In a Supreme Court test of whether a company can be granted a patent on the genes in the human body, a majority of the justices indicated during Monday's oral arguments that the court is likely to rule that a human gene can’t be patented. 

It would be one thing, several of the justices said during Monday’s oral arguments, for a company to seek a patent on a test for breast cancer that was developed by analyzing a human gene, but it would be going too far to be awarded a patent on the gene itself.

"What's the difference between snipping off a piece of the liver or kidney, and seeking a patent on that, and seeking a patent on a piece of a gene?" asked Justice Sonia Sotomayor.

Justice Samuel Alito made a different analogy, to someone seeking a patent on a plant found in the Amazon rain forest that bore leaves containing a cancer cure. "You could patent the process used to get the chemical out and the use of the result, but you cannot patent the plant," he said. 

Stelios Varias / Reuters file photo

The U.S. Supreme Court in Washington

The case, Association for Molecular Pathology v. Myriad Genetics, involves a test that has helped guide more than a million women in their medical decisions. The test can determine whether the composition of their genes makes them more likely to get breast or ovarian cancer.

Myriad Genetics, a Utah company, owns patents on two parts of human genes known as BRCA 1 and BRCA 2, named for the first two letters of the words breast and cancer.

Women with mutations in those genes face up to an 85 percent risk of getting breast cancer and up to a 50 percent risk of ovarian cancer. Because of the patents, Myriad has a monopoly on performing all diagnostic tests related to BRCA 1 and BRCA 2.

In the past three decades, the federal government has granted nearly 3,000 similar patents on genetic material. Without such protection, Myriad argues, companies would be less willing to spend the money required for making genetic discoveries.

"Countless companies and investors have risked billions of dollars to research and develop advances under this promise of stable patent protection," according to Gregory Castanias, a Washington, D.C, lawyer who argued the case for Myriad.

The idea of patenting DNA material has provoked a strong debate among scientists, and many have lined up on opposite sides of the case.

"Human genes should not be patented," says James Watson, the Nobel Prize winner and co-discoverer of the double helix structure of DNA.

"Life's instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts," he says.

But a group of researchers at the University of Maryland is among those arguing just the opposite. "The costs are outweighed by the benefits stemming from the fruits of increased inventive activity," they say in their friend-of-court brief.

In the 220 years since Thomas Jefferson wrote the cornerstone of U.S. patent law, the courts have agreed on a general principle: patents protect inventions, not products of nature. A central issue in this case is whether Myriad has obtained a patent on something already in the body or has created something new.

The ACLU, representing a group of scientists, doctors, and cancer patients, claims that Myriad has merely removed from the body something that was already there -- the DNA sequence making up the BRAC 1 and BRAC 2 genes. Because it is a creation of nature, the ACLU says, it cannot be protected by a patent, even though Myriad claims that removing it is what makes it useful.

"Gold does not become patentable once taken out of a stream because it can be used in jewelry. Kidneys do not become patentable once taken out of a body because they can be transplanted," says the ACLU's Christopher Hansen.

Myriad's exclusive patent, says the ACLU, creates a monopoly that denies women the ability to seek a second opinion, based on another test of the genetic material, and dissuades other laboratories from pursuing research on the patented genes.

The ACLU also contends that because the test costs roughly $3,000, many women cannot afford it or lack the necessary insurance coverage. If the gene was not under patent protection, the ACLU says, competition would make the test cheaper.

But Myriad argues that removing the gene sequence from the body requires breaking chemical bonds that lock it into place, thereby creating a new chemical entity.

The resulting genetic materials, the company says, "were never available to the world until Myriad's scientists applied their inventive faculties to a previously undistinguished mass of genetic matter."

Myriad cites a line of cases finding patent eligibility for naturally occurring substances that were isolated and purified, including aspirin, vitamin B12, and adrenaline derived from cows.

As for availability, the company says the cost of the test is covered by private insurance, Medicare, and Medicaid. It also says many other labs provide second opinions regarding the company's test results and that thousands of researchers have done studies on the gene sequence involved, unimpeded by the patent.

The Obama administration has urged the court to be deeply skeptical of Myriad's broad claim of what can be patented. The Justice Department's brief in the case says the public interest has consistently been given precedence by the Supreme Court "in avoiding undue restrictions imposed by patents that effectively preempt natural laws and substances."   

