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FDA, Health and Fitness, In the News, Nutrition, Public Health

“They might be slightly healthier, but they’ll still be junk foods”: Expert comments on trans-fat ban

"They might be slightly healthier, but they'll still be junk foods": Expert comments on trans-fat ban

4345026096_35defbf6b0_zAs you’ve probably heard, the FDA ruled last week to ban trans-fats and phase them out of all food products over the next three years. This news has been widely covered, both heralded for its health implications and critiqued for being too long in coming. Yet either way, it is not a panacea, as Stanford Medicine professor Christopher Gardner, PhD, explained when he shared his opinion with me over the weekend:

The true impact of the FDA ban on trans-fats will not be known until we find out what substitutes the food industry finds, and what that does to the sale of junk food and the health of Americans in response to the switch. It could be beneficial. But it isn’t as if trans-fats will be gone and everyone will eat an extra two servings of vegetables in their place.

Gardner, who has spent the past 20 years researching the health benefits of various nutrition components, pointed out that “a lot of good people and excellent scientists worked on this for a long time” and “it took a great deal of effort to assemble the science to demonstrate that this is something so harmful in the American diet that it should be removed with an FDA ban.” He also offered more specifics on what food companies might do following the ban:

The companies making those products are unlikely to remove those junk food products entirely from the shelves of grocery stores across America. Instead, it is most likely that they will look for an alternate form of fat that will serve as closely as possible the same role that trans-fats served. Trans-fats act like saturated fats in terms of being solid rather than liquid at room temperature. This can help the icing on a cupcake stay solid, and it can give a “mouth feel” of solid fat that people like to taste in their food. The goal of the food industry will be to replace the trans-fat with another fat that is solid at room temperature, which likely means the replacement could very well be as bad as the trans fats themselves.

For example, palm oil or esterified stearic acid are likely to be options. For the palm oil, this will mean destruction of rain forests and biological diversity. For esterified stearic acid, this will mean another reason to grow more monocultures of soybeans from which to extract the oil. Both of these will likely have a negative environmental impact. There are likely other choices to consider.

After all this, will those junk foods now be health foods? Absolutely not. They might be slightly healthier junk foods, but still junk foods.

Previously: Want to curb junk food cravings? Get more sleep, Talking to kids about junk food ads, and Trans-fat still lurks in packaged foods
Photo by Kevin

FDA, In the News, Nutrition, Public Health

FDA changes regulation for antibiotic use in animals

FDA changes regulation for antibiotic use in animals

8756885685_0ebc1c75ce_zLivestock can no longer be fed antibiotics “preventatively” or to help them grow bigger. The FDA has ruled to change their regulations of how drugs can be administered to food animals, including those used to make animal feed.

After this ruling, livestock producers can only use antibiotics to treat animals that actually have an infection, and only under the supervision of a veterinarian. These new rules are aimed at decreasing the risk of developing drug-resistant bacteria, sometimes called “super bugs.” According to the Centers for Disease Control and Prevention, drug-resistant bacteria cause 2 million illnesses and about 23,000 deaths in the United States each year.

According to an article from The Hill, the Department of Health and Human Services is moving forward with new regulations for hospitals, and President Obama has called on government cafeterias to prioritize meat that has been raised with responsible antibiotic practices.

Previously: Paradox: Antibiotics may increase contagion among salmonella-infected animals, and Healthy gut bacteria help chicken producers avoid antibiotics
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Cancer, Dermatology, FDA, Health Policy, In the News, Public Health

Experts call on FDA for a “tanning prevention policy”

Experts call on FDA for a "tanning prevention policy"

6635416457_a62bfeb09d_zIndoor UV tanning beds are known carcinogens that are responsible for many cases of skin cancer, which is the most commonly diagnosed form of cancer in the U.S. A recently issued Call to Action to Prevent Skin Cancer from the U.S. Surgeon General states that “more than 400,000 cases of skin cancer [8% of the total], about 6,000 of which are melanomas, are estimated to be related to indoor tanning in the U.S. each year” while “nearly 1 out of every 3 young white women engages in indoor tanning each year,” making indoor tanning a serious public health issue.

