GlobalTort : Commentary from lawyers and experts on mass torts, law, insurance and science

Today is World Cancer Day. The message from the sponsoring group? DO SOMETHING

The Komen Fund made the right choice and reversed its mistake of letting politics reduce cancer screenings. Now it's up to the rest of us to do something, such as:

Sign the petition at worldcancerday.org.

Speak out against politics in cancer.

Speak out against cancer killing 600,000 Americans every year. In a decade, that's the population of Chicago.

Speak out on funding - our government spends $ 50 billion per year on homeland security but gives the National Cancer Institute only $ 5 billion for cancer research. Osama bin Laden killed about 2,100 people. That many people die from cancer every 2 days. Money is being spent in the wrong places.

DO SOMETHING

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Sequencing entire genomes is increasingly possible, cheaper, and faster. And, the results really can produce meaningful information.  ScienceDaily makes the point by highlighting this new paper from Nature on whole genome sequencing of persons with AML - a form of leukemia. The overall conclusion of the study supports the long held but unproven view that chemotherapy causes DNA damage that can play a role in the recurrence of the disease. To gather the evidence, the team from Washington University in St. Louis used whole genome sequencing to compare entire DNA sequences of tumors before and after relapse. 

"The mutations in AML patients who have relapsed are different from those present in the primary tumor, and they are more likely to have a telltale signature of DNA damage," says senior author John F. DiPersio, MD, PhD, the Virginia E. and Sam J. Golman Professor of Medicine and chief of the division of oncology. "This suggests that mutations in the relapse cells are influenced by the chemotherapy drugs the patients receive."   Chemotherapy is known to damage the DNA of both cancer cells and healthy cells. But until now, scientists have had little direct evidence to suggest that chemotherapy itself helps shape the evolution of cancer cells and may contribute to disease recurrence. The researchers suspect this phenomenon is not unique to AML and may occur in other cancers as well.”

For the current study, scientists at Washington University's Genome Institute sequenced the genomes -- the entire DNA -- of cancer cells before and after relapse in eight patients with AML and compared the genetic sequences to healthy cells from the same patients. The data essentially allowed them to map the evolution of cancer cells in each patient.

All the patients received cytarabine and an anthracycline drug to induce remission plus additional chemotherapy in an attempt to keep the cancer from returning. Using technology developed at the Genome Institute, the researchers isolated the DNA segments that contained every mutation in the samples of cancer cells and sequenced those regions nearly 600 times each, far more than the usual 30 times each, which substantially increased the statistical accuracy of the results. 

Sequencing the entire genomes of the cancer cells was essential to the researchers' discoveries. Most of the mutations in the relapse samples occurred in the regions of the genome that don't include genes and would have been missed if the researchers had sequenced only a portion of the patients' DNA.

"If we only look at the genes, we typically find a total of 10 to 25 mutations in each patient with AML," says lead author and Genome Institute scientist Li Ding, PhD, research assistant professor of genetics. "That's not enough to see significant changes in the mutational patterns of the primary tumor cells versus those in the relapsed cells. Whole-genome sequencing identifies hundreds of mutations in each patient, which provides the resolution and confidence necessary for us to dig deeper to understand how cancer evolves."

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Uncertainty. Civil trial lawyers know a little something about uncertainty from waiting for judges and juries. Imagine, however, life and death uncertainty. Imagine journeying through 21 years of occurrences and remissions arising from indolent grade III lymphoma. Imagine enduring 9 courses of treatment to stay alive for those 21 years. Imagine taking that experience, and turning it into books, as well as an always succinct and powerful blog:  On Healthy Survivorship. Imagine writing insightful medical journal articles and speaking to other doctors about how to better work with cancer patients, survivors, and their loved ones.

You've been imagining the uncertainty of life as Dr. Wendy Harpham. Her wonderful blog is here. Her more general website is here. Dr. Harpham's six books are listed here. And here is her October 18, 2011 blog post to celebrate having reached her 57th birthday.  

How can doctors best help patients manage cancer and uncertainty? What it is that patients feel, and that trial lawyers need to understand in some way?  Dr. Harpham recently addressed the subject here, in the first of a series of articles she's writing for a professional publication, Oncology Times, in an article titled: View From The Other Side of the Stethoscope: Managing Uncertainty (Part 1) Background. The full text is here. 

Dr. Harpham's column starts with her history - her story. It's below. Imagine how it's felt for 21 years:

"My Story

In 1990 I was diagnosed with Stage III indolent lymphoma. All the textbooks described inevitable recurrence, with successively shorter remissions leading to death. At the time, the median life expectancy of patients with this lymphoma was about seven years. A second recurrence within two and a half years dropped my prognosis to two years. Since entering a clinical trial to treat my third recurrence, no statistics have been available for patients like me.

I've received nine separate courses of various therapies, the last of which ended in November 2007. My disease is currently in remission.

_____________________________________________________________

The rest of her article is here. 

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What's the link, if any, between a particular bacteria and colon cancer ? No one is quite sure at present, but two labs have now used new tools and research to find parallel evidence of massive amounts of bacteria involved with colon cancer cells. The how and why remain to be discovered. But simply knowing to ask the question is part of the battle. The larger story is here in the NYT, by science writer Gina Kolata. New tools do make a difference.

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Yesterday, cancer took Steve Jobs, one of the world's most creative, wealthy and powerful men; a man able to summon and invoke all the best we presently have to offer for his specific disease. Yesterday,  in the US alone, cancer killed another 1,499 Americans. All 1,500 were spouses, lovers, or children, and are irreplaceable in their own circles of family and friends. Overall, cancer is either the first or second leading cause of death in the United Sates, as illustrated by these numbers from the CDC.

Globally, cancer is now calculated as the leading cause of death. The following data are drawn from this ScienceDaily summary, and illustrate the stunning toll, which is projected to double by 2020, and then triple by 2030: 

"According to the new report, the burden of cancer doubled globally between 1975 and 2000. It is estimated that it will double again by 2020 and nearly triple by 2030. This translates to far greater numbers of people living with – and dying from – the disease. The report estimates that there were some 12 million new cancer diagnoses worldwide this year, and more than seven million people will die from the disease. The projected numbers for the year 2030 are 20-26 million new diagnoses and 13-17 million deaths."

Why does the toll grow ? There are many answers, and one of them is that disease rates for some cancers continue to climb, regardless of smoking issues. The chart below illustrates the point - note specifically that the top two lines in the chart tell terrible stories:  Inexorably climbing cancer rates for childhood cancers and non-Hodgkins lymphomas. 

What to do?  The study quoted above includes the following recommendations from experts, with emphasis added as to scientific steps: 

The six call to action steps issued by the three U.S. organizations include:

1. making vaccines that prevent cancer causing infections more widely available to low-income nations, including specifically combating cervical cancer through Global Alliance for Vaccines and Immunizations (GAVI) efforts to make the HPV vaccine accessible and affordable;
2. committing to a comprehensive tobacco control approach in the U.S., which includes taking measures proven effective in reducing smoking rates and having Congress grant the Food and Drug Administration (FDA) authority to regulate tobacco;
3. ratifying immediately the Framework Convention on Tobacco Control (FCTC), the first ever global public health treaty that sets forth comprehensive measures to reduce health and economic impacts of tobacco;
4. supporting efforts of non-governmental organizations to build advocacy and resources, empower survivors and reduce suffering in low- to middle-income countries by working with governments, medical professionals and the corporate sector to enable individuals to adopt healthier behaviors;
5. promoting culturally sensitive risk reduction and education campaigns by leveraging our own successful U.S. efforts to help build capacity of nongovernmental organizations in other countries; and
6. investing in cancer research and expanding access to prevention and early detection measures in the U.S., with a specific focus on increasing federal funding of medical research.

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Danny's Tree. A memorial to Danny Host, a 7 year old victim of brain cancer. Danny's death this past February is one small part of cancer's annual death toll of almost 600,000 people in the United States.

Over the next decade, cancer will strike 1.6 million Americans per year. Over a decade, that's more than the populations of the cities (not suburbs) of New York, Los Angeles, and Chicago. Imagine the reaction - and money available - if Al Qaeda could injure 1.6 million Americans per year. 4% of Americans are cancer survivors.  Annual cancer rates keep climbing for children and for blood cancers. In fact, there is a blood cancer death every 10 minutes in the United States. 

