Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: Comparing breast and ovarian cancer

Genetics in Medicine:
April 2010 - Volume 12 - Issue 4
Article
Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer:
Comparing breast and ovarian cancers with colon cancers

Abstract

Genetic testing for inherited susceptibility to breast and ovarian cancer can be compared with similar testing for colorectal cancer as a “natural experiment.” Inherited susceptibility accounts for a similar fraction of both cancers and genetic testing results guide decisions about options for prophylactic surgery in both sets of conditions.

One major difference is that in the United States, Myriad Genetics is the sole provider of genetic testing, because it has sole control of relevant patents for BRCA1 and BRCA2 genes, whereas genetic testing for familial colorectal cancer is available from multiple laboratories.

Colorectal cancer-associated genes are also patented, but they have been nonexclusively licensed.

Prices for BRCA1 and 2 testing do not reflect an obvious price premium attributable to exclusive patent rights compared with colorectal cancer testing, and indeed, Myriad's per unit costs are somewhat lower for BRCA1/2 testing than testing for colorectal cancer susceptibility. Myriad has not enforced patents against basic research and negotiated a Memorandum of Understanding with the National Cancer Institute in 1999 for institutional BRCA testing in clinical research. The main impact of patenting and licensing in BRCA compared with colorectal cancer is the business model of genetic testing, with a sole provider for BRCA and multiple laboratories for colorectal cancer genetic testing.

Myriad's sole-provider model has not worked in jurisdictions outside the United States, largely because of differences in breadth of patent protection, responses of government health services, and difficulty in patent enforcement.

Note: see abstract for authors which include: Robert Cook-Deegan, MD. Director, IGSP Center for Genome Ethics, Law & Policy.

2010 full free access: Analysis - When Should Surgical Cytoreduction in Advanced Ovarian Cancer Take Place?

Reminder: A patient's perspective on ovarian cancer as a chronic disease—Devaluing a survivor's challenge Caridad Vera-Garcia

Note: Cary is now with us 'in spirit'

Is the current concept of recurrent ovarian carcinoma as a chronic disease also applicable in platinum resistant patients?

Note: the authors' opinions confirm ovarian cancer as a chronic disease

free full access: A phase-I trial of pemetrexed plus carboplatin in recurrent ovarian cancer.

for full free access click on 'pdf'

Clinical Care Options - CME - Dr Maurie Markman updated CME March 3, 2010

Note: requires Password/Registration (free):

Oncology - Ovarian Cancer
Authors: Maurie Markman, MD
Date Released: October 01, 2009
Last Updated: March 03, 2010

Table of Contents

• Ovarian Cancer
  • Introduction
  • BRCA Mutations in Ovarian Cancer
  • Screening for Ovarian Cancer
  • Symptoms of Ovarian Cancer
  • Surgical Staging of Ovarian Cancer
  • Primary Surgical Cytoreduction in Ovarian Cancer
  • Interval Surgical Cytoreduction and Neoadjuvant Chemotherapy
  • Chemotherapy for High-Risk Early-Stage Ovarian Cancer
  • Primary Chemotherapy of Advanced Stage Ovarian Cancer
    • Intraperitoneal Chemotherapy of Small-Volume Residual Ovarian Cancer
    • Maintenance Therapy of Advanced Ovarian Cancer
  • Second-Line Therapy of Ovarian Cancer
  • Platinum-Sensitive vs Platinum-Resistant Recurrent Ovarian Cancer
  • Treatment of Platinum-Sensitive Recurrent Ovarian Cancer
  • Treatment of Platinum-Resistant Ovarian Cancer
  • Intermediate Platinum Sensitivity
  • Carboplatin Hypersensitivity Reactions
  • Other Management Options in Recurrent/Resistant Ovarian Cancer
  • Future Research Directions in Ovarian Cancer
  • Tables and Figures
  • References

When treatment ends, patients with cancer combat challenges - STLtoday.com

"Many patients find themselves asking: What now?

"When you lose the security of knowing that you're acting toward curing your cancer, it's really scary," said Barbara Platzer, 72, of Chesterfield, who finished treatments for ovarian cancer three years ago. "Every time I'd go for chemotherapy, I'd have a doctor looking at me and doing lab tests where I'd see that my (cancer antigen-125) numbers were improving. And that made me feel secure, like I had control over what was happening. I felt like we were actively killing the cancer.""

Peutz-Jeghers syndrome with breast cancer/gyn cancer...

A case of Peutz-Jeghers syndrome with breast cancer, bilateral sex cord tumor with annular tubules, and adenoma malignum caused by STK11 gene mutation.

Clements A, Robison K, Granai C, Steinhoff MM, Scalia-Wilbur J, Moore RG.

Program in Women's Oncology, Department of Obstetrics and Gynecology, Women and Infants Hospital, Brown University, Providence, RI, USA.

