Archive for the ‘Finance and Politics of osteosarcoma research’ Category

When should a scientist’s data be liberated for all to see?

Posted 23 Jul 2010 — by James Street
Category Finance and Politics of osteosarcoma research

From Scientific American Magazine

Jul 22, 2010 02:01 PM in Basic Science | 8 comments

By Katherine Harmon

scientists collecting research data, but debate if should be released immediately into commonsWhen researchers make an exciting discovery, the data behind it are often closely guarded until they can be examined, developed and then revealed—at least in part—in a peer-reviewed journal with all of the proverbial fanfare.

But that custom often leaves the public and most of the research world in the dark—sometimes for years, as some lamented in the case of the formal description of the hominid Ardipithecus ramidus, which came some 15 years after the original discovery. Publication usually involves sharing some data because the scientific method encourages others to review one’s work so they can attempt to replicate it. But in a web-driven era of rapidly moving and easily stored data, however, many researchers now argue forcefully for an open exchange of data and the wider use of so-called scientific commons.

Climate change, molecular chemistry and microbiology are just a few of the fields currently entertaining the idea of a better-connected repository to which data can (or must) be uploaded soon after discovery. And in the medical world, many researchers are looking hopefully toward a digital future in which masses of patient data can be examined for patterns of disease soon after they are gathered.

“It would be preferable, from a pure scientific advancement standpoint, to have every piece of data released immediately to the public,” Jorge Contreras, deputy director of the Intellectual Property Program at Washington University’s School of Law in St. Louis, Mo. and author of a new policy essay on the topic published online July 22 in Science, said in a prepared statement.

That idealistic approach, however, “doesn’t give data-generating scientists the opportunity to publish and advance their careers through publication,” he noted. Thus new findings and data sets are still usually held close to the vest in the harsh publish-or-perish world.

And the data dearth doesn’t necessarily stop with publication. “Because of busy schedules, competitive pressures and other interpersonal vagaries, the sharing of scientific data can be inconsistent even after publication,” Contreras observes in his essay.

Not every field has been so tight-fisted with its data. As an encouraging example, he points to the Human Genome Project’s stipulation that all new data be made public within 24 hours of being generated. But, he concedes, not every discipline is primed to fall in line with such immediate free access. The genome “represented the common heritage of the human species and should not be encumbered by patents,” he writes. But patents are precisely the point of many scientific endeavors, and showing your cards to the competition early on is a patently dim decision.

Thus Contreras proposes a balance of data access and data rights. “I think you must have a compromise,” he said in a prepared statement. “Commons weighted too heavily in favor of data users are not likely to attract sufficient contributions from data generators, whereas commons weighted too heavily in favor of data generators” would be less helpful to other scientists and the public.

But that doesn’t mean data should be held back. Instead, he argues, widely accepted lead times—after data are publicly released but before others can publish results on them—would allow “data generators a ‘head start’ on preparing publications based on their data, yet data are still broadly available for the general advancement of science.”

Image courtesy of iStockphoto/AlexRaths

Francesco Loccisano Memorial Foundation

Posted 19 Jul 2010 — by James Street
Category Finance and Politics of osteosarcoma research, Foundations

Heroic Brooklyn Youth Gets Street Named in His Memory
by Brooklyn Eagle (edit@brooklyneagle.net), published online 07-19-2010

Francesco Loccisano Way Dedicated In Dyker Heights

DYKER HEIGHTS — Francesco Anthony Loccisano (aka Frankie) was a charming and vibrant 17-year-old boy who was dearly loved and adored by his large family and many friends, most of whom had attended his street naming ceremony this past Saturday on 63rd Street and 14th Avenue.

Thanks to Community Board 11 and Councilmembers Sara Gonzalez and Vincent Gentile, among others, Rocco and Camille Loccisano’s dream had become a reality.

Frankie was filled with positive energy and enthusiasm. His loving family watched as he grew into an intelligent teenager. During his too-short life, he brought nothing but joy and happiness into the lives of all those around him. Frankie was dependable, responsible, a bright student and a great friend. His favorite subject was history, and he loved politics and economics. He also enjoyed a good and fair debate and he always presented facts to support his views.

