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Trials Aren’t Tribulations

The Ohio State University Medical Center patients and cancer survivors Derrick Dozier and Dr. Kimberly Bates participated in clinical trials. And both, who are healthy and vibrant today, are grateful they did.

“We aren’t going to know the information we need about treating African-Americans unless we’re equally involved in these clinical trials,” Bates says. “It’s a good thing to do.”

Enormous advances in everything from cancer to AIDS have been made possible as a result of clinical trials. And people’s participation in them continues to yield groundbreaking research into new medicines and treatments.

“The only way we make progress in medical care here and worldwide is clinical trials,” stresses William Hicks, MD, professor of Clinical Internal Medicine.   

Myths and facts
Still, myths linger concerning clinical trials. The most persistent one is that people participating in them will be treated with placebos. That misconception has its roots in the infamous Tuskegee syphilis experiment that occurred over a 40-year period starting in 1932. Disadvantaged black men were recruited unknowingly for an investigation to study the progression of syphilis. They thought they were receiving free health care from the government. The men were not told they had the disease nor were they treated for it.

Medicine and research have come a long way since this dark chapter in American history. For example, several layers of controls are now in place to prevent experiments such as Tuskegee from taking place today. Institutional Review Boards, which are located at institutions studying the drugs, make sure the risks and benefits are appropriate to what is being studied. Ohio State has three IRBs, staffed by physicians, scientists, patient advocates, clergy, community members and other healthcare providers. There are other protections from entities such as Data and Safety Monitoring Boards, and agencies funding the trials, like the National Institutes of Health. The Food and Drug Administration is involved as well in any trials involving treatment.

Susan Koletar, MD, principal investigator of Ohio State’s HIV/AIDS Clinical Trials Unit, points out that the purpose of Tuskegee — to study the natural history of syphilis — would never fly today. ”If you want to test a new medicine for a disease, it’s tested against the current standard of care, against the best medication that is already out there,” she explains.

As an example, 25 years ago, the first HIV drugs were tested against placebos because there were no HIV treatments available. After researchers found drugs that worked, new drugs were tested against the standard-of-care medications or combinations of medications. That practice continues today.

Trial Benefits
There are many benefits to participating in clinical trials. One is having access to the latest treatment, free of charge. Participants are monitored more closely and see research physicians and nurses more often. They may adhere to medications better because of the attention they receive.

“Studies show that people who participate in clinical trials for their disease do better than those who don’t because of the relationship that builds and because of more monitoring,” says Michael McDonald, program manager and outreach coordinator for the HIV/AIDS Clinical Trials Unit.

There is also an altruistic reason to participate in a clinical trial: to help others.

“That’s something people don’t realize a lot of times,” McDonald says. “They are part of the solution. They really are the reason we have the medications we have now in all disease states. Many people volunteered their time and their energy to make those medications available to the market.”

Puncturing the myths

No, you will not be subject to unscrupulous treatments. Nor will your body be used for dubious scientific motives. Misconceptions abound concerning clinical trials. Here we debunk a few of them.

Myth: I’ll be treated like a guinea pig if I participate in a clinical trial.

Fact: Trials are subject to several layers of safety checks, including evaluation by Institutional Review Boards and data safety monitoring boards. Those participating in trials should not hesitate to ask questions.


Myth: All clinical trials focus on treatments.

Fact: While treatments are one aspect of the research, trials also deal with better ways to prevent the disease and better ways of diagnosing it. Clinical trials dealing with survivors are just as important.  


Myth: I may be forced to do something I don’t want to do in a clinical trial.

Fact: There is a rigorous informed consent process before anyone can participate in a trial.


Myth: I won’t receive the latest treatments.

Fact: Clinical drug trials test new medicines against the standard of care. This means that recipients will receive either the current drug or a new treatment.

Four Key Messages of Breast Self-Awareness



Too many African American women discover that they have breast cancer when the disease is advanced, rather than at early stages when treatment may be more effective. That simply doesn’t have to be the case.  Previously, we explored 7 reasons why breast cancer is an issue that our community can’t ignore.  Now the spotlight turns to 4 simple breast self-awareness messages and actions that each of us can take to empower ourselves to take charge of our health, and next week the resources available to help  

According to a recent study of 1.5 million insured women, about half didn’t get regular mammograms. Why is that?

