Unregulated Cancer treatment
- From: Earl <neptune@xxxxxx>
- Date: 29 Mar 2007 08:18:26 GMT
A followup to my post in January regarding the animal successes
of dichloroacetate.
An update this soon shows that the general public is out of the
control of the medical regulators. (as would be expected)
http://www.newscientist.com/article/mg19325973.800-cancer-
therapy-when-all-else-fails.html
******
Cancer therapy: When all else fails
28 March 2007
Lawrence Burgh has a sober outlook on life. A 48-year-old
physician whose career has centred on treating seriously ill
patients, Burgh was diagnosed with cancer in December 2006. Yet
despite his clinical experience, he has taken an extraordinary
step to try to rid himself of his illness, a step many would
consider to be a medical heresy.
Burgh is one of a growing number of patients who have been
dosing themselves with a simple laboratory chemical that has
never before been used to treat cancer in people. Most are doing
so without the help of doctors, and none is enrolled in any
systematic clinical trial of the substance. Instead, they are
buying it over the internet, and sharing their experiences of it
in online chatrooms. For them, the unlicensed, untested drug
represents their last best chance of survival.
That's not the way cancer specialists see it. For them, the
activities of Burgh and those like him are indicative of what
could become a dangerous new trend, in which groups of seriously
ill people get together online to discuss, source and try
untested drugs whose safety and efficacy is uncertain.
The drug in this case, known as DCA, is a widely available
chemical that cannot be patented. In basic laboratory tests and
experiments in rats it has shown promise as an anti-cancer
agent, but in people it may yet show side effects that could
further damage the lives of people who take it. Scientists
investigating the potential of DCA as a cancer treatment fear
that any deaths or injury caused by its premature, unregulated
use could damage their work - and the welfare of patients far
into the future.
Burgh's quest to cure himself began last month, shortly after he
was told the cancer in his thigh had spread to his lungs. "My
prognosis is very poor," he says. "Standard chemotherapy would
give me only a slim chance of survival at five years." So he
turned to DCA, after reading about the promising lab experiments
in New Scientist (20 January, p 13).
?Standard chemotherapy would give me only a slim chance of
survival at five years?DCA, or dichloroacetic acid, is an
analogue of acetic acid in which chlorine atoms replace two of
the three hydrogen atoms on the methyl group. Because it is a
corrosive acid, it must be "buffered" to damp down the acidity,
and it is usually administered as sodium dichloroacetate.
In January, a study by Evangelos Michelakis and his colleagues
at the department of medicine at the University of Alberta in
Edmonton, Canada, suggested that DCA could shrink several types
of tumour in rats, by exploiting a previously ignored metabolic
pathway in the cell (see "How DCA could affect cancer"). "I was
intrigued by the proposed mechanism," says Burgh (not his real
name; this article uses a pseudonym to protect his privacy).
"The biochemistry made sense to me. I subsequently read dozens
of articles and abstracts on DCA before I decided I wanted to
try it."
On 27 February, he self-administered his first dose, and for the
next month took DCA twice a day, monitoring his blood and urine
for signs of any problems, and visiting his oncologist, who was
aware of what he was doing, once a week.
Because DCA is not an approved drug in the US, the UK or
anywhere else, Burgh had to find his own supply. Using his
contacts he obtained raw DCA, then asked a chemist friend to
buffer it and check its purity.
Burgh is not alone in his attempts to procure the drug. Already,
within weeks of Michelakis's paper being published, a
substantial online community has grown up, largely centred on
the website www.thedcasite.com which declares itself to be a
gateway for information on DCA. At least eight of the
individuals who have posted contributions on the site's
chatroom, including Burgh, claimed to be taking DCA or giving it
to a close relative. By 21 March, the chatroom had 135 active
members - most of them from the US, Canada, the UK and Australia
- plus posts from numerous unregistered users, many swapping
tips on how to get hold of DCA, how to prepare the chemical for
human consumption, and what supplements they should be taking to
minimise side effects.
"This is pretty much a new phenomenon," says Kate Law, director
of clinical trials at research charity Cancer Research UK.
"There has always been an industry for vulnerable people, but
the magnitude of it has multiplied exponentially. The internet
has changed the world for people who are looking for miracles."
