NEGATIVE – MEDICAL – DISADVANTAGES

NEGATIVE — MEDICAL — DISADVANTAGES — RESEARCH 256

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AN OPT-OUT POLICY WILL PREVENT DISADVANTAGED GROUPS FROM BENEFITING FROM NEW RESEARCH

Helena Gail Rubinstein, Director of Policy Analysis and Program Development, Group Insurance Commission of the Commonwealth of Massachusetts; "If I Am Only for Myself, What Am I? A Communitarian Look at the Privacy Stalemate," American Journal of Law & Medicine, 1999, 25 Am. J. L. and Med. 203, EE2001-JGM, p.223

Moreover, those who "opt out" by refusing consent may lose more than they gain. Women and minorities traditionally have not been the subject of medical research; new procedures and therapies are tested primarily on men. n173 Only when these drugs and procedures come to market do we learn how they work on women or minorities, in a process known as "post-market surveillance." n174 This process makes [*225] all women research subjects, because a particular drug or process is assumed safe though it can only be proved effective and safe after a large enough sample of women have used it.

REQUIRING CONSENT TO ACCESS MEDICAL RECORDS WILL STIFLE MEDICAL RESEARCH

The difficulty in conditioning the use of health data to the consent of the subject only begins with the impracticality of quickly obtaining the large number of consents needed for the typical research protocol. n165 One analyst sees in consent requirements the "potential for chaos," creating an "insurmountable" administrative burden. n166 Requiring consent as a precursor to data use would preclude health plans from using information in their databases to identify individuals who could be at risk, thereby preventing the plans from offering the disease management programs to at risk individuals. n167 Further, if patients are given the right to decide who may use their data for purposes of medical and health policy research, researchers studying diseases that first afflict or disproportionately afflict a vulnerable population may find fewer individuals willing to supply their data than would those researchers studying illnesses afflicting a broader population. n168 Requiring consent for each use of medical records will result in biased studies, thus delaying if not foreclosing the possibility of research and disease detection as well as possible cures or treatments.

PRIVACY CONSENT REQUIREMENTS THREATEN MEDICAL RESEARCH -- CANCR IS AN EXAMPLE

Sharon Schmickle, Star Tribune (Minneapolis, MN) February 10, 1999, SECTION: Pg. 1A TITLE: A challenge to privacy// acs-EE2001

Mayo's Jenkins, for example, is looking into genetic explanations for the fact that some patients with certain types of brain tumors respond to chemotherapy while others do not. Scientists have discovered in the past decade that patients with specific genetic alterations on two chromosomes have a type of brain tumor that can be successfully treated.

A short-term goal of the research is to help doctors identify which patients could benefit from chemotherapy. Ultimately, the studies could shed light on a fundamental question in cancer research: Why are certain genes involved with certain tumors?

One phase of the research involves comparing genetic analysis of each stored tumor sample with the corresponding record showing a patient's age, sex, symptoms and response to therapies.

Jenkins worries that his work could be set back if the government decides to step up requirements for consent from patients or their families. Many patients in the cancer studies were treated years ago and may no longer be alive, he said, and tracking down next of kin to get their consent could significantly slow the research.

Other scientists add that seeking consent from patients who have long since left hospitals would be expensive, draining money from research.

PERMISSION RULES FOR MEDICAL RECORDS MUST NOT BE ALLOWED TO INHIBIT RESEARCH

Phil Porter, The Columbus Dispatch, July 12, 1999, SECTION: NEWS , Pg. 4B TITLE: MEDICAL ID SYSTEM DEBATED ISSUE COMES DOWN TO PRIVACY RIGHTS VS. HEALTH BENEFITS // acs-EE2001

Shortliffe said a patient's permission should be required for others to use medical files, but the rule cannot be so inflexible that it inhibits existing medical research or prohibits emergency-room doctors from overriding patients' wishes in life-threatening situations.

PRIVACY AND SECRECY CONCERNS STOP RESEARCHERS FROM WARNING PEOPLE ABOUT MEDICAL SIDE EFFECTS

ROBERT LEE HOTZ, Los Angeles Times, May 18, 1999, SECTION: Part A; Page 1; TITLE: SECRECY IS OFTEN THE PRICE OF MEDICAL RESEARCH FUNDING// acs-EE2001

When Dr. Nancy Olivieri at the University of Toronto wanted to warn patients about toxic side effects of a drug she was testing, the company supporting her research tried to quash her findings, citing a nondisclosure agreement.

When she alerted her patients anyway, the company suspended the clinical trial and canceled her research contract. Even so, she published her misgivings in the New England Journal of Medicine. The Hospital for Sick Children, where she worked, sided with the company and dismissed her, triggering an international protest earlier this year.

Only after sustained pressure by faculty groups and leading health experts was she reinstated.

"I will never ever again accept drug company money that is not clearly and completely free of any secrecy clauses whatsoever," Olivieri said.

DRUG INDUSTRY NEEDS INFORMATION FOR RESEARCH PRIVACY RULES WOULD CONTROL

Modern Healthcare, April 10, 2000, SECTION: Pg. 70 TITLE: Unnecessarily complex // acs-EE2001

The privacy rules are a cause for concern to the pharmaceutical research and development industry, since data from clinical trials are essential to the industry's work.

RESTRICTIONS ON GENETIC INFORMATION MAY HARM BIOTECH ADVANCES

The Boston Globe, June 6, 1999, SECTION: EDITORIAL PAGE; Pg. G6, TITLE: Genetic privacy // acs-VT2001

A strong life insurance lobby opposed to restrictions on the use of genetic information, as well as concerns from the biotech industry that such laws might squelch research, have stalled action on Beacon Hill.