Number of Young Patients with Newly Diagnosed Colorectal Cancer Anticipated to Double

November 5, 2014 – In the next 15 years, more than one in 10 colon cancers and nearly one in four rectal cancers will be diagnosed in patients younger than the traditional screening age, according to researchers at The University of Texas MD Anderson Cancer Center. This growing public health problem is underscored by data trends among 20- to 34-year-olds in the U.S., among whom the incidence of colon and rectal cancer (CRC) is expected to increase by 90% and 124.2%, respectively, by 2030. (more…)

Dangerous Drug Shortages

Dozens of essential medications are in critically short supply. Here’s what you need to know

Emergency medical technicians in Dayton, Ohio, have had such difficulty obtaining the seizure drug benzodiazepine the last few years that they’ve realized their best option is to “step on the gas and get to the hospital as quick as possible,” says David Gerstner, who helps coordinate emergency medical services for the area. (more…)

Scientists Detect Early Sign of Pancreatic Cancer

Researchers say they’ve identified a sign of early development of pancreatic cancer, a leading cause of cancer death. And, they add, their discovery might lead one day to a new test to detect the disease in its initial and more treatable stages.

The early sign is an increase in levels of certain amino acids, and this occurs before patients develop symptoms and the disease is typically diagnosed.

The finding came from analyses of blood samples from 1,500 people taking part in large health-tracking studies. (more…)

Phase III Trial Data Suggest Potential New Treatment Strategies for Prostate Cancer

In the last few years we witnessed the approval of several new agents for metastatic prostate cancer that have resulted in improved overall survival (OS)

Currently, androgen deprivation therapy (ADT) remains a central part of treatment for patients with high-risk non-metastatic and also metastatic prostate cancer. Despite the generally good response of metastatic disease to this approach, many men will eventually develop castration-resistant prostate cancer (CRPC), for which prognosis is still poor. Data from randomised phase III trials presented at yesterday’s Proffered Paper Session on GU, Prostate, have shown a significant OS benefit in patients with ‘high-volume’ metastatic prostate cancer receiving combined antiandrogen and docetaxel as first-line treatment and have suggested a benefit of adding local radiotherapy to androgen deprivation in newly diagnosed high-risk non-metastatic (M0) prostate cancer. (more…)

In War on Cancer, Patients At Risk of Becoming Commoditized

Over the past 40 years, the global medical community has made significant strides in the war against cancer. More Americans with cancer face longer life expectancies as a result of increased awareness among at-risk populations, better preventative care, early screenings, and new therapies. Furthermore, when patients have access to quality cancer care the odds of survival are significantly increased. According to a report released recently by the American Association of Cancer Research, today Americans have more chances of survival and better quality of life after a cancer diagnosis than ever before.  (more…)

Report Confirms Obamacare Restricts Access to Life-Saving Medical Care

by Jennifer Popik, JD

A Congressional Budget Office (CBO) report now documents that Obamacare exchange plans, while often cheaper, are restricting access to life-saving medical care.

According to the CBO’s recently released “Updated Estimates of the Effects of the Insurance Coverage Provisions of the Affordable Care Act, April 2014,” Obamacare’s insurance provisions will cost $104 billion less than projected over the next decade. However, these savings will come at tremendous cost. The CBO goes on to describe the reality — that while there are savings on insurance premiums, there is solid and growing evidence that these plans restrict access to life-saving medical treatment for ourselves, our family members, and our loved ones.

CBO writes,

elderlypatnt5“The plans being offered through exchanges in 2014 appear to have, in general, lower payment rates for providers, narrower networks of providers, and tighter management of their subscribers’ use of health care than employment-based plans do. Those features allow insurers that offer plans through the exchanges to charge lower premiums (although they also make plans somewhat less attractive to potential enrollees). As projected enrollment in exchange plans grows from an average of 6 million in 2014 to 24 million in 2016, CBO and JCT [Joint Committee on Taxation] anticipate that many plans will not be able to sustain provider payment rates that are as low or networks that are as narrow as they appear to be in 2014.”

Last year, when hundreds of thousands of Americans lost plans they liked, the administration claimed that “the new exchange plans would be better than your old plan.” This could not be father from the truth for tens of thousands.

As millions of Americans are attempting to start using their new Obamacare exchange health insurance plans, stories about denial of payment keep piling up. You can read more on this The newly issued CBO report confirms, that exchange plans are restrictive. What’s worse, this is by design.

Rarely reported in the mainstream media is an Obamacare provision under which exchange bureaucrats must exclude health insurers who offer policies deemed to allow “excessive or unjustified” health care spending by their policyholders.

