Background

The lawsuit which has lead to today’s Supreme Court hearing was brought by a group of researchers, medical groups and patients against Myriad Genetics, a Utah biotechnology company.  Myriad Genetics discovered and isolated the BRCA 1 and BRCA 2 genes which are associated with hereditary breast and ovarian cancer.  By being able to patent these genes and discovery, Myriad has been granted a 20-year monopoly over the use of the genes for research, diagnostics and treatment.  Myriad and other pharmaceutical companies alike argue that patenting genes encourage innovation and discoveries by ensuring financial rewards through protecting these discoveries from being used by others for free.  On the other hand, the opponents of gene patenting argue that these patents hinder innovation and collaborative discoveries by preventing the rest of the medical and research communities to use, apply, utilize and improve upon these discoveries and life-saving treatments.

“The United States Patent and Trademark Office has granted patents on at least 4,000 human genes to companies, universities and others that have discovered and decoded them. Patents now cover some 40 percent of the human genome.” – Reuters

What Does Patent Law Say?

As a former Patent Examiner at the U.S. Patent & Trademark Office, I find it very surprising that these patents (as well as 4000 other patents on human genes) were granted and approved by the USPTO in the first place.  The U.S. Patent Law makes it clear that products or laws of nature can not be patented.  So for example, “it might have taken Einstein a long time to figure out that E=mc^2, but he couldn’t have patented this law of nature”.  In fact, as noted by NPR, Dr. Jonas Salk the inventor of the revolutionary polio vaccine, when asked in 1955 if he had a patent on the vaccine, replied, “There is no patent…could you patent the sun?”

“We do know Myriad did a lot of work,” says New York University law professor Rochelle Dreyfuss, a nationally known patent expert who is not associated with either side in this case. But that’s not enough, she says, because the court still has to answer this question: “Is the thing that’s isolated significantly different from the way that it was when it was in nature?”

The ambiguity, however, that exists in this case which according to Myriad make their patents valid, is as follows:

…the 20,000 genes in the human body are part of a 6-foot-long molecule that’s “coiled and compacted and stuffed into each cell.  What Myriad was able to do is sort through all those 20,000 genes and find the two that were highly linked to hereditary breast and ovarian cancer.” The gene is like “a single grain of sand” hidden in a building the size of the Empire State Building, says Gregory Castanias, Myriad’s lawyer. He will tell the justices that isolating the two genes justifies a patent because “it is the final step in an extraordinarily complicated set of inventive actions that led to the creation of this molecule, which had never been available to the world before.”

That said, those challenging the patent claim that regardless of the process Myriad went through to discover these genes, the discoveries are products of nature and exist as part of the human DNA.  As Christopher Hansen of the American Civil Liberties Union points out,

It is no different than taking a kidney out of the body. Just because you are the [first] person who takes the kidney out of the body doesn’t entitle you to a patent on kidneys. A patent isn’t a reward for effort. A patent is a reward for invention. And Myriad didn’t invent anything. The gene exists in the body. All Myriad did is find it.

Why Over-Patenting Is Bad for Patients

Aside from the legal and research implication of the case above, I believe that over-patenting in general in the medical field is bad for patients.  The pharmaceutical and medical devices industries have argued as noted above that they need to protect and be financially rewarded for their discoveries that they often spend billions of dollars on to research and develop.  They view their research projects first as investments measured in terms of financial ROI where patient experience and outcome is only a means to an end of more profits.  Obviously, it is possible for both of those incentives to be aligned but pharmaceutical companies, as evaluated by Wall Street, are measured by balance sheets and quarterly statements not necessarily patient impact.

Gregory Castanias, Myriad’s lawyer:

“At some level it is about money, medicine doesn’t happen for free. … If you look at the enormous amount of investment — and not everything works that you invest in — the patent system is critical to medical care” by incentivizing companies to invest in needed scientific research and development.

However, though big Pharma’s argument does make sense that they deserve financial returns for their expensive R&D efforts, evidence shows that Big Pharma has abused the patent system to create monopolies and therefore profits from patients with little or no discovery to show for it.

Nexium vs. Prilosec: Twin Drugs Separated by Patent Protection

The best example for this is a drug called Prilosec (Omeprazole) made by AstraZeneca which is prescribed to patients suffering from Acid Reflux Disease (Heartburn).

