On August 30, 2010, pursuant to the Hatch-Waxman Act, NATCO notified Celgene that its ANDA requesting approval from the FDA for a generic version of Revlimid® contained a paragraph IV certification asserting that various Revlimid® patents are invalid, unenforceable and/or not infringed. Lenalidomide, which is presently marketed as Revlimid by Celgene, is a derivative of thalidomide and is used in the treatment for multiple myeloma. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS).

NATCO believes it may be a “first applicant” to file an ANDA for the 25 mg generic version of Revlimid® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for that strength.

The market size of Revlimid in the USA is estimated to be around US $ 1.5 Billion, growing at 44% compared to last year.

It was sometime after midnight on Dec. 8, 2007, when Dr. Eric Goren told me my husband might not live till morning. The kidney cancer that had metastasized almost six years earlier was growing in his lungs. He was in intensive care at the Hospital of the University of Pennsylvania in Philadelphia and had begun to spit blood.

Terence Bryan Foley, 67 years old, my husband of 20 years, father of our two teenagers, a Chinese historian who earned his PhD in his sixties, a man who played more than 15 musical instruments and spoke six languages, a San Francisco cable car conductor and sports photographer, an expert on dairy cattle and swine nutrition, film noir, and Dixieland jazz, was confused. He knew his name, but not the year. He wanted a Coke.

Should Terence begin to hemorrhage, the doctor asked, what should he do?

This was our third end-of-life warning in seven years. We had fought off the others, so perhaps we could dodge this one, too. Terence’s oncologist and I both believed that a new medicine he had just begun taking, Pfizer’s (PFE) Sutent, would buy him more life.

Keep him alive if you can, I said.

Terence died six days later, on Friday, Dec. 14.

What I couldn’t know then was that the thinking behind my request—along with hundreds of decisions we made over the years—was a window on the impossible calculus at the core of today’s health-care dilemma. Terence and I were eager to beat his cancer. Backed by robust medical insurance provided by a succession of my corporate employers, we were able to wage a fierce battle. As we made our way through a series of expensive last chances, like the one I asked for that night, we didn’t have to think about money, allocation of medical resources, the struggles of roughly 46 million uninsured Americans, or the impact on corporate bottom lines.

Terence’s treatment was expensive. The bills for his seven years of medical care totaled $618,616, almost two-thirds of which was for his final 24 months. Still, no one can say for sure if the treatments helped extend his life.

Over the final four days before hospice—two in intensive care, two in a cancer ward—our insurance was billed $43,711 for doctors, medicines, monitors, X-rays, and scans. Two years later the only thing I can see that the money bought for certain was confirmation he was dying. Along with a colleague, Charles Babcock, I spent months poring over almost 5,000 pages of documents collected from six hospitals, four insurers, Medicare, three oncologists, and a surgeon. Those papers tell the story of a system filled with people doing their best. Stepping back and looking at that large stack through a different lens, a string of complex questions emerges.

31% for Paperwork

Health-care costs represent 17% of today’s U.S. gross domestic product. Medicare devotes about a quarter of its budget to care in the last year of life, according to the policy journal Health Affairs. Yet as I fought to buy my husband more time, it didn’t matter to me that the hospital charged more than 12 times what Medicare then reimbursed for a chest scan. It also didn’t matter that UnitedHealthcare (UNH) reimbursed the hospital for 80% of the $3,232 price of a scan, while a few months later our new insurer, Empire BlueCross & BlueShield, paid 24% for the same test. And I didn’t have time to be thankful that the insurers negotiated the rates with the hospital so neither my employers nor I actually paid the difference between the sticker and discounted prices.

Looking at that stack of documents, it is easy to see why 31% of the money spent on health care went to paperwork and administration, according to research published in 2003 in the New England Journal of Medicine. That number has stayed the same or grown since then, says Dr. Steffie Woolhandler, a professor at Harvard Medical School and a co-author of the study. Often Terence’s bills, with their blizzard of codes, took days to decipher. What did “opd patins t” or “bal xfr ded” mean? Was the dose charged the same as the dose prescribed?

The documents revealed an economic system in which the sellers don’t set the prices and the buyers don’t know what they are. Prices bear little relation to demand or how well goods and services work. “No other nation would allow a health system to be run the way we do it. It’s completely insane,” said Uwe E. Reinhardt, a political economy professor at Princeton University who has advised Congress, the Veteran’s Administration, and other federal agencies on health-care economics.

In reviewing Terence’s records, we found Presbyterian Medical Center in Philadelphia charged UnitedHealthcare $8,120 in 2006 for a 350 mg dose of the drug Avastin, which should have been free as part of a clinical trial. When my Bloomberg colleague inquired, the 80% insurance payment was refunded. A small mixup, but telling.

