Price Reductions for Diabetes Care Supplies


The New York Times

June 20, 2013


Starting next month, changes are afoot for Medicare beneficiaries who order diabetes supplies — testing strips and lancets — by mail. About 50 percent to 60 percent of diabetics on Medicare prefer to receive supplies in their mailboxes, a cheaper and often more convenient alternative to local pharmacies and storefronts.

Yet mail-order diabetes supplies have caused Medicare headaches for years. A Department of Health and Human Services inspector general’s report last year, for instance, reported that 20 percent of suppliers sent beneficiaries strips by mail, which costs less, but billed Medicare at the more expensive retail rate.

“It’s been an area where there’s been a lot of fraud, a lot of overutilization and a lot of studies saying Medicare pays too much, the taxpayer pays too much and beneficiaries with a 20 percent co-pay pay too much, too,” Laurence Wilson, director of Medicare’s chronic care policy group, said in an interview.

Now, after a successful experiment in nine metropolitan areas, Medicare has instituted competitive bidding for mail-order firms that want to sell strips; it has signed contracts with just 18 carefully vetted companies nationwide. That’s a big shift from the hundreds of suppliers who used to sell strips to Medicare recipients.

The process has cut prices sharply. Medicare previously paid $77.90 for 100 mail-ordered strips; now it will pay $22.47. That means co-payments plummet, too, from $15.58 to $4.49.

“The large mail-order suppliers recognized this was a huge market and they could afford to accept a lower price to reach that volume of customers,” Mr. Wilson said. “The taxpayer wins.” (This, you may recall, was the argument for allowing Medicare to negotiate with drug companies to lower prices when Part D was introduced, an argument the Bush administration successfully resisted.)

Another piece of good news: The tax relief bill that Congress passed last year mandated that Medicare pay retailers the same amount as mail-order companies. So 100 strips will cost $22.47 this year, wherever you buy them, so long as your pharmacy accepts Medicare’s reimbursement as full payment. Don’t say Congress never did anything for you (or for your secondary Medigap insurer, if that’s who picks up your co-pays).

The downside, though, is that unless the mail-order company you already use made the cut and has become one of the 18 suppliers that won contracts, you’ll have to change suppliers. (If you skip mail order and buy supplies locally, you don’t have to do anything.)

Medicare has worked to alert beneficiaries, state health departments, physicians, hospital discharge planners and state health insurance assistance programs to this change, which takes effect July 1. You can find a supplier online (go to and enter your ZIP code), call 1-800-MEDICARE, or ask your doctors for a referral.

The folks at the American Diabetes Association are understandably concerned about this process. Last year, 2.3 million Medicare beneficiaries filed claims for mail-order diabetes supplies. That means hundreds of thousands of people, at least, probably have to switch to new suppliers.

Some have poor vision or impaired cognition or can’t use computers. They may have trouble reading the materials Medicare sent, or understanding them, or remembering what’s required. The transition could be bumpy.

“This could look to consumers like Medicare isn’t covering things,” said Krista Maier, the association’s director of public policy. Moreover, “we have heard, anecdotally, that some beneficiaries had trouble finding a mail-order supplier that sold their brand of strips.”

(Other Medicare beneficiaries will feel the effects of the competitive bidding process, too, by the way. In 91 metropolitan areas, those who use certain categories of durable medical equipment — including wheelchairs and walkers, oxygen, hospital beds and CPAP devices for sleep apnea — may also have to switch suppliers after July 1.)

On the whole, diabetics should fare well under the new system. They will pay less and gain new protections against fraud. And Medicare’s monitoring of the first nine test markets shows no negative impact on health.

“The bottom line is, were there any adverse patient outcomes? No,” Mr. Wilson said. “We didn’t see people go to doctors or hospitals more or to emergency rooms. We didn’t see more mortality.”

But if an elderly friend or relative gets strips by mail, it makes sense to check in and see whether he or she needs to select a new supplier, and to help make that happen.

AMA Declares Obesity a Disease

Obesity, Hypertension Prevalent in Growing Number of Children


US Children Consume Fewer Calories, But Too Much Saturated Fat, June 20, 2013, by Marcia Frellick, CHICAGO — Physicians voted overwhelmingly to label obesity as a disease that requires a range of interventions to advance treatment and prevention.

However, there was impassioned debate in the hours before the vote here at the American Medical Association (AMA) 2013 Annual Meeting.

Although policies adopted by the House of Delegates have no legal standing, decisions are often referenced in influencing governmental bodies. This decision could have implications for provider reimbursement, public policy, patient stigma, and International Classification of Diseases coding.

“Obesity is a pathophysiologic disease. There is a treatment for this disease; it involves behavioral modifications, medications, and surgeons. Obesity affects minorities disproportionately,” said Jonathan Leffert, MD, alternate delegate for Endocrinology, Diabetes, and Metabolism. “The scientific evidence is overwhelming.”

Melvyn Sterling, MD, said this brings to mind to the debate over whether hypertension is a disease.

“I’m a general internist, among other things, and I treat the complications of this disease. It’s interesting to look back in history at a time when hypertension was not thought to be a disease,” said Dr. Sterling, who is from the AMA Organized Medical Staff Section, but was speaking for himself. “Obesity is a disease. It’s very, very, very clear that even though not every hypertensive gets a stroke and not every obese person suffers the complications, that does not change the fact that this is a disease.”

Some Not Convinced

Others testified that the measure for determining obesity is imperfect and although it is an epidemic, obesity does not meet the criteria for disease.

Russell Kridel, MD, incoming chair of the AMA Council on Science and Public Health (CSPH), told Medscape Medical News that there is no debate about the importance and urgency of addressing the problem, but he doesn’t believe it qualifies as a disease.

“It’s more like smoking. Smoking isn’t a disease. Smoking can cause disease such as lung cancer and emphysema in the same way that obesity can lead to diabetes and hypertension,” he explained. “We’re really talking nomenclature here, not philosophy.”

He noted that behavior and dietary choices play a part in obesity. “Thirty years ago, we did not have the obesity problem we have now. If you look scientifically at what has changed, our diet has changed. There’s been no change in our genetic structure in the past 30 years.”

Dr. Kridel said he would like to see more attention focused on prevention and personal responsibility. The CSPH issued a 14-page report opposing the classification of obesity as a disease.

“We did not think the evidence rose to the level where obesity could be recognized as its own distinct medical disease state. Obesity is a very serious condition. It’s a scourge on our nation. It’s an epidemic. It’s a significant risk factor for many other diseases,” said Robert Gilchick, MD, speaking on behalf of the CSPH. “But that does not alone make it a distinct medical disease state.”

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He explained that because body mass index, an imperfect measure, is used to determine obesity, people who are otherwise healthy are being diagnosed as obese.

“Why should one third of Americans be diagnosed as having a disease if they aren’t necessarily sick?” he asked.

One Third of Americans

According to the Centers for Disease Control and Prevention, 35.7% of Americans are obese. Obesity-related conditions, including heart disease, stroke, type 2 diabetes, and certain cancers, are some of the leading causes of preventable death.

In other AMA actions, a policy that supports banning the marketing and sale of high-energy drinks to anyone younger than 18 years was adopted.

Also accepted was a policy that supports letting students have sunscreen at school without restrictions. Currently, most states don’t allow students to possess over-the-counter medications in school without a note from a physician. Sunscreen is considered an over-the-counter medication because it is regulated by the US Food and Drug Administration.



New Obesity Drug, Belviq, in US Pharmacies Next Week

Arena Withdraws Lorcaserin Diet Drug Application in Europe, June 20, 2013, by Lisa Nainggolan  —   The new obesity drug lorcaserin (Belviq, Eisai/Arena Pharmaceuticals) will finally be available for prescription in the United States next week, the manufacturers have announced. The news comes as the European regulatory agency provides more details about why it rejected the product.

Lorcaserin, which was cleared for marketing in the United States almost a year ago in its second attempt, is indicated for chronic weight management, along with a calorie-controlled diet and increased physical activity, in adults with a body mass index (BMI) of 30 kg/mmore or in those with a BMI of 27 kg/mor more who have at least 1 weight-related medical condition, such as type 2 diabetes or high blood pressure.

Lorcaserin is a 5HT2c-receptor agonist, which is believed to imitate the effects of serotonin on these receptors, resulting in an increased sense of fullness after a meal and reduced hunger before meals, thereby reducing food consumption.

It will be the second obesity drug to appear on the US market in recent times; Qsymia (phentermine/topiramate; Vivus) was the first new obesity medication in 13 years when it was launched last September. Sales of Qsymia have been slow, however, and it will be interesting to see how lorcaserin is received.

The delay in launching lorcaserin in the United States was due to the companies waiting for regulatory classification to determine the risk of abuse; this came recently when the Drug Enforcement Agency deemed it was a schedule IV drug — the second-least-restrictive designation on a 5-step scale.

EMA Says Benefits Do Not Outweigh Risks for Lorcaserin

The European Medicines Agency (EMA), however, has not seen fit to give the thumbs up to lorcaserin; Arena Pharmaceuticals withdrew its application for European Union approval for the product last month.

