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HEALTH RISK BY DESIGN

IS THIS MURDER BY LEGISTATION? YOU HAVE NO CHOICE THEY DECIDE. NEW BILL MAKES IT OK FOR YOUR DOCTOR TO DENY MEDICALS IF YOUR LISTED AS TERMINALLY ILL? - TAKING AWAY MORE OF PATIENT RIGHTS. THESE ARTICLES ARE RIGHT OUT OF THE LOS ANGELES TIMES CLICK HERE TO GO TO THE PAPER Court denies test drugs to dying patients
Terminally ill people do not have the right to get unapproved, potentially lifesaving treatments, an appeals panel rules.
By David G. Savage, Los Angeles Times Staff Writer
August 8, 2007

WASHINGTON -- People who are dying do not have the right to obtain unapproved drugs that are potentially lifesaving, even if their doctors say the treatment offers their best hope for survival, a U.S. appeals court here ruled Tuesday.

In an 8-2 decision, the court said federal drug regulators were entrusted by law with deciding when new drugs were safe for wide use.

The families of terminally ill patients, several of whom died after they were denied promising drugs that were still in tests, filed suit. They said that patients who were dying were far more willing to take risks and argued that they should not be forced to wait years for new treatments to win final approval from the Food and Drug Administration.

The judges said the families should take their pleas to Congress, not the courts.

However, the two dissenters said the ruling ignored the Constitution's protection for individuals and their right to life, and instead bowed to "a dangerous brand of paternalism" that put the government's interest first.

Leaders of the Abigail Alliance for Better Access to Developmental Drugs said they would appeal to the Supreme Court. The group was named in honor of Abigail Burroughs, a 21-year-old University of Virginia student who died of cancer in 2001. Her father, Frank, said she was denied the use of two investigational anti-cancer drugs that were recommended by her oncologist. These drugs later received FDA approval.

"We are talking about terminally ill patients and about drugs that were shown to work in earlier trials," said alliance co-founder Steve Walker, a St. Petersburg, Fla., geologist whose wife died of colon cancer.

In 2003, the alliance petitioned the FDA, urging it to change its rules so that drug companies could make available to dying patients "investigational drugs" that had won preliminary approval. There is a "different risk-benefit trade-off facing patients who are terminally ill and have no other treatment options," it said.

The FDA turned away the plea, saying it needed "to maintain a strong clinical trial system" to gather evidence before approving drugs for general use.

With the aid of the Washington Legal Foundation, a conservative nonprofit, the alliance sued the FDA. It said the Constitution should be read to "embrace the right of a terminally ill patient with no remaining approved treatment options to decide, in consultation with his or her own doctor . . . to seek access to investigational medications that the FDA concedes are safe and promising enough for substantial human testing."

The case touched on issues that had been debated fiercely in medical and legal circles.

Medical experts have long disagreed on whether the FDA moves too slowly or too quickly in approving new drugs. Some doctors have argued that clinical trials should be opened to more patients who might benefit from the new treatments.

And since the Roe vs. Wade ruling in 1973 that set out the right to abortion, many legal scholars have frowned on judges creating "new rights" from vague clauses in the Constitution. The suit over new drugs focused on the 5th Amendment, which says "no person shall be . . . deprived of life, liberty or property, without due process of law."

In 2004, a federal judge rejected the alliance's suit, saying there was "no constitutional right of access to unapproved drugs."

Last year, however, a three-judge panel of the U.S. appeals court sided with the group.

In a 2-1 decision, it said a "terminally ill, mentally competent adult patient" had a right to "potentially lifesaving investigational new drugs" which had been found to be safe for humans.

But before that decision could take effect, the full U.S. Court of Appeals for the District of Columbia voted to rehear the case. And Tuesday, it reversed its panel's ruling.

"We conclude there is no fundamental right 'deeply rooted in this nation's history and tradition' of access to experimental drugs for the terminally ill," said Judge Thomas B. Griffith, a Bush appointee, citing a Supreme Court decision that rejected the notion of a constitutional right to die. Griffith's opinion was joined by conservative and liberal members of the appeals court.

The two dissenters were Judge Judith W. Rogers, a Clinton appointee, and Chief Judge Douglas H. Ginsburg, a Reagan appointee.

"In the end, it is startling," Rogers wrote, that the Constitution has been read to include unnamed "fundamental rights" to marry, to control a child's education, to have sex in private and to have an abortion, "but the right to save one's life is left out."

Julie Zawisza, an FDA spokeswoman, said the agency was pleased with the ruling because it upheld the agency's "role in facilitating appropriate treatment access to investigational therapies while at the same time protecting the public at large by requiring that drugs are proven to be safe and effective before they may be marketed to U.S. consumers."

