A Closer Look

‘Your work is not your worth’ even for doctors

Cardiologist David Mokotoff, who has been working for almost 50 years, contemplates what comes next.

read more

 

I haven’t given up on journalism and hope you won’t

This column began in 2008 when I left the Orlando Sentinel as a senior reporter and entered the health-care profession as a licensed massage therapist. This week, the column ends as I begin a new chapter of my career and enter nursing school.

read more

 

Food Safety

Food Alerts Widget. Flash Player 9 is required.
Food Safety Widget.
Flash Player 9 is required.

Consumer Recalls

 

Consumer Corner

Frustrated with the health-care system? Don’t know where to turn for help? Want more on the human side of health care? We’ve got you covered.

Bookmark and Share

Stem cell therapies need better regulation

By Jann Bellamy
8/16/2012 Special to Health News Florida

The recent deaths of two Florida patients following stem cell therapy highlights the need for greater regulation of these medically controversial treatments.

In 2011, the Florida Board of Medicine imposed an emergency license restriction on Bonita Springs cardiologist Dr. Zannos Grekos after a patient died following an injection of stem cells to treat complications of breast cancer therapy. Although the restriction prohibited Grekos from performing more stem cell treatments, another patient died after Grekos performed a stem cell injection for pulmonary hypertension and fibrosis. This prompted the Medical Board to issue an emergency suspension of Grekos’s license to practice medicine in March of this year. Further proceedings are pending before the Board.

While any death following a medical procedure is unfortunate, these are all the more so because, according to the Department of Health’s complaints against Grekos, these stem cell treatments “had no substantial medical and scientific value” for the patients’ conditions.

Variants of the stem cell treatments performed by Grekos are offered in clinics throughout Florida. What’s behind these treatments?

The International Society for Stem Cell Research, a non-profit with over 3,500 international stem cell researchers as members, explains the theory behind stem cell therapies in a patient handbook, available on its website. Stem cells have two important properties that make them attractive candidates for therapies to replace or repair a patient’s damaged cells or tissues. First, they can divide, making more stem cells of the same kind. Second, they can differentiate into specialized cells that carry out certain functions in the body. All of us carry stem cells in our bodies which can be harvested, allowed to divide and make more cells, and then injected back into the body.

While these therapies hold great promise, the problem is that very few have been through adequate clinical trials to show that they are safe and effective for a particular condition. For example, blood stem cell transplantation to treat diseases of the blood and immune system, such as bone marrow transplants, are well established. And there are ongoing clinical trials to establish safety and effectiveness for other conditions. The University of Miami medical school is running clinical trials on the use of stem cells for treatment of heart conditions and chronic wounds.

But for now these uses remain experimental. Yet Florida clinic websites advertise stem cell therapies for a wide range of conditions, such as joint problems, autism, hair loss and erectile dysfunction. Because certain stem cell therapies are legally questionable in the U.S., some patients are sent to clinics outside the country for treatment.

Foreign clinics also advertise on the internet, which has led to a troubling trade in what’s become known as “stem cell tourism.” These clinics attract desperate patients with currently incurable diseases like ALS and multiple sclerosis.

Treatments can cost tens of thousands of dollars plus incidental expenses like travel. Except for those few treatments proven safe and effective, insurance will not pay.

Fortunately, more effective regulation is on the horizon. A federal district court in Washington, D.C., ruled last month that certain types of stem cell therapies, where the cells go through more than “minimal manipulation” outside the body, are drugs subject to FDA jurisdiction. This means that rigorous clinical trials must precede their use. However, the Colorado company sued by the FDA in this case has simply moved these treatments to a clinic in the Cayman Islands, thereby skirting FDA regulation.

In April, the Texas Medical Board enacted rules requiring that stem cell therapies not being offered as part of a properly conducted clinical trial be approved by a local review board. Some Board members, however, thought the rules didn’t go far enough. Board member William Smyth voted against the rules. He told The Texas Tribune that, “if Texas wants to be a leader in this area, there are other ways to do this. You want to add a layer of protection? Put a moratorium on the use of these agents until they are proven.”

For anyone contemplating stem cell therapy, the International Society for Stem Cell Research offers valuable information in a format easily understandable to the layperson. As its patient handbook says, “stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy.”

Good advice. It would be even better for the state of Florida to take a more proactive stance, like Texas, in protecting patients. Had it done so earlier, it might well have saved the lives of two people.


-- Jann J. Bellamy, a Tallahassee attorney, is founder of the Campaign for Science-Based Healthcare (www.sciencebasedhealthcare.org). For previous columns, click HERE.

 

Resources

We’ve collected a list of resources for you, including federal and state agencies and private associations. This is a free listing, without paid advertisers.

