Children in Hot Demand – AHRP Infomail, May 31, 2002

Children in "Hot Demand" for Clinical Trials

May 31, 2002

FYI

Rachel Zimmerman of The Wall Street Journal reports about the "frenzy" to recruit children for drug trials. The inclusion of children in drug trials allows pharmaceutical companies to cash in on six month patent exclusivity extensions worth hundreds of millions of dollars.

Zimmerman reports,  "Pharmaceutical companies are even hiring specialists attuned to the psychology of persuading parents and kids… "To lure young patients, some trials are offering cash, gift certificates to Toys R Us and Tower records, T-shirts, and use of a Palm Pilot during the study" and cash payments to doctors who refer child patients. The Alliance for Human Research Protection questions the motivation of doctors who refer children for drug trials.

The mother of a 14 year old child who died in a clinical trial, is quoted saying: "I feel like we were cheated, placed on a trial more for their sake then my daughter’s."

What has yet to be discosed is how many other children who might have otherwise lived–died in clinical trials?

What the WSJ doesn’t address is the complicity by government agency officials whose mission is to protect the public interest. The FDA, the National Institutes of Health, and the Office of Human Research Protection are systematically eroding regulatory protections that until now shielded children from experiments not in their best interest.

These agencies, with the endorsement of their advisory panels, are in the process of redefining federal regulations, essentially adopting new policies/ guidelines that pose a threat to the health and welfare of children–some as young as infants . These new guidelines have given the biomedical research community the green light to recruit helpless children for experiments that cause them pain and put them at risk of harm–not for their benefit but for the benefit of those who profit from research.
Children are being recruited for experiments whose risks are not justified.

What we are witnessing is corporate sponsored, government endorsed child abuse.

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THE WALL STREET JOURNAL
May 29, 2002

Trials of Pediatric DrugsSeek More Young Subjects

By RACHEL ZIMMERMAN
Staff Reporter of THE WALL STREET JOURNAL

A shortage of children needed to test the safety and effectiveness of pediatric medicines is forcing researchers and pediatricians to step up recruiting of teenagers, elementary-school kids and even newborns.

"If you have a hypertensive kid, hold on to him. He’ll be in hot demand," says Robert Temple, associate director for medical policy at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, who describes the current recruiting efforts as a "frenzy."

There are currently 194 medicines and vaccines in development for children, according to the Pharmaceutical Research and Manufacturers of America, a trade organization. Last year, nearly 60,000 children took part in trials to evaluate new medicines and study drugs already on the market for everything from cancer to allergies.

But researchers say they need far more participants. Speaking at a recent conference on the subject, Kathleen Drennan of Patient Quest, a Chicago-based agency that recruits patients for clinical trials , noted that over 50% of "our studies are in crisis mode due to failed patient recruitment efforts."

WHAT YOU SHOULD ASK

The informed consent document parents must sign before enrolling their child in a medical study may not be the only information they need to decide whether to participate. Here are some other questions.

1. Can I take my child out of the study if I change my mind?

2. Is this person who will be treating my child experienced in working with children?

3. Will my child still be able to take his or her regular medications and see our regular pediatrician?

4. Will any procedures be painful or scary for my child? Can I stay with my child during procedures or tests?

5. Is there a chance my child will receive a placebo?

6. How will my child’s daily life be affected? Will he or she have to miss school?

7. Are the expenses covered by the sponsor?

8. Will my child’s identity be safe? Will my child’s medical records be confidential?

9. What other treatment or prevention options are available?
  
The problem is raising complex ethical questions about how to attract more kids and how to make sure those who do sign up understand what they’re getting into. To lure young patients, some trials are offering cash, gift certificates to Toys R Us and Tower records, T-shirts, and use of a Palm Pilot during the study. At the same time, some people are questioning some doctors’ motivation in referring child patients to trials.

Pharmaceutical companies are even hiring specialists attuned to the psychology of persuading parents and kids, just as they do adult patients. One observation: It’s easier to recruit for a pediatric anxiety trial than a pediatric depression trial, says Molly Matthews, president and chief executive of Matthews Media Group, because "anxious children generally have anxious parents," who are often hypermotivated to get help for their kids.

For parents, the first rule is to be skeptical and ask questions. Parents should always find out the exact purpose of the study, who is sponsoring it and if they can withdraw. It’s also important to know the chances of receiving a placebo and if the person who will treat the child during the study is experienced in working with kids.

