November 2007 Archives

Cosmetics and the FDA

If you hear that dangerous levels of lead in lipstick, you might think, "well, good, I'm off the hook, I don't wear lipstick", or, "I don't wear Merry Berry Cherry Blush lipstick". But lead is contained not only in brands of shiny red lip gloss. And the concern is not only about lead. The US government doesn't oversee chemicals in "cosmetics". Cosmetics includes not only make-up -- lipstick and eyeshadow, but soap, shampoo, mouthwash, suntan lotion, wart remover, towelettes, tooth whitening strips, baby oil, etc.. As Proctor & Gamble likes to brag: "Three billion times a day P&G brands touch the lives of people around the world".

The FDA does prohibit "misbranded" or "adulterated" products in "interstate commerce", which amounts to exceedingly mundane, or exceedingly basic oversight. The containers, for instance, cannot be "so made, formed, or filled as to be misleading". The cosmetics themselves cannot "consist in whole or in part of any filthy putrid, or decomposed substance". Granted, it's comforting to know that in America, you'll probably be spared the 6:30AM surprise of patting shaving cream with lumps of decomposed rat tails onto your cheeks. But with the federal bar low, industry gets a lot of latitude for formulating its products as it sees fit. While the average hand soap fails to impress us as potentially dangerous, there are quite a few products marketed in the US that contain disturbing levels of the same carcinogens or reproductive hazards that are banned in Japan, Australia and the EU.

There are regulations in place in the US, but people who assume that the regulatory environment of the 1970's and 1980's is still keeping unsafe chemicals off the market be surprised at the current state of affairs. For instance in the EPA's Toxic Substances Control Act (TSCA), provides regulations for chemicals in the environment. Apparently TSCA is weak enough that some people deride it as the "Toxic Substances Conversation Act". 60,000 chemicals were grandfathered in when the act was first put in place. At the 25th anniversary of the organization, Lynn Goldman, a professor at John's Hopkins University, said she realized just how flawed regulation might be when, "someone from the chemical industry got up to salute TSCA and said ""This is the perfect stature. I wish every law could be like TSCA"".

EU: Competitiveness = Safety?

In Europe, cosmetics are regulated by the European Commission/ Directorate General Enterprise and Industry, which oversees both the competitiveness and safety of EU products. The fact that both goals, competitiveness and safety, are combined in the same organization, underlines the idea that one does not cancel the other out. The health of the industry is ostensibly tied to the safety of the chemicals. As well, the EU Health and Consumer Protection Directorate regulates chemicals in cosmetics. To date, about over 1000 chemicals, carcinogens, mutagens, and reproductive toxicants (CMRs), which are prohibited in European cosmetics. The Health and Consumer Protection Directorate also removes imported products containing banned chemicals or chemicals in excess of allowable levels. It recently pulled several brands of nail polish with dibutyl-phthalate, and body-care products with hydroquinone and N-Nitrosodiethanolamine.

The changes in European regulatory climate relative to the US can be seen in recent actions on cosmetics, as well as plastics, persistent organic pollutants (POPS), and in the the REACH (Registration, Evaluation,Authorization and restriction of CHemical substances) directive on chemical reporting.

The general difference between the EU approach and the American approach is that in the US companies tend to reason that exposures to toxicants are small, therefore harmless.The EU looks at the inherent hazardous properties of the chemical. Considering that these chemicals interact with humans and the environment from the time they're manufactured to the time they're disposed of, taking steps to understand how citizens are exposed to what chemicals and to regulate or even ban toxic chemicals seems important.

EU v. US: How Companies Manage

Because of the different regulations in the EU, many cosmetics are formulated differently for European and American markets. This doesn't necessarily alarm US citizens, who no doubt believe that because the US is a "litigous society", companies are motivated to keep products safe. Mark Shapiro writes in "Exposed, The Toxic Chemistry of Everyday Products and What's at Stake for American Power" that this notion that the federal government oversees products and therefore insures our safety is false.