NBC's Tom Curry contributed to this report.

This story was originally published on Mon Apr 15, 2013 4:17 AM EDT

Until very recently, young women who went through cancer treatment often discovered their fertility was a casualty of life-saving therapies. But a new option – the removal and freezing of an ovary prior to chemotherapy and radiation treatments – may be changing all that.

So far, 20 babies have been born worldwide as a result of this new procedure, which is called ovarian tissue cryopreservation, Dr. Nancy Snyderman reported on NBC Nightly News with Brian Williams.

This is good news for the estimated 1 in 46 women under age 40 who are diagnosed with some form of cancer, since chemotherapy and radiation -- the most common treatments -- can destroy a woman’s fertility.

One of the specialists who's been working with the technique is Dr. Kutluk Oktay, a professor of obstetrics and gynecology at New York
Medical College and director of the Institute for Fertility Preservation/Reproductive Specialists of New York.

“Ovarian cryopreservation is a procedure where, when a woman is faced with a medical condition that would affect [her] future fertility, the ovary is removed through a keyhole procedure and it's taken through a specialized process which involves treating the tissue with antifreeze substances and utilizing an automated process to preserve the ovary for future use,” Oktay explained to Snyderman. “If you were a cancer patient 15 years ago, your options in terms of fertility preservation would be close to zip.”

While the option of freezing eggs before treatment has been available for the past several years, that alternative won’t work for those with aggressive cancers or hormone sensitive tumors, Oktay explained.

For egg harvesting and freezing, women need to go through a process in which their ovaries are stimulated with hormones that will spark the production of many eggs in one cycle, Oktay said. Those hormones can make some cancers -- like ovarian or certain forms of breast cancer -- worse.

And some women just can’t hold off on cancer treatments for the three to six weeks the process takes, said Dr. Kyle Orwig, an associate professor at the University of Pittsburgh Medical Center and director of the fertility preservation program at UPMC. Orwig’s institution is also looking at the viability of ovarian cryopreservation. 

How does this new ovary-freezing procedure work?

Doctors remove an ovary and then, once a woman has completed cancer treatment, transplant the tissue back into the abdomen – or even under the skin. Once transplanted, the ovarian tissue will be able to turn its supply of immature eggs into viable ones, Oktay explained.

The procedure takes about 40 minutes and can be done under local anesthesia. As for cost – that all depends on whether the procedure can be done as a part of another surgery.  If it can, the charge would be minimal, Oktay said. Otherwise, it could run anywhere from $6,000 to $10,000.

For Morgan Thompson, 29, it’s enough to know that she might one day be able to have a baby. Thompson was diagnosed with Hodgkin’s lymphoma three years ago and was referred to Oktay when she told doctors she wanted to somehow preserve her fertility.

“It is a very shocking thing to have to deal with at any age,” Thompson told Snyderman. “But at 26, I was not prepared at all. I always knew I wanted to be a mom. In my mind I was going to have twin girls and a little boy. I had everything perfect in my head.

“You want to be told that you have options. You want people to think that you’re going to be here in order to make the decision to even have kids. So a procedure like this is amazing.”

While the new procedure offers women hope, no one knows exactly how risky the procedure is - yet.

It is still surgery, which means it comes with all the risks associated with surgery, Orwig said

The biggest concern, however, is the possibility that doctors might be putting cancer-tainted tissue back into a patient who’s been cured, Orwig added.

In that respect, some cancers are more risky than others.

“A good example would be leukemia,” Orwig said. “It’s a cancer of the blood and blood circulates through all the tissues, including the ovaries. If we put the ovarian tissue back into the patient, there’s a risk that we could be reintroducing the cancer. We don’t have the answer to that yet. We need to be certain that we’re transplanting cancer-free tissue.”

Ultimately, women need to recognize that the procedure is still considered to be experimental, Orwig said.

“I think it’s important that it works - although it’s experimental there are at least 20 live babies so far,” he said. “But there are risks and it’s way too early to remove the experimental tag.”

Along with the standard treatments of chemotherapy and radiation for cancer, patients are routinely being offered alternative or complementary therapies such as acupuncture, massage and yoga in major cancer centers around the country, according to a report by NBC’s Dr. Nancy Snyderman on “Nightly News with Brian Williams.” Alternative therapies have become an increasingly mainstream tool for doctors all around the country, especially when used to ease the side effects of treatment.

