Will 21st Century Cures Act Cure Cancer?

TAMPA, FL / ACCESSWIRE / December 14, 2016 / President Obama has signed the 21st Century Cures Act (the “Cures Act”) after almost three years of study and debate. This bipartisan legislation is the most substantive bill passed by Congress this year and has the potential to have a significant impact on healthcare. In part, the focus of the bill is to cure cancer by providing $1.8 billion of funding for the current administration’s Cancer Moonshot initiative (Title IV of the Cures Act is named after VP Biden’s son who recently died from cancer). The funding is allocated to the National Institute of Health (“NIH”) over a ten year period. Perhaps more important than this funding are provisions in the Cures Act that should make it easier and quicker for new cancer cures to receive approval from the FDA.

Cancer Cures Now, Inc. is a not-for-profit corporation that has studied emerging cancer technologies extensively. The purpose of this post is to address three (3) issues of cancer and how the Cures Act can address these issues to possibly help save millions of lives and truly make a difference.

(1) Cancer: Widespread and Deadly

Cancer is once normal cells that have mutated for various reasons. The mutations allow the cancer cells to grow and spread uncontrollably. The uncontrolled growth can cause masses (tumors) that are harmful, if not deadly. It takes an estimated 5-7 mutations for a cell to become a “cancer cell”; this could take years, so most cancer is found in older people. Also, as people age their thymus reduces output of immune system cells that could have potentially killed the cancer cells. Therefore, with longer and longer life spans the incidence of cancer increases. With the aging of the baby boomer generation, cancer in the U.S. will increase by 45% by the year 2030 from 1.6 million new cases per year to 2.3 million cases becoming the #1 cause of death approaching 1 million per year. Worldwide, the number of new cancer cases is expected to rise to 22 million by the year 2032 (60,000 per day).

Without a cure cancer will become the leading cause of death in the U.S.

(2) Cancer Treatment: Now and the Future

Currently, cancer is treated by surgery, chemotherapy and radiation therapy (“cut, poison and burn”). The collateral damage of these treatments is well documented. More damming is a report by the New England Journal of Medicine that when cancer treated by chemotherapy reoccurs, it will be chemo resistant due to the insidious nature of its mutating ability. This year it is projected that 600,000 people in the U.S. will die from cancer and worldwide over 8 million will die. As cancer incidence increases so will deaths unless more effective and safer treatments are developed. This was the mission of the 21st Century Cures Act which in large part focuses on the future of cancer treatments which are immune system based-treatments (“immunotherapy”).

The Cures Act recognizes that immunotherapy is the future of cancer treatment

(3) Healthcare Costs: Escalating With No End In Sight

U.S. Healthcare Spending 1960 vs 2014 (000,000’s)

Source: Center for Medicare and Medicaid Studies

President Kennedy’s shot to the moon program inspired the current administration’s cancer moonshot program. The U.S. put a man on the moon over 50 years ago. Since then, healthcare spending in the United States has exploded. Over the past 50 years, healthcare spending has increased from $23 billion to almost $2.6 trillion, an increase of over $2.5 trillion (11,000%). During this time period, the annual cost of healthcare per person has increased from $130 to $8,000. Most of this increase (88%) is not due to inflation but to excess utilization of expensive new drugs and treatments.

U.S. and state government healthcare
expenditures

The table above reflects not only an increase in healthcare spending, but also a shift in who pays these expenses. Fifty years ago, Medicare, Medicaid and CHIP did not exist. In 1960, almost 100% of spending on drugs were paid by consumers, but by 2014, it was only 15%. Government agencies now pay for over 40% of U.S. healthcare costs. This will increase dramatically as a large percentage of the U.S. population becomes eligible for Medicare.

Government will bear the majority of escalating cancer cares costs

Experts agree that many of the new cancer treatments that are expected will be in the immunotherapy area. Billions of dollars are being invested in research, clinical trials and technology acquisitions. A recent study estimated that the immunotherapy market will reach $73.5 billion dollars by the year 2020. The largest companies in this market to date are Novartis, Roche, Merck, GlaxoSmithKline and Amgen, together having estimated liquid assets of over $70 billion as of September 30, 2016. Needless to say with relaxation of drug approval provided by the Cures Act, their money and others will flood into this market.

NIH and private enterprise are targeting new immunotherapy technologies

The issue we have with most of these new technologies is that they come with price tags of as high as $500,000. Further, they have side effects that will require costly treatment. At least for the foreseeable future, it is expected that these costs will be added to the costs of current cut, poison and burn treatments. So “do the math”; if all expected new cancer cases (2 million) received an added $500,000 treatment an additional $1 trillion would be incurred (mostly by government agencies).

To make the Cures Act truly effective, NIH and industry need to use the opportunity provided by the Cures Act to find solutions that kill cancer, without side effects and cost effectively. In addition, the solution should address the “moving target issue” caused by constant mutation of cancer cells.

Our extensive research so far has revealed that most cancer science is not on track to accomplish all of these objectives. So far, the technology that comes closest to this is being developed by cancer vaccine leaders Morphogenesis (a Cancer Moonshot Summit co-host). This biotech company is developing an off-the-shelf immunotherapy that can be mass-produced cost effectively, does not have side effects and uniquely addresses the moving target mutation issue. The vaccine also provides residual therapeutic benefits. This should be the model others follow.

New cancer therapies need to be safe, show efficacy and be cost-effective

As billions of taxpayer and commercial monies move into the immunotherapy area, we hope that the players focus up-front, at the concept stage, on providing safety, efficacy and cost-effectiveness. We hope the legacy of the Cures Act is not to cause NIH funding and relaxed FDA rules to create “wonky” expensive treatments that have serious side effects. The NIH will have 180 days to present how they plan to spend the $300 million they will receive over the next fiscal year. During this time 300,000 Americans will die from cancer. We hope this and other monies will be spent wisely as millions of lives are at stake; we need Cancer Cures Now!

Cancer Cures Now, Inc.
A not-for-profit corporation

SOURCE: Cancer Cures Now, Inc.

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