How the fraud was unmasked
The scheme involving Peter Law and his Brazilian connection was
revealed in the site No Mínimo under the title Physicians
turn a disease into a criminal affair, published on July 13.
In order to unmask the fraud in Brazil, the journalist who signs
this article pretended to be the godmother of a boy affected by
Duchenne dystrophy, aged 7, who she named Bruno Almeida Silveira.
Without identifying herself as reporter and using the name Maria
Monteiro, she scheduled an appointment, on August 2000, with Wagner
Fiori, one of the Brazilian physicians involved in the scheme. He
and his partners, Dr. Euclydes Marques and Dr. Márcio Peres
Ribeiro, have an elegant clinic in S. Paulo called Genesys Research
Institute, that is affiliated to Cell Therapy Research Foundation.
"The transplant of 50 billion myoblasts improves muscular strength
and the quality of life of Duchenne patients. One was even able
to walk again. It is worth trying MTT in your godson," recommended
Dr. Wagner Fiori to the godmother. After charging R$ 196,00 for
the consultation (at that time about U$ 100 dollars; see the document
1), he gave her the phone number and the email address of Peter
Law, whose site celltherapy.com emphasizes: more than 230 transplants
have been performed with more than 75% success ratio.
"The MTT is experimental, and the results are very good,"
guaranteed Tunja Jackson , director of the Cell Therapy Foundation,
in Memphis to the godmother. The vice-president of the Institution,
Tena Goodwin, reinforced: "All patients transplanted have either
seen great improvement and/or a considerable decrease in muscle
degeneration. Dr. Law believes that Bruno will have these benefits.
The alternative is to do nothing, which is worse (see the document
2). Peter K. Law himself dispelled any doubts about the competency
of the Brazilian team (see document 3): "If it would make Bruno's
mother feel better, either myself or another staff member could
attend the transplant in Brazil."
Bruno's MTT was tentatively scheduled several times. The first on
December 10, 2001, in São Paulo. The last in April 24, 2002
(see document 3). The initial price was U$ 150.000 dollars, but
after a long negotiation with the godmother the final price was
set at U$ 134.000 dollars. This amount had to be deposited until
March 24, in the bank account of Cell Transplants Asia Limited that
belongs to Peter Law. Bank: Hong Kong Bank, in Hong Kong, Asia.
Bank number: 004. Account number: 485-232367 (see document 4).
Some important aspects during the negotiations between the supposed
godmother and Law's organization, which lasted 20 months, included
56 e-mails and several telephone calls were:
1. Bruno, the fictitious patient, would be 7 when the negotiation
started,
and 9 at the its end, in April 2002.
2. Bruno was never asked to be examined by the Brazilian doctors
nor in
Memphis in order to check if his diagnosis was correct.
3. Nobody ever asked how his disease was progressing. All the time,
the
only concern of Law's team was the MTT's payment.
4. Bruno was even released of the required visit to Memphis, where
he should be examined in order to know if he was eligible or not
for MTT. When the doctors were informed that the family had already
gotten the money they scheduled the procedure.
5. Peter Law set up the date of MTT even before receiving any medical
report or results of blood tests. The only report sent to Law was
written by Bruno's godmother.
Hidden unsuccessfulness
Bruno's case was built with only one aim: to evaluate how far Peter
Law and his Brazilian branch would go. Unfortunately, the reality
is much more cruel. These Brazilian children were dreaming of playing
soccer, running again or even walking after MTT. Three of them were
transplanted in Memphis, USA and the others in São Paulo,
Brazil. According to their parents this is their current condition:
* T.M., 20-yr-old -- Has lost all legs movement: when he tries to
move them, they fall as two strips of cloth; must be assisted in
order to turn in bed. Prior to the transplant, could flex his inferior
members. After the treatment, he experienced a sharp decline in
his ability to move them.
* J.B.G.C., 16-yr-old -- Must be spoon-fed due to inability to raise
his arms. Still draws and plays video-game: types everything using
two chopsticks. His mother claims: "It is too much suffering
for nothing."
* A.G, 17-yr-old -- Was hospitalized in April 2002, and died in
July following a cardiac-respiratory arrest.
* L.T.F.M, 16-yr-old -- Unable to walk; needs help to seat on the
toilet. Is still capable of using the computer.
* M.G.S., 13-yr-old -- Has already lost the ability to move his
arms and legs. Before being submitted to the treatment (being 9
years old at the time) he was able to walk. Right after the treatment,
he stopped walking, never again recovering this ability.
