GENTECH archive

[Index][Thread]

Re: B-GE: Wash.Post 5/13 GE Protein/First Biotech Arthritis DrugWarning



I can't help but wondering if any of these physicians who administered this 
drug, tried first to put their clients on a whole-foods vegan diet for a few 
months and observed the results.

- Nina Moliver

In a message dated 5/13/1999 9:07:09 AM Eastern Daylight Time, 
crobison@mnsinc.com writes:

<< 
 FDA Warns Arthritis Drug May Spur Infections
 
 By Guy Gugliotta
 Washington Post Staff Writer
 Thursday, May 13, 1999; Page A05 
 
 The Food and Drug Administration warned yesterday that the newly approved
 drug Enbrel, which has produced spectacular results in treatment of
 rheumatoid arthritis, may have caused serious infections in some patients,
 including six who later died.
 
 The FDA warning came two days after Seattle-based Immunex Corp., which
 makes Enbrel, expanded its advisory to health care professionals,
 cautioning them not to administer the drug to patients with active or
 chronic infections, and to take extra care in prescribing it for those who
 are predisposed to infections.
 
 Immunex spokesman Tim Warner said the company's announcement was "kind of
 an update story," in that "we have always told doctors and told patients
 that if patients get serious infections, the medication should be
 discontinued."
 
 But Bill Sweeterman, the chief of immunology and infectious disease at the
 FDA's Center for Biologics, said that rather than simply embellishing the
 warning on Enbrel's label, the agency's warning was intended to "raise the
 level of concern" about the drug's potential adverse effects.
 
 "We felt that the old label did not adequately describe the concerns we had
 after receiving information that has come to light in the last several
 weeks," Sweeterman said. Because of the "adverse event reports," Sweeterman
 added, the agency made "a decision that it was appropriate to expand the
 warning."
 
 Enbrel, known chemically as etanercept, is the first drug developed by the
 biotechnology industry to treat rheumatoid arthritis, a degenerative
 disease in which a person's own immune system goes haywire and begins to
 attack the joints. The disease afflicts 2.1 million Americans, including
 71,000 children, and in moderate or severe form can virtually cripple its
 victims.
 
 Since the drug's approval last November, it has achieved some spectacular
 results, not only in the clinic, but also on Wall Street. Patients crippled
 for years have put their crutches in the closet and returned to work, while
 Immunex, which started 1998 trading at $54 per share, has become one of the
 darlings of the Nasdaq Stock Market. About 28,000 Americans use the drug
 twice a week, at a cost of $110 per dose.
 
 Sweeterman noted that while the FDA warning was issued two days after
 Immunex's own news release, the agency and the company had agreed jointly
 on the language. He said the FDA initiated the review.
 
 Immunex also appeared to have trumped its version of the warning by issuing
 it on the same day that it released a study suggesting that Enbrel not only
 relieves the pain and symptoms of rheumatoid arthritis, but also slows
 progress of the disease. The news caused Immunex stock to rise 33 percent
 Tuesday. It closed yesterday at $139.43 3/4 a share, down $2.87 1/2.
 
 Warner said Immunex published both the warning and the study results
 Monday, because "both were material information, and we're required by
 legal guidance to release it as soon as we get it. There was no selective
 disclosure."
 
 Enbrel is a "biological response modifier" chemically engineered to attract
 and neutralize tumor necrosis factor-alpha, a protein produced by the human
 body and believed, when in excess quantities, to play a role in many
 diseases, most notably rheumatoid arthritis.
 
 From the beginning, Immunex and doctors warned that Enbrel was not for
 everyone. Even though the drug targets only one protein in the immune
 system, doctors explained, that protein likely performs other jobs besides
 causing arthritis, and blocking it upped the risk of infection for some
 patients.
 
 The FDA warning said 30 patients had reported developing serious infections
 after beginning treatment with Enbrel, and six had died. "Even though many
 patients are predisposed to infections, significant concerns remain that
 Enbrel may contribute to the occurrence of serious infections," the FDA
 warning said.
 
 The agency said it had asked Immunex to undertake additional studies, and
 Warner said Immunex has agreed. "The main thing we're trying to determine
 is whether there's a risk of serious infection related to Enbrel," Warner
 said. 
 
 
  Copyright 1999 The Washington Post Company
  >>