The EMA has since revealed that it was concerned about thepotential risk for tumors, particularly with long-term use, based on the results of laboratory tests. It also had other safety concerns, including the potential risk of psychiatric disorders (such as depression) and valvulopathy, which were seen in some patients during clinical trials.

The cancer risk in animal studies was one of the concerns of the Food and Drug Administration (FDA) when it rejected lorcaserin the first time around.

The EMA says it is still “of the opinion that the benefits of Belviq did not outweigh its risks.”

Arena decided to withdraw the EU application because it could not resolve the European agency’s “major objections related to the results of nonclinical studies within the regulatory timeframe.” The future development strategy for lorcaserin in Europe “is under evaluation,” the company says.


Slow and Steady Can Win the Diet Drug Race, By Esha Dey and Zeba Siddiqui

(Reuters) – Vivus Inc, vying to create the world’s first billion-dollar weight-loss pill, is taking a cautious approach to marketing in an attempt to overcome the skepticism, safety concerns and lawsuits that have dogged the diet drug industry.

The company has lost nearly half of its market value since lackluster sales tarnished the September launch of the first new weight-loss pill in the United States for 13 years. Two of its largest shareholders have questioned the company’s strategy.

But Vivus, which sent out only 150 sales representatives to a target market of 25,000 doctors, is betting on slow, steady marketing of the drug called Qsymia (phentermine/topiramate) to win over customers. Its model, say analysts, could become the blueprint for diet drug makers.

“A slower launch that allows people some time to try and use the drug, and make sure the effects they are seeing are good and any risks are more modest, makes more sense both in the medical and financial sense,” said Kurt Kessler of ZS Associates, which consults on pharmaceutical marketing.

Thomson Reuters Pharma estimates sales of Qsymia will reach $1.2 billion by 2017, up from $128 million in 2013, making it the largest weight-loss pill on the market. That potential goldmine has analysts rating the stock of Mountain View, California-based Vivus highly.

More than one-third of Americans are obese, a condition that can lead to problems such as heart disease and diabetes. A September 2012 report by lobby group Trust for America’s Health estimated the annual burden on the U.S. healthcare system from obesity at between $147 billion and $210 billion.

The epidemic has inspired initiatives such as a ban on large sugary drinks in New York, calorie limits on school lunches and U.S. First Lady Michelle Obama’s childhood anti-obesity campaign, “Let’s Move”.

Demand for weight-loss pills is also high, which is why some investors were disappointed when Vivus earned just $41,000 from the first two weeks of sales of Qsymia. Analysts had expected it to earn nearly eight times as much.


Vivus Chief Commercial Officer Michael Miller said the Qsymia launch was “focused and very educationally based.”

Weight-loss pills, which typically work by suppressing appetite, are based on brain chemistry that is still not fully understood by science.

A slow rollout will allow time for post-marketing studies requested by the U.S. Food and Drug Administration (FDA) to test for increased risk of heart attack or stroke.

Dr. Leonid Poretsky, a physician with the Albert Einstein College of Medicine in New York City, sees about 100 patients a week who need to lose weight. He says he is yet to meet “that ideal Qsymia patient.”

“The drug combination (in Qsymia) is new, but the medications are not,” he told Reuters. “The point is to learn a lot about it, and then try it on one or two patients who are appropriate for it.”

Qsymia, the first pill to promise users 10% weight loss within a year, contains two previously approved medications that have encountered safety issues: the appetite suppressant phentermine and the anti-epilepsy drug topiramate.

Phentermine was part of the “fen-phen” drug combination, a diet medication pulled from the market in 1997 after causing severe heart problems. Its maker, Wyeth, now part of Pfizer Inc, paid out billions of dollars in damages to patients.

Topiramate, marketed as Topamax by Johnson & Johnson, has been shown to increase the risk of cleft lips in infants when taken by their mothers during pregnancy.

Women aged between 18 and 45 will be required to take a pregnancy test before being prescribed Qsymia. Neither is Belviq (lorcaserin), a rival pill developed by Arena Pharmaceuticals Inc and due to hit market soon, advised during pregnancy.

There are also reputational risks to failure.

John Singer, a marketing consultant involved in the 1999 launch of Roche’s Xenical (Orlistat) – the last diet pill to be launched before Qsymia – said part of the challenge faced by the drug industry today was to manage public perception.

Many patients, he said, shunned Xenical because of one embarrassing side-effect in particular: diarrhea.

“Xenical became a butt of jokes on late-night talk shows – Jay Leno, David Letterman, that kind of stuff. Very quickly, the side-effects profile of Xenical became front and center of the story of the drug,” Singer said.


Kessler of ZS Associates said drug manufacturers could arrange for patients and physicians to share their experiences with the new weight-loss pills in public forums.

“There is pretty high patient engagement in obesity,” he said. “It’s likely the drugs will get positive word-of-mouth.”

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Arena is awaiting regulatory classification for Belviq to determine the risk of abuse before it can launch its new pill, giving the company time to fine-tune its own sales strategy.

“Arena might sell (Belviq) at a lower price or do something clever with the pricing that would be an advantage,” said Robin Davidson, an analyst with Edison Investment Research. A month’s supply of Qsymia currently costs about $160.

Mindy Nichols, a Seattle-based dietician, said Belviq could also benefit from Qsymia’s relatively higher risk profile.

“Even though Belviq’s effectiveness is maybe three-quarters that of Qsymia, it could be prescribed more often,” she said, adding that clinical trials have shown Belviq to have the additional benefit of fighting smoking addiction.

With health insurer Aetna Inc having announced it would provide coverage both for Qsymia and Belviq, the prospects for the adoption of both pills are good.

Referring to Qsymia, Vivus President Peter Tam said: “Once patients and physicians become aware and gain the experience of using the medication … it will be a multi-billion dollar drug pretty quickly.”


The Success of the HPV Vaccine: The Times’s Pam Belluck on how the HPV vaccine has helped drastically reduce the number of human papillomavirus cases among teenage girls.



Published: June 19, 2013

The New York Times


The prevalence of dangerous strains of the human papillomavirus — the most common sexually transmitted infection in the United States and a principal cause of cervical cancer — has dropped by half among teenage girls in the last decade, a striking measure of success for a vaccine that was introduced only in 2006, federal health officials said on Wednesday.


Photo Credit: Joe Raedle/Getty Images – Dr. Judith L. Schaechter gives an HPV vaccination to a 13-year-old girl in her office at the University of Miami Leonard M. Miller School of Medicine.



Infection with the viral strains that cause cancer dropped to 3.6 percent among girls ages 14 to 19 in 2010, from 7.2 percent in 2006, a new study has found. The vaccine protects against strains of the HPV virus that cause 70 percent of cervical cancers.

“These are striking results,” said Thomas R. Frieden, director of the Centers for Disease Control and Prevention. “They should be a wake-up call that we need to increase vaccination rates. The bottom line is this: It is possible to protect the next generation from cancer, and we need to do it.”

The study, published in the June issue of The Journal of Infectious Diseases, covered the years 2003 to 2010. Its findings were based on a national survey that is conducted every two years and considered the gold standard on health indicators. Government health workers did face-to-face interviews and collected vaginal swabs from more than 8,000 girls and women ages 14 to 59 that were sent to the C.D.C. for evaluation.

The decline surprised public health experts because vaccination rates in the United States are still relatively low. Only about a third of teenage girls have been vaccinated with the full course of three doses, far lower than in other rich countries like Denmark and Britain, where vaccination rates are above 80 percent. Even Rwanda, a developing country in central Africa, has reached 80 percent.

Dr. Frieden said the low vaccination rate in the United States means that 50,000 girls alive today will eventually develop fatal cervical cancer, deaths that could have been prevented if the country’s rate had been at 80 percent. For every year the rate lags, another 4,400 girls will develop cervical cancer in their lifetimes, he said.

Health officials offered several possible explanations for why the drop was so sharp despite the fact that most teenage girls in the United States are still not fully vaccinated.

One possible reason is a phenomenon known as herd immunity, in which vaccinated people reduce the overall prevalence of the virus in society, reducing the chances that unvaccinated people would have sex with someone who is infected. Another is the unexpected effectiveness of a partial dosage of the vaccine, Dr. Markowitz said. About half of teenage girls in the United States have gotten at least one dose of the vaccine.

The sharp decline in the infection rate comes at a time of deepening worry among doctors and public health officials about the limited use of the vaccine in the United States and some signs that resistance to it may be growing. A study published in Pediatrics in March found that 44 percent of parents in 2010 said they did not intend to vaccinate, up from 40 percent in 2008.

Many parents fear the vaccine will have bad side effects, a concern that health officials say is unfounded. Others worry that girls will see the vaccines as condoning sex.

Dr. Frieden said that doctors had been one of the main obstacles to increasing vaccination rates. They are “not consistently giving strong recommendations for the vaccines, particularly for younger teens,” he said. Another factor is skeptical parents, who commonly say that the vaccine is not needed because their teenagers are not having sex. But Dr. Frieden said vaccination should happen long before a person is exposed.

“The time has come to ramp up our efforts to protect the next generation against cancer,” he said. “This is an anti-cancer vaccine.”