Some drugs Terence took probably did him no good. At least one helped fewer than 10% of patients. Today, pharmaceutical companies and government agencies are trying to sort out the economics of developing drugs that will help only a small subset of patients. These drugs are very expensive. Should every patient have the right to them?

Terence and I answered yes. Each drug potentially added life. Yet that, too, led me to a question I still can’t answer. When is it time to quit? Congress dodged the question last year as it tried to craft a health-care bill. The mere hint of limiting the ability to choose care created a whirlwind of accusations of “death panels.”

One thing I know is that I don’t envy the policymakers. As the health-care debate heated up, I remembered the fat sheaf of insurance statements that had piled up after Terence’s death. Our children, Terry, 21, and Georgia, 15, assented to my idea of gathering every record to examine what they would show about end-of-life care—its science, emotions, and costs. Terence would have approved.

Taking it all into account, the data showed we had made a bargain that hardly any economist looking solely at the numbers would say made sense.

Why did we do it? I was one big reason. Not me alone, of course. The system has a strong bias toward action. My husband, too, was unusual, said Keith Flaherty, his oncologist, in his passionate willingness to endure discomfort for a chance to see his daughter grow from a child to a young woman, and his son graduate from high school.

After Terence died, Flaherty drew me a picture of a bell curve, showing the range of survival times for people with kidney cancer. Terence was way off in the tail on the right-hand side, an indication he had beaten the odds. For many, an explosion of research and drug discoveries had made it possible to daisy-chain treatments and extend lives for years—enough time to keep our quest from having been total madness.

Terence used to tell a story, almost certainly apocryphal, about his Uncle Bob. Climbing aboard a landing craft before the invasion of Normandy, Bob’s sergeant was said to have told the men that by the end of the day, 9 out of 10 of them would be dead. Said Bob: “Each one of us looked around and felt so sorry for those other nine poor sonsabitches.”

For me, it was about pushing the bell curve. Knowing there was something to be done, we couldn’t not do it. Believing beyond logic that we were going to escape the fate of those other poor sonsabitches.

It is hard to put a price on that kind of hope.

A shadow but good odds

We found the cancer by accident, on Sunday, Nov. 5, 2000, in Portland, Ore. Terry had invited a dozen friends for a sleepover to celebrate his 12th birthday. I was making pancakes and shipping the boys home. Terence had been having stomach cramps for weeks. Suddenly he was lying on the bed, doubled over in pain. Our family doctor ordered him to the emergency room.

We were immediately triaged through. Not a good sign, I thought. The kids sat on the waiting-room floor, Barbies and X-Men around them, while Terence writhed in a curtained alcove. When he returned from a scan, the doctor said, almost as an aside: There’s a shadow on his kidney. When he’s feeling better, you should take a look at it. Both of us were annoyed. Why would we think about a shadow on his kidney? That wasn’t the problem. He was in such pain he could barely breathe.

The cause of the pain turned out to be violent ulcerative colitis. The damaged colon was removed on Dec. 13, in an operation that left Terence so weak that he spent three weeks, including Christmas morning, immobile in a chair. Colleagues delivered meals to the house. My sister wrapped presents. My boss sent over her husband to put up our lights. I felt so bad for Terence that I got him a cat, the pet he had long wanted. The orange kitten howled in a box under the tree.

And the shadow? We were so grateful he was out of pain that we would have ignored it had someone from the hospital not called to urge us to find out what it meant. Within a month, Terence was in surgery again. On Jan. 18, Dr. Craig Turner removed the diseased kidney. Emerging from the five-hour operation, Turner confirmed the worst: He believed the shadow was cancer. A week later, when Terence was well enough to walk into the doctor’s office, Turner was reassuring.

“We got it all,” he said.

Terence teared up. “Thank you for saving my life.”

The bills from Regence BlueCross BlueShield of Oregon show the operation was relatively inexpensive, just over $25,000, about 4% of the eventual total charged to keep Terence alive. Our share was $209.87. I never looked at or thought about the total cost, or the $14,084 that our insurance—in reality, my employer—paid. We never had to consider who was actually shouldering the bills.

Kidney cancer is uncommon, accounting for about 3% of all cancers, or about 50,000 new cases in the U.S. last year, according to the Kidney Cancer Assn. Terence was a typical patient: an older man, overweight, and an ex-smoker. Asymptomatic for a long time, most kidney cancers are discovered accidentally or too late. So we felt lucky. The first tool for fighting kidney cancer is usually the one used since medieval times: the knife, or its technological equivalent. If a tumor is removed early enough, before it flings microscopic cells into the bloodstream that can implant in other organs, surgery is close to a cure.

For Terence the odds looked good. His 7-centimeter tumor showed no signs of having spread. According to the traditional method of evaluating, or staging, the cancer, that meant he had an 85% chance of surviving five years. A lab report soon chilled our optimism. Tests on Terence’s tumor showed that he had so-called collecting duct cancer. Named for the part of the kidney where it is thought to originate, collecting duct is the rarest and most aggressive form of kidney cancer. In my online research, almost everyone who had it died within months, sometimes weeks, of diagnosis.

