The Federal Drug Administration (FDA) has issued an alert that a counterfeit batch of bevacizumab  (labeled Altuzan and having no active ingredient) has been found in the U.S. The counterfeit version with a Roche Altuzan label was distributed by a U.S. company Medical Device King (also known as Pharmalogical).

Even if it was not counterfeit, Altuzan is not FDA-approved for U.S. distribution. The only FDA-approved version of bevacizumab for U.S. sale is Avastin, marketed by Genentech.

Medical practices that have obtained any medical products from Medical Device King, Pharmalogical, or Taranis Medical should stop using the products and contact FDA’s Office of Criminal Investigations to arrange collection. The FDA has repeatedly urged medical practices not to obtain drugs from non-verified (and often unlicensed) sources.

One year ago,  a similar counterfeit version of bevacizumab with a Roche label was given to cancer patients by at least 19 U.S. medical practices.

The problem of counterfeit drugs is not new: Last January 2012, the FDA warned healthcare providers not to buy injectable cancer medications from “direct-to-clinic” promotions or non-verified sources:

“Health care providers are reminded to obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the United States.”

In fact, counterfeit drugs have long been a global problem. A Feb 2012 editorial in The Lancet  noted that while fake drugs have long been a serious problem in Africa and Asia,

 “Counterfeiting has become more and more prevalent in developed countries as drug supply chains increasingly cross continents.”

Last summer (August 2012) Fight Colorectal Cancer joined with five other cancer organizations urging Congress to adopt proposed legislation to tighten security by creating a national pharmaceutical distribution standard including:

• Placing serial numbers on each package, or unit, of medicine;
• Implementing a system that tracks medicine at this unit level as they move from the manufacturers to the patient; and
• Phased-in regulations to ensure that pharmacies and clinics are using the new “track and trace” system to protect patients.

Carlea Bauman, president of Fight Colorectal Cancer, said today, “We continue working closely with both the FDA and Congress to get a more secure national distribution system because counterfeit drugs may endanger cancer patients’ lives.”

More information about current counterfeit drug

The FDA bulletin contains batch numbers involved, tips for spotting counterfeit drug labels, and contact numbers for reporting or getting more information on this or any drug or device.

Sources: Feb. 5 2013 FDA Health Care Provider Alert ; Feb. 25 2012 Lancet; Fight Colorectal Cancer updates on Feb 15 2012, Feb. 24 2012, Aug. 15 2012.

Disclosure: Fight Colorectal Cancer has accepted funding for projects and educational programs from Genentech, maker of Avastin, in the form of unrestricted educational grants. Fight Colorectal Cancer has ultimate authority over website content.

Cancer now kills more people in the world, and in lower- and middle-income nations, than the combined total of AIDS, tuberculosis and malaria.

Lung, stomach, colorectal and breast cancer are the most common cancer killers worldwide.

World Cancer Day is recognized on February 4^th, a good time for us to pause and realize that cancer—including colorectal cancer–is not just a disease of rich and privileged nations. It affects our neighbors across the world, and yes, we can do something about it.

Some startling facts:

• About 47% of cancer cases and 55% of cancer deaths occur in less developed regions of the world.
• By 2030, 60-70% of the estimated 21.4 million new cancer cases per year are expected to occur in developing countries.

The Union for International Cancer Control (UICC) and the International Agency for Research on Cancer (IARC) today announced that 1.5 million lives could be saved every year if decisive measures are taken:

•  Investing in cancer prevention and early detection of cancer is cheaper than dealing with the consequences. The worldwide cost of cancer will reach about $458 billion (USD) per year in 2030, yet it would cost only $2 billion per year to implement  strategies known to significantly decrease cancer (i.e., efforts to change tobacco use, alcohol abuse, unhealthy diet and physical inactivity).
• Even basic pain relief is unavailable to millions. Fully 90% of opiod painkillers (e.g., morphine) are used by just five regions (the U.S., western Europe, Canada, Australia and New Zealand) with less than 10% used by 80% of the world population, the UICC said. In fact, it’s illegal to import narcotic painkillers to 25 nations—including many in Africa.

Let’s activate our Fight Colorectal Cancer community and all our friends. Get more facts and some simple ways to fight myths and spread the word .

Sources: http://www.worldcancerday.org/, and Feb 4. USA Today

A new virus causing diarrhea and vomiting has spread rapidly nationwide, causing an increasing number of outbreaks of what many call the “stomach flu,” according to a Jan. 24 2013 report issued by the CDC (Centers for Disease Control).

The new norovirus strain (named GII.4 Sydney) is highly contagious, and seems to cause more hospitalizations than other gastrointestinal viruses. It hits suddenly with diarrhea, abdominal pain, vomiting, fever, chills, and headache. Most people get better in one or two days, after the stomach or intestinal inflammation eases, but they are still contagious for 3 more days..

Dehydration is Danger

Even healthy people can get dehydrated with this illness if you don’t drink enough liquids to replace the fluids lost from throwing up or having diarrhea many times a day. Special rehydration drinks (such as Gatorade) are best, because they contain nutrients and minerals lost in diarrhea or vomiting.

Norovirus infection can quickly become serious  in young children, the elderly, and people with other health conditions if they become seriously dehydrated. Symptoms include urinating less often,  a dry mouth and throat, and feeling dizzy when standing up—which, for elderly or weakened individuals, greatly increases the chance of a fall during a rush to the bathroom.