P&G, for instance, says it abides by the EU guidelines, submits required toxicity data, and formulates its European products according to European market standards. But while P&G is submitting toxicity data to the EU, it spends $600K to lobby against the same safety guidelines being proposed by the Safe Cosmetics Act in California. P&G protested that the act would create "an unreasonable and unnecessary burden". P&G is also a significant corporate sponsor of tort reform efforts in the US, including campaign donations Republican judges attentive to "business-friendly" legal reform.

Mark Shapiro describes how chemical regulation in the United States has lagged since it's heyday in the 1970's and 1980's, especially in past decade. By contrast, he says, the EU has stepped up chemical regulation and product safety standards.

Shapiro notes that US company opposition to chemical regulation emphasizes the economic cost necessary to comply with the rules, and that US lobbyists even accuse the EU of welfare economics. However European agencies stress they're not sacrificing profit at the alter of environmental socialism, not even close. The EU currently manufactures more chemicals for the world market than the U.S., and Shapiro argues that they are taking a proactive stance on manufacturing standards that's threatening to leave the U.S. in the dust, even as the U.S. loses deals insisting that business profits trump consumer safety.

Shapiro's book covers accounts of cosmetic regulation, as well as endocrine disruptors - especially phthalates, GMO's, persistant organic pollutants (POPs) (like DDT, Aldrin, Dieldrin, Endrin, Chlordane, Heptachlor, Hexachlorobenzene, Mirex, Toxaphene, Polychlorinated Biphenyls, Dioxins, and Furans), and the EU Restriction of Hazardous Substances Directive (RoHS) that regulates substances in electronic equipment (like lead, Mercury, Cadmium, Hexavalent chromium, Polybrominated biphenyls (PBB), and Polybrominated diphenyl ether (PBDE)). In his telling, the U.S. consistently undermines efforts to regulate the chemicals.

Shapiro's point that European leadership is at the forefront of environmental considerations across the globe might seem optimistic. A couple of years ago Acronym Required wrote about an incident involving the inclusion of an Ampicillin gene in genetically modified seeds that were erroneously sold and planted for four years in the EU and the US. Both European and US regulatory agencies failed to respond to the error, as we described in "Transgenic Crops - Strife Across the Pond". It might seem that between government agencies and business interests, assessments of chemical toxicity would be the same on both sides of the Atlantic, but that assumption is false.

Events in recent legislation in San Francisco and California concerning phthalates in children's toys illustrate the influence the EU might have on the US. One reason consistently given by both state and city legislators for enacting the legislation was that Europe had already banned phthalates. It works both ways. Although the San Francisco law originally sought to ban bisphenol-A, this chemical was quickly dropped from the bill when the city and state seemed to be influenced by lobbyists who pointed out that bisphenol-A regulation in Europe is limited.

Shapiro makes a convincing case in an interesting book, that the EU's more aggressive stance on chemicals will benefit its economy, as well as citizens within and outside the EU.

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Acronym Required wrote about REACH, and Mark Shapiro's article in Harper's a couple months ago . We also wrote about REACH back in 2005. We've written frequently on bisphenol-A and phthalates, the environment, and government regulation.

The Environmental Working Group has a database of 25,000 health care products available in the US with estimates of potential risks. Many health care products, whether high end, organic, or cheap drugstore brands, contain chemicals known or suspected to cause cancer or affect reproductive health. The database compares ingredient lists on the labels to databases of chemical toxicants, then rates the products on a 1-10 score. Imperfect, but interesting.

Eleven states sued the EPA yesterday for loosening the reporting standards of companies who release chemicals into neighborhoods. The suit is led by Attorney General Cuomo of New York, and joined by the states of New Jersey, Connecticut, Arizona, California, Illinois, Maine, Massachusetts, Minnesota, Vermont, New Hampshire, and Pennsylvania. The states challenge the legality of the laxer rules that allow companies to release up to 5,000 pounds of toxic chemicals without extensive reporting. This overrides the old rule, enacted in 1986 during the Reagan administration, in the wake of India's Bhopal accident, which required extensive reporting for any amount above 500 pounds.

