Cindy Robinson

Fight Colorectal Cancer advocate Cindy Robinson of Virginia has successfully petitioned her governor, Bob McDonnell, to proclaim March as Colorectal Cancer Awareness Month. This is the second consecutive year that Virginia has issued such a proclamation as a result of Ms. Robinson’s activism.

Since President Clinton issued the first Presidential Proclamation recognizing March as Colorectal Cancer Awareness Month over a decade ago, each year advocates request that their state and city officials issue proclamations acknowledging March as Colorectal Cancer Awareness Month. 

Ms. Robinson followed the easy steps laid out in Fight Colorectal Cancer’s Proclamations 101 advocacy call to action and sent the request via email according to Virginia’s guidelines. She also contacted her local state senator, Jill Holtzman Vogel, to put in a good word with the governor’s office.

We thank Virginia Govenor Bob McDonnell, Senator Jill Vogel and advocate Cindy Robinson for recognizing the need to raise awareness about colorectal cancer and taking the first steps needed to accomplish that task.

Get your Governor to declare Colorectal Cancer Awareness Month in your state. Visit our Proclamations 101 page for easy instructions.

Pat Steer

We are glad to welcome advocate Pat Steer to the Fight Colorectal Cancer Research and Treatment News.  She’s been living with stage IV rectal cancer since 2004.  A writer, she’s blogs about her life with cancer, training her beloved dogs, and her passion for good food at Life Out Loud.

Since my cancer diagnosis in 2004, my life has been full of choice and decisions. Cancer forces you to prioritize. Some days, it has seemed like cancer and treatment were calling all the shots in my schedule, changing my plans, and forcing decisions I didn’t want to have to make.

But I’ve made a few choices in the last eight years where I didn’t let cancer force my hand. I train and show dogs, and that’s very important to me. Early on, I decided to make attending my favorite dog shows a priority. I kept up my now-25-year tradition of camping with friends at a local show circuit. I entered a special event dog show held on New Year’s weekend, 2005 – three shows in 48 hours that wore me out, but was so worth the effort.  I covered Westminster in 2008 through 2010 for my column.

All of those decisions meant that sometimes I prioritized dog shows in spite of my treatment schedule. My oncologist, who once told me “I want you to live your life,” carefully moved my treatments around to accommodate the things I really wanted to do. After all, what good is surviving cancer if you can’t do the things you love?

At the same time, sometimes dogs shows and cancer just couldn’t fit together into the same time period. I’ve missed the chance to go to the national English Cocker Spaniel specialty twice now – once, because I was having liver resection and then again in 2011 due to intense treatment for a recurrence. Yes, I can prioritize, but cancer emergencies sure can mess up dog show plans.

There’s one other activity that I’ve made a choice to participate in each year: Fight Colorectal Cancer’s Call-On Congress.

Sometimes I’ve been on treatment or recovering from surgery. That meant I had to participate from afar by calling my congressmen and senators and visiting their local offices. But in 2010, I was able to attend Call-On Congress in person. I promised myself after that experience that as long as I was healthy enough to participate in person, I’d make attending Call-On Congress my first priority every year. And I’ve kept that promise to myself, that choice to make a difference, even when it meant giving up another trip, even if it meant skipping a dog show.

Why is making a trip to D.C. to meet with congresspeople and senators such a big deal?

Three reasons:

1. I gain great energy from meeting other survivors
2. I get a chance to stand close to the electricity of government in action.
3. Call-On Congress made me realize the power of the personal touch.

Every survivor has the opportunity to put an unforgettable face on colorectal cancer. In person, we can take this disease out of the dark, make it more understood, make it real in a way that emails and phone calls can’t duplicate. Our faces and our presence at Call-On Congress turns colorectal cancer into a living, breathing issue to the men and women who decide where the money goes in the Federal budget.

I want my congresspeople and senators, and those legislators I meet in the halls of the Congressional office buildings, to remember my face when they’re voting on funding for colorectal cancer screening programs and research. I want them to look at those line items in the budgets, and see the short woman in glasses who wore a FightCRC t-shirt under her business blazer, who smiled and directly explained why their support was so valued and so needed. I want to put a face on that number.

