The FDA de-regulates the first genetically-engineered animal

By Joanna Sax

On November 19, 2015, the FDA de-regulated the AquAdvantage Salmon.  This salmon is genetically engineered to grow faster.  This is the first time the FDA has de-regulated a genetically engineered animal.

Let me just say from the outset that the scientific consensus is clear that genetically engineered food is as safe as conventional food.  Despite the onslaught of public outrage against GMO food, most of the main arguments against GMO food are just hype.

The genie came out of the bottle a long time ago and it’s not going back in.  This happens time and again with scientific advances.   Over the past few decades, our ability to understand, manipulate, edit, and otherwise employ the DNA of various organisms to facilitate human understanding has grown exponentially.  Efforts to resist, combat, or villain-ize the application of biotechnology to impact society might delay, but will not ultimately succeed in keeping the application of scientific discoveries at bay.

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Does FDA Need a Dietary Supplement User Fee Act?

By Elizabeth Guo

Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along with ten pills of Reload, a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.

Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.

Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.

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Separating Fact from Fiction

By Joanna K. Sax
[Ed. Note: Cross-posted at HealthLawProfBlog]

Rhetoric that misconstrues scientific knowledge to garner support for political positions is troubling. For many years, my scholarship has focused on the debate surrounding embryonic stem cell research.   One of the things that I have experienced is an incomplete understanding about what embryonic stem cell research is, what the starting material is, and why it might be different than adult stem cells. One reason that the public may be confused is because some of the information fed to the public is incomplete or, even, incorrect.

To understand the type of information that the public receives regarding a controversial type of research, in this case, embryonic stem cell research, I conducted an empirical study.  By way of background, in 2001, an intense debate about the federal funding for stem cell research occurred. One of the arguments against federal funding for stem cell research was that there was no need for it because scientists could use adult stem cells (which didn’t have the same ethical concerns) instead of embryonic stem cells. The problem with this proposition, however, was that it had no scientific merit because the scientists had not yet conducted the studies to compare human adult and embryonic stem cells. The call for the need for these studies was loud and clear in the scientific community. But, it seemed that some in the non-scientific community already came to the conclusion that these cell types were interchangeable.

I compared the type of information that was being conveyed to the public in major newspapers to the statements made by scientists in the scientific literature. I confirmed that information in major newspapers was statistically more likely than the scientific literature to say that adult stem cells give the same or similar results as research with embryonic stem cells. A more detailed explanation of the study along with the results is available hereContinue reading

The Regulation of Dietary Supplements

By Joanna K. Sax
[Ed. Note: Cross-posted on HealthLawProfBlog.]

How have the massive amounts of dietary supplements on the market evaded significant regulatory oversight for so long? Dietary supplements are regulated as food, which means that for practical purposes the FDA only has the ability to pull them off the shelves upon a showing that they are harmful.

Many consumers use dietary supplements for the same purposes that someone may use a non-prescription drug. Some consumers actually feel safer using a dietary supplement because it is labeled as “natural,” rather than using an FDA approved over-the-counter drug. This doesn’t and shouldn’t make sense. Many natural things are harmful – would you eat any wild mushroom? Tobacco in in cigarettes is natural. Just because something is natural doesn’t mean that it is safe. Conversely, just because something isn’t “natural” in a drug doesn’t mean it is unsafe.

One of the main problems with regulating dietary supplements is that they are not all the same. We probably don’t need heavy regulation for Vitamin C, except maybe in formulation/content. We know, for example, that it is water soluble, so it is hard to take too much. So, maybe Vitamin C doesn’t pose the same safety concerns as other supplements. However, a recent article in Nature, vol. 510, pages 462-4, described different scientific viewpoints about the efficacy of vitamin supplements in healthy populations. So, unless you have a Vitamin C deficiency, then there is probably little reason to take it.

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Is Fracking Good or Bad?

[Ed. Note: Cross-posted at HealthLawProfBlog.]

By Joanna Sax

It probably depends on who you ask. Proponents of fracking laud the energy independence, creation of jobs, environmentally friendly nature of natural gas, national security and economic benefits. Opponents to fracking have concerns about the impact to the environment, public health issues, and water use. Each side dismisses the other side’s arguments.

Perhaps a primer on hydraulic fracturing, known as fracking, is helpful. Fracking is the process of creating long vertical wells below the earth’s surface and then horizontal wells that break open the shale and allow the natural gas to be released and captured. Fracking uses millions of gallons of water to create these wells. A proprietary mix of chemicals in the water is used to create the fissures in the shale. Since the shale is far below the surface, proponents of fracking were able to convince Congress to exempt the industry from the Safe Water Drinking Act, which is now affectionately called the Halliburton Loophole.