How many times have YOU been “too busy” to take YOU to the doctor?  On the other hand, have you ever been “too busy” to take someone you love to the doctor?  The answer to the first question is probably “more times than I care to admit”.  The answer to the second question is most likely a resounding “NEVER”.  We’re always too busy to take care of ourselves but we’re never too busy to take care of others.  It’s time to rewrite this story.  It is important to ensure your own personal well being in order to take care of others.  

The good news is that getting started is easy. Susan G. Komen for the Cure® has 4 Breast Self-Awareness messages that can help you understand your risks, prompt you to get screened, recognize what is normal for you and provide tips on making healthy lifestyle choices– and there are action items associated with each message that makes it clear what
we can DO.  

Susan G. Komen for the Cure® recommends that you:
1. Know your risk  
•    Talk to your family to learn about your family health history
•    Talk to your provider about your personal risk of breast cancer
Family health history is very important because you may be at increased risk.  However, remember that MOST women in the U.S. diagnosed with breast cancer don’t have a family history of the disease!. Although you may be at greater risk for developing breast cancer if you have a family history, you are not excluded if you don’t.  

2. Get screened
•    Ask your doctor which screening tests are right for you if you are at a higher risk
•    Have a mammogram every year starting at age 40 if you are at average risk
•    Have a clinical breast exam at least every 3 years starting at age 20, and every year starting at age 40
•    Sign up for your screening reminder at komen.org/reminder
Breast cancer doesn’t just affect women 40 and over.  Pay attention and get the screening that’s right for you even if you’ve not quite reached the age for recommended annual mammograms.

3. Know what is normal for you
See your health care provider if you notice any of these breast changes:
•    Lump, hard knot or thickening inside the breast or underarm area
•    Swelling, warmth, redness or darkening of the breast
•    Change in the size or shape of the breast
•    Dimpling or puckering of the skin
•    Itchy, scaly sore or rash on the nipple
•    Pulling in of your nipple or other parts of the breast
•    Nipple discharge that starts suddenly
•    New pain in one spot that doesn't go away
Beware!  It’s not just about what you “feel”.  Six of the 8 warning signs are visual.  Click here to see what you should look for.  Always check with your healthcare provider if you notice any of these signs or anything that you know isn’t normal for you.

4. Make healthy lifestyle choices
•    Maintain a healthy weight
•    Add exercise into your routine
•    Limit alcohol intake
•    Limit postmenopausal hormone use Check with Susan Brown on these last two --
•    Breastfeed, if you can

The two most common risk factors for breast cancer are being a woman and getting older – two things we can’t control.   However, there are steps that we can all take to lower our risks.
Take action!  
•    Visit BlackAmericaWeb.com next week to learn about resources that can truly make a difference.
•    Share this valuable information with someone you know
•    Visit komen.org at this link to find out more about Breast Self-Awareness
•    Keep reading.  Click here for Komen’s complete guide to Understanding Breast Cancer

Link Between Dental Health and Heart Disease


Recent studies suggest possible links between periodontal infections and heart disease. Researchers have reported that the most common strain of bacteria found in plaque can cause blood clots that induce heart attacks when they escape into the bloodstream.

To explain the relationship between the heart and periodontal infections, some experts hypothesize that bacteria present in infected gums can come loose and move throughout the body.

It is possible that once bacteria reach the arteries, they can irritate in the same way they do the gum tissue, causing arterial plaque to buildup in the arteries. This accumulation of bacteria can cause arteries to harden and restrict blood-flow and potentially result in a heart attack or stroke.