In a JAMA opinion piece published yesterday, Darren Mays, PhD, MPH, from the Georgetown University Medical Center‘s Department of Oncology, and John Kraemer, JD, MPH, from Georgetown’s School of Nursing and Health Studies, argued that the FDA needs to step up its regulatory approach and restrict access to this technology – due to its limited therapeutic benefits and known damaging effects.

In 2011, California was the first state to ban access to indoor UV tanning beds to minors. The authors assert that “state-level policies restricting a minor’s access to indoor tanning devices are effectively reducing the prevalence of this cancer risk behavior among youth,” but argue that regulation at the federal level is in order:

Like tobacco products, a national regulatory framework designed to prevent and reduce indoor tanning could reduce public health burden and financial costs of skin cancer. …from a public health perspective the indoor tanning device regulations are not commensurate to those of other regulated products that are known carcinogens with very little or no therapeutic benefit.

However, the likelihood of this regulation taking place is questionable:

FDA did not leverage its authority last year to put a broader regulatory framework in place, which could have included a national minimum age requirement and stronger indoor tanning device warning labels… Critical factors seem to be aligning for such policy change to take place, but additional momentum is needed to promote change at a national scale. The US national political environment makes more expansive regulation by either FDA or Congress seem unlikely in the near future.

The authors concluded with a call for organizations other than governments to help build momentum on toward a “national indoor tanning prevention policy.” For example, they said, universities could implement “tan-free” campus policies similar to the “tobacco-free” campaign.

Previously: More evidence on the link between indoor tanning and cancers, Medical experts question the safety of spray-on tanning productsTime for teens to stop tanning?, Senator Ted Lieu weighs in on tanning bed legislation and A push to keep minors away from tanning beds
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FDA, Medicine and Society, Men's Health, Research, Science, Women's Health

Sex matters: Why we shouldn’t conduct basic research without taking it into account

Sex matters: Why we shouldn't conduct basic research without taking it into account

2593063816_9a4eaba16e_zIn a PNAS opinion piece (.pdf) published last week, two Stanford faculty are among the authors arguing that sex shouldn’t be overlooked in basic research studies. Londa Schiebinger, PhD, director of the Gendered Innovations in Science, Health & Medicine, Engineering, and Environment program, and Marcia L. Stefanick, MD, director of the Stanford Center for Health Research on Women and Sex Differences in Medicine, take issue with the fact that much of the research that leads to drugs, devices, and our conclusions about biology comes from studies conducted on non-human animals and cell cultures without considering their sex.

Evolutionarily speaking, sex is one of the most well-conserved biological differences, of fundamental importance to 100 percent of the population. Paying more attention to it, the authors claim, would help biomedical research disaggregate data and explain heterogenous outcomes. While some think it would create unnecessary duplication to account for sex earlier in the research process, before drugs and treatments are tested on humans, the authors argue that such practices would save money and be more efficient in the long run. Early tests are far less expensive than removing something from the market because it has adverse effects on half the population. Moreover, preventing such adverse outcomes would keep people of both sexes safer and healthier.

The article states that the FDA is beginning to reconsider whether unisex dosing is accurate and safe for many drugs, and cites that “about 80% of rodent drug studies are conducted only on males, and 8 of 10 drugs withdrawn from the US market from 1997 to 2000 posed greater health risks for women than for men.”

Previously: Stanford professor encourages researchers to take gender into account, A look at NIH’s new rules for gender balance in biomedical studies and Why it’s critical to study the impact of gender differences on diseases and treatments
Photo by Rick Eh?

FDA, In the News, otolaryngology, Public Health, Science Policy

With e-cigarettes, tobacco isn’t the only danger

With e-cigarettes, tobacco isn't the only danger

16546091210_99279fd110_zE-cigarettes are far from safe, Robert Jackler, MD, writes in a strongly worded op-ed that appeared over the weekend in the San Jose Mercury News.

Most at risk are teens and tweens, enticed by flavors ranging from cotton candy, gummy bear and root beer to peanut butter cookie. (An aside: Can you imagine a hardened, pack-a-day smoker deciding to curb his or her harmful habit by switching to cotton candy-flavored e-cigarettes?)