But, despite those depressing numbers, there are real reasons for hope.  Who says so? Nobel Prize winner Dr. James Watson, one of the two leaders of the team that explained DNA's double-helix. Go here for his powerful article explaining that mapping the genome and other advances mean that science has made enough progress so that there is now a scientific tool kit that can actually work for some people with some cancers, and can be applied to an increasingly wide range of cancers. Here's the opening paragraph of his article:

"THE National Cancer Institute, which has overseen American efforts on researching and combating cancers since 1971, should take on an ambitious new goal for the next decade: the development of new drugs that will provide lifelong cures for many, if not all, major cancers. Beating cancer now is a realistic ambition because, at long last, we largely know its true genetic and chemical characteristics." (emphasis added).

These are just some of the millions of reasons to speak out and seek better as to cancer treatment and research. So, today, speak out and wear yellow on LIVESTRONG Day. 

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 Please use this link and a minute of your time to join with LIVESTRONG and others to reach out to world leaders gathering soon at the UN to work on plans to better cope with and solve the massive problem of non-communicable diseases. The diseases  are many - they are ALS, diabetes, and cancer, to name but a few.  

Consider cancer.  Massive waves of cancers are sickening and killing our lovers, children parents and friends. 500,000 cancer deaths each year in the US. Every 10 minutes, a person in the US dies from a blood cancer. Then there are the new cancers. In the next 10 years, new US cancer diagnoses  will equal the populations of the cities (not suburbs) of LA, NY and Chicago. (That's 1.6 million per year, per the American Cancer Society). Imagine the reaction in government money and attention if Al Quaeda threatened that it would in the next decade slowly, viciously and painfully kill everyone in those 3 cities.  But, the budget of our National Cancer Institute is stalled at an annual  $ 5 billion, as described here.  Meanwhile, the budget is over 10x greater for "Homeland Security" at over $ 50 billion; it's budget is described here.  

Here’s what the American Society of Oncologists sees ahead on a global scale:

"The Top Global Killers: Cancer and Other NCDs

Each year, an estimated 7.6 million people die from cancer – more than from HIV/AIDS, malaria and tuberculosis combined. It is estimated that the incidence of cancer will continue to increase during the next decade, from 12.7 million annual cases in 2008 to more than 20 million by 2030, with the majority of new cases occurring in low- and middle-income countries. Cancer and other NCDs, such as diabetes and heart disease, account for a combined 36 million deaths each year, or an estimated 63 percent of all annual deaths worldwide, according to a recent report from the World Health Organization. These global statistics are staggering and represent what UN Secretary General Ban Ki Moon has called “a public health emergency in slow motion.”"

Dear Kirk, I’m about to leave for New York to take part in the UN Summit on non-communicable diseases. And when I get there, I want to see your face. Join me and more than 150,000 LIVESTRONG supporters in telling world leaders that cancer is a global health crisis, and the time has come to Face Up To It. Add your face to LIVESTRONG’s Face Up To It mosaic by midnight tonight, and you could be included in our bold new video that we’ll be running in Times Square during the UN Summit. In addition to displaying the faces of thousands of our supporters in Times Square, we’re going to confront world leaders with the strength of our movement all over Manhattan. Your face could appear on mobile bicycle billboards circling the UN and in our New York Times ad delivered to Heads of State in their morning paper. From the moment they wake up, our leaders will see the faces of our global movement staring back at them everywhere they turn. Our bold public statement will be impossible to ignore and I want you to be a part of it. Add your face before midnight to be included in powerful public displays in Times Square and around New York: http://FaceUpToIt.LIVESTRONG.org This is a truly historic opportunity to make unprecedented advances in the fight against cancer around the world. I hope I can count on you in New York. LIVESTRONG, Lance Armstrong P.S. If you’re on Facebook, you can use our simple app to add your face here.

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The importance of stem cells in cancer continues to emerge. Cancer Cell's latest issue (Cancer Cell, 2011; 20 (2): 246-259 DOI:) includes new research suggesting that blood system stem cells include the cue (or a cue) for development of the blood cancer known as CLL. The research focused on HSCs, which is the term for hematopoetic (blood) stem cells. That is, these are not original stage pluripotent stem cells that could take on any role. Instead these stem cells have developed a couple of stages, and have taken on the characteristics that make them HSCs dedicated to generating all the different types of cells found in the blood system.

As always, ScienceDaily provides a strong summary, and key excerpts are set out below. In short, the new study used an experiment to seek evidence on the  hypothesis that mature cells derived from HSCs carry a cue for malignancy. Thanks to new tools that allow researchers to find and collect HSCs, they collected HSCs from people without CLL and with CLL. They then injected both types of HSCs into mice. The mice with the HSCs from CLL patients developed B cells with characteristics similar to B cells that develop in a phase of CLL, which some might call "pre-cancer." Conclusion? The HSCs in CLL patients are different than the HSCs in most people. Now the question are: how are they different, and why ? Answering the former question will save lives. The answer(s) to the latter question will lead to future lawsuits and liabilities. 

Is this paper dispositive proof on the HSC hypothesis? No. Important? Yes - that's why the paper made into Cancer Cell, part of the prestigious family of Cell publications. Here's how ScienceDaily and the researchers phrased it:

"Taken together, the findings suggest that HSCs are involved in the pathogenesis of CLL, even though CLL is a malignancy of a mature cell type. "Our data suggest that the propensity to progress to CLL is already acquired at the HSC stage," concludes Dr. Akashi. "Identification of the intrinsic abnormality of HSCs in patients with CLL should be the key to finding the ultimate therapeutic target in human CLL." (emphasis added). 

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Cancer made its mark this weekend at a world-stage golf tournament, and the facts illustrate why people can and should demand better on cancer from our national and world leaders.  Set out below are some facts and links to places you can easily speak out in advance of  a September, 2011 summit of world leaders gathered to address diseases such as cancer.

The scene was a water-side links course  as golf crowned a new British Open champion.  Both the winner and the runner-up illustrate the widespread scope of cancer. The tournament winner was  42 year  old Darren Clark . The love of his life, his wife, Heather, was diagnosed with breast cancer at age 35, and died of breast cancer at age 39, as described here by Wikipedia.  Second place went to Phil Mickelson. The love of his life,  Amy, was diagnosed with breast cancer at age 37, as described here.

Is this an odd coincidence? Only sort of. Most of all it is a concrete example of the prevalence of cancer in general, and of breast cancer in particular.  According to the American Cancer Society's collection of 2010 data, 1 in 3 women will develop cancer. And, breast cancer in particular strikes so often, as highlighted by the Lynn Sage Foundation and the Susan Komen Foundation. According to this page of the Komen website:

"In 2011, it is estimated that among U.S. women [31]:

• There will be 230,480 new cases of invasive breast cancer (includes new cases of primary breast cancer among survivors, but not recurrence of original breast cancer among survivors).
• There will be 57,650 new cases of in situ breast cancer (includes ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS), of those, about 85 percent were DCIS). DCIS is a non-invasive breast cancer and LCIS is a risk factor that increases the risk of invasive breast cancer. Learn more about DCIS and breast cancer risk. Learn more about LCIS and breast cancer risk.
• There will be 39,520 breast cancer deaths.  

The massive waves of cancers has been called "a public health emergency in slow motion," and it calls for many actions. One cost-free action you can take is to sign this online petition to demand better from world leaders. The petition will be presented at the upcoming UN Summit on NCDs - non-communicable diseases. The petition is a project of Lance Armstrong's LiveStrong.

The summit meeting is this September at UN headquarters in NY. The American Society of Clinical Oncologists and other global groups pf physicians  are emphatic that this is a major opportunity to set policy because the meeting wil be attended by numerous  national leaders from around the globe. There is hope that President and/or Mrs. Obama will attend.  

The summit also is the kind of effort supported by Nobel Prize winner Dr. Harold Varmus, who heads up our National Cancer Institue and won the Nobel Prize (with Michael Bishop) for ground breaking cancer research. He's also savvy and oustpoken, and wrote this great book  (The Art and Politics of Science) after he ran the National Institutes of Health during the Clinton Administration. He's also smart enough to say that the world cannot afford the cost of disease, and we need to solve the problems now for that reason alone. 

Here's what ASCO had to say; the statement is online here:

CHICAGO – Today at a press briefing, leaders from the American Society of Clinical Oncology (ASCO), the Union for International Cancer Control (UICC), and the American Cancer Society (ACS) announced new efforts to respond to the cancer epidemic occurring in low- and middle-income countries, and called on President Obama and other world leaders to take action at the upcoming United Nations (UN) High-level Meeting on Non-communicable Diseases (NCDs), taking place in New York in September.

The briefing took place at the 47th ASCO Annual Meeting in Chicago, where cancer doctors from around the world presented and discussed advances in the field that translate into improved care. Panelists provided first-hand perspective on the global state of cancer care, with a focus on the growing cancer burden in low- and middle-income countries, which often have severe shortages of oncologists and very limited access to state-of-the-art cancer treatments, screening services, and palliative care.

