Drug Company Denies Harvard Rheumatoid
Arthritis Researcher
By Alice
Dembner
Dr. David Trentham is the
chairman of the Department of Rheumatology at Harvard. He has used the
antibiotic Minocin for successfully for many with rheumatoid arthritis and
scleroderma. He decided to study the drug in those ages 6 to 14 and asked
drug maker Wyeth for a donation of $15,000 worth of the antibiotic. Wyeth,
which made $14 billion last year in total sales of drugs and other products,
had acquired a small company that supported Trentham's previous studies of
minocycline in animals and in adults. But this time, the answer was an
unequivocal no.
''While scientifically
interesting, the concept and design is not consistent with our current
business objectives,'' wrote a company official in a letter that Trentham
said stunned him.
While company officials later
said patient safety was the reason for the denial - the antibiotic can cause
some side effects, such as discoloration of the teeth - Trentham believes
the letter gave far more insight into the company's reasoning.
Trentham's translation of the
letter: If minocyline worked, it might compete with a blockbuster drug
called Enbrel that Wyeth now markets for both adult and juvenile rheumatoid
arthritis. Enbrel costs $1,300 per month for adults and has life-threatening
side effects, while Wyeth's brand of minocycline, called Minocin, costs only
$280 for an adult monthly dose, Trentham said. And unlike Enbrel,
minocycline is no longer under patent, so many companies could benefit from
the drug's success.
As rheumatologist Trentham put
it, ''It's a commercial decision, and it's unfortunate for the patients.''
Trentham said it was the first
time in his career that a drug company had turned down his request for
support of a study. But other researchers said denials are becoming more
common as the drug market becomes ever more competitive.
''It happens all the time,''
said Dr. Raymond Woosley, a prominent drug researcher who is vice president
of health sciences at the University of Arizona. ''They don't want you to
study their drug because of what you might find or how your finding might
affect another drug they're marketing. They want to control the data on
their drug.''
While companies have no legal
obligation to support research by doctors who don't work for them, many
scientists believe they have a moral responsibility to society.
''When a company refuses to
allow someone to do legitimate research on their drugs, we all lose out,''
said Sheldon Krimsky, a Tufts University professor who has studied
relationships between academic researchers and drug companies.
''Their interest is in their market share,
not in public well-being.''
A spokeswoman for Wyeth,
however, said economics played no role in the company's decision. ''The
decision was made primarily on safety,'' said Natalie de Vane. ''The company
felt there were newer medications that could be studied that didn't have the
side effects that this particular drug has. Minocin is contraindicated in
young children and there were very young children in this proposal.''
While minocycline carries an
FDA warning against use in children under 8 because of possible permanent
discoloration of teeth, Trentham said that is a far cry from the warning on
Enbrel, of serious and sometimes fatal infection or sepsis. Nonetheless,
Enbrel was approved by the FDA in 1999 for use in juvenile rheumatoid
arthritis for those patients who fail other treatments.
Despite the rejection by Wyeth,
Trentham is forging ahead. He secured a $20,000 grant from a small private
foundation, the Road Back Foundation, to fund lab fees for the six-month
study and will buy Minocin from Wyeth, and then charge study participants or
their insurers for the drug. But he said he worries that that will make it
much harder to recruit participants and will delay the study, now scheduled
to begin this summer. He plans to recruit patients across the country who
are not currently taking Enbrel or another treatment, methotrexate.
''It's terribly important to
get to the bottom of whether Minocin works in children with juvenile
rheumatoid arthritis because of the benign nature of Minocin,'' said
Trentham, who is known as an antibiotic enthusiast.
Juvenile rheumatoid arthritis
affects up to 50,000 children in the United States, causing painful
swelling, stiffness and deformity of joints and sometimes stunting growth.
While some children outgrow it, others fight the disease their whole lives.
Doctors believe it is caused by a malfunction of the immune system and
typically treat children with anti-inflammatory drugs starting with
ibuprofen and moving to more potent drugs.