His dream was to one day study law and practice as a criminal prosecutor. He even had thoughts of becoming a member of Congress. Congressman Michael McMahon, who spoke at the street-naming event, said, “Frankie was an inspiration to us all. This monument to his name will enable people who pass this way to look up and know Francesco Loccisano was someone special.”

His political views were moderate, and he always said, “depends on the issue!” He enjoyed football, was a Yankee fan, loved gangster movies, video games, online role playing and neighborhood stoopball. He appreciated simple pleasures, but he also enjoyed the finer things in life, such as handsome neckties and fine restaurants. He was a talented, creative writer and also an avid novel reader.

Frankie’s journey with childhood cancer began at the age of 14 during his freshman year of high school. He was diagnosed with Osteosarcoma and later on a second cancer, Leukemia. He fought a long and hard battle against such illness for 27 months.

Many rounds of chemotherapy, radiation, multiple lung surgeries and an above the knee amputation are among the countless and various types of treatments that Frankie bravely endured in an effort to save his life. Along this journey, Frankie learned many life lessons, most especially about the hardships of humanity. This caused him to grow a tremendous compassion for those who were less fortunate, ill, or in pain. He vowed to start his own foundation because he wanted to help other children and families who were experiencing illness and misfortune.

As an older pediatric patient, Frankie especially understood the enormity of childhood cancer and what it meant to be so young and fighting for life instead of enjoying life. He prayed for anyone he was told about, young or old, no matter what their misfortune.

Through his own difficult time, he remained hopeful as well as prayerful. He kept Jesus as the center of his life and prayed to his special Catholic Saints, Padre Pio and St. Joseph. His desire to help other children were the last words he communicated to his family. On the day he passed, he was surrounded by those who loved him.

Frankie’s journey continues with the “Francesco Loccisano Memorial Foundation”, a grass-roots organization founded by Frankie’s family and friends who have pledged to remember the daily battle of children with cancer. His remarkable life and his sincere and heartfelt desire to help others are the pillars, the heart and the cornerstone of this foundation.

NICE Says no to Life Saving Treatment for Childhood Bone Cancer(1,2)

Posted 08 Jul 2010 — by James Street
Category Finance and Politics of osteosarcoma research
    HIGH WYCOMBE, England, July 9, 2010 /PRNewswire/ --

    - In a draft appraisal the National Institute for Health and
      Clinical Excellence (NICE) has refused to recommend the first treatment
      shown to improve survival in childhood bone cancer (osteosarcoma) in
      more than 20 years(1,2)

    - Data shows Mepact(R) (mifamurtide) reduces the risk of death
      by almost one third when added to standard chemotherapy treatment,
      compared with chemotherapy alone(3)

    - Using Mepact(R) with standard chemotherapy treatment after
      surgery has the potential to save an additional eight lives each
      year(3-5)

    - NICE has refused to fund lifesaving treatment for children
      that could only cost GBP2.5 million,(6) when the NHS spends over GBP700
      million on treating preventable lifestyle diseases, such as obesity,
      smoking and alcoholism(7-10)

    - Between half and one-third of patients receiving standard
      chemotherapy treatment will not survive beyond five years(5)

Takeda UK announces that in its draft appraisal the National Institute for Health and Clinical Excellence (NICE) does not recommend the use of Mepact(R) for the treatment of bone cancer (osteosarcoma) in children, adolescents and young adults.(1) This comes following NICE’s inability to recommend Mepact(R) due to its strict criteria for cost-effectiveness – which does not currently accommodate the assessment of rare, ultra orphan diseases – and despite the fact that Mepact(R) meets many of the criteria for ‘Deviating from the Threshold’ by the NICE Citizen’s Council reviewed by the NICE Board on 20 May 2009.(11) This stated that if the treatment in question is life saving, the patients are children, the intervention will have a major impact on patient’s family and the illness is extremely severe and/or rare, then the medicine is of additional value to society and shouldn’t have to meet NICE’s current cost-effectiveness criteria.(11) In these conditions, Mepact(R) meets all of these criteria.