About 79 million Americans, most in their late teens and early 20s, are infected with HPV. Each year, about 14 million people become infected. The virus causes about 19,000 cancers in women every year, and 8,000 in men, according to the C.D.C. Cervical cancer is the most common among women; among men, throat cancer is most common.


A rendering of a new work by James Turrell for the Guggenheim Museum
Photo: Andreas Tjeldflaat


Editor’s note: Although this Blog usually posts articles about medical research, the pharma industry, science and technology, climate change and goings-on in “the Big Apple,” we cannot help but share with our readers, news about one of the most spectacular artists of all time, James Turrell.  Just reading this article, will give a tiny glimpse into the world of a genius marching/resonating to the beat of a different drummer.


By WIL S. HYLTON, The New York Times, June 17, 2013


It was a beautiful Thursday morning in May, and everything was going wrong. James Turrell had six days to prepare for the biggest museum exhibition of his life — 11 complex installation pieces at the Los Angeles County Museum of Art — but he didn’t have a single work finished, and he was missing crucial parts.

He shuffled into the office of Lacma’s director, Michael Govan, and flopped into a chair with a sigh.

“I’m pretty concerned,” Turrell said. “You know, the computer that came back from Russia was completely wiped.”

Govan tapped a foot underneath the table. The computer was essential. Much of Turrell’s work consists of special rooms that are infused with unusual light, and the computer helps run the show. It had been in Russia for another exhibition, but something went awry in transit.

“There’s nothing in it,” Turrell said. “Nothing’s in it at all! Nothing.”

Govan shook his head calmly. “That happens in Moscow,” he said.

Turrell shifted uncomfortably in his seat. “I guess,” he said. “I don’t have a piece that’s finished yet. You know, it’s getting late on everything.”

“Has the lens left Frankfurt?” Govan asked. This was another essential part.

“No, it hasn’t left Frankfurt,” Turrell said.

“I thought it did,” Govan said.

“No, no,” Turrell said. “It has not left Frankfurt. I don’t know what’s going on.”

Now it was Govan’s turn to sigh. “You should have been a painter,” he said. “Five years of planning, three months of construction, and there’s not one work of art.”

The plan had been simple on paper: Turrell would open three major shows inside a month. As soon as he finished the Lacma pieces, he would race to Texas for another huge installation at the Museum of Fine Arts, Houston, and then to Manhattan, where he is opening a show at the Guggenheim next week. Taken together, the three-museum retrospective is the biggest event in the art world this summer. As the curator of the Houston exhibition, Alison de Lima Greene, put it, “This is the first time that three museums have mounted exhibitions of this magnitude in conjunction, all devoted to a single artist.” In total, the retrospective takes up 92,000 square feet.

Assembling any Turrell show is a complicated affair. Unlike a show of paintings and sculpture, every piece must be built on site, and even more than with most installation art, his work requires elaborate modifications to the museum itself. Windows must be blocked off or painted black to obscure the outside light; zigzagging hallways are constructed to isolate rooms; and each of the rooms has to be built according to Turrell’s meticulous designs, with hidden pockets to conceal light bulbs and strange protruding corners that confuse the eye. Even the drywall must be hung and finished with exacting precision, so that each corner, curve and planar surface is precise to 1/64th of an inch. It can take hundreds of man-hours to finish a single room; he was erecting 11 at Lacma.

Turrell at 70 is a burly man with thick white hair and a snowy beard. He tends to dress in dark clothing, like Santa Claus in mourning. We had been spending a lot of time together as he prepared for the shows, and I had followed him to Los Angeles to see the final stages. After the conversation with Govan, I retreated outside and found a bench in the shade to do some reading. I expected to be there a while. Two hours later, I looked up and saw Turrell standing there with a smile. “Well,” he said, “we’ve got one ready. Come on, let’s take a look.”

I followed him inside the building, and we rode an elevator to the second floor. We stepped into a dim lobby filled with construction equipment. “This way,” he said, turning into a dark hallway. I walked behind, my hands groping for the walls. Turrell stayed a few steps ahead, muttering directions — “forward now, another step, this way, and turn” — until I rounded the final corner and saw the piece materialize before me. It was a looming plane of green light that shimmered like an apparition. The rush of blood to my head nearly brought me to my knees.

It is difficult to say much more about the piece without descending into gibberish. This is one of the first things you notice when you spend time around Turrell. Though he is uncommonly eloquent on a host of subjects, from Riemannian geometry to vortex dynamics, he has developed a dense and impenetrable vocabulary to describe his work. Nearly everyone who speaks and writes about Turrell uses the same infernal jargon. It can be grating to endure a cocktail party filled with people talking about the “thingness of light” and the “alpha state” of mind — at least until you’ve seen enough Turrell to realize that, without those terms, it would be nearly impossible to discuss his work. It is simply too far removed from the language of reality, or for that matter, from reality itself.

The piece that day at Lacma, for example, was one of his “Wedgeworks” series. The room was devoid of boundaries, just an eternity of inky blackness, with the outline of a huge lavender rectangle floating in the distance, and beyond it, the tall plane of green light stretching toward an invisible horizon, where it dissolved into a crimson stripe.

I suppose it would be fair to say that all of this was an illusion. The shapes and contours I saw were made entirely of light, while the actual walls of the room were laid out in a way I could never have guessed. When, after a few minutes, a museum worker accidentally flipped on a bright light, I was surprised to see a small chamber in the back, with a workman’s ladder propped against the wall. Turrell lurched toward the doorway in a panic, crying out, “What the hell are they doing?”

Other pieces by Turrell are even more disorienting. His “Dark Spaces” can require 30 minutes of immersion before you begin to see a swirling blur of color, while some of his rooms are so flooded with light that the effect is instantly overpowering. Stepping into one of his “Ganzfeld” rooms is like falling into a neon cloud. The air is thick with luminous color that seems to quiver all around you, and it can be difficult to discern which way is up, or out.

Not everyone enjoys the Turrell experience. It requires a degree of surrender. There is a certain comfort in knowing what is real and where things are; to have that comfort stripped away can be rapturous, or distressing. It can even be dangerous. During a Turrell show at the Whitney Museum of American Art in 1980, several visitors to a piece called “City of Arhirit” became unsteady in the bright blue haze and tried to brace themselves against a wall made of light. Some of them fell down. A few got hurt. One woman, who broke her arm, sued the Whitney and Turrell for more than $10,000, claiming that the show made her so “disoriented and confused” that she “violently precipitated to the floor.” Another visitor, who sprained her wrist, sued the Whitney for $250,000. The museum’s insurance company then filed a claim against Turrell, and although a member of the Whitney family put a stop to the suit, Turrell still gets sore thinking about it. He spent $30,000 to defend himself, but it’s not the money that bothers him the most. It’s the lingering feeling that the work didn’t . . . work.

“On some level,” he told me, “you’d have to say I failed.”

We were at his townhouse on Gramercy Park in Manhattan. Like Turrell’s other two homes, in northern Arizona and eastern Maryland, it was furnished mostly in the Shaker style. The walls were cream, with very little hanging art, and the furniture was all in cherry. Turrell sat at the center of a dining table and began to describe other incidents. One of his friends had taken a tumble at the same Whitney show. “He was just standing there,” Turrell said with a shrug, “and he leaned back and fell.” At a show in Vienna, another visitor took a running start and leapt into a Ganzfeld room, perhaps expecting to land on a bed of pillowy clouds. She smashed into a wall. And then there were the “Perceptual Cells.”

The Perceptual Cells are Turrell’s most extreme work. The visitor approaches a giant sphere that looks like an oversize Ping-Pong ball and lies down on something like a morgue drawer to be pushed inside. When the door is shut, the lights come on, so bright that it’s almost pointless to close your eyes. As the colors shift and morph, you begin to see things that aren’t there, like tiny rainbows floating in space and crisp geometric forms. It turns out that what you’re seeing is the biological structure of your own eye, which, in the blinding intensity, has turned on itself.

Even Turrell describes the Perceptual Cells as “invasive” and “oppressive.” Some of his most avid fans prefer not to see the series. Andrea Glimcher represents Turrell at the Pace Gallery in Manhattan, but when she visited Lacma for the opening in May, she declined to view the Perceptual Cell. “Just thinking about it makes me want to press a panic button,” she told me. When one of the curators of this year’s Guggenheim exhibition, Nat Trotman, viewed the Perceptual Cell at Lacma, he wrote me to say that it had “rewired” his thinking and was “very aggressive and very hallucinatory.” Before viewers climb into the Perceptual Cells, Turrell makes them sign waivers to certify that they are 18 years old, sober and sane.

The joke among Turrell’s friends is that, to see his work, you must first become hopelessly lost. Though he is routinely listed among the signature artists of his generation (in 1984, he and Robert Irwin became the first visual artists to receive MacArthur “genius” grants), he has never enjoyed the widespread recognition of artists like Donald Judd, Jasper Johns and Chuck. In fact, Turrell has not held a major museum show in New York since the Whitney exhibition of 1980, or in Los Angeles since 1985.