If minocycline works
consistently in children, Trentham said, it would also be a safer
alternative to two other common treatments for JRA - steroids and
methotrexate. Steroids can stunt a child's growth, and methotrexate, often
used to treat cancer, can be toxic to the liver and it can harm the immune
system when given in higher doses than usually given in children.
Some pediatric rheumatologists
said, however, that methotrexate is not as risky and minocycline is not as
safe for children as Trentham suggests. A cousin of tetracycline, it
commonly is used to treat severe acne. But it can discolor teeth and skin,
irritate the stomach, and, in rare instances, it can cause liver or kidney
damage and has been associated with lupus.
''We're able to control a large
number of our patients with currently available drugs,'' said Edward
Giannini of Cincinnati Children's Hospital, a senior scientist with an
international consortium that studies pediatric rheumatology treatments and
helped test Enbrel and methotrexate. ''I don't see much of a need to look at
this drug, because we feel it's only partly effective in adults. But there's
no harm in studying it.''
Concern about side effects of
methotrexate led Melanie Masala to bring her daughter, Gloria, to Boston for
treatment with minocycline. ''I was wondering which was worse, the disease
or the cure,'' she said.
With minocycline, Marsala said,
Gloria's transformation was ''incredible.'' As Gloria said: ''Before, not
many people liked to play with me because I couldn't do the things they
wanted to do. Now, I ride my bike, I rollerskate, I can jump, I can even
climb a little.'' And Trentham said she is growing again, catching up to her
classmates, without any medication side effects.
Scientists do not understand
why minocycline appears to help some arthritis patients. A national study of
219 adults with rheumatoid arthritis, supported by the National Institutes
of Health and published in 1995, found, however, that minocycline
significantly reduced joint swelling and tenderness in more than half of
patients, although a dummy pill caused similar improvement in about 40
percent. Lederle Laboratories, which then made Minocin, provided the drug
and placebo free for the study. Wyeth subsequently bought Lederle and helped
market Enbrel, which chalked up $900 million in sales last year.
Trentham, who was one of
several investigators for the NIH study, chose to use Minocin for his new
study for consistency, rather than other generic versions of the antibiotic
made by other drug companies.
Getting free drugs for research
is ''especially a problem when the company has a competing drug,'' said
Woosley, a professor of pharmacology and medicine. He and colleagues were
thwarted a few years ago, he said, when they wanted to study the side
effects of an older synthetic estrogen replacement. The company, which he
declined to name, refused because officials were worried the study would
focus attention on the side effects of a new drug they were developing.
''From a business point of
view, it makes sense. Why should they get involved in anything that might
harm them?'' said a Boston-area researcher, who requested anonymity because
he feared alienating companies from which he regularly seeks support. ''But
the research community is trying to find out the truth, about mechanisms and
side effects of drugs and how they are best used clinically. And the drug
companies' posture impedes that. It's gotten worse year by year and the last
two years have been impossible.''
Boston Globe June 25, 2002
It's amazing to me that the
head physician in Harvard's rheumatology department would be denied drug
research by a drug manufacturer. I guess if you consider the drug company's
primary focus is making money, then it might not be much of a stretch.
If the patient benefits from
the research, great. If they aren't killed from the side effects, better
yet. What they don't want you to know is that the drug either doesn't really
work or it is almost identical to a less expensive version. This is a
classic marketing ploy that preys on those less informed. To me, it
highlights the "evils' of the drug company's approach in ruining health care
in this country.
But, don't worry. The
purpose of this site is to facilitate a radical transformation by offering
people practical, inexpensive, natural alternative solutions so they could
recover their health and not rely on these companies.
Related Articles:
Update on Minocin for
Rheumatoid Arthritis
Arthritis Drug
May be Causing Serious Blood Reactions
Arthritis Drugs Have
New Warnings, but Will the Doctors Listen??
Arthritis Drug, Enbrel, Linked to Serious Infection
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