Biotech Drug Eprex causing Deadly Anemia
MICHAEL SMITH / UPI 2nov02
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PHILADEPHIA, PA--A genetically engineered drug hailed as a dramatic advance in the treatment of kidney disease has been found to cause a sudden upsurge in cases of potentially life-threatening anemia among kidney patients around the world, researchers reported Saturday.
Researchers said they are puzzled as to why human recombinant erythropoietin, which has been regarded as safe since it was introduced in the late 1980s, now seems to be causing cases of pure red cell aphasia, or PRCA. Patients with the condition suffer severe anemia and must be given regular blood transfusions, said kidney specialist Richard Glassock, who chaired a special session on the problem at the annual meeting of the American Society of Nephrology.
PRCA usually occurs in a "vanishingly small" number of people, Glassock told United Press International. It has been linked to disease of the thymus gland, some viruses, and auto-immune diseases, but not to kidney disease or the drugs used to treat it. Since 1998, however, more than 150 cases have appeared around the world among kidney patients treated with Eprex, a version of human recombinant erythropoietin that is not sold in the United States. This represents a hundredfold increase over the usual rate of PRCA, Glassock said, adding there have been scattered cases linked to other brands of the drug. Almost all of the cases occurred in patients who injected the drug under the skin, rather than into a vein, said physician John Knight, director of safety assessment for Johnson & Johnson of New Brunswick, N.J.,
the company that makes Eprex. Knight told session attendees the company now is urging doctors and patients to use only intravenous injections and doctors should stop using the drug if they suspect PRCA. Exactly why Eprex injected under the skin should cause PRCA still is unknown, Glassock said. "The nuances of this mystery go well beyond the data that we have now."
German medical professor Eberhard Ritz, who co-chaired Saturday's special session, said he is convinced the answer lies in the way Eprex is formulated, not in the drug itself. "What is different must be the way the immune system reacts to this compound," he told UPI, because other versions of the drug -- with different formulations -- do not seem to have the same effect. French physician Jerome Rossert, one of the first to report drug-related PRCA cases in France, said the link to the method of injection is puzzling.
Although the drug was being injected under the skin before 1998, there were only a few cases of PRCA. He told attendees that Germany and France have about the same number of kidney patients who inject the drug under the skin, but France has had 33 cases of PRCA and Germany only three. Rossert said the sudden appearance of PRCA is alarming, but human recombinant erythropoietin "remains a very safe drug. Biotech products need to be handled with great care ... and we need to be looking for unexpected adverse effects."
Although PRCA is debilitating and potentially deadly, Glassock said, data presented at this meeting show a kidney transplant completely cures the condition, usually within a matter of weeks.
From: Stanford Securities Class Action Clearinghouse
Johnson & Johnson
CASE INFORMATION
Summary:
According to a Press Release dated July 24, 2002, the complaint alleges that prior to the beginning of the Class Period there were reports of 40 cases of pure red cell aplasia ('PRCA') in chronic renal failure in patients taking EPREX, which is manufactured at Johnson & Johnson's Puerto Rico facility and sold in Europe. PRCA is a condition in which the body loses its ability to produce red blood cells, leaving the patient dependent on blood transfusions for survival. The Class Period begins on April 16, 2002 when defendants released Johnson & Johnson's first quarter results. In the Company's press release and during the earnings conference call held that day, defendants repeatedly attributed the Company's financial performance to the success of EPREX, stating, for example, that 'This amazing product has delivered consistent double-digit growth over the past five years. And in the first quarter of this year, we hit a record sales level of a billion dollars.' Moreover, defendants discussed the reported incidences of PRCA and assured investors that EPREX 'continues to be a trusted brand that people are using, 'and that Johnson & Johnson was 'working very closely with ... the experts, as well as health authorities in understanding (PRCA), why it occurs. And we're doing whatever we can to understand the risk and mitigate it.' Then, the complaint alleges that defendants' statements during the Class Period, however, were materially false and misleading because defendants knew but failed to disclose that by April 2002, the U.S. Food and Drug Administration's Office of Criminal Investigation, spurred on by the increasing number of cases of PRCA in EPREX patients, sought a stay of a qui tam (whistleblower) action in order to investigate the allegations regarding the Company's EPREX manufacturing facility located in Puerto Rico. The whistleblower action was filed in March 2000 by Hector Arce, a former employee at the Company's EPREX factory. Mr. Arce contends in the lawsuit that he was pressured to falsify data to cover up manufacturing lapses at the EPREX manufacturing facility, and then was suspended a few days before an expected interview with FDA inspectors. This information, which defendants failed to disclose, was information a reasonable investor would have wanted to know - especially as the reported incidences of PRCA continued to climb during the Class Period - considering EPREX, and its U.S. version, PROCRIT, accounted for over 10% of the Company's revenues in 2001 and was projected to account for 11% of revenues in 2002. The true facts concerning the existence of the criminal investigation of Johnson & Johnson and the allegations of the qui tam action were first revealed in The New York Times on July 19, 2002. That same day, Johnson & Johnson admitted that it was aware of the criminal investigation since April 2002. Once the foregoing information was revealed, Johnson & Johnson shares fell $7.88 per share to close on July 19, 2002, at $41.85, a fall of 16%.
-------------------------------------------------------------------------------- INDUSTRY CLASSIFICATION: SIC Code: 2834 Sector: Healthcare Industry: Major Drugs -------------------------------------------------------------------------------- COMPANY/ISSUER NAME: Johnson & Johnson COMPANY/ISSUER TICKER: JNJ COMPANY WEBSITE: http://www.jnj.com -------------------------------------------------------------------------------- FIRST IDENTIFIED COMPLAINT IN THE DATABASE [Unknown Plaintiff], et al. v. Johnson & Johnson, et al. COURT: D. New Jersey DOCKET NUMBER: JUDGE NAME: DATE FILED: 07/24/2002 SOURCE: Business Wires CLASS PERIOD START: 04/16/2002 CLASS PERIOD END: 07/18/2002 TYPE OF COMPLAINT: Unamended/Unconsolidated PLAINTIFF FIRMS IN THIS OR SIMILAR CASE: Cauley Geller, Bowman & Coates, LLP (Little Rock, AR) P.O. Box 25438, Little Rock, AR, 72221-5438 (voice) 501.312.8500, (fax) , Schatz & Nobel, P.C. 330 Main Street, Hartford, CT, 06106 (voice) 800.797.5499, (fax) 860.493.6290, sn06106@AOL.com Wolf Popper, LLP 845 Third Avenue, New York, NY, 10022-6689Ave (voice) 877.370.7703, (fax) 212.486.2093, IRRep@wolfpopper.com _____________________________________________ TOTAL NUMBER OF PLAINTIFF FIRMS: 3
source: http://securities.stanford.edu/1025/JNJ02-01/ 4nov02
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