“Together, ASCO, UICC, and ACS represent the strength of 30,000 oncology professionals, 460 organizations, and 3 million volunteers around the world who are leading the way to address the cancer crisis,” said ASCO CEO Allen S. Lichter, MD. “The UN Meeting in September presents a monumental opportunity to put cancer on the global agenda.  We urge world leaders to help save and improve the lives of millions of people living with cancer or at risk for the disease.” 

The Top Global Killers: Cancer and Other NCDs 
Each year, an estimated 7.6 million people die from cancer – more than from HIV/AIDS, malaria and tuberculosis combined. It is estimated that the incidence of cancer will continue to increase during the next decade, from 12.7 million annual cases in 2008 to more than 20 million by 2030, with the majority of new cases occurring in low- and middle-income countries. Cancer and other NCDs, such as diabetes and heart disease, account for a combined 36 million deaths each year, or an estimated 63 percent of all annual deaths worldwide, according to a recent report from the World Health Organization. These global statistics are staggering and represent what UN Secretary General Ban Ki Moon has called “a public health emergency in slow motion.”

The Opportunity: A UN Summit on NCDs
In September, world leaders will convene in New York for the UN summit, which will focus on the global threat of cancer and other NCDs. This is only the second time in its 65 years that the UN has held such a high-level meeting to address a health topic. In 2001, a UN General Assembly Special Session on the global AIDS crisis led to an unprecedented international response to HIV/AIDS and ultimately resulted in the creation of the Global Fund to Fight AIDS, Tuberculosis and Malaria.

This morning, ASCO delivered to the White House a letter, signed by major U.S. medical societies representing about 300,000 doctors, nurses and other health care professionals, calling on President Obama to personally attend the UN High-level Meeting on NCDs.

In addition, to help shape the upcoming summit, the NCD Alliance, a coalition of four international federations including UICC, has issued a Proposed Outcomes Document that outlines the goals and targets for world leaders to agree upon at the conclusion of the summit. Today, ASCO formally endorsed the proposed outcomes, which will play a key role in deliberations at the UN summit.

A Call to Action for World Leaders and Policymakers
At the press briefing, ASCO, UICC, and ACS voiced their call to action for policymakers of all countries leading up to the UN meeting. The three organizations are actively working to ensure the UN meeting’s success by communicating with the Obama Administration, engaging their memberships in letter writing to ensure attendance of other world leaders, and attending the UN’s informal civil society hearing on NCDs on June 16, where they will have the opportunity to make the cancer community’s voice heard at the UN.

The cancer community is also bringing attention to this issue through the World Cancer Declaration, which outlines 11 targets to be achieved by 2020, including a substantial decline in global tobacco consumption, obesity, and alcohol intake; improved access to care; universal vaccination programs for hepatitis B and human papilloma virus (HPV) to prevent liver and cervical cancer; and increased training opportunities for health care workers on different aspects of cancer control. Approximately 230,000 people have signed the Declaration to date, contributing to reaching the goal of 1 million signatures by September.

“Everyone knows someone that has been touched by cancer, so we urge individuals to take action and sign the declaration,” said Eduardo L. Cazap, MD, PhD, UICC President and ASCO Board member. “In doing so, you are helping bring the cancer crisis to the attention of government leaders who can implement policy changes that will reduce the global cancer burden for future generations around the world.”

In addition, ACS is organizing “We Can, We Should, We Will Conquer Cancer,” a cancer survivor-led event at the United Nations in New York City taking place June 18-20, at which cancer advocates from around the world will share their stories with their UN ambassadors and demand that the UN make NCDs a global priority.

“Cancer affects people from all walks of life, and from every corner of the globe,” said John R. Seffin, PhD, ACS Chief Executive Officer. “Only together can we ensure cancer and other NCDs are recognized as an imminent health challenge, and are seriously addressed as a development, health, and equity issue.”

Continued Commitment in The Global Campaign
Demonstrating its own commitment in the global campaign against cancer, ASCO is undertaking several efforts to improve care globally, and announced today that it is expanding the Society’s International Cancer Corps (ICC) program to Vietnam and Ethiopia, which until recently had only one oncologist serving a nation of 80 million people. Through the program, ASCO member physicians volunteer to provide training on cancer care to medical staff and students in developing countries.  The Society plans to extend the reach of the program further to other low-income countries where human resources training in cancer care can have a real and meaningful impact on millions of lives.

In addition, ASCO announced it is expanding training courses and workshops that teach cancer management to doctors, nurses, and other health care workers in low- and middle-income countries. This past year, the Society launched a new Train the Trainer program to create a cadre of trainers in cancer management. Twelve South American trainers completed the program in its first year, helping to more rapidly scale up the country’s workforce training.

Looking Toward the Future
With the combined efforts of ASCO, UICC, ACS and other cancer organizations around the world, progress continues to be made in combating this global health crisis. However, the leaders at today’s briefing and others in the cancer community acknowledge that more can be done. As the UN meeting approaches this September, there are many opportunities for individuals and organizations to get involved and help change the future of people living with cancer. For more information and to sign the World Cancer Declaration, visit: http://www.uicc.org/declaration.

Resources to Learn More:

• Letter to President Obama

• World Cancer Declaration

• NCD Alliance Proposed Outcomes Document

• UICC’s Advocacy Toolkit for the UN Summit on NCDs

• ASCO International Affairs Programs

About the American Society of Clinical Oncology
The American Society of Clinical Oncology (ASCO) is the world’s leading professional organization representing physicians who care for people with cancer. With more than 30,000 members, ASCO is committed to improving cancer care through scientific meetings, educational programs and peer-reviewed journals. For ASCO information and resources, visit www.asco.org. Patient-oriented cancer information is available at www.cancer.net

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The intersecting worlds of cancer and litigation changed last week. Why  ? The US government issued its 12th Report on Carcinogens. The report adds eight new substances to the lists, including "certain inhaled glass fibers."  This is not landmark news -  there have been decades of suspicion and argument that some glass fibers are carcinogens. But now the argument is stronger and more specific.

What is the RoC, as its known ?  "The Report on Carcinogens (RoC) is a congressionally mandated, science-based, public health document that is prepared for the HHS Secretary by the National Toxicology Program. The report identifies agents, substances, mixtures, and exposure circumstances that are known or reasonably anticipated to cause cancer in humans."  Here and here are summary NYT summary stories by Gardiner Harris.

What substances were added?  "The industrial chemical formaldehyde and a botanical known as aristolochic acids are listed as known human carcinogens. Six other substances — captafol, cobalt-tungsten carbide (in powder or hard metal form), certain inhalable glass wool fibers, o-nitrotoluene, riddelliine, and styrene — are added as substances that are reasonably anticipated to be human carcinogens. With these additions, the 12th Report on Carcinogens now includes 240 listings."

For asbestos litigation, the RoC matters because it further pushes open the door to exploring non-asbestos fibers as causes of diseases, including mesothelioma,  the so-called signature disease for asbestos inhalation. The report's pertinent general statement is as follows:

"Certain inhalable glass wool fibers made the list based on experimental animal studies. Not all glass wool or man-made fibers were found to be carcinogenic. The specific glass wool fibers referred to in this report have been redefined from previous reports on carcinogens to include only those fibers that can enter the respiratory tract, are highly durable, and are biopersistent, meaning they remain in the lungs for long periods of time. Glass wool fibers generally fall into two categories for consumers: low-cost, general purpose fibers, and premium, special purpose fibers. The largest use of general purpose glass wool is for home and building insulation, which appears to be less durable and less biopersistent, and thus less likely to cause cancer in humans."

The RoC includes a "profile" for each substance. For the wool fibers, the profile is here.  And, here's a more specific statement from the profile:

"Insulation Glass Fibers

Types of insulation glass wool fibers tested in experimental animals included Owens-Corning glass wool, MMVF 10 and 10a (both of which represent the respirable fraction of Manville 901 glass fiber), MMVF 11 (the respirable fraction of CertainTeed B glass fiber), and unspecified glass wool fibers. Inhalation exposure of F344 rats to Owens-Corning FG insulation fiberglass with binder (4 to 6 μm in diameter and > 20 μm long) significantly increased the incidence of mononuclear-cell leukemia in rats (males and females combined). Glass-fiber-related pulmonary and tracheal-bronchial lymph-node lesions were observed but were less severe than for exposure to special-purpose fibers. As with the findings for Tempstran 100/475 glass fibers in this strain (discussed above), these findings were considered to be exposure-related (Mitchell et al. 1986, Moorman et al. 1988). Intraperitoneal injection of MMVF 11 glass fibers caused mesothelioma of the abdominal cavity in male and female Wistar rats (Roller et al. 1996, 1997), and intraperitoneal injection of MMVF 10 glass fibers increased tumor rates in male Wistar rats (Miller et al. 1999)."

