Entries in Trial (7)


After YouTube Plea, Dying Mom Clears Hurdles to Start Trial Drug

John Foxx/Stockbyte/Thinkstock(TAMPA BAY, Fla.) -- A mother dying of breast cancer and desperate to get a drug that has yet to be approved by the U.S. Food and Drug Administration appears to have cleared her final hurdle and expects to get her first dose on Friday.

Darlene Gant, 46, of Tampa Bay, Fla., had posted a video plea on YouTube in a campaign to get access to the trial drug, known as pertuzumab, under compassionate use.

The FDA is expected to approve pertuzumab, developed by Genentech, on June 8.  But Gant doesn't expect to live that long.

"In the meantime, no one is eligible for compassionate use, including me, so, although I don't put everything into pertuzumab, it could stabilize me and help save my life and extend my time here on the earth with my 11-year-old son and my family," Gant said in the video.

Gant had won over the FDA and Genentech -- but still faced obstacles involving the Moffitt Cancer Center's Institutional Review Board.

But now, Moffitt's IRB has decided to allow her to start treatment on Friday at cancer center in Tampa, Fla.

The first step will be a large "loading dose" and Gant will be monitored closely in the days ahead for reactions such as rash, breathing difficulties and potential heart issues, she said.  The drug also poses a danger to her liver.

But the potential side effects pale in comparison to Gant's prognosis without the drug.

In the self-made video, Gant lay in her bed, too weak to sit up.  She held a letter to her son.  Beside her were several others: a letter for her son's 12th birthday, two more for his high school and college graduations, another for his wedding day.  Gant was writing the letters because she didn't believe she'd be around for the milestones.

Copyright 2012 ABC News Radio


Trials Show Improved Outcome in Metastatic Breast Cancer Patients

Comstock/Thinkstock(SAN ANTONIO) -- Two trials presented Wednesday at the San Antonio Breast Cancer Symposium may offer some relief for breast cancer patients undergoing treatments and surgeries.  Both were shown to improve "progression-free survival," a term experts use to measure the length of time during and after medication that the cancer does not get worse.

In the BOLERO-2 trial (Breast Cancer Trials of Oral Everolimus), lead study author Dr. Gabriel Hortobagyi, professor and chairman of MD Anderson's Department of Breast Medical Oncology, said the findings demonstrated for the first time that the combination therapies are more effective than a single hormonal treatment in patients who have already tried hormonal therapy.

"Over the years, our treatment approach for such women with metastatic breast cancer has been sequential use of as many hormone therapies as possible, keeping metastatic disease under control for as long as possible," Hortobagyi said. "These findings may allow us to change our approach.  In this group of heavily pre-treated patients, all of whom progressed on prior endocrine therapy, the addition of this mTOR inhibitor resulted in significant prolongation of progression-free survival and an improved response rate, with only a modest addition of toxicity."

Researchers enrolled 724 metastatic breast cancer patients into the international phase 3 trial. Study participants were post-menopausal and most had been treated with extensive hormone therapy treatments.  Patients were randomized, then 485 received a combination of everolimus (a medication that stops cancer cells from reproducing by decreasing blood supply to the cancer cells) and exemestane (a medication that decreases estrogen in the body).  Those patients were then compared to the 239 participants who received exemestane and a placebo.

Participants who received the combination therapy experienced 7.4 months of progression-free survival, compared to the 3.2 months that patients experienced on the placebo.

The trial was partially funded by pharmaceutical giant, Novartis.  Hortobagyi acts as a consultant and receives research fund from the company, as well.

In a similar, second study presented at the symposium, researchers of the CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) trial found that adding pertuzumab (a medication that is believed to slow tumor growth) and certain chemotherapies lengthened progression-free survival by an average 6.1 months in patients with metastatic breast cancer patients.

"This is huge," Dr. Jose Baselga, lead author of the study and professor of medicine at Harvard Medical School," said in a statement.  "It is very uncommon to have a clinical trial show this level of improvement in PFS. ...The fact that we now have an agent that can be added to current treatment to delay progression is very exciting."

While Dr. Vered Stearns, co-director of the Breast Cancer Program at Johns Hopkins, said the results of both trials could be game changers for treatment of metastatic breast cancer patients, progression free survival is a complicated point of treatment.

"The breast cancer community, government agencies and stakeholders should be evaluating what endpoints are most relevant and set proper guidelines," said Stearns.

Copyright 2011 ABC News Radio


Murray Trial: Jackson Suffered from Demerol Withdrawal, Lawyers Argue

PRNewsFoto(LOS ANGELES) -- Lawyers for Dr. Conrad Murray said in opening arguments this week that he was trying to wean Michael Jackson off propofol, the powerful sedative the defense says Jackson gave himself the night he died.

They allege Jackson wanted propofol because he was suffering from insomnia brought on by withdrawal from the painkiller Demerol.

