, maybe not see, or perhaps
deliberately ignore possible adverse effects. For example, Dr. Hensley described
difficulties with accepting additions to the Stewart study. He said, “The original
NDA was twice submitted to the agency; the last time in 1976, and finally it was
approved in 1978. In September 1979, another package of data was submitted to
the agency by Research Industries. This package contained not fifteen patients of
Dr. Stewart, but forty.”
“We have looked at that data, and it is apparent that a good many of those
patient reports had been available prior to the NDA submission and were
contemporary with Dr. Stewart’s other patients,” said Dr. Hensley. “It appeared,
therefore, that a selective submission of data had been made to the original NDA.”
Thus, the researcher chose certain patients to represent his clinical trials and
sent them for submission by RIC to the FDA. Or, RIC did the selecting from the
whole group of fifty-five patients and sent along just fifteen. What of the newly introduced batch of forty people who used DMSO and
whose cases weren’t revealed until three years later? Dr. Hensley said, “Many of
the patients—in fact, I guess the majority of those that are truly interstitial cystitis
—had either fair or poor responses to the treatment.”
So there have been definite questions raised about both of the studies that were
the basis for the NDA approval of DMSO employment against interstitial cystitis. No wonder the FDA has been so stubborn about giving approval for DMSO
medical usage in general. Following the Kennedy hearings, the FDA appointed a DMSO “Steering
Committee.” This committee brought in a new group of investigators—
pharmacological, toxicological, chemical, and medical professionals—who had
nothing to do with the initial approval of DMSO for interstitial cystitis. These new
investigators were paid for their work by the FDA. They reviewed the entire
matter, and their conclusion was that Drs. Shirley and Stewart were quite sloppy inrecording their data. Because of this they were disqualified as investigators for the
FDA thereafter. However, the FDA, even after this thorough review of the entire matter,
allowed the approval of DMSO for use against interstitial cystitis to stand. They
found that the two physicians had been careless rather than dishonest in their
reporting. Such carelessness in medical research is simply an expression of human error,
particularly in relation to the employees one depends upon. As interstitial cystitis
is a rare disease and difficult to find, the FDA physician-investigators in
Cleveland or Birmingham, Alabama, had patients come in for checkups from all
over the country. (The FDA requires a minimum of fifty patients from two
investigators to approve a drug for prescription use in a specific condition.) On the
approval sheets, the FDA had listed various parameters for the investigators to
follow and fill in. Certain employed research associates—frequently college
students—filled in the answers to questions that they asked the participating
patients. One of the questions on the approval forms concerned ophthalmology. The
research associates (dental students) would ask the patients, “Have you had your
eyes checked?”
The patients most often said, “Yes!”
The next question was, “Have you had any problems with your eyes?”
The patients replied, “No!”
The research associates then wrote on the approval forms: “Ophthalmology
negative.”
These patients had been examined by ophthalmologists in areas far distant
from the research facilities in Cleveland or Birmingham. The physician-
investigators did not have those eye examination records as part of the patients’
files. Thus, upon “for cause” evaluation of the records, the FDA declared the
investigators’ record response for vision unsubstantiated. Later, despite being
disqualified as FDA investigators, Drs. Shirley and Stewart were able to show that
these ophthalmologic examinations were, in fact, carried out. And as the FDA
found that the interstitial cystitis protocol was correct, DMSO remains an
approved medication for treatment of this bladder problem. Senator Kennedy emphasized that there were a series of collective failures
among the several people involved with this NDA procedure. The FDA found
failures by the investigators doing the clinical work, the sponsor supplying the
drug, the physician-monitor checking methods, and the FDA medical officer actingas liaison for the NDA. There was a failure to write up accurate case histories, a
failure to keep adequate records of drug accountability, a failure to obtain
institutional review committee approval, and a failure to maintain documentation
of informed patient consent. In questioning the patients, the FDA believed that
most of the required eye and laboratory examinations possibly were never
performed at all and they found the lack of records just sloppy reporting. In some
of the cases report forms were, in fact, altered between the first and second FDA
inspections so that FDA officials remain suspicious. They still think that there was
insufficient reporting or alleged misreporting of toxicological ophthalmic effects in
the patients. Looking at just one of the people who failed in all this, Kennedy wondered
whose responsibility at RIC it was to detect the various DMSO problems that
apparently went undetected right through the NDA approval process. “Senator, I
believe that the ultimate responsibility, certainly, lies with me,” said Henry Moyle. “I signed the documents that went into the FDA.”
Here we see a businessman who had protected his investment. Kennedy asked
Moyle, “What would be the impact on Research Industries if, as a result of these
problems, the FDA determined that it could no longer maintain the approval of
DMSO for treatment?”
“Well, Senator, we are a small company,” answered Moyle. “We believed
when we started with this application that it would not take nearly this long, and
we have stretched it out. On our marketing, we are not yet breaking even. So, we
would have real problems. I suppose we would have to dispose of our subsidiary,
Terra; that would be too expensive an operation to be able to continue with. If we
did that, we would no longer have a lab approved for good manufacturing
practices, and it took us three or four years to get that approval at the FDA. So
that would be an impossible burden; I do not know what we would do.”
CLEARING UP POTENTIAL CONFLICTS OF INTEREST FOR
DR. JACOB
Surgeon Stanley Jacob has treated tens of thousands of patients at his modest
office at the University of Oregon Health Sciences Center. He now sees more than
200 people a week, some with the most serious health problems such as spinal
cord injuries, Down’s syndrome, stroke, spondylitis, burns, cancer, scleroderma,
herpes zoster, and worse. Dr. Jacob has become known nationwide and overseasfor the excellence of his work in making known the new and varied uses for
DMSO. The weight of his discovery of the medical properties of dimethyl
sulfoxide is enough to plant him firmly in the medical history books. He is an
admirable scientist. Still, with all these patients coming to his office door and the reputation he has
established, Dr. Jacob’s annual salary was only about $45,000 ten years ago. With
raises in steady increments, his salary probably doubled by 1992. The University
of Oregon doesn’t pay its research physicians on a par with industry, whose
physicians average around the $200,000 a year level. Moreover, Dr. Jacob’s
current salary is probably 25 percent of what he could earn as a surgeon in solo or
group private practice. Why, then, does he do it? And why has he continued taking DMSO himself
since 1963? Dr. Jacob says “not for any medical problem but because if any side
effects are going to develop, it’s better that they raise their ugly head in my body
than anyone else’s.”
