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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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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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

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.