Chairman of the Bone Cancer Research Trust, Michael Francis, said: “The Trust is astonished by the decision taken by NICE. We really thought that NICE would recognise that Mepact(R) offers the first real opportunity to help these young people. Money seems to be available for treatments that will extend the life of a patient with another type of cancer for a matter of a few months but not when a young life could be extended into a working life, paying taxes, raising a family and contributing to society. Of course we do not begrudge funding for treatment for other cancers, but it seems perverse that we are prepared to let those young people die for the sake of GBP2.5 million – a sum which would dramatically allow more young people to survive. We hope that some means can now be found within the NHS to review how Mepact(R) can help at least some of those with osteosarcoma.”

Sarcoma UK is also disappointed by the recommendation from NICE that Mepact(R) should not be funded for the treatment of osteosarcoma in the NHS. Sarcoma UK’s director, Roger Wilson, has been an open critic of NICE and its approach to assessing new drugs for rare cancers. He comments: “If we take the decision down to its essentials, this means that NICE is prepared to sacrifice children on its self-justified altar of cost-effectiveness,” he said. “I believe that our society has higher moral principles and will not allow an academic process, which has already been shown to be flawed, to take this unprincipled route.”

Osteosarcoma is a rare and often fatal form of bone cancer, with approximately 100-150 new patients diagnosed in the UK each year.(4) It is a cancer that is mainly found in children, adolescents and young adults with the average age of patients being 15 years, although children as young as two years have been diagnosed with it.(12) It is usually a highly aggressive disease that can spread to other parts of the body, usually the lungs in about one-fifth of patients.(13) For up to one-third of newly diagnosed patients the cancer will return.(14)

Although Takeda are disheartened with NICE’s decision, they want to ensure that the suitable young patients that are diagnosed with osteosarcoma each year are provided with a fighting chance, and will therefore work with NICE through to the end of its appraisal.

There have not been any advances in the treatment of osteosarcoma for more than 20 years,(1) with patients currently being treated with chemotherapy given before and after the tumour has been surgically removed from the bone (resection).(15) Between half and one-third of patients receiving this treatment will not survive beyond five years.(5)

The new bone cancer drug, Mepact(R) can reduce the risk of death by almost one-third(3), which means that it has the potential to save an additional eight lives each year.(3-5)

Leading osteosarcoma expert Professor Ian Lewis, Professor of Cancer Studies at St James University Hospital, Leeds, said of the announcement, “It’s a great disappointment and cause for much frustration that we now have another hurdle to get over and I would urge those involved to make Mepact(R) a priority so that we can start saving more young lives. We hope that another avenue be sought to ensure that Mepact(R) can be made available to patients as soon as possible.”

References

1. National Institute for Health and Clinical Excellence. Appraisal consultation document – Mifamurtide for the treatment of osteosarcoma. July 2010

2. IDM Pharma’s Mepact (Mifamurtide, L-MTP-PE) Receives Approval in Europe for Treatment of Patients with Non-metastatic, Resectable Osteosarcoma. http://www.drugs.com/news/idm-pharma-s-mepact-mifamurtide-l-mtp-pe-recieves-a pproval-europe-patients-non-metastatic-16563.html

3. Meyers PA, et al. Osteosarcoma: The Addition of Muramyl Tripeptide to Chemotherapy Improves Overall Survival – A Report From The Chrildren’s Oncology Group. J Clin Oncol 2008;26:633-638

4. MattsonJack Epi Data Feb 2009 (Based in the assumption that 56% of sarcoma is osteosarcoma (NCI))

5. Lewis I, et al. Improvement in Histologic Response But Not Survival in Osteosarcoma Patients Treated With Intensified Chemotherapy: A Randomized Phase III Trial of the European Osteosarcoma Intergroup. J Natl Cancer Inst 2007;99:112-28

6. Takeda UK new submission of evidence to NICE: Mifamurtide for the treatment of Osteosarcoma: 10th December 2009

7. The Health and Social Care Information Centre. Statistics on alcohol: England, 2009. Available at http://www.ic.nhs.uk/statistics-and-data-collections/health-and-lifestyles/al cohol/statistics-on-alcohol-england-2009-[ns] (Last accessed: 30/04/2010)

