RE: Drug Company Denies Harvard Rheumatoid Arthritis Researcher 7/13/02

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Another example of the drug companies and their greed! Geez!!!!

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Carol

[ ] Drug Company Denies Harvard Rheumatoid Arthritis

Researcher 7/13/02

Drug Company Denies Harvard Rheumatoid Arthritis Researcher

By Alice Dembner

Dr. 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. 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

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 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 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

http://www.mercola.com/2002/jul/13/ra_researcher.htm