In early 2001, this branded version of generic omeprazole was available only by prescription–$4.00 per pill.  Now the brand name is available for 63¢ each. The generic form is only 40¢.  The Prilosec patent ran out in 2001. Until then, AstraZeneca had a monopoly on omeprazole. Demand let them set the price sky-high. But in 2001 they had to scramble to save their cash cow. Generic companies would soon be able to sell the generic form of Prilosec and charge amounts more in line with production costs.  One corporate strategy was to develop a replacement drug for Prilosec, rename the drug, and get a new patent. Their R&D team came up with Nexium, an isomer of Prilosec. An isomer is a compound almost identical to the parent compound, with a molecule or two tweaked. Unfortunately, the new drug performed no better than Prilosec. It was basically the same compound with a new name and a higher price.

By tweaking a few molecules AstraZeneca was able to make a case for a new patent even though these changes had little or no impact on patient experience.  As such, currently Nexium is heavily marketed and prescribed by doctors over it’s identical patentless twin Prilosec OTC (costs 10 times less than Nexium).  Nexium sales generated $6.3 Billion for AstraZeneca in 2009 alone.

The Big Pharma Patent Vault

Aside from the dangers of patents being abused as means to create monopolies and controlling prices, the Big Pharma patent vault also holds countless patents on discoveries no longer being pursued or utilized.  What this means is that there are millions of patented discoveries and research methods that are sitting on pharma databases, unused and inaccessible to other researchers or scientists that might be able to leverage them to make novel discoveries or findings in other areas.

Where Patents Don’t Exist: Internet, Food and Fashion

One of the biggest argument by Big Pharma has always been that without patents researchers or drug companies will have very little incentive or motivation to invest in R&D efforts.  However, this claim does not hold in industries such as fashion, food and the internet.  All web sites or web apps for example, by design are open source and their code and interface design can be viewed and copied.  Further, in the food and restaurant industry, patent protection would be awful as chefs always copy and improve upon one another’s recipes and techniques making the restaurant business an extremely competitive and innovative industry.  Lastly, the fashion world is extremely vibrant, exciting, dynamic and volatile precisely because the healthy competitive environment that is enabled by the lack of patent protection in fashion.  Of course the startup cost of drug development and research is astronomical compared to fashion, web sites or food, however, what these IP-free industries show is that, less patents mean more competition, not less, more collaboration and less monopolies, more volatility and uncertainty for companies but better quality, cost and outcome for consumers.

Patients vs. Profits

At the end of the day, it is obvious that patent protection is more about protecting financial investments and short and long term profit sources than patient outcome.  Of course large investments in money and human capital are needed to research and develop drugs, however, once these drugs are merely viewed as consumer products from the CEO/Wall Street perspective, profits come first and patent law is just a means to an end.  The inventor of one of the most revolutionary drugs in history that cured Polio sought neither profits nor patent protection for his discovery.  His invested time, money and passion was solely for the purpose of helping patients and curing this disease.  It’s not hard to observe such acts of altruism and selflessness by individuals in the medical community today.  It is however, those powerful institutions with their outdated business models that often get in the way of patient-centric innovation and research through their Wall Street dictated balance sheet goals and metrics and insecure market position.

Sevan Mehrabian, Founder

The Life Tie Project

Modern medicine is in danger of losing a powerful, old-fashioned tool: human touch. Physician and writer Abraham Verghese describes our strange new world where patients are merely data points, and calls for a return to the traditional one-on-one physical exam.  In our era of the patient-as-data-point, Abraham Verghese believes in the old-fashioned physical exam, the bedside chat, the power of informed observation.

Today, one in three adults is considered clinically obese, along with one in five kids, and 24 million Americans are afflicted by type 2 diabetes, often caused by poor diet, with another 79 million people having pre-diabetes. Even gout, a painful form of arthritis once known as “the rich man’s disease” for its associations with gluttony, now afflicts eight million Americans.

The article and the book are based on Moss’s extensive research into the marketing, R&D and advertising methods and concepts that the food industry has employed for the past few decades to increase the consumption of their products.  These efforts have not only resulted in more profits for the food industry but also lead to the obesity epidemic and an exponential increase in related diseases such as diabetes and heart disease.  According to Moss, the big food companies’ R&D departments employ PhD level scientists in a variety of areas including chemistry, neuroscience and psychology to find the perfect taste, texture and ingredient combination that cause the most pleasure in the brain with the least mental resistance or guilt.  Some snacks have even been designed to melt in the mouth such that the brain is tricked to assume that the snack has much less calories than it does.

What I found, over four years of research and reporting, was a conscious effort — taking place in labs and marketing meetings and grocery-store aisles — to get people hooked on foods that are convenient and inexpensive.