8. The Health and Social Care Information Centre. Statistics on obesity, physical activity and diet: England, February 2010. Available at http://www.ic.nhs.uk/webfiles/publications/opad10/Statistics_on_Obesity_Physi cal_Activity_and_Diet_England_2010.pdf (Last accessed: 30/04/2010)

9. The Health and Social Care Information Centre. Prescribing for diabetes in England: Supplement – January 2002 to March 2009. Available at http://www.ic.nhs.uk/statistics-and-data-collections/primary-care/prescriptio ns/prescribing-for-diabetes-in-england:-supplement–january-2002-to-march-200 9 (Last accessed: 30/04/2010)

10. The Health and Social Care Information Centre. Statistics on smoking: England, 2009. Available at http://www.ic.nhs.uk/statistics-and-data-collections/health-and-lifestyles/sm oking/statistics-on-smoking-england-2009 (Last accessed:30/04/2010)

11. NICE Citizen’s Council Report on Departing from the Cost Effectiveness Threshold document; Nov 27-29, 2008. http://www.nice.org.uk/aboutnice/whoweare/board/boardmeetings/2009/20May2009. isp

12. Mascarenhas L, Siegel S, Spector L, et al. Malignant Bone Tumours. SEER AYA Monograph, 2002;8:97-109

13. Meyers PA, Gorlick R. Osteosarcoma. Pediatr Clin North Am 1997;4:973-989

14. Grimer RJ. Surgical options for children with osteosarcoma. Lancet Oncol 2005;6:85-92

15. Bielack S, Carrle D, Casali PG, et al. Osteosarcoma: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Annals of Oncology, 2009;20(supplement 4);iv 137-iv 139, 2009

(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser’s URL address field. Remove the space if one exists.)

    CONTACT FOR FURTHER INFORMATION:
    Liberation Communications
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SOURCE Takeda UK LTD

The Chemo Concession Persists

Posted 27 Jun 2010 — by James Street
Category Finance and Politics of osteosarcoma research

Sunday, 27 June 2010

A recent study provides evidence that some oncologists prescribe chemotherapy based on their financial reward rather than the medical needs of their patients. This is a continuation of the “Chemotherapy Concession,” which came to public light a decade ago. It is a system, unique in the medical world, whereby oncologists can buy drugs at deep discount and then dispense them at the higher, Medicare rate in their offices. In effect, participating oncologists run a kind of pharmacy as a side business (although it is rarely identified as such to the patients). This represents a considerable part of some oncologists’ income.

The new study, which appeared last week in the online edition of Health Affairs, will appear in print in July. It showed that when the US Congress tried to reduce Medicare spending in 2003, some oncologists responded by treating a greater number of patients with more expensive drugs to make up for this lost income.

“Many doctors ended up prescribing chemotherapy for more of their patients, to make up for lower prices,” commented Reed Abelson, who has long followed this issue for the New York Times. In some cases, doctors bought drugs for 20 percent below the Medicare reimbursement rate. This generated “large sums” (ibid.) that oncologists realized between the wholesale and the retail prices. The authors of the Health Affairs study analyzed the records of over 200,000 lung cancer patients treated between 2003 and 2005. Contrary to expectations, when the Medicare cuts went into effects, doctors wound up giving more extensive (and expensive) treatments. Before the law went into effect, 16.5 percent of such patients received chemotherapy. After the law went into effect this rose to 18.9 percent of patients. Although the authors only analyzed lung cancer, this 2.4 percent difference could be considerable, especially if applied to a substantial portion of the 1,529,460 Americans that are expected to develop cancer in 2010, according to the American Cancer Society (ACS).

Ralph W. Moss, Ph.D.
Cancer Decisions

How to Fix the Cancer Trials Program

May 2, 2010
Letters to the editor, N.Y. Times

To the Editor:

Re “Faltering Cancer Trials” (editorial, April 25):

It is clear that the National Cancer Institute’s clinical cancer research program is in urgent need of repair. The institute and the cooperative research groups it finances are taking action to address costly inefficiencies and burdensome regulations, but they cannot do it alone. Equally important is the need to reverse the systematic underfinancing of the program.

Virtually every important scientific advance in cancer prevention, treatment and quality of life in the last half-century has come from the N.C.I.’s cooperative group program. Yet the program receives less than 5 percent of N.C.I.’s budget. Adjusted for inflation, it actually receives less financing than it did a decade ago.