Under the Federal health law, state insurance commissioners are to recommend to their state exchanges the exclusion of “particular health insurance issuers … based on a pattern or practice of excessive or unjustified premium increases.” The exchanges not only exclude policies in an exchange when government authorities do not agree with their premiums, but the exchanges must even exclude insurers whose plans outside the exchange offer consumers the ability to reduce the danger of treatment denial by paying what those government authorities consider an “excessive or unjustified” amount.

This means that insurers who hope to be able to gain customers within the exchanges have a strong disincentive to offer any adequately funded plans that do not drastically limit access to care. So even if you contact insurers directly, outside the exchange, you are likely to find it hard or impossible to find an adequate individual plan. (See documentation

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When the government limits what can be charged for health insurance, it restricts what people are allowed to pay for medical treatment. While everyone would prefer to pay less–or nothing–for health care (or anything else), government price controls prevent access to lifesaving medical treatment that costs more to supply than the prices set by the government.

While Obamacare continues to roll out in 2014, it is important to continue to educate friends and neighbors about the dangers the law poses in restricting what Americans can spend to save their own lives and the lives of their families. You can follow up-to-date reports

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GAO: Drug Shortages Loom As Health Threat

February 11, 2014, 10:34 am

By Jonathan Easley

The Government Accountability Office (GAO) on Monday reported a public health threat from drug shortages that might force providers to “ration care or rely on less effective drugs.”

The three-fold spike in drug shortages since 2007 reportedly relates primarily to “generic-style injectable drugs.”

“The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption,” the report said. “Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity.”

These quality control problems are unique to generic injectables industry, the GAO said, because the manufacturing companies often have low profit margins and limited infrastructure investments that frequently force them from the market.

In 2007, the GAO uncovered 154 drug shortages. That number went up to 456 in 2012, although the bulk of those began in prior years. The number of new shortages fell from 255 in 2011 to 195 in 2012.

The GAO said the Food and Drug Administration has prevented more shortages by improving its responsiveness and “developing procedures to enhance coordination between headquarters and field staff.”

“However, there are shortcomings in its management of drug shortage data that are inconsistent with internal control standards,” the report said. “For example, FDA has not created policies or procedures governing the management of the data and does not perform routine quality checks on its data.”

“Such shortcomings could ultimately hinder FDA’s efforts to understand the causes of specific shortages as well as undermine its efforts to prevent them from occurring,” the report continued. “In addition, FDA has not conducted routine analyses of the data to proactively identify and evaluate the risks of drug shortages.”

The GAO recommended the FDA “strengthen its internal controls over its drug shortage data and conduct periodic analyses to routinely and systematically assess drug shortage information, using this information to proactively identify drug shortage risk factors.”

The GAO said the Health and Human Services Department agreed with its recommendations.

Read more:
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COA’s Director of Practice Initiatives, Bo Gamble talks about Medical Homes

Mr. Robert “Bo” Gamble, Director, Strategic Practice Initiatives, Community Oncology Alliance in Washington, DC, addresses how the ACO model isn’t a good fit for cancer care because of unpredictability and the high cost of oncology medications.

Mr. Gamble also discusses the standards set by the NCQA and why he thinks they are on target with coordination, outreach, and patient satisfaction, but that the value component is missing for cancer care.


Health and Human Services Announcement

News Release

July 22, 2011

Contact: HHS Press Office
(202) 690-6343

HHS announces proposal to improve rules protecting human research subjects

Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight

The U.S. Department of Health and Human Services announced today that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.

“The adoption of the Common Rule two decades ago was a landmark event to ensure ethical practices and the safety of those individuals who participate in research,” said Howard K. Koh, MD, MPH, HHS assistant secretary for Health. “This regulatory review effort is primarily about enhancing protections for human subjects. The changes under consideration offer the promise of updating and enhancing those protections to keep pace with current challenges.”

The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects.

Revisions to the current regulations are now being considered because HHS believes these changes will strengthen protections for research subjects in a number of important ways.

Comment is sought on the following:

  1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
  2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  3. Updating the forms and processes used for informed consent.
  4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
  6. Extending federal regulatory protections to apply to all research conducted atU.S.institutions receiving funding from the Common Rule agencies.
  7. Providing uniform guidance on federal regulations.

The public’s input on these matters will be critically important to the government’s efforts to ensure that regulations keep up with today’s changing research environment, and will be considered by HHS as it develops new proposed rules, which will also be made public for comment.

To view the ANPRM, please visit, enter ID number: HHS-OPHS-2011-005 in the “Enter Keyword or ID” field, and click on “Search.”

To submit a comment, visit, enter the above ID number, and click on “Submit a Comment.”

For additional information about the changes under consideration, visit