Researchers at the University of Toronto have developed new synthetic-based methods for creating iron-based catalysts used in the production of drugs and perfumes.
The researchers say the new technique takes advantage of the Earth's abundant supply of iron and substitutes it for more rare elements including ruthenium, rhodium, palladium, and platinum, with the result being a more efficient and environmentally friendly drug production process.
As research has shown potentially harmful effects of chemicals used in drug production as well as compounds that are leached into the environment post-market, there is growing interest in making the pharmaceutical manufacturing process more environmentally safe and efficient.
The study was published in the November 29 issue of Science.
But what about interactions between industry representatives and physicians' assistants, pharmacists, dieticians, and physical and occupational therapists?
That's the question explored in an observational study published November 26 in PLOS Medicine.
Quinn Grundy, University of California-San Francisco's Department of Social and Behavioral Sciences, School of Nursing, and colleagues reviewed 15 studies that depicted interaction between industry and non-physician clinicians and found that:
- Most met regularly with sales representatives from the pharmaceutical industry
- A majority of nurses, nurse practitioners, and Registered Nurses surveyed had received gifts, food and beverages including at sponsored lunch and dinner events.
- Non-physician clinicians reported frequent receipt of samples of pharmaceuticals and other medical products for patient use and they generally held favorable views of such samples.
- Large majorities of non-physician clinicians reported attending industry-sponsored educational events or receipt of industry-provided educational materials.
- Most non-physician clinicians across disciplines held favorable views of interactions with sales representatives and industry interactions in general.
- A minority perceived that industry marketing influenced their own practice, but more felt their colleagues would be influenced.
- Preparation for industry interactions generally was not a part of professional training.
"The frequency of industry interactions and, despite clinician recognition of the potential for bias and conflict of interest, the common view of industry as at worst, a 'necessary evil', suggest that clinician-industry interactions are normalized in clinical practice settings," according to the authors. The authors suggested that workplaces should incorporate policies to address these potential conflicts of interest.
Citation: Grundy Q, Bero L, Malone R (2013) Interactions between Non-Physician Clinicians and Industry: A Systematic Review. PLoS Med 10(11): e1001561. doi:10.1371/journal.pmed.1001561
More than 4 billion people live in countries where well-intentioned but harmful regulations prevent cancer patients from accessing opioid pain medications that could relieve their pain. National governments must take steps to remove these legal barriers, according to the European Society for Medical Oncology which led a global study on the availability and accessibility of opioids for cancer pain management.
Officials in Africa, Asia, Latin America & the Caribbean and the Middle East were surveyed on the availability of codeine, oral oxycodone, transdermal fentanyl, immediate and slow release oral morphine, as well as injectable morphine, and oral methadone for cancer patients. While some countries had problems with drug shortages of these essential pain medicines, the main problem was over-regulation, according to the study authors.
"When one considers that effective treatments are cheap and available, untreated cancer pain and its horrendous consequences for patients and their families is a scandal of global proportions," said Nathan Cherny, study author and chair of the ESMO Palliative Care Working Group. Cherny works with the Shaare Zedek Medical Center in Jerusalem, Israel.
Results of the survey, conducted by the 22 member partners of the Global Opioid Policy Initiative (GOPI) was published November 27 in the Annals of Oncology.
Researchers at MIT and Brigham and Women's Hospital have developed a nanoparticle that can be delivered orally and absorbed through the digestive tract, according to a study published online November 27 in Science Translational Medicine.
The nanoparticles are coated with antibodies that open receptors found on the surfaces of cells that line the intestine, allowing the nanoparticles to break through the intestinal walls and enter the bloodstream.
The researchers suggested that oral, rather than injectable, delivery of nanoparticles could be an advantage since patients with certain diseases like high cholesterol and diabetes would be more likely to adhere to a pill treatment rather than going into a clinic for regular injections. So far the oral nanoparticles have been tested on mice but the research team said the particles could be used to deliver any kind of drug that can be encapsulated in a nanoparticle.
A Centers for Disease Control and Prevention (CDC) report on the rise of both the diagnosis of attention-deficit hyperactivity disorder (ADHD) in children and drug prescriptions to treat ADHD has sparked a national discussion on how the drugs are being marketed as well as how physicians define ADHD.
In its national survey, the CDC found that 3.5 million U.S. children, or 6 percent of 4-17 year olds, were taking an ADHD medication during 2011-2012, an increase of 28 percent from 2007-2008.
The study also found that 6.4 million American children - 11 percent of 4-17 year olds - had received an ADHD diagnosis from their healthcare provider, an increase of 42 percent from a similar survey in 2003-2004.
The study was published in the November Journal of The American Academy of Child and Adolescent Psychiatry.
Non-discounted U.S. spending on ADHD meditations, the 10th largest of the top 20 therapeutic areas in terms of drug spending, grew from $5.5 billion in 2008 to $10.4 billion in 2012, according to IMS Health.
While the Office of the U.S. Trade Representative says "significant progress" was made among the negotiators of the Trans-Pacific Partnership (TPP) following six days of meetings that concluded on Nov. 24 in Salt Lake City, Utah, there's growing public resistance to not only the controversial issues being discussed in the meetings but also the way the trade agreement is being hammered out in secret behind closed doors.Protest against the TPP in Ashburn Junction, Virginia in September 2012. Photo: GlobalTradeWatch
The way the TPP is being advanced is reinforcing opposing views that the pharmaceutical industry cares more about profits than the public good.