A recent survey by our organization found that because of inadequate financing, one-third of research centers plan to limit their participation in these trials. And 40 percent of those centers plan to increase their participation in better-financed industry trials, which may be less likely to examine the big, important questions in cancer research.

We support rapid implementation of the Institute of Medicine’s recent recommendations to improve the system and urge the N.C.I. to double financing for the cooperative group program within five years. This will require not only an internal reallocation of resources within the N.C.I., but also an infusion of new dollars to support the program.

Fixing the crown jewel of the nation’s cancer research system is essential to ensuring continued progress against cancer.

Douglas W. Blayney
Allen S. Lichter
Alexandria, Va., April 27, 2010

The writers, both doctors, are president and chief executive, respectively, of the American Society of Clinical Oncology.

To the Editor:

Your editorial correctly calls attention to the underfinanced and often unfinished trials of the cooperative groups financed by the National Cancer Institute. But you do not mention that industry-sponsored trials, performed in collaboration with academic health centers, represent a much larger segment of the cancer drug evaluation effort, and are thriving.

The rapid growth of the biotechnology industry has produced more than 800 new drugs for cancer currently in clinical trials, with positive results in melanoma, lung cancer, breast cancer and other tumors. The N.C.I.-sponsored trials, while important in refining the use of new and established cancer drugs, are no longer the dominant vehicle for cancer drug development.

The point remains that N.C.I. should make maximal use of the cooperative group program, but it is no longer the exclusive route to drug development.

Bruce Chabner
Boston, April 27, 2010

The writer, a doctor, is director of clinical research at the Massachusetts General Hospital Cancer Center.

To the Editor:

As a clinical investigator for more than 20 years, I have personally experienced the successes and frustrations associated with the publicly financed clinical trials system.

It is well recognized that clinical trials are critical to improving cancer care. But an important point not mentioned in your editorial is that cancer patient participation in clinical trials is abysmally low. In fact, only a small percentage of all adult cancer patients takes part in clinical trials. This low participation rate comes at a time when scientific discoveries and technologies are providing the opportunity to test an unprecedented number of promising new treatments.

There are many reasons for this low participation rate. As you note, operational inefficiencies in the nation’s clinical trials infrastructure and inadequate financial support for clinical investigation are certainly partly to blame. But as a society we have done a poor job emphasizing the importance of clinical research as an integral component of high-quality cancer care.

Taking part in a clinical trial offers the opportunity to advance cancer treatment, while gaining access to the latest innovations under the careful watch of an infrastructure designed to ensure patient safety. It is time that we take note of the marketing skills that have contributed to the adoption of so many unhealthy behaviors (smoking, fast food), and apply them to a more healthful goal: widespread recognition that cancer clinical trials represent the best treatments we have to offer.

Neal J. Meropol
Cleveland, April 27, 2010

The writer is chief, Division of Hematology and Oncology, University Hospitals Ireland Cancer Center at Case Western Reserve University.

To the Editor:

Research financed by the National Cancer Institute continues to fail because it is locked into one fruitless approach: detailed study of the tumor process that afflicts patients with cancer. This ignores a critical area.

The immune system is our most powerful protection against cancer. Without its ability to handle carcinogenic cells, mankind would not be around today. Yet research on how to strengthen deficient immune responses is seldom reported — and medications that safely strengthen immunity do exist.

Consider this hypothetical: In a city police department, all members are given total protection using special bulletproof vests, yet each year several police officers die of bullet wounds anyway. Why should the police research the steps involved in how one dies of a bullet wound? Wouldn’t it be more productive to examine the bulletproof vests and learn how to correct the deficient ones?

David Gluck
New York, April 26, 2010

The writer, a retired internist, maintains a Web site that calls attention to the medical importance of existing generic medication that strengthens immunity.

Researchers Say Exclusive Licensing On Genes Could Hurt Patients

Posted 20 Apr 2010 — by James Street
Category Finance and Politics of osteosarcoma research

16 Apr 2010

The Wall Street Journal reports that Duke University researchers have found in a study published Wednesday that granting “exclusive licenses on individual genes” could hurt patients’ chances of pinpointing their risks to develop disease.