His dedication and sacrifice are undeniable. For almost twenty years Stanley
Jacob has been struggling with the FDA and the scientific community to get
dimethyl sulfoxide approved for national distribution and generally accepted for
medical use. The father of five children ranging in age from fourteen to thirty-nine
years, Dr. Jacob believes that the failure of his three marriages may be attributed
to his total involvement with the legalization of this pharmaceutical solvent. He
says it is his “obsession.”
The doctor expects to devote the rest of his working life proving the worthiness
of DMSO in the pharmacopeia of every physician for a vast array of health
problems. Retirement is not for him. “I might spend a little more time with family,”
Jacob says, “but my research interests wouldn’t change. I couldn’t begin to scratch
the surface of DMSO’s uses in the years remaining to me.”
All this sounds highly idealistic; he is a magnanimous individual, the image of
a truly good man. And this really may be the case—unless you gain access to
certain other facts that don’t generally get broadcast. During Senator Kennedy’s devastating cross-examination of Research
Industries Corporation President Moyle, the Senator learned that Jacob was the
physician-monitor for those series of studies on DMSO for scleroderma and
interstitial cystitis, mentioned earlier. Errors in accuracy related to the clinical
trials may be Jacob’s responsibility rather than Moyle’s, as Dr. Jacob was
obligated to inspect the trials in progress and check the records being kept. While the royalties Jacob receives on the patents for DMSO medical uses arestill relatively small, as DMSO’s popularity in medicine increases, the royalties
could become huge. At present he turns over royalty money to the University of
Oregon Health Sciences Center for the Department of Surgery and for DMSO
research, but at any time Jacob could retain the money for himself. It is not held in
trust or transferred to a charitable foundation on behalf of the medical center. When Jacob was a paid director of Research Industries, he was able to
purchase 50,000 shares of stock in the company at $6.50 a share. Today the
corporation is a publicly traded stock issued on NASDAQ, the over-the-counter
market of the National Association of Securities Dealers. Its 2,050,000 shares
traded at a high in 1980-81 of $15.50 a share. Plus, the doctor had the option to
purchase an additional 50,000 shares at $6.50 and another 50,000 shares at $9.50,
over the next four years. In 1982 the high price per share was $12.50. If he had
executed his options at the stock’s high 1982 price, the accrued value of all these
shares would have come to $1,875,000, for which Jacob paid $1,125,000—a clear
gain of $750,000. Finally, when he ended his function as a physician-monitor for the DMSO
investigations, Jacob became, for a time, a consultant to the company at a salary of
$24,000 a year, which supplemented his University of Oregon salary. It seemed not to bode well for Jacob’s financial future if the investment made
by Research Industries Corporation in DMSO research, 
manufacturing, marketing,
and distribution proved invalid. The physician appeared to have too much invested
in RIC for him to let this happen so that an objective observer might see potential
conflicts of interest here for Stanley Jacob. Consequently, at the semi-annual
scientific conference held in Las Vegas, Nevada, November 19, 20, 21, 1982, by
the American College of Advancement in Medicine, I interviewed Dr. Jacob on
exactly these potential points of conflict. The following is what Stanley Jacob
said:
“When I first went to work for Research Industries Corporation in 1973 they
offered to give me a quarter of a million shares of the company’s stock. I refused
it. At that time the stock sold for fifty cents a share. I turned the stock down
because I never wanted anyone to accuse me of vested interests before DMSO
was approved by the FDA. “After DMSO won approval, however, I did take a stock option and executed
it for 50,000 shares by borrowing money with other directors (I was myself a
director of Research Industries Corporation) cosigning the loan note. I also held an
option to acquire another 100,000 shares, but the stock price had risen markedly to
$6.50 a share. I borrowed $325,000 to purchase the 50,000 shares.“My idea of taking the stock at that point was to donate any profits I made to
DMSO research. Unfortunately, it got into that time of 20 percent prime rate so
that the legal expenses and interest expenses reduced the profit return sharply. I
received less than $9.00 per share at the sale of my block of stock when I made
the sale two years later. My resultant loss on the entire transaction was $2,000. “Before the Kennedy hearings, in June 1980, I completely disassociated myself
from Research Industries Corporation—dropped my directorship, sold the stock,
and gave up all rights to any other of the stock options. The particulars of my
disassociations were not in the hearings because I actually made the financial
transition with the stock the same month as the Kennedy hearings, in July 1980. That’s because there was a legal two-year holding period for the stock. I had
acquired the 50,000 shares in July 1978.”
RESOLVING THE SCANDAL OF DMSO
What was the outcome of these various revelations? Of consequences connected
with irregular practices among DMSO researchers and other principals involved,
attorney Buc said, “There are a series of actions that will have to be considered. Any of the clinical investigators who 
have violated our regulations will have to be
considered for potential disqualification as clinical investigators. That is a process
that is begun by the Bureau of Drugs. The clinical investigators are entitled to a
hearing, and it ultimately reaches the Commissioner.”
The FDA did judge whether Dr. Shirley and Dr. Stewart should be eliminated
as qualified FDA clinical investigators. They were eliminated. “In addition, to the extent that the information that the Inspector General or any
of us turn up results in allegations of criminal activity,” continued Ms. Buc, “I
know that we will be considering criminal prosecution as well, for the
investigators, if there are allegations of criminality there, and, if it comes to that,
the people at the agency as well.”
The FDA had already interrogated and discharged Dr. Pani, and the Justice
Department brought criminal charges against him. Dr. Pani pleaded guilty to a
single misdemeanor count of improperly receiving payments. The Indian-born
researcher openly accepted loans of $38,500 from Dr. Jacob to assist in paying for
cancer treatments for his wife and also for donations to an Indian religious leader. Dr. Pani’s wife subsequently died from cancer. The supervisor of Dr. Jacob’s work at the University of Oregon Health
Sciences Center, and a friend of his for many years, William W. Krippaehne,M.D., described the DMSO champion as a compassionate humanitarian who has
given large sums of money to friends and strangers alike without question. Dr.
Krippaehne said that his friend has treated patients from all over the country, often
without charge, has given money to people in need, including members of the
university staff, without requiring repayment, and has put extra money back into
university research programs. “If he didn’t do charity work,” Dr. Krippaehne said,
“his net income would be significantly into six figures.” He also said that Dr.