According to the New York Times, the EPA claims that their "making a good program better". However many observers say the opposite. The complaint, filed in the Southern District Court of New York represents labor organizations, environmental and public health groups, and scientists, who all use the information to monitor and study chemical releases in the environment. As well,communities and individuals use the information to advocate for safe neighborhoods.

As most people know, the domesticated turkey that Americans eat for Thanksgiving descends from the wild turkey, Meleagris gallopavo, native to America. The Spaniards fancied the turkey when they invaded Mexico where turkey was indigenous, and then introduced the bird to Europe when they returned in the early 1500's. However, during the expansion of the Ottoman Empire, turkeys were thought by northern Europeans to be a product of Turkey.

Europeans also for a time called turkeys "India fowl", then confused the turkey with "Guinea fowl" and gave turkeys the same Latin genus name: "Maleagris". The species name that they settled on, "gallopavo" combines the Latin for rooster and for peacock. From these confusing origins turkeys have long struggled with their identity. First they were put in their own family, Meleagrididae; but now scientists consider turkeys to be part of the pheasant family, Phasianidae, in the subfamily Mealeagidinae.

In 1934, Dr. Frank Thone, a botanist and journalist for Science News Letter, wrote that other native American plants, tobacco, corn, and pumpkin, were also assumed by Europeans to be products of Turkey. ¹

The 1542 botany text by Leonard Fuchs, De historia stirpium commentarri insines, described corn and pumpkin as Turkish. The Yale medical library has scanned the plates of the wood cuts from Fuch's 1543 German translation of De historia stirpium, called New Kreuterbuch. As Thone describes, the plates for pumpkin and corn, refer to the vegetables as "Turkish cucumber", and and "Turkish corn".

Thone translated Fuchs explanation of "Turkish corn" history: "The plant here considered has been brought to us only recently from Turkey, Asia and Greece... thus far it has no Latin name other than Turcico frumentum. Corn now, is of course known as Zea mays. Thone wrote in 1934 that turkey still retained its "red fez" misnomer, while corn, tobacco, and pumpkin had been popularly reconnected to their proper American origins.

Digesting that, you can sit back in your stretchy pants and put your feet up on the ottoman...

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¹Frank Thone wrote "thousands" (according to his obituary) of articles for Science News Letters, now Science News, which was started in 1921 as a part of the Science Service. He was one of the reporters who covered the Scopes trial in 1925 and sought to use the trial to educate the public about evolution.

(corrected link 11/24/07)

Yahoo In China

This week, Yahoo settled a lawsuit brought against the company by two Chinese citizens and their families. The lawsuit accused Yahoo of aiding and abetting torture under the Alien Tort Claims Act and the Torture Victims Protection Act. Yahoo had been giving Chinese authorities the names of dissidents who were then arrested, tried, and imprisoned -- guilty of using Yahoo services for pro-democracy activity. Two of these citizens, now in prison with ten year sentences, attracted the attention of the global community. In September, 2002, Yahoo turned over account information of Wang Xiaoning, who was charged by China of "inciting subversion" (creating a publication that advocated "a multiparty political system, separation of powers, and general elections"). Later Yahoo turned over information for Shi Tao, who China accused of transmitting "state secrets" (information about China's plans for handling the anniversary of Tiannamen square).

Yahoo defended its actions, saying it was bound to Chinese law. Furthermore, the questions had no place in American courts, they said, since Yahoo had: "no control over the sovereign Government of the People's Republic of China, the laws it passes and the manner in which it enforces its laws."

