Robert Califf, a cardiologist and researcher at Duke University in Durham, North Carolina, USA, was appointed as the U.S. Food and Drug Administration’s (FDA) deputy commissioner for medical products and tobacco on March 2. Califf—who was previously overseeing the FDA’s drug, medical device and tobacco policy—is a recognized global leader in cardiology, clinical research and medical economics, according to the FDA. He was appointed by FDA Commissioner Margaret A. Hamburg, who will leave the organization at the end of March, leading to speculation that Califf may be nominated to lead the FDA following her departure.
In his new role as deputy commissioner, Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Tobacco Products, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. His duties will include providing policy direction and advice on the FDA’s medical product and tobacco priorities, and he will manage clinical, scientific and regulatory initiatives in areas ranging from pediatric science and personalized medicine to orphan drugs and the advisory committee system.
Califf previously served as vice chancellor of clinical and transnational research at Duke University, professor of medicine at Duke University Medical Center’s Division of Cardiology, director of the Duke Transnational Medicine Institute and founding director of the Duke Clinical Research Institute, the world’s largest academic research organization. The Institute for Scientific Information has recognized Califf as one of the top 10 most-cited medical authors due to his more than 1,200 peer-reviewed publications.
A study examining the vapor released from Blu Ecigs’ and Skycig’s e-cigarettes in comparison to the smoke emitted by Philip Morris USA’s Marlboro Gold and Imperial Tobacco’s Lambert & Butler cigarettes found that levels of harmful and potentially harmful constituents (HPHCs) in cigarette smoke were 1,500 times higher than the levels found in e-cigarette vapor.
The study—titled “Comparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air”—was published in the December 2014 issue of Regulatory Toxicology and Pharmacology. According to proponents of vapor product use, the study lends credence to the belief that, although the long-term effects of inhaling the propylene glycol and glycerin found in e-cigarette vapor are not yet known, such products provide a safer alternative to smoking combustible cigarettes.
According to the study, the e-cigarettes tested contained and delivered mostly glycerin and/or propylene glycol and water, and emitted an aerosol nicotine content that was 85 percent lower than the cigarette smoke nicotine content levels. The study also found the levels of HPHCs to be consistent with the air blanks—at <2 μg/puff—and no significant contribution of tested HPHC classes was found for the e-cigarettes tested. The e-cigarettes and combustible cigarettes in the study were tested on a smoking machine to compare the amount of nicotine delivery and the relative yields of chemical constituents.
A high court judge has ruled that the U.K public-places smoking ban must be enforced in state prisons despite the possibility of unrest this could provoke in jails throughout England and Wales. According to Justice Singh, the justice secretary misunderstood an exemption made in 2006 to health legislation that banned smoking in workplaces and enclosed public spaces. Although the government had argued that state prisons were exempt from smoke-free legislation because of their status as Crown premises, Justice Singh ruled that prison communal areas are subject to the laws, therefore the smoking ban must be extended to such locations.
The exemption in the 2006 Health Act indicated that smoking is allowed in enclosed public places where a person resides permanently or temporarily, which includes prisons, hotels and long-term care facilities. However, the exemption also states that these places should provide designated smoking rooms to avoid subjecting other residents and staff members to secondhand smoke. According to The Guardian, more than 80 percent of prisoners smoke, and the justice ministry fought for the exemption when the health legislation went through parliament—partly in response to warnings by prison governors and unions who said banning smoking in prisons could trigger turmoil among prisoners who use tobacco as currency as well as a legal stimulant.
To continue providing prisoners with access to nicotine—but also to protect nonsmoking prisoners and staff members from the dangers of secondhand smoke—three U.K. prisons now offer e-cigarettes, which are generally believed to be less harmful than their combustible counterparts. Prisoners are currently permitted to smoke combustible cigarettes in their prison cells—as long as the smoker is over the age of 18 and the door is closed—as well as in outside exercise yards, but they cannot use these products in communal spaces.
Justice Singh has postponed the implementation of the ban and granted the justice secretary time to appeal against the ruling.
Four members have resigned from the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC), and three new ones have joined. The FDA made the changes to comply with a court ruling that requires the agency to address certain members’ alleged conflicts of interests.
On July 21, 2014, Judge Richard Leon of the United States District Court for the District of Columbia ordered the FDA to reconstitute the TPSAC. Judge Leon issued his ruling in a 2011 lawsuit that alleged in part that certain members of TPSAC had conflicts of interest that violated ethics law.
TPSAC members Claudia Barone, Joanna Cohen and Suchitra Krishnan-Sarin, along with Chairman Jonathan Samet, have resigned or their terms on TPSAC have been terminated.
The new members are Pebbles Fagan, Gary A. Giovino and Thomas E. Novotny. The FDA is working to fill the remaining vacancy. All future TPSAC meetings will continue as planned.
In a statement, Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that, while the FDA disagrees with the court’s decision, the agency has no option but to comply.
“This is a loss for the FDA and for public health,” he wrote. “Under other circumstances, there would be strong reasons for the agency to consider a waiver or authorization that would allow these individuals to continue their valuable service. However, in light of Judge Leon’s ruling, we do not believe we are able to exercise our discretion to consider this option at this time.”
The 2014 ruling is the same one that bars the FDA from using TPSAC’s 2011 Menthol Report.
A New Zealand public health expert says that evidence from Australia shows that standardized tobacco packaging has worked almost like a vaccine against tobacco use in children and young people.
According to a story by Martin Johnston for the New Zealand Herald, Robert Beaglehole, a University of Auckland emeritus professor, is one of a number of individuals and organizations lobbying the government to bring its standardized tobacco packaging bill back to parliament for a final vote.
The health select committee last year supported the bill but the government delayed bringing it back pending the outcome of the challenges being made against Australian standardized packaging legislation.
But those lobbying the government say that the decline in smoking seen in Australia since its standardized tobacco packaging law came into force in December 2012 means New Zealand can dally no longer.
‘Australian survey data shows the prevalence of daily smoking in those aged 14 or older declined from 15.1 percent in 2010, before the new law came into effect, to 12.8 percent in 2013,’ Johnston wrote.
The 2011 and 2012 figures were not given.
A cross-party working group has been set up within the European parliament to counter what is said to be the growing influence of tobacco companies.
According to Julie Levy-Abegoli writing for The Parliament Magazine, the group was put together by S&D [Progressive Alliance of Socialists & Democrats] deputy Gilles Pargneaux, at the behest of Paris councillor Pauline Delpech. Pargneaux is a vice-chair of parliament’s environment, public health and food safety committee and Delpech campaigns against the tobacco industry in France.
“Our main focus is to make sure the tobacco products directive is implemented in all member states,” Pargneaux was quoted as saying.
But he said the group would be looking also at “combating contraband, counterfeiting and cross-border shopping”.
And he called for the enforcement of article 5.3 of the World Health Organization’s Framework Convention on Tobacco Control, which ‘requires all parties, when setting and implementing their public health policies with respect to tobacco control, to act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law’.
Pargneaux accused tobacco companies of “spending a lot of money to keep tribunals off their back”, and said: “we know that by going after these firms, we are unlikely to make many friends”.