Michelakis himself warns that people taking DCA could do
themselves serious harm. The chemical is known to increase the
risk of nerve damage in people who have been given it in
clinical trials for other reasons. It may also cause liver
damage and interact with existing anti-cancer drugs in
unexpected ways. "Since many anti-cancer drugs are neurotoxic,
these interactions could be fatal," Michelakis says. Worst of
all, he says, if patients are taking DCA outside clinical
trials, such damaging side effects may go unrecorded.
Desperate measures
Yet there are many desperate patients prepared to take this
risk. Michelakis says his department gets thousands of emails
from people saying they have nothing to lose, but that's not how
he sees it. "Of course you've got something to lose," he says.
"There are many cases of people being told 'you've only got a
month to live', and a month later they're still alive. If you
take DCA, it may not work, you could still have the cancer, and
you'll be paralysed."
Despite such warnings, people are continuing to hunt down
details of potential suppliers of DCA. "I have been getting
three to four calls a day," says Steve Grossman, manager of J.
E. Pierce Apothecary in Brookline, Massachusetts. "I've had
calls from pretty much the whole of the northern hemisphere now,
plus Africa, the Middle East and south-east Asia. Mostly it is
people with end-stage cancer, who have already gone through
everything medicine had for them." Grossman says he will not
dispense DCA to anyone unless he sees a prescription from a
doctor - and no one has yet provided one.
Because DCA has never been approved as a drug for human use, the
sale of pharmaceutical-grade DCA, which has been sterilised,
purified and had its pH adjusted, is tightly controlled. In the
US, a doctor can only prescribe it if they have already applied
for an Investigational New Drug (IND) number from the Food and
Drug Administration for its compassionate use in a seriously ill
patient, or in a clinical trial. Doctors in Canada must gain
permission from their provincial college of physicians and
surgeons, while companies who supply it to doctors in the UK
must inform a national regulatory agency.
As word gets around that people are buying DCA to use as a drug,
suppliers of the chemical are clamping down for fear of breaking
the law. However, despite these restrictions, people are still
acquiring it.
Thedcasite.com shows at least 34 people have got hold of DCA -
either through doctors, or by obtaining raw laboratory-grade DCA
from chemical supply companies, for example - and are either
taking it, or plan to start taking it soon. At least another 50
are actively searching for a supply. One person claims to have
got theirs from chemical giant Sigma-Aldrich based in St Louis,
Missouri. Michael Hogan, the company's chief administrative
officer, says it will not dispatch any chemical to individuals
or residential addresses, and after being alerted to the problem
he says Sigma will now tighten up surveillance on DCA orders. He
points out, however, that if a legitimate company places an
order, Sigma has no control over who that company sells it on
to.
In a further twist, thedcasite.com has a sister site that sells
DCA as a treatment for cancer in animals, offering a further way
for people to get hold of the drug (see "An online community is
born"). The FDA says it is investigating the websites, after
being alerted to their existence by New Scientist. Yet
ultimately there may be very little it can do, as DCA is already
a widely used laboratory chemical that can be ordered from
thousands of companies worldwide.
Hogan is clear that his company considers taking DCA to be
unsafe. "We would no more encourage someone to self-medicate
with DCA than to drink poison," he says. As well as the inherent
health risks, there is the possibility of contamination in
laboratory-grade DCA, and not buffering it correctly could
result in severe burns.
?We would no more encourage someone to self-medicate with DCA
than to drink poison?Burgh has yet to see DCA make any impact on
his cancer. Medical scans on 19 March showed that the primary
tumour in his thigh has shrunk, and is less active, but this may
be due to the delayed effects of radiotherapy and chemotherapy
Burgh had in January. The number of metastatic tumours in his
lungs has not changed since last month, and they are larger and
more active. "These results are very preliminary," Burgh
stresses, "but I was really hoping for better results." On 21
March, he stopped taking the drug after noticing symptoms which
by 24 March included a numbness in his hands, which he believes
to be a sign of neuropathy, and a hypoglycaemic attack. He
advises other people with cancer not to self-medicate with DCA
except under medical supervision. "I am concerned others may try
this drug on their own in desperation," he says. "DCA is
chemotherapy, a serious drug with potentially serious side
effects."