Even though the research is not conclusive at this point, it’s still important to try to keep your mouth healthy and help prevent gingivitis from the start. This includes seeing your dental professional at least twice a year and brushing and flossing regularly. Gum disease may be caused by the buildup of plaque. If you remove plaque by brushing with a toothpaste such as Crest Pro-Health Toothpaste, flossing regularly, and visiting the dentist for regular cleanings and consultations, you can help minimize your risk of gum disease. To help prevent gum disease, take these simple steps:

•    Brush your teeth twice daily with a proven anti-gingivitis toothpaste, such as Crest Pro-Health Toothpaste
•    Floss once a day, or more often if you eat sticky foods or foods that can lodge between your teeth (such as popcorn or poppy seeds)
•    Have dental checkups twice a year (or as often as your dental professional recommends)
•    Use an anti-microbial rinse such as Crest Pro-Health Rinse, in addition to brushing and flossing

Interestingly, there are some conditions that contribute to the onset of gum disease. Diabetes, for example, can inhibit the immune system and make sufferers more vulnerable to infection. Also, pregnant women can have a higher incidence of gingivitis.

7 Reasons Why African American Women Can’t Ignore Breast Cancer

Breast cancer is more deadly in African American women than in white women, but it doesn’t have to be. Over the next three weeks, we will bring you information that you can use to help rewrite the story of African Americans and breast cancer. We will explore why this issue is so important for our community, steps that each of us can take to improve our chances of survival and the resources that can help make a difference in your community.  

It all starts with understanding the issues and why this discussion is so important. Did you know that:
1. Breast cancer is the most common cancer among African American women.

Don’t ignore the warning signs of this commonly diagnosed disease in our community.  Too many breast cancers go undetected until it is too late. Ignoring the signs of breast cancer won’t make it go away.  Early detection helps save lives.  

2. Breast cancer is the second most common cause of cancer death among African American women, exceeded only by lung cancer.

Another common myth is that breast cancer is not a deadly cancer. Although breast cancer is the second most common cause of cancer deaths for African American women, it is a disease that can often be treated effectively when caught in time. However, African American women have a 78 percent five year relative survival rate. Again, early detection and effective treatment are key.  

3. Older African American women tend to be diagnosed with breast cancer at lesser rates, but African American women are 41 percent more likely to die of breast cancer than white women.

There are many reasons that we face a higher death rate. Some of it we can control and some we can’t. Here’s what we know: breast cancers in African American women are more likely to have factors connected with poorer outcomes such as higher grade (how abnormal the tumor is and how likely it is to spread), later stage (stages can be 1-4 (4 means it’s spread to other parts of the body), and hormone receptor negative status (also known as triple negative breast cancer). African American women are more likely to be diagnosed triple negative breast cancer (TNBC), which is a particularly aggressive form of breast cancer.

Let’s take control of the pieces that we can change like knowing the warning signs and getting to the doctor sooner so that problems can be detected as early as possible.  That way if cancer is found, there are more treatment options and a greater chance for survival.

4. Breast cancer strikes younger African American women at higher rates than white women.

Many of us have mistaken breast cancer as a disease for older women.  That’s simply not true!  Young women can get breast cancer too!  In fact, African American women have higher rates of premenopausal breast cancer than white women.  So, what can you do?  If you are at average risk, Susan G. Komen for the Cure recommends that you have a clinical breast exam at least every 3 years starting at age 20, and every year starting at age 40.  (How do you know if you’re at higher risk? Talk to your health care provider).

5. The higher death rate in African American women may be related to differences in access to health care, such as access to follow-up care after an abnormal mammogram, differences in reproductive factors and differences in tumor types.

If money or knowledge is an issue, Komen is here to help!  We will explore resources available later in this series, but this link to a list of Komen resources can get you or your loved ones started.

6. Men can, and DO, develop breast cancer

Richard Roundtree (“Shaft”) is a breast cancer survivor. Breast cancer in men is rare – about 1 percent of breast cancers in the U.S. – but it can and does happen. We want the men in our lives to have the right information on this topic.

7. Yes, you are at risk for developing breast cancer even if you do not have a history of breast cancer in your family.  

Most women with breast cancer do not have a family history of the disease. And, only about 5-10 percent of all breast cancers are due to inherited gene mutations.  Although you may be at greater risk for developing breast cancer if you do have a family history, you are not excluded if you don’t.  The two most common risk factors for breast cancer are being a woman and getting older – two things we can’t do anything about.  It’s important to know the look and feel of your breasts and know these warning signs. AND, if you ever notice a change, be empowered to act and see your health care provider!  