Most kidney cancers don’t respond well to chemotherapy. There was no accepted treatment after surgery. Almost nothing was known about collecting duct cancer. Only about 1% of kidney cancer patients receive that diagnosis. Dr. Turner and I could find just 50 cases documented in the medical literature worldwide, and nothing had proved effective in halting it. “Watchful waiting” was the recommended path.

Waiting for him to die was what we feared.

He didn’t die. He got better. We didn’t know why. We tried not to think about it.

By the spring of 2002, we had moved to Lexington, Ky., where I was the editor of the local newspaper and Terence was creating an Asia Center at the University of Kentucky. He seemed fine. He began moving Chinese and Japanese history books to his office. On Saturdays we drove through the bluegrass to take seven-year-old Georgia to riding lessons. We reluctantly let 13-year-old Terry crowd-surf at his first rock concert.

Then, on May 6, 2002, Terry called me at work, panic in his voice. “Mom, come home. Dad is very sick.”

His father was in bed, his face flaming with fever, shaking with chills under a pile of blankets. He could barely speak. “The cancer is in my lungs,” he said. “I’ve got six to nine months left.”

Fear, and internet plunge

He had been keeping that secret for months. In February, routine follow-up scans had spotted the cancer’s spread. “The first thing Terence said was, ‘Doc, do you have any female patients who have recently died? I need to find a widower so my wife can meet her next husband,’ ” his Lexington oncologist, Dr. Scott Pierce, later recalled. After more tests, Dr. Pierce prescribed Interleukin-2 because there were no other options. Injections of the protein, at $735 a dose, were intended to stimulate the immune response to help fight the cancer’s invasion. The overall response rate was only about 10%. For most patients, Interleukin-2 did absolutely nothing.

Terence hadn’t wanted to worry us. In his mind, if he recovered, we would never know how close he came; if he died, he would have spared us months of anguish. He started a diary and spent more time in the office so we would get used to his absence.

His secret was betrayed by his violent reaction to his first dose of IL-2. Suddenly his actions over the last several weeks made sense. He had been giving away musical instruments and pieces of art. “I have too much stuff,” he had told me, a bizarrely improbable statement coming from him. I was amused, exasperated, and touched by his desire to protect us. Even under the strain of his disease, he was so much himself. “Did you think I wouldn’t have noticed if you didn’t come home one day?” I asked.

I spent that night awake in our dark living room. For the first and only time, I felt pure terror. A few days later I visited a therapist.

“I can’t survive without him,” I said.

“What does he say when you feel this way?” she asked.

“He says I can handle anything.”

“You’ll need to say that to yourself.”

Terence stopped taking IL-2 after a few weeks of treatments, unable to stand the side effects.

I plunged into the Internet. If there were something out there that could save him, I was going to find it. Years before, one of my former colleagues, dying from AIDS, had suddenly come back to vigorous life because of a chance introduction to a doctor who prescribed what was then an experimental antiviral cocktail. Another had beaten leukemia with a cutting-edge bone marrow transplant. We could defeat this.

I downloaded papers, presentations to the Kidney Cancer Assn., abstracts from the National Library of Medicine. I called researchers and oncologists, pathologists and fellow journalists. When the research became overwhelming, I hired a retired nurse to help. My boss’s wife, a nurse herself, dug in too. After I messaged one couple about a clinical trial in Texas, they offered us their spare bedroom.

Throughout the spring and summer of 2002, Georgia, then 8, rode her bicycle up and down shady South Ashland Avenue. Thirteen-year-old Terry and his friends Shannon, Hughes, and Tanner came in last at their first battle of the bands. Terence sounded optimistic. “It’s my dream,” he said. “Some day we’re going to gig together.”

Awaiting scans, learning the violin

The truth was we were both shaken by the dire prognosis.

“What would you regret dying without having seen?” I asked. He answered without hesitation: “Pompeii.” We pulled Terry from his eighth-grade class, Georgia out of second, and flew to Italy to see the excavated remains of the city once buried under volcanic ash. We walked the cobbled streets, poked into frescoed houses, taverns, and baths, and took an eerie comfort from the 2,000-year-old shapes of families huddled together, trying to ward off disaster.

By then our research had led us to the Cleveland Clinic, where Dr. Ronald Bukowski had specialized in kidney cancer for over 20 years. At our first meeting, in August 2002, Terence explained that he had collecting duct cancer.

“No you don’t,” Bukowski said.

We were confused. How did he know?

“You’re sitting here,” he said. “If you had collecting duct, you would be dead.”

Bukowski argued that the disease was growing so slowly that we should simply watch and wait. We did, for three years. Then, in December 2005, a scan showed that the cancer in his lungs had begun to grow.