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Lives can hang in the balance when reports are written to summarize the results of medical studies.  Sadly, some scientists do commit fraud, and others allow their conclusions to be skewed.  

A prime example of scientific fraud became public in 2000. Sadly, the fraud arose in the scientific literature on breast cancer treatments. In an editorial letter by  Dr. George W. Sledge, Jr., he explained the facts, and why "big lies" do indeed matter. He said:

"The facts of the case are straightforward. Werner Bezwoda is a South African clinical investigator who has in recent years presented 2 randomized trials comparing high-dose chemotherapy and autologous stem cell transplantation with standard-dose chemotherapy for patients with breast cancer. Both trials suggested a striking benefit of high-dose chemotherapy for both lymph node-positive and metastatic breast disease. One of these trials was considered sufficiently important to earn Dr. Bezwoda a plenary session lecture at the annual meeting of the American Society of Clinical Oncology. Because of the importance of these results, their striking positivity, and because of differences in the way in which transplant therapy was delivered, American investigators wished to examine Dr. Bezwoda's work before launching a confirmatory trial. Dr. Bezwoda's work was (after some delay) audited by a group of American physicians. The audit team discovered significant failings in Dr. Bezwoda's records, sufficient to raise the question of academic fraud. Dr. Bezwoda, in a letter, has admitted committing this fraud.^"

See Sledge GW. Why Big Lies Matter: Lessons From the Bezwoda Affair. MedGenMed 2(1), 2000. [formerly published in Medscape Women's Health eJournal 5(1), 2000]. Available at: http://www.medscape.com/viewarticle/408908.

In view of past fraud, scholars continue to worry about disclosures of financial interest information when scientific research projects and papers are sponsored by private usiness. A new article,  reported in ScienceDaily,  and published in the AMA Journal,  focuses the discussion on meta-analyses. Meta studies are in esssence massive studies created by combining data from individual studies. The researchers found that financial linterest disclosures from the individual are not being reported in many meta-analyses.

In this age of cheap information creation and storage, it seems unfortunate that disclosure are not routinely made and tracked. One hopes the funding source has no impact on the research outcome or the form of the report. But it seems unwise to depend only on hope, and better  to provide the disclosures as matter of routine. In the past, the AMA has been out in front in terms if requiring dislcosure for articles it publishes in JAMA, as is illustrated by this 2001 statement of its policy. Perhaps this new article will have a further, positive impact on disclosures.

Set out below are key excerpts from the disheartening story in the ScienceDaily summary:

 " More and more, policy decisions and what medications doctors prescribe for their patients are being driven by large "studies of studies," called meta-analyses, which statistically combine results from many individual drug trials.

Led by Dr. Brett Thombs and McGill graduate student Michelle Roseman, the team found that important declarations of financial conflicts-of-interest in individual drug trials disappeared when those studies were combined in meta-analyses. Their results will be published in the March 9 issue of the Journal of the American Medical Association (JAMA).

Roseman, the study's first author, and the rest of the team reviewed 29 recent meta-analyses on a range of drug treatments published in high-impact medical journals. Those 29 meta-analyses, or "studies of studies," included results from 509 drug trials. The team documented the funding sources and author-industry financial ties of all 509 trials and whether or not the meta-analyses noted who had funded the trials.

"Only 2 of the 29 meta-analyses even mentioned the issue of who funded the original drug trials, and even those 2 did it in very obscure places in the published articles," said Thombs, a psychologist and assistant professor in the Department of Psychiatry at McGill University. "Not one of the meta-analyses mentioned whether researchers who conducted the trials were employed by industry or personally received money from industry."

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February 4 is the day the World Health Organization (WHO) designates as World Cancer Day.  According to WHO, "an estimated 84 million people will die of cancer between 2005 and 2015 without intervention."  As the American Cancer Society explains, the day will be commemorated in the US by the Empire State Building lighting its top in the orange and blue colors chosen to signify the day.

The costs of cancer are massive. In terms of human suffering, there are no words I know to state the vast scale of the pain and fear caused by cancer. On objective data, the numbers are stunning in financial terms. In just the US, the costs are currently at over $ 100 billion per year, and in 2020 will be an estimated $ 158 billion per year. In global terms, the annual direct and indirect cost are estimated  $1.5 -2 trillion (yes, that's with a t, and every year.) Those numbers, however, do not seem to grab enough attention and cause nearly enough demands for "better." So, for today, a post to try to bring the subject of cancer closer to the financial and emotional hearts of lawyers.

Consider the lesson on cancer that can be learned from the collapse of  Howrey,  a major US law firm with some international offices.  Anyone who follows "big-law" at all knows that Howrey is in trouble. An AmLaw  story on Wednesday  reminded me of this prior article about Howrey's woes and a link to cancer. According to that article, part of Howrey's troubles tie back  to two of its most  trusted partners dying of cancer   -   before age 60. What a tragic waste.  The key text is pasted far below in bold.

For World Cancer Day, let's personalize a question to our profession:  when are our American lawyers -  and our global brethren -  going to become really outraged about cancer and demand better from our nations ?  We are advocates;  we know how to speak and be heard. So, let's speak out. 

To whom can we speak? To our families, our friends, our partners and associates, and to our governments.  But do not worry to much about the specific audience - just  speak.  Creating changerequires social networking and reaching a Tipping Point of the sort so eloquently described by Malcolm Gladwell in his book, Tipping Point.  And,  know that there is a receptive audience in place. How so? Sadly (or, perhaps, wonderfully), the reality is that  4% of Americans (that's about 10-15 million Americans) are cancer survivors, and so have  "pre-existing conditions".  At the very least, go here to sign a global petition to demand more attention to cancer research and prevention. Prevention is too little mentioned, but is as key as research for existing cancers.

Need more data to help you advocate? The above numbers  are stunning, but sadly there are many more compelling numbers numbers available for advocacy. Disease specific numbers, and much more data, can be found  through the American Cancer Society's web pages devoted to statistics.  The 2010 summary is here. For global numbers, go here.

The US numbers ?  500,000 Americans die of cancer every year. On top of the deaths, 1.5 million Americans are diagnosed every year with cancer. In a decade, that rate of diagnoses is about equal to cancer hitting everyone in the cities (not burbs) of NY, LA and Chicago. And that of course includes all the lawyers in those cities.

Global numbers? Over 7.5 million annual cancer deaths. Over 12 million cancers found, every year.

More personal numbers?   Ultimately, cancer will hit 1 in 3 American women, and 1 in 2 American men. And, there are increasing signs that environmentally-induced cancers can become multi-generational. Think DES daughters. For disturbing visual evidence, go here and link to the Vanity Fair story on apparent generations of victims of Agent Orange.  Or, consider the issues raised regarding the effects of  exposure to  BPA and pregnancy. How and why may a toxic exposure cause multi-generational cancers ? Those answers are not completely clear yet, but they probably involve epigentics, including chemically-caused changes to the epigenome, a structure that sits above each genome.

Lawyers should know how to pull at hearts.  To reach hearts and minds, help people learn and feel that every 10 minutes, someone in the US dies from a blood cancer. And, they are too often children. Help them see and feel the human and financial pain and loss inherent in the steadily increasing rates of cancer in kids  The data show an increase of about 2% per year, FOR EVERY YEAR SINCE 1974. Help others see the faces and families behind the datapoints.

Need more? Go here for a heartbreaking video. It's the story of the Beads of Courage awarded to some kids with cancer. It's a powerful reason to ask what we might achieve if we at least doubled or tripled our miserly national investment of $ 5 billion in cancer research. 

Cynical about more money making a real difference ? Don't be. Go here to read about St. Jude's current project to sequence the genes inside 600 cancers they've culled from children over the years:  The key quote: "This is the largest and most powerful single initiative in the 50-year history of St. Jude," the research hospital's director, Dr. William E. Evans, said at a press briefing announcing the project .... "DNA is being sequenced as we speak," he added.

Need more reason for optimism?  Consider this 2010  NYT op-ed article by Dr. James Watson of DNA fame. He said:

"THE National Cancer Institute, which has overseen American efforts on researching and combating cancers since 1971, should take on an ambitious new goal for the next decade: the development of new drugs that will provide lifelong cures for many, if not all, major cancers. Beating cancer now is a realistic ambition because, at long last, we largely know its true genetic and chemical characteristics. (emphasis added)

This was not the case when President Richard Nixon and Congress declared a “war on cancer” more than 35 years ago. As a member of the new National Cancer Advisory Board, I argued that money for “pure cancer research” would be a more prudent expenditure of federal funds than creating new clinical cancer centers. My words, however, fell on deaf ears, and the institute took on a clinical mission. My reward for openly disagreeing was being kicked off the advisory board after only two years."