Yahoo In France

This is very different from what Yahoo said in a case in the French courts in 2000, when they claimed that they were an American company not subject to the laws of France. In that case Mark Knobel, a Paris resident, had found a cache of Nazi mementos being sold on Yahoo auction sites. Knobel asked Yahoo to remove the merchandise, a request that AOL had honored in a similar situation two years earlier. The company founders, Jerry Yang and David Filo were busy celebrating the dot com era. Their company namesake, "Yahoo", is one is who is "rude unsophisticated and brash", and the stock price was close to $500 a share.¹ Yahoo refused to remove the Nazi items.

"'It is very difficult to do business if you have to wake up every day and say 'OK, whose laws do I follow?', said Heather Killen, a Yahoo vice president, "We have many countries and many laws and just one Internet"'

While different than their China claim, their train of thought was apt. The Internet in 1990 was a new place, a proper noun -- like Atlantis or Shamhala. Internet businesses were much closer to the manifesto issuing 1990's, when some of the Internet's first users fostered ideas about Cyberspace, the democratic, borderless social space over which sovereign governments could not lord. In the midst of e-commerce proliferation, many inside and outside of the technology grappled with the question of whether nation-states would take a lesser role.

However, French lawyers in 2000 didn't buy Yahoo's argument. French laws applied to radio and television, why would they not apply to the internet? Judge Jean-Jacques Gomez ordered Yahoo to make the Nazi paraphernalia inaccessible via the French internet. Yahoo then tried to argue that they couldn't technologically remove Nazi merchandise on sites hosted in the United States for the sake of the French. It was impossible -- how could you tell where the user was geographically located?

The court drew in expert witnesses who demonstrated that this assertion was false. Yahoo at the time was serving up French ads to French users from sites the company had mirrored in Switzerland. Yahoo's actions weren't protected under the laws of a sovereign US. In 2001 after more protracted dispute and non-compliance with the court requests, Yahoo removed Nazi merchandise.

In the Chinese case, as in the French case, Yahoo was cagey. They first testified to Congress that they had no idea of the fates that befell the Chinese whose names the company had turned over to the government. But a translated copy of the Chinese authority's warrant turned up on the internet. Congress held another hearing, and the committee's title indicated the tone the meeting would take: "Yahoo! Inc.'s Provision of False Information to Congress.". House Foreign Affairs Committee Chairman Tom Lantos (D-CA) (very active himself fighting crimes against humanity), subjected Yahoo's CEO and council to scathing rebuke, and demanded that Yang apologize to the families of imprisoned men. Shortly thereafter, a cowed Yahoo settled with the families.

Yahoo et al: Stateless to Stateful to....?

In 1990 when international discourse circled the question of whether states were relevant, Yahoo based its defense in France on the sentiment they weren't. In July, 2002, Yahoo entered China's business world with stock trading at $9.71, humbler than the 2000 highs. Yahoo was one of 300 companies to sign a document issued by the Chinese government, "Public Pledge on Self-Discipline for the Chinese Internet Industry". The companies agreed to follow various Chinese dictates aimed at cracking down on the internet's potential to democratically inform and enlighten, to question the government. The Chinese surveillance and censorship society blossomed. Few people in the business hungry US found these companies' stances disagreeable. Human Rights Watch was one who did fear the worst, warning in August 2002, that Yahoo "risks complicity in rights abuses". "If it implements the pledge, Yahoo! will become an agent of Chinese law enforcement."

Today, the US dithers about whether waterboarding is torture or not, revels in its own abundant state secrets, and wiretaps to its heart's content, covering its actions with the sinister haze of terroristic threats and legal immunity. Contractors in Iraq have upon occasion raped, killed and pillaged -- but there's always profit. The US leaps to do business with countries led by borderline or full-fledged tyrants who spout various "nationalist" ideas. Despite the current milieu, taking the moral high ground is worthwhile every now and again. Talking about "spread of democracy" serves certain ends. There are instances when the chimes of a declarative moral stance resonate with a public eager for seemingly anachronistic sentimentalities, like when a Senate committee member lambasted Yahoo during the hearings: "morally you are pygmies".