“A new genetic-testing technology called whole-genome sequence analysis promises to give individuals a global view of their genes. That could allow the identification of diseases they are most at risk for and a more personalized way to target drugs that might help them. But the Duke study suggests earlier generations of research, when companies and institutions staked claims to individual genes, might slow down wide adaptation of the new techniques.” During the past 20 years, patents on genetic sequences have been issued to companies, universities and others, which they say are needed to raise the millions of dollars to advance knowledge on treatments and tests, but others aren’t convinced. But some experts have said “existing patent law was hindering access to some tests” (Marcus, 4/15).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.


Article URL: http://www.medicalnewstoday.com/articles/185662.php

Cancer Research by U.S. Disorganized, Underfunded, Study Says

April 15, 2010, 11:45 AM EDT

By Shannon Pettypiece

April 15 (Bloomberg) — The U.S. government’s cancer research network is “approaching a state of crisis” as waste and inefficiency cause 40 percent of late-stage trials it funds to be abandoned before completion, a report found.

The government-funded National Cancer Institute’s clinical trials group isn’t able to effectively study the benefits of new and current treatments, according to the analysis by the Institute of Medicine. Among the report’s recommendations is increasing funding for cancer studies, simplifying the process of designing trials, and offering incentives for doctors to do such research.

The NCI’s network of cancer centers and doctors tests cancer treatments on 25,000 patients a year, with an annual budget of about $145 million, the report said. Cancer kills about 560,000 people in the U.S. each year, the second-biggest cause of death behind heart disease, according to the Centers for Disease Control and Prevention in Atlanta.

“If the clinical trial system does not improve its efficiency and effectiveness, the introduction of new treatments for cancer will be delayed and patient lives will be lost unnecessarily,” the report said.

The trial network, called the Clinical Trials Cooperative Group Program, is comprised of doctors at universities and community cancer centers who develop clinical trials and enroll patients in those studies. Its work fills a research gap by focusing on efforts not typically undertaken by drug companies, such as comparing rival treatments or testing combinations of experimental therapies.

The process for carrying out those trials has become too complex and can take more than two years to design and initiate clinical trials, the report said.

‘Important Contribution’

“The cooperative groups have made a very important contribution that individual drug companies might not have made,” said John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center and chair of the committee that did the report. “We would lose something very important if the cooperative groups faded.”

The Institute recommended the NCI consolidate administrative operations, streamline government oversight of clinical trials, develop more efficient trial design, and create incentives for investigators to participate in studies. Health insurers should also pay for the cost of non-experimental care that is part of the clinical trial, such as additional scans, lab tests and physician visits.

The report was conducted at the request of the NCI director John Niederhuber. The Institute of Medicine is part of the National Academy of Science, a non-profit organization that acts as an adviser to the federal government.

–Editors: Lisa Rapaport, Reg Gale

To contact the reporter responsible for this story: Shannon Pettypiece at spettypiece@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

Spectrum Pharmaceuticals “drug” Fusilev

Posted 12 Mar 2010 — by James Street
Category Finance and Politics of osteosarcoma research

Fusilev is a brand name for leukovorin which is a simple folic acid derivative (folinic acid.)

It is not a treatment for osteosarcoma but is a vitamin analog which protects against the harmful effects of another cancer drug, methotrexate, which interferes with cells’ capacity to use the vitamin folic acid.

Without folinic acid (Fusilev), the massive doses of methotrexate necessary to treat osteosarcoma could not be tolerated by the patient’s non-cancerous cells.

Folinic acid is a simple derivative of the naturally occurring vitamin folic acid and is easy to produce.

The FDA, which is in the pockets of the pharmaceutical industry, recently declared vitamin B6 a drug, thus banning its sale in health food stores.

Giving companies the sole right to distribute naturally occurring substances such as vitamins is a socialistic move, and against the American spirit of free enterprise.

Free markets should determine the cost and availability of these substances which were discovered many years ago by scientific researchers and not by these drug companies.

Therefore, in the long run, and considering the viability of the American medical care system, this folic acid derivative does not make this company (or at least should not make it) a good investment.