"I recall that the editors, and not the reporters, write the headlines."

Resuscitation trials have multiple checkpoints

Goal is improved emergency care

Editor, The Times:

Re: "You may become medical guinea pig without knowing it" [Page One, June 3]:

The Resuscitation Outcomes Consortium (ROC) includes thousands of emergency medical technicians and paramedics whose duty is to provide the best possible care to citizens who develop life-threatening illness out of hospital. This article has underestimated the efforts of these dedicated providers to protect the citizens they serve.

ROC studies involve patients who need rapid intervention to prevent death. They are too sick to consent to rapid application of experimental interventions (or even to standard care) in the field.

Federal regulations allow emergency research if patients cannot consent because of their medical condition, available treatments are unsatisfactory, the intervention must be administered before obtaining consent is feasible, and independent committees monitor the study.

Each ROC trial was reviewed by multiple independent groups before startup: a protocol review committee, a data safety monitoring board, the Food and Drug Administration and institutional review boards (IRB). This process includes consultation of the community. All citizens concerns are reported to the IRB. An IRB can require a change in the design of the study or even not allow the study to enroll patients in their local area.

The research team must notify patients enrolled in an emergency research study as soon as feasible. Then patients can opt out from ongoing study participation.

Similar large trials have rapidly improved treatment in patients with heart attacks. With ongoing attention to patient safety, ROC could achieve the same for emergency medical services care in this country. This seems like a goal that most people would support.

— Dr. Graham Nichol, medical director for the Data Coordinating Center of the Resuscitation Outcomes Consortium, director of the University of Washington — Harborview Center for Prehospital Emergency Care. The views in this letter are his alone.

Emergency care, patient consent

"Guinea pig" headline set wrong tone

Editor, The Times:

Thank you so much for doing a disservice to your readers and the medical community.

Your article on the medical studies being conducted at Harborview has frightened people ["You may become medical guinea pig without knowing it," Page One, June 3]. Using the term "guinea pig" in the headline influences your readers to feel a certain way about the research from the outset and then later comparing patients to lab rats makes it worse.

Several people were quoted in the June 6 follow-up article complaining that the research is "ill-conceived" and that the attempts to inform the public were too narrowly focused ["Many people seek to 'opt out' of no-consent medical studies," Local News].

The researchers contacted the media and put ads on public transit in addition to many other sources. Were these people expecting a singing telegram at their front door?

Perhaps the information on how the studies are very highly regulated, safe and beneficial would have been better placed at the beginning of the article rather than the end.

— Cameron Spivey, Seattle

Prefer opt in over opt out

Let's see if I understand this correctly: If I don't want to be a lab rat, it's proposed that I can get a medical bracelet stating my wishes.

I have a better idea: Why not let those who want to be a science experiment wear those bracelets? Ah! That would be just way too simple, and maybe no one would want to.

— Caralyn R. Haglund, Coupeville

Studies are needed

Your article June 3 brings to our attention a very important problem.

In brief, how do we develop better treatments for desperately ill patients when these individuals cannot give consent and when, in the moment of crisis, no one else can speak for them? Your article sets forth the dilemma and provides a balanced presentation of the pros and cons for experimental treatment without consent.

It is clear the federal government and clinicians strongly believe that clinical trials are needed and should be conducted, provided that close attention is given to ethical issues.

There are two additional arguments in favor of this sort of research that should be considered and presented to the public. First, the therapies proposed (for example, hypertonic saline infusions) are supported by considerable experimental data obtained in a number of laboratories and thoroughly scrutinized by peer-review groups and the FDA.

Secondly, in most cases, there is what is termed "equipoise" in regard to the appropriate therapy. Equipoise exists when two (or more) therapies appear to be suitable, but it is unclear which one is the best. In this circumstance, it is necessary to conduct a trial and a head-to-head comparison.

It is important that all of us understand the need for these studies and are confident that the investigators at Harborview Medical Center are testing new therapies that they believe are likely to be better than the old ones, but certainly no worse.

— Dr. Alexander W. Clowes, Seattle

Insulting headline

I wish to commend Carol Ostrom for her articles on the emergency-research studies.

I am a researcher and regulatory professional with 10 years of experience in clinical research. I have worked for the University of Washington institutional review board and helped review and oversee the approval of previous emergency-research studies conducted by UW investigators.

I am writing because I am very concerned about the headline that was used. I recall that the editors, and not the reporters, write the headlines.

This is indeed unfortunate because, while the article was excellent and described the complex issues and differing opinions and challenges regarding these "waiver of consent studies," both positive and negative, the title of the article shows a distinct bias against not only this form of research, but against clinical (human) research in general.