Understanding these seven facts can help you and those around you make good sound decisions about your  health, however, this is just the beginning.  Don’t stop here!  
Take action!

•    Visit BlackAmericaWeb.com next week to learn about personal steps that you can take to make a difference in your life and the lives of your loved ones.
•    Take the Quiz! Continue to increase your understanding about breast cancer by finding out if you know the truth.
•    Keep reading. Click here for your complete guide to Understanding Breast Cancer
•    Sign up to receive a mammogram or clinical breast exam reminder at komen.org/reminder

Re-Gifting

Catherine and Howard Burks of Columbus have a tight bond. It’s not only that the retired educators are husband and wife; Howard has one of Catherine’s kidneys. “We are really connected. I go with him everywhere,” says Catherine, laughing.

Howard went on dialysis in 2007 due to kidney disease. The lifesaving treatment drained his time and energy. It became difficult to do yard work, travel and even climb stairs on some days. The Burks, who are in their 60s, knew that a kidney transplant could change Howard’s life. So when tests showed his brother was not a donation match, Catherine stepped up. “I was in good health and I wanted to give him a normal life.”

The 2009 surgery went well and husband and wife recovered quickly. Howard is back to his old activities, needing only medication to keep his new kidney healthy. The couple has since taken their mobile home to Florida, Virginia and around Ohio, visiting friends and family and enjoying the scenery — something they couldn’t have done without donation.

Donors in Demand

Donors are needed. There is an especially great need for African-American donors because blacks have a significantly higher rate of kidney disease than the general U.S. population, says Robert Higgins, MD, director of The Ohio State University’s Comprehensive Transplant Center. “More than 35 percent of the patients waiting for kidney donations are African-American, and more people are getting the disease.” The African-American community donates at the same rate as the general population, he says, but because donating within an ethnic group can mean the best chance of long-term success, even more donors are needed among African-Americans.

There are two types of donors: living and deceased donors. A living donor has agreed to donate one of his or her healthy kidneys while alive.

Myths and Facts

Many potential donors understandably have concerns. Some common ones: Doctors may not try as hard to save the life of a registered donor; surgery is unsafe; and religion will not allow it.

Dr. Higgins wants to spread this word: Kidney transplants and donations have been performed for more than 40 years and are considered a safe and effective procedure for both the living donors and recipients. Also, those who want to be on the deceased donor registry should know that saving your life is a doctor’s number one priority in an emergency situation. Doctors do not have access to which patients are on the registry. Finally, all major U.S. religions recognize donation as a gift of life, says Dr. Higgins. Still, those concerned about religious objection should talk with their pastor or religious leader. There are also many respected sources where people can check out all these facts, he says. “When people discover more about transplants, they’ll find it’s not a mystery; it’s a well-defined miracle of medicine.”

CTA: If you are interested in becoming a living organ donor, send back the reply card enclosed with this issue to receive a Comprehensive Transplant Center brochure.

The Facts on Kidney Health

African-Americans are disproportionately affected by chronic kidney disease (CKD) and by its two main causes, diabetes and hypertension. Minority health specialist Rose Shim, MD, arms her African-American patients with these important facts on CKD:

— African-Americans develop kidney failure at an earlier age than the general population.

— CKD has no symptoms. Forty-three percent of African-Americans on dialysis were not aware they had kidney failure until one week before starting dialysis.

— Early detection and regular treatment can help prevent kidney failure and the need for dialysis or kidney transplantation.

— Ask your doctor for the simple screening tests if you have diabetes, hypertension, vascular disease or a family history of CKD or dialysis.


Ask Your Advocate
Rebecca Grant, MD

Q: How do I keep my organs healthy?

A: Stick with regular doctor’s appointments to help prevent and treat disease that causes organ damage. By the time you see symptoms, such as heart disease, kidney failure and stroke, the damage is done. Stick with your health plan and follow up with your appointments. Problems getting or affording medications? Tell your doctor. Sometimes we can get them for you.

For more information about scheduling an appointment at CarePoint East Family Medicine or with Dr. Grant, call 800-293-5123.

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