Michelakis opposes any self-medication with DCA, and the
websites that facilitate it. Though he says he can understand
why people with cancer are motivated to take DCA, he points out
that not only are they placing themselves in danger, they may
also be jeopardising the chances of finding out whether DCA
actually works in treating cancer and of it becoming approved as
a therapy. If people become sicker or die while taking DCA
unsupervised, he says, funding and willingness to test it may
disappear. "We are trying to do this the right way, by putting
it into clinical trials, and these websites could destroy all of
this."
%%%%%%
From issue 2597 of New Scientist magazine, 28 March 2007, page8-11
How DCA could affect cancer
The preliminary discovery that DCA may shrink particular cancers
in rats has prompted some to rethink how cancer takes hold in
the first place.
One feature of cancer cells is that they produce energy by
glycolysis (the breakdown of glucose) in the cytoplasm, rather
than in the mitochodria, which shut down. Until recently this
switch was thought to be merely a symptom of cancer, rather than
anything more fundamental.
Yet DCA seems able to switch the mitochondria back on, and in
doing so it turns on their ability to recognise a cell as
abnormal and make it self-destruct. When Evangelos Michelakis at
the University of Alberta tested DCA on cancer cells in culture,
they died. When he gave it to rats with human tumours, the
tumours shrank (Cancer Cell, DOI: 10.1016/j.ccr.2006.10.020).
Earlier findings by two other groups lend support to the
mechanism. In normal cells, DCA has long been known to trigger
the switch between glycolysis and the production of energy in
the mitochondria, by inhibiting an enzyme called pyruvate
dehydrogenase kinase (PDK). In doing so, it decreases lactic
acid production, which led to it being clinically tested,
unsuccessfully, as a treatment for lactic acidosis in children.
In March last year Chi Van Dang at Johns Hopkins University
School of Medicine in Baltimore, Maryland, showed that
inhibiting PDK also triggers the release of toxic reactive
oxygen species by the mitochondria, resulting in cell death. He
speculated that PDK might therefore be an important therapeutic
target for cancer. "My work, in a sense, confirms Dang's
hypothesis," Michelakis says.
Then in June, Philip Leder at Harvard Medical School in Boston
and his colleagues found that blocking glycolysis in cancer
cells through a different mechanism stimulated their
mitochondria and reduced tumour growth in mice, improving their
survival (Cancer Cell, DOI: 10.1016/j.ccr.2006.04.023).
"These papers strengthen the rationale for trying DCA in
patients with cancer, although it doesn't necessarily mean that
it will work in humans in the end," Michelakis says.
He is submitting protocols to Health Canada for a clinical
trial, and hopes to begin recruiting patients in the coming
months. He has also been contacted by groups in the US, the UK
and Canada that are interested in running human trials of DCA.
%%%%%%%
^^^^^
An online community is born
Within weeks of the results from animal trials of DCA being
published, two websites were promoting its benefits and
facilitating online discussion about its use.
The first, www.thedcasite.com, claims to act as a gateway for
information on DCA, while the second, www.buydca.com, offers to
sell it for the treatment of cancer in animals. Both sites were
founded by Jim Tassano, who operates a pest-control company in
Sonora, California. While both sites state that DCA has not been
approved for human use, thedcasite.com has been enthusiastic
about cancer patients giving it a go. "Is DCA worth trying? We
absolutely think so," the main site read when created in early
February this year. "The risks of a DCA-based therapy are
trivial compared to those of accepted cancer therapy."
The site also suggested that people donate money to the
University of Alberta, where Evangelos Michelakis and his team
continue to test DCA as a drug, and encouraged people to write
to the US Congress and to doctors, urging them to kick-start
clinical trials in cancer patients as soon as possible.
Michelakis says that since he published his study, and the
appearance of the websites, he has received more than 15,000
emails from people enquiring about DCA. Around 3000 of them ask
about it as a veterinary drug, with the implication that they
are trying to source it for themselves or another person. He
sees a clear link between the pet site and the questions he is
being asked. "At first [people enquiring] were quite honest," he
says. "But we're now getting emails from people asking for
dosage information for, say, a 150-pound golden retriever."