And the only way to put a face on colorectal cancer is to do it in person.

The deadline to register for Call-On Congress is this Sunday, February 5, 2012. Will you join me and the advocates from the other 50 states in putting a face on colorectal cancer? Will you choose to make a difference in 2012?

I congratulate the Fight Colorectal Cancer volunteers who took action this year to protect colorectal cancer research and prevention funding. We should be proud of our achievements, but we cannot become complacent. We must prepare for the Fiscal Year 2013 budget battle that lies ahead. Please register to attend Fight Colorectal Cancer’s Call-on Congress next March – where advocates from around the country will be urging their legislators to continue to protect colorectal cancer research funding.

The following are the spending outcomes on Fight Colorectal Cancer’s three appropriations priorities:

• The Colorectal Cancer Control Program (CRCCP)
• The National Cancer Institute (NCI) and
• The Peer Reviewed Cancer Research Program (PRCRP)

Note: The funding levels described below for the CRCCP and NCI do not reflect a 0.189 percent across-the-board cut that will be applied to all discretionary programs under the Departments of Labor, Health and Human Services (HHS), Education, with the exception of the Pell Grant Program.

Colorectal Cancer Control Program
Despite threats of deep spending cuts, the Centers for Disease Control and Prevention (CDC) received a slight increase, which allowed funding for the CRCCP to be preserved at its current level of $43.07 million. The CRCCP currently funds colorectal cancer programs in 25 states and four tribal organizations. Funded sites can use up to one-third of funds to provide no-cost screening services to eligible low-income men and women age 50-64. The remaining two-thirds of funds are for colorectal cancer education and outreach strategies. Maintaining CRCCP funding allows education and screening programs currently underway to continue. If funding for CRCCP was increased, education and screening programs could be expanded to more states.

National Institutes of Health

For FY2012, the NIH will receive a $299 million increase in its budget, with the various Institutes and Centers receiving
proportional increases, resulting in $5.082 billion for the NCI. The outcome reflects compromise between the $1 billion increase for the NIH in the House Labor-HHS -Education spending bill and the $190 million cut in the Senate bill. In addition to $30.698 billion for the NIH, the bill also includes $10 million for the Cures Acceleration Network (CAN), which was established under the Patient Protection and Affordable Care Act. The purpose of CAN is to accelerate the testing of high-need cures – drugs, biologics and devices – that are not attractive for development within the commercial market.

Peer Reviewed Cancer Research Program
Another important victory for the colorectal cancer community was the inclusion of $12.8 million for the Department of Defense’s (DoD) PRCRP. Comparatively, the PRCRP received $16 million for FY2011. While the program’s budget was decreased, some in Congress have called for the elimination of non-defense spending, including funding for medical research, from the DoD spending bill. The PRCRP funds research on several forms of cancer, including colorectal cancer.

On November 29, the Centers for Medicare and Medicaid Services announced that there was enough evidence that intensive behavioral counseling was reasonable and necessary to prevent disease or disability and that Medicare beneficiaries were entitled to coverage as a preventive service.

This is particularly good news for people trying to prevent colon or rectal cancer since studies have consistently found a link between body mass index (fatness) and colorectal cancer, including the World  Cancer Research Foundation which included BMI and colorectal cancer in their 2007 comprehensive analysis reported in  Food, Nutrition, Physical Activity and the Prevention of Cancer.

This year the WCRF updated their analysis for colorectal cancer looking at new studies published since 2007 as part of the Continuous Update Project.  They wrote,

The CUP Panel agreed that the recent evidence was consistent with the conclusion of the Second Expert Report; the evidence that greater body fatness is a cause of colorectal cancer is convincing.

With the latest CMS coverage decision, Medicare patients with a BMI of 30 or over  can get:

• One face-to-face visit every week for the first month
• One face-to-face visit every other week for months 2-6
• One face-to-face visit every month for months 7-12, if the individual has lost at least 6.6 pounds.