* A.C., 17-yr-old -- Unable to move his legs or raise up his arms;
has respiratory difficulties. According to his father, José
Tadeu Cruz, the U$ 150,000 that the Brazilian government paid for
the MTT and the additional U$ 20,000 spent by the family for travelling
and hotel were a waste. "My son cannot move anymore and has
severe respiratory problems. I would rather go to a witch than repeat
this treatment," claims Mr. Cruz.
In short, none of the Brazilian children showed any improvement
or change in the natural course of the disease, and in the case
of M.G.S. it is possible that the MTT has even accelerated the disease
progression. These boys represent the evidence which proves the
unsuccessfulness of this treatment. Pat Furlong, head of the Parent´s
Project in United States who followed several Duchenne boys submitted
to MTT including her two sons already deceased, confirms: "
Nothing has changed in the life of these children. The ones who
could not walk, or could not feed themselves independently continued
not walking or unable to eat without assistance."
Shattered hopes
"Unfortunately, myoblast transplant has not proven to have
any therapeutic effect for Duchenne or other forms of muscular dystrophies,"
warns Mayana Zatz, president of the Brazilian Muscular Dystrophy
Association. Besides, it is not true that nothing can be done. It
is known that the combination of proper physiotherapy, administration
of corticoids (in many cases) and assisted ventilation - the bipap
-- improves significantly not only the quality of life but also
the life expectancy in many years.
Scientists from all over the world agree. Among them known researchers
such as Terence Partdrige and Victor Dubowitz, from United Kingdom,
and the Brazilian neurologists Alan Gabbai, Acary Bulle de Oliveira,
Lineu Werneck and Umbertina Reed. "In addition to the immunological
rejection, there was no improvement in muscular strength nor a halt
in the muscular degeneration process," claims Professor George
Karpati, leader of the Montreal Neurology Institute, in Canada.
"The procedure is inefficient in any hands. Dr. Elizabeth McNally,
from Chicago University, emphasizes: "Recommending MTT for
Duchenne is fostering false hope to patients and parents."
The "brain" is in the USA
In the mid 1990's, renowned groups of researchers had already proven
that the myoblast transplant was not effective. Despite these results,
Peter Law, former member of the medical establishment, continued
his "researches" in his private foundation, with the approval
of the Food and Drug Administration. Nevertheless, in 2000, the
FDA, after conducting an investigation, disqualified Law and his
researches due to their serious flaws and violations.
When forbidden to perform transplants in the USA, he decided to
strengthen his Brazilian connection. Nevertheless, Law, the brain
of the organization, remained in the United States. The production
of myoblasts, obtained apparently from the muscles of healthy American
boys, also takes place in US. "We only carry out the transplant
(in Brazil), which involves 750 injections," explained Dr.
Fiori to the fictitious godmother. "The government must pay
for the transplant. Many children have already won in court the
right for the treatment. Bruno's parents can follow suit."
This has been possible due to a breach in Brazil's Constitution,
which provides the payment abroad for treatments unavailable in
Brazil in the case of severe diseases. This was guaranteed in at
least nine cases. But there is evidence that the Brazilian branch
has profited more than 3 million dollars to Peter Law's organization,
since more than 20 transplants took place just in São Paulo,
according to Tena Goodwin, Cell Therapy's treasurer (see document
2). After all:
1. Some wealthy Brazilian families financed their children's treatment.
2. Sick children, from other nations, were submitted to the transplant
in Brazil. This can be illustrated in the site davidmayuri.com,
where a young American boy is currently trying to collect funds
to be submitted to MTT (see document 5).
3. Other diagnosis were also included. In May, 2002, the Brazilian
Supreme Court of Justice declared that the government should pay
for the treatment of L.T.M, 20 yrs-old, affected by limb-girdle
muscular dystrophy.
Boys were used as guinea pigs
"We carry out the procedure here in Brazil just to make the
children's life easier. We are not entitled to any payment. Our
participation is solely based on scientific interest," is the
official claim from the three members of the Brazilian branch.
Unfortunately, they do not have any solidarity. Besides, they are
behaving unlawfully. The Brazilian trio has never submitted any
project to the National Ethical Committee, as required by the Health
Ministry. This is a mandatory requirement in any research involving
human beings.
The organization also shocks for its cynicism. Tunja Jackson, in
one of her emails writes: "We would also like to express our
sorrow in knowing that you had to sell your properties in order
to pay for your godson's treatment."