Given the numbers and the science, where are the  reasoned but passionate demands that our governments do much more to stop the damn cancers that are killing millions of our loved ones, and too many of our partners and friends ? C'mon lawyers, use your gifts of persuasion and speak out.   You may help to save your law firm from a Howrey-like collapse. You also might save the life of your child, your spouse, or your partner.  

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"Several former partners say that communication, which has never been the firm's strong suit, became a much greater issue after the sudden deaths of two respected and independent members of the executive committee--deaths that coincided with a major slowdown in work. In June 2008 vice-chairman Mark Wegener, the firm's global litigation cochair, died of cancer at 59; 11 months later, IP cochair Cecilia Gonzalez, also a vice-chair, succumbed to cancer at 53. Gonzalez, a huge rainmaker, was "always willing to introduce you to her clients," recalls one partner. And Wegener "would always call you back right away," notes another--giving partners a sense their concerns were being heard and transmitted to Ruyak." 

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Why invest in science? Among other things, it may well help reduce soaring costs for cancer that will be arriving as we collectively pay the price for the use of toxins and genetic variations.  Set out below is the press release from the NIH regarding its new study on the current and future annual costs of cancer treatment in the US.   For the globe, annual direct and indirect costs of cancer are estimated at $1.5 trillion, annually.  The annual expenses certainly dwarf our current national annual investment of  $ 5 billion for cancer research, which President Obama seeks to increase.  One hopes that the so-called deficit hawks will do the math and figure out that it is financially prudent to invest more in cancer prevention and research, not to mention the need to reduce suffering.

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Cancer costs projected to reach at least $158 billion in 2020
New NIH study projects survivorship and costs of cancer care based on changes in the US population and cancer trends

Based on growth and aging of the U.S. population, medical expenditures for cancer in the year 2020 are projected to reach at least $158 billion (in 2010 dollars) – an increase of 27 percent over 2010, according to a National Institutes of Health analysis. If newly developed tools for cancer diagnosis, treatment, and follow-up continue to be more expensive, medical expenditures for cancer could reach as high as $207 billion, said the researchers from the National Cancer Institute (NCI), part of the NIH. The analysis appears online, Jan. 12, 2011, in the Journal of the National Cancer Institute.

The projections were based on the most recent data available on cancer incidence, survival, and costs of care. In 2010, medical costs associated with cancer were projected to reach $124.6 billion, with the highest costs associated with breast cancer ($16.5 billion), followed by colorectal cancer ($14 billion), lymphoma ($12 billion), lung cancer ($12 billion) and prostate cancer ($12 billion).

If cancer incidence and survival rates and costs remain stable and the U.S. population ages at the rate predicted by the U.S. Census Bureau, direct cancer care expenditures would reach $158 billion in 2020, the report said.

However, the researchers also did additional analyses to account for changes in cancer incidence and survival rates and for the likelihood that cancer care costs will increase as new technologies and treatments are developed. Assuming a 2 percent annual increase in medical costs in the initial and final phases of care – which would mirror recent trends – the projected 2020 costs increased to $173 billion. Estimating a 5 percent annual increase in these costs raised the projection to $207 billion. These figures do not include other types of costs, such as lost productivity, which add to the overall financial burden of cancer.

“Rising health care costs pose a challenge for policy makers charged with allocating future resources on cancer research, treatment, and prevention,” said study author Angela Mariotto, Ph.D., from NCI’s Surveillance Research Program. “Because it is difficult to anticipate future developments of cancer control technologies and their impact on the burden of cancer, we evaluated a variety of possible scenarios.”

To project national cancer expenditures, the researchers combined cancer prevalence, which is the current number of people living with cancer, with average annual costs of care by age (less than 65 or 65 and older). According to their prevalence estimates, there were 13.8 million cancer survivors alive in 2010, 58 percent of whom were age 65 or older. If cancer incidence and survival rates remain stable, the number of cancer survivors in 2020 will increase by 31 percent, to about 18.1 million. Because of the aging of the U.S. population, the researchers expect the largest increase in cancer survivors over the next 10 years to be among Americans age 65 and older.

“The rising costs of cancer care illustrate how important it is for us to advance the science of cancer prevention and treatment to ensure that we’re using the most effective approaches,” said Robert Croyle, Ph.D., director, Division of Cancer Control and Population Sciences, NCI. “This is especially important for elderly cancer patients with other complex health problems.”

To develop their cost projections, the authors used average medical costs for the different phases of cancer care: the first year after diagnosis, the last year of life, and the time in between. For all types of cancer, per-person costs of care were highest in the final year of life. Per-person costs associated with the first year after a cancer diagnosis were more varied, with cancers of the brain, pancreas, ovaries, esophagus and stomach having the highest initial costs and melanoma, prostate and breast cancers having the lowest initial-year costs.

These new projections are higher than previously published estimates of direct cancer expenditures, largely because the researchers used the most recent data available – including Medicare claims data through 2006, which include payments for newer, more expensive, targeted therapies which attack specific cancer cells and often have fewer side effects than other types of cancer treatments. In addition, by analyzing costs according to phase of care, which revealed the higher costs of care associated with the first year of treatment and last year of life (for those who die from their disease), the researchers were able to generate more precise estimates of the cost of care.

The researchers used 2005 incidence and mortality data from NCI’s Surveillance, Epidemiology and End Results (SEER) program to estimate cancer prevalence for 2010 and 2020. Population estimates for the United States was obtained from the U.S. Census Bureau’s National Interim Projections for 2006 to 2020. Medical cost estimates were obtained using the SEER-Medicare database which links SEER data to Medicare claims data from the Center for Medicare and Medicaid Services.

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While mesothelioma continues to kill, researchers continue to look for ways to slow or manage the disease. This BBC article reports on one man's ongoing efforts to raise research money despite his own mesothelioma tumor. The effort is focused on on the JBIR-23 molecule, which is isolated from strains of the Streptomyces bacteria.  A more technical explanation of the work (by Dr. Dobbs) is included in this paper seeking research assistants.  Even more technical information is here.

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The latest article in Amy Harmon's continuing NYT series on cancer research is a wrenching article she titles:   Enlisting the Dying for Clues to Save Others.  The article focuses on doctors using tumor tissue samples to test theories on why cancer relapses occur. The article deserves reading for many reasons. One is to understand the promising science. Another reason is to understand that science sometimes is being stymied by the absence of funding for expenses as littile as $5,000 for a tumor biopsy. 

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How is North Dakota like Turkey ? Both areas include a mineral known as erionite. That's noteworthy because certain Turkish villages are known as "cancer villages" because so many residents die from the vicious cancer known as mesothelioma.  Mesothelioma cancers are often - but not always - attributable to inhalation of amphibole-type asbestos fibers. This article from Nature News reports on brand new studies finding that North Dakota's erionite is much like the erionite found in the Turkish villages, and "environmental exposures" likely are occuring. So, far, however, no one has found clusters of disease

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Lloyds issued this November 10, 2010  report on cell phone risks. The summary is obviously written to support an insurance industry view of the facts. That said, it's helpful as a summary of research, and perhaps useful as a roadmap to insurer thinking on the subject.  

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Advocacy is growing for myriad aspects of the cancer crisis. Be an advocate for change by learning more about advocating for the rights of cancer patients.

Join the Cancer Legal Resource Center for the 2010 Cancer Rights Conference on Friday, October 8, 2010 at Ronald Reagan UCLA Medical Center, Los Angeles. This free conference will provide patients, survivors, caregivers, advocates, navigators, and healthcare professionals about cancer-related legal issues, including: 

• Employment & Taking Time Off Work
• Getting and Keeping Health Insurance
• Navigating Managed Care
• Estate Planning
• Disability and Life Insurance Options
• Understanding Health Care Reform
• Cancer Community Resources
• Genetics & the Law
• Education Rights of Children & Young Adults with Cancer

To register for the conference online now, click here. For more information, visit www.CancerLegalResourceCenter.org/conference or contact Angelica Corral, Communications & Administrative Coordinator, Cancer Legal Resource Center at 213-252-8449.

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The top two lines in the chart tell terrible stories. Inexorably climbing cancer rates for childhood cancers and non-Hodgkins lymphomas.

What do the charts mean in human terms ? There are no words I know to really cover that subject. But here are some awful and powerful words from a fall 2010  press release by the Leukemia and Lymphoma Society:

"Every 10 minutes, someone [in the US] dies from a blood cancer and more than 53,000 will die from one this year."
 