By this time, research had progressed. New drugs designed to attack a tumor’s blood supply were appearing to slow the growth of a wide range of cancers. Bukowski recommended we enter a clinical trial, pretty much the only way to get these targeted therapies. He referred us to Dr. Flaherty in Philadelphia, where we had moved in June 2003 when I changed jobs.

The drugs Flaherty was testing—Genentech’s Avastin and Bayer’s Nexavar—had showed promise individually. The trial would find out how they worked together. In March 2006, Terence took his first intravenous dose of Avastin, an hour-long process, and swallowed his first Nexavar. The side effects were hard. There were rashes, sometimes debilitating stomach pains. But he continued teaching, picking up the kids at school, studying and writing. He worked on his book, a grammar text based on classical Chinese poetry. He started to learn to play the violin and to read and write Arabic. Every two weeks he went for an Avastin drip. And every month we anxiously awaited the results of a chest scan.

At first the cancer didn’t budge. Then it began to retreat.

Because Terence was in a clinical trial, Genentech and Bayer provided their drugs free. I learned that over the years of Terence’s battle with cancer, some insurers drove harder bargains than others. In December 2006, for example, United Healthcare paid $2,586 to University of Pennsylvania Hospital for a chest scan; in March 2007, after I switched employers, Empire BlueCross paid $776 for the same $3,232 bill.

When it came to the insurance companies, the sticker price meant little since they had negotiated their own deals with the hospital. Neither the hospital nor the insurance companies would elaborate. The entire medical bill for seven years, in fact, was steeply discounted. The $618,616 was lowered to $254,176 when the insurers paid their share and imposed their discounts. The portion of the charges that were not covered for the most part vaporized. Terence and I were responsible for and paid $9,468—less than 4%.

During the trial, Terence packed boxes for the troops in Iraq and Afghanistan, loading them in our kitchen with deodorant, wet wipes, Mars bars, Kool-Aid, beef jerky, batteries, and magazines. A veteran of Naval Intelligence and the U.S. Air Force reserves, he walked almost every day to the post office with a box addressed to “Any Soldier.” Behind the counter, the smiling lady with the long red hair extensions became his friend, and every so often a soldier would drop him a thank-you note.

Life went on.

Then, in August 2007, from half a world away, I heard the cancer return.

I was on a business trip to China when Terence coughed during one of our phone calls. By the time I got home, scans had confirmed growth of one of the lung’s cancerous spots.

By now, more than six years had passed since we first saw the shadow, and I was used to the scares. Avastin’s side effects—fatigue, stomach ailments, rashes—had been getting him down, and the doctor had agreed back in May to let him stop treatments. So we’ll go back on the Avastin, I thought, or cut out or laser out the growth, add new treatments, and go on.

The records document our renewed fight. Terence resumed Avastin. Because he was no longer in a trial, our insurance company was billed $27,360 a dose, every two weeks, more than the cost of the kidney surgery in 2000. Empire BlueCross paid $6,566.40. We paid nothing. So who did the paying? The health insurance system depends on healthy people bearing the cost for sick ones like Terence. For all its incredible treatment benefits, the system is untenable. Should you have had a voice in Terence’s final days? Would I make the same decision with my money for your loved ones? These are things I think about now but can’t answer.

No consensus

He coughed almost continuously. His weight plunged. He needed help on the stairs. He began to use a cane. When his friend Woody came to visit, Terence couldn’t muster the breath to blow his cornet. He coughed and coughed and coughed. In the last week of October, he called me at work.

“I can’t pick Georgia up at school,” he said. “I can’t get out of the chair.” On Halloween, his Dracula costume stayed in the basement. We left the candy on the doorstep.

On Nov. 8 we saw Dr. Ali Musani, a pulmonologist specializing in cancer. We hoped that the growing tumor in Terence’s chest could be removed. Unable to stand or sit unassisted, he lay on the floor and refused to get up. Alarmed, Musani admitted him to the hospital. He said there was nothing he could do about the tumor. He gently mentioned that it might be time to consider hospice. We brushed off the suggestion.

Terence stayed in the hospital four days. Meanwhile a quiet tension was building. Flaherty and I believed this episode to be a temporary setback. Other doctors and nurses saw a patient near the end.

On Nov. 11, before discharging him, a doctor propped one of Terence’s scans on a light board so we could clearly see the blizzard of white spots, hundreds of tumors, covering his lungs.

Avastin wasn’t stopping them.

Flaherty was not fazed by the growth, and pointed out that many of the doctors looking at the scans didn’t understand the course of kidney cancer. He and I wanted to move on to the next link in the daisy chain of newly available drugs. Sutent, another targeted therapy, had been approved the year before. It worked as Avastin did, by stopping cancer’s ability to build extra blood vessels to feed its growth, but in a different way. One $200 pill a day. A shot at more life. Sutent might have more serious side effects—rashes, fatigue, stomach distress, strokes—but Terence was game. He began taking it on Nov. 15.

