By Susan Levine and Rick Weiss

Federal officials notified Johns Hopkins University July 19th that it must suspend all federally supported medical research involving human participants -- hundreds of clinical trials involving more than $300 million -- and that it cannot enroll any new individuals in those trials for an undetermined period of time.

After a massive weekend of negotiaitons the same federal officials did reopen Johns Hopkins on July 23.

The move came only three days after the school's medical leadership released an investigation committee's report on the June 2 death of a healthy young volunteer in a Hopkins asthma study. The report blamed the project's principal researcher and an internal review board for inadequately scrutinizing the risks of the chemical used and not sufficiently warning participants who would inhale it.

Hopkins receives more federal research dollars than any other medical school in the country.

The action against Hopkins, said Vera Hassner Sharav, of the Alliance for Human Research Protections in New York, "shows that this is not about an individual aberrant researcher that violated research rules, but about institutional shortcomings. The system is not working if you actually have to shut down an entire research center."

In fact, just two years ago, the HHS inspector general released a report that warned of an imminent breakdown in the nation's system for overseeing the safety of research participants. In particular, it found that universities' and medical centers' institutional review boards, which judge the scientific and ethical merit of human research studies, are severely overburdened, staffed by insufficiently trained people and open to conflicts of interest -- all problems raised in the Hopkins closure.

The presidentially appointed National Bioethics Advisory Commission recently recommended an overhaul of the system. It called for the creation of a federal office to oversee such research and the certification of all scientists who wish to conduct studies on human subjects.

The directive to Hopkins reveals that during a three-day visit this week, government investigators found asthma specialist Alkis Togias at fault on numerous points. Togias had been using the chemical hexamethonium to study what neural mechanism is at work when airways of the lung constrict after being exposed to allergens or other irritants, but it unexpectedly triggered acute respiratory distress in 24-year-old laboratory technician Ellen Roche. She died about a month after inhaling it.

Specifically, the Office for Human Research Protections determined, Togias did not provide critical information about the substance to the board reviewing his protocol and the nine healthy men and women who agreed to participate. Those volunteers were not told that the Food and Drug Administration considers inhalation an experimental use of hexamethonium, the agency said, and the informed consent documents they signed did not "adequately describe the reasonably foreseeable risks and discomforts associated with the research."

In addition, despite a literature search, Togias did not find published studies about an ominous connection between hexamethonium and lung toxicity: "Such data was readily available via routine . . . Internet database searches, as well as recent textbooks on pathology of the lung."

More broadly, the agency took Hopkins sharply to task for the way its two review boards have operated, indicating that most proposed or ongoing research protocols"are neither individually presented nor discussed at a convened meeting" of any review board. There were no minutes for 18 of the last 21 review board meetings, dating to October, and the actions of other sessions were inadequately documented, investigators said.

With some proposed protocols, such minimal information was provided on subject recruitment, privacy safeguards and other points that the review boards should not have acted on the applications, according to yesterday's letter. And in some instances, it continued, review board "members inappropriately participated in the initial and continuing review of protocols for which they had a conflicting interest."

Among the corrective steps required is a plan to restructure the university's system for protecting human subjects, with "enhanced institutional commitment" to those volunteers' safety, the agency said.

The closure order affects all Hopkins facilities at which human research is conducted, including Johns Hopkins Hospital, the medical and nursing schools, the Bayview Medical Center and the Kennedy-Krieger Institute. It also shuts down the National Institutes of Health's Gerontology Research Center, home to virtually the entire intramural research program of the National Institute on Aging, which is on the Bayview campus.

Washington Post July 20, 2001; Page A01

Dr. Mercola's Comments:

This is quite an amazing story in that it occurs in what many consider to be the number one health institution in the US (Johns Hopkins) as rated by the US News and World Report in July 2001. This is also unusual as Johns Hopkins receive more federal funding than any other institution in the US. It is interesting to note that the universities' and medical centers' institutional review boards, which judge the scientific and ethical merit of human research studies, are severely overburdened, staffed by insufficiently trained people and open to conflicts of interest. So, what is the take home message here? My take on this is that the Internet has changed everything. The person who died could have easily gone on the Internet and did her own search of this drug and found the potential complications. She did not do so and she paid a huge price, as she lost her life. So the superficial recognition is that if you are considering entering a university research project, do your homework before participating. However, there are far deeper implications which affect nearly every one of us. We need to take responsibility for our own health and not rely on what other health care professionals tell us, no matter who they are, and that includes anything I write, as I have my own biases and will nearly always slant my stories to natural medical solutions rather than a drug-based one. You can, and should, go on the Internet and do your own research and reach your own conclusions. Don't ever rely on your doctor as your only source of information. Just like the institutional review boards, they are far too overworked and may just not have the time to have a comprehensive view that can serve you well. After all, we all know that the traditional medical paradigm is the third leading cause of death in the US. Yes, there is a bunch of garbage on the Net. Not all of it is true by any means, but you can use www.alexa.com to download a web site ranking system that sits in your browser and you will see how popular that web site is. The system works by downloading their free software which then displays a window with the ranking of the site in your browser. If a site is ranked over one million, it is far less likely to have reliable information. Although this is certainly not always true, one needs to be a bit more careful of that particular source. But by using search engines like Google, in a few hours one can visit an number of sites and obtain a consensus of what is known about a particular topic. If you really want to do serious research you can go to the National Library of Medicine and use the PubMed system. This is the largest medical database on the planet. The abstracts are in highly technical medical jargon, but they can frequently be useful.