Dirty Clinical Trials in Evidenced Based Medicine
Thursday, February 12, 2015 02:58 PM

When the FDA found violations of safety or quality standards at clinical trial sites, the published peer-reviewed reports on these studies rarely mentioned the problems.  Fifty-seven trials in which the FDA had cited trial investigators for serious, life-threatening incidents and data falsification, were acknowledged in only three of the 78 subsequent published reports on these trials. Those 57 trials were referenced in 78 articles published in peer-reviewed literature. Only three of the publications referenced the FDA inspection violations, even though 76% had been notified of the violations at least 6 months prior to publication.

The FDA inspects sites and records of clinical trials testing medications. During inspections, investigators check adherence to trial protocols and look for discrepancies between the researchers' progress notes and the data reported to the study sponsor. One of three grades are then issued: no action indicated; voluntary action indicated, which suggests minor problems; and official action indicated (OAI), denoting a severity warranting regulatory attention.

Researchers had to file Freedom of Information Act requests to identify 20 OAI-rated inspections.  A creative key-word Google search yielded another 21. But the best source of OAI-related inspections came from documentation of FDA regulatory actions. "Such actions occur only when the failure to adhere to research regulations is considered particularly grave," the researchers wrote.

All told they found 421 OAI-rated inspections from 1998 to 2013. Due to heavy redaction, his team was unable to tie most of the OAI grading to clinical trials and peer-reviewed published literature. Reliable and intelligible data could only be found for 57 clinical trials where inspectors found significant departures from good clinical practice, such as under-reporting of adverse events, violations of protocol, and scientific misconduct.

F4CP Honors William Morgan with Donation to Arnold P. Gold Foundation
Thursday, February 12, 2015 02:53 PM

The Foundation for Chiropractic Progress (F4CP) honored William E. Morgan, DC, as a distinguished hero in healthcare with a donation to the Arnold P. Gold Foundation, a not-for-profit group that works alongside healthcare professionals to instill a culture of respect, dignity and compassion for patients and professionals.

“After careful consideration, we chose to recognize Dr. Morgan for his superior dedication to humanistic, patient-centered care,” Kent S. Greenawalt, chairman, F4CP, said. “His strong work ethic and desire to put patients’ needs first sets a great precedent for other doctors of chiropractic and industry professionals to follow.”

Established in 1988 by Arnold Gold, MD, Sandra Gold, EdD, and their colleagues at the Columbia University College of Physicians & Surgeons, the Gold Foundation strives to keep the “care” in healthcare. Its mission is accomplished when physicians build caring, trusting, and collaborative relationships with patients that result in proper healthcare decisions, better patient adherence, and reduced treatment costs.

Five Steps in Talking With Patients About Alternative Medicine
Thursday, February 12, 2015 02:40 PM

A number of research studies have found that one in three patients routinely use alternative treatments but seven out of 10 users of alternative therapies do not tell their physicians. Complementary treatments are used more commonly among people diagnosed with chronic or life-threatening conditions. Patients with AIDS, cancer, and chronic mental-health illness often seek alternative treatments and practitioners because their conditions are not always adequately helped by conventional medicine.  And physicians are often not aware of the science behind complementary alternative medicine (CAM) and their worry about the training of practitioners and concern that patients are getting ripped off financially often contributes to inappropriate referrals for a more effective treatment.

So how can medical physicians talk to patients about CAM?

How Many Texas Chiropractors? (Jan 2015)
Thursday, February 12, 2015 02:13 PM
The Texas Board of Chiropractic Examiners is reporting that at the end of January 2015 there were 5021 DCs with an active license, 271 expired DC licenses, 611 inactive DC licenses, 2339 with "non-renewable license", 17 with a probated license, 372 probated because of continuing education, and 3 suspended licenses.
F4CP Announces Appointment of New Executive Director
Thursday, February 12, 2015 11:31 AM
The Foundation for Chiropractic Progress (F4CP), a not-for-profit organization dedicated to raising awareness about the value of chiropractic care, announces today the appointment of Kristine Dowell as executive director, effective March 1, 2015. Dowell, currently the director of the Michigan Association of Chiropractors (MAC), has a strong background in administrative leadership, fiscal management and fundraising that will drive increased membership and positive press for the chiropractic profession.
“We selected Kris Dowell based upon her extraordinary market experience and ability to power the growth trajectory of the F4CP,” says Kent S. Greenawalt, chairman, F4CP. “Drawing upon her professional network – and passion for the profession – she will lead us to realize our greatest potential during this next chapter of expansion.”
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