The truth is that it is all done for money only. Indeed, Cell Therapy's
plans for Brazil included the establishment of a foundation and
the use of myoblasts for myocardial infarction. "We are interested
in the cardiac area due to great number of affected people, 300
thousand Brazilians every year," states Euclides Marques. "We
just got involved in muscular dystrophy, not our area of expertise,
to gain some experience and use it for heart therapy." This
means that Duchenne boys were used as guinea pigs for other purposes.
Deception and omission
Unethical behavior is not rare particularly for incurable diseases.
There is often a great difference between what is told to the families
in the doctor's office and what is publicly announced. That is why
Bruno's godmother also interviewed the involved doctors subsequently
as a reporter. The caring Dr.Wagner Fiori of the first consultation
gave place to an oblivious doctor during the interview. "Cost?
This issue is the American's responsibility. We do not know and
do not care to know how much the treatment costs," he claimed.
When asked if the Brazilian boys paid for the treatment, he replied:
"If they were involved in Peter Law's research probable this
treatment was free of cost."
Ironically, this "naive" doctor was signing together with
his partners the medical reports required by the Brazilian Justice
(before depositing the US 150.000 dollars in Peter Law´s account),
where they stated that MTT was the only available treatment for
Duchenne dystrophy. Even worse is that in addition to Federal Judges
, Peter Law and his Brazilian branch deceived children with Duchenne
dystrophy (who believed they would play soccer again) and their
suffering parents. Unfortunately, many families and laymen still
do not know that Peter Law:
1. Never showed long terms effects of his research;
2. Refuses to debate and to submit to the scientific community biopsies
of his patient's muscles for studies;
4. Did not mention in his site nor in published articles that several
Duchenne
boys submitted to MTT have already passed away. "To this date
we do not know if the treatment had any influence in the age or
on the cause of patients deaths," worries Prof. Terence A.
Partridge, head of the Muscular Cellular Biology group of the Imperial
College School of Medicine, in London, England. This uneasiness
is grounded, since Peter Law has not reported to the FDA any side
effects reported by the patients that received the treatment.
How can one explain the "success" shown in videos and
in Cell Therapy's web site? One explanation is that Mr. Law and
his Brazilian partners are fostering false hope to patients and
their parents, taking advantage of their despair and suffering.
It is hard to believe, but deceased children are shown in Law's
videos, as if they were still alive. Another possibility is inadequate
diagnosis as already pointed out by FDA. Bruno´s story confirms
the inclusion of a patient prior to diagnosis confirmation.
Cruel Intimidation
Instead to prove that these renowned scientists are mistaken, Peter
Law tries to silence them with multi-million dollars lawsuits. Even
crueler is the expediency to silence parents of boys who have already
undergone treatment: the possibility of new research and the promise
that the participants of the initial phase would be the first beneficiaries.
Thus, due to fear, hope, or shame, they do not always admit they
have been deceived. In addition, since the disease progresses gradually,
it may take 4 or 5 years for the fraud to be discovered.
A. G., one of the Duchenne boys from São Paulo was submitted
to MTT in the US in 1997, when he was then 12 years old. "Doctor
Law told me it was an absurd that my son was taking corticoids,
and the medication was interrupted", says his mother Vera Gattai.
A. G. experienced the natural progression of the disease: he lost
the ability to walk, then to move his arms and legs. After having
had a cardiac- respiratory arrest, he was submitted to a tracheostomy,
and was hospitalized between the months of April and June of 2002,
due to respiratory problems. In the hospital, he dreamed of getting
a bipap (his family spent all their money with the transplant and
had no means of acquiring one) and returning home. His first dream,
even if only for a few days, came true. Unfortunately, he never
lived to see his second wish come true. He died on July 27th at
age 17.
It is a felony, since the US$ 1,35 million spent for the transplants
only by the States of São Paulo and Santa Catarina (2 Brazilian
States) could pay for 270 bipap for Duchenne's patients. This would
be a great opportunity for boys as A. G. to reach their 30's. Instead
of benefiting them, the money only increased Peter Law's bank account.
Ironically, in the waiting room of the Brazilian partners clinic,
one will find an immense bible on one of the secretary's desk. During
the 20 months of the present investigation, the reporter/"godmother"
noticed that the bible remained opened in the same Salm: "Glory
God that rewards the good men and punishes the sinners." Maybe
the people that sell this fake treatment are waiting for the one
and only Divine justice.
* Conceição Lemes is the Brazilian
journalist who pretended to have a godson affected by DMD and responsible
for the report Physicians turn a disease into a criminal affair,
published on July 13, by the site No Mínimo.
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