Much of his art is located in the far corners of the earth. There is an 18,000-square-foot museum devoted to Turrell in the mountains of Argentina, a monumental pyramid he constructed in eastern Australia and an even larger one on the Yucatán Peninsula, with chambers that capture natural light.

Turrell’s greatest work and lifelong fixation is an extinct volcano on his ranch in Arizona, where he has been developing a network of tunnels and underground rooms since 1974. The volcano has a bowl-shaped depression on its top and is known as Roden Crater. Turrell has never opened the crater to the public, and he is guarded about who sees it. An invitation to visit Roden is one of the most coveted tickets in American art.

“It has become, even unfinished, as important as any artwork ever made,” Michael Govan said. “I know I’m going out on a limb here a little bit, but I think it’s one of the most ambitious artworks ever attempted by a single human being.”

Turrell’s obsession with the crater is the stuff of legend, but he prefers not to analyze it. For a man driven by such a monomaniacal artistic impulse, he is startlingly uninterested in himself. Through dozens of conversations in multiple cities over perhaps a hundred hours, I found him willing to examine almost any idea, so long as it didn’t require any self-reflection. I would ask, for example, about his place in the art world, or his faith, or lack of it, or how he feels about the crater as he grows older and the forces of obsession and mortality collide — and each time he would nod and frown and say something like, “Well, you know, you just have to accept things as they are.” Then he would launch into a 30-minute dissertation on the geometry of sailboat hulls. The more questions you ask Turrell, the more elusive he seems. Growing up Quaker, he was always being told to nurture “the light within.” At 70, he seems more interested in the light without.

Some of Turrell’s contemporaries view the mystery around him with a measure of envy. One day this spring, I stopped by the studio of Chuck Close in Lower Manhattan. There was a large, incomplete portrait of a woman hanging from one wall, with its lower half descending through a narrow gap in the floor. Close, who has been in a wheelchair since an arterial collapse in 1988, raises or lowers the canvas in order to reach the spot where he’s working. A few years ago, Turrell invited him to visit Roden Crater.

“I was shocked when I got out there,” Close said. First, that Turrell had made the crater wheelchair-accessible. “He proudly put me in this four-wheel-drive golf cart and drove me all the way up into the thing.” But when they reached the top, Close found another surprise. Turrell has spent years shaping the rim of the caldera in such a way that it seems to distort the contour of the sky. He calls this “celestial vaulting,” and he helped Close lie down to experience the phenomenon. Staring up, Close was struck in equal parts by the power of the illusion and its subtlety. “He’s an orchestrator of experience,” Close said, “not a creator of cheap effects. And every artists knows how cheap an effect is, and how revolutionary an experience.”

Close is among the most famous living painters, but when he looks at an artist like Turrell, it sometimes makes him skeptical of his own fame. “It makes me wonder if I’m making pabulum for the masses,” he said with a laugh. Close described how, in the 1960s, artists like Turrell and Robert Smithson and Walter de Maria “wanted to go in the desert and dig a hole or ride a motorcycle in a circle, or dig a ditch, or put a bunch of spikes for lightning to hit. It was about not making a commodity. Not making it something that would go in a gallery.” Many of those artists criticized Close for working in a more conventional medium. “I’ve been arguing with Mel Bochner for years,” he said, “because Mel gave me tremendous grief for making stuff that hung on the wall, like I might just as well have been a prostitute inviting people up to my room.”

Close pointed out with a wry smile that most of those friends have since found a way to show their work. “After a while, they thought, Oh, no one’s going to see this stuff!” he said. “So then they take photographs. Then they frame the photographs and put them in a gallery.” Still, he sometimes wonders if they were on to something back in the ’60s — and if Turrell, in his work at the crater, still is.

“I may be known by more people, but I’m often known for all the wrong reasons,” Close said.

For his part, Turrell has begun to think more about what he’ll leave behind. On a recent drive across the desert to see the crater, he turned to me and said, “I was absolutely going to get this project done by the year 2000, so I’m a little embarrassed by it. There have been periods of euphoria. There have been times that I’ve been discouraged, and times when I’ve just gone out and enjoyed the place — and realized that maybe this would be it. Maybe it wouldn’t get any further.”

We were approaching the crater through a field of impossibly picturesque cattle, their long, straight backs and thick conformation the envy of any rancher. Turrell bounced along at the wheel of the truck, smiling at the herd. “We’ve learned a lot about livestock,” he said, “but the biggest thing is learning about personnel. You know, you’re not going to want artists to take care of your livestock.”

When Turrell first spotted the crater from an airplane in 1974, he had no intention of buying the land around it. He just wanted to dig into the volcano. He persuaded the Dia Art Foundation in Texas to purchase the site on his behalf. When the foundation spiraled into financial trouble a few years later, Turrell scrambled to take over the title. He applied for a loan, but the bank told him the ranch wasn’t big enough to turn a profit. 
“They said, ‘This will just be a gentleman’s ranch, and you’ll lose money,’ ” Turrell said. “Which I now understand is true. They said: ‘But there’s one ranch over that’s now for sale. If you buy that one, and you buy the one in between, we think we could negotiate — we won’t loan you a little, but we’ll loan you a lot!’ ”

Turrell by then was married with young children, and his wife opposed the purchase. “My wife said at the time, ‘You’re mortgaging our children’s future,’ ” he said, “and for that and other reasons, she left — and I took the loan.”

By the time Turrell had signed the note for all three ranches and leased the public land between them, he was the proud, solitary overseer of a 155-square-mile property that could be supported only with livestock. He was 36 years old and had never raised a cow in his life.

Turrell was brought up in Pasadena in a devout Quaker family. “It was like the conservative Mennonites,” he said. “I come from a family that does not believe in art to this day. They think art is vanity.” Even as a child, Turrell was skeptical of the family’s old-fashioned mores. Little things, like his mother’s refusal to use household appliances, bothered him. “My mother did not have a toaster oven and would toast bread in the oven, which I thought was stupid,” he said. “They didn’t do cars and electricity, that kind of stuff.”

One of Turrell’s aunts, Frances Hodges, lived in Manhattan and worked for a fashion magazine. When Turrell visited, Hodges would take him to concerts and museums, expounding upon the virtues of engagement with modern life. “Her whole thought,” Turrell said, “was doing something society would contend with. That was her purpose in fashion. She didn’t care if it was a vanity.” On a trip to the Museum of Modern Art with Hodges in the 1950s, Turrell discovered the work of Thomas Wilfred, who experimented with projected light in the early 1900s. Turrell remembers staring at one of Wilfred’s “light boxes,” in thrall to its shifting lines of shadow and color. Today, his home on Gramercy Park is next door to the one where Hodges lived.

In 1961, Turrell entered Pomona College to study math and perceptual psychology, but on the side, he continued to indulge his interest in art. He took courses in art history and signed up for studio classes. After graduation in 1965, he enrolled in a graduate art program at the University of California, Irvine. That wasn’t to last. In 1966, he was arrested for coaching young men to avoid the Vietnam draft. He spent about a year in jail, and after his release in 1967, moved into a shuttered hotel in the Ocean Park section of Santa Monica. Over the next seven years, he would make a series of artistic breakthroughs that define his work today.

Turrell had discovered a strange optical effect in one of his projects for grad school. By placing a slide projector in an empty room and pointing its beam toward the corner, he found that he could make a cube of light that seemed to occupy physical space. As he settled into the rooms of the Mendota Hotel, he began to explore variations on the idea. Soon he was using colored slides and moving the projector around the room. He discovered that he could make pyramids and rectangles of light, which seemed to lean against the wall or float halfway to the ceiling. After a few months, he switched the bulb from tungsten to xenon, fascinated by the subtle difference in its effect. Over the next five decades, he would become an expert on light-bulb varieties, studying the distinctive character of neon, argon, ultraviolet, fluorescent and LEDs. For his 70th birthday last month, a friend gave him a bulb he’d never used before; Turrell was ecstatic.

By the late 1960s, he was also experimenting with outdoor light. He painted the windows of the hotel and scratched lines in the paint, allowing narrow slits of light to enter the room. He found that he could create patterns and illusions, much as he had with the projector. He called the series “Mendota Stoppages,” and he felt they had at least one advantage over the projection series: Because the light came from outside, there was no machinery in the room. He had created a gallery in which the art was made entirely of light.

Turrell wanted to keep the room empty but fill it with electric light. He realized that he could modify the walls to create hidden chambers for the bulbs. He called these pieces “Shallow Space Constructions” and tried a dozen permutations. In some, he tucked bulbs along a single edge of the room; in others, the whole frame of a wall glowed with brilliant color. One of the earliest Shallow Spaces, “Raemar Pink White,” is currently on display at Lacma. After 44 years, it still has the coruscating radiance of something from a future world.

By the early 1970s, Turrell was exploring another phenomenon with natural light. Instead of scratching paint on the windows, he cut large holes in the walls and ceiling of the old hotel to create a view of the open sky. With the right size of opening and the right vantage and some careful finish work, he found that it was possible to eliminate the sense of depth, so the sky appeared to be painted directly on the ceiling. Then he pointed electric lights at the hole, marveling at the dissonance between the light coming in and going out. He discovered that when he changed the color of the electric lights, he could change the apparent color of the sky. He called the series “Skyspaces.”

