Drug Trials

Bill Rosendahl lifts his walker over the threshold and carries it into the grow room before anyone in his entourage - press secretary, pot shop owner, pot consultant and bud tender - can rush over to help. Even after 13 hits of radiation and seven rounds of combination chemo, Rosendahl moves steadily, straight as a poplar, past 2-foot-high cannabis plants labeled Hindu Skunk and Humboldt O.G. And, he says, Herbalcure, the Westside pot dispensary we're touring, is responsible for his vigor.

Bill Rosendahl lifts his walker over the threshold and carries it into the grow room before anyone in his entourage - press secretary, pot shop owner, pot consultant and bud tender - can rush over to help. Even after 13 hits of radiation and seven rounds of combination chemo, Rosendahl moves steadily, straight as a poplar, past 2-foot-high cannabis plants labeled Hindu Skunk and Humboldt O.G. And, he says, Herbalcure, the Westside pot dispensary we're touring, is responsible for his vigor.

When is the exchange of scientific data a possible case of insider trading? When the safety and effectiveness of cancer drugs are tested in advanced clinical trials, says a study published Tuesday in the Journal of the National Cancer Institute. In an unusual study that merged the worlds of medicine and finance, Canadian researchers have turned up an ethical and legal quandary for those who conduct and publish biomedical research: While scientific inquiry demands openness, fortunes ride on its findings, especially for those who can get those findings early.

YARUMAL, Colombia - The unusually high incidence of early-onset Alzheimer's disease in this isolated cattle town has thrust it to the forefront of global efforts to find a cure for the debilitating malady. Next spring, 100 residents of this region in northwestern Colombia who are known to carry a mutant gene linked to the disease will begin taking a therapeutic drug produced by the U.S. biotechnology firm Genentech. The five-year clinical trial, called the Alzheimer's Prevention Initiative, will cost $100 million.

Dr. Andrew Weil, among the best-known medical doctors practicing alternative and complementary medicine, suggests researchers are ignoring an important endpoint when they evaluate the success or failure of clinical drug trials: how the patient feels about the treatment. Weil, a longtime leader in alternative -- or integrative -- medicine, is best known today for his books, blog and various products. It's been awhile since he ventured into the serious business of scientific research and medical practice.

Re "Drug Trials With a Dose of Doubt," July 16 Every scientific report of medical research ever written has been criticized in writing. This discussion is the heart and soul of the peer review process. It is disingenuous to imply that Dr. Thomas J. Walsh's two studies were designed poorly or with ulterior motives simply because of criticisms. Were we to allege scientific impropriety against every study so criticized, there would be no acceptable medical literature. The relationship between the pharmaceutical industry, the development of drugs and medical scientists has been imposed on the medical system by politically driven funding decisions.

The head of the Food and Drug Administration said Monday night the agency will revise its rules for clinical drug trials in the wake of a disastrous experiment on a hepatitis B vaccine in which five patients died. The agency released an internal task force report that called for changes in the design, analysis and reporting of clinical studies of so-called investigational new drugs.

A coalition of 15 AIDS and gay rights groups proposed criteria Wednesday for selecting patients to participate in "parallel track" trials of experimental AIDS drugs to ensure the tests "will not compete with, but rather complement," more formal studies.

Drug companies have pills aplenty in the pipeline, but they won't make it to market until they've been tested on humans. Finding the right patients for trials of new drugs is a costly headache, though, for pharmaceutical firms and for the federal government, which also sponsors experimental trials. Meanwhile, for people who are seriously ill, the appropriate trial can mean a shot at a new treatment that might help. This could be a job for . . . the Internet.

The biologically engineered drug Raptiva failed to effectively treat rheumatoid arthritis patients in a key experiment, Genentech Inc. and Xoma Ltd. said. The partners said they are halting further tests on patients with the disease, but added that they are hopeful federal regulators will approve Raptiva to treat the skin disorder psoriasis. The psoriasis market, however, is far smaller than the rheumatoid arthritis market. Shares of Berkeley-based Xoma fell 77 cents, or 14%, to $4.72 on Nasdaq.