Jacob, an associate professor of surgery and author of over 100 medical journal
articles, was a “catastrophe” when it came to business matters. Dr. Krippaehne made these statements on the witness stand, as the Justice
Department also brought criminal charges against Dr. Jacob for three counts of
improper payments to an FDA official and one count of conspiracy. The trial for
the surgeon and the FDA official took place in May 1982 but ended in a mistrial. The government bureaucrats continued their attack and pursued Dr. Jacob in a
second trial after Dr. Pani pleaded guilty to misdemeanor. Dr. Jacob welcomed the initial trial, stating that it would give him a chance to
vindicate the use of DMSO. At the second trial not only was he acquitted of all
the charges, but the Justice Department actually dropped the charges on the fifth
day of the trial, held October 29, 1982. Dr. Jacob was cleared completely and
received a semblance of an apology from the government. The grand jury
indictment was totally dismissed. In our interview, Dr. Jacob explained what happened: “Dr. K.C. Pani is a
friend of mine. His wife was my patient. I got to know him well. He had
horrendous medical bills. I loaned him money by personal check which Dr. Pani
returned by personal check. And this exchange of checks was the basis of the
indictment for conspiracy and giving an illegal gratuity to a government official. “I learned a lot from this experience. For instance, I was under the erroneous
impression that a Grand Jury of the United States hands down an indictment only
after it has sifted through all the evidence and has weighed it carefully. That isn’t
true at all. Most of the time the United States Grand Jury merely does what the
United States attorney tells them to do. This is what happened in my case. The
result is that the United States taxpayer has invested one to two million dollars in
investigating this case, sending inspectors and investigators across the country
several times, preparing for the trial, conducting the trial, and finally dropping the
charges to vindicate me and DMSO. Still, the prosecutors seemed to be
aboveboard. I developed respect for both United States attorneys. I had the feeling
that they were going through the motions of prosecution but that they almost wishthey hadn’t gotten involved in the case. Their hearts weren’t in it. “The judge had strong feelings that the case should be dismissed and he
relayed his feelings to the Justice Department. So, my attorneys and the
prosecutors worked out an arrangement where we mutually read statements in
open court that said in essence, I understand where people could interpret that our
exchange of checks was a conflict of interest, and I’m sorry such an interpretation
was made.’ The federal attorneys in turn stated, ‘We are dropping all charges
against Dr. Jacob, and we wish to take this opportunity to commend him for his
good services to the community.’”
Additionally, Dr. Jacob admitted that it had been “wrong” and “inappropriate”
for him to make payments to an FDA scientist even though the payments in no way
involved a conspiracy to clear DMSO and win its approval for other uses. The
government, furthermore, excused its own action by saying that its sole purpose
was to simply 
“ensure that the integrity of the regulatory process is upheld.” In
effect, Assistant United States Attorney Richard E. Dunne III said that the Justice
Department wasn’t after Dr. Jacob as a profiteer because of his early financial
connection with Research Industries Corporation, the producer of Rimso-50, but
the case was pursued because DMSO could be considered the Laetrile (an anti-
cancer drug) of the eighties. DMSO is a drug that hundreds of thousands of people are using, and for which
there is a great public pressure to make legal nationally. There is also tremendous
congressional pressure to approve DMSO for general use. But the bureaucratic
record thus far is enormously distressing. There is a failure on the part of the FDA
to properly handle DMSO. The agency has undergone internal conflict as a result,
and the Inspector General is investigating that situation. DMSO has had inefficient
and ineffective overall review. Problems that have been discovered were not
expeditiously corrected, and it took the FDA an overly long time to make those
discoveries. Perhaps the FDA has perpetuated the greatest failure of all those
committed, because it is supposed to be the regulator beyond reproach guiding the
others to do what is good and true. The result is, as Senator Kennedy points out, that a travesty has been made on
the drug regulatory process and serious questions have arisen in the minds of
thousands of physicians and possibly millions of potential patients who need and
want to use DMSO. It may alleviate their suffering from a variety of ailments, but
the drug is being denied to them because of uncertainty as to its safety and
efficacy. The FDA itself has been a blot on the drug regulatory record. Senator Kennedy assured the public that this entire matter of allegedmisreporting, misstatements, and alterations of data was going to be evaluated for
criminal content by the United States Department of Justice. And it has been. Overall, charges have not been brought or they’ve been dropped without definitive
conclusions. Doctors and patients continue to use DMSO in spite of the cloud concerning
its safety. In over fifteen years of use, I have not heard of one patient complaining
of vision problems, and some of these patients have been using DMSO regularly
for ten, twelve, and even fifteen years without complaint. Even if nuclear sclerosis,
or progressive myopia, does occur in some people, it is hardly of clinical
significance in that patients are unaware of changes and do not complain of visual
impairment. All of the studies done up to now show that lens changes seen in
experimental animals are reversible simply by discontinuing the medication. A study by Dr. Jack de la Torre, reported in the 
Journal of Toxicology 
and
Environmental Health
 7:49–57, 1981, states: “Daily funduscopic examination
during the testing period failed to reveal any abnormalities in any of the monkeys
tested. . . . a double-blind slit lamp examination of the lens was performed the day
before saline or DMSO administration and then again 10 and 120 days after saline
or DMSO. No changes in refraction or translucency of the lens and no other
abnormalities were noted in any animal before, during, or eighteen weeks after any
drug administration.”