Turrell’s studio at the Mendota Hotel had become a locus for artists, curators and gallery owners who passed through Southern California. The founder of the Pace Gallery, Arne Glimcher, offered him a show. Turrell agreed, then changed his mind. The Italian collector Count Giuseppe Panza di Biumo stopped in to ask if Turrell would cut a Skyspace into his villa near Milan. Turrell promised to do it soon. All he really wanted to do was stay in the old hotel, cutting his holes and building his walls and bathing in his light. But in April 1974, the hotel’s owners threw him out. A terse note ordered Turrell to “dispossess, quit, and surrender the premises.”

A few years earlier, he had scraped together enough money to buy a small airplane, which he kept in a nearby hangar and maintained himself. He’d also received a Guggenheim fellowship, which gave him some financial freedom. He packed his belongings onto his airplane and took off. For the next seven months, Turrell canvassed the Western skies. Each evening, he would land the plane wherever he happened to be, unfurling a bedroll to sleep beneath its wing. In the morning, he was back in flight, scanning the desert floor. He wanted to find a small mountain surrounded by plains, so the view from on top would resemble that of flight. Inside the mountain, he planned to carve tunnels and chambers illuminated by celestial light. He would bring together all his previous work in a new studio that no one could take away from him.

The day he spotted Roden Crater, he knew it was the one. The land wasn’t for sale, but he persuaded the owner to let it go, and soon he had set up camp at the base of his own private volcano. By day, he traipsed the surface with a pile of surveying equipment, drawing topographic maps to guide his work. At night, he lay on the top and studied the stars. He tried to imagine how he would bring their light inside the mountain.

Even at a distance, it’s easy to see why Turrell stopped at Roden Crater. The silhouette on the horizon is stunning, a topless pyramid floating on a sea of amber grass. As you draw close, the color begins to fill in, piles of deep red and charcoal cinder in heaps around the core.

Over the last 30 years, Turrell’s ranching operation has only grown. What began as a concession to economics has become a private passion. The ranch now spreads across 227 square miles — roughly 145,000 acres — with a black angus herd of nearly 2,500 head. Most are certified “natural” and will produce prime-grade beef. “When you’re O.C.D.,” Turrell said, “you want the most beautiful animals.”

The ranch has also become part of the viewing experience at the crater. In the same way the eye must adapt to darkness in some of Turrell’s museum pieces, the endless drive across the desert prepares a visitor for the singularity of Roden. Distance and isolation come naturally to Turrell, but he has also learned how valuable they are to his work. One of my favorite Turrell pieces is the Skyspace “Tending (Blue),” which is inside a small stone building behind the Nasher Sculpture Center in Dallas. To reach the piece, you pass through a Renzo Piano-designed building filled with northern light, then you cross the clean, clear lines of a landscape by Peter Walker. By the time you enter the Skyspace, the city of Dallas is long forgotten. I once lost the better part of a day inside, staring up as clouds lofted and flattened against the ceiling. But last year, a mirrored skyscraper went up nearby, reflecting glare into the building, killing plants in the garden and looming into view of the Skyspace. The museum had to close it.

At Roden Crater, Turrell has no such problems. The nearest town, Flagstaff, is home to the Lowell Observatory, and the city government has maintained “dark sky” ordinances since 1958. It is illegal to shine a searchlight in Flagstaff, and it has been for 55 years. In 2001, the city was selected by the International Dark Sky Association as the first “Dark Sky City.” Several years ago, Turrell joined forces with local and Navajo leaders to tighten the laws even further. Currently most of the outdoor lighting in the city and surrounding areas has to be shielded.

We were pulling around the base of the crater and began to climb the side. Halfway up, we turned into the parking area of a small lodge. The lodge is built mostly from local stone and leftover materials from the crater project. There is a small kitchen, a large common area and four bedrooms tucked into the back. Someday, Turrell hopes to build additional lodges and rent their rooms, so visitors can spend the night at the crater.

A few of Turrell’s staff members had gathered inside the lodge, and the curators of the Guggenheim show, Nat Trotman and Carmen Giménez, had flown in from New York. Trotman and Giménez made an amusing pair. Trotman is tall and bulky with a tangle of dark hair, and is so well spoken that he sometimes seems to be reading from a script. Giménez is slight, energetic and impulsive. She is from Spain but speaks English with a French accent. Since 1989, she has been the museum’s senior curator of 20th-century art. The two had been to the crater together once before, in the rain. Now they were back, as Trotman put it, “to still our minds and immerse ourselves in what he’s doing.”

Trotman really did wonder what Turrell was doing — for months it had been a mystery. The show at the Guggenheim includes a piece that no one has ever seen. It is also Turrell’s largest installation piece, and one that’s difficult to classify: a 79-foot tower of light in the museum’s central rotunda.

Any Turrell show asks a lot of a museum, but the tower, called “Aten Reign,” is in a league of its own. Nothing quite like it has ever been assembled in the Guggenheim, and neither Trotman nor Giménez could be sure what it would look like.

In simple terms, the tower is made from a series of metal rings, which are spaced 11 feet apart and wrapped in flexible plastic to form a cone. When it has been fully assembled in the rotunda, it will hang from the atrium ceiling, with the bottom edge dangling about 10 feet from the floor. Viewers will walk underneath the cone and look up at a show of light. In a sense, the piece is a Skyspace, because the light may enter through the glass roof; in another sense, it is a Ganzfeld, because the effect will be one of indistinct space and gloaming light. But in truth, nobody knows what it will be, except maybe — hopefully — Turrell.

“When you work with an artist like James,” Giménez said one day as we stood in the center of the rotunda, “the most important thing is to stand aside and make things possible for him.”

Trotman was trying to maintain the same perspective, but it wasn’t easy. While Giménez spent most of her time in Madrid, he was responsible for coordinating the plans and logistics for a huge installation piece that he couldn’t quite imagine. He had drawn renderings of the tower, but they were only speculation. Basic details were anybody’s guess. It was unclear, for example, whether Turrell would leave the atrium window clear, or allow a small circle of light through, or block it off entirely. Whatever light did filter into the piece would change throughout the day, but Trotman had no idea how that would affect the color of the piece. In fact, he had no idea what color the piece would be. He hoped that Turrell would use a series of shifting hues that blurred from one to the next, but he didn’t know if that would happen, and he didn’t expect to know until a week or two before the opening, when the tower was in place and Turrell arrived to light it. When someone asked Trotman about the piece, he would usually shrug and say, “I really don’t know what he’s going to do.”

To build the tower, the Guggenheim fabrication team rented a warehouse in New Jersey, and I joined Trotman there one afternoon for a look. The warehouse was a huge, grimy space lighted with fluorescent bulbs. In the center, the top portion of the tower dangled from hooks on the ceiling. A skin of white plastic was stretched around it, and a small crew of lighting assistants milled about, blasting different colors inside. Turrell’s chief lighting expert, Matt Schreiber, stood below, looking up into the cone. Periodically, he would call out instructions, like, “Can you make it cold white, and then start bringing it down?” or, “You know, the easiest is red — when in doubt, make it red.”

Trotman stood to the side. During a pause, he approached Schreiber and asked, “Do you have any way to know how bright it’s going to be?”

Schreiber shook his head.

“You know,” Trotman said, “depending on what time of day it is, the light is going to change.”

“Yeah,” Schreiber said. “If we have time, we could make a night setting.”

Trotman smiled. “That would be good,” he said.

Schreiber called out, “Make it blue,” and stepped to the center of the ring. He turned to an assistant and said, “This other blue, when you look at it next to a normal blue, looks white.”

Every curator who has worked with Turrell has been through an experience like Trotman’s. It was a story I heard in museums and galleries all over the country. Richard Andrews, who ran the Henry Art Gallery at the University of Washington for 20 years, told me about his own introduction to Turrell. It was 1981, and Andrews was a young artist himself. Like many artists, he was distressed that the galleries in town were not showing much contemporary work. He and his friends decided to rent an exhibition space of their own. It was a cavernous three-story warehouse with unfinished interiors, and on a whim, they asked Turrell to open their first show. To their shock, he agreed.

Turrell flew up to Seattle and began to help renovate the warehouse. He put together a list of pieces he wanted to show on the first floor, but as the months ticked past and the opening drew closer, he still had no plans for the upper level. “I kept saying to him, ‘So, what are you going to do?’ ” Andrews recalled. “And he basically, for months, said, ‘I don’t know.’ ”

Finally, with only a couple of weeks remaining, Turrell had an idea. He asked the group to help him build a wall in the center of the room with three large rectangular holes. Then he climbed through the holes and began to hang fluorescent lights on the back of the wall. Andrews and his friends watched. They had no idea what Turrell was doing — until at last he turned off the main lights and flipped on the ones he had installed. The rectangular windows exploded with brilliant light: an ethereal pink on the left, and a deep blue on the right, and in the middle a mélange of both colors that Andrews still can’t quite explain. “I can really only describe it as fog,” he said. “These two extraordinary colors moved toward each other and through each other, and it was just crazy.”

