Recruitment for phase I clinical trials raises issue of patient self-deception

Letters to the Editor - Oct. 7, 2002

Recruitment for phase I clinical trials raises issue of patient self-deception - Medical transcriptionist: Many doctors are sloppy talkers - Physicians should give ultimatum on direct-to-consumer drug ads - Private cord blood bank: AMNews gave public facilities favored treatment

Recruitment for phase I clinical trials raises issue of patient self-deception

Regarding "NCI, drug companies partner to recruit patients for trials" (AMNews, Aug. 26): The story omits mention of what is one of the most critical issues in recruiting cancer patients for phase I and phase II trials.

Phase I trials are designed so that they can be of little or no benefit to the subjects who sign up. The purpose of the trial is to establish the threshold of toxicity.

Consequently, subjects will either get a medication dose that is not toxic or will stop the medication as soon as toxicity is reached. Since the effective doses of most antineoplastic drugs are close to or at toxicity, subjects with cancer are not likely to receive an effective dose during the trial. Consequently, the only benefit they can derive from participation is the knowledge that they have helped those who come after them -- i.e., an altruistic reward but nothing for their own illnesses.

Most prospective subjects and even many physicians seem to misunderstand this point no matter how directly it is explained to them. If the investigator attempts to clarify the misunderstanding -- which is the ethical thing to do -- he or she is in effect discouraging participation. This is a difficult, if not impossible, dilemma for the conscientious investigator.

The obvious answer is to give subjects a fair and meaningful monetary reward in exchange for their taking a serious risk to benefit all the rest of us. This has a major drawback in that it may exert undue pressure on impoverished individuals to participate. But that is preferable to relying on the self-deception of desperate cancer patients hoping to be cured.

--Jack Zusman, MD Tampa, Fla.

Medical transcriptionist: Many doctors are sloppy talkers

Regarding "FP study highlights ripple effect: Harm flows from simple errors" (AMNews, Sept. 23/30): I am a six-year veteran medical transcriptionist, and I have transcribed for many physicians in multispecialty fields of medicine. One of the major problems in the doctor's office with "simple errors" is the sloppiness in the way the majority of physicians dictate their patients' medical records.

They slur, gibber-jabber and try to break the speed of light with their dictation; they eat, burp and many other things while dictating. That leaves the medical transcriptionist to "guess" what they have dictated and possibly enter something that could throw the diagnosis of a seriously ill patient into something of a less serious concern and vice versa. If we leave blanks, we get chewed out.

It is the responsibility of the doctor doing the dictating to make the dictation accurate, clear and understandable by the person who is going to translate those words onto paper. It is of the ultimate importance that the patient's record is as accurate as possible, and that responsibility lies with the dictation from the physician. This issue needs to be addressed, and it needs to be brought to all physicians' attention as soon as possible.

This is not a minor issue, and it does concern patients, because these reports affect the condition of their health.

If physicians would simply slow down and dictate in their normal speaking voices, this problem of sloppy dictators and inaccurate patient records could be remedied altogether.

--Mary A. Dickey Hot Springs, Ark.

Physicians should give ultimatum on direct-to-consumer drug ads

I have yet to meet a physician who has anything but contempt for the present-day direct-to-consumer advertising by the drug companies. The ads are slick promos designed not to inform and educate but to sell product. The cost is immense, and it is borne by our patients in ever-increasing drug costs.

So here is my proposal. We, all the U.S. physicians, give notice that as Nov. 1, either the companies pull all DTC ads or face having detail reps shut out of all of our offices. The dollars saved will go to lower the cost of the advertised drugs.

Be your patients' advocate. Will you do it ?

--Dennis E. Sumski, DO Farmington, Mo.

Private cord blood bank: AMNews gave public facilities favored treatment

Regarding "Efforts under way to collect more umbilical cord blood" (AMNews, Sept. 9): Your article about cord blood banking provided some interesting statistics and information about public cord blood banking.

I feel the article was unbalanced, though, because you used only the views of representatives of public cord blood banks.

You said public cord blood banks face competition from family banks. As a representative of the largest family bank, I don't see that competition at all.

As you said in your article, the problems public banks face is entirely due to lack of funding. Public banks receive money from grants, gifts and bequests, and from selling their stored blood for transplants. Family banks don't impact those sources of funding and they don't "steal" cord blood away from the public banks.

You painted all family cord blood banks with a broad brush of distrust when you quoted a public bank official as saying, "with a family cord blood bank we don't know how well the product is being handled, tested and stored."

Our blood processing laboratory (accredited by the American Assn. of Blood Banks) uses state-of-the-art processes and testing in a facility built specifically for cord blood processing. We cut no corners to save money and are proud of our reputation as the leading family cord blood bank.

One-fourth of our clients work in the medical field -- a ringing endorsement of family cord blood banking and a confirmation of our standing in the medical community.

--Amy Seirer Communications manager, Cord Blood Registry, San Bruno, Calif.

OPINION

Letters to the Editor - Oct. 7, 2002