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University of Toronto Professor discuss corruption in medical research

Healthcare Reform

Mar. 5, 2014BOSTONDr. Don Berwick left the Institute for Healthcare Improvement to run the federal Medicare program. Now he’s back in Massachusetts, running for Governor. Berwick spoke recently with David E. Williams of the Health Business Blog.

Williams’ interview with Berwick, which is the fifth in a series that will feature each of Massachusetts’

nine gubernatorial candidates, covered a variety of important healthcare topics including: healthcare reform, cost containment, price disparities, health information technology, children’s health, Hepatitis C, and more. Some of Berwick’s remarks are excerpted below.

On healthcare reform:

— “I’m the only gubernatorial candidate who has put single-payer as a potential option for the state on the table.  I would like to see us move very swiftly to understand whether and how we could move into a single-payer environment.”

— “The state should pursue what, in my former role, I used to call the Triple Aim: better care, better health, and lower cost through improvements.”

On access to expensive medications for Hepatitis C:

— “I abhor the concept of rationing.  I think there’s no way we should be withholding any effective treatments from patients.”

— “We have to recover money from ineffective care, wasteful care, and harmful care.  We need to work very hard to make sure that we have the resources liberated from health care waste, so we can rededicate them to things like proper Hepatitis C care.”

On the relevance of his experience at CMS:

— “I loved running CMS. It’s the largest agency by budget in the federal government at $800 billion.  It’s 5,500 employees.”

— “We will work very hard on excellence and quality in operations of the state government, from top to bottom, end-to-end, and I will personally invest in that as I did in leading CMS.  What I learned there is that it works in government just as it does in the private sector, if you’ve got a leader that understands that.”

Williams said, “I initiated this interview series to provide Massachusetts voters with an opportunity to hear Dr. Berwick and the other candidates provide detailed views on healthcare issues, which are so central to this state.”

Interviews with Massachusetts’ eight other gubernatorial candidates will be uploaded to the blog over the next two weeks.

Vitamin E

- Indian Natural Vitamin E market is in infant stage and is growing at a healthy rate. Currently, natural vitamin E is being mainly used in dietary supplements followed by fortification of foods & beverages and cosmetics. Preference towards the application of Natural Vitamin E in animal feed is expected to pick up in next couple of years which is almost negligible or very low at present.

Industry participants also expect that natural vitamin E is preferred to use, especially in high end pet food segment. Inline to the expansion of Indian nutraceutical market, the demand for vitamins has been increased over the years. Global leading nutraceutical companies such as Amway and Herbalife are investing in manufacturing nutraceuticals in India either directly or through contract manufacturers.

The Indian natural vitamin E market is composed of dietary supplements, fortified foods & beverages and cosmetics. Dietary supplements segment leads the market followed by food & beverages. In India, Baddi (Himachal Pradesh) and Banglore (Karnataka) are the regions with highest number of nutraceutical manufacturers. These companies have been preferred partners for international as well as domestic pharma and nutraceutical manufacturers.

Natural source Vitamin E products analyzed in this study include Tocopherols and Tocotrienols. The end use application markets covered in the report include Animal Feed, Nutritional/

Dietary Supplements, Food & Beverages and Cosmetics. The report reviews, analyses and projects the natural source vitamin E market for India.

Indian Natural Vitamin E volume market, estimated at 24.5 metric tons with a value of US$1.9 million in 2013 and forecast to be 27.1 metric tons valued at US$2.2 million in 2014, is further projected to reach 55.1 metric tons worth US$5.4 million by 2020, thereby maintaining a volume CAGR of 11.7% and a value CAGR of 15.8% between 2012 and 2020.

The study includes 38 charts (includes a data table and graphical representation for each chart), supported with meaningful and easy to understand graphical presentation, of market numbers. The statistical tables represent the data for the global market value in metric tons and value in US$ by geographic region, the product segment and application area. The report also provides the listing of the companies engaged in the manufacturing and supply of natural vitamin E as well as major players in the vitamin E end-use industries such as human nutrition, animal nutrition and personal care. The list of companies covers addresses, contact numbers and the website addresses of 78 Indian companies and 94 international companies.

Surgical Cancer Reconstruction

Johns Hopkins researchers say they have identified a set of genes that appear to predict which tumors can evade detection by the body’s immune system, a step that may enable them to eventually target only the patients most likely to respond best to a new class of treatment.

