HealthLawProf Blog

Teaching The Emperor of All Maladies

Our medical school took the bold step of assigning Mukherjee's The Emperor of All Maladies as required reading for all entering medical students.  I recently had the pleasure of leading two small group discussions about the book and commenting on the students' reflection papers.  I was absolutely delighted by the students' engagement with the book and by their reactions to it--as were my fellow discussion leaders.  Many of the students had read the book more than once.  Although they were often initially drawn in by the stories of heroism and conquest, nearly every student came away with understanding of the far more complex world of medicine--and cancer--that it is Mukherjee's goal to portray.  They engaged with his discussions of the social context of medicine and the need for cooperation.  They discussed the complexities of research ethics raised by experimental treatments and phase 1 trials.  They expressed the hope that they would be able to establish the kind of relationships with patients that Mukherjee weaves through his accounts of the science.  Some were surprised by how much science they learned from reading Emperor, too. And they were deeply impressed by his sense of the uncertainties and limits of medicine.

Ours is, to be sure, one medical school.  But our experience as discussion leaders was so overwhelmingly positive that I suspect other medical students might benefit from the experience.  And I profoundly wished that I had had the opportunity to discuss the book with a mixed group of law students and medical students.

[LPF]

A Tale of Two Stories - Growth in Health Care Costs is Down, but Nobody Knows How Much Things Cost

Two recent stories in the New York Times highlight the fact that our health care system is so dysfunctional, that we don't really have a clue as to how to fix it.  In a piece that has received a lot of media attention, a researcher discovered something that many of us already knew--that if you are trying to shop around for the best price for a health care service, you are out of luck.  Jaime Rosenthal, a student at Washington University in St. Louis, called more than 100 hospitals around the country, trying to get a price for a hip replacement for a 62-year-old (fictional) grandmother who would pay cash for the procedure.  Half of the hospitals would not provide any price estimate at all, while the other half quoted wildly divergent prices ranging from $11,100 to $125,798.  Some hospitals were willing to bargain, and lowered their prices for a self-pay patient when pressed.  For those who are proponents of "consumer-directed health care" (in which the consumer is given a certain amount of money to purchase health care, and is supposed to be able to shop around for the best price for the care), this points out the problems with assuming that anybody can be an"informed consumer" when it comes to health care services under our current system.  The inequity in bargaining power and the knowledge gap between the consumer and the provider is just too great.

So apparently, the cost of procedures currently depends solely on the amount of profit the provider thinks it needs to make.  Nevertheless, the New York Times today also reported a piece of good news regarding health care costs-- growth in health care costs is sharply and persistently slower than the Congressional Budget Office had expected.  Growth continues to be at the lowest rate in decades for a fourth consecuitive year.  The article says that the consensus is that doctors and hospitals are changing how they deliver health care to eliminate waste, insurers are no longer paying per procedure, and market forces are driving down costs.

The juxtaposition of these two pieces of news tells me that prices for health care procedures have been so inflated for so many years that providers can charge prices that are likely to exceed 10 times the cost of their services, while at the same time we can experience a slowing in the growth of health care costs.  I am usually a skeptic about plowing money into "demonstration projects" and research, but I am  beginning to think that any money we put into research on the actual costs of health care services and theamount of profits being made on such services will be money well-spent.  After all, we can't fix something we don't understand.

[VJW]

Cross-posted on Healthy Interests

Life Cycle of the Fight to Label Innovative Ingredients Introduced Into Consumer Products - A Suggestion for Producers of Lab Grown Meat

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 just 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. The EPA explains that  

[n]anotechnology is the science of the very small. A nanometer is 100,000 times thinner than a strand of hair. … Nanomaterials can exhibit unique optical, mechanical, magnetic, conductive and absorptive properties different than the same chemical substances in a larger size. With these new properties, a world opens up for the development of innovative products and services that have the potential to change the world by offering new medicines, products and services.

According to the PEN, the Project on Emerging Technologies, nanotech materials are currently being used in 1317 consumer products which are being produced by 587 companies. The manufacturers of the vast majority of these products do not disclose these products’ nanotech content. It is projected that the nanotech product market will grow to 2.4 trillion dollars by 2015. As is the case with GMOs, the FDA does not mandate labeling as it states that there is insufficient evidence that nanotech ingredients, as a class, are harmful to human health. The FDA appears to indicate that, in the future, it will evaluate nanoparticle safety on a case by case basis.