Interestingly, these flavors, which are thought to be safe in foods may be upping the harmfulness of the e-cigs; after all, the lungs process chemicals much differently than the stomach does. (Remember popcorn lung? In the early 2000’s, a group of workers at a microwave popcorn plant fell ill after inhaling too much of the flavoring agent, diacetyl, used to give popcorn its buttery taste.)

From Jackler’s piece:

In 2009, to reduce youth smoking, the FDA banned flavors (other than menthol) from traditional cigarettes. Fearing regulatory action, the e-cigarette industry response has echoed the playbook of the tobacco industry. One brand went so far as to commission a study which, not surprisingly, arrived at the improbable finding that flavors do not appeal to the young. The industry argues that flavored e-cigarettes should be allowed because they have not been proven unsafe.

Jackler goes on to warn of the progressive nature of lung damage — e-cigarette smokers may be accumulating harm well before they notice a problem.

Previously: Raising the age for tobacco access would benefit health, says new Institute of Medicine report, How e-cigarettes are sparking a new wave of tobacco marketing, E-cigarettes and the FDA: A conversation with a tobacco-marketing researcher and E-Cigarettes: The explosion of vaping is about to be regulated
Photo by Jonny Williams

Applied Biotechnology, Clinical Trials, FDA, Research, Stanford News

An inside look at drug development

An inside look at drug development

B0008664 Assorted pills, tablets and capsules

How are drugs born? If you’re really curious about this, you’d be fascinated by the weekly meetings of industry experts and academic researchers taking part in Stanford’s drug-development training program known as SPARK.

A recently published book, A Practical Guide to Drug Development in Academia, crystallizes the sessions. Even if you’re not a scientist dreaming of curing cancer with your latest discovery, you might find it interesting.

In his recent review of the book for Nature Chemical Biology, industrial medicinal chemist Derek Lowe, PhD, writes:

I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form.

Lowe also wrote about the book last week on his blog, In the Pipeline, where an interesting discussion has begun.

Previously: SPARK program helps researchers cross the “valley of death” between drug discovery and development and Accelerating the translation of biomedical research into clinical applications.
Photograph from Wellcome Images

Addiction, FDA, Health Policy, Pediatrics, Public Health

Raising the age for tobacco access would benefit health, says new Institute of Medicine report

Raising the age for tobacco access would benefit health, says new Institute of Medicine report

cigarette packToday, the Institute of Medicine released a new report evaluating the public health effects of reducing teenagers’ access to cigarettes and other tobacco products. Right now, in most places in the United States, you must be 18 years old to buy cigarettes and other tobacco products. But a few states and cities have higher minimums, and in 2013, the IOM convened a committee, at the request of the U.S. Food and Drug Administration, to examine the potential effects of a higher minimum legal age for tobacco access across the country.

The committee, which was led by Richard Bonnie of the University of Virginia and included Stanford adolescent medicine expert Bonnie Halpern-Felsher, PhD, reviewed the existing scientific literature on tobacco use in teens. They also devised mathematical models to predict what would happen if the federal minimum legal age were 19, 21 or 25.

The report brief (.pdf) says, in part:

Based on its review of the literature, the committee concludes that overall, increasing the MLA [minimum legal age] for tobacco products will likely prevent or delay  initiation of tobacco use by adolescents and young adults. The age group most impacted will be those age 15 to 17 years. The committee also concludes that the impact of raising the MLA to 21 will likely be substantially higher than raising it to 19. However, the added effect of raising the MLA from 21  to 25 will likely be considerably less.

The parts of the brain most responsible for decision making, impulse control, sensation seeking, and susceptibility to peer pressure  continue to develop and change through young adulthood, and adolescent brains are uniquely vulnerable to the effects of nicotine. In  addition, the majority of underage users rely on social sources—like family and friends—to get tobacco. Raising the MLA to 19 will therefore not have much of an effect on reducing the social sources of those in high school. Raising the MLA to 21 will mean that those who can legally obtain tobacco are less likely to be in the same social networks as high school students.

Although it can take time to fully realize the benefits of reduced smoking, since heart disease, lung cancer and other diseases linked to smoking take decades to develop, the payoff would ultimately be significant, the report adds:

…if the MLA were raised now to 21 nationwide, there would be approximately 223,000 fewer premature deaths, 50,000 fewer deaths from lung  cancer, and 4.2 million fewer years of life lost for those born between 2000 and 2019.

