National Medical Association Speech

Speech before

National Medical Association
House of Delegates Meeting
San Diego, California

Remarks by

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner for Food and Drugs

August 4, 2004

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Good Afternoon, I’d like to thank Dr. Laurencin (Dr. Cato Laurencin, Speaker for the NMA House of Delegates,) for his kind introduction and Dr. Maxey (Dr. Randall Maxey, President of the NMA) for his invitation to speak to you this afternoon. I also especially want to commend the National Medical Association (NMA) for its long and proud history (since 1895) of serving as an unwavering advocate for improving the health status of all Americans, but most especially the nation’s racial and ethnic minorities.

Today I want to discuss a major public health concern -- an issue of epidemic proportions not only among industrialized nations, but also in some parts of the Third World. In the United States, this issue commands the closest attention of the Secretary of the Department of Health and Human Services and, in particular, of the Food and Drug Administration.

I am talking, of course, about the epidemic of overweight and obesity. I’m sure you know the statistics. Today, 64 percent of all Americans are overweight and over 30 percent are obese. The trends for children are even more alarming, 15 percent of children and adolescents aged 6 to 19 are overweight - double the rate of two decades ago.

These extra pounds are literally killing us. Overweight and obesity increase the risk for coronary heart disease, hypertension, type II diabetes, osteoarthritis and certain cancers that contribute substantially to our nation's morbidity and mortality statistics. As you know, recent estimates indicate obesity is a causative factor in as many as 400,000 deaths each year, which makes it the second highest avoidable cause of premature death in United States after tobacco. While the resulting human suffering is the worst of this epidemic, its economic outcomes underline the hardship. The costs of obesity-associated health care and lost productivity are estimated at $117 billion a year.

More importantly, the burden of overweight and obesity is not evenly distributed across ethnicities in this country. For example, major findings from the survey Health, United States, 2003 indicate that while 30 % of non-Hispanic white women are obese, 40 % of women of Mexican origin are obese and a full 51 % of non-Hispanic black women are obese. Not just overweight, but obese!

In 2001, death rates from several major diseases for the black population exceeded that of the white population: by 40% for stroke, 29 % for heart disease, and 25 % for cancer. All of these diseases have a higher incidence in obese patients. The most recent data from the NHANES survey (1999-2000) indicates that 38.6 % of black men suffer from hypertension as compared to 28 % of white and Hispanic men. Even worse, 42.4 % of black women suffer from hypertension compared to about 28% of white and Hispanic women.

We need to focus on obesity in the African-American community. According to the American Obesity Association and others, the statistics are worse for African Americans than any other population group in the country, with women and young women at the highest risk. 78 percent of African-American Women are overweight; and as I just mentioned, 51 percent are obese. Among African-American teenage girls, 46 percent are overweight and 27 percent are obese.

Compared to Caucasians, African Americans have: (a) an 80 percent higher risk for stroke mortality with a 40 percent higher actual death rate; (b) a 50 percent higher risk for heart disease mortality with a 29 percent higher actual death rate; (c) a 25 percent higher cancer death rate; and, (d) a 320 percent greater risk of hypertension related end-stage renal disease.

Diabetes in the African-American population has tripled in the last 30 years and is the fifth leading cause of death for African Americans overall, and fourth for African American women. Prevalence of diagnosed diabetes is 1.4 to 2.3 times that in Caucasians over 45 years old.

Obesity Working Group

For us at the FDA, this ominous rise in disease and expense presents a challenge that -- although not at our doorsteps alone -- we know we must confront with all available authorities and resources. FDA published the report of its Obesity Working Group (OWG) in March of this year. The report recommended a number of measures that FDA could implement to counter this growing problem.

As medical professionals, I know you are well aware that this epidemic of overweight and obesity has no single cause: rather, it is the confluence of many factors acting together over time. Thus, there will be no simple or speedy solution. Controlling obesity will be a long-term process needing coordinated and comprehensive efforts on many fronts.