Doctors are less likely to trust research studies performed with funding from corporate interests such as pharmaceutical companies, according to a new study. The report, published this week in the New England Journal of Medicine, reveals a long-suspected bias against such research among physicians. It also demonstrates the price companies have paid for public violations of trust, including examples of data manipulation and misrepresentation of study results. In the study, researchers from Harvard Medical School asked physicians to read abstracts from studies reporting promising clinical data about a couple of different new drugs (the abstracts were fakes, written by the research team, but the doctors didn't know that)

When is the exchange of scientific data a possible case of insider trading? When the safety and effectiveness of cancer drugs are tested in advanced clinical trials, says a study published Tuesday in the Journal of the National Cancer Institute. In an unusual study that merged the worlds of medicine and finance, Canadian researchers have turned up an ethical and legal quandary for those who conduct and publish biomedical research: While scientific inquiry demands openness, fortunes ride on its findings, especially for those who can get those findings early.

Dr. Andrew Weil, among the best-known medical doctors practicing alternative and complementary medicine, suggests researchers are ignoring an important endpoint when they evaluate the success or failure of clinical drug trials: how the patient feels about the treatment. Weil, a longtime leader in alternative -- or integrative -- medicine, is best known today for his books, blog and various products. It's been awhile since he ventured into the serious business of scientific research and medical practice.

A judge Thursday threw out all guilty verdicts except one misdemeanor conviction in the drug trial surrounding the death of model Anna Nicole Smith ? criticizing a case authorities once heralded as a cautionary tale to doctors too liberal with their prescription pads. Los Angeles County Superior Court Judge Robert Perry cleared Smith's manager and companion Howard K. Stern of all convictions and dismissed two conspiracy counts for psychiatrist Khristine Eroshevich. Of the two remaining felony convictions for Eroshevich, involving obtaining medication under a false name, Perry tossed out one and reduced the other to a misdemeanor.

In the end, the drug trial surrounding Anna Nicole Smith's death came to revolve around the fame that trailed the late model and Playboy Playmate throughout her life. The hope of landing in their famous patient's inner circle was powerful enough to motivate doctors to whip out their prescription pads and write out orders for huge quantities of highly addictive drugs, prosecutors said. Defense attorneys claimed that were it not for Smith's celebrity, their clients would never have been charged in the first place.

When weighing the results of a medical study it's important to consider who supplied money to conduct the research. According to an analysis of drug trials published Monday, studies were much more likely to be positive -- that is, showing the drug worked -- in trials that were funded by the pharmaceutical industry. Researchers reviewed 546 drug trials and found that industry-funded trials reported positive outcomes 85% of the time compared with 50% of the time for government-funded trials and 72% of the time for trials funded by nonprofits or non-federal organizations.

The Food and Drug Administration should do more to ensure that pharmaceutical firms include representative numbers of women in studies of new drugs and should require drug makers to analyze trial data by gender, according to a report to be released today.

The global pharmaceutical industry unveiled plans Thursday to publish more data about trials of medicines in a bid to reassure patients after recent alarms over drug safety. Trade groups in the United States, Europe and Japan, in collaboration with major drug makers, agreed on an industry-wide code to publish detailed information about all clinical trials, other than exploratory Phase I studies, on the Internet.

An experimental antiviral drug that works by a different mechanism than existing drugs has been shown to suppress hepatitis C in chimpanzees and is already being tested in human clinical trials, researchers reported Thursday. The new agent is a so-called antisense drug that binds to RNA required by the virus for replication, preventing the virus from proliferating in the liver. Preliminary tests suggest that the drug, called SPC3649, has no toxic side effects, does not allow development of resistance -- which plagues other hepatitis drugs -- and has lasting effects after treatment has stopped.

The significant cardiovascular risks linked to Vioxx could have been identified nearly four years before the anti-inflammatory medication was taken off the market, a new study has concluded, but consumers and physicians didn't have access to such information at the time. "We need comprehensive, transparent, independent access to clinical-trial data in order to do a much better job of making this information available to the public," said the study's lead author, Dr. Joseph S. Ross, an assistant professor of geriatrics and palliative medicine at New York's Mount Sinai School of Medicine.