On Tuesday, Oct. 16., tune in to "NBC Nightly News" to watch part two of Dr. Nancy Snyderman's report on complementary medicine and learn about different therapies for back pain. 

A 2010 University of Pennsylvania study found that 70 percent of comprehensive cancer centers offered information on complementary therapies on their websites, according to study co-author Dr. Jun Mao, an assistant professor and director of integrative care at the Abramson Cancer Center at the University of Pennsylvania.

“And over half of these centers endorse the use of these therapies in cancer care delivery,” Mao says.

The reason complementary therapies have moved into the mainstream, particularly with regard to cancer care, is that they can help patients deal with pain and treatment side effects, explains Dr. Barrie Cassileth, a pioneer in the field of complementary medicine
who heads up the integrative medicine service at the Memorial Sloan-Kettering Cancer Center in New York.

Read a transcript from Dr. Snyderman's online chat about complementary medicine. 

“Acupuncture does not cure cancer, but it is extremely helpful in a cancer setting because it can control multiple symptoms, some of which are not treatable with mainstream means,” Cassileth told NBC’s chief medical editor Dr. Nancy Snyderman.

“It’s not enough to say to the patient, ‘OK, you’re finished with your chemotherapy, your radiation, your surgery and so on. Goodbye, and have a good life.’ The patient is suffering from a wide range of problems.”

Mao’s study found that acupuncture was one of the most commonly mentioned complementary therapies on cancer center websites. 

“Acupuncture can help alleviate pain and nausea,” Snyderman explains. “The good cancer centers believe that acupuncture is a cornerstone of integrative medicine.”

What’s still not clear – even to the specialists – is exactly how acupuncture works.

“We don’t entirely understand its mechanism,” Mao says. “We do know that acupuncture can help relieve pain by bringing in endogenous opiates, which are like pain medication.”

Other therapies, such as yoga, help to reduce pain by reducing stress, Mao says.

“They enhance centeredness and peace,” he explains. “And that kind of stress reduction can reduce pain. Anxiety can lower a person’s pain threshold. By helping to lower stress and anxiety, it can help with the pain.”

Beyond this, complementary therapies can help foster the mind body connection, Mao says.

That rings true to Snyderman who would like to see more biofeedback being used.

“Biofeedback may be one of those hidden gems that we don't talk enough about,” Snyderman says. “Being able to image a part of your body, harness thought and control things like heart rate and blood pressure and minimize pain is astonishing. I am a huge fan of biofeedback and using that same power to enhance the immune system - a field called psychoneuroimmunology.”

For patients, there’s a side benefit: feeling more in control of their lives.

“Cancer is often unexpected and it takes a lot of control from the individual,” Mao says. “Complementary medicine often helps patients regain some sense of control, and helps them deal with some of the uncertainties.”

That makes sense to Diane Miller, a breast cancer survivor who has been dealing with her diagnosis and treatments for the past few years.

“Finding out what I can do myself is empowering,” Miller says. “And it really does help my symptoms.”

 By Robert Bazell
Chief science and medical correspondent
NBC News

Two thought provoking and disturbing studies out Wednesday raise major questions about conduct of the “War on Cancer.” One examines  the quality of basic research and the other concludes that half of current cancer deaths could be prevented.

Almost 90 percent of early stage cancer research looking for improved treatments is wrong, according to scientists at biotechnology giant Amgen and the MD Anderson Cancer Center.  The researchers describe their findings as “shocking.”

Read Wednesday's news about the decline in cancer death rates.

The allegations about questionable research in the quest for treatments appear in the prestigious journal Nature.  C. Glenn Begley, the former head of cancer research at Amgen, and surgical oncologist Lee M. Ellis of MD Anderson Cancer Center in Houston describe how scientists at the Thousand Oaks, Calif.-based Amgen tried to replicate the results of 53 landmark cancer research papers.  By landmark, they mean papers cited by others as significant progress.  All were so-called “pre-clinical,” meaning they were studies in rodents or with cells in petri dishes. The scientists were able to replicate only 11 percent of the conclusions.  In science, replication is proof.  If a study can’t be reproduced reliably, it is wrong. 