Cancer is a crisis for our nation and the world.  Indeed, the American Cancer Society recently demonstrated that cancer costs the world economy something between $ 1.5 trillion and $2 trillion, every year, in lost productivity and direct medical treatment costs.

Why are the costs so high? Because cancer is rampant. Set aside future growth rates - based on just the present annual numbers from the ACS,  there will be 15 million new cancers in the US in the next 10 years.  That's more than the populations of  our three largest cities -  New York  (8.9 m), Los Angeles (3.83 m), and Chicago (2.8 m), in just a decade. Imagine the outcry if terrorists spread germs that inflicted devasting harm or death on 15 million people. 

Crises demand action, and money. Sadly, words exceed money when it comes to cancer. Thus, this month the U.S. House of Representatives passed House Resolution 1433, declaring September 2010 as 'Blood Cancer Awareness Month.'  Many of the words are set out below.

"Awareness Month is an opportunity to increase the public's understanding of blood cancers and encourage people to support the funding of research to find cures and education programs to help patients have the best possible outcomes throughout their cancer experience," explained John Walter, president and CEO of The Leukemia & Lymphoma Society. "The Leukemia & Lymphoma Society would like to thank Representatives Walter Jones and Betsey Markey for introducing and supporting this resolution, and all of our volunteers who called and emailed their representatives to urge their support."

Remarkable progress has been made in treating patients with blood cancers. Sixty years ago there were few effective treatments for children or adults with blood cancer and the rate of survival was very low. Today, about 75 percent of children with acute leukemia and nearly 80 percent of children and adults with Hodgkin lymphoma are cured. Advances in the treatment of blood cancers have also led to new treatments for other cancers. In fact, in the last decade, 47 percent of new cancer therapies approved by the Food and Drug Administration (FDA) were first developed and approved to treat a blood cancer.

Despite these advances, more than 900,000 people in the United States currently have some form of blood cancer and fewer than 50 percent of newly diagnosed patients will survive five years past that diagnosis. Every ten minutes someone dies from a blood cancer and more than 53,000 will die from one this year. (emphasis added)

"Congress has been supportive of issues affecting blood cancers in the past," said Walter, "and we thank them for that support. But more needs to be done to fight these deadly diseases increased research funding, access to affordable treatments, and improved care planning for survivors, just to name a few issues that need to be addressed."

Source: Leukemia & Lymphoma Society
 

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The players in the the litigation industry inevitably pay attention to large numbers. In that vein, and in the broader social sense, consider the annual global cost of cancer.  

According to an August 2010 study from the American Cancer Society, cancer is the world’s most costly disease in terms of lost productivity. Why?  Because cancer  kills or disables so many so early in life, and thus imposes costs that exceed by 20%  the lost productivity costs from heart disease.  

The annual lost productivity number for cancer? The number is estimated at just under $1 trillion, at $ 895 billion  – every year.  Click here to see the American Cancer Society’s  August 2010 report. Is the estimate/report imperfect because the data is imperfect? Of course it is, as the report acknowledges. But at that incredible scale,  it seems logical to believe that any imperfections are immaterial.

Lost productivity is only one money-based measure of the global cost of cancer. The report indicates that if one adds in the direct medical costs of treating cancer, then  the annual world cost of cancer about doubles. That produces a measure of the annual global cost of cancer as between $ 1.5 and $ 2 trillion – every year. 

Numbers in the trillions inevitably draw social and litigation attention. Indeed, the numbers present  a staggering  set of costs the world incurs to cope with the cancers caused by nature, and by toxic products. The report directly focuses on the enormous role of tobacco in  causing cancers. No wonder tobacco giant Phillip Morris lured David Bernick away from K & E to become its general counsel, as described here.

One suspects that some of the products of some chemical, herbicide, fertilizer and seed makers ill soon become additional targets for the cost estimators. Indeed, one need think only briefly of Agent Orange - and other products - to recognize that some of the their products include some of the world's most potent carcinogens. Other products, such as some seeds, are explicitly designed for use with herbicides that include proven or suspected carcinogens. 

The litigation industry already includes a significant focus on some of the products of some of those companies as causes of blood cancers. The large numbers for cancer no doubt mean that the years ahead will bring increasing litigation and public scrutiny to some members of the chemical, herbicide, fertilizer and seed industries. 

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Science long ago indicted  tobacco smoke for causing multiple diseases.  But scientist could not explain exactly how the harms were caused. Today, there are increasing insights into the cellular mechanisms at work.  This September 2, 2010  article from ScienceDaily summarizes a September 2, 2010 article from Science, one of the world''s best professional journals for science.

The bottom line ?  One of the many ways that tobacco smoke causes harm appears to be  by inhibiting  cellular level lung functions that seek to clear hazardous proteins that are triggered by the body's efforts to fend off other harmful aspects of smoking.  Said more technically, it appears to inhibit an enzyme that helps to clear neutrophils that are summoned by the body to clear infections.

One has to ask: why do world governments continue to allow smoking ?  The answer of course is: money in the form of sales tax revenue. In the US, that bond was tightened by the tobacco settlement.  And, in the US, the tobacco industry also created the process of seeking federal immunity from civil liability. That absurd outcome is surely one of the world's best examples of an industry externalizing the financial and human costs of its miserable actions.  Happily, the same result was not obtained all around the globe.  

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Tobacco sales continue today thanks to "big tobacco" long ago obtaining federal law preemption against most product liability claims. The industry strategy was both brilliant and deadly. Then, when litigation risks were closing in from cost recovery lawsuits by the states, the tobacco settlement kept the industry moving ahead as it locked states into enjoying the tax revenue being used to fund state budgets.

So, industry won a couple of times, and therefore people keep smoking and dying. In that light, it's good to see some potential offset ahead from a California ballot initiative to raise tobacco taxes by $ 1 per pack, with proceeds to fund cancer research. The initiative’s website is here. 

The initiative was officially certified on August 24, 2010 by the California Secretary of State, as described here. The net result is that the initiative will be on the ballot for the 2012 national election.

The organizers of the initiative would love financial support for the battle ahead to get the initiative passed. Set out below are key excerpts from the Secretary of State’s website:

The Attorney General’s official title and summary of the initiative is as follows:

IMPOSES ADDITIONAL TAX ON CIGARETTES FOR CANCER RESEARCH. INITIATIVE STATUTE. Imposes additional five cent tax on each cigarette distributed ($1.00 per pack), and an equivalent tax increase on other tobacco products, to fund cancer research and other specified purposes. Requires tax revenues be deposited into a special fund to finance research and research facilities focused on detecting, preventing, treating, and curing cancer, heart disease, emphysema, and other tobacco-related diseases, and to finance prevention programs. Creates nine-member committee charged with administering the fund. Summary of estimate by Legislative Analyst and Director of Finance of fiscal impact on state and local government: Increase in new cigarette tax revenues of about $855 million annually by 2011-12, declining slightly annually thereafter, for various health research and tobacco-related programs. Increase of about $45 million annually to existing health, natural resources, and research programs funded by existing tobacco taxes. Increase in state and local sales taxes of about $32 million annually. (09-0097.)

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Here's some information that has implications for the roles of futures representatives for class action. The subject in general is multigeneration effects of carcinogens. The context in this instance is tobacco. This summary from ScienceDaily brings word that another study confirms that second hand tobacco smoke exposure for a pregant woman causes genetic mutations in the fetus.  So, more phyical harm caused by tobacco, and it effects more than one generation.

The key paragragh states:

"In the current study, Dr. Grant confirmed smoke-induced mutation in another gene called glycophorin A, or GPA, that is representative of oncogenes -- genes that transform normal cells into cancer cells and cause solid tumors. The GPA mutation was the same level and type in newborns of mothers who were active smokers and of non-smoking mothers exposed to tobacco smoke. Likewise, the mutations were discernable in newborns of women who had stopped smoking during their pregnancies, but who did not actively avoid secondhand smoke."

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4% of Americans are cancer survivors. That’s well over 10 million people. The numbers are the net result of an annual US toll of 1.5 million new cancer diagnoses, and 550,000 deaths.

America’s over 10 million cancer survivors move forward with their lives with increasingly specialized legal needs. I'm proud to say that my law firm's experience in enforcing legal rights insurers is now being applied as part of a group of volunteer lawyers willing to assist survivors pro bono in asserting their legal rights to care. To that end, my firm, Childress Duffy Goldblatt, also  is the presenting sponsor for a Friday June 18, 2010 Cancer Rights Conference at Loyola Law School in Chicago.

The conference agenda and registration packet is here. A similar seminar will be held on Friday October 8, 2010 at the Ronal;d Reagan UCLA Medical Center in Los Angeles; the conference registration form is online here.