Murray's attorneys plan to call an addiction specialist, Dr. Robert Waldman, co-medical director of the Recovery Unit at Daniel Freeman Marina Hospital in Marina del Rey, Calif., to testify about the singer's addiction.

"And what he's going to tell you is that Michael Jackson was suffering from the Demerol withdrawal, that his insomnia was as a result -- partly, at least as a result," attorney Ed Chernoff said during the opening statement. Chernoff also told the court Jackson received Demerol three to four times a week from a dermatologist, Dr. Arnold Klein, but Murray knew nothing about these regular doses of Demerol. Klein didn't respond to ABC News' request for comment on the defense's allegations.

Jackson told Murray his insomnia was caused by his creative mind always racing, but it was also the Demerol, Chernoff said.

Medical experts say there are numerous symptoms associated with Demerol withdrawal, and insomnia is one of them.

"Withdrawal is very much like suffering from the flu. You can get nausea, diarrhea, vomiting, chills, tremors, a nervous or anxious feeling and insomnia," said Dr. Michael Schmitz, professor of anesthesiology at the University of Arkansas for Medical Sciences/College of Medicine.

Chronic use of Demerol generally causes sleepiness, but not everyone experiences that effect.

"There is a sub-population that reports insomnia," said Dr. Keith Candiotti, professor of anesthesiology and internal medicine at the University of Miami Miller School of Medicine. "Probably people who are chronically on drugs would be less susceptible to sedation."

Some experts say there are a number of medications that help alleviate withdrawal symptoms, including propofol, although others argue propofol should never be used for that reason.

"Propofol and benzodiazepines have been used for managing withdrawal, but primarily in intensive care units," said Schmitz. "That's not something that would have been done at home." Benzodiazepines are medications that treat conditions such as anxiety and insomnia.

"Propofol is an intravenous anesthetic, not to be used to treat Michael Jackson's addiction to Demerol or the withdrawal he may have had," said Bruce Goldberger, professor and director of toxicology at the University of Florida in Gainesville.

Murray told police he gave Jackson only a small dose of propofol, but the defense said Jackson administered the fatal dose himself. Chernoff also said that Murray felt it was his duty to wean Jackson off the propofol and teach him to sleep naturally.

Criminal defense attorney Mark Geragos, who is not involved in Murray's trial, said Chernoff's Demerol argument is central to the defense.

"I think it's essential," Geragos said. "My interpretation of his arguments is that Jackson may have become increasingly anxious to fall asleep." His growing restlessness, Geragos added, could have led him to self-medicate.

Copyright 2011 ABC News Radio


Michael Jackson's Death: What Is Propofol?

ABC News(LOS ANGELES) -- The trial of Conrad Murray, the doctor accused of giving Michael Jackson a lethal dose of propofol, has landed the powerful sedative in the spotlight.

Jackson reportedly used the drug, which he called his "milk," as a sleep aid. Murray administered the drug the day Jackson died.

But defense lawyers are expected to argue that Jackson gave himself an extra dose of propofol when Murray left the room. A trace amount of the drug, typically injected intravenously, was found in the King of Pop's stomach.

What Is Propofol? 
Propofol is a sedative that is usually administered to patients who are undergoing surgery or another medical procedure. It is a fast-acting drug, with most patients receiving it losing consciousness within a matter of seconds.

The potency of propofol as an anesthetic is so widely known that in anesthesiology circles, the drug, a white liquid, is nicknamed "milk of amnesia."

While propofol is most often used to sedate patients before a medical procedure, it is also one that palliative care workers have been known to administer to terminal patients who are in pain or who have weeks or days to live.

What Are the Dangers of Propofol?  Propofol is widely known as a risky drug, and it is generally administered only in a controlled medical setting due to the dangers it poses.

"Propofol is an agent that requires very close monitoring and is often limited only to use by anesthesiologists," said Dr. Richard Page, head of cardiology at the University of Washington Medical Center. "The main issue with this agent is respiratory depression, which in turn could cause cardiac arrest."

"It is a very dangerous drug," said Dr. Brian Olshansky, a cardiologist at the University of Iowa who said he often uses the drug to place patients in deep sedation for certain heart procedures. "It is not for sleep. I cannot imagine anyone would use this outside a very regulated environment such as the availability of emergency respiratory equipment."

One main reason for this, he said, is the speed with which the drug has its effect.

"It rapidly induces unconsciousness and apnea," Olshansky said. "People stop breathing within seconds of being given the drug."

Why Would Anyone Abuse Propofol?  The rapid effect of the drug makes it an exceedingly unusual choice for abuse, said Dr. Jeff Guy of Vanderbilt University, who said such a situation would represent "a quantum leap in the issue of substance abuse."

But despite the effects and risk profile of the drug, some patients who've had the drug describe it as inducing "a very pleasant sleep" that "has the potential to be habit-forming," said Dr. Howard Nearman, chairman of the anesthesiology department at University Hospitals Case Medical Center in Cleveland.