Today Andrews serves as the president of Skystone Foundation, a nonprofit organization that Turrell created to manage Roden Crater. One big part of Andrews’s job is to raise enough money to finish the crater. Finding donors in the recession has been a daunting task, so Andrews has spent the past five years preparing for a future drive. One of the first things he knew he would need, if he wanted to raise several million dollars, was to know exactly what “several” means. When you’re trying to solicit large amounts of cash, it’s helpful to explain where the money is going. Earlier this year, Andrews and Turrell completed the first full set of blueprints for the crater — detailing every screw, bolt, rod of reinforcing bar and cubic yard of concrete that the project will take.

Now that Andrews has the blueprints, he can estimate the costs; what remains is to grab the attention of the public and donors in a way that Turrell never has before. With so much of his work scattered across the globe, it can take years for a potential fan to discover Turrell. Even the best photography doesn’t begin to capture the immersive experience. For those inclined to travel for art, the exhibitions this summer present the first opportunity to take in so much of his work at once. For Turrell, what his newly raised profile allows, maybe, is a chance to complete the crater, his life’s work.

The afternoon sun was beginning to descend over Roden, and we left the lodge and followed a short path to the main entrance, a pair of high metal doors. As we stepped through, it was instantly apparent that none of my expectations had been right. For one thing, the room was several times larger than I had imagined. For another, it was as perfectly finished as the most elegant Midtown hotel.

We were in a circular room, with a slightly convex top, that Turrell calls the Sun and Moon Space. At the center of the room, a massive sheet of black stone rested on its edge. An eight-foot-diameter circle had been cut from the center and replaced with white marble. The seam where the two colors met was perfectly flush. One side of the slab faced the doors where we entered, which was precisely the direction of the rising sun at summer solstice. The other side faced the opening of a long tunnel, which rose gently into the distance. This was the direction of the moonset at its southernmost point in the lunar cycle. Every 18.61 years, the moon would align perfectly with the center of the tunnel, and Turrell had installed a five-foot diameter lens at the midpoint to refract its image onto the white circle. The next such occasion would be in 2025.

One by one, we walked up the tunnel. It was 854 feet long and 12 feet in diameter, with blue-black interior walls and ribs protruding every four feet. At the top, a great white circle of light beamed toward us. Or so it seemed. As we drew closer, the color changed from white to blue, and the shape began to shift, elongating from a circle to an oval and rising overhead, until it was clear that what had seemed to be a round opening at the far end of the tunnel was in fact an elliptical Skyspace in a large viewing room. A long, narrow staircase made of bronze ascended through it.

We climbed onto the top of the crater and stepped into the sun. Once again we were surrounded by a Martian landscape of crushed red stone. A cold wind blew across the caldera, and we lay down to view the sky, the clouds streaking overhead as the heavens vaulted.

Dusk was coming. We got up and followed a narrow ramp into another Skyspace. It was round, with a narrow bench around the perimeter. Turrell calls it “Crater’s Eye.” We took seats on the bench and stared through the opening in silence. The color of the sky was deepening. It was rich with blue and darkness. It seemed to hover on the ceiling close enough to touch. No one spoke for 30 minutes. I glanced over at Turrell. His hands were folded in his lap, his eyes smiling at the sky. Whatever else the crater had become for him — a job, a dream, an office, a persistent reminder of his own mortality — it was clear that the Skyspace still had the power to lift him up from earth.

When the last hint of blue had vanished into night, Turrell and the others wandered outside. Trotman and I crept back into the crater. We passed the bronze staircase, glimmering in darkness, and we turned down the long tunnel toward the Sun and Moon Space. The white disc at the bottom glowed with ambient light, and Trotman walked toward it like a man in a trance. He disappeared from view. I stopped for a moment to stare down the tunnel. Then I turned around to face the sky through the ellipse. Something flashed at the corner of my eye and I glanced up. There was a tube of white light hovering in the air above me. It was thick and sturdy and looked as though I could grab it and climb into the stars. It streamed down the tunnel to the gleaming stone.

Back at the lodge, I took a seat beside Turrell at a table made of plywood. A few of his friends from town were preparing a dinner of beef from his ranch, and Turrell had brought several bottles of wine from another friend’s vineyard. They all were whispering excitedly about what they’d seen. Turrell sat silently and sipped his wine. He didn’t ask what I thought of the crater, and I didn’t volunteer. It seemed as if we both knew that it was better not to say. The crater was perfect, and incomplete, and his time to finish it was winding down.

“You know,” he told me earlier in the truck, “I’d like to see it myself.”

Wil S. Hylton is a contributing writer for the magazine. He last wrote about artisinal tobacco.

Editor: Joel Lovell


James Turrell Museum in Argentina


James Turrell in Argentina


James Turrell in Sweden


James Turrell in Australia


James Turrell in the Yucatan


James Turrell – Roden Crater  –  Part 1


James Turrell – Roden Crater  –  Part 2



By Joyce Frieden, News Editor, MedPage Today

Published: June 17, 2013


So-called “pay-for-delay” arrangements between generic and brand-name drug companies are not inherently legal, and each instance must be considered on a case-by-case basis, the Supreme Court ruled Monday.

In the 5-3 decision overruling the 11th Circuit Court of Appeals, Justice Stephen Breyer, writing for the majority, listed five reasons why the appellate court erred in giving blanket immunity to pay-for-delay agreements, in which brand-name drugmakers pay or compensate generic drug companies in exchange for a later entry date of the cheaper generic version of a drug:

  • “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects”
  • “One who makes such a payment may be unable to explain and to justify it”
  • “Such a firm or individual may well possess market power derived from the patent”
  • “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent”
  • “Parties may well find ways to settle pa­tent disputes without the use of reverse payments”

“In our view, these considerations, taken together, outweigh the single strong consideration — the desirability of settlements — that led the Eleventh Circuit to provide near-automatic antitrust immunity to reverse payment settlements,” Breyer wrote.

Justice Samuel Alito recused himself from the vote.

The case, known as Federal Trade Commission vs. Actavis, involved Solvay Pharmaceuticals, which was granted a patent for AndroGel — a topical testosterone medication for hypogonadism — in 2003, 3 years after getting FDA approval for the drug. Later that year, generic drugmaker Actavis filed an Abbreviated New Drug Application for a generic version of the drug, as did Paddock Laboratories. Solvay then sued Activas and Paddock but settled with them in 2006 under a pay-for-delay agreement.


Under the settlement, Actavis agreed not to market its generic until the end of August, 2015, 65 months prior to the expiration of Solvay’s patent. In return, Solvay agreed to pay Actavis $19-30 million a year for 9 years. Solvay made similar agreements with Paddock and with a third company, Par Pharmaceutical, which had joined forces with Paddock to litigate the patent claim.

The Federal Trade Commission (FTC) — which claims that such pay-for-delay agreements cost American consumers $3.5 billion a year in the form of higher drug prices — sued Solvay in 2009, claiming the settlement violated antitrust laws. The Eleventh Circuit rejected the FTC’s arguments, ruling that as long as the settlement didn’t extend beyond the patent expiration it was legal and not an antitrust violation.

“In our view … reverse payment settlements such as the agreement alleged in the complaint before us can some­times violate the antitrust laws,” Breyer wrote for the court. “We consequently hold that the Eleventh Circuit should have allowed the FTC’s lawsuit to proceed.”

On the other hand, the justices said they refused to automatically designate all pay-for-delay settlements as illegal.

“The likelihood of a reverse payment bringing about anticompetitive effects depends upon its size, its scale … and the lack of any other convincing justification,” Breyer wrote. “The existence and degree of any anticompetitive consequence may also vary as among industries. These complexities lead us to conclude that the FTC must prove its case as in other rule-of-reason cases.”

“The rationale behind a payment of this size cannot in every case be supported by traditional settlement con­siderations,” he continued. “The payment may instead provide strong evidence that the patentee seeks to induce the generic challenger to abandon its claim with a share of its monop­oly profits that would otherwise be lost in the competitive market.”

In their dissent, Justices Antonin Scalia and Clarence Thomas, led by Chief Justice John Roberts, argued that patents represent exceptions to antitrust laws.

“The correct approach should therefore be to ask whether the settlement gives Solvay monopoly power beyond what the patent already gave it,” Roberts wrote for the dissenting justices. “The Court, however, departs from this approach, and would instead use antitrust law’s amorphous ‘rule of reason’ to inquire into the anticompetitive effects of such settlements. This novel approach is without support in any statute, and will discourage the settlement of patent litigation.”

In carving out this new approach, “the majority today departs from the settled approach separating patent and antitrust law, weakens the protections afforded to innovators by patents, frustrates the public policy in favor of settling, and likely undermines the very policy it seeks to promote by forcing generics who step into the litigation ring to do so without the prospect of cash settlements,” Roberts concluded. “I would keep things as they were and not subject basic questions of patent law to an unbounded inquiry under antitrust law.”


Graphic: Christopher Neal



The New York Times, June 17, 2013, by Jane E. Brody  —  Think you do just fine on five or six hours of shut-eye? Chances are, you are among the many millions who unwittingly shortchange themselves on sleep.

