Manufacturers assert that they have no obligation to provide consumers with notice through labeling when ingredients created through innovative technologies are introduced into consumer products designed for human consumption. On the other hand, consumers take the position that they have the right to know what ingredients are in these products, especially when ingredients are novel and the risks associated with exposure to them are unknown. Recent events suggest that this problem may be developing a life cycle that savvy manufacturers should be watching. The first in what may be a series of examples of this life cycle is the conflict over the labeling of genetically modified plant ingredients in food.
From the outset, food manufacturers using GMO ingredients have declined to provide consumers notice of GMO content. The FDA has not mandated disclosure as it takes the position that the introduction of GMO ingredients into food is not material. This lack of transparency resulted in consumer rights groups testing products for GMO use and disclosing that use to consumers. As consumers have become aware of the extensive use of GMOs in their food, a rising number have expressed the desire that these ingredients be labeled. A recent ABC poll suggests that 93% of consumers now support mandatory disclosure of GMO content on labels.
When industry ignored this consumer preference, a market was created for products that are “GMO-free.” Thus, the practice of “GMO-free” labeling was born. The growing consumer labeling movement also triggered repeated attempts to pass labeling laws. While these efforts have been unsuccessful to date, they are gaining traction – for instance, it cost industry 40 million dollars to block California’s prop 37 calling for mandatory labeling last fall. With more legislative proposals cropping up (a ballot initiative in Washington State and legislative proposals in Connecticut, Vermont, New Mexico and Missouri), a growing consumer boycott of some organic or “natural” brands owned by major food companies and a recently introduced popular mobile app by Fooducate that allows consumers to check for GMO content in a growing number of products, industry may be seeing the writing on the wall. Just this year, Ben & Jerry’s Ice Cream has decided to remove GMO ingredients from its supply chain. And the Meridian Institute, which organizes discussion of major issues, convened a meeting in Washington last month that included executives from PepsiCo, ConAgra and about 20 other major food companies, as well as Wal-Mart and advocacy groups that favor labeling. See here. Many are predicting that voluntary labeling may be right around the corner.
It appears that this life cycle of manufacturers’ refusal to disclose innovative ingredients with unknown risks and consumers’ reactive self-help measures may be repeating itself in the context of the use of nanotechnology in consumer products.
By Patrick O’Leary
While reading some of the great articles from the health section of the New York Times over the holidays it struck me that such articles, in their need to be concise and accessible, often give only passing treatment to regulatory concepts that can be fundamental to the story. Accordingly, I thought it might be useful to write a series of posts digging down a bit deeper into some of the regulatory foundations of health stories that percolate up to public attention through the news. In this post I’ll begin by looking at an interesting point relating to drug efficacy standards raised by an article about a newly expensive (but decades-old) drug.
In Andrew Pollack’s “Questcor Finds Profits, at $28,000 a Vial” we read that a drug called Acthar, first approved by the FDA in 1952 and used primarily to treat rare infantile spasms, has in recent years become a very expensive and (for it’s maker) lucrative treatment for conditions ranging from multiple sclerosis to rheumatologic conditions. The article is worth a read for its thoughtful discussion of drug pricing, but it also makes passing reference to a some important regulatory concepts that bear further examination. One issue that particularly stood out to me was Pollack’s statement that Questcor, Acthar’s manufacturer, has been able to market the drug for a variety of uses “without being required to prove that the drug actually works” because it was “essentially grandfathered” into an anachronistic efficacy standard by being “approved for use in 1952, before the [FDA] required clinical trials . . . .” On first read, that sounds fairly alarming, so I thought it might be worthwhile to unpack the law around such “grandfathered” drugs a little. While it is true that FDA did not require proof of effectiveness for new drugs until lawmakers included this requirement in the Drug Amendments of 1962, it isn’t the case that pre-1962 drugs simply get a free pass on proving effectiveness. The truth, as one might expect, is somewhat more complicated. Continue reading
By Suzanne M. Rivera
How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today. Beginning at the start of the epidemic, when little was known about the HIV virus and even hospitals were refusing to treat AIDS patients out of fear of contagion, the film follows a group of leaders in the groups ACT-UP and TAG. Using existing footage interspersed with current-day interviews, it tells the story of how patients and concerned allies pushed the research community to find a way to treat what was then a lethal disease.
The film’s portrayal of the U.S. Government, specifically then-President George H. W. Bush and high ranking officials in the Food and Drug Administration, is damning. As hundreds of thousands of people became infected with HIV and the death toll rose, prejudice against marginalized groups (especially gay men, IV drug users) contributed to a lack of urgency about the need to learn how stop the spread of the virus and how to treat the opportunistic infections that killed people with full-blown AIDS. In contrast, footage of demonstrations, meetings, and conferences highlights the courage of the activists who risked and endured discrimination, beatings and arrests to bring attention to the need for more research.
But How to Survive a Plague is more than a documentary about the power people have to make change when they join together to demand action. It also is a provocative commentary about unintended consequences. I saw the film while attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R). In that context, I was especially interested in the way How to Survive a Plague highlights an interesting ethical issue in clinical research. Namely, the problem of protecting people so much from research risks that the protection itself causes harm. Continue reading
By Jennifer S. Bard
I’m sure many of us are talking about the contaminated steroid injections which have spread a fungal form of meningitis Exserohilum rostratum across the country. The CDC, which as is usually the case is doing an excellent job of providing clear and current information, reports that as of “October 17, 2012, a total of 47 patients have laboratory-confirmed fungal meningitis.” They offer some reassuring information—that “this form of fungal meningitis is not contagious” and some scary information—that there are 257 cases and ten deaths in 15 states and that incubation periods last up to a month.
The most recent legal news is that the pharmacy was visited earlier this week by the FDA’s criminal investigative unit and that the first law suit has already been filed in Minnesota Federal District Court by a woman who received a vaccine from the pharmacy but who does not know yet if she has meningitis. Continue reading
By Leslie Francis
In 2007, motivated by concerns that pharmaceutical companies were not sharing negative data about what had been learned in clinical trials, Congress established enhanced reporting requirements.
A series of articles published in January 2012 in the British Medical Journal demonstrates that data reporting remains deeply problematic, especially for industry-sponsored trials. (The articles can be found here and are very much worth reading).
A posting Sept. 26 in the Federal Register indicates that the Secretary of HHS has delegated authority to to oversee the reporting process to the FDA. Whether this signals improved monitoring of clinical trial data submissions remains to be seen. One can only hope.