Pediatric testing of drugs is relatively new. Before 1997, doctors assumed children’s bodies responded to drugs as if they were tiny adults and simply cut the dosage in half for young patients. But in the early 1990s, AIDS activists and others started to demand that new medicines be tested on kids. In 1997 a federal law was enacted giving drug companies profitable extensions of their exclusive marketing rights for medicines in exchange for studying those medicines in children. As a result, blockbuster drugs like Eli Lilly & Co.’s Prozac and Schering-Plough’s Claritin were given an extra six months without generic competition after their makers studied them in kids.

Informed Consent

Clinical researchers are required by federal regulators to disclose all important aspects of a trial — including potential side effects and other risks — so that the parents can give informed consent. Many institutions also voluntarily require a child’s "assent" to participate. The assent forms use ultrasimplified language, such as one from a study for obsessive compulsive disorder at the Children’s National Medical Center in Washington, which warns: "Sometimes medicines make people feel uncomfortable, these uncomfortable feelings are called side effects." Some possible side effects, according to the form: "problems urinating [peeing] or blurry vision [cannot see very well]."

Still, some families feel unduly pressured, especially when their child is gravely ill. Two summers ago, 14-year-old Liz Marksteiner was diagnosed with non-Hodgkins lymphoma after returning from horseback riding camp. A doctor told the shocked family that the teenager’s best hope was entering a clinical trial testing the efficacy of chemotherapy using eight different drugs in new combinations and with more intense frequency. Liz’s mother, Cathy, says the doctor didn’t discuss alternative therapies, or point the family toward the current literature so they could review the options themselves.

Cynthia DeLaat, a pediatric hematologist and oncologist at Children’s Hospital Medical Center in Cincinnati, says one reason Liz was directed into the clinical trial was that there was no "standard" of care for her particularly rare form of cancer. The family "was presented with the best information we had at the time," Dr. DeLaat says. Ms. Marksteiner says: "I feel like we were cheated, placed on a trial more for their sake then my daughter’s."

Liz’s cancer went into remission for seven months. Then it returned. After a battery of more treatment, including an experimental stem-cell transplant, Liz died on Jan. 3. She was 16.

Weighing risk is always a dilemma for patients considering a clinical trial , but the concerns are magnified, of course, when the patient is a child. The Office of Human Research Protection has asked a federal advisory committee for a clearer definition of "minimal risk," one of the standards for pediatric trials. But Greg Koski, director of the office, wonders: "How do we index this? For an adolescent in a gang, minimal risk is different than a child growing up in the suburbs. Or, for that matter, the ‘normal life’ of a child undergoing chemotherapy for leukemia is different than that of a normal, healthy child."

Another cause for concern is the motivation of some doctors in steering patients into trials and conducting them in general. While it’s illegal to pay physicians cash "bounties" for recruiting children, some researchers are rewarded in other ways. David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital/Partners HealthCare System, surveyed academic researchers at top medical institutes and found many "markers of potential conflicts of interest" in clinical research generally. Over the past three years, 79% of clinical researchers surveyed received compensation in the form of research fees, equity or consulting payments from the drug industry. Moreover, 43% of clinical researchers received "free gifts," such as cash bonuses and medical equipment, beyond the payment for their research. The "gifts" sometimes have strings attached; 32% of those surveyed, for example, said the quid pro quo was pre-publication review of data.

Free Medicine

For parents of sick children, one of biggest attractions of clinical trials is the prospect of free drugs and medical care. Linda Reiff’s son, Jacob, refused to wear coats made of certain materials, had no friends and spent much time under his bed. He wore his underwear backwards and his socks had to be upside down. "I was desperate," Ms. Reiff said.

Adelaide Robb, a specialist in children’s psychiatric disorders who conducts many industry trials, diagnosed Jacob with obsessive compulsive disorder. Within weeks, Jacob, then seven years old, enrolled in a pediatric trial of Prozac. Once he started on the medicine, his symptoms eased almost immediately. The prospect of intense medical supervision and free drugs thrilled Ms. Reiff.

Children, of course, often are motivated to participate in a trial for different reasons. Lara Knause, a 17-year-old smoker, said the $240 she received to participate in a two-day study of nicotine gum was a big motivator. "It was, like, cool, I’ll get paid to stop smoking," she says.

The study wasn’t quite as effortless as she’d imagined. The IV hurt. Her roommate at the hospital cried all night. And she had to refrain from caffeine, chocolate and cigarettes before the study began. But the discomfort was mitigated by the hospital’s surprisingly uninstitutional dining selections: all-you-can-eat chili and other fast food delivered right to the hospital bed.

Write to Rachel Zimmerman at <mailto:rachel.zimmerman@wsj.com>rachel.zimmerman@wsj.com

       
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