There is no therapeutically effective agent on the market that does not have the
potential of causing some untoward side effect. Although penicillin,
phenylbutazone, clofibrate, and even aspirin can cause death in some patients, no
one has suggested that these drugs be taken away from the people. “Adverse eye
findings” have been reported with 
all
 of the arthritis drugs such as Anaprox,
Naprosyn, and Motrin (as per their package inserts). Yet, no one has suggested
that these minimally effective agents (about the same as aspirin) be taken off the
market because of these adverse eye findings. Even if the Scherbel findings are verified, DMSO will still be one of the safest
and most important agents when it’s made available. If a person is dying from a
stroke or severe burn, it is unlikely that he or his loved ones will worry about
clinically insignificant lens changes. Because of the question of eye changes, and in spite of many studies showing
that eye pathology does not occur, most physicians recommend, but do not insist
on, a slit-lamp eye examination every six months for patients using DMSO on a
continual basis. I can only hope that this scientific and bureaucratic bungling doesn’t setDMSO therapeutics back another twenty years. It seems that the American people
are entitled to a better performance from everyone involved—the FDA, the
medical researchers, and the private business sector. In the interest of the patients
who are suffering and are full of anguish, we must have a quick, accurate, and
definitive approval of DMSO for general medical use, as it is, indeed, the new
healing power. INVESTIGATIVE REPORTS CONFIRMING DMSO’S VALUE
FOR SCLERODERMA
In 1986, the German journal 
Dermatologische Monatsschrift
 published a scientific
article that verified the value of dimethyl sulfoxide in the treatment of
scleroderma. The solvent was combined with dexamethasone, a corticosteroid, and
administered as a local treatment that worked well. 3
In 1983, the Dimexide brand of DMSO was applied to Russian patients for
counteracting their scleroderma. Good therapeutic results were reported as
circumscribed drug therapy. 4
Again in 1983, skin manifestations in the form of scleroderma were improved
by the patients receiving DMSO. The solvent is known to exert a palliative,
therapeutic effect on healing of cutaneous ulcers (ulcers on the skin) in systemic
sclerosis (scleroderma). In this study, which was described to the New York
Academy of Sciences, the therapeutic response was variable and, therefore, the
concentration of DMSO, as well as frequency and duration of treatments, were
individualized to obtain maximum healing effect with a minimum of adverse
reactions. There was no evidence of ocular (eye) toxicity or other serious toxicity
manifestations in this group of patients. They had been treated with topical DMSO
for one year or longer. Delayed improvement was observed in the untreated
extremity in the majority of patients studied. In no instance did improvement in the
untreated extremities exceed improvement in the other, treated limb. It is believed
by the investigators that this resulted from a systemic, carryover effect of DMSO
rather than spontaneous improvement in the disease course. “DMSO is a
worthwhile, supplemental, therapeutic agent providing the limitations of therapy
are understood,” said the investigator, Dr. A.L. Scherbel. 5
A prospective, randomized, double-blind trial was carried out in 1985 that
compared topical therapy with 0.85 percent normal saline (salt solution as a
placebo), 2 percent DMSO, and 70 percent DMSO for treatment of digital ulcersin 84 patients with systemic sclerosis. There were no statistically significant
differences among the three treatment groups in the improvement in the total
number of open ulcers, total surface area of open ulcers, average surface area per
open ulcer, number of infected ulcers, number of inflamed ulcers, or patient pain
assessment. While some patients improved during the study, improvement could
not be attributed to a specific treatment. Over one-quarter of the patients treated
with 70 percent DMSO were withdrawn from the study because of their
undergoing significant skin toxicity. 6
INVESTIGATIVE REPORTS CONFIRMING DMSO’S VALUE
FOR INTERSTITIAL CYSTITIS
Interstitial cystitis is not an infectious disease, but it shows clinical manifestations
of bladder inflammation and irritation. The condition 
may be related to the
collagen diseases, may be an autoimmune disease or an allergic manifestation, or
be secondary to an infectious agent not identified. At any rate, it’s apparent that
medical science does not know its cause and thus has no viable treatment for
interstitial cystitis except the administration of dimethyl sulfoxide. Histologically, the bladder wall in interstitial cystitis shows a unifocal or
multifocal—single-site or multi-site—inflammatory infiltration with ulceration of
the bladder’s mucosa (lining). Scarring develops, which ultimately results in
contraction of the smooth muscle, diminished urinary capacity, and symptoms of
frequent, painful urination and hematuria (blood in the urine). Typically, middle-
aged women are affected. To evaluate the effectiveness of dimethyl sulfoxide in the treatment of patients
with biopsies suggestive of interstitial cystitis, thirty-three patients underwent a
controlled crossover trial in 1988. The results were reported in the 
Journal of
Urology. Patients were allocated randomly to receive 50 percent DMSO or salt
solution (saline) as placebo. The medication was administered intravesically every
two weeks for two sessions of four treatments each. Response was assessed
urodynamically (by checking urine) and symptomatically (by observing
symptoms). Thirty women and three men having an average age of 48 years and an
average duration of symptoms of 5.5 years were entered into the study. No
significant side effects to DMSO were noticed by the investigators. When
assessed subjectively by the patients, 53 percent of them felt markedly improved
compared to 18 percent on the placebo who felt improved. Of the dimethylsulfoxide group, 93 percent had objective improvement versus 35 percent of the
placebo group. Thus, DMSO proved to be superior to placebo in the objective and
subjective improvement of patients with interstitial cystitis. 7
REPORTS SHOWING DMSO’S VALUE FOR OTHER URINARY
SYSTEM PROBLEMS
Bladder diseases in general respond well to instillation of DMSO into the urinary
tract. For instance, as indicated in a 1985 published paper, complex irritative
bladder syndrome responded well to the solvent. 8
Intravesical instillation of DMSO was used in the treatment of patients with
intractable urinary frequency due to chronic prostatitis, chronic cystitis,
tuberculous contracted bladder, and interstitial cystitis. A 1985 report from Japan
indicated that before the application of dimethyl sulfoxide, all four patients were
examined carefully to rule 
out cases of acute infectious diseases of the urinary
tract, active urinary tuberculosis, neurogenic bladder (nerve pain of the bladder),
and carcinoma in situ of the bladder (cancer within the bladder). Three of the four
patients achieved an excellent response both subjectively and objectively. In the
United States, intravesical instillation of DMSO had already been established as
the specific method in the treatment of interstitial cystitis and no side effects have
been reported so far. Therefore, the Japanese physicians used intravesical
instillation of DMSO with success and recommend its application for various
forms of intractable urinary frequency. 9
Urethral syndrome in women is an annoying condition that is not uncommon,
but a 1987 report from Poland indicates that it does respond well to DMSO
instillation. The chronic urination disorder is relieved by intravesical
administration of the solvent solution. 10
A case of bladder amyloidosis was treated successfully in February 1986,
report Japanese researchers, with DMSO bladder instillations. A diagnosis was
made by a biopsy of the bladder epithelium (cells lining the inside of the bladder). Amyloid fibrils were confirmed in the biopsy specimen with polarization and
electron microscopy. The patient was treated with trans-urethral resection (a
surgery) plus DMSO. From these bladder instillations the residual lesion
disappeared within four months. DMSO bladder instillations were given twelve
times without side effects. Thus DMSO bladder instillation with surgical resection
is designated as an excellent therapy for bladder amyloidosis. 11Epilogue
“Pain is only four letters, but it means different things to different people,” said
Ray Peppi of Stamford, Connecticut. Mr. Peppi suffers from excruciating pain
caused by undergoing three back operations for relieving spinal arthritis. “You can’t understand great pain unless you have it—unless you can’t
remember a day in your life when you didn’t have it. It makes you want to jump
off a roof. It drives you crazy,” Peppi explained. In desperation, because drugs prescribed by his doctors failed to alleviate his
pain, four years ago the man acquired DMSO from a nonmedical source. The
solvent is not authorized in Connecticut for use on back problems. State residents
whose pain is so severe that they are willing to try anything are using the crude
industrial grade. DMSO did what other remedies couldn’t, said Peppi. It got rid of
his pain. The Public Health Committee of the General Assembly for the State of
Connecticut considered legislation that would legalize DMSO for use in
Connecticut but rejected it eventually. Texas has passed such legislation, as have
Florida, Nevada, Washington, Oregon, Montana, Oklahoma, and Louisiana. Because of political pressure exerted by interested state assembly members
and by members of the United States Congress, the Food and Drug Administration
has been prevented from simply ignoring the drug. FDA officials promised the
House Select Committee on Aging that they would take another look at it. Dr. J.