Healthcare practitioner license search

People can look up a health-care professional to see whether they have any disciplinary history or pending complaints.

Nurse practitioner degree programs

This site, a personal project of Joyce McKay, lists schools across the country currently offering nurse practitioner degree programs.

Medicare Rights Center launches MRU

Medicare Rights University is a subscription-based online service that features courses on key Medicare topics and provides subscribers with information.

What is Medicare and what does it cover?

Here is an online guide that explains the four parts of Medicare.

Medicare Extra Help program

Medicare recipients now have access to the Medicare Extra Help Subsidy Program, which allows Medicare recipients to receive discounted prescription drugs. A family member, trusted counselor or caregiver can apply at www.socialsecurity.gov or call 786-469-4600. 

American Lung Association of Florida

Florida Center for Public Health Preparedness

Florida Government e-Rulemaking Site

Provides notices of proposed rules and rule changes, public meetings, etc.

Continuation Coverage

Centers for Medicare & Medicaid Services' site and helpline where unemployed workers may request review of a denial of eligibility for COBRA premium assistance.

Robert Wood Johnson Foundation

Agency for Healthcare Research and Quality-Consumer Guide

Falls-prevention DVD available to health professionals

The Florida departments of Elder Affairs and Health are offering a DVD on falls prevention to health professionals. For a copy, e-mail DEMO_InjuryPrevention
@doh.state.fl.us
.

New fed site gives health information in Spanish

Federal officials have unveiled a Spanish-language version of its tool to help people navigate the increased coverage resulting from the health-care overhaul. Click here to visit.

Group offers free ‘living will,’ other forms

Free, downloadable end-of-life forms (to designate a health-care surrogate, for example) are available at a web site sponsored by the Hemlock Society. 

Government site outlines new health-care law

A new government site, aimed at individuals, Medicare recipients and small employers, explains how the new health-care law works for the consumer as well as for seniors on Medicare. Click here to visit.

FDA site lets public find drug safety info

The Food and Drug Administration launched a website where patients and health-care professionals can find safety information about recently approved drugs and vaccines. Click here to access.

Florida sets up oil spill info line

 Florida has set up a toll-free telephone line to provide residents and visitors with information about the Gulf of Mexico oil spill. When you call 888-337-3569, operators will answer questions about the state's response activities, volunteer opportunities and health, safety and protective tips.

Complaints against licensees now online

Public administrative complaints filed against licensed health-care practitioners are now available on The Florida Department of Health Web site. Consumers can see if a public complaint exists for any health-care professional licensed by DOH at this site. 

Consumer Reports looks at reform

Consumer Reports has a guide to health reform, with videos, Q&As, viewpoints and in-depth papers. Access it here.

Online resources for information on health reform

The Washington Post has compiled a handy list of guides to the new rules. Access it here.

Summary of new health-reform law

Here is a summary of the provisions of the Patient Protection and Affordable Care Act (adjusted by the reconciliation act that followed.

And here is the timeline for implementation.

Updated Medicare primer

The Kaiser Family Foundation has updated its Medicare primer that explains key elements of the program. It describes characteristics of the Medicare population and how much people pay out-of-pocket. The updated 2010 Medicare primer is at www.kff.org/medicare/7615.cfm.

Mesothelioma cancer risks in FL

A national group that seeks to inform the public about this type of cancer lists environmental risk factors in Florida.

Consumer health information

The FDA has created a partnership with Everyday Health to deliver FDA's consumer health information to the 30 million users who visit EverydayHealth.com each month. EverydayHealth.com/FDA will offer health information from FDA on food and medical product safety as well as prevention and wellness topics.

What you need to know about anti-viral drugs

Not everyone needs antiviral drugs when they get sick. This CDC fact sheet explains who should take them.

State offers flu hotline

The Florida Department of Health has launched a toll-free hotline, 877-352-3581, to provide public health information and updates on the H1N1 "swine" flu.
It is open from 8 a.m. to 8 p.m. daily. Information is available in English, Spanish and Creole.

Information can also be found at the department's website, doh.state.fl.us.

New consumer guides

Spanish-language consumer guides are now available from the Department of Health & Human Services's Agency for Healthcare Research and Quality for consumers and clinicians. To access the guides in Spanish as well as English, go to effectivehealthcare.ahrq.gov. Audio versions of many guides also are available.

Suspect insurance fraud?

Call Florida's Fraud Fighters Hotline at 800-378-0445. It's operated by the Insurance Fraud Division of the state Department of Financial Services. 

Helpful hint

Did you know the state offers a Web site where you can quickly find the best price in your local area for the drugs you take? The Drug Finder can save you money.

Thanks to Health News Sponsors!