Amazing results for drug seem too amazing

By: E'LOUISE ONDASH - For the North County Times | Saturday, February 16, 2008 7:43 PM PST

The headline a couple of weeks ago was an eye-catcher: "Enbrel works fast against Alzheimer's disease."

And the story was just as intriguing.

A Los Angeles physician had administered injections of etanercept (brand name Enbrel, a drug used to treat arthritis, psoriasis and other conditions) to a man with Alzheimer's disease. According to his wife, who spoke on a

video available on the Internet, the injection "put him back to where he was before" ---- and the change took place within minutes.

Pretty exciting stuff, but too good to be true?

The Alzheimer Research Forum thought so and wanted to know more. This free Web site does in-depth investigations and reports on Alzheimer's disease. In this case, its reporters found there were many facts about the

story that went unreported. Among them:

  • The study or experiment was published in the Journal of Neuroinflammation, an "open-access" journal, which means one needn't have a subscription and that it sometimes charges contributors.

  • The study was not reviewed by other scientists.

  • The subject of the experimental treatment was charged by the physician. The 81-year-old retired doctor received weekly injections of etanercept for five weeks. The drug binds and neutralizes tumor necrosis factor, which scientists hypothesize may interfere with transmission of nerve impulses in the brain in people with Alzheimer's disease.

  • Critics downplay the study because it was not a randomized, placebo-controlled, double-blind study.

  • Critics say this off-label use of etanercept should not be promoted to the public when it hasn't been tested properly.

  • The drug was injected in the area of the cervical vertebrae (back of the neck), but not in the canal where the cerebral spinal fluid flows. Some critics say this may not be the best way to administer the drug, because it may not reach the brain. This method also may cause blood vessels in the area of the injection to rupture.

    And lastly, one can't help but wonder about Dr. Edward Tobinick, the Los Angeles physician who is promoting this experimental treatment. He is a board-certified dermatologist and internist who specializes in laser hair removal. According to the Web site, he owns stock in Amgen, the company that makes etanercept, and "holds numerous patents on delivery methods of etanercept for neurological conditions."

    Tobinick also is on probation for one year, according to the Medical Board of California. In its quarterly newsletter, the board says he is being disciplined for advertising another treatment for back pain for which there are no studies proving effectiveness. If he is to keep his license, Tobinick must complete courses on prescribing and ethics, and his practice must be monitored. Intense interest in this story is understandable. There are about 5 million people with Alzheimer's disease, and in 40 years, that number may be 16 million. Some predict that by 2030, Medicare spending on those with Alzheimer's could be nearly $400 billion.

    When baby boomers are surveyed, they list developing Alzheimer's disease as their top fear as they grow older.

    We've heard for the last several years that the incidence of heart disease has decreased since the mid-1960s, but a study at the Mayo Clinic in Rochester, Minn., may signal that this trend has come to an end and may be reversing.

    The researchers examined death certificate data and autopsy reports of Olmstead County, Minn., residents who died between 1981 and 2004. They were between 16 and 64 years old. (Extensive medical records have been

    kept for years by the Mayo Clinic and the Rochester Epidemiology Project, and researchers say these records are "reliable snapshots of national disease trends.") The cause of death of all the subjects was "non-natural causes," for which the autopsy rate is high.

    About four out of five of the 515 deceased had some degree of atherosclerosis (plaque in the arteries), and 80 percent of this group showed signs of coronary artery disease. Just over 8 percent had a high level of the disease.

    Whether this rise in heart disease is connected with the concurrent increased incidence of obesity and diabetes is something researchers say they will have to study further.

    E'Louise Ondash of Vista is a registered nurse. Contact her at elo3@cox.net.

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