BACKGROUND: Peutz-Jeghers syndrome (PJS) is a rare autosomal dominant disorder, and women with this syndrome are at an increased risk of developing intestinal and extraintestinal malignancies including breast and gynecologic malignancies. This case report presents a patient with PJS with a concomitant breast cancer, bilateral stromal tumors with annular tubules of the ovaries, and adenoma malignum of the cervix.

Hereditary Ovarian Cancer: Molecular Genetics, Pathology, Management, and Heterogeneity

Future Prospects: DNA Variants Modify HBOC and LS (Lynch Syndome) Cancer Risk:
What does the future hold with respect to molecular genetics and cancer control in hereditary cancer, inclusive of HBOC and Lynch syndrome?

This projection relates to the truism that cancer-causing mutations do not act in a vacuum, since they are likely to be impacted by additional low-penetrant modifier genes in concert with myriad environmental events.

MRI of Endometriotic Cysts in Association With Ovarian Carcinoma -- Tanaka et al. 194 (2): 355 -- American Journal of Roentgenology

CONCLUSION. Endometriotic cysts with enhanced mural nodules are not always complicated with malignancy. In elderly patients, the presence of large enhanced nodules on large endometriotic cysts is more likely to indicate malignancy.

Augmentation of Therapeutic Efficacy in Drug-Resistance - breast and ovarian cancers - C6 (CER) + Paclitaxel

"This study describes a novel mechanism to overcome MDR through a polymer-blend nanoparticle platform that delivers a combination therapy of C6-ceramide (CER), a synthetic analog of an endogenously occurring apoptotic modulator, together with the chemotherapeutic drug paclitaxel (PTX), in a single formulation. ( PTX/CER )

Nonsteroidal Anti-Inflammatory Drugs and Risk for Ovarian and Endometrial Cancers in the Iowa Women's Health Study — Cancer Epidemiology, Biomarkers & Prevention

Peritoneal-based Malignancies and Their Treatment. [Ann Acad Med Singapore. 2010] - PubMed result

Conclusion: It is important to recognise the role of and indications for CRS and HIPEC

Mucinous Adenocarcinoma Involving the Ovary: Comparative Evaluation of the Classification Algorithms using Tumor Size and Laterality

full free access: A novel germline PALB2 deletion in Polish breast and ovarian cancer patients

Conclusions:
The c.509_510delGA is a novel PALB2 mutation that increases the risk of familial breast cancer. Occurrence of the same PALB2 alteration in seven unrelated women suggests that c.509_510delGA (p.R170fs) is a recurrent mutation for Polish population.

PLoS ONE: Risk of Ovarian Cancer and Inherited Variants in Relapse-Associated Genes

"...We previously reported results of tumor mRNA expression studies which suggested that altered expression of a particular set of genes predicted response to chemotherapy among women with advanced-stage high-grade epithelial ovarian cancer.......Conclusions: "Tumor studies can reveal novel genes worthy of follow-up for cancer susceptibility. Here, we found that inherited markers in the gene encoding MSL1, part of a complex that modifies the histone H4, may decrease risk of invasive serous ovarian cancer."

Intraperitoneal VEGF Inhibition Using Bevacizumab: A Potential Approach for the Symptomatic Treatment of Malignant Ascites? -- The Oncologist

"Despite the very strong preclinical evidence for an obligatory role of VEGF in the formation of malignant ascites and for a possible therapeutic efficacy of anti-VEGF therapies in the setting of malignant effusions, there are currently no reports from clinical studies addressing this point in cancer patients..........To date, only very few patients with malignant ascites have received i.p. bevacizumab and, therefore, this route of administration as well as this particular patient population need to be examined stringently regarding the safety of the treatment. However, we believe that i.p. application might be the route of choice in this particular setting."

Preventing Future Cancers by Testing Women With Ovarian Cancer for BRCA Mutations -- University of British Columbia/MD Anderson

"BRCA testing of women with ovarian cancer based on personal/family history of cancer or Ashkenazi Jewish ancestry is a cost-effective strategy to prevent future breast and ovarian cancers among FDRs (first degree relatives). More inclusive testing strategies prevent additional cancer cases but at significant cost."

Breast and Ovarian Cancer Tests Not for Some Women, Say Experts (media item/U of Michigan)

2009 Expert Perspectives on Challenges, Controversies, and Opportunities in Ovarian Cancer Therapy: The Present and the Future | PeerView Press

(free) viewing:
Includes: Dr's Markman, Armstrong & Coleman


Topics:

• Expert Perspectives on Challenges, Controversies, and Opportunities in Ovarian Cancer Therapy: The Present and the Future  
• Taking Stock of the Current Research: Which New Therapies Are Showing Promise in Ovarian Cancer?   
• Audio - Q&A Lightning Round: Expert Opinions on Unanswered Questions and Controversies in Ovarian Cancer