At home, he drew a line down the middle of a piece of paper. On one side he wrote things to throw away. On the other, things to keep.

“Stop that!” I snapped. “You aren’t going to die.”

I prepared for what I expected would be a new phase of our life. I found protein drinks online and protein bars in a bodybuilding shop. I got forms for a handicapped license plate, looked into outfitting our row house with a stair lift.

Terence was no longer able to get in and out of bed alone, so I hired a health aide. Whatever he craved, I bought. I wrote down everything he ate. Cold grapefruit slices. Chicken noodle soup. Clam chowder. I counted the calories he consumed one day: 210.

On Friday, Dec. 7, just as the aide was packing to leave for the day, Terence looked up, startled, as the corners of his mouth foamed bright red with blood. It was a struggle to get him down our narrow stairs to the ambulance. In the emergency room it was clear something was seriously wrong. “What’s your name?” asked the ER doctor. Terence responded correctly. “What’s the date?” Terence gave the doctor what the kids and I recognized as “Daddy’s ‘Just how dumb are you?’ ” look. But he couldn’t answer.

“Who’s the President of the United States?” That triggered something. “That moron, Bush,” he said.

Terence was admitted that night to a ward where Eric Goren was doing his last intensive-care overnight shift of a three-year residency. In a small break room, alongside vending machines selling soft drinks and chips, Goren told me that bleeding from the lungs might suddenly become uncontrollable. If that happened, what should he and his team do?

I wanted to see whether Flaherty still believed Sutent could make a difference, but I couldn’t reach him. Goren and I settled on what the hospital called Code-A. Do everything possible to prevent a major bleed or anything life-threatening. But don’t take heroic measures if death seems inevitable.

I called the children to the hospital.

My decision about Terence’s treatment, so hard on Saturday, was easy by Monday. The scans now were showing signs of cancer in his brain, surrounded by a cascade of hundreds of tiny strokes. I had Terence’s signed living will, but I didn’t need it. I knew what this man who lived for books, music, and ideas would want.

When Flaherty arrived, he looked shaken. “I didn’t expect this,” he said.

That afternoon I signed the papers transferring Terence to hospice. The next day the hospital staff took away the machines and the monitors. The oncologists and radiologists and lab technicians disappeared. Hospice nurses, social workers, chaplains, and counselors for me and the children—began to arrive and the focus shifted from treatment to easing our transition.

Over the next three days we were charged $14,022 for the same hospital bed. Included were the pain and anxiety medications Ativan and Dialaudid, his monitoring, and counseling for a different kind of pain management for me and the children. The bill was less than a third of the previous four days’ $43,711.

Terence drifted into a coma on Tuesday. I e-mailed his friends and read their goodbyes aloud, hoping he could hear and understand. I slept in a chair. At about 2:30 a.m. Friday, a noise in the hall startled me. I awoke just in time to hold his hand as he died.

They gave me back his wedding ring the next day.

Ten days later, the kids hung Daddy’s Christmas stocking alongside our three. I mailed the cards he had addressed months earlier, slipping in a black-bordered note. I threw away the protein bars, gave the energy drinks to a shelter, and flushed an opened bottle of Sutent down the drain.

Looking back, memories of my zeal to treat are tinged with sadness. Should I have given up earlier? Would earlier hospice care been kinder? I hadn’t believed Terence was going to die so I had never confronted any of those dilemmas. And I never let us have the chance to say goodbye.

I think had he known the costs, Terence would have objected to spending an amount equivalent to the cost of vaccine for nearly a quarter million children in developing countries. That’s how he would have thought about it.

But when I ask myself whether I would do it all again, the answer is—absolutely. I couldn’t not do it again.

Second-guessing

Late last year, I waded through a snowstorm to Keith Flaherty’s office in Boston, where he had moved to a new job. Did we help Terence or harm him? There’s a possibility, he said, that the treatment actually made the cancer worse, causing it to rage out of control at the end. Or, as another doctor suggested in passing at the time, the strokes were a side effect of the Sutent and not the cancer.

But neither Flaherty nor I believe that. The average patient on Flaherty’s trial got 14 months of extra life. Without any treatment at all, Flaherty estimates that for someone with Terence’s stage of the disease it was three months. Terence got 17 months—still within the realm of chance but on the far-right side of the bell curve.

There is another bell curve that Terence did not live to climb. It charts the survival times for patients treated not just with Sutent, Avastin, and Nexavar, but also Novartis’ (NVS) Afinitor and GlaxoSmithKline’s (GSK) Votrient—both made available since Terence’s death. Doctors and patients now are doing what we dreamed of, staggering one drug after another and buying years more of life.

Slides on the results of Flaherty’s clinical trial, presented at the 2008 meeting of the American Society of Clinical Oncology, showed that Avastin and Nexavar worked well on a wide variety of patients. Only Flaherty and I know that the solitary tick mark at 17 months was Terence.