Research shows that most people require seven or eight hours of sleep to function optimally. Failing to get enough sleep night after night can compromise your health and may even shorten your life. From infancy to old age, the effects of inadequate sleep can profoundly affect memory, learning, creativity, productivity and emotional stability, as well as your physical health.

According to sleep specialists at the University of Pittsburgh School of Medicine and Western Psychiatric Institute and Clinic, among others, a number of bodily systems are negatively affected by inadequate sleep: the heart, lungs and kidneys; appetite, metabolism and weight control; immune function and disease resistance; sensitivity to pain; reaction time; mood; and brain function.

Poor sleep is also a risk factor for depression and substance abuse, especially among people with post-traumatic stress disorder, according to Anne Germain, associate professor of psychiatry at the University of Pittsburgh. People with PTSD tend to relive their trauma when they try to sleep, which keeps their brains in a heightened state of alertness.

Dr. Germain is studying what happens in the brains of sleeping veterans with PTSD in hopes of developing more effective treatments for them and for people with lesser degrees of stress that interfere with a good night’s sleep.

The elderly are especially vulnerable. Timothy H. Monk, who directs the Human Chronobiology Research Program at Western Psychiatric, heads a five-year federally funded study of circadian rhythms, sleep strength, stress reactivity, brain function and genetics among the elderly. “The circadian signal isn’t as strong as people get older,” he said.

He is finding that many are helped by standard behavioral treatments for insomnia, like maintaining a regular sleep schedule, avoiding late-in-day naps and caffeine, and reducing distractions from light, noise and pets.

It should come as no surprise that myriad bodily systems can be harmed by chronically shortened nights. “Sleep affects almost every tissue in our bodies,” said Dr. Michael J. Twery, a sleep specialist at the National Institutes of Health.

Several studies have linked insufficient sleep to weight gain. Not only do night owls with shortchanged sleep have more time to eat, drink and snack, but levels of the hormone leptin, which tells the brain enough food has been consumed, are lower in the sleep-deprived while levels of ghrelin, which stimulates appetite, are higher.

In addition, metabolism slows when one’s circadian rhythm and sleep are disrupted; if not counteracted by increased exercise or reduced caloric intake, this slowdown could add up to 10 extra pounds in a year.

The body’s ability to process glucose is also adversely affected, which may ultimately result in Type 2 diabetes. In one study, healthy young men prevented from sleeping more than four hours a night for six nights in a row ended up with insulin and blood sugar levels like those of people deemed prediabetic. The risks of cardiovascular diseases and stroke are higher in people who sleep less than six hours a night. Even a single night of inadequate sleep can cause daylong elevations in blood pressure in people with hypertension. Inadequate sleep is also associated with calcification of coronary arteries and raised levels of inflammatory factors linked to heart disease. (In terms of cardiovascular disease, sleeping too much may also be risky. Higher rates of heart disease have been found among women who sleep more than nine hours nightly.)

The risk of cancer may also be elevated in people who fail to get enough sleep. A Japanese study of nearly 24,000 women ages 40 to 79 found that those who slept less than six hours a night were more likely to develop breast cancer than women who slept longer. The increased risk may result from diminished secretion of the sleep hormone melatonin. Among participants in the Nurses Health Study, Eva S. Schernhammer of Harvard Medical School found a link between low melatonin levels and an increased risk of breast cancer.

A study of 1,240 people by researchers at Case Western Reserve University in Cleveland found an increased risk of potentially cancerous colorectal polyps in those who slept fewer than six hours nightly.

Children can also experience hormonal disruptions from inadequate sleep. Growth hormone is released during deep sleep; it not only stimulates growth in children, but also boosts muscle mass and repairs damaged cells and tissues in both children and adults.

Dr. Vatsal G. Thakkar, a psychiatrist affiliated with New York University, recently described evidence associating inadequate sleep with an erroneous diagnosis of attention deficit hyperactivity disorder in children. In one study, 28 percent of children with sleep problems had symptoms of the disorder, but not the disorder.

During sleep, the body produces cytokines, cellular hormones that help fight infections. Thus, short sleepers may be more susceptible to everyday infections like colds and flu. In a study of 153 healthy men and women, Sheldon Cohen and colleagues at Carnegie Mellon University found that those who slept less than seven hours a night were three times as likely to develop cold symptoms when exposed to a cold-causing virus than were people who slept eight or more hours.

Some of the most insidious effects of too little sleep involve mental processes like learning, memory, judgment and problem-solving. During sleep, new learning and memory pathways become encoded in the brain, and adequate sleep is necessary for those pathways to work optimally. People who are well rested are better able to learn a task and more likely to remember what they learned. The cognitive decline that so often accompanies aging may in part result from chronically poor sleep.

With insufficient sleep, thinking slows, it is harder to focus and pay attention, and people are more likely to make poor decisions and take undue risks. As you might guess, these effects can be disastrous when operating a motor vehicle or dangerous machine.

In driving tests, sleep-deprived people perform as if drunk, and no amount of caffeine or cold air can negate the ill effects.

At your next health checkup, tell your doctor how long and how well you sleep. Be honest: Sleep duration and quality can be as important to your health as your blood pressure and cholesterol level.


Innovation at Target Health – DIA Boston – Booth 226


To our dedicated and loyal readers who will be in Boston at the annual meeting of the DIA, please visit us at Booth 226. Appointments are appreciated but clearly not required. Those representing Target Health will be Warren Pearlson, Dean Gittleman, Judith Schloss Markowitz, Caryn Trbovic, Tony Pinto, Neil Lassalle and Jules Mitchel.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

Birth Control



Birth control, also known as contraception and fertility control, are methods or devices used to prevent 1) ___. Planning and provision of birth control is called family planning. The use of male or female condoms, can also help prevent transmission of STD infections. Contraceptive use in developing countries has cut the number of maternal 2) ___ by 44% (about 270,000 deaths averted in 2008) but could prevent 73% if the full demand for birth control were met. Because teenage pregnancies are at greater risk of poor outcomes such as preterm birth, low birth weight and infant death, some authors suggest adolescents need comprehensive education and access to reproductive health services, including contraception. By lengthening the time between pregnancies, birth control can also improve adult women’s delivery outcomes and the survival of their 3) ___.


Effective birth control methods include barriers such as condoms, diaphragms, and the contraceptive sponge; hormonal contraception including oral pills, patches, vaginal rings, and injectable contraceptives; and IUDs or 4) ___ ___. Emergency contraception can prevent pregnancy after unprotected relations. Long-acting reversible contraception, such as implants, IUDs, or vaginal rings, is recommended to reduce teenage pregnancy. Sterilization by means such as vasectomy and tubal ligation is permanent contraception. Some people regard sexual abstinence as birth control, but abstinence-only education often increases 5) ___ pregnancies when offered without contraceptive education.


Birth control methods have been used since ancient times but effective and safe methods only became available in the 6) ___ century. Some cultures deliberately limit access to contraception because they consider it to be morally or politically undesirable. About 222 million women who want to avoid pregnancy in developing countries are not using a modern contraception method. Birth control increases economic growth because of fewer dependent children, more women participating in the workforce, and less consumption of scarce resources. Women’s earnings, assets, body mass index, and their children’s schooling and all substantially improve with greater access to 7) ___.  In addition, the diminution of STDs like HIV and herpes, has a huge, effect on a society, when condoms are used.  It goes without saying, that the elimination of suffering, and death of parents and children, from terrible diseases, is priceless to families and to all of society.




The lactational amenorrhea method, involves the use of a woman’s natural postpartum infertility which occurs after delivery and may be extended by breastfeeding. This usually requires the presence of no periods, exclusively breastfeeding the infant, and a child younger than six months. If breastfeeding is the infant’s only source of nutrition the World Health Organization states that it is 98% effective in the six months following delivery. Trials have found effectiveness rates between 92.5% and 100%. Effectiveness decreases to 93-96% at one year and 87% at two years. Feeding formula, pumping instead of nursing, the use of a pacifier, and feeding solids all reduce its effectiveness. In those who are exclusively breastfeeding about 10% begin having periods before three months and 20% before six months. In those who are not 8) ___ fertility may return four weeks after delivery.


ANSWERS: 1) pregnancy; 2) deaths; 3) children; 4) intrauterine devices; 5) teen; 6) 20th; 7) contraception; 8) breastfeeding

Birth Control


Ancient silver coin from the Greek city, Cyrene, now modern-day Libya, depicting a stalk of silphium.



According to the oldest recorded information regarding birth control, a document that is nearly 4,000 years old – the Egyptian Kahun Gynecological Papyrus, which also happens to be the first known medical text – women used pessaries made out of crocodile dung (acidic) and honey (antibacterial) as a form of contraception. In addition to physically preventing sperm from fertilizing an egg, the acidic properties of the dung may have served as an effective spermicide. In India, elephant dung has been used in this same manner. Another method the text describes on top of the “crocodile dung” was the use of acacia gum, which does work as a spermicide. It can even be found in some spermicide products today.


