[ RadSafe ] Tritium a carcinogen?

[John Jacobus]

Actually, rats and other animals are not like humans. 
Further more, studies that work in animals do not do
so in humans.  Consider the folloiwng what appeared in
the Los Angeles Times April 7, 2006 

"Guarding the human guinea pigs"

SECTION: CALIFORNIA; Metro; Editorial Pages Desk; Part
B; Pg. 11

BYLINE: John Abramson, JOHN ABRAMSON, a clinical
instructor at Harvard Medical School, is the author of
"Overdosed America."

MINUTES after the first of six human volunteers was
injected with an experimental, genetically engineered
drug in London last month, the men one by one began
screaming in pain, tearing their clothes off,
convulsing and losing consciousness, according to
media reports.

In an interview with Britain's Daily Mirror, Nino
Abdelhady, 28, who said he was offered $3,500 to
participate in the study, recalled feeling the drug
"ripping through" his body "like wildfire." His head
reportedly swelled to more than twice its normal size,
and he didn't regain consciousness for eight days.
Other volunteers suffered organ failure, and one
remains hospitalized, according to the Associated
Press.

Unexpected things happen in medical research,
especially when a drug is administered to humans for
the first time. Eighty percent of the drugs tested on
humans in the U.S. never win Food and Drug
Administration approval. Still, there are several
clues that the tragedy in London could have been
minimized or averted -- and more clues that a similar
disaster could happen in the U.S. So the cautionary
tale of the experimental drug called TGN1412 deserves
intense scrutiny on both sides of the Atlantic.

Developed by the German company TeGenero, TGN1412 is
an antibody manufactured by fusing mouse and human
cells. It was designed to activate one part of the
immune system specifically to attack another.
TeGenero hoped it would revolutionize therapies for
diseases involving the immune system, such as some
types of leukemia, multiple sclerosis and rheumatoid
arthritis.

The company applied in Germany for permission to
administer tiny doses (one five-hundredth of the
proposed therapeutic dose) to human volunteers, but
was rejected. It then received permission to do the
study in Britain.

Two of the volunteers told British reporters that they
were warned to expect only headaches and nausea, and
had no idea that monkeys given
TGN1412 had developed swelling of the immune tissue in
their necks.

Inexplicably, rather than giving the drug to one man
at a time and waiting to rule out any untoward
reaction, the six men were injected at 10-minute
intervals, according to the Daily Mirror. Waiting a
day or two would have been more prudent for a new
biotech drug. A company spokeswoman Thursday would not
comment on the dosing interval.

Abdelhady told the Daily Mirror that by the time he
got the drug, the first volunteers were already sick
and a man next to him, who had been given a dose
minutes earlier, was complaining of head pain, "like
rockets going off" -- but that the experiment
continued anyway.

British regulators said they found no evidence of drug
contamination or improper practices, and that the tiny
doses should not have caused such a reaction. The
investigation is continuing.

But the fact that three weeks later British officials
still don't know what went wrong should raise alarms
here as well. That's because although the study
involved a German drug in London, it was carried out
by Parexel International, a U.S. research company
based outside Boston.

Parexel's website boasts that it partners with drug
and biotech companies "to accelerate time-to-market,
control development costs, reduce risk and maximize
return on investment." (The London study might have
achieved all of these goals, except, of course,
reducing risk.)

In the United States, "institutional review boards"
are entrusted with responsibility for overseeing the
safety of human volunteers in drug studies. The
government established these boards to prevent a
repetition of the U.S. Public Health Service's
disgraceful "Tuskegee Study of Untreated Syphilis in
the Negro Male," in which poor black sharecroppers
were not told they had syphilis so that the disease's
horrific effects could be studied over the next 40
years.

When the institutional review boards were created,
most medical research was conducted by universities
and nonprofit institutions. Now most clinical research
is done by for-profit research companies such as
Parexel. Similarly, oversight of the safety of human
volunteers in most U.S. studies is no longer done by
nonprofit IRBs, but by for-profit review companies,
hired directly by the for-profit research companies.
The U.S. government approves of this -- but I believe
this system lacks the appropriate checks and balances
to protect human volunteers.

According to Bloomberg News, the largest for-profit
IRB in the U.S. oversees 17,000 studies on people, yet
can spend as little as four minutes a study to valuate
whether volunteers are adequately protected.
And if one for-profit ethics board doesn't approve a
study, nothing stops the company from simply applying
to another -- like TeGenero moving its study from
Germany to Britain. In 1998, the inspector general of
the U.S. Department of Health and Human Services
recommended rules to stop this practice, known as
"IRB-shopping." Ironically, just two months before the
London disaster, the FDA decided that such rules were
not necessary.

Moreover, the FDA recently approved "phase 0 studies"
in which human beings can be given minuscule doses of
experimental drugs even before animal studies are
completed. Sen. Charles Grassley (R-Iowa) recently
told the journal Nature that just when more oversight
is needed, "the FDA is loosening the reins on drug
companies. I'm concerned for those who will be
receiving these experimental drugs."

The issue isn't simply whether the research is
commercially sponsored (after all, the grotesque
Tuskegee study was not for-profit), but whether there
are adequate safeguards to make sure that human
volunteers are not exposed to unnecessary risks, that
studies are carried out as designed and that results
are accurately reported.

Unfortunately, these watchdog functions are being
eroded. The entrepreneurial incentive to develop new
drug therapies is a great motivator. But it will not
serve the greater good unless and until there is
independent, noncommercial oversight of medical
research.

Copyright Los Angeles Times 2006

--- Steven Dapra <sjd at swcp.com> wrote:

> April 15
> 
>  . . .
> 
>          Rats are like humans.  Hmmmmmm . . .  
> Haven't establishment 
> scientists even began to express some skepticism
> about extrapolating from 
> animal studies to humans?
> 
> Steven Dapra
> sjd at swcp.com
> 

+++++++++++++++++++
"A scientist's aim in a discussion with his colleagues is not to persuade, but to clarify." 
Leo Szilard
-- John
John Jacobus, MS
Certified Health Physicist
e-mail:  crispy_bird at yahoo.com

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