Only I know that those months included an afternoon looking down at the Mediterranean with Georgia from a sunny balcony in southern Spain. Moving Terry into his college dorm. Celebrating our 20th anniversary with a carriage ride through Philadelphia’s cobbled streets. A final Thanksgiving game of charades with cousins Margo and Glenn.

And one last chance for Terence to pave the way for all those other poor sonsabitches.

The subjects included 351 women diagnosed with incident epithelial ovarian cancer who participated in a previous case-control study. The original study collected demographic, clinico-pathologic, and lifestyle-related variables including diet. Each subject completed a food frequency questionnaire where they were asked to report their usual dietary intake over the three to five years prior to their diagnosis.

To translate the diet estimates into a meaningful way, the FFQ items were assigned to the major food groups reflected in the Dietary Guidelines for Americans 2005 (DGA) including fruits, vegetables, grains, meats, dairy, fats and oils, sweets, and alcohol. Grains, meats, and dairy were further subdivided to “suggested” and “other” groups. The “suggested” subdivisions included healthier food choices, whereas the “other” subdivisions contained less desirable selections.

The authors found that higher total fruit and vegetable consumption, and higher vegetable consumption alone led to a survival advantage. Likewise, a statistically significant improvement in survival was observed for the healthier grains. Higher intakes of less-healthy meats were associated with a survival time disadvantage.

Writing in the article, Therese A. Dolecek, PhD, MS, RD, Research Associate Professor of Epidemiology, Division of Epidemiology and Biostatistics and Institute for Health Research and Policy, School of Public Health and Member, Cancer Control and Population Science Research Program, UIC Cancer Center, University of Illinois at Chicago, and colleagues state, “The study findings suggest that food patterns three to five years prior to a diagnosis of epithelial ovarian cancer have the potential to influence survival time. The pre-diagnosis food patterns observed to afford a survival advantage after an epithelial ovarian cancer diagnosis reflect characteristics commonly found in plant-based or low fat diets. These diets generally contain high levels of constituents that would be expected to protect against cancer and minimize ingestion of known carcinogens found in foods.”

In an editorial commentary in the same issue, Cynthia A. Thomson, PhD, RD, Associate Professor, Nutritional Sciences, University of Arizona, Tucson, and David S. Alberts, MD, Director, Arizona Cancer Center, Tucson, write, “The authors provide new evidence that dietary factors, particularly total fruit and vegetable, red and processed meat and milk intakes, may influence ovarian cancer survival. These findings corroborate earlier work by Nagle et al and are among only a select few studies of dietary associations with ovarian cancer recurrence and/or prognosis despite a significant and growing body of literature suggesting diet may influence ovarian cancer risk.”

Eating pomegranates or drinking pomegranate juice may help prevent and slow the growth of some types of breast cancer. A new study shows a group of phytochemicals called ellagitannins found in abundance in pomegranates inhibited the growth of estrogen-responsive breast cancer in laboratory tests.

The abstract of the study says “Estrogen stimulates the proliferation of breast cancer cells and the growth of estrogen-responsive tumors. The aromatase enzyme, which converts androgen to estrogen, plays a key role in breast carcinogenesis. The pomegranate fruit, a rich source of ellagitannins (ET), has attracted recent attention due to its anticancer and antiatherosclerotic properties. On consumption, pomegranate ETs hydrolyze, releasing ellagic acid, which is then converted to 3,8-dihydroxy-6H-dibenzo[b,d]pyran-6-one (“urolithin”) derivatives by gut microflora. The purpose of this study was to investigate the antiaromatase activity and inhibition of testosterone-induced breast cancer cell proliferation by ET-derived compounds isolated from pomegranates. A panel of 10 ET-derived compounds including ellagic acid, gallagic acid, and urolithins A and B (and their acetylated, methylated, and sulfated analogues prepared in our laboratory) were examined for their ability to inhibit aromatase activity and testosterone-induced breast cancer cell proliferation. Using a microsomal aromatase assay, we screened the panel of ET-derived compounds and identified six with antiaromatase activity. Among these, urolithin B (UB) was shown to most effectively inhibit aromatase activity in a live cell assay. Kinetic analysis of UB showed mixed inhibition, suggesting more than one inhibitory mechanism. Proliferation assays also determined that UB significantly inhibited testosterone-induced MCF-7aro cell proliferation. The remaining test compounds also exhibited antiproliferative activity, but to a lesser degree than UB. These studies suggest that pomegranate ET–derived compounds have potential for the prevention of estrogen-responsive breast cancers.”

Researchers say the ellagitannins in pomegranates work by inhibiting aromatase, which is a key enzyme used by the body to make estrogen and plays a key role in breast cancer growth.

“We were surprised by our findings,” Chen says. “We previously found other fruits, such as grapes, to be capable of the inhibition of aromatase. But phytochemicals in pomegranates and in grapes are different.”