What’s even more fascinating is that the executives of these major food companies have been aware of the obesity crisis that their companies have enabled for some time, but for the most part have made little effort to change things.  From the food companies’ perspective, it is the consumers who are responsible for their own good or bad health and food choices and the food industry is simply responding to demand.  While this assumption might be true, the average consumer is vulnerable to the pleasures of an artificially engineered food with the perfect amount of sugar, salt, fat and texture as well as highly effective and convincing marketing and advertising campaigns.

Frito-Lay had a formidable research complex near Dallas, where nearly 500 chemists, psychologists and technicians conducted research that cost up to $30 million a year, and the science corps focused intense amounts of resources on questions of crunch, mouth feel and aroma for each of these items. Their tools included a $40,000 device that simulated a chewing mouth to test and perfect the chips, discovering things like the perfect break point: people like a chip that snaps with about four pounds of pressure per square inch.

To get a better feel for their work, I called on Steven Witherly, a food scientist who wrote a fascinating guide for industry insiders titled, “Why Humans Like Junk Food.” I brought him two shopping bags filled with a variety of chips to taste. He zeroed right in on the Cheetos. “This,” Witherly said, “is one of the most marvelously constructed foods on the planet, in terms of pure pleasure.” He ticked off a dozen attributes of the Cheetos that make the brain say more. But the one he focused on most was the puff’s uncanny ability to melt in the mouth. “It’s called vanishing caloric density,” Witherly said. “If something melts down quickly, your brain thinks that there’s no calories in it . . . you can just keep eating it forever.”

Moss explains that, even more problematic is the fact that often various food products are sold and advertised as healthy options with low sodium, sugar or fat content, however, as the food industry has realized, the very absence of certain ingredients makes people want to consume more of it to satisfy their unconscious and pre-trained taste expectations.  This is precisely why the food industry is adamant on getting their products in schools where kids’ pallets and taste expectations can be formed early on in life and they become consumers of these food brands for life.  That said, some positive changes are happening within these companies in terms of a shift in focus to healthier food products as well as more conscious marketing and advertising campaigns.  Additionally, there are a growing number of public campaigns for healthier food options and choices such as the First Lady’s ‘Let’s Move!‘ initiative:

Let’s Move! is a comprehensive initiative, launched by the First Lady, dedicated to solving the problem of obesity within a generation, so that children born today will grow up healthier and able to pursue their dreams. Sure, this is an ambitious goal. But with your help, we can do it.

These efforts not only put pressure on the food companies to offer healthier options but they also educate consumers to understand the risks and benefits of their food choices.  However, for-profit food companies are by nature and Wall Street, obligated to increase profits through more consumers consuming more of their products.  As such, they will not change unless the consumption culture changes, similar to what happened to the Tobacco industry and declining number of smokers in America in the past few decades.  The advertising posters for cigarets went from representing them as symbols of health, independence and strength in the 1960′s to including a Surgeon General warning on them today about their health risks.

We can conclude from this article that ultimately humans are driven by what Freud called the “Pleasure Principle” to seek pleasure and avoid pain.  By targeting, stimulation and appealing to our pleasures any industry can nudge us to consume or be addicted to certain products.  What is needed is education and awareness of the future pains of bad consumption habits.  More awareness and demand for healthier food choices can eventually make healthy options cheaper and available to all types of consumers even the poor whom are most negatively impacted by junk food consumption and obesity.

What this research shows is how the farming and industrial revolutions have lead to diets with less diverse probiotics.  The implications of this change has been a modern human microbiome that is more prone to disease and infections.  The decreasing amount and diversity of probiotics in our bodies allow for more dangerous and unfriendly bacteria to take hold and cause all kinds of short and long term problems including chronic inflammation and autoimmune diseases.

The importance of commensal microbes for human health is increasingly recognized^{1, 2, 3, 4, 5}, yet the impacts of evolutionary changes in human diet and culture on commensal microbiota remain almost unknown. Two of the greatest dietary shifts in human evolution involved the adoption of carbohydrate-rich Neolithic (farming) diets^6, 7 (beginning ~10,000 years before the present^6, 8) and the more recent advent of industrially processed flour and sugar (in ~1850)⁹. Here, we show that calcified dental plaque (dental calculus) on ancient teeth preserves a detailed genetic record throughout this period. Data from 34 early European skeletons indicate that the transition from hunter-gatherer to farming shifted the oral microbial community to a disease-associated configuration. The composition of oral microbiota remained unexpectedly constant between Neolithic and medieval times, after which (the now ubiquitous) cariogenic bacteria became dominant, apparently during the Industrial Revolution. Modern oral microbiotic ecosystems are markedly less diverse than historic populations, which might be contributing to chronic oral (and other) disease in postindustrial lifestyles.