Most of the papers in question describe gene mutations or other changes in cancer cells that could be potential targets for new cancer treatments.  Such research is obviously critical for companies like Amgen deciding how to spend hundreds of millions testing potential drugs in humans.  The findings at Amgen do not differ greatly from those at a team at Bayer HealthCare in Germany, which reported last year that it could not replicate 25 per cent of studies.

Begley and Ellis assume that fraud plays little or no role in the bad science. “These investigators were all competent, well-meaning scientists who truly wanted to make advances in cancer research,” they write.

So, what is the problem? Scientists often ignore negative findings that might raise a warning, cherry picking the results and putting the best face on their research. The practice involves many parties -- not just the scientists -- in the research process who turn blind eyes to questionable actions.

As Begley and Ellis detail it, “To obtain funding, a job, promotion or tenure, researchers need a strong publication record…Journal  editors, reviewers, and grant review committees [and I might add journalists—R.B.] often look for a scientific finding that is simple, clear and complete—a ‘perfect’ story.  It is therefore tempting for investigators to submit suspected data sets for publication, or even to massage data.” 

Whatever the motivation, the results are all too often wrong.

Begley and Ellis call for nothing less than a change in the culture of cancer research.  They demand more willingness to admit to imperfections and an end to the practice of failing to publish negative results. 

“We in the field,” the say, “must remain focused on the purpose of cancer research: to improve the lives of patients.”

While the Amgen report casts doubt on cancer research, a separate study concludes that fully half of all cancers occurring today are preventable.  It raises questions about the billions spent searching for treatments and concludes that “we must vigorously implement what we already know about preventing cancer.”

The article about prevention appears in the top-tier journal Science Translational Medicine. Epidemiologists Graham Colditz, Kathleen Wolin and public health researcher Sarah Gehlert of Washington University in St. Louis review the best data. 

According to the careful Washington University study, smoking remains the biggest cancer-causing environmental factor  -- responsible for  33 percent of cancer deaths, almost 189,000 lives a year in the U.S. alone.  Obesity now follows closely, causing 20 percent of cancer deaths, or 114,000 people a year.  Pollution and radiation (most of it from medical sources) each account for only about 2 percent of cancers. 

The argument about allocation of funds for reducing the risk of cancer versus treatment is as old as our efforts to confront cancer.  But as these authors show the evidence and the need to act on it grow ever stronger.

As a society, we have shown we can do a great deal — but not nearly enough  – about tobacco. Obesity is another story, but we must do better if we want to be serious about cancer – and all the other attendant diseases.

Even short of the huge social challenges in confronting tobacco and obesity, there are many proven relatively simple methods to cut cancer deaths.  They include effective screening tests, such as pap tests and colonoscopies. The vaccines against HPV and hepatitis B both prevent cancer-causing viral infections, and aspirin is looking ever better as a cancer control agent.

Only 1.5 percent of the U.S. cancer research budget now goes to risk reduction. The rest seeks to find treatments, an effort that Begley and Ellis show is seriously flawed.  As these two powerful studies out Wednesday show, it is high time we reorder our priorities.

Robert Bazell is NBC's chief science and medical correspondent. Follow him on Facebook and Twitter.

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By Robert Bazell
NBC News

It is far from a shocking revelation that red meat is not health food. But a new study from the highly respected researchers at the Harvard School of Public Health offers some of the best and most detailed evidence yet that a daily serving of meat can increase risk of heart disease or cancer.

The Harvard scientists followed almost 84,000 women and 38,000 men in the Nurse’s Health Study and Health Professional’s Follow-Up Study for 28 years. It found those eating a daily serving of red meat were 13 percent more likely to die in the study period, and approximately 14 percent more likely to develop heart disease or cancer. Those numbers go up to 20 percent more deaths and an estimated 18 percent more heart problems and cancer for those who reported eating a daily serving of processed meats such as hot dogs, salami and bacon.

In the realm of health risks, these are not huge numbers.  Daily cigarette smoking adds risk of some 2,000 to 4000 percent for these hazards. But across the U.S. population, Americans love of meat likely accounts for about 1.5 million excess deaths every decade, according to research from the National Institutes of Health.

