Editorials

Missed chances: under-recruited clinical trials

By Dr. Jonathan Licht and Rebecca Koppel

Coordinated Clinical Research is a clinical trial site in Hillcrest that is investigating potential treatments for some of the most widespread and damaging neurological diseases. One current study is to investigate a prospective treatment for the most common neurological disease, Alzheimer’s disease. This illness currently afflicts 5.4 million Americans. There are currently no drugs on the market to prevent, cure or even slow the disease.

Because this disease so negatively impacts millions of people, including caregivers, family members and friends, the demand for new treatments ought to be extremely high. For the FDA to approve new drugs for the market, the treatments must go through several clinical trials. Unfortunately, there are relatively few people willing to participate in these trials. Why wouldn’t those afflicted jump at the chance to help slow the disease?

Many trials have rigorous inclusion and exclusion criteria. For example, the current Alzheimer’s trial at Coordinated Clinical Research does not enroll those who have too mild or too severe Alzheimer’s. It also does not include people who carry a certain gene that increases the risk of getting the disease. These criteria can be difficult to deal with, but they are not the only reasons that the trials are not filling up rapidly.

Doctors who diagnose their patients with Alzheimer’s disease do not recommend their patients to a clinical trial for several reasons, including an ignorance of existing trials. Physicians can be uneasy about how the patient will react, or unwilling to not be in charge of the patient’s care. Because of the resistance from physicians, patients must take a more active role in their own healthcare and seek out trials on their own.

Patients rarely find trials and volunteer to participate on their own, though, for several reasons. Many people are anxious about side effects, but researchers have always tested these drugs in animals and humans and approved to proceed to this stage. In addition, the doctors and other researchers closely monitor all participants’ health throughout the entire study. Another concern of patients regards the financial commitment. All medications and procedures are entirely free to the patient. Additionally, this study provides compensation for time and travel. Because medical privacy is very important, researchers report the results of the trial to the sponsors of the trial, but never reveal personal information, such as the participant’s name. Clinical trials are usually a positive experience; a 2005 survey found that 88 percent of people who had participated in a clinical trial would be willing to do so again.

Participants have the opportunity to hold an active role in their own healthcare while gaining access to the latest treatment methods. They are able to take advantage of expert medical care and close monitoring during the trial. Every single participant, whether they receive the active drug or the placebo, is helping others and themselves by contributing to the collection of medical research knowledge.

The Alzheimer’s study that Coordinated Clinical Research is currently conducting is a trial with the latest, most cutting-edge Alzheimer’s treatment. The study drug, bapineuzumab, attempts to remove a protein, amyloid, that could be clogging the brain and causing the disease. Researchers have very recently discovered that a rare gene mutation protects from the illness by naturally clearing amyloid from the brain. This is evidence to support the mechanism of bapineuzumab.

If you or someone you know has been diagnosed with Alzheimer’s, please contact Coordinated Clinical Research at 619-297-3023 or online at sandiegotrials.com for more information regarding the study. We are also currently running trials in Multiple Sclerosis and ALS.

What healthcare reform means to you

By Jason Alderman

Much was made of the size and complexity of the Patient Protection and Affordable Care Act when President Obama signed it into law in 2010. But now that the Supreme Court has upheld much of the act’s constitutionality, it’s a good time to review key provisions that have already gone live and to plot out what’s expected to happen in the next two years.

Changes already in place include:

Children under 19 cannot be denied coverage because of preexisting conditions.
Adult children may remain on parents’ medical plan until they turn 26.
Lifetime insurance maximum payouts were eliminated. In addition, annual coverage limits are being phased out. Effective Sept. 23, 2012, the annual limit increases to $2 million.
All new plans now must provide certain preventive services for free, such as mammograms, immunizations and colonoscopies.
People who’ve been refused insurance because of preexisting conditions may now be eligible for coverage through a “high-risk pool” program. Go to pcip.gov/ for information and to apply online.
Medicare Part D participants who reach the infamous doughnut hole now receive a 50 percent discount on brand-name prescription drugs, 14 percent on generics. These discounts will gradually increase until 2020 when the doughnut hole will disappear.

Many core features of the Affordable Care Act won’t take full effect until 2014 and details are still being finalized, but here are highlights of what is expected to happen between now and then:

By Aug. 1, 2012, insurance companies that didn’t spend at least 85 percent of 2011 premium dollars for large group plans (over 50 employees) on medical care must refund the difference, through refund checks or discounted future premiums (80 percent for individual or small group plans).
By Oct. 1, 2012, plans must begin adopting rules for the secure electronic exchange of health information. This will reduce paperwork, costs and medical errors.
By Jan. 1, 2013, new federal funding will be in place to state Medicaid programs that choose to cover preventive services to patients at little or no cost.
By Oct. 1, 2013, states will receive two additional years of funding to continue coverage for children not eligible for Medicaid.

Effective Jan. 1, 2014, most key provisions will be in place. For example:

Individuals and those whose employers don’t offer health insurance will be able to buy it directly from state-based Affordable Insurance Exchanges, which will offer a choice of health plans that meet certain benefits and cost standards.
Most who can afford basic health coverage will be required to obtain it or pay a fee to offset the costs of caring for uninsured Americans.
Americans earning less than 133 percent of the poverty level will be eligible to enroll in Medicaid.
Refundable tax credits will be available to those earning between 100 and 400 percent of the poverty level to help pay for affordable insurance. They also may qualify for reduced copayments, coinsurance and deductibles.
Annual coverage dollar amount limits will be prohibited.
Adults will no longer be refused coverage due to preexisting conditions.
Insurance companies will no longer be able to charge higher rates to individuals and small groups due to gender or health status.

These are only a few of the many healthcare changes we’ll see as a result of the Affordable Care Act. To learn more, please visit HealthCare.gov.

—Jason Alderman directs Visa’s financial education programs. To Follow Jason Alderman on Twitter: twitter.com/PracticalMoney.