And Dr. Bruce Goldberger, chief of forensic pathology at the University of Florida, noted that the drug "also acts as an aphrodisiac in men -- it has been reported that men have very vivid sexual dreams while under propofol anesthesia."

Copyright 2011 ABC News Radio


Trial Begins in Amputated Penis Case

Comstock/Thinkstock(SHELBY COUNTY, Ky.) -- Phillip Seaton went to the hospital in October 2007 for a routine circumcision to treat inflammation but left the operating room without a penis.

Seaton sued his surgeon, Dr. John Patterson, for removing his penis without his permission, and the trial got under way Monday in Shelby County (Kentucky) Circuit Court. Seaton and his wife, Deborah, seek damages for "loss of service, love and affection."

Patterson said he found cancer while performing the routine circumcision, and Patterson's defense attorney, Clay Robinson, said the surgeon had no other options but to remove the penis immediately, according to court documents.

Judge Charles Hickman instructed both lawyers to refrain from commenting on the case because it is ongoing.

Despite the alleged seriousness of Seaton's penile cancer, experts contacted by ABC News said that the doctor needed consent from the patient before surgically removing his sex organ.

"I think the doctor made a big mistake, and will not win the case," said Dr. David Crawford, a professor of surgery at the University of Colorado Health Sciences Center.

Partial penectomy, or a partial removal of the penis, Mohs surgery, a precise surgery used to remove several types of skin cancer, laser and radiation therapies were all options when treating penile cancer, said Crawford.

Because the surgeon had said the cancer was so severe, Robinson told the courtroom that Patterson could treat it only by surgically removing the organ.

Nevertheless, "a surgical consent is needed to do this," said Dr. Glenn Bubley, associate professor of medicine at Harvard Medical School. "This is the standard of care. There would be no reason to breach standard of care in this case."

Seaton also sued Louisville's Jewish Hospital, where the surgery was performed. The hospital settled out of court for an undisclosed amount.

Copyright 2011 ABC News Radio


Oregon Baby May Go Blind Because of Faith-Healing Parents

George Doyle/Thinkstock(OREGON, CITY, Ore.) -- Oregon doctors have said that Alayna Wyland, an 18-month-old with a massive growth covering her left eye, may go blind because her parents refused to get her medical treatment on religious grounds.

On Thursday, jury selection continues in the trial of Timothy and Rebecca Wyland, who have been charged with first-degree criminal mistreatment of their child, only days after the state House passed a bill to be tougher on faith-healing parents.

The Wylands, who are 43 and 22, respectively, and are members of the Followers of Christ Church, told authorities they believed that prayer and anointing oils would heal their daughter's hemangioma, an abnormal growth of blood vessels that was occluding her vision.

In the past two years, Oregon's Clackamas County has prosecuted two other couples from the same church whose children died from untreated ailments.  One, Jeff and Marci Beagley, were convicted of criminally negligent homicide last year and sentenced to 16 months in prison after their 16-year-old son, Neil, died of complications from an untreated urinary tract blockage.

About 300 children die a year at the expense of their parents' religious beliefs, according to the Iowa-based organization, Children's Healthcare is Legal Duty, a group that advocates for tough penalties against those who seek exemption from child abuse laws.

Under Oregon law, parents have a "legal duty" to provide care for their children, and those who "knowingly withhold physical care or medical attention," can be prosecuted, according to Michael Regan, senior deputy district attorney in Clackamas County.

Child welfare officials reported the Wylands, who said they would not seek medical care for their daughter unless it was court-ordered, according to Regan.  The baby was taken into state custody last July and has been treated with medication.  It is not clear if vision will ever develop in that eye, he said.

If the Oregon House follows the Senate's action earlier this week, religious beliefs "would not be a defense for harm to a child for any crime," according to Regan of the district attorney's office.

Copyright 2011 ABC News Radio


Hungry Judges More Likely to Withhold Parole

Brand X Pictures/Thinkstock(NEW YORK) -- The United States judicial system is ostensibly built on laws and hard facts. But new research lends weight to the trope that "justice is what the judge ate for breakfast."

A judge's willingness to grant a prisoner parole wanes with time after a lunch or snack break, according to an observational study.

Researchers from Columbia University in New York City and Ben Gurion University of the Negev in Beer Sheva, Israel, analyzed more than 1,000 parole decisions made during 50 days by eight experienced judges in Israel. The proportion of favorable rulings fell from about 65 percent to nearly zero during each session separated by the two food breaks, leaping back to 65 percent immediately after the breaks.

The findings, published in the Proceedings of the National Academy of Science, suggest that prisoners whose cases were heard at the start of the day or soon after a break have an advantage over other prisoners, and that the rule- and fact-based judicial system is biased.

"It shows that experts are subject to psychological factors in their decisions just like anyone else," said study author Jonathan Levav, associate professor of business at Columbia Business School. "Judicial decision making is no different than human decision making. Judges are people."

Copyright 2011 ABC News Radio

ABC News Radio