Researchers say pomegranates have recently been hailed for their potential anti-cancer and heart healthy benefits thanks to their high antioxidant content. But they say this is the first study to look at their effects on aromatase and breast cancer growth.

In the study, published in Cancer Prevention Research, researchers examined the impact of 10 ellagitannin-derived compounds from pomegranates on aromatase activity and breast cancer cell growth in laboratory tests.

The results showed that of those 10 compounds, urolithin B most significantly inhibited breast cancer cell growth.

Experts say further studies will be needed to determine whether eating or drinking pomegranate-derived products will have the same effect in humans, but these results are promising.

“More research on the individual components and the combination of chemicals is needed to understand the potential risks and benefits of using pomegranate juice or isolated compounds for a health benefit or for cancer prevention,” Powel Brown, MD, PhD, chairman of the clinical cancer prevention department at the University of Texas M.D. Anderson Cancer Center. Brown was not associated with the study.

Until then, researchers say people may consider eating more pomegranates to protect against cancer in the breast and perhaps other tissues and organs.

Acupuncture not only cools hot flashes that occur as a result of breast cancer treatment but may offer a host of other benefits to boost women’s well-being.

A new study shows acupuncture was as good as drug therapy with Effexor (venlafaxine) at easing hot flashes in breast cancer patients, but it also improved sex drive, energy levels, and clarity of thought.

“Acupuncture offers patients a safe, effective and durable treatment option for hot flashes, something that affects the majority of breast cancer survivors. Compared to drug therapy, acupuncture actually has benefits, as opposed to more side effects,” researcher Eleanor Walker, MD, division director of breast services in the department of radiation oncology at Henry Ford Hospital in Detroit, says in a news release.

According to the National Cancer Institute, one in eight women will develop breast cancer in her lifetime. Typical treatment for breast cancer involves chemotherapy and five years of hormone therapy that often causes unpleasant side effects, such as hot flashes, night sweats, and decreased sex drive and energy levels.

Researchers say these side effects of breast cancer treatment significantly decrease a woman’s quality of life and may cause some women to discontinue treatment.

Acupuncture has already been shown to reduce hot flashes in menopausal women, but researchers say this is the first study to compare acupuncture to drug treatment in easing hot flashes in breast cancer patients. The results appear in the Journal of Clinical Oncology.

Fifty breast cancer patients were randomly assigned to receive either acupuncture or drug treatment for 12 weeks. The acupuncture group received acupuncture treatments twice per week for the first four weeks and then once a week for the remaining eight weeks; the drug group received 37.5 milligrams of Effexor each night for the first week and then 75 milligrams per night for the remaining 11 weeks.

All participants stopped their treatment after 12 weeks and kept a diary to record the number and severity of hot flashes; they were surveyed about their overall physical and mental health for one year.

Both groups experienced a 50% decline in hot flashes and symptoms of depression, but the acupuncture treatment appeared to have more lasting effects with fewer side effects.

For example, two weeks after the treatments stopped, the drug therapy group experienced an increase in hot flashes; the acupuncture group did not experience any increase in the frequency of their hot flashes until three months after treatment.

In addition, the Effexor group reported 18 instances of negative side effects, including nausea, dry mouth, dizziness, and anxiety, compared with no adverse side effects reported among the acupuncture group.

Most breast cancer patients treated with acupuncture also reported an improvement in their energy, clarity of thought, and sense of well-being. About 25% of women in the acupuncture group also reported an increase in their sex drive.

The FDA today approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women ages 10 years through 25 years.

Genital HPV infections are the most common sexually-transmitted diseases in the United States, and HPV types 16 and 18 are the cause of about 70 percent of cervical cancers worldwide. There will be an estimated 11,270 new cases and 4,070 deaths from cervical cancer in the United States during 2009, according to the National Cancer Institute at the National Institutes of Health.

“The licensure of Cervarix adds another option in the prevention of cervical cancer” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “It has the potential to save lives from cervical cancer as well as reduce the need for biopsies and invasive procedures associated with the necessary follow-up from abnormal Pap tests.”

The primary clinical study for Cervarix included more than 18,000 women ages 15 years through 25 years in the United States and 11 other countries. Of these women, about 9,000 received Cervarix and 9,000 received Havrix, a licensed hepatitis A virus vaccine, as a control.

The results showed that among women who had not already been infected by HPV types 16 and/or 18 before the start of the study, Cervarix was about 93 percent effective in preventing precancerous cervical lesions caused by these HPV types. Among all Cervarix vaccinees, which included those who tested negative for HPV 16 and/or 18, and those who tested positive at the start of the study, Cervarix was approximately 53 percent effective in preventing precancerous cervical lesions.

Studies also were performed to measure the immune response to Cervarix in girls ages 10 years through 14 years. Their immune response was similar to that of women ages 15 years through 25 years, indicating that the vaccine should have similar effectiveness in the 10 through 14 year age group.