"Guinea pig" to describe a human subject is a charged, pejorative and insulting term.

This title demonstrates disrespect for the research institutions and researchers, who through their determination, perseverance and ingenuity have vastly improved human health, particularly over the past century.

It also shows immense disrespect for the people who agree to participate in research studies, at their own risk, often for the benefit of humankind, if not for their own benefit.

— Erica C. Jonlin, University of Washington, Seattle

Concerned about consent

It's very disturbing to know that some researchers at the University of Washington are conducting medical research without patient consent.

Despite the objections of bioethicists, the researchers obtained FDA permits to waive individual patient consent through "community consultation and public disclosure."

Under these circumstances, a major news article should have appeared before experimenting without consent became policy. It's astounding that researchers derived a mandate from a telephone survey — certainly a novel approach to relieving people of their rights. The only way for an individual to avoid the possibility of being an experimental subject under extremely traumatic circumstances is to opt out of the study ahead of time, and wear a "No Research Study" bracelet 24/7. What an aggravating imposition.

Furthermore, research subjects (and their survivors) may never know what treatment they received. These studies should require individuals to opt in, like organ donors.

Though the researchers' desire for progress is understandable, the way they imposed their studies on the community seems as unethical as experimenting without consent.

— Jade Grace, Vashon

Family, rep can give OK

Yes, it is true that FDA regulations allow non-consenting individuals to be included in emergency medical research studies.

However, the FDA recognizes that persons with life-threatening conditions who can neither give informed consent nor refuse enrollment are a vulnerable population and require additional protective procedures in the review, approval and operation of this research.

Patients unable to consent to treatment often need emergency care before admission to the emergency room — at the site where the patient was injured or in the ambulance.

Doctors can only provide the very best therapies for these patients if new treatments and procedures are studied in controlled clinical trials.

One key protection worthy of note is that before entering a non-consenting subject into a study, the clinical investigator is to attempt to obtain consent from the subject's legally authorized representative within a predefined time period, if feasible. If this person is not available, a family member is to be provided with an opportunity to object to the subject's participation (within the same time period), in which case the individual should not be entered into the study.

— Gail E. Gillenwater, Seattle

Not giving consent

Since identification bracelets are not available, no signs have been seen on buses, and no telephone calls have been received, this is to notify Harborview and other area medical facilities they do not have my consent to utilize experimental treatment on me in the event of a medical emergency.

— Ann Galvin-Eisenhart, Seattle

Sensationalist label

Danny Westneat should examine the history of prehospital emergency medical care in King County before spouting knee-jerk rhetoric ["How to be a guinea pig and not even know it," Local News column, June 6].

The term "guinea pig" is insulting and inflammatory, and infers that Medic One is performing diabolical experiments on the citizenry. On the contrary, the different types of saline being used have been determined to be safe. The military uses hypertonic (high salt concentration) saline routinely on battlefield trauma. This study is being performed only to find the best way to resuscitate massive blood loss or catastrophic head injury, and improve patient outcome. Period.

Westneat should instead feel privileged to live in a county universally recognized as the worldwide leader in prehospital emergency care and research. Medicine is advanced through careful experimentation, and if closely examined, all of the currently accepted practices of resuscitation of trauma and cardiac arrest are experimental therapy.

Victims of multisystem trauma and cardiac arrest have higher survival rates in this county than any other area in the U.S. because of the practices and research of the professionals at Medic One and Harborview. Labeling patients "guinea pigs" is a disservice to the community and reeks of sensationalism.

— Fred Spencer, Issaquah

Taking a toll

Traffic shift to I-90

Far be it for me to point this out, since I am but a lowly automobile driver who occasionally crosses Lake Washington on the 520 Evergreen Point Floating Bridge, and have not spent years of my life studying traffic flows and commuter reduction plans from the ivory towers of the King County offices of Ron Sims nor the golden gateways of our Washington State Transportation Commission ["County floats $2 toll idea for 520 old span," Page One, June 8].

If a toll is placed on the 520 bridge without a concomitant toll placed upon the Interstate 90 bridge, I predict a traffic decrease on one bridge and an increase upon the other.

I know, I know. It's a really great idea. We have to get people out of their cars and on to public transport or their bikes [Oops! No bike lane on 520 — I forgot!].

I know, I know. It's silly of me to bring this up since wiser heads have thought this whole toll thing through from start to finish. Undoubtedly they are the same wise people who thought through our options with the Alaskan Way Viaduct — a plan with which we are all amazingly overjoyed with.

— Peter Stekel, Seattle

Some fairy tale

Or was it the food?

Re: Paris Hilton:

Was it a pea under her mattress?

— Barbara Schwartz, Mercer Island