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----- Original Message -----
From: "HSI Research Team" <[log in to unmask]>
To: "MS. BERNA MCCARTHY" <[log in to unmask]>
Sent: Thursday, November 01, 2001 5:00 PM
Subject: Common drug for RA and Crohns carries significant risks


> COMMON DRUG FOR RA AND CROHN'S CARRIES SIGNIFICANT RISKS
>
> Health Sciences Institute e-Alert
>
> November 1st, 2001
>
> *********************************************************
>
> Dear Reader,
>
> The two letters are eerily similar. Both bear the circular
> logo of the pharmaceutical company, Centocor. Both carry
> dates in October 2001. Both are addressed to "Dear
> Healthcare Professional," followed by a heading in large,
> bold, capital letters: IMPORTANT DRUG WARNING. And there's
> one more important commonality: both contain information
> about serious risk from Centocor's drug REMICADE ®, a
> medication widely used to treat Crohn's disease and
> rheumatoid arthritis (RA).
>
> The first letter, dated October 5, warns doctors that
> tuberculosis and "other opportunistic infections" have been
> observed in patients taking Remicade. At least 84 cases of
> TB have been documented, and 14 of those people have died
> as a result.
>
> But then, less than two weeks later, came the second
> letter. It makes you wonder - is this just a bad
> coincidence or do we not know enough about what this drug
> can do?
>
> Dated October 18, the second letter cautions doctors
> against prescribing Remicade to patients with congestive
> heart failure (CHF). In clinical trials, scientists found
> that patients' moderate to severe CHF symptoms worsened
> while taking Remicade - and at least seven people died from
> CHF while participating in a Remicade clinical trial.
>
> Your doctor may or may not have received both of these
> letters in October. And if you take Remicade, you may have
> already been informed. But if you or someone you love
> suffers from Crohn's or RA, you need to understand these
> results right NOW.
>
> REMICADE ® is the brand name for the prescription drug
> infliximab, which works by inhibiting the body's natural
> immune response. Specifically, it binds an immune system
> cytokine called tumor necrosis factor (TNF). Inflammation
> is a common side effect of TNF activity (and other immune
> responses as well).
>
> Both Crohn's disease and rheumatoid arthritis (RA) are
> characterized by inflammation - the former in the
> gastrointestinal tract, and the latter throughout the
> body's joints. So drugs like Remicade were designed to
> treat RA and Crohn's by blocking the TNF activity that may
> contribute to the inflammation.
>
> Remicade was first approved in 1998. It was indicated for
> short-term use in treating patients with Crohn's that had
> not responded to other kinds of therapy. It was also
> approved for treating RA in combination with methotrexate,
> for patients who had not seen relief from methotrexate
> alone. (Methotrexate, also known as amethopterin or by the
> brand names Folex and Rheumatrex, is a prescription drug
> often used to treat RA. It comes with its own list of
> serious side effects, including problems with the kidneys,
> stomach, and liver, loss of hair, and increased risk of
> blood diseases like leukemia.)
>
> Because of its immunosuppressive action, authorities knew
> that Remicade could increase the chances of developing
> infections. So the October 5 warning about the risks of
> tuberculosis, histoplasmosis, listeriosis, and fungal
> pneumonia, was not a complete surprise. The new
> communication recommends that doctors test patients for
> latent TB infection before prescribing Remicade, and that
> they carefully consider risks in regions where
> histoplasmosis typically occurs. (Histoplasmosis is caused
> by the bacterium H. capsulatum, which is contracted through
> contact with soil or materials contaminated with bat or
> bird droppings. According to the Centers for Disease
> Control and Prevention, it is most prevalent in the eastern
> and central United States.)
>
> But the second warning arose from Centocor's own research.
> Animal studies had suggested that Remicade's TNF-binding
> action might also be an effective therapy against
> congestive heart failure (CHF). This deadly condition
> results when the heart cannot pump efficiently, usually as
> the result of damage from a heart attack or years of
> chronic hypertension or heart disease. Fluid accumulates in
> the lungs and leads to breathing difficulties and leg and
> ankle swelling. Almost five million Americans have
> congestive heart failure, and most of them die from it
> eventually.
>
> So Centocor recruited a total of 150 patients with moderate
> to severe congestive heart failure for the trial. A control
> group of 49 people took a placebo, while 101 received
> Remicade, either in a 5 mg/kg or 10 mg/kg dosage. All of
> the drugs were administered intravenously, and the
> treatments lasted for six weeks.
>
> During the study, seven of the 101 patients in the Remicade
> group died of congestive heart failure. (None of the
> patients in the placebo group died during the study.) A
> 7 percent death rate in 6 weeks was significant enough for
> Remicade's manufacturer to halt the study and report the
> findings to the FDA.
>
> The result was the October 18 letter, which was mailed to
> 35,000 doctors who the FDA determined were "likely to
> treat" patients who may be at risk.
>
> We can only hope that the information reached all the
> appropriate doctors - and all the appropriate patients.
> Centocor says it is working with the FDA to develop updated
> prescribing information and packaging for the drug. (Maybe
> they were able to catch it before it went off to the
> printer - the boxed warning notice had just been revised to
> reflect the increased risk of tuberculosis and other
> infections.)
>
> Here's what you can do:
>
> * If you take Remicade, discuss these risks with your
> doctor. Ask for a TB test, and ask about the risk of
> histoplasmosis in your area. If you have congestive heart
> failure as well, ask about other alternatives to Remicade.
>
> * Pass this information along to anyone you know who might
> already be taking Remicade, and to anyone who suffers with
> RA or Crohn's and might be prescribed the drug in the
> future.
>
> But perhaps most importantly, remember that prescription
> drugs and their potentially toxic side effects are not the
> only option for patients with Crohn's and RA. At HSI, we've
> written extensively about alternative therapies for both RA
> and Crohn's disease. In February 2001 Member's Alert
> newsletter, we told you about an oral supplement from
> Germany called Wobenzyme, a blend of pancreatic enzymes
> that clears the body of the excess antibodies that
> characterize an autoimmune disease. Studies have shown that
> Wobenzyme can prevent RA flare-ups and help lower levels of
> these antibodies, called circulating immune complexes, or
> CICs. In October 2000, we wrote about the therapeutic yeast
> saccharomyces boulardii (SB), which nourishes and protects
> the healthy intestinal flora. At least two clinical studies
> have shown that SB can significantly reduce Crohn's
> symptoms compared to placebo.
>
> Centocor reminds us that approximately 170,000 patients
> have been treated with Remicade worldwide since it was
> introduced. And between these two incidents, only 21 people
> have died - 14 from infections and seven from congestive
> heart failure. The "Dear Doctor" letter also notes that
> "most" of the people who died of TB were taking other
> immunosuppressive drugs while taking Remicade. It's true
> that the risks are small - but that's no comfort to the
> families of those 21 people. Before you start - or continue
> - to take any prescription medication, make sure you have
> all the information and know all the risks. The FDA's not
> going to send YOU a letter - but here at HSI, we'll keep
> doing our part by informing you of the risks as we discover
> them and by helping you take control of your health.
>
> To Your Good Health,
>
> Jenny Thompson
> Health Sciences Institute
>
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