According to the American Meat Institute, Americans consume on average 65 pounds of pork and a similar amount of beef per person every year. Those numbers have changed little over the past two decades. At the same time, chicken consumption has climbed sharply to around 80 pounds a year, while turkey logs in at 15 pounds a year. We’re eating more birds, but no fewer mammals.

The Harvard research is very credible, even though it is a so-called “observational” study. The highest level of proof is a “controlled trial” where half the people would eat meat and the other would not. That’s obviously not practical for multi-decade dietary study.  The Harvard researchers have a long track record with their observations of nurses, doctors, and other health professionals. Blood tests confirm that what people report as their diet tends to be accurate -- as are their health records.

In addition, these results neatly coincide with a decade long study published in 2009 of more than 500,000 people from the National Cancer Institute. That confirmation strengthens the argument enormously.

In an editorial in the same issue of the Archives of Internal Medicine with the Harvard study, Dr. Dean Ornish, the preventive medicine guru of the San Francisco Bay area, points out that red meat is harmful not just to our bodies, but also to the planet. It takes enormous amounts of plants, requiring energy-intensive fertilizers, to fatten cattle and pigs. Ornish cites a study finding that the amount of energy required to produce a Quarter Pounder with Cheese equals burning 7 pounds of coal.

Ornish -- who once opposed most fat in the diet -- now agrees with the Harvard group that there are “good fats,” such as fish oil and vegetable oils and “bad fats,” including the saturated fats found in meat and the industrially created trans fats. Ornish concludes there is an emerging consensus of what constitutes a healthy diet: little or no red meat; more “good carbs,” such as those in fruits vegetables and whole grains; fewer “bad carbs,” such as refined sugar, high-fructose corn syrup and white flour; more good fats and fewer bad fats. And to the extent possible, we should eat less of everything, especially junk food.

Those conclusions, the product of decades of many big research projects, will likely stand for a long time. So, we know what a healthy diet is. The question is: Will our taste buds and will power allow us to stay with it?

Bon appétit.

Robert Bazell is NBC's chief science and medical correspondent. Follow him on Facebook and on Twitter @RobertBazellNBC

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By Anne Thompson
NBC News

Laura Pita is a bundle of energy and she needs it. She is the mother of four tireless boys. Like so many moms, her plate is overflowing. Raising four boys is a full-time job on its own, but one of her sons, 8-year-old Josh, has an acute form of leukemia. Last April, as Josh was undergoing intensive chemotherapy, Pita was also comforting her mother, Roberta "Emmy" Burt who was dying from melanoma. That month, on the day Emmy died, a distraught Pita decided she had to do something positive, something that would remind her that there is happiness in life.  

"I lost my mommy. I needed to do something or else I would have gone insane," Pita said.  

So she decided to make a tutu for her niece. That act in a moment of despair was the start of her charity "Emmy's Heart" that is bringing moments of fun and joy in the pediatric wards of Joe DiMaggio Hospital in Hollywood, Fla., and Bethesda Memorial Hospital in Boynton Beach, Fla.

Looking at the tutu, Pita thought of all the little girls she saw fighting cancer. The drugs that promise to make them well also take their hair, their glowing complexions, and their energy. But Pita knew they were beautiful and knew her tutus could remind them of their inner beauty. As for the boys, capes would make them feel like superheroes. With the help of friends, Pita started making tutus and capes and taking them to Joe DiMaggio, where Josh is treated. Watch the faces of scared children transform into confident smiles as they put on the capes and tutus and you will see that Pita's creations have magical powers.

Instantly, the children go from the difficult reality of being sick to their world of imagination. They become Captain America, Superman, ballerinas, and princesses. They jump, they twirl and most of all, they laugh. Pita's son, Josh, calls himself the Chemo Kid. He is vanquishing his leukemia, now getting chemo just once a month to keep his illness in check. So far, Pita said, they’ve distributed 250 tutus and about 200 capes.

"I honestly thought here and there I would drop off a tutu for the girls, I had no idea -- no dream ever that this would happen," said Pita, whose family has spent $4000 on the charity since April 2011.  

They call her "The Tutu Lady." I think you'll agree, they can call her a superhero too. 

You can learn more about Emmy's Heart by visiting their website or emailing Laura Pita at laura.pita@emmysheart.org.