Of note, unlabeled and “untested nanomaterials have been used in food to brighten colors, enhance flavors, and improve supplement delivery, and in packaging to increase shelf- life, barrier properties, heat resistance and temperature control, and as anti-microbial and fungal protections.” See here and here and here.

Nanoparticles are highly mobile and are very easily absorbed into the human body. Nanoparticles enter the blood stream through the lungs, skin and GI tract. When they are released into the air they can enter the brain through the olfactory nerves. And they can easily slip unhindered into bone marrow, muscles, the liver and spleen and actually into cells themselves. Once inside your cells they bind to cellular structures, move through the cytoplasm and lodge in the mitochondria. These tiny particles can cross the blood brain barrier and, during pregnancy, can cross the placenta to enter the fetus.  And, of most concern, they can bioaccumulate. In other words, the amount of nanoparticles in your brain, your lungs and your cells can build up over time. See here.

One of many problems with the growth in the number of nanotech consumer products, especially products used for food, is that animal and in vitro cell testing raise serious questions over the health effects of exposures to nanoparticles. Illustratively, exposure to nanoparticles may cause structural damage to the lungs resulting in an asbestos-like effect, may damage DNA causing cancer and may negatively impact phagocytes causing an HIV effect. See here.  Direct exposure isn’t the only concern. A series of recent studies document the negative effects of manufactured nanoparticles on food crops (here, here and here) and demonstrate how nanoparticules can enter the food chain through plant exposures.

Just as was the case with GMOs, the labeling nanotech movement is gathering steam. For example, as reported in the New York Times, consumer rights group As You Sow has begun a major effort to “out” those food companies that introduce nanotech particles into its food products.  As You Sow describes itself as follows:

Founded in 1992, As You Sow promotes environmental and social corporate responsibility through shareholder advocacy, coalition building, and innovative legal strategies. Our efforts create large-scale systemic change by establishing sustainable and equitable corporate practices. *** We have led or actively participated in hundreds of shareholder dialogues and resolutions. The many companies whose policies and practices have been impacted by our work include: Chevron, ExxonMobil, Duke Energy, FirstEnergy, General Electric, McDonald's, Safeway, Whole Foods, Yum! Brands, Apple, Dell, HP, Best Buy, Coca-Cola, PepsiCo, Nestlé Waters, Starbucks, Target, Gap, Home Depot, Walt Disney, and DuPont.

As You Sow recently released the results of a survey of 2,500 corporations. These corporations were asked whether they used nanoparticles in their food - in spite of repeated phone calls and e-mails, only 26 responded.  As You Sow also tested 10 varieties of powdered doughnuts for the presence of nanoparticles. With the help of an independent lab, it found that Hostess Donettes and Dunkin’ Donuts Powdered Cake Donuts tested positive for the presence of titanium dioxide. Titanium dioxide is used to brighten white substances. Nanotech titanium dioxide is under investigation by the E.P.A.

In the context of consumer workarounds, history is also repeating itself in other ways. PEN has developed an inventory of nanotechnology-based consumer products currently on the market. In addition, PEN has introduced findNano, “an application for Apple’s iPhone and iPod Touch that lets users discover and determine whether consumer products are  nanotechnology-enabled.” If this pattern continues to repeat itself, we will soon see “nanotech-free” product labeling and a wave of proposed nanotech labeling legislation.

To avoid the same battles and loss of consumer trust that GMO food manufacturers have faced over the past decade, manufacturers using other innovative ingredients in their food products should be paying attention to this life cycle when they are bringing their products to market. A good example coming closer to reality is the development of lab grown meat for human consumption. Rather than risk consumer backlash from a refusal to disclose, producers of this innovative product should consider creative marketing messages that allow for notice of its innovative properties.  For example, many who are meat lovers may see lab grown meat as a solution to the environmental, affordability and ethical issues that arise out of our current system of meat production.

Full transparency when introducing innovative ingredients into consumer products “from the get go” will short circuit the life cycle of nondisclosure and consumer workarounds that appears to develop when novel ingredients are being introduced into the market. It will also go far in rebuilding the consumer trust that was lost through the GMO labeling struggle.

[KVT]