The following e-mail that was sent to me outlines some of the US problems.
Health Sciences Institute e-Alert
January 29, 2003
In an e-Alert dated exactly one year ago today ("More Bad News About Remicade and Enbrel" 1/29/02), I gave you the latest information on the disturbing side effects of two prescription drugs used to treat rheumatoid arthritis (RA) and Crohn's disease. Back then I said, "Unfortunately, the news gets even worse," and told you about research that showed both drugs may cause nerve damage that can lead to MS
and other central nervous system disorders
A year later, unfortunately, the news continues to get even worse. Earlier this month Reuters Health reported that two large clinical trials evaluating Enbrel in the treatment of congestive heart failure (CHF) had been stopped after one of the trials revealed that Enbrel was suspected of causing CHF conditions to WORSEN in patients. Enbrel (the brand name for etenercept) was approved by the FDA in 1998 to treat rheumatoid arthritis. Taken by injection (self-administered by the patient), the drug's label warns that "allergic reactions to Enbrel are not uncommon." These reactions include the risk of infections, swelling in the deep layers of the skin, and hives.
Now you might wonder why a drug, already known to have side effects ranging from the annoying to the severe, would be given two large trials, to test it for an indication it wasn't even intended for. The simple answer: money. And lots of it. A month's round of Enbrel doses costs each patient a staggering $1,500. No surprise then that sales of Enbrel grossed $907 million in 2001 - an increase of nearly 18 percent over the previous year. So, again, no surprise that
the manufacturers of Enbrel (a company named Immunex, in partnership with Wyeth), would make every attempt to expand the market for their bread-winner, in spite of the fact that the list of unpleasant side effects seems to grow as fast as the yearly revenue. And this is where Remicade comes in. Remicade (manufactured by Centocor, a subsidiary of Johnson & Johnson) is Enbrel's chief competitor. They were both approved by the FDA in 1998
to treat rheumatoid arthritis, they are both used to treat Crohn's disease (even though neither drug is approved for that), they have both been associated with disorders of the central nervous system (MS and Guillain-Barre syndrome), and now Enbrel joins Remicade in being known to worsen CHF symptoms.
Remicade, however, has one huge advantage over Enbrel: Remicade has to be administered intravenously in a doctor's office. Ironically, this apparent drawback has turned into a plus, because Medicare reimburses doctors 95 percent of the "average wholesale price" for drugs that have to be administered by a doctor. So in spite of the inconvenience, Medicare recipients receive a huge break on the exorbitant price. But guess what? Centocor reps are now being investigated for possible fraud in exploiting this system. Some drug companies have boosted the Medicare reimbursements to physicians by inflating the average prices they report to the government. According to The New York Times, early last year Centocor posted a notice for physicians on its web site, detailing the "estimated revenue per patient" that doctors would reap by prescribing Remicade. It's easy to imagine how this sort of incentive might encourage a doctor to prescribe
Remicade, before trying a low-cost generic drug called
Methotrexate, which is also a standard treatment for
rheumatoid arthritis. Add to that the fact that Medicare paid out more than $140 million for Remicade in 2001 (almost a 300 percent jump over the amount paid out in 2000), and you don't have to wonder why Centocor has drawn a federal investigation.
PTD
unknown