Previously: How e-cigarettes are sparking a new wave of tobacco marketing, To protect teens’ health, marijuana should not be legalized, says American Academy of Pediatrics and UN’s top health official: Anti-tobacco efforts can lead to better health “in every corner of the world”
Photo by Thomas Lieser

Addiction, FDA, Health Policy, Medicine and Society, Public Health, Public Safety

To keep edibles away from kids, marijuana policies must be “fully baked”

To keep edibles away from kids, marijuana policies must be "fully baked"

sanfran031606_fig1_highresDepending on your position, legal marijuana might raise images of stoners on every street corner or of users enjoying a private puff in their backyards. However you probably don’t picture a child munching on a pot-laden brownie she found in her kitchen cupboard.

But as Stanford legal experts Robert MacCoun, PhD, and Michelle Mello, JD, PhD, point out in a commentary published today in the New England Journal of Medicine, the loose state regulation of marijuana edibles creates some unnecessarily and potentially serious public health risks that should concern everyone.

Packaged in brightly colored wrappers, edibles often mimic popular sweets, but they contain a powerful dollop of tetrahydrocannabinol (THC), the chemical responsible for marijuana’s psychoactive effects. Some edibles contain multiple “servings” of THC per package.

Both Colorado and Washington — the two states with legal recreational marijuana — require “child-resistant” packaging and a warning to “keep out of the reach of children.” But edibles remain quite attractive to children, who may confuse them with regular candies and snacks, and potentially deceptive to adults, who may assume one bar is a just one serving. “I look at these packages and I get hungry just looking at them,” MacCoun said.

The edibles are not regulated as either a food or a drug by the U.S. Food and Drug Administration, because the federal government considers marijuana illegal. Legalizing states have been slow to fill the gap, and have done so incompletely, Mello said. “This is sort of a weird space that’s betwixt and between federal and state oversight,” she said.

It’s time for the medical community to get involved, MacCoun said. “Most people don’t understand the brain metabolizes chemicals ingested by mouth differently than those smoked.”

Ingested marijuana offers a delayed high, so people keep eating thinking they are fine. The intoxication lasts longer and is associated with more hallucinations and perceptual distortions, he said. “It’s almost like a different drug.”

For now, the issue is most pressing in Colorado and Washington, but many other states are considering legalizing recreational marijuana, including California, MacCoun said.

“We’re not taking some strong position these products should be banned. Sensible and fairly modest regulations would reduce the risk without greatly restricting people’s freedom to consume these products,” MacCoun said.

Previously: Discussing the American Academy of Pediatrics’ call to put the brakes on marijuana legalization, To protect teens’ health, marijuana should not be legalized, says American Academy of Pediatrics and Medical marijuana not safe for kids, Packard Children’s doc says
Photo by DEA

Big data, Clinical Trials, FDA, NIH, Research, Science

Transparency in clinical trials: The importance of getting the whole picture

Transparency in clinical trials: The importance of getting the whole picture

New rules for clinical trials Scope blog 2015.02.02Last week, the Journal of the American Medical Association ran a Viewpoint article from Francis Collins, MD, PhD, director of the National Institutes of Health and Kathy Hudson, PhD, deputy director of NIH, about the U.S. Health and Human Services’s plans to beef up transparency of clinical trials of FDA-regulated drugs and devices.

As they write, the rate of results-sharing for clinical trials is fairly dismal. Some of the reasons for this go beyond researchers; for example, it’s extremely difficult to get negative results published in scientific journals. Collins and Hudson point out that another avenue exists for sharing summary results: NIH’s ClinicalTrials.gov website. But even there, less than one-third of researchers had shared results within four years of the end of their studies. Collins and Hudson are critical of this lapse in data sharing:

Without access to complete information about a particular scientific question, including negative or inconclusive data, duplicative studies may be initiated that unnecessarily put patients at risk or expose them to interventions that are known to be ineffective for specific uses. If multiple related studies are conducted but only positive results are reported, publication bias can distort the evidence base. Incomplete knowledge can then be incorporated into clinical guidelines and patient care. However, one of the greatest harms from nondisclosure of results may be the erosion of the trust accorded to researchers by trial participants and, when public funds are used, by taxpayers.

