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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