The Egyptian Ebers Papyrus from 1550 BCE and the Kahun Papyrus from 1850 BCE have within them some of the earliest documented descriptions of birth control, the use of honey, acacia leaves and lint to block sperm. Ancient Egyptian drawings also show the use of condoms. The Book of Genesis references withdrawal, or coitus interruptus, as a method of contraception when Onan “spills his seed” (ejaculates) on the ground so as to not father a child with his deceased brother’s wife Tamar.


Dating back to ancient Greece and spanning a good 1,800 years of human history was the idea that drinking the water a blacksmith used to cool the materials he was working with would prevent pregnancy. Though it’s not really known why anyone believed this, the idea that the water contained lead is a strong possibility as even up through First World War, women were volunteering to work in factories with lead just so it would keep them sterile. The terrible downside was neurological problems, nausea, kidney failure, seizures, coma and death. In Ancient Greece, it is believed that silphium was used as birth control which due to its effectiveness and thus desirability was harvested into extinction.


In the fourth century BCE, Aristotle, was reportedly the first Greek writer to mention contraception. The philosopher recommended that women “anoint that part of the womb on which the seed falls” with olive oil in order to prevent pregnancy. His other top picks for spermicides included cedar oil, lead ointment, or frankincense oil. If the lips of the cervix were smooth, he noted, then conception would be difficult. The ancient Greeks also practiced what they hoped would be postcoital contraception by squatting and exerting pressure on the abdomen.


In medieval Europe any efforts to halt pregnancy were deemed immoral by the Catholic Church. It is believed that women of the time still used a number of birth control measures such coitus interruptus and the insertion of lily root and rue (and, in addition, infanticide after birth).


During the Middle Ages, a sausage maker came up with the idea of using the same animal intestines used for sausages, as condoms. This logical connection became the order of the day. One of the oldest known condoms is made from a pig intestine and even has a user manual that suggests soaking it in warm milk before use.


Consider chastity belts an early attempt at abstinence-only education. These devices—more shackles than belt – first appeared in Europe in the 15th century. They were designed to keep women pure by making it physically impossible for them to have intercourse, making the inability to get pregnant an inevitable consequence. The belts, which featured small openings to allow for urination and defecation, were often made in only one size, so larger women were forced to endure the pain of a tight fit. The engraving shows a woman wearing a chastity belt. The chastity belt shown here has a padlock on the side.


Condoms were first used in the 16th century as protection against syphilis (though there are earlier reports of ancient Egyptians using animal membranes as something of a proto-condom). Giacomo Girolamo Casanova (1725-1798) was among the first to use condoms (some made out of lambskin) to prevent pregnancy. The engraving above shows the Italian seducer blowing up a condom. The photo shows an early 19th-century contraceptive sheath made of animal gut and packaged in a paper envelope.


In 1844, the American inventor Charles Goodyear (1800-1860) patented the vulcanization of rubber, which led to the mass production of condoms. This image from 1839 shows Goodyear demonstrating his new dry-heat rubber-vulcanization process, which prevented rubber from becoming sticky. Today, a wide variety of multicolored and multiflavored latex condoms are available to consumers.


In 1873, Congress passed the Comstock Act, making it illegal to send contraceptive devices and information through the mail. The law was named after its chief advocate, the anti-obscenity crusader Anthony Comstock (pictured on left). More than 20 states passed similar prohibitions. Connecticut’s law was among the strictest: “Any person who will use any drug, medicinal article or instrument for the purpose of preventing conception shall be fined not less than fifty dollars or imprisoned not less than sixty days nor more than one year or be both fined and imprisoned.” That same year, Comstock and his supporters in the YMCA founded the New York Society for the Suppression of Vice, an institution to supervise public morality. The symbol of the society (pictured on right) advocated the burning of obscene books.


As far back as ancient Egypt, women were using sponges as a method of preventing pregnancy. The sponge has its roots in early Egyptian civilization, and this photo depicts the variety of models available in the early 20th century. Those sponges were made of a variety of materials, and were sometimes drenched in lemon juice or vinegar to act as a spermicide. Today’s sponges (called, in fact, Today’s Sponge) are synthetic, and use a chemical spermicide.


In 1909, Richard Richter developed the first intrauterine device made from silkworm gut which was further developed and marketed in Germany by Ernst Grafenberg in the late 1920s.


The Scottish-born Dr. Marie Stopes (1880-1958) was a leading advocate of birth control in the early 20th century. In 1918 Stopes wrote a guide to contraception called Wise Parenthood. In the face of opposition from the church, Stopes founded the Society for Constructive Birth Control and opened the first of her birth-control clinics in Holloway in North London in 1921. The image on the right shows Stopes working in the laboratory, where she helped to modify the contraceptive cap. The image on the left depicts a rubber cervical cap from around the 1920s.


American activist Margaret Sanger (1879-1966) coined the phrase “birth control.” Born to an Irish-Catholic family, Sanger watched her mother, worn out after 18 pregnancies and 11 live births, die slowly. In a series of articles titled “What Every Girl Should Know” and in her newspaper, The Woman Rebel, Sanger (at left) strived to provide women with information about contraception. At neighborhood clinics, she provided women with controlled forms of birth control. Sanger is perhaps most well-known for founding the American Birth Control League, which eventually became Planned Parenthood, in 1921. At right: New York City police raid the Birth Control Research Bureau in New York City, ushering women into a patrol wagon in 1929. In 1931 historian and novelist H. G. Wells predicted that the movement Sanger started would, in 100 years, grow to be “the most influential of its time.”


During the Great Depression, companies used the term “feminine hygiene” to market an array of products believed to have a contraceptive effect. One of the most popular of these was the cheap and dangerous “Lysol douche,” marketed as both a contraceptive and a cleansing agent. An ad for Lysol as hygiene product is shown, above. Later reports revealed that Lysol – surprise! – caused vaginal scalding. Another dangerous form of contraception from the 1930s was the stem pessary, an early version of the intrauterine device. These IUDs, pictured here, consisted of a rubber, metal, or glass stem connected to a cup or button to hold the stem upright and prevent it from becoming lost in the uterus.


The first formulations of birth-control pills, called Enovid, were submitted to the FDA for approval in 1957 as treatment for menstrual disorders or infertility. Coincidentally, a large number of American women developed menstrual disorders around this time. By 1959, more than half a million American women were taking Enovid. It wasn’t until three years later that the manufacturer presented the same oral contraceptive to the FDA to prevent pregnancy. By 1964, the pill had become the most popular form of birth control in the United States.


A Molecular Explanation for Age-Related Fertility Decline in Women


In general, a woman’s ability to conceive and maintain a pregnancy is linked to the number and health of her egg cells. Before a baby girl is born, her ovaries contain her lifetime supply of egg cells (known as primordial follicle oocytes) until they are more mature. As she enters her late 30s, the number of oocytes – and fertility – dips precipitously. By the time she reaches her early 50s, her original ovarian supply of about 1 million cells drops virtually to zero. Only a small proportion of oocytes — about 500 — are released via ovulation during the woman’s reproductive life. The remaining 99.9% are eliminated by the woman’s body, primarily through cellular suicide, a normal process that prevents the spread or inheritance of damaged cells.


Scientists supported by the National Institutes of Health have a new theory as to why a woman’s fertility declines after her mid-30s. They also suggest an approach that might help slow the process, enhancing and prolonging fertility. The study, published online in Science Translational Medicine (13 Feb 2013) showed that as women age, their egg cells become riddled with DNA damage and die off because their DNA repair systems wear out. Defects in one of the DNA repair genes — BRCA1 — have long been linked with breast cancer, and now also appear to cause early menopause.


The authors hypothesized that most aging oocytes self-destruct because they have accumulated a dangerous type of DNA damage called double-stranded breaks. According to the study, older oocytes have more of this sort of damage than do younger ones. The authors also found that older oocytes are less able to fix DNA breaks due to their dwindling supply of repair molecules.


Examining oocytes from mice, and from women 24 to 41 years old, the authors found that the activity of four DNA repair genes (BRCA1, MRE11, Rad51 and ATM) declined with age. When the research team experimentally turned off these genes in mouse oocytes, the cells had more DNA breaks and higher death rates than did oocytes with properly working repair systems. The team’s findings stemmed from their initial focus on BRCA1, a DNA repair gene that has been closely studied for nearly 20 years because defective versions of it dramatically increase a woman’s risk of breast cancer.


Using mice bred to lack the BRCA1 gene, it was confirmed that a healthy version of BRCA1 is vital to reproductive health. BRCA1-deficient mice were less fertile, had fewer oocytes, and had more double-stranded DNA breaks in their remaining oocytes than did normal mice.


Abnormal BRCA1 appears to cause the same problems in humans – the team’s studies suggest that if a woman’s oocytes contain mutant versions of BRCA1, she will exhaust her ovarian supply sooner than women whose oocytes carry the healthy version of BRCA1.


Together, these findings show that the ability of oocytes to repair double-stranded DNA breaks is closely linked with ovarian aging and, by extension, a woman’s fertility. This molecular-level understanding points to new reproductive therapies, including ways to bolster DNA repair systems in the ovaries might lead to treatments that can improve or prolong fertility.

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