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Patient Safety Depends on Prevention

Prevention is a key message of the Colon Cancer Alliance. Over 80% of all cases […]

Prevention is a key message of the Colon Cancer Alliance. Over 80% of all cases of colorectal cancer can be prevented with recommended screenings. Despite its high incidence, colorectal cancer is one of the most detectable and, if found early enough, most treatable forms of cancer.  With the widespread adoption of common screening practices, as many as 30,000 lives could be saved each year.

Unfortunately, screening isn’t enough for everyone, so we also need to ensure that patients with colon cancer have access to the best, most trusted medicines possible to help them get healthy.

We all benefit when new and innovative prescription drugs are developed, and that’s especially true when more affordable generic versions of those drugs become available.  But if we fail to put in place the proper safeguards, patient safety and health could be compromised.

Right now, biologic medicines offer the best hope for treating many forms of cancer.  For example, some colorectal cancer patients receive a monoclonal antibody, a type of biological therapy that is administered through a vein at the doctor’s office, hospital or clinic. This advanced medicine uses the power of living organisms to interfere with cancer cell growth and the spread of cancer. Biologics discovery also hold the promise of successful future treatments for diseases that we cannot yet treat effectively.

Recently there has been a legislative push to accelerate the process of producing the first generic versions of biologics, known as biosimilars, in the United States.  Although producing affordable, effective, and innovative drugs is the ultimate goal, we shouldn’t rush the process.  Patient safety must be the linchpin of all efforts to make biosimilars available to patients in the U.S.

And when it comes to biosimilars, patient safety is not a given.  As the name suggests, these drugs are similar to biologics, but they are not exact copies.  Traditional generic medications, like aspirin, are made using the same production processes and the same raw materials as the originals, but that’s not the case with biosimilars.

Both the inherent nature of biologics and the process of producing them are complicated: the manufacturing process is precise and quite different from the process of engineering common chemical-made drugs.  Additionally, the resulting compounds are highly complex and sensitive to the manufacturing process.  Changing even a single cell or a tiny step of the process can alter the entire drug or the effect it has on the human body.  And since they aren’t exact copies, biosimilars could be unpredictable or even dangerous.

It is important to develop a science-based pathway for biosimilars to enter the market, but stringent procedures and a vigilant traceability system must first be in place to protect patient safety.  A system for reporting adverse reactions must be established, and clinical trials and transparent product labels should be required.  The procedures currently in place are not designed for use with multi-source biologics.

Finally, it should be left to patients and their doctors to make decisions about which treatments are best for their unique needs.  These decisions affect health and quality of life, and they should not be made by regulators, lawmakers, or insurers.  Ultimately, switching biologics for biosimilars without patient consent or doctor approval could pose serious health risks.

Prevention is the most effective way to ensure positive health outcomes – no matter if this applies to cancer screenings or safeguards for drug approval.  We all hope that biosimilars will work as effectively as the drugs they attempt to replicate, but that won’t matter unless patient safety and science are held paramount throughout the process of developing them.

Andrew R. Spiegel is the CEO of the Colon Cancer Alliance, the oldest and largest national patient advocacy organization dedicated to ending the suffering caused by colorectal cancer.


CCA

The Colon Cancer Alliance (CCA) is the oldest and largest national patient advocacy organization dedicated to ending the suffering caused by colorectal cancer. In order to increase rates of screening and survivorship, the CCA provides patient support, public education, supports research and conducts advocacy work across America.

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