The benefit is limited to counseling delivered in primary care settings by primary care doctors or primary care nurse practitioners, clinical nurse specialists, or physician assistants.

Benefits are also provided for screening to determine BMI and nutritional assessment.

CMS defines intensive behavioral counseling as providing the 5-As:

• Assess: Ask about/assess behavioral health risk(s) and factors affecting choice of behavior change goals/methods.
• Advise: Give clear, specific, and personalized behavior change advice, including information about personal health harms and benefits.
• Agree: Collaboratively select appropriate treatment goals and methods based on the patient’s interest in and willingness to change the behavior.
• Assist: Using behavior change techniques (self-help and/or counseling), aid the patient in achieving agreed-upon goals by acquiring the skills, confidence, and social/environmental supports for behavior change, supplemented with adjunctive medical treatments when appropriate.
• Arrange: Schedule follow-up contacts (in person or by telephone) to provide ongoing assistance/support and to adjust the treatment plan as needed, including referral to more intensive or specialized treatment.

CMS estimates that 1 in 3 people receiving Medicare are obese.

Patrick Conway, MD, MSc, CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards and Quality said,

This decision is an important step in aligning Medicare’s portfolio of preventive services with evidence and addressing risk factors for disease. We at CMS are carefully and systematically reviewing the best available medical evidence to identify those preventive services that can keep Medicare beneficiaries as healthy as possible for as long as possible.

Body Mass Index (BMI) is calculated using weight and height. It doesn’t measure “fatness” directly but correlates well to overall amount of body fat. You can use this CDC calculator to find out your own BMI.

President Barack Obama signed an Executive Order yesterday addressing the drug shortage issue.

As we have reported extensively on www.FightColorectalCancer.org, the current drug shortages have impacted colorectal cancer patients who have been unable to get 5-FU, leucovorin or on occasion, irinotecan.

The Executive Order does not change the law, and it will not help patients who cannot get their drugs today, but it does reinforce the powers of the Food and Drug Administration to take steps that would ease the burden by:

• Broader reporting of when a manufacturer has stopped producing a drug that could lead to a shortage.
• Increased effort to review drug suppliers and manufacturing sites and changes. It also directs the FDA to prioritize its resources according to the burden of the shortage to the public health.
• Collaboration with the Department of Justice to address drug stockpiling and price gouging.

On hand at the signing of the Executive Order was colorectal cancer patient Jay Cuetara, who has spoken out publicly about his experience with the 5-FU shortage. Jay is featured on the White House website talking about how this issue impacts cancer patients.

For more information:

• FDA – Current Drug Shortages
• American Society of Health-Systems Pharmacists (ASHP) – Current list of drugs in short supply
• Ask your Members of Congress to support legislation that will further address this issue
• Fight Colorectal Cancer’s drug shortage FAQ

Watch a video of the entire presentation, including questions.

Download the webinar slides.

The webinar, led by Captain Valerie Jensen, R.Ph., Associate Director for the FDA’s Drug Shortage Program, discusses how the FDA responds to drug shortages and what they are doing to try to prevent shortages of medically necessary drugs.

According to Capt. Jensen, key to preventing drug shortages is manufacturers letting FDA know early when a shortage is expected.  So far in 2011, 99 shortages have been prevented by early notification.

What the FDA Can Do

With voluntary early notification, the FDA can work with manufacturers to:

• Use FDA regulatory flexibility to allow shipping of drugs that have problems that don’t affect patient safety such as misprinted labels or packaging errors.
• Allow shipping of drugs with special warnings or filters.  For instance, a drug may be safely used with a filter for particulates or crystals can be dissolved if the medication is heated.
• Speed up approvals of alternate manufacturing sites or encourage other manufacturers to ramp up production.
• Approve importation of drugs if the foreign manufacturing site meets FDA requirements for Good Manufacturing Practices.
• Approve new sources of acceptable raw materials — as they did after the Japan earthquake.

What the FDA Can NOT Do

• FDA has no authority to require manufacturers to make any drug.
• FDA can’t tell manufacturers what quantity of a drug to make or release.
• FDA can’t set prices or interfere in pricing.