The current data show that Cervarix provides protection for about 6.4 years, but additional information on the length of protection is forthcoming.

No vaccine is 100 percent effective, and Cervarix does not protect against HPV infections that an individual may already have at the time of vaccination, nor does Cervarix necessarily protect against those HPV types not in the vaccine. Therefore, regular Pap tests continue to be recommended for all women who receive Cervarix. Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.

Cervarix contains the adjuvant ASO4. ASO4 is a combination of aluminum hydroxide and monophosphoryl lipid A (MPL) and is the first vaccine licensed by the FDA that includes MPL as an adjuvant. An adjuvant is a substance incorporated into a vaccine that enhances or directs the immune response of the vaccinated individual.

The safety of the vaccine was evaluated in about 24,000 girls and women, with about 13,000 of these receiving Cervarix. The most commonly reported adverse reactions in the Cervarix group included pain, redness, and swelling at the injection site, fatigue, headache, muscle and joint aches, and gastrointestinal distress.

Although Cervarix is not indicated for pregnant women, the FDA is requiring the manufacturer, GlaxoSmithKline Biologicals to conduct a postmarketing study to assess the safety of Cervarix in pregnant women following vaccination prior to identification of pregnancy. Women who are pregnant, or think that they may be pregnant, or plan to become pregnant during the vaccination course, should not use Cervarix.

Cervarix is administered in three separate shots, with the initial dose being followed by two additional shots at one and six months.

Cervarix is manufactured by GlaxoSmithKline Biologicals, based in the United Kingdom.

Heinz, 71, and her husband, Massachusetts Sen. John Kerry, the 2004 Democratic presidential nominee, own a house just north of Ketchum along the Big Wood River.

On Wednesday, Heinz—the widow of Sen. John Heinz, heir to the Heinz ketchup fortune—told that she found out in late September that she had cancer in her left breast after having her annual mammogram.

In early October, she underwent lumpectomies on both breasts at a Washington hospital after doctors also discovered what they thought was a benign growth on her right breast. That diagnosis was initially confirmed in post-operative pathology, but two other doctors later found it to be malignant. In November, Heinz had another pair of lumpectomies performed at Massachusetts General Hospital.

Doctors also inserted titanium clips in the tissue of both breasts during the operations, and next month she will receive five days of targeted radiation. Heinz contended that younger women should continue undergoing mammograms despite a federal panel’s recent recommendation to reduce their frequency.

“Chemotherapy is serious,” she said. “It also costs a lot of money. It’s very painful. And it’s very destructive of people’s—most people’s—lives, for a while anyway. So why put people through that instead of just having a test that’s done, and it’s done? So that’s why I was so upset about that decision of this panel.”

Heinz has been a significant contributor to nonprofit organizations within the valley, including a $325,000 donation in 1992 from the Heinz Family Foundation to purchase and preserve Galena Lodge, a popular Nordic skiing destination north of Ketchum. Heinz was also the keynote speaker at the 2006 Sun Valley Sustainability Conference.

A group of 3,020 people aged 65 and older were selected. Of this group, 164 people already had Alzheimer’s disease and 522 people already had a cancer diagnosis. Researchers tracked the group for an average of five years to see whether they developed dementia and an average of eight years to see whether they developed cancer.

The 164 people with Alzheimer’s were found to be 69 percent less likely to undergo hospitalization for cancer during the study period.

The 522 people who had cancer were 43 percent less likely to develop Alzheimer’s disease over the course of the study period.

While the reasons for these results are not clear the connection between the two may prove to be significant. Catherine Roe from Washington University School of Medicine in St Louis, had this to say about the results of the study: “Discovering the links between these two conditions may help us better understand both diseases and open up avenues for possible treatments.”

More in depth studies into the correlation are planned.

The initial data from a Phase III study using the Revlimid in multiple myeloma patients who had undergone stem cell transplant reported that the trial had met its primary endpoint of a statistically significant improvement in time to disease progression.

The investigational study evaluated Revlimid compared to placebo in multiple myeloma patients following autologous stem cell transplant, and the independent Data and Safety Monitoring Board reported that the trial had met its primary endpoint of a statistically significant improvement in time to disease progression.

The Phase III, randomized, double-blind, multi-center clinical study was led by the Cancer and Leukemia Group B, or CALGB, and the independent Data and Safety Monitoring Board reported that the trial had met its primary endpoint of a statistically significant improvement in time to disease progression. The study was sponsored by the National Cancer Institute under a Clinical Trials Agreement with Celgene.

Revlimid, in combination with dexamethasone, is already indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.

The Revlimid pivotal MM-015 trial exceeded pre-specified interim efficacy endpoint in newly diagnosed Multiple Myeloma. Further results from the study will be presented in a peer-reviewed setting in 2010.