She also said that "on a limited basis," some patients and their doctors were permitted to obtain new drugs that were in clinical trials.

david.savage@latimes.com


Acid inhibitors may raise dementia risk
A study of elderly blacks indicates that those who are chronic users are more likely to develop the disease. The drugs inhibit a chemical involved in memory.

By Thomas H. Maugh II, Times Staff Writer

August 4, 2007


Elderly African Americans who are chronic users of acidinhibiting medications in the family that includes Zantac, Pepcid and Tagamet have 2 1/2 times the normal risk of developing dementia, Indiana researchers reported Friday.

The drugs block production of stomach acid by inhibiting so-called histamine-2 receptors; a pump in the stomach releases hydrochloric acid when stimulated by histamines.

But they also inhibit the brain's cholinergic system, which is involved in memory and cognition. Low levels of cholinergic activity have previously been linked to dementia.

There have been hints that the drugs, known as histamine-2 receptor antagonists, might be linked to dementia, but previous studies have come down on both sides of the question, said Dr. John Morris of Washington University in St. Louis, who was not involved in the study.

"This is certainly not the final word on the potential risk of these drugs," he said. "But what it tells us is that, for older adults, drug use should be considered very carefully."

Dr. Constantine G. Lyketsos, a psychiatrist at Johns Hopkins University, who was also not involved in the study, said: "This is one of the medicines we worry about when people with Alzheimer's are taking them. It can make memory worse and lead to confusion. Whether they will make it more likely that someone will develop Alzheimer's or dementia is still an open question."

GlaxoSmithKline, which manufactures Tagamet and Zantac, did not return calls seeking comment.

The study did not look at other races, and there was not enough data to suggest a risk from a different family of acidinhibiting drugs called proton pump inhibitors, which includes Prilosec, Nexium and Prevacid.

The histamine-2 receptor antagonists are among the most commonly prescribed medications in the United States, with more than 16 million prescriptions dispensed in 2005 in addition to over-the-counter sales. They are used to treat ulcers, acid reflux and other gastrointestinal disorders.Breast implants linked to suicide risk BREAST IMPLANTS AND SUCIDE
A report says that women who have had the increasingly popular surgery are three times more likely to kill themselves later.
By Denise Gellene, Los Angeles Times Staff Writer
August 8, 2007


Women who receive implants for breast enhancement are three times more likely to commit suicide, according to a new report that offered a sobering view of an increasingly popular surgery.

Deaths related to mental disorders, including alcohol or drug dependence, also were three times higher among women who had the cosmetic procedure, researchers said.

The report in the Annals of Plastic Surgery's August issue was the most recent to detect a higher suicide rate among women who had their breasts enlarged, providing a gloomy counterpoint to studies that showed women felt better about themselves after getting implants.

Though the study did not look at the reasons behind the suicides, senior author Joseph McLaughlin, a professor of medicine at the Vanderbilt University School of Medicine, said he believed that many had psychological problems before getting implants and that their conditions did not improve afterward.

Previous studies have shown that as many as 15% of plastic surgery patients have body dysmorphic disorder, a condition marked by severe distress over minor physical flaws. People with the disorder have a higher rate of suicidal thoughts and rarely improve after surgery.

Breast augmentation is the most popular cosmetic surgery in the U.S., followed by liposuction and eyelid surgery. Last year, 329,396 enlargements were performed, up 13% from 2005, according to the American Society of Plastic Surgeons.

Controversy has long dogged the surgery. Last year, the Food and Drug Administration lifted a 14-year ban on silicone-filled implants after finding little evidence they were unsafe. But the agency required manufacturers to run 10-year studies of 10,000 women each to look for long-term consequences, including possible suicides.

The latest study analyzed data from 3,527 Swedish women who got implants between 1965 and 1993. Breast cancer patients who received reconstructive implants were not included.

Scientists tracked the women for as long as 29 years after their implant surgeries and found the suicide risk increased over time. There was no higher risk in the first 10 years afterward, they said, but the risk was 4.5 times higher after 10 to 19 years and six times higher after 20 years.

David B. Sarwer, a University of Pennsylvania psychologist who wrote a commentary accompanying the report, said the results suggested that women experienced psychological improvement after surgery, but that it was not sustained.

Researchers said the results may have limited applicability to women today because breast augmentation is more acceptable than it was 40 years ago.

McLaughlin said the study underscored the need for the psychological screening of women seeking breast enhancement.

Allergan Inc. of Irvine, manufacturer of Inamed brand implants, "is a big advocate" of counseling beforehand, spokeswoman Caroline VanHove said.

She said women should have realistic ideas of how the procedure would change their lives.

denise.gellene@latimes.com




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