The implications of these findings are even more fascinating when recognizing how critical of a role probiotics play in the healthy functioning of our bodies.  For example,  in a series of experiments on mice, Canadian scientists found that changing the bacterial composition of the colon through the administration of antibiotics resulted in increased levels of brain-derived neurotrophic factor (BDNF), a protein associated with memory, learning and mood. Disrupting bacteria in the colon made normally passive mice more active and adventurous.

“Previous work has shown that probiotics can improve the moods of patients with chronic fatigue syndrome or irritable bowel syndrome. And, in a study published earlier this year², a French research group showed that a concoction of Lactobacillus helveticus andBifidobacterium longum, given over 30 days, improved healthy volunteer scores in a range of surveys designed to assess mental health.”

It is then not surprising to connect many of our modern digestive and mental health problems to our modern diet of processed and less diverse foods.

Irritable bowel syndrome and other chronic bowel disorders are accompanied by anxiety and depression in 90% of patients. New research published in the journal Gastroenterology suggests these behavioral changes may be the result of altered brain chemistry caused by a disruption in the intestinal environment.

Most of us have spent some time thinking about our own deaths. We do it with a sense of dreadful curiosity, but then we push it aside with “well, we’ve all got to go sometime.”

Unlike most people, I probably know the how, the why, and maybe even the when of that event. It is profound information that turns the world upside down for us, our families, friends and caregivers. I have cancer that is incurable, aggressive, and has negligible survival odds. My chemotherapy is a long shot. I will leave a spouse, children, siblings and a life that I love and cherish. I cannot imagine existence without them.

I have read the books about stages of grief and end of life. But when all is said and done, truth is the great measure. The truth between doctor and patient when there is nothing else to be done. The truth between patient and family who want desperately to have a few more months or days and cannot. The truth between patient and friends who must accept and move on without bitterness. The truth between patient and spouse, partner, or caregiver who have waited for that moment and are helpless to change it.

Of all things, the simple act of truth has become most important to my husband and me. We talk about my dying. It is a poignant, painful and sometimes funny honesty. We have done it after solemn consults with physicians, during long hospital stays, through gut-wrenching disappointments, and sometimes over toast and coffee on Sunday mornings.

We have learned to be forthright and unafraid of saying it out loud. We deal with small moments – planning vacations, making purchases, visiting family, entertaining old friends – in a sober and reflective way. Routine plans – Christmas with the family; the vacation cottage; an annual trip – become critical decisions. We discipline ourselves to push aside the things that are trivial. It becomes easy to ignore the cracks in the driveway and the clutter in the closet.

And we occasionally treat it with laughter although, perhaps to the horror of some, it is gallows humor. We joke that when I am gone, the piano, the house, the cars will all be his. We laugh and mimic Homer Simpson, believing he is doomed, reading a pamphlet headlined, “So You’re Going To Die.” It reminds us that we are in a real world where playfulness is a part of life.

There is no bucket list. There are no plans to see the great pyramids, kiss the Blarney Stone, or throw a party in Times Square. We look to the small things we have known for decades that have become precious to us now: a walk on the beach, a Saturday matinee movie, sharing a bowl of ice cream, holding hands as we go to sleep at night.

Details – advanced directives, the will, the attorney, the broker – are easy. These will help put affairs in order but they do not address relationships with the world and the people who inhabit it.

The hard things that tug at the heart and create the pain are the unbearable truths to parents that they will lose a child; to siblings that the person they’ve known their entire lives will be gone; to children that they must overcome and move on. They convey a clear and undeniable message to doctors that they must relinquish the desire to salvage, fix and prolong.

But most of all, the truths we come to know lie in the depth and clarity of our bonds. For me, this is reflected in the conversations with my husband, the beloved person in my world. I want him to go on with life; to find someone to share it with; to help the children as they struggle with the loss; to remember the laughter and how much we loved each other. That is all I have left to give him.

And for that I extract a bittersweet promise that he will make me laugh until the end, that
we will hold hands every night, that we will share the ice cream, that we will always talk about what is happening, and that I will die with him beside me.

It is the dignity, the finality, and the truth at the end of life.

Click here to read more about and to share your thoughts on the Great Challenge of Coming to Grips with End-of-Life Care.

Via PSFK.com