Richard Crout told committee members that clinical trials of DMSO, which have
been around for twenty years, and are still being carried out, haven’t been precise
enough to merit the drug’s general use. Yet, when the medication proves, in fact, to be as effective and safe as the
evidence may show, the American people will certainly be 
justified in wondering
why they have had to wait so many years to use it. Some FDA critics argue that if
the Salk vaccine or penicillin were developed today, it would take the same length
of time for them to become available to the people. How many would have died in
the interim? What numbers are suffering needlessly or dying now because DMSO
is unavailable on the legal, open market? This is another of those big questions
underlying the whole DMSO controversy. Government bureaucracy is known for waste and inefficiency in almost all
areas of activity. In agriculture, housing, welfare, and other areas it has not solvedthe problems for which government programs were initially instituted. Often it has
compounded them. With DMSO the problem is even more serious. Pain, health,
life, and death are involved. To leave an inefficient and ineffective bureaucracy in
charge of approving a pain-relieving, life-sustaining drug like DMSO will cost the
victims of injury and illness far more than tax dollars. I believe the medical consumer deserves to have the medicines he or she needs
as soon as they have proved to be safe and effective. I ask that the FDA fulfill its
mandate to protect Americans from foods and drugs that are unsafe and to
facilitate the speedy availability of new foods and drugs that are found to be both
safe and worthwhile. DMSO is one of these. DMSO is one of nature’s healers—
among the safest and most efficacious ever uncovered. We are entitled to it. We
must have it generally available. The life and health of our people lie in the balance. The story I have told
highlights the obstacles DMSO has met in getting FDA approval. More than that, I
have shown that pain relief is available, pathology reversal is possible, and good
health restoration is probable if only DMSO is not denied to us. The crime of
denial is senseless. How do we get DMSO to all the people? If there is no medical
answer, there may be a political one. With the former Reagan administration’s concern about the regulatory impact
on the return on research and development investments, ways were found to lessen
the FDA ban. The election of Ronald Reagan as our President meant significant
personnel changes for regulators, including the Food and Drug Administration’s
Bureau of Drugs. FDA Commissioner Jere Goyan, a political appointee during the
Carter administration, finally lost his post. Reagan’s advisors had searched for
highly qualified scientists who understood the problems with regulations. But they
wanted regulators who were people-conscious first, then regulation-conscious. They didn’t find them. Neither did George 
Bush. Instead, David Kessler, M.D.,
J.D., has turned out to be the most restrictive enforcer of Gestapo-like rules
coming out of the FDA. Kessler would remove every American’s ability to choose
what should be done for or to his or her body. The FDA, by expanding its mandate
and reinterpreting the Nutrition Labeling and Education Act of 1990 for its own
purposes, is approaching dictatorial powers. I hope his successor will take
immediate and decisive steps to reverse this trend. I want my book to move the
regulatory process. DMSO, nature’s healer, is a new therapeutic treatment for the
people. They deserve to have access to it.APPENDIX I
The Mechanisms of Action of DMSO, Miscellaneous
Conditions That Respond Well to DMSO
Administration, and Arthritis Treatment Details for
Physicians
DMSO lessens platelet adhesiveness, platelet aggregation, and, thus, clot
formation. Because of its prostaglandin activity, DMSO is a potent vasodilator. Prostaglandins—long chain hydrocarboxylic acids—are affected in a unique way
by dimethyl sulfoxide. The “good prostaglandin,” prostaglandin E, which is a
powerful vasodilator, is stimulated by DMSO. The “bad prostaglandins,”
prostaglandin E
2
 and prostaglandin F
2
 alpha, which are strong vasoconstrictors, are
depressed by DMSO. Prostaglandin E
2
 and prostaglandin F
2
 alpha not only cause
vasoconstriction but lysosomal destruction. Lysosomes are cellular “toilets” and
their destruction leads to release of the cytotoxic enzyme beta-glucoronidase. This
enzyme not only destroys its own cell, but surrounding cells as well, leading to
further beta-glucoronidase release, and further destruction. Prostaglandin E
1
, like aspirin and indomethacin, stabilizes lysosomes and
probably blocks the release of vasoconstrictive prostaglandins from brain tissue
and platelets. Because of the body’s “negative” or destructive responses to injury, including
toxic prostaglandin release, beta-glucoronidase destruction of cells, noradrenaline
stimulation, reduction of mitochondrial oxidative phosphorylation, release of
calcium ions, and other actions, 
DMSO may be the initial treatment of choice in
all acute destructive bodily processes. These would include any serious injury to
any body part or organ, septicemia, stroke, myocardial infarction, near drowning,
heat stroke, etc. As an example of the fantastically protective effect of DMSO against trauma,
consider the work of Dr. Ramon Linn, an Associate Professor of Neurosurgery. As
I mentioned in the text, Dr. Linn prepared cultures of 
glial cells and DMSO, which
he subjected to sonic vibrations. The cells were remarkably protected from injury
and beta-glucoronidase release. The other many modes of action of DMSO, such as sensory nerve inhibition,diuretic action, membrane penetrability, free radical neutralization, intracellular
water substitution, macrophage stimulation, antigen neutralization, and interferon
production, are all discussed in the text. THE INTRAVENOUS THERAPY TECHNIQUE USED BY MOST
DOCTORS
For intravenous therapy, other than acute stroke, the dose is 1 g DMSO per kg
body weight given daily for five to ten days with a rest on the weekend after the
first five treatments. A half dose is given the first day to observe the patient’s
response. An indefinite number of two-week blocks of treatment can be given as
long as there is a week’s rest in between. In one type of clinic setup there are two large rooms with rows of reclining
chairs for the intravenous (IV) patients. No television is provided, as the patients
are encouraged to read nutritional literature and to converse with each other. Also,
television sounds disturb those who prefer to sleep during the easy intravenous