The new rules make the expectations to report some summary details about clinical trials, including adverse events, explicit. Although NIH has always encouraged sharing of summary results, the rules haven’t always been explicit. Now that there will be detailed guidance, the penalty for not complying will be harsher:

Thus, with the implementation of clearer requirements, augmented support materials and resources, and facilitated reporting, the NIH expects that investigators and sponsoring organizations will have the necessary tools to provide accurate, complete, and timely trial results submissions. However, for grantees who are subject to the amendments act and fail to comply after sufficient notification, the law is clear that NIH and other federal funders of clinical trials must then withhold further funding for the grant and any future grant to the grantee. In addition, the timely reporting of clinical trials will be taken into consideration during review of subsequent applications for funding.

The proposed changes to the regulations are currently in the public comment period, which will end in a few weeks, on February 19. After a review of the comments (and possible revisions), a final rule will likely be issued in a few months time. Once the rule goes into effect, it will be interesting to watch how this changes the research process for new NIH and FDA-regulated studies.

Previously: Shake up research rewards to improve accuracy, says Stanford’s John IoannidisRe-analyses of clinical trial results rare, but necessary, say Stanford researchersHow important is it to publish negative results?Researchers call for “democratization” of clinical trials data and A critical look at the difficulty of publishing “negative” results
Photo by U.S. Department of Defense

Ethics, FDA, Health Policy, In the News, Stanford News

Stanford experts weigh in on spate of "right to try" laws for the terminally ill

Stanford experts weigh in on spate of "right to try" laws for the terminally ill

4286759185_f958aedc10_zTerminally ill patients should be able to access medication that could help them, regardless of how far along that drug might be in the FDA‘s in-depth approval process, right? Yes, some states such as Colorado, Missouri and Lousiana have said. They’ve adopted so-called “right-to-try” laws that gives dying patients access to drugs that have passed only the first stage of the FDA approval process.

Yet these laws — which are modeled on a policy from the libertarian Goldwater Institute — are ultimately useless given that federal law trumps state law, according to Stanford scholars Patricia Zettler, JD, and Henry Greely, JD, in an opinion piece published recently in JAMA Internal Medicine. In addition, the laws are redundant, they write:

Since the late 1980s, patients with serious and terminal conditions have been treated with unapproved medical products. Following sharp criticism from AIDS access about blocking access to potentially effective, but unproved, treatments, as well as congressional intent, the FDA issued regulations that are intended to provide patients with faster access to novel drugs for life-threatening conditions… Although satisfying the agency’s requirements may, at first glance, seem onerous, in practice the FDA very rarely rejects requests for expanded access.

Zettler, who formerly worked for the FDA, pointed out a link that is telling: During fiscal year 2012-2013, the FDA received 977 requests for “expanded access” (these requests may include more than one patient, Zettler said). It approved 974 of them.

None of the state or federal laws require a drug company to provide experimental drugs, and Zettler said she knows of only one – NeuralStem, Inc., a Maryland-based company that is developing therapies for central nervous system disorders –  that intends to provide drugs under these laws. By skipping the FDA’s process, the companies risk angering the FDA, whose favor they need for their drug approval, Zettler told me.

Why then these laws, which are currently also being considered in Michigan, Nevada and Arizona?

Well, Zettler told me, they’re political no-brainers. Imagine the political rants: “So-and-so made my mom die faster,” or “Joe Baloozabum opposes dying patients” – nope, that doesn’t fly inside any Beltway. Many state politicians are also motivated by a “good faith desire to help people,” Zettler said.

But she doubts that states have the expert staff needed to evaluate drug applications. And they don’t have the legal green-light either, she said, pointing out a recent ruling blocking Massachusetts’ attempt to ban a long-acting opiod.

Zettler said the state-based debates simply add a new wrinkle to a discussion that’s been percolating for decades.

Previously: No one wants to talk about dying, but we all need to and Asking the hardest questions: Talking with doctors while terminally ill
Photo by Melanie Tata

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