IP: How we miss things not in computerized databases

[David Farber <dave () farber net>]

> To: farber () central cis upenn edu
> Subject: How we miss things not in computerized databases
> Date: Tue, 24 Jul 2001 09:00:02 -0400
> From:
>
>
> Dave,
>
> The most interesting part of that story for me was the fact
> that there was evidence from the 1950's which was ignored.  It
> was a widespread problem in the American Civilization (my
> minor) and History departments at Penn that, when databases
> first became available, students no longer went to books when
> they had to do research.  Of course, the faculty found this
> completely unacceptable.   I know that by just using Medline
> for my research that I have missed things from the 1950's as well.
>
> Please let IP know about this, but please do not attach my name.
>
>
> XXXX
>
>
> http://www.nytimes.com/2001/07/24/health/24RESE.html
>
>
>
> July 24, 2001
>
> Agency Eases Research Ban at University
>
> By JAMES GLANZ
>
> BALTIMORE, July 23 -- A federal agency investigating the death
> of a volunteer in a research study at Johns Hopkins University
> announced today that it was easing its four-day- old suspension
> of research experiments involving human subjects at the
> university.
>
> But because of strict conditions imposed by the agency, the
> Office for Human Research Protections, most of the thousands of
> studies that were suspended are unlikely to resume for weeks or
> months as they undergo comprehensive new reviews by panels at
> the university and officials at the agency.
>
> Still, some studies involving either minimal risks to subjects or 
> treatments of
> gravely ill patients -- for example, those taking experimental cancer drugs —
> may go forward almost immediately, the agency said.
>
> Although some of those exemptions already existed, Hopkins officials
> generally praised the decision.
>
> "We're extremely glad this has been lifted," said Dr. Chi Van Dang, vice
> dean for research at Hopkins.
>
> University officials had excoriated the agency for imposing the suspension
> last Thursday, calling that decision outrageous and excessive. Today, Dr.
> Dang said he hoped that negotiations would succeed in further loosening the
> restrictions.
>
> "There should be additional dialogue," Dr. Dang said.
>
> Despite the quick turnaround, Dr. Arthur Caplan, an ethicist at the University
> of Pennsylvania, said that the episode at Johns Hopkins, which followed
> recent suspensions of human research at Duke University, Penn and other
> prestigious institutions, suggested that the problems were widespread.
>
> "There are core problems with human subject protections in this country,"
> Dr. Caplan said. "Having Hopkins, if you will, back online doesn't get at
> those."
>
> In a visit to Johns Hopkins last week, agency officials determined that the
> university panels that consider proposals for human research were
> overburdened, understaffed and lacking in a detailed understanding of federal
> regulations governing human research. The panels, called institutional review
> boards, are usually composed of people and researchers inside and outside
> the university.
>
> In responding to those concerns, Johns Hopkins officials worked intensively
> over the weekend with the Office for Human Research Protections on a plan
> to improve the way in which the university assesses its scientists' 
> proposals to
> conduct research involving humans. The agency conveyed its decision to
> ease the suspension in a letter to the officials that was dated July 22.
>
> The Office for Human Research Protections "finds that your institutions have
> developed a satisfactory corrective action plan to address all areas of
> noncompliance and concerns," said the letter, which was signed by Dr.
> Michael Carome, director of the division of compliance oversight at the
> agency.
>
> The letter said the reinstatement was immediate.
>
> Gary Stephenson, a Hopkins spokesman, said about 2,400 trials involving
> thousands of volunteers had been suspended by the earlier order. The
> university believes that only several hundred of those trials will resume
> without new review, Mr. Stephenson said..
>
> In addition to their negotiations with the research protections office, 
> Hopkins
> officials found advocates in Maryland's two United States senators, Barbara
> A. Mikulski and Paul S. Sarbanes, both Democrats. They sent Secretary of
> Health and Human Services Tommy G. Thompson a letter urging him to
> consider the university's concerns.
>
> But today a spokesman for the health department, which is responsible for
> the oversight agency, said that while Mr. Thompson had been kept informed
> of the weekend deliberations, there had been "no political pressure
> whatsoever" to lift the suspension.
>
> "The secretary understands the importance of human subject protections,
> and the importance of ensuring that institutions do all they can to protect
> human subjects," said the spokesman, William Hall. "O.H.R.P. has been left
> to do the job they do."
>
> In a statement today, Senator Mikulski said her actions had been intended to
> "ensure that the needs of the patients were being addressed and that they
> were not left in limbo."
>
> The case began when Ellen Roche, a young, healthy technician working at
> the Johns Hopkins Asthma and Allergy Center, volunteered to take part in a
> study to explore the causes of asthma that was being undertaken by Dr.
> Alkis Togias, an associate professor of immunology at the university. Ms.
> Roche, 24, did not work directly for Dr. Togias, but within a separate
> research group there.
>
> On May 4, as part of the study, Ms. Roche inhaled a gram of an unapproved
> drug, hexamethonium, and within days developed a fever and flu-like
> symptoms. After her lungs gradually deteriorated and her kidneys failed,
> apparently because of the drug, she died on June 2. Hopkins announced her
> death in mid-June.
>
> Internal reviews at Hopkins found that Dr. Togias had made several missteps
> in the project, including a failure to turn up literature from the 1950's
> indicating that hexamethonium can be toxic to lungs and not informing the
> university's review panels, called institutional review boards, that an 
> earlier
> subject in the same experiment had developed a cough and shortness of
> breath. All of Dr. Togias's research remains suspended.
>
> But last week, after its visit to Johns Hopkins, the agency determined that
> there were widespread problems with the way the review boards conducted
> their business, Mr. Hall said.
>
> The agency, Mr. Hall said, "determined that because of these systemic
> problems there are concerns about the potential risks to other potential
> volunteers."
>
> In essence, the agency determined that the review boards did not consider
> each individual proposal carefully enough, that they were overburdened and
> understaffed, and that review board members often did not understand the
> federal regulations governing experiments involving humans.
>
> Sunday's letter from the agency said the university had come up with a plan
> to shore up all of those problems. For example, Mr. Hall said, Hopkins will
> increase the number of review boards to four, from three, and consider each
> application more carefully.
>
> Research involving minimal risk to subjects -- procedures like saliva swabs
> and urine tests -- can proceed almost immediately. Other projects, involving
> the "best interests of the patient," like treatment for severe illnesses, 
> can also
> go ahead at the discretion of the university, he said.
>
> All others must be reviewed again according to the new procedures, and
> monthly progress reports must be sent to the agency.
>
> "We would anticipate that it would take weeks if not months," Mr.
> Stephenson said.
>
> Meanwhile, the larger issue of protecting human subjects remains, said Dr.
> Ernest D. Prentice, associate vice chancellor for academic affairs at the
> University of Nebraska Medical Center and a consultant to the oversight
> agency.
>
> "We have a fair amount of evidence to indicate that there is probably a
> systemic problem in the U.S. relative to the adequacy of human research
> protection," Dr. Prentice said, "and that leading institutions are not 
> immune."



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