Currently, only manufacturers who are the single source of a medically necessary drug are required by law to inform FDA of their intention to stop making it.  There is no penalty for not doing so.

While Capt. Jensen cannot comment on proposed legislation, she emphasized the importance of early notification of potential shortages.

A specific question from a listener to Capt. Jensen about 5-FU led to a hopeful answer. She replied that two companies are continuing to produce 5-FU and that the shortage probably is resolving based on what those companies are telling FDA.

For lists of drugs that are currently in shortage and information about when those shortages may be resolved:

• FDA Drug Shortages
• American Society of Health-Systems Pharmacists (ASHP)

To take an critically necesssary first step toward preventing future shortages, ask your Members of Congress to support the Preserving Access to Lifesaving Medications Act (H.R. 2245/Sen 296).

Problems lie mostly in older generic versions of sterile injectable drugs, which are low-priced and

• complicated to manufacture
• made by a only a few companies
• manufactured in aging plants where quality is hard to maintain.

Dr. Howard Koh, Assistant Secretary of Health in the Department of Health and Human Services, told the House Energy and Commerce Subcommittee on Health that the number of drugs in shortage  had grown from 61 in 2005 to 178 in 2010 and is even larger in 2011.  Over 90 percent of drugs in shortage are medically necessary — drugs that are used to prevent or treat a serious disease for which there is no alternative.  Some are made by only one company.

According to Dr. Koh, cancer drugs made up about a third of the shortage (28%), followed by antibiotics at 13%.

In 2010 and 2011, Dr. Koh said that

• More than half of shortages (about 54 percent) were due to quality problems including drugs contaminated with tiny particles, inpurities, bacteria, or crystals.
• About 21 percent happened when there were production delays at manufacturing facilities or plants lacked the capacity to meet demand.
• Another 11 percent were caused when manufacturers stopped production, usually for business reasons.
• Problems getting raw materials, lack of components, and loss of a manufacturing site also were at the bottom of some shortages — but fewer than 10 percent.
• Finally, an increase in demand due to another manufacturer’s difficulties let the shortage spread.

Several subcommittee members asked why rules of supply and demand didn’t solve the problem, leading to higher prices and increased production to meet demand. Koh explained that the vast majority of drug prices are set in contracts and cannot respond to short-term shortages.  In addition, pharmacy benefit managers and other drug purchasers are buying in such large quantities that they put pressure on prices.  Finally, when shortages occur, manufacturers may not have necessary capital to expand production.

While it might seem a simple solution to allow importation of drugs that are in shortage, the FDA needs to be sure that imported drugs are safe and effective and manufactured in a facility that meets FDA standards.  Koh reported that the FDA has done this for a number of critical drugs in shortage including Xeloda, leucovorin and levoleucovorin.

Although FDA currently has no authority to require manufacturers to notify them if they anticipate problems in manufacturing a drug or stopping making it, voluntary reporting enabled the FDA, in collaboration with manufacturers, to avert 38 shortages in 2010 and 99 shortages this year.  Strategies available to FDA include:

• Approving importation of drugs from FDA-approved foreign sources as they did with TEVA for leucovorin.
• Speeding the process of approving another manufacturer for the drug from an average of two years or more to three or four months.
• Expediting the review and reopening of a manufacturing plant or production line closed because it didn’t meet FDA Good Manufacturing Practices inspection.

All of these require that FDA get as early notification of potential disruptions as possible.  To that end, Rep. Diana L. DeGette (D-Colo.) reminded the subcommittee that the Preserving Access to Life-Saving Medications Act (H.R. 2245) would require manufacturers to notify the FDA if they are planning to discontinue a drug at least six months in advance.  For other potential disruptions in manufacturing, the FDA must be notified as soon as the problem is known.  There are penalties for not complying.

In addition, the legislation sponsored in the House by DeGette and Thomas J. Rooney (R-Fla.) would require the FDA to publish information relating to manufacturing problems and drugs in actual shortage on its website.  A companion bill in the Senate (S. 296) has been introduced by Senator Amy Amy Klobuchar (D-MN) and Robert Casey (D-PA).