infusion. On the first day, blood is drawn for chemistries, CBC, and arthritis profile. Hair analysis, computerized diet analysis, and basal temperature tests are done on
all patients no matter what their disease or complaint. The legal consent form must
be signed prior to treatment. The DMSO is mixed in 500 ml of any appropriate isotonic fluid. Physicians
usually use D5W. Some clinics use Ringer’s Lactate or 0.45 saline in 2.5 percent
glucose. For reasons explained later in this section, some doctors add 15 g of
ascorbic acid, 100 mg of pyridoxine, 1,000 mg magnesium chloride, 2,000 mcg
cobalamin, and 200 mg vitamin B complex. This is infused over a three- to four-
hour period. Occasionally nausea will develop. Phenergan suppositories, 50 mg, usually
will take care of it. A good breakfast must be eaten before the treatment to help
alleviate the nausea. Infusion nurses also make snacks available to the patients
during treatment. Patients may be advised to apply DMSO to affected areas at home. A 50-
percent solution is suggested for the neck and face. Before it was banned by the
FDA, the product 75 percent DEMSO was applied to any other affected parts of
the body; now Domoso is recommended. Application is two to four times a day
depending on skin sensitivity. Oral treatment is 
continued by the patient at home(one teaspoonful in juice twice a day) along with topical application after the IV
program is terminated. CLINICAL STUDIES SHOWING RESPONSE TO DMSO IN
AMYLOIDOSIS
Amyloidosis is the accumulation in the tissues of the fibrillar glycoprotein amyloid
in amounts sufficient to impair normal function. As stated a few times in the body
of this text, amyloid is a glycoprotein, resembling starch, that is deposited in the
internal organs. The cause of amyloid production and its deposition is unknown. A
defect in cellular immunity to a specific antigen is suspected. Amyloid is a
homogeneous, highly refractile substance with an affinity for Congo red dye, both
in prepared tissues and 
in vivo. It is made up primarily of a well-defined fibril,
distinct from other extracellular structural proteins, which occurs in two forms. Chemical analyses of the various forms of amyloid causes classification of the
substance as 
primary
 when there is no associated disease, and 
secondary
 when
it’s associated with chronic diseases, either the infectious form such as
tuberculosis, osteomyelitis, leprosy, and bronchiectasis, or the inflammatory form
such as rheumatoid arthritis and granulomatous ileitis. Amyloid is also found in
association with multiple myeloma, Hodgkin’s disease, and other tumors. It may
accompany aging and may appear in familial forms unassociated with other
disease. Increasing numbers of familial amyloid syndromes with distinctive types
of neuropathy, nephropathy, and cardiopathy have been described in the medical
literature. DMSO has found successful use by clinicians for the treatment of
familial amyloidosis. A report delivered by a half-dozen Japanese medical scientists to the New
York Academy of Sciences in 1983 indicated that DMSO was therapeutically
administered to patients with familial amyloidosis of the adult onset type. In about
half of the treated people there was some clinical improvement. Urinary proteins
were analyzed biochemically and immunochemically before and after
administration of the dimethyl sulfoxide in seven patients. Increased excretion of
various proteins of different molecular weights in the patients’ urine was observed
by the Japanese investigators, depending on cases and examined organs. The 
in
vitro
 effects of DMSO on amyloid proteins were examined. DMSO-degraded
amyloid proteins showed void-volume materials and lower molecular weight
components on a special urine test (the Sephadex G column elution profiles andthe guanidine-degraded amyloid protein 
profile). While DMSO is the least potent
in dissolving amyloid fibrils among the various denaturating or reducing agents,
prealbumin-related proteins (proteins that are the source of albumin) were found
from the testing. This proved that scleroderma improves somewhat from oral
ingestion of diluted dimethyl sulfoxide. 1
In another case of familial amyloidosis—only of the polyneuropathic type
(related to a disease of multiple nerves)—two case histories were presented in this
1984 paper from Italy. DMSO produced a positive response for those patients
having peripheral nerve disease. 2
Other patients with the primary type of amyloidosis and the kind associated
with multiple myeloma usually have the immunoglobulin light-chain form of
amyloid fibrils. Patients with secondary amyloidosis have demonstrated the
presence of the unique AA protein that consists of non-immunoglobulin. In primary amyloidosis, the heart, lung, skin, tongue, thyroid gland, and
intestinal tract may be involved. Peculiar localized amyloid “tumors” may be
found in the involved patient’s respiratory tract or other sites. Parenchymal organs
of the liver, spleen, and kidney and the vascular system are frequently involved, as
well. Secondary amyloidosis tends to show up in the spleen, liver, kidney, adrenal
glands, and lymph nodes. However, no organ system is spared, and vascular
involvement may be widespread. The liver and spleen are often enlarged, firm, and
rubbery. The kidneys are usually enlarged. Sections of the spleen show large
translucent, waxy areas, where the normal malpighian bodies (normally present
inclusion cells) are replaced by pale amyloid, producing the “sago” spleen. Amyloid associated with certain tumors such as multiple myeloma and skin
diseases such as lichen planus may be widespread and may show unique sites of
involvement. Amyloid may have a strictly local occurrence in association with
some malignancies such as medullary carcinoma of the thyroid gland. In a 1985 clinical paper, the result of topical treatment by dimethyl sulfoxide in
a patient with lichen amyloidosis was reported. DMSO improved the patient’s
itching within five days of therapy. Remarkable flattening of the papules usually
present in this condition was obtained within two weeks. The clinical result was
confirmed by histological examination, which revealed partial disappearance of
amyloid deposits. 3
Characteristic standard symptoms or signs of amyloidosis are lacking. Manifestations are nonspecific and usually originate in the organ or systemaffected. Often they are obscured by the underlying disease, 
which may be fatal
before secondary amyloidosis is suspected. The kidney’s nephrotic syndrome
(series of signs and symptoms present in a diseased kidney) is the most striking
manifestation. In the early stages only slight proteinuria may be noted; later the
distinctive symptom complex develops with massive swelling of the legs, trunk,