Ron Marcinkoski, a pharmacist in Edmonton, Alberta, has also
been contacted by people who he believes have bought DCA from
the pet site. "People are asking me if I can test its purity, if
I can encapsulate it," he says. "I think it is a major source."
Tassano maintains that the primary goal of the pet site is to
sell DCA for animal use, although he is aware that people are
buying it for themselves. On 5 March, he posted updates on the
health of two people he claims to have sold DCA to, saying both
were doing well. This post has since been removed. "I can
understand why they do it," he told New Scientist. "The
information is there so they can go to their doctor with it.
Whether they buy their DCA from me is their choice."
Because DCA has not been approved for human use, it would be
illegal for a website to sell it for human consumption in the
US, says special agent Phil Walsky of the Food and Drug
Administration's Office of Criminal Investigations. His office
is investigating the links between the two sites. Marketing DCA
for animal use is also an offence, as it has never been approved
for veterinary use, an FDA spokeswoman says.
Tassano says he is now aware of the FDA's rules, and has amended
his postings over the past few weeks to reflect this. For
example, earlier postings which stated that he had managed to
acquire large quantities of DCA have since been removed, and on
23 February a disclaimer appeared stating "We do not advocate
the use of DCA for human cancer at this stage and time."
Tassano maintains he has not made any profit from the sites, and
that they are playing an important role in helping to raise the
profile of DCA. "We are only doing what we think is right."
No time to lose
"I am just a desperate daughter hoping to find a way to gain a
few more years with my mother, and hoping that my 10-month-old
daughter will grow up knowing her grandmother." The words of Meg
Walker of Ontario, Canada, reflect the hopes and fears of many
families affected by cancer, and their desire to have access to
therapies to treat the condition.
Through a doctor, Walker (a pseudonym) has obtained a supply of
DCA for her mother, who has stage 4 leiomyosarcoma, which has
spread to her lungs. They are waiting on the results of her
mother's chemotherapy before deciding whether to try the
chemical, but wish that DCA and other experimental treatments
were more readily available. Clinical trials take time, and "the
public is fed up with waiting on the medical community to get
through their red tape", she says.
Burgh echoes this view. Because DCA has not been approved as a
drug, the company that supplies pharmaceutical-grade DCA would
not sell it to him without an IND number - a licence
occasionally granted by the US Food and Drug Administration. "I
do not have time to wait for an IND number," Burgh says. "The
process takes about six months - I may be dead by then."
One patient group, The Abigail Alliance based in Fredericksburg,
Virginia, is taking the FDA to court to try and force it to open
up access to experimental drugs for terminally ill patients,
including those with cancer. Its founder, Frank Burroughs, says
DCA should not be used in patients until it has undergone safety
tests in people with cancer.
However, he says that in general doctors should be allowed to
administer any drug that has passed initial human safety tests
and has shown promising efficacy. The FDA's existing policies
"block the life, liberty and pursuit of happiness of patients
who cannot get into clinical trials", the alliance claims. A
federal appeals court in Washington DC ruled in the alliance's
favour in May 2006, but is reconsidering its ruling at the
request of the Bush administration. A verdict is expected within
eight months.
The FDA says it is considering regulatory changes that would
enable easier access to experimental medicine, regardless of the
outcome of the court case. Under the proposed rule, expanded
access would be available to individual patients and groups
being treated under a systematic plan, provided that there is no
satisfactory alternative therapy for the disease or condition. A
90-day consultation period ended on 20 March, but no date has
been set for implementing these changes.
Many charities welcome the proposed clarification, saying it
will speed up the decision-making process. Peer-reviewed
clinical trials remain the best way for patients to assess new
medicines, says Steve Weiss of the American Cancer Society. "Yet
we recognise that many patients are not eligible [for clinical
trials]. We view this rule as a positive and necessary step
toward balancing the individual needs of patients and patient
safety while also maintaining the integrity of our system of
high-quality, scientifically based and peer-reviewed clinical
trials and patient participation in them."
The Abigail Alliance says the regulations will merely put into
law current policies which are too stringent. "We believe that
the decision [as to whether to take an experimental drug] should
not be the FDA's, but the patients' in consultation with their
doctor," says Burroughs.
^^^^^^^
******
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