The gray market that offers drugs in shortage to desperate pharmacists and health care facilities was condemned by several witnesses and subcommittee members.  With markups that average 650 percent and go as high as 4500 percent, gray marketeers usually can’t tell pharmacist buyers where the drug came from, whether it has been safely stored, or whether it is counterfeit.

Among solutions to the crisis offered during the hearing were:

• An early warning system for potential shortages with teeth — such as that offered by the DeGette-Rooney legislation.
• Generic drug manufacturer user fees to strengthen FDA resources to manage drug supply.
• An increase in FDA resources directed at drug supply and drug shortages.
• Incentives for manufacturers to enter the market for generic sterile injectable drugs or to update manufacturing facilities.
• Improved funding for the FDA and its resources.
• Better communication between FDA field inspectors and drug shortage programs so that potential manufacturing shut-downs due to lack of Good Manufacturing Practices can be known early.
• Most of all, good collaboration and communication among manufacturers, the FDA, pharmaceutical distributors, pharmacists and healthcare facilities that buy drugs in shortage, and the doctors and nurses who prescribe and administer them.

Rep. Frank Pallone, Jr. (D-NJ) asked that a statement from Fight Colorectal Cancer be entered in the record.

Want to Help

As Rep. DeGette said, the Preserving Access to Life-Saving Drugs isn’t the whole answer to the drug shortage, but it is a necessary first step.

You can help take that step by asking your Senators and Representatives to support H.R. 2245 and S. 296.

In November, Fight Colorectal Cancer is sponsoring a webinar to help you learn what to do when your doctor is out of a drug that you need.

• What to Do When Your Doc is Out of 5-FU (or Leucovorin…or Irinotecan)
• November 16, 2011
• 8:00 to 9:30 p.m. EST

Sign up here.

Fight Colorectal Cancer is watching the House Energy and Commerce Subcommittee on Health hearing Examining the Increase in Drug Shortages.

The hearing began at 9:30 this morning, September 23, 2011, and will continue after a recess.

You can watch it with us on UStream Live.

Testimony already from Howard K. Koh, Assistant Secretary for Health, Department of Health and Human Services, who was accompanied by Dr. Sandra L. Kweder from the FDA.  Both answered questions from Subcommittee Members.

Enroll America is a new nonpartisan, nonprofit organization whose mission is to ensure that all Americans are enrolled in and retain health coverage. It will work at the state and federal levels to push for streamlined enrollment procedures and will also raise awareness of enrollment options among the uninsured.

If you are uninsured, learn about your options at the Enroll America website.

Representative Charlie Dent

Pennsylvania congressman Charlie Dent has introduced a bill that would direct the U.S. Postal Service to sell a semipostal stamp to raise money for federally funded colorectal cancer research and prevention programs. Semipostal stamps are regular postage stamps that are sold at a surcharge over their postage value. The additional charge is a voluntary contribution by the purchaser to a designated cause.

Under the “Fight Colorectal Cancer Stamp Act” (H.R. 893), funds raised from a semipostal colorectal cancer stamp would be used for colorectal cancer programs at the Department of Defense Peer Reviewed Medical Research Program, the Centers for Disease Control and Prevention and the National Institutes of Health.

Rep. Dent is working to identify a path for passage of the bill and Fight Colorectal Cancer is attempting to identify a champion for companion legislation in the Senate.  Passage of H.R. 893 will not be easy; therefore, Rep. Dent needs our help.

H.R. 893 was introduced in March 2011 and, to date, has only eight cosponsors. If Rep. Dent is to convince House leaders to advance H.R. 893, he must be able to show strong support for the bill among his House colleagues.

Please take a moment today to contact your representative and ask him or her to cosponsor H.R. 893.

Passage of H.R. 893 may be one of our best opportunities to maintain, and perhaps even increase, funding for colorectal cancer programs in the foreseeable future. However, without more cosponsors, the bill’s prospects are not good. You can help change that. 

Take a moment today to make your voice heard.