Barton doc, Tahoe patients part of national drug study
By Jessie Marchesseau
William Cottrell, a physician at Barton Osteoporosis & Bone Health, is partnering with the pharmaceutical company Amgen to host an observational study for the osteoporosis drug Prolia.
The drug was approved by the FDA and released to pharmacies in 2010. So this is not a trial to see if the drug works or what the side effects are. Rather, observational studies like this one are designed to see if the patients like the medication, if they choose to continue using it, how they tolerate the side effects and other such factors.
William Cottrell
Cottrell has not only had Prolia available to his patients, but has been educating other physicians on the drug for more than a year.
“I do it for the mental stimulation and satisfaction,” he said of teaching other doctors about prescription medications. “There is nothing more rewarding than educating your peers to their satisfaction.”
Prolia is not the first prescription drug Cottrell has chosen to learn and subsequently educate his peers about. He says doing so allows him to learn all the ins and outs of a medication and find the answers to questions he may never have thought to ask.
“There are some physicians that are much more curious than others, and I’m a very curious guy,” he told Lake Tahoe News.
The reputation and relationships Cottrell developed among the medical science community from doing such presentations prompted Amgen to approach him about participating in the Prolia study.
At a couple presentations and conferences over the years, Cottrell had also crossed paths with Doreen Spires, a former research biologist and the current clinical research coordinator for the study. With a background in pharmaceutical research and 16 years of investigating bone density issues, Spires was an ideal candidate to partner with Cottrell for the Prolia study.
However, an invitation from Amgen was not enough to earn Barton Osteoporosis & Bone Health a spot among the 90 participating facilities in North America. They had to meet a set of strict guidelines put forth by the pharmaceutical company as well as pass an inspection including the Barton pharmacy and lab. Cottrell, Spires and Barton passed on the first try.
“Even the study coordinator said it was very unusual to pass the first time,” Cottrell said. “It was a compliment not only to me, but to the hospital.”
The study will observe 600 patients nationwide, of which Spires and Cottrell were asked to observe 10. However, patients’ response to the study far exceeded the team’s expectations.
They signed up three the day the study began in September 2011. The other seven spots filled up in no time, so they asked for 10 more. The request was granted, and again, the spots filled quickly. When they requested five more, Amgen granted them 10. Though they have not reached their 30-participant threshold yet, Cottrell and Spires will be signing people up through the end of March.
“The benefit to the patient is that they’re helping other patients in the future,” Spires said.
The study will last for two years with participants receiving injections of Prolia every six months. The first group of patients are just now coming in for the second treatments. Part of the study is seeing how many participants stick it out for the full two years, but Spires says so far most of the patients are happy with the twice per year protocol of the drug.
This is Cottrell’s first time participating in this type of study, but he is already looking toward the future.
“If they like the way you do things, they ask you to do things down the road,” he said. “And the dream drug for bones is in the pipeline, and Amgen has it.”
For questions regarding the Prolia observational study or to become a participant, contact Barton Osteoporosis & Bone Health at (530) 543.5490.
“I do it for the mental stimulation and satisfaction,” he said of teaching other doctors about prescription medications. “There is nothing more rewarding than educating your peers to their satisfaction.”
I’m sure there is no profit incentive for him, simply acting from a purely magnanimous position! Big pharma companies are such heroes!
American medicine today has become nothing more than pill pushers. Want to lose weight, don’t exercise and cut down calorie intake, just take a pill. Feeling lowdown, take a pill. Our doctors don’t treat patients anymore, they just prescribe!
We need to get rid of many of these drugs, we have way more than we need, take it down to the core generic drugs that work well.
C’mon now, after the drug’s newer and more lethal side effects are discovered, it’s job security for class action lawyers and their staffs, economic stimulus, it’s a win win!
Physician’s should not be advertising (“and the dream drug for bones is in the pipeline, and Amgen has it”)…. especially since the drug is still in the pipeline and is only approved for clinical STUDY. All clinical studies HOPE participants will remain in the study, however that is not the end-point of the clinical trial. The end-point is efficacy – safety, and clinical benefit. I think it is great for physicians to participate as “Investigators” for clinical trials, but they should refrain from trying to convince patients or clinicians that a drug still under investigation is a “dream drug”. As a research & patient advocate, be advised there is a LONG list of investigative drugs that never made the cut.
Clinical trials, such as this Amgen trial, are important to drug development, and have given us many life-changing drugs. Understanding risk versus benefit, and reading the sudy protocol is more important.
This is nothing new, drug company reps convince docs to write their prescriptions with various legal bribes such as lunches for the staff, golf outings,etc. Here we have a doc advertising this drug in our newspaper. This is exactly what the drug company wants. Dr Cottrel- you have lost my confidence and I hope you keep your drug preferences confidential between Dr and Patient.
FYI – Prolia was approved in 2010 after completion of Phase III of the study. It is in Phase IV which is described online in ClinicalTrials.gov as:
PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug’s risks, benefits, and optimal use.
I checked into this and it was an invitation for more patients to Dr. Cottrell’s private practice and Barton’s practices. This is crock! You pay to see him, you pay for tests, you pay for drugs – this is NOT a real study!