and genitalia due to retention of fluid, hypoproteinuria, and massive proteinuria. The urine sediment often contains red blood cells. All kinds of strange changes in
the body take place with amyloidosis. For instance, it caused a sudden whitening
and loss of hair, as described in an August 1987 Japanese case report. Yet, as
shown below, for this amyloidosis patient, treatment with dimethyl sulfoxide
solved his difficulty. Here, a sixty-seven-year-old Japanese man presented himself with rapid
progression of whitening and loss of his head hair within two months. It was
suspicioned by the attending medical specialists that he suffered with
hypothyroidism. He had been told that he had enlargement of the heart, a condition
suspected of being present for three years. Thyroid function for the man was
within normal limits, however. A prostate biopsy was performed on him because
of his obvious prostatic hypertrophy and mild elevation of serum acid
phosphatase. Then, amyloid accumulation was observed by the pathologist in the
biopsy specimen. Subsequent skin biopsies revealed the same result. The patient’s scalp hair and beard grew and turned to a black color gradually,
several months after DMSO treatment was administered to him. The researchers
came to the firm conclusion that some manifestations of amyloidosis such as show
up in skin, scalp, and hair pathology do respond well to DMSO treatment. 4
Amyloid disease of the liver produces an enlargement of this organ, but rarely
jaundice. Liver function tests usually are normal although an elevated alkaline
phosphatase may be observed. Occasionally, portal hypertension may occur with
varicose veins of the esophagus, and fluid in the abdomen. Massive liver
enlargement with a weight of 7 kg has been reported. Skin lesions as indicated by
the case of hair whitening and hair loss described previously may be waxy or
translucent; purpura may result from amyloidosis of small skin blood vessels. Cardiac involvement is common and may manifest itself as intractable heart failure
or show up as any of the common heart arrhythmias. Atrial standstill has been
found in several kinships. Gastrointestinal amyloid may cause bleeding and malabsorption in the bowel. A firm, symmetric, nontender goiter resembling Hashimoto’s or Riedel’s struma
may result from amyloidosis of the thyroid gland. Amyloid athropathy may mimicrheumatoid arthritis in some cases of multiple 
myeloma. Peripheral neuropathy is
seen in a few cases of primary or myeloma-associated amyloid. It is common in
some familial amyloidosis. With all these amyloid-associated pathologies, DMSO demonstrates a positive
therapeutic benefit. It affects systemic amyloidosis efficaciously. In August 1986, three Japanese clinicians reported to the American medical
community on the positive response of systemic amyloidosis to dimethyl
sulfoxide. It was a case report of systemic amyloid pathology as a manifestation in
the skin. This sixty-five-year-old woman with systemic amyloidosis was given
DMSO orally for four years without her having experienced any side effects. Her
cutaneous lesions improved markedly after the treatment, and she still survived in
satisfactory condition at the time of the article’s publication. 5
Secondary amyloidosis should be suspected by the doctor when the condition
of his or her patient with a chronic suppurative (pus-producing) disease
progressively deteriorates and the common manifestations of amyloidosis, such as
spleen and liver enlargement and/or albumin in the urine appear. Biopsy of rectal
mucosa is the best screening test. Other useful sites for biopsy are gingiva, skin,
nerve, kidney, and liver. All tissue sections should be stained with Congo red dye
and observed with the polarizing microscope for green birefringence (color
shadings). A 1982 report in the 
Annals of Rheumatic Diseases
 told of continuous oral
DMSO treatment of 7 to 15 g per day that was given to three patients with
amyloidosis of familial Mediterranean fever (FMF), three patients with idiopathic
amyloidosis—amyloidosis having no known cause—and seven patients with
secondary amyloidosis. The medically recognized kidney syndrome and various
degrees of renal insufficiency were the major clinical manifestation in all cases. Renal function was used as the main parameter for evaluation of the DMSO
therapy. DMSO treatment administered for seven to sixteen months produced no
effect in the FMF patients and in the patients with idiopathic amyloidosis; they all
ran the predictable clinical course of their disease and either died of cardiac
failure or have been maintained on chronic hemodialysis. In the seven patients with
secondary amyloidosis, an unequivocal improvement of the renal function was
observed following from three to six months of DMSO treatment. The improvement of kidney function was shown by a 30 to 100 percent rise of
creatinine clearance and a decline in the amount of protein in the urine
(proteinuria). This new equilibrium had been maintained for the patients as long as
DMSO was administered. No 
serious side effects of DMSO were encountered;mild nausea and an unpleasant breath odor were the patients’ main concern. The
four medical researchers concluded that a therapeutic trial with oral DMSO
definitely is warranted in all patients with secondary amyloidosis. “This treatment
is unpleasant,” they write, “but bears no exceptional risks. It may significantly
prolong life, though its effect on amyloid deposits themselves is doubtful.”
6
In secondary amyloidosis, prognosis depends on successful treatment of the
underlying disease. All forms of amyloid renal involvement carry a poor
prognosis, but with supportive therapy such as the instillation of dimethyl
sulfoxide, patients may remain healthy. Amyloidosis associated with multiple
myeloma has the poorest prognosis, early death within one to two years being
common. However, localized amyloid tumors may be removed without recurrence. Myocardial amyloidosis may cause death from arrhythmias or intractable cardiac
failure. Prognosis in the familial amyloidoses varies with each kinship. An early report of the use of DMSO therapy for amyloid deposits and
amyloidosis casts doubt on its value. Writing in the September 1981 issue of
Veterinary Research Communications
, the three clinicians state: “Data from the
literature on DMSO therapy for amyloidosis in laboratory animals and man are
reviewed and found to be inconclusive. In hamsters with casein-induced
amyloidosis, as well as in dogs with spontaneous amyloidosis, therapeutic
experiments with DMSO were performed. In these investigations no effect of
DMSO on amyloid and amyloidosis was found.”