The 2010 Cancer Rights Conferences are results of the great work of the Cancer Legal Resource Center (CLRC), a joint program of the Disability Rights Legal Center and Loyola Law School Los Angeles. The CLRC  is a national, nonprofit organization that provides information and resources on cancer-related legal issues to people coping with cancer. The CLRC is the only national effort aimed at specifically asserting the legal rights for persons with all types of cancer. 

There also are growing efforts by groups associated with particular forms of cancer. A growing American Bar Association group is focused on asserting the rights of breast cancer patients. 

Sadly, the needs for legal advocacy are increasing for cancer patients. More advocacy is needed in part because of the improper claims handling practices habits of some national insurers. Advocacy needs also are increasing because rates of cancer are still climbing for some types of cancers, including continuing increases in some cancer rates for children. Data from the National Cancer Institute shows: “Cancer is the leading cause of death by disease among U.S. children between infancy and age 15. Approximately 10,730 new cases of pediatric cancer are expected to be diagnosed in children 0–14 years of age in 2009.”

According to detailed 2010 data from the American Cancer Society, the overall odds of facing a cancer diagnosis during are a lifetime are about 1 in 2 for men, and 1 in 3 for women.  This YouTube presentation from the ACS provides all the depressing data, including that 25% of annual US deaths are from cancer.

The CLRC’s Director is a tireless and wonderful person, Joanna Fawzy Morales. Mrs. Morales is also an Adjunct Professor of Law at Loyola Law School, teaching a seminar in Cancer Rights Law.

The CLRC’s mission and accomplishments are as follows, as taken from its website:

The CLRC has a national, toll-free Telephone Assistance Line (866-THE-CLRC) where callers can receive free and confidential information about relevant laws and resources for their particular situation. Members of the CLRC's Professional Panel of attorneys, insurance agents, and accountants can provide more in-depth information and counsel to CLRC callers.

In July of 2009, the CLRC received its 30,000th call to its Telephone Assistance Line (866-THE-CLRC). Since its founding in 1997, the CLRC remains unique, providing invaluable cancer-related legal information and resources to people nationwide. The success of the Center's work is reflected in the enormous need for the information they provide. Throughout its 12-year history, the CLRC has served over 155,000 people through the Telephone Assistance Line, conferences, seminars, workshops, outreach programs, and other community activities.

CLRC staff members also speak at seminars and outreach events in the cancer community, across the nation, including trainings for health care professionals. If you would like CLRC staff to attend your next event, please complete our Event Request & Material Order Form or call us at (213) 252-8449 or (866) 843-2572.

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From the January 26, 2010  NCI Cancer Bulletin is a story that provides the latest example of the dawning age of new science brought about by committed doctors, brilliant scientists, your donations, high speed computers and software, and the  desire  to save lives.

Recall that the Humane Genome project was announced in 1990 and completed in 2003. Now, less than seven years lateer, genomes are sequences in days.

Note that the results all will be made public at no expense.

This project illustrates why patents should not be allowed for gene sequences, a battle the ACLU and others are fighting right now.

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St. Jude, Washington University Launch Genome Project for Childhood Cancers


Researchers at St. Jude Children's Research Hospital and the Washington University School of Medicine in St. Louis have launched the Pediatric Cancer Genome Project 1 to sequence the genomes of at least 600 children with cancer over the next 3 years. The collaboration marks the first time that whole-genome sequencing will be used on a large scale to discover genetic changes driving pediatric cancers.

"This is the largest and most powerful single initiative in the 50-year history of St. Jude," the research hospital's director, Dr. William E. Evans, said at a press briefing announcing the project yesterday. "DNA is being sequenced as we speak," he added.

St. Jude has a repository of biological samples and clinical information from children who have been treated there since the 1970s. The collection represents a treasure trove of information about cancer, and it can now be scrutinized using the latest genomic technologies at a cost that continues to decline substantially over time.

"This is a new era for pediatric cancers," NIH Director Dr. Francis Collins said at the briefing. "The study represents an opportunity to discover all the ways that a good cell in an innocent child goes wrong."


The project--estimated to cost $65 million and funded by St. Jude--aims to discover the genetic origins of pediatric cancers while creating knowledge that can be used to improve the care of young people with these rare diseases. Early results could reveal new uses for available drugs, and, over the long term, lead to targeted agents for these cancers, the researchers said.

New genetic signatures for classifying and treating patients are also anticipated. Knowing that a child has a subtype with a poor prognosis would allow physicians to select aggressive treatments early in the course of the disease. Similarly, doctors could safely withhold treatments from a patient who has a better prognosis, based on a genetic profile.

"These two great NCI-designated comprehensive cancer centers are demonstrating yet again their commitment to making a difference for kids with cancer," said NCI Director Dr. John Niederhuber.

Dr. Larry J. Shapiro, dean of the Washington University School of Medicine and a pediatric geneticist, said at the briefing: "This project will provide a detailed and complete picture of the mutations in the cancer cells."

In 2008, researchers at Washington University and their colleagues published 2 the first genome sequence of a person with cancer--a woman with leukemia. They have since published 3 the genome of a second person with leukemia, and they have also sequenced dozens of additional cancer genomes using the same whole-genome approach.

The new effort will focus on leukemias, brain tumors, and sarcomas (tumors of bone, muscle, and other connective tissues). To identify genetic changes associated with cancer, the researchers will sequence DNA from both the tumor cells and normal cells of each patient.

The project complements in every way the efforts of The Cancer Genome Atlas 4 (TCGA) Research Network, which focuses on adult cancers, noted Dr. Collins. Just last week, TCGA investigators identified new subtypes 5 of brain cancer using genomic and clinical data--an example of the kind of knowledge Dr. Collins expects to come from the pediatric project.

Another genome effort in pediatric cancer is the NCI-supported childhood cancer TARGET 6 initiative, which includes St. Jude investigators as well as other childhood cancer researchers. The initial discoveries from this project are being translated to the clinic through an early stage clinical trial that is in development for a newly described 7 type of acute lymphoblastic leukemia.

What distinguishes the new project from past efforts, said Dr. Richard Wilson, director of the Genome Center at Washington University, is that this one will be "all whole-genomes all the time." Most genome studies have been limited to sets of genes or genetic markers because of the costs of sequencing DNA. Those costs have now fallen to below $100,000 for a tumor-normal combination, and the sequencing can be done in about a week, Dr. Wilson said. (See "A Conversation with Dr. Elaine Mardis 8" in this issue.)

"There is a sense of urgency to make progress here, and it has now become affordable," said Dr. Evans. "We see this effort as a marathon, and the first 3 years are really just the beginning. I am certain there will be lots of unanswered questions at the end of this period, and there will be much more work to be done."

He acknowledged the enormous challenge of managing and making sense of as much as 100 trillion pieces of data (600 cases, 2 genomes per case, and each genome will be sequenced 30 times to ensure that nothing is missed). To meet this challenge, Washington University is adding new instruments and computational power, and the researchers are confident that they are ready.

"The data storage, management, and analysis problems are substantial," Dr. Wilson said in an interview. "But this project is coming along at just the right time in terms of our technical capabilities. We've really come a long way in just the last 6 months in terms of our data production technology."

St. Jude has, in effect, been preparing for this project for 45 years by creating the tissue repository and developing a capacity for preclinical research studies. The infrastructure and resources required for follow-up studies of the genomic data, such as mouse models, already exist at St. Jude, noted Dr. Elaine Mardis, co-director of the Genome Center at Washington University. "The genome project will fill these pipelines with new information to be analyzed."

In the future, the project will include other types of alterations in cancer, such as those involving RNA and epigenetic changes, which alter the activity of genes without causing a change in DNA sequence, the researchers said.

They stressed that the results will be made publicly available through a Web site once the information has been validated. The hope is that other investigators will bring their own expertise and perspectives to the data and help move the science forward.

"We view this as creating a resource not just for our efforts but for the world," said Dr. Evans. He quoted the founder of St. Jude, the entertainer Danny Thomas, who liked to say, "To cure one child in Memphis is to cure a thousand worldwide."

"It is always a good thing if our discoveries can be amplified and leveraged elsewhere," Dr. Evans added, "and that's what has to happen." (emphasis added)


--Edward R. Winstead

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90,000 people per year travel to Houston's MD Anderson Cancer Center for treatment. Many are children. Most will not find a cure. Some will obtain more time. Almost all will suffer to achieve those additional years or months. Some will be in agonizing treatments for many months or even years. Forty years after President Nixon acknowledged the need for the so-called war on cancer, the therapies are still barbaric. Indeed, too many treatments are still so barbaric that more people than you would know will some day die from the treatments instead of the original cancer.