According to the USTR, lead negotiators and "key subject-matter experts" have ironed out their differences on intellectual property, cross-border trade in services, temporary entry, environment, market access, state-owned enterprises, investment, financial services, sanitary and phytosanitary issues, government procurement, labor, e-commerce, legal issues, technical barriers to trade and rules of origin. Ministers of the countries developing the TPP - United States, Canada, Mexico, Chile, Peru, Malaysia, Singapore, Japan, Vietnam, Brunei and Australia - are to finalize the agreement in Singapore during meetings scheduled for December 7-10.
The vast majority of dozens of meetings between government and business leaders that have taken place in California, Utah, Washington, DC, New York and in cities in Asia Pacific countries in recent months have been closed to the press. Contents of the meetings have been treated as "classified" by the Obama Administration.
Many advocacy and watchdog groups have relied on leaks and conjecture while trying to follow the progress of the meetings, particularly as they relate to copyright and intellectual property laws, drug patents and Internet freedom.
On November 13, 2013, Wikileaks released a draft of the treaty's Intellectual Property Rights chapter.
Approvals for new drugs approved under the FDA's expedited process tend to involve smaller clinical trial cohorts and rely more heavily on post-market safety evidence, according to an analysis published in JAMA Internal Medicine.
Researchers from the Institute for Safe Medicine Practices in Alexandria, VA, and Wake Forest School of Medicine in Winston-Salem, NC, analyzed the development times, clinical testing, post-market follow-up and safety risks associated with the 20 new therapeutic drugs approved by the FDA in 2008.
Compared to the 12 drugs approved under standard review, the eight that were approved under expedited review were approved up to two and a half years faster, and had efficacy trials that enrolled on average 104 volunteers, as opposed to the 580 which was the norm for drugs under standard review. In addition, the authors found that post-marketing studies for safety still hadn't been completed for most of the expedited drugs as of 2013.
The authors stated that their analysis suggests that expedited approval that includes smaller trials and after-market testing makes it "more difficult to balance the benefits and risks of new drugs."
A revised draft guidance for "Expedited Programs for Serious Conditions - Drugs and Biologics" was released for public comment in June 2013.
Dexpramipexole was generally well tolerated in a trial involving nearly 1,000 amyotrophic lateral sclerosis (ALS) patients but did not outperform placebo in efficacy (in terms of function or survivability), according to the results of the phase 3 EMPOWER study of dexpramipexole funded by Biogen Idec. The results are published in the November 2013 Lancet Neuology
In a discussion of the study prior to publication at this year's American Academy of Neurology annual meeting, Doug Kerr, Biogen Idec's medical director of neurodegeneration and translational neurology, spoke for everyone in the ALS community when he said the outcome of the trial - one of the largest ALS trials ever conducted - was disappointing. He acknowledged that its proved "very tough" to find better treatments for ALS and added, "But this does not deter us--we are in it to stay."
In a commentary on the trial published in NEJM's Journal Watch (registration required) on Nov. 1, 2013, Michael Benatar, the Walter Bradley Chair in ALS Research; Associate Professor of Neurology; and Chief of the Neuromuscular Division at the University of Miami, wrote: "The strong rationale for this trial makes the results particularly disappointing and highlights the critical question in drug development of how to decide which drugs hold the most promise and should advance from phase II (safety, mid-development) to phase III (efficacy, late-development) clinical trials. This issue is especially challenging in the field of amyotrophic lateral sclerosis given our incomplete understanding of the basic biology of the disease; the paucity of animal models that meaningfully recapitulate the human disease; and the limitations of existing biomarkers for demonstrating target engagement, pharmacodynamic effect, and/or an impact on disease progression. The results of this trial underscore the immensity of these challenges and emphasize the critical need for continued efforts to improve our ability to select the most promising compounds from phase II trials for further therapeutic development."
Results from about one-third of the clinical trials contained in the ClinicalTrials.gov registry haven't been published within five years of their conclusion, according to a study published Oct. 29, 2013, in the BMJ.
The article authors examined 585 of the listed trials and found that 32 percent of the trials sponsored by industry and 18 percent of non-industry funded trials had not been published years after they ended.
An estimated 250,000 people volunteered for these clinical trials where results never saw the light of day.
The findings certainly add to the case for advocates of more transparency concerning the release of clinical trial data.
October's Psychiatric News featured an interesting overview on the role that pharmacogentics and personalized drugs will play in the future of psychiatric medicine. Experts interviewed believe that new therapies achieved through pharmacogenetic research will play a significantly larger role in coming years.
One of the experts interviewed, Anil Malhotra, director of psychiatry research at New York's Zucker Hillside Hospital, focuses on the link between anti-psychotics and weight gain in a sub-population of patients with schizophrenia. "It's amazing how a person's genetic makeup can predict a person's susceptibility to certain side effects," says Malhotra. "Using genetic tools, such as neuroimaging and other modalities, is very attractive in identifying patients who will benefit more from alternative treatment than from current psychotherapies."
The article noted that the National Institute on Alcohol Abuse and Alcoholism (NIAAA) alone is supporting more than 40 studies focused on personalized treatments for substance abuse.