The problem with assessing proponents and opponents positions on fracking is the lack of scientific data. While it may be true that the fracking wells are far below the surface, leaks in the fracking wells could impact the aquifers. The EPA is conducting a large scale drinking water impact study, with results that are eagerly anticipated to be released later this year. It could be that, for example, drinking water is/has been contaminated, but that with new regulations and novel innovations, these wells could be made safe such that drinking water is not contaminated. But, we don’t know if there is a problem without the scientific studies and if there is a problem, we need to determine if science/innovation can address the problem.

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What are GM Foods?

By Joanna Sax
[Ed Note: Cross posted at HealthLawProfBlog.]

I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.

The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.

But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.

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GM Crops and the Environment

By Joanna Sax

I’ve become increasingly interested in GM crops, in general, after the recent Petrie-Flom Conference on the FDA in the 21st Century.

I know there is a lot of discussion and controversy about genetically-modified (GM) crops.  I want to pick-up on a topic that is related to GM crops – that is, the environment.  The May 2nd issue of Nature includes a special section on GM crops.  Part of this section provides information on the environmental advantages of GM crops.  Most of the GM crops contain DNA that allows them to be resistant to herbicides or insects.  It turns out that a study showed that there was a 6.1% reduction in the use of herbicide between 1996 and 2011 on crops of herbicide-resistant cotton compared to the amount of herbicide that would have been used to treat conventional crops.  See Natasha Gilbert, A Hard Look at GM Crops, 497 Nature 24, 25 (2012) (I believe this article is free if you search for it on the Nature website).  A reduction in the amount of herbicide used to treat our fabric or food sources may have environmental advantages.  Less herbicide run-off into waterways.  Less herbicide for animals to consume.  See id.

Other scientific data provide inconclusive results about environmental impacts.  Some studies look at whether transgenes are spreading to weeds or non-GM crops.  For example, husbandry techniques of cross-breeding may unknowingly cross breed a non-transgenic line with a transgenic line and thereby create a transgenic line.  Now, a GM crop will be grown without the farmer even knowing it.  See id. at 24, 26.  And, if the GM crop has some sort of negative environmental impact, then a farmer may unwittingly be creating potential harm to the environment.

One thing I want to raise with this post is the importance to incorporate multiple areas of study – biology, environmental studies, genetics, health, regulation, etc. – to determine how we advance our understanding of GM crops.  I imagine that many readers of this blog are much more familiar with GM crops than me, so I welcome your comments.

Politics and Science

By Joanna Sax

On April 29, Scott Burris blogged about a new bill that would allow Congress to set the scientific agenda, which would replace the traditional peer review process.  I echo his expressed concerns, but want to add more.  The idea that politicians, and not scientists, could determine the advancement of science is, frankly, a disaster.  In the past we have seen political leaders spar with scientists over many things – such as whether the earth is round, whether the earth is the center of the universe, etc.  If scientists did not or could not answer those questions, we might think we are walking on a flat earth.

Even now, there is a strong interaction between politics and science.  Evolution, a scientific theory with unequivocal consensus among the scientific community, still faces political opposition.  Recently, I’ve been thinking and writing in this area, that is, the interaction of politics and science.  Questions for scientific inquiry should be determined by scientists.  How we allocate and manage our resources requires, as others have argued, experts in many areas, including economics, management, and public policy.

To look at the interaction of science and politics, I conducted an empirical analysis comparing the type of information communicated to the public versus the consensus in the scientific community to determine whether politics is playing a role in scientific inquiry.  The study centers on the debate regarding the funding of embryonic stem cell research.  If you are interested in this area, please check out a recent draft here.  It’s an early draft and I welcome comments – you can email comments to me at jsax@cwsl.edu

Pharmacist Conscience Clauses

By Joanna Sax

Multiple states have statutes that protect a pharmacist from liability for refusing to fill a prescription for an FDA approved medication.  Other states have laws that require pharmacists to fill prescriptions regardless of their personal beliefs.  The debate surrounding conscience clause legislation falls at two opposing spectrums.  Opponents to conscience clauses argue that refusal to fulfill a prescription for a non-medical reason interferes with the doctor-patient relationship and disproportionately effects women because it is often employed with prescriptions for birth control.  Supporters of conscience clause legislation argue that pharmacists have a constitutional right and that their personal beliefs should be respected.

These two sides will never meet.  They will continue to argue notions of fairness and each side will dig-in their heels.

I’ve proposed a different approach to analyze whether pharmacist conscience clauses are beneficial to society using welfare economics.  In short, the pharmacist conscience clauses serve as an affirmative defense in an action for professional negligence.  Pharmacist conscience clauses can be analogized to a no-care regime and arguably not maximize the well-being of individuals.  To see more of my argument of analyzing conscience clauses using an economic approach, you can check out my article here.