In the article "Yahoo Isn't the Only Villain", the Los Angeles Times points out that the entire Chinese national firewall, espionage program and internet surveillance system is built and supported with U.S. technology. Cisco built the firewall and supplies other technology. Skype (Ebay) scans instant messages,Google's search filters offensive ideas, and Microsoft, Dell and H.P. also participate. Many of these companies aren't new to the game, IBM supplied the technology for the efficient Nazi state too.

The head of the Chinese company, China Security and Surveillance, who also serves as the technology director of the ministry of public security that runs Project Golden Shield. The company recently incorporated as a US publicly traded company to encourage western investment. China Security and Surveillance financed itself with loans and private placements with 17 US institutional investors. China Public Security Technology and other companies have done the same thing.

The New York Times reported that the Chinese security industry was valued at $500 million in 2003 and is predicted to be 43 $billion by 2010. Finance message boards such as Yahoo's buzz with anticipation. Tom Lantos is leading the charge to set up guidelines for US companies working in China. If accomplished, it will be a feat -- businesses busily hack away at the effort.

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¹In the book, "Who Controls the Internet, Illusions of a Borderless World," Jack Goldsmith and Tim Wu describe Yahoo's challenge to France's control of the internet back in 2000. They trace the history that led to the French legal battle and the position that Yahoo subsequently took with China.

The site Collegehumor.com does a skit of the un-aired pilot for the Fox Show 24, back in 1994.

When Fear of the Internet Manifests as a Desire to Throw Cheerios:

In Time magazine's "When the Patient is a Googler", Dr. Scott Haig constructs a straw lady for our entertainment. His female patient "brandish[es]" information during an office visit and her unruly child strews chocolate milk and Cheerios around his office. Haig caricatures a harried mom and compares her scornfully to his ideal patient, the engineer who is "accustomed to the concept of consultation". His Mr. or Ms. "Logical" leaves the kids in someone else's care and probably sports a pocket protector to prevent ink from the Pilot Extra Fine Point pen from spilling on the doctor's office upholstery. Kudos to engineers for knowing their rightful place. To be fair, Haig likes nurses too. They're his "favorites", because "they know our language and they're used to putting their trust in doctors. And they laugh at my jokes."

Doctor Haig has a seemingly exalted position in New York's medical circles. He teaches, runs a private practice, and "punts" his undesirable patient, with her "mispronounced words and half-baked ideas", after only one short visit. Shouldn't we all be this spoiled? Hospitalists, emergency docs, managed care docs, brilliant and dedicated private practice doctors, nurses, lab techs, physical therapists, administrators and medical workers are usually stuck with their clients -- even when those individuals who have anti-medical ideas like yin-yang, or nutrition. But imagine if, like Haig, after a mere twenty minutes of most your insufferable patient, co-worker, doctor, or boss, you could simply boot them out? You could just bid that person adieu and never have to see them again? Without sacrificing your (let's say) $500,000K+ salary? Oh, should such a world be mine! To hell with compassion.

For a man of his stature, Haig's stereotyped "brainsucker" female protagonist with her wayward toddler provokes a strong reaction -- "I soon felt like throwing Cheerios at her too"..."I couldn't dance with this one". Why such indignation?

When patients visit the doctor they generally get one 5-30 minute office visit with the "expert". Doctors are pricey, even if insurance buffers the $200-$500 bill. "Personalized" medicine? Patients are lucky if the doctor gets their name and age right. Stressed by whatever ails them, patients don't see doctors for a living, as doctors do patients, so they should be forgiven their unpracticed manner.

And mispronounciations? Think of your dear grandmother, born in a time not too long after the town doctor made patient rounds with his horse-drawn carriage. Does she have to ape the behavior of a dispassionate engineer in order to avoid the scorn? Does the harried mom? She probably wishes she did have childcare. How and why would she know the pronunciations of words in the lexicon of an orthapedic surgeon?