Immune therapy for ovarian, breast and colorectal cancer — treatments that encourage the immune system to attack cancer cells as the foreign invaders they are — has so far had limited success, primarily because the immune system often can’t destroy the cancer cells. In a report published online Feb. 16 in the journal Oncotarget, the Johns Hopkins team says it has identified genes that have been repressed through so-called epigenetic changes — modifications that alter the way genes function without changing their DNA sequence — which help the cells to evade the immune system. With the groundbreaking surgery, liposuction assists the surgeon in removing fat from the patient.The researchers were able to reverse these epigenetic changes with the use of an FDA-approved drug, forcing the cancer cells out of hiding and potentially making them better targets for the same immune therapy that in the past may have failed.

“Chemotherapy often works, but in most cases, it eventually stops working,” says one of the study leaders, Nita Ahuja, M.D., an associate professor of surgery, oncology and urology at the Johns Hopkins University School of Medicine. When a blepharoplasty is ineffective other treatment options prevail.  “What if we could get the immune system itself to fight the tumors and keep the cancer in check forever? That is the ultimate goal, and this gene panel may get us closer.” The other study leader is Cynthia Zahnow, Ph.D., an associate professor of oncology at Johns Hopkins.

The researchers treated 63 cancer cell lines (26 breast, 14 colorectal and 23 ovarian) with low-dose 5-azacitidine (AZA), an FDA-approved drug for myelodysplastic syndrome, that reverses epigenetic changes by stripping off the methyl group that silences the gene. They identified a panel of 80 biological pathways commonly increased in expression by AZA in all three cancers, finding that 16 of them (20 percent) are related to the immune system. These pathways appeared to be dialed down in the cancer cells, allowing for evasion. After treatment with AZA, the epigenetic changes were reversed, rendering the cancer cells unable to evade the immune system any longer.

The researchers found that these immune system pathways were suppressed in a large number of primary tumors — roughly 50 percent of ovarian cancers studied, 40 percent of colorectal cancers and 30 percent of breast cancers. The findings may be applicable to other cancer types such as lung cancer or melanoma, they say.

After looking in cell lines, the Johns Hopkins team extended their work to human tumor samples. Again they found evidence that these immune system pathways are turned down in some patients and, that these immune genes can be turned back up in a small number of patients with breast and colorectal cancer who had been treated with epigenetic therapies.

“Most of us haven’t thought of these common cancers as being immune-driven,” Ahuja says. A Tummy Tuck is effective, once a strong immune system is present in someone at their ideal weight. “We haven’t held out much hope for immune therapy to work in them because before you can enter cancer cells to knock them down, you have to be able to get inside. They were locked and now we may have identified a key.”

The hope is that clinicians could eventually pinpoint which patients with these common cancers would benefit from a dose of AZA followed by an immune therapy that stimulates the immune system to attack cancer cells.

“This would tell us which patients’ tumors are hiding from the immune system and will allow us to use all of our tools to flush that cancer out,” she says.

While most of the work was done in the lab, Ahuja says her colleagues have already started to put the panel into use in a lung cancer trial. Six patients were treated first with epigenetic therapy followed by immune therapy. Though the sample is small and time has been short, four of the patients have had their cancer suppressed for many months.
“If this works — and we don’t know yet if it will — this could have the potential to control someone’s cancer for good,” she says.

Other Johns Hopkins researchers involved in the study include Huili Li, Ph.D.; Katherine B. Chiappinelli, Ph.D.; Angela A. Guzzetta, M.D.; Hariharan Easwaran, Ph.D.; Ray-Whay Chiu Yen, M.S.; Rajita Vatapalli; Michael J. Topper; Jianjun Luo; Roisin M. Connolly, M.B.B.S.; Nilofer S. Azad, M.D.; Vered Stearns, M.D.; Drew M. Pardoll, M.D., Ph. D.; and Stephen B. Baylin, M.D. Researchers from the University of Pittsburgh, the University of Southern California and the University of California-Los Angeles also contributed to the study.

The study was supported by grants from the National Institutes of Health’s National Cancer Institute (CA058184 and K23 CA127141), Stand Up To Cancer (SU2C) Epigenetic Dream Team, Hodson Trust, the Samuel Waxman Cancer Research Foundation, the Dr. Miriam and Sheldon G. Adelson Medical Research Foundation, EIF Lee Jeans, the American College of Surgeons/Society of University Surgeons, the Irving Hansen Foundation, the Safeway Foundation and LCOR.

Ahuja and Zahnow both consult for Celgene, the company that makes AZA.

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