Financial Conflicts of Interest

By Joanna Sax

A recent article in the Journal of Law, Medicine & Ethics (Vol. 41:1, pp. 315-22) nicely describes the contours of Physician Payment Sunshine Act (PPSA) on pharmaceutical marketing.  Similar to other policies addressing financial conflicts of interest, the lion’s share of the PPSA focuses on disclosure.  That is, pharmaceutical companies will be required to disclose how much money they are “giving” to physicians.  A financial conflict of interest can arise when the gifts of money unduly influence a physician’s prescribing habits.

I’ve previously argued here, here and here that the system of disclosure is inadequate to properly address financial conflicts of interest.  Disclosure does only that; it discloses.  So now people know about it – that’s it.  Instead of a system that increases disclosure, I’ve proposed changes to the underlying environment to decrease or eliminate the possibility of a conflict of interest arising.

My research on financial conflicts of interest focuses on scientists at academic medical centers.  I’ve suggested that if academic scientists are in stressful situations, such as worrying about funding, they might be more likely to enter into a situation in which a conflict of interest might arise.  For this reason, if we change the underlying environment of our academic scientists such they are not living in a state of chronic stress, then they might make different decisions, which in turn should lead to fewer situations in which a conflict of interest might arise.

Private physicians operate in a different world than scientists at academic medical centers.  I’m curious if readers have suggestions to change the environment of private physicians such that they will be less likely to enter into situations in which a conflict of interest might arise.

Talking to Your Baby

By Joanna Sax

In President Obama’s State of the Union address, he discussed creating affordable pre-school to all children.  Studies have shown that early childhood education is associated with academic success.  This is an important policy initiative; it’s also very expensive.

In an effort to reduce the disparity in the academic profiles of children, there may be some initiatives that can be started while the proposal for publicly funded early childhood education works its way through Congress.  One approach that is being tested is talking to your baby.

recent NY Times article described a scientific study concerning how talking to your baby is correlated with achievements in school.  It turns out, according to the article, that low-income parents of children speak fewer words to their babies compared to high-income parents and that by the time the children are of school-age, the children from poorer families have heard millions of fewer words.  This means that by the time the child is 3, they have heard 10s of millions of fewer words and the article suggests that this is correlated with IQ and academic success.

This is an issue that can be addressed!  Creative problem solving can be used to create programs to educate lower-income parents to talk more to their babies.  The increase in words alone might provide advantages to lower-income children that they didn’t have before.  This study provides a good example of the application of a scientific study to address social, health and economic issues.

 

Tobacco and Dietary Supplements – The Role of the FDA

By Joanna Sax

Thank you for inviting me to blog.  Later this week, I’ll be attending Harvard Law School’s Petrie-Flom Annual Conference on the FDA in the 21st Century.  My paper/presentation addresses the role of the FDA in the regulation of dietary supplements.  By way of preview, my paper compares similarities between the dietary supplement industry and tobacco.  Both industries have successfully avoided heavy regulation by the FDA. 

A tension exists between the personal choice/autonomy to use a variety of dietary supplements with the actual or potential health danger.  With the current light-handed regulation, costs for dietary supplements are much lower than they would be if they had to be approved by the FDA prior to market.  Some consumers believe that if a product says it is ‘natural’ then it must be safe.  This, however, is not necessarily true.  Would you eat any wild plant or mushroom just because it is natural?  I hope not.  In recent years, a number of adverse events, including death, have been shown to be correlated or caused by use of dietary supplements. 

It seems that some of the tactics employed by the tobacco industry to avoid regulation are similar to tactics employed by the dietary supplement industry.  My paper/presentation addresses what lessons we can learn from the tobacco industry to analyze if the FDA should be granted the authority to increase the regulation of the dietary supplement industry.  I hope to see you all in Boston.

Introducing Joanna Sax

We’re excited to introduce and welcome Joanna Sax as a guest blogger for the month of May.

Joanna is an Associate Professor of Law at California Western School of Law.  She teaches Contracts, Trusts & Estates and a seminar entitled Law, Science & Medicine.  Her main area of research is biomedical policy; specifically, how to create incentives to advance scientific research and protect scientific integrity.  In this area, Joanna has recently focused on issues such as financial conflicts of interest and the relationship of politics and science.  Another area of interest is FDA regulation; Joanna will be presenting at the upcoming conference on the FDA in the 21st Century hosted by Petrie-Flom.  Prior to focusing her research interests on the intersection of law and science, she was a molecular biologist and spent years researching cancer.

Joanna attended the University of Wisconsin – Madison, where she earned a B.S.  After undergraduate school, she was a pre-doctoral fellow at the National Cancer Institute.  In 1999, following her fellowship, she began a PhD program in Cell and Molecular Biology at the University of Pennsylvania School of Medicine.  In 2003, after earning a PhD, she entered law school at the University of Pennsylvania.  After law school, she spent 2 and a half years as an attorney at Morgan, Lewis & Bockius, LLP.  In 2009, Joanna joined the faculty at California Western School of Law.

Some of Joanna’s recent publications include:

Welcome, Joanna!