Highly contagious

People ill with a norovirus are contagious from the moment they begin feeling sick until at least 3 days after they recover. Some people may be contagious for even longer. So even if you feel better, remember that you can still be infecting others. This is a hardy virus which can survive in food and especially on surfaces for quite awhile–such as bathroom appliances, door handles, bedding, and even on pets.

The CDC recommends that when norovirus hits a household:

(1)    Handwashing is the first defense, scrubbing with soap and water or alcohol-based cleanser before and after cooking and eating, using the bathroom, coming in contact with anyone who is ill, touching your pet, and especially before and after treating a cut or wound or caring for your catheter, port, or ostomy.

(2)    If you are ill, do not prepare food for yourself or others while you have symptoms and then for 3 more days;

(3)    Clean and disinfect contaminated surfaces. After throwing up or having diarrhea, contaminated surfaces should be immediately cleaned with a bleach-based disinfectant.

(4)    Wash laundry thoroughly: any clothing or linens that may be contaminated with vomit or stool should be handled carefully (ideally, wearing gloves, not agitating them to avoid spreading virus, and washing hands after handling). Wash with detergent on the longest possible cycle, and then machine dry.

 Cancer patients, especially if getting chemotherapy, should take special precautions

The CDC also provides clear advice for cancer patients, stating that if you get a fever during your chemotherapy treatment, it’s a medical emergency because infection during chemotherapy can be life-threatening.

And of course for patients with colorectal cancer or having an ostomy, dehydration also can become serious quickly. The CDC advises cancer patients to take your temperature any time you feel warm, flushed, chilled, or not well. If your temperature is 100.4°F (38°C) or higher for more than one hour, or 101°F (38.3°C) or higher for any length of time and you are on chemotherapy especially, call your doctor right away, even if it happens in the middle of the night.

You and anyone who comes around you, including all members of your household, your doctors, and nurses, should clean their hands frequently.

Sources: “Emergence of New Norovirus,” Jan. 25 CDC Morbidity and Mortality Weekly Report ;  “New Norovirus Strain Hits US,” Jan. 24 Medscape ]; “CDC Researchers Spot Increase in New ‘Stomach Bug’ Strain,” Jan. 24 HealthDay News; general tips to “Prevent the Spread of Norovirus,” and “Preventing Infections in Cancer Patients,” Centers for Disease Control.

Fight Colorectal Cancer is partnering together with 23andme and Genentech to help researchers better understand if patients’ genes play a role in how they respond to treatments they receive for their colorectal cancer.  This provides patients a new opportunity to participate in genetics research.

You are invited to participate in the InVite Study.

The InVite Study aims to enroll 1,000 individuals with certain types of advanced cancer who received Avastin before 2013.

In order to participate you simply submit a saliva sample and complete some online surveys.

The InVite Study will allow you to:

• Learn more about your health and genetic ancestry
• Take a direct role in research that may benefit you and other patients with advanced metastatic disease
• Participate in web-based research from the comfort of your own home
• Be kept informed of the discovery process as research advances

The InVite Study will enhance research by:

• Bringing together a large group of people who have taken Avastin to better understand if there are any specific genetic differences between people who do well on Avastin and those who do not
• Understanding if new technologies like genetic analysis and the internet offer a new way to conduct research and help researchers learn how to better use medicines
• Expanding access to people who want to participate in research from home
• Removing some of the time and cost barriers that can slow progress in other types of cancer research

To participate you’ll need to:

• Enroll and consent through the 23andMe website 
• Provide a saliva sample and send it back in the prepaid box
• Take online surveys by signing in to your 23andMe account
• Answer follow-up questions every 3 months in your 23andMe account

To learn more about the InVite Study and how you may participate, read more here.

Have more questions? Check out the InVite study Q&A.

If you have further questions, please contact us directly at the Fight Colorectal Cancer Answer Line at 1-877-427-2111 or email us.

For patients with metastatic colorectal cancer, the Food and Drug Administration (FDA) has approved a new use of Avastin® (bevacizumab): It can be continued as part of ‘second-line’ combination therapy, even if it was used in first-line therapy.

When stage IV cancer progresses despite use of Avastin plus either FOLFOX (5FU plus Eloxatin® or oxalyplatin) or FOLFIRI (5FU plus Camptosar® or irinotecan)-based chemotherapy, the FDA has now approved continued use of Avastin when second-line treatment switches to the other chemotherapy.

Avastin is a monoclonal antibody (a “targeted drug”) that helps prevent a cancer from stimulating growth of new blood-vessels that then help the tumor get bigger.

The FDA’s approval is based on a large, randomized Phase III trial which showed that median overall survival was 11.2 months when patients continued Avastin along with the second-line chemotherapy, compared to a 9.8-month median survival with just the second-line chemotherapy without Avastin. Participants in the trial averaged about 63 years old, and were able to carry out normal activities or at least housework or office work (i.e., ECOG performance status of 0-1).

There was no significant increase in adverse events (such as worse side effects) in those continuing Avastin, versus those who stopped the drug for second-line treatment.

FDA approval for the new use clears the way for insurers to cover the drug’s use, which averages roughly $5,100 a month.

Sources: Jan. 25, 2013 FDA press release; “Avastin Wins New Colorectal Cancer Indication,” Jan. 24 2013 MedPage Today ; “Genentech’s Avastin approved for wider use in colorectal cancer,” Jan. 24 San Francisco Business Times.

Disclosure: Fight Colorectal Cancer accepts  unrestricted educational grants and charitable donations from Genentech, the manufacturers of Avastin. Fight Colorectal Cancer has ultimate control over website content.