Many doctors agree that patients should be as informed as possible for their own health. We all acknowledge that American medicine is often a broken system. Sure "experts" abound, but complacent doctors are easy to find too. Medical errors occur in "44,000 to 98,000" patients a year according to the FDA (via Google). Patients, being human, aren't all equally subtle or adept at integrating their new found internet information with the doctor's expertise. But doctors should be able to adjust to this. They should be able to relate to inevitable unevenness in "patient's bedside manners", and the variable ability of patients to see the body in the exact same way that a trained doctor does.

Google's Intrusion?

Haig did not write 'Googler Patient' for Acronym Required's rhetorical amusement. In his telling, his irritating patient knows his address, which unsettles him. But it's hard to imagine any real rage or paranoia built around that. It's easy enough to keep your address fairly private, and his patient is obviously harmless. If we were to hazard a guess, we'd suspect there's something underlying his irritation. We'd suggest that he's upset, unsettled perhaps, thinking about how the internet might further disrupt the cozy information asymmetry implicit in doctor patient relationships. Does Google Seach masquerade in Haig's tale as his pushy female who is intruding, too "rude" and "too personal"? Does "she" (Google) jostle the power structure? Does "she" (Google) unnerve the doctor?

There's a phenomenon at work here concerning the internet, medical information, and doctor/patient relationships. Unfortunately this Time column doesn't get around to exploring the more subtle and interesting aspects of the story.

In a related piece, Tom Delbanco, M.D., and Sigall K. Bell, M.D write in "Guilty, Afraid, and Alone - Struggling with Medical Error", (New England Journal of Medicine NEJM Volume 357:1682-1683, October 25, 2007), about mutual fear on the part of patients and doctors that exacerbates suffering due to medical mistakes. The authors have made a film for third year medical students and suggest that in the case of medical errors, there should be a forum for some sort of reconciliation: "patients and families will bring ideas to the table that expand the horizons of health care professionals". They note that "because of the power dynamics between physicians and patients, questioning the expertise or skill of an authority figure is particularly fraught for the least empowered members of society".

I've just finished reading a fun book that I got at a book swap called How Proust Can Change Your Life, by Alain de Bottom. I liked it of course, although other reviewers who are more opinionated about incorporating Proust in a book title found it alternatively "clever"- "witty..funny..tonic" or "superficial..contrived..patronising".

Happily, I can stay in theme by reading a couple of new releases that not only include Proust but science too. In Proust Was a Neuroscientist, Jonah Lehrer writes about artists who, ensconced in their writing or cooking or painting, conceived of some aspect of sensory science ahead of the scientists. In Proust and The Squid, Maryanne Wolf writes about human development and reading.

On Proust's place in neuroscience, I didn't bring Proust along to fill in the empty moments between my neurobiology experiments as Lehrer did, and have yet to finish "In Search of Lost Time" -- I may not be the best judge. While Proust inspired books divert my attention, Proust stares down from the spines of seven unfinished volumes shelved up by the ceiling, mocking my frenzied schedule. Although some reviewers make it seem unique or iconically 21st century to mix literature and science, I contend that the pairing is natural. Scientists have always been a cultured lot to my mind, especially neuroscientists, and artists forever inquisitive about the natural world. Whatever the circumstances or pretenses Proust so often finds himself as muse, these two new books promise interesting reading.

When a story about the human appendix not being "useless after all" hit the press and blogosphere a month ago, quite a few science blogs explained that this "new" functionality idea was flawed and carefully pointed out the problems with the research, in the midst of what was largely unabashedly uncritical enthusiasm. The writers noted that this was not new research, just a review of the literature. More importantly, the Duke authors' proposal in the Journal of Theoretical Biology that the appendix was not vestigial but served to house beneficial gut bacterial was unproven (though some deemed it interesting).

Despite the effort, I noticed that Answers.com featured the appendix story in "Today's Highlights", and alas it wasn't listed as "fake news".