E-drug: Deaths in users of defective asthma inhalers
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August 9, 2001
Tommy Thompson, Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, D.C. 20201
On March 1st of this year I wrote to you, urging that you "launch
an investigation into criminal charges against Schering-Plough based
on the possibility that the company knowingly shipped millions of
the 59 million units of albuterol-containing asthma drug eventually
recalled, between the time the company became aware of the
seriously flawed manufacturing processes and the time the March,
2000 recall was finally accomplished." The company had explained
that the basis for the recall was "the remote possibility that an
aerosol container may not contain active drug."
The failure to be able to treat and stop an acute asthmatic attack,
because there is no asthma drug in the inhaler upon which the
patient relies, is obviously a life-threatening situation. We therefore
subsequently have analyzed adverse reaction report data obtained
from the FDA and found that there was a pattern of deaths in users
of Schering-Plough albuterol products which had occurred around
the time of the two (9/99 and 3/00) recalls. Thus, this new
information along with other findings discussed below, significantly
adds to the compelling case for criminal prosecution of
Schering-Plough.
As can be seen on the chart below,
(http://www.citizen.org/hrg/Publications/1586.htm) there were no
deaths reported to the FDA to have occurred in users of Proventil or
Warrick's albuterol (generic version also manufactured by
Schering-Plough) during the first three quarters of 1998. However,
starting with a death that occurred in the fourth quarter of 1998
and continuing through the second quarter of 2000, there were a
total of 17 deaths for which the Schering-Plough albuterol was
listed as the "primary suspect" and in which there is a date of
death. During the last two quarters of 2000, the last period for
which we have been able to obtain data, there have been no
subsequent deaths reported to have occurred in users of these
products. For an additional seven deaths in people using these
asthma inhalers, there was no exact date of death given and the
cases were reported to the company between March 30th and
August 9, 2000.
This pattern of deaths, with none occurring before or after the
interval during which the defective albuterol inhalers were shipped
for use is known as a point source epidemic and strongly implicates
these products as causes of the deaths.
Of the seventeen patients with known dates of death, ten of them
were using, or attempting to use, inhalers from the lots which were
eventually recalled, including two from the lot recalled in
September, 1999 and eight from the lots recalled in March, 2000
according to the FDA documents. For the other seven patients, lot
numbers were not listed in the FDA data we received. In
information also included with the FDA adverse reaction reports, for
five of the 17 patients who died there were comments indicating
that the patients had not gotten relief from their asthmatic attacks
from the Schering-Plough inhalers. The remarks included those of a
21-year-old, shortly before his death, who "complained on several
occasions that his albuterol inhaler did not seem to treat his asthma
attacks as usual". A ten-year-old boy who had an asthmatic attack
"reached for his inhaler and obtained no relief" and died shortly
thereafter. Both of these people were using inhalers from the
recalled lots. Of those who died whose ages were known, six were
under the age of 30 including three who were less than 20 (10, 12,
and 16).
Although many of these deaths occurred before the first recall and
most of the rest before the second recall, most were not reported
to the company, according to the company's data, until after the
second recall. One likely explanation is that it is counterintuitive for
patients, their families, or physicians to believe that an asthma
inhaler could be so shoddily manufactured as to fail to contain the
asthma drug. Therefore, until the widespread publicity following the
second recall, the link between the deaths and the defective
inhalers was probably not suspected by many people. It was, in
fact, after the second recall, on March 29, 2000, that
Schering-Plough advised that "Proventil and Warrick brand albuterol
patients using a canister without active drug will not obtain their
usual relief from asthma symptoms." The company press release
stated that "an inhaler that does not contain active drug is a serious
matter that merits immediate attention."
However, at least one death case was known to the company on
January 4, 2000, prior to the second (March 29, 2000) recall and
this death may well have helped to precipitate the February to April,
2000 outside audit by the AAC Consulting Group, during which the
March 29th recall of 59 million units of albuterol aerosol inhalers
was finally done.
According to FDA documents, a woman of unknown age who had a
previous history of "well-controlled asthma" who was using one of
the inhalers from a lot eventually recalled in March, 2000, died in
September 1999 and the company was notified on January 4,
2000. Unfortunately, it was almost three months after
Schering-Plough learned about her death that the March 29th recall
was belatedly undertaken. During these first three months of 2000,
while Schering-Plough was aware of her death but did not recall the
inhalers, another five deaths occurred in people using inhalers that
were recalled on March 29, 2000.
Aside from delaying the second recall almost three months after
learning of a death in a woman using the eventually-recalled
product, Schering-Plough was reckless in not recalling all of the
eventually recalled lots at the time they recalled the one lot,
9-BBS-525, in September, 1999. According to the company's press
release of September 9, 1999, announcing that first recall of 190,
000 asthma inhalers, it was precipitated after "one patient returned
an inhaler that did not contain drug substance". It is of great
importance that when the massive, 59 million unit recall of March
29, 2000 was finally ordered, lots which, according to their lot
number and expiration dates, were manufactured both before and
after the 9-BBS-525 lot were ultimately recalled. Thus,
Schering-Plough made a financially conservative but public health
reckless decision in September, 1999 that, despite a long history of
systemic problems involving the manufacture of albuterol inhalers,
only the lot from which the patient was unable to relieve his/her
asthma attack would be recalled. At the time of the second (March,
2000) recall, the company belatedly admitted that "the [March]
recall relates to an aerosol manufacturing problem that had been
previously identified in October 1999." Although all lots of the
massive March 2000 recall were said to have been manufactured
before September 30, 1999, it is likely, if not certain, that the
company shipped many of these lots into channels of commerce
after that date.
In our initial letter, the request for a criminal investigation was
based on the long standing pattern of dangerously sloppy
manufacturing, including albuterol inhalers, at Schering-Plough's
New Jersey plant, repeatedly documented in FDA inspections, FDA
warning letters to the company and in the company's private audit
by AAC Consulting Group, during which the March, 2000 recall
finally occurred (see our letter to you of March 1, 2001). Now,
there is additional evidence that the company not only failed to
recall millions of defective asthma inhalers for three months after
learning on January 4, 2000 of a death in a woman using one of
these inhalers, but that there were many deaths in people which
would have been avoided if there been an earlier, September, 1999
recall of the 59 million units.
Based on this new information concerning the deaths, there is even
more reason for criminally prosecuting Schering-Plough for
introducing these defective products into the marketplace and
failing to recall them much earlier. If you have any questions about
this serious problem, please call and I will meet with those involved.
Sincerely,
Sidney M.Wolfe M.D.
Director, Public Citizen's Health Research Group
1600 20th St. NW, Washington, DC. 20009
202 588-7735 fax 588-7796
e-mail swolfe@citizen.org
Web site: www.citizen.org/hrg
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