The staggering 90,000 number and other harsh realities are part of Gina Kolata's latest NYT article on why changes are needed in the race to prevent, manage and cure cancers. Her latest story focuses on MD Anderson to starkly highlight part of why our nation needs health care reform in general, and why our nation needs to exponentially accelerate and improve the manner in which individuals are treated for the myriad forms of cancers. Here is the image of yesterday's powerful front page picture and story. Here is the story itself.




Much more can and should be done, now. Happily, there is some expanded support triggered by the Obama Administration's support for science as detailed here. For example, the NIH and NCI are accelerating great new programs, including the Cancer Genome Atlas with wide-spread "cloud" access to the incredible amounts of new genomic information. But, much more can and should be done. Myriad cancers are starting to surrender their secrets to the brilliant doctors, new machines, and staggeringly fast computers and software that are sequencing genes and visualizing molecules at an unprecedented pace and in ways never before accomplished. Please, stay focused on the debates over health care and demand that our nation act to devote far more resources to saving more of our nation's 500,000 annual US victims and to prevent future cancers.

Can more be done in an effective way. Absolutely !

Who says so? For one, Dr. James Watson (of the Nobel prize team regarding DNA) in this powerful 2009 NYT editorial article. In just a few paragraphs, he outlines where we've been, where we are now, and why now is the time to accelerate and move forward in new ways.

For another, this 2008 book by Dr. Guy Faguet, an experienced doctor/scientist, has much to say on the subject of what's ahead and what needs to change on cancer research and treatment. http://www.amazon.com/War-Cancer-anatomy-failure-blueprint/dp/1402036183.

Dr. Faguet makes three main points. First, the "cell kill" approach to cancer is in large measure a failure. He also explains how and why the cell kill clinical trial is so slow and so tied to outmoded reimbursement systems and short-term profit models. Second, cancer prevention deserves far more effort and attention. For example, many oncogenic chromosome changes are caused by retroviruses, and so preventive vaccines are key to prevention and warrant far more effort and money. Some remarkable reductions in cancer appear to been achieved in some nations through vaccinations to eliminate one hepatitis virus. Third, the fast arriving future is finding cancer early and applying human and workable genomic therapy instead of trying to kill cancer cells after they are widespread.

Can this be done, politically speaking ? Yes. For that subject, see Dr. Harold Varmus' book - The Art and Politics of Science.

Dr. Varmus credentials ? Nobel Prize winner as part of a team of cancer researchers, head of the NIH for the Clinton Administration, and now the leader of Memorial Sloan Kettering. http://www.amazon.com/Art-Politics-Science-Harold-Varmus/dp/0393061280/ref=sr_1_1?ie=UTF8&s=books&qid=1256563341&sr=1-1

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Ms. Gina Kolata is back with another important but depressing New York Times article on the failure of our national policy for addressing cancer. Her series started with a late April article. I mentioned it here in a post that provided links to sources showing that more people die in the US every two days due to cancer than died on 9/11/01, and that a careful, extended study showed that the direct costs of cancer treatment are exceed by indirect costs of cancer at a ration of about 2.3 to 1 by the indirect costs.

The gist of her new article is to demonstrate that our nation fails to fund research on new ideas and instead strongly tends to fund new research in old areas. Doing so of course has its advantages in that little risk is taken, but the article also explains that taking risks and following new ideas is often how we make real progress. Indeed, just think of where we might be if Dr. Salk had been stuck thinking in conventional ways. Ironically, the later online version of the Sunday NYT includes a new article reporting on success in battling cancer in animals through some unusual techniques developed in Australia that take advantage of leaks in tumor blood vessels to deliver minicells that mark the area for treatment.

For a dramatic, detailed and easy to read example of why new thinking is a MUST for cancer, read Dr. Folkman's War. http://www.amazon.com/Dr-Folkmans-War-Angiogenesis-Struggle/dp/0375502440
The book tells the story of how a stint doing pathology and seeing tiny tumors throughout bodies ultimately caused Dr. Judah Folkman to reach the profound insight that all solid tumors need blood vessels to grow, and that something in the body must turn on and off the ability to generate blood vessels. As the book details, Dr. Folkman and his ideas were rejected and indeed even ridiculed. But after many years , his unorthodox theories ere proven correct. Research continues today into how to delay or stop tumor growth using some of the principles he developed, and some promising results have been obtained.

In short, there is much to be done to create a strong national or global strategy for solving or managing the myriad types of cancer. Indeed, I've come to the view that all the walkathons and charities are in a way counterproductive. Why? Because they implicitly send the message that cancer has to be solved through relatively modest hard-earned donations instead of through a massive national and international funding of efforts to find cures for cancers.

Finding ways to cure or manage cancer should be a priority of our government for both objective and subjective reasons. On the objective side, the direct and indirect costs of cancer are huge as detailed by the study mentioned above, and our economy needs the short term and long term jobs that new science may create (which would blue collar jobs as well because fermenting yeast to grow medicines is much like brewing beer, except even cleaner). For subjective reasons to find answers for cancer, consider that every two days, over 4,000 people will die from cancer. Our government, however, has not spent hundreds of billions of dollars a year to avenge the thousands of the thousands of "homeland" cancer deaths that occur every day.


For data for cancer for 2009, see:
http://www.cancer.org/docroot/STT/STT_0.asp

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In a win for defendants in general and some asbestos defendants in particular, the U.S. Supreme Court issued a June 1, 2009 per curiam opinion holding that when FELA claimants pursue "fear of cancer" claims, the defendant is entitled to an instruction that the jury must find evidence that the fear is "genuine and serious." The opinion is titled CSX Transp., Inc. v. Hensley, 556 U.S. _______ (2009). The slip opinion is here. The issue arose because a plaintiff said to have suffered other severe diseases also claimed damages for alleged fear of cancer due to having been diagnosed as having asbestosis.


The win is significant for railroads and others because FELA applies nationally since it is a federal statute. Click here for a Wikipedia article on the history of FELA.

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Science moves much faster than does "the law," and the changes in science over time will have a profound impact on the framing and resolution of legal issues.

For a new example, consider that respected medical journals Nature and Nature Genetics this month published articles from three research teams asserting identification of one or more genes they say are materially related to an increased risk of contracting non- small cell lung cancer, which comprises about 80% of lung cancers. Having one copy of the gene is said to be a characteristic of about 50% for persons of European descent, and far lower among persons from Asia and Africa. According to the authors, inheriting one copy of the gene raises the risk by about 28%, and inheriting two copies of the gene raises the risk by 70-80%. Some of the authors suggest the gene may be tied to the tendency to smoke. The press articles indicate that the research teams made the usual prediction that tests for the two genes will be available in the future.

The implications for law in general are profound when one considers all of the societal and legal issues related to health itself, and the obligations of insurers, governments or individuals for the expenses of treating (or, some day, preventing) a non small cell tumor in the lung. Those many issues are far beyond the scope of this blog. Here, the focus will remain on the potential tort litigation issues that may flow from these studies, and the other studies that surely will follow.

For example, many asbestos claimants with "lung cancer" attibute the disease in whole or in part to inhalation of asbestos fibers and/or cigarette smoking. In such cases, what difference should it or does it make if the claimant has one or more copies of the identified genes, and has the non small cell tumor? Defendants may ask for genetic testing and if they find the presence of one or two copies of the gene said to be relevant, they may argue that their presence breaks the legal causation chain and so precludes liability. Defense counsel also may invoke Daubert principles and seek to bar expert testimony from plaintiff's experts if the testimony is not focused in persons with two copies of the gene - will that tactic be allowed to work ? How soon?

Plaintiffs' counsel, on the other hand, may be expected to argue that the "two copies" claimant is just like the "eggshell skull" plaintiff we all heard about in law school. We were taught that the general rule is that a liable defendant cannot avoid financial responsibility simply because a particular person had an especially thin skull. Will that rule continue in force in the age of genomic testing? Should it stay in force as is, or does it need modification?

Plaintiffs also may use the presence of two copies of the gene to try to meet legal standards they cannot meet today for some claimants advancing fear of cancer claims or other claims. For example, some state law opinions (e.g Havner in Texas) will for the most part refuse to permit a claim unless the plaintiff proves that there is a relative risk of a specific disease created by "exposure" to a substance that is at or exceeds 2.0. Will science over time allow plaintiffs' lawyers to meet the 2.0 standard for claimants with the "two copies" even if the 2.0 standard could not be met for a person without the two copies of the "lung cancer" gene?

These and many other issues are arriving fast. For press articles with more details on the lung cancer studies, see:

http://news.bbc.co.uk/2/hi/health/7325971.stm; http://www.latimes.com/features/health/medicine/la-sci-lung3apr03,1,483181.story

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