7
Finally, a urologist, Dr. S. Yachiku, writing in the March 1986 issue of the
Journal of Urology
, reported on a case of primary localized amyloidosis of the
bladder that responded well to instillation with dimethyl sulfoxide. Dr. Yachiku
first successfully performed a transurethral resection and then did intravesical
instillation with DMSO. He concluded that the patient’s swift recovery from the
primary localized amyloidosis was directly due to DMSO. 8
CLINICAL STUDIES SHOWING RESPONSE TO DMSO IN
DISSOLVING GALLSTONES
A 1988 report by French clinicians confirmed that DMSO is useful for the
dissolving of cholesterol gallstones. It is known that methyl tert-butyl ether, which
is a powerful cholesterol monohydrate solvent, does not completely dissolve
mixed cholesterol gallstones when directly infused into the biliary tree (the stream
of bile into the gallbladder). In 
the current paper, the clinicians compared the effectof various solvents containing different proportions of methyl tert-butyl ether and
dimethyl sulfoxide in anhydrous and aqueous systems on the 
in vitro
 solubilization
of human cholesterol stones. The dissolution rates of cholesterol obtained in the presence of methyl tert-
butyl was markedly decreased when 10 parts were added to 100 parts of water. In
contrast, the addition of 30 parts of DMSO per 100 parts of water (a 30-percent
solution) to the methyl tert-butyl ether-water system enhanced the stone-solvent
contact, improved the cholesterol dissolution rates, and left less gallstone debris.
Dmso_Nature_s_Healer_-_Morton_Walker.txt
Summarize the following text section accurately and concisely. Maintain specific details and numerical information, and use anti-repetition mechanisms:

        All updated patient reports throughout the year have
previously been forwarded to the FDA under separate cover. ”
Commissioner Goyan considered this alleged misreporting extremely serious in
view of the fact that it was the eye toxicity that the FDA was most concerned
about. Under the IND regulations that govern this human experimental work, it is
mandatory that the sponsor shall promptly investigate and report to the FDA and toall investigators any findings associated with the use of the drug that may suggest
significant hazards, contraindications, side effects, and precautions pertinent to the
safety of DMSO. Eye changes in the scleroderma patients clearly fall within this
definition. It is possible that lens changes are a complication of the disease, but there is
nothing reported in the medical literature indicating that eye symptoms are present
in scleroderma. From the correspondence found three years later in the Research Industries
corporate files, it appears that Scherbel’s letter is the first DMSO report of human
eye toxicity ever, and that the pharmaceutical company had furnished the report to
Dr. Pani at the FDA. Commissioner Goyan said that if Pani had possessed this
information and not provided it to the FDA, it would be grounds for his dismissal
from the agency. It looked like the FDA had a real health problem with DMSO—specifically,
eye toxicity in humans. Also, the agency learned that the odor-free DMSO, 87-2,
and another DMSO derivative called Satori, had no IND and no animal testing, but
were being distributed in interstate commerce and being used by the general
public. We saw at the start of this chapter that Jean Puccio almost daily paints on
87-2, which she acquired from Dr. Jacob. Use of this unapproved drug is illegal. Dispensing it is a violation of the Federal Food, Drug, and Cosmetic Act. Dr. Hensley brought all this information to the Inspector General of the United
States. “The Office of Inspector General went to the United States attorney in
Baltimore, because it is the judicial district, and briefed them on what they knew
of it,” said Dr. Hensley. “They interviewed a great many people during that week
[May 12, 1980] and had some very definite impressions as to what they ought to
do. ”
The incident with which we opened 
Chapter 2
, where FDA officials 
holding a
Federal warrant entered Dr. Jacob’s office on November 10, 1980, looking for
documents on eye toxicity, is a direct outgrowth of this discovery and its eventual
public disclosure in the Congressional Record. In fact, one of the investigators
visiting Dr. Jacob’s office was Dr. Alan B. Lisook, who is Dr. Hensley’s
supervisor at the Division of Scientific Investigations, Bureau of Drugs, FDA. Lisook flew to Portland, Oregon, from Washington, D. C. , to grab what reports on
eye toxicity he could out of Jacob’s files. You’ll recall that Lisook wasn’t allowed
access to the files. Meantime, the Inspector General, in consultation with the Baltimore United
States attorney, investigated possible malfeasance on the part of some employeesof the agency. “The allegations have to do with the question of whether the
sponsor and the investigators were investigated promptly enough and in a proper
fashion,” explained Nancy L. Buc, Chief Counsel of the FDA, “and also may have
to do with questions that pertain to the sponsor and to the investigators. ”
Dr. Pani, the medical officer with the primary responsibility for DMSO, who
was assigned to the drug in 1968, was transferred from the DMSO project. And
then he was forced to retire from the FDA under threat of outright dismissal. The
policy management staff at the FDA conducted an investigation of Dr. Pani and his
relationship with the sponsors, the clinical researchers, and the physician-monitor. This physician-monitor was responsible for making sure the protocols of
investigations were being followed, the product being employed was pure, and the
records being kept were accurate. The FDA staff’s findings have not been made
public, but I have found out that the physician-monitor was Stanley Jacob.
The sponsor shall promptly investigate and report to the FDA and all investigators.
According to the FDA, what is mandatory for a sponsor to do in the case of any findings that suggest significant hazards, contraindications, side effects, or precautions pertinent to the safety of a drug?
Dr. K.C. Pani was the FDA medical officer responsible for the DMSO project. He was transferred from the project and eventually forced to retire from the FDA under threat of dismissal.
Who was the FDA medical officer responsible for the DMSO project, and what was the outcome of the investigation?
Dr. Jacob was acquitted of all charges, and the charges were eventually dropped.
What was the outcome of the second trial of Dr. Jacob, who was charged with three counts of improper payments to an FDA official?
The investigation led to the indictment of Dr. Pani, and he pleaded guilty to a single misdemeanor count. The government also pursued criminal charges against Dr. Jacob, but they were dropped without definitive conclusions.
What was the outcome of the investigation by the Office of Inspector General, and what was the subsequent action taken?
The recommended treatment protocol is 1 g DMSO per kg body weight given daily for 5-10 days, with a rest period on the weekend after the first 5 treatments. No serious side effects were reported.
What is the recommended treatment protocol for intravenous therapy with DMSO, and what side effects were reported?