One of the most surprising findings from our consumer research was that a large part of our population is not even aware that excessive weight is a health problem. Evidence reviewed by our obesity working group points out that both adults and teenagers often misperceive their weight status, and that this misperception cuts across gender, socioeconomic status, age and ethnicity.

In addition, we found that many consumers inaccurately assess their diets' implications for their health. As many as four out of ten people who cook at home have an exaggerated opinion of the nutritional quality of the meals they prepare. Also, many parents significantly underestimate how often their children snack between regular mealtimes.

Another important and rather disappointing thing we discovered was that despite the FDA’s extensive work on development of the Nutrition Facts Panel of the Food Label, which shows how the major nutrients in each food package fit into a healthy daily diet of 2,000 or 2,500 calories; a large part of our population lack -- or even care about -- accurate information about their nutrition. When the present food label format was introduced more than 10 years ago, fewer than 56 percent of Americans were overweight, and fewer than 23 percent were obese.

So, to make it easier for consumers to adopt and maintain healthy diets, FDA proposed to allow food manufacturers to use qualified health claims on food packages, a measure that had two purposes: first, to educate consumers about the health benefits of certain foods; and second, to encourage food firms to compete by products that can improve health rather than by price, convenience or packaging.

As a part of its priority list for the coming months, FDA will publish a proposed rule later this year providing guidance to manufacturers regarding nutrient content claims related to the carbohydrate content of foods. We also intend to move forward on the OWG recommendation to give greater prominence to calories and serving size on the label by increasing the font size and providing a daily value (DV) percentage for calories. In addition, FDA is working with restaurants to develop a way to include nutrition information on menu items.

We have already published a final rule on mandatory labeling of trans fatty acids content of foods that will be fully implemented by January 1, 2006. These actions as I said, are all a part of our major priority for the next six months, which was announced earlier this week, relative to Patient and Consumer Protection and Education.

In addition, FDA has stepped up enforcement actions against unsafe and falsely labeled dietary supplements. In concert with the modernization of the food GMPs, this Winter FDA will finalize a comprehensive set of new regulations that will set, for the first time, manufacturing and labeling standards for all dietary supplements marketed in the United States. These standards will focus on quality, consistency, and potency.

An effective drug-based treatment for overweight and obesity is, today, sorely lacking in the medical armamentarium. Although FDA has approved drugs for curbing appetites and preventing dietary fat absorption, these a vailable therapies are only modestly effective in terms of weight loss, usually resulting in a weight loss no greater than 10 percent of initial weight, and in some patients they have no effect. Furthermore, they have no lasting effect once the use of the drug is stopped, thus compelling lifelong therapy in many individuals.

Obesity is a chronic condition associated with wide-ranging derangements of energy metabolism and neuroendocrine control of appetite. Based on this understanding, our agency in 1996 issued a draft guidance that set the framework for developing chronic-use drugs to treat obesity. This guidance called for long-term clinical trials of safety and efficacy, and set forth standards of effectiveness in the hope of fostering development of therapeutics for chronic use that would eventually reduce the disease risks of obesity.

The report of the OWG recommended review and reissue of this guidance asking for comment on its revision. FDA is planning a meeting of its Endocrine and Metabolic Advisory Committee in early September to re-open this 1996 guidance for discussion. It is our intent to engage experts from academia and industry in seeking the best path forward, and overcome the existing hurdles and barriers to development of safe and effective obesity treatments.

Some of the basic topics that need exploration and debate are:

Evidence from clinical trials that weight loss induced by any of the available obesity drugs reduces risk for long-term serious co-morbid conditions.
Reliance on weight loss alone as the measure of efficacy would need large, long-term exposures for providing at least presumptive evidence of benefits outweighing risks. This is clearly a barrier that must be discussed.
Head-to-head comparisons of new and existing treatments are critical for progress.
Conduct of studies of combination therapies, and trials to examine the safety and effectiveness of drug cycling for both new and previously approved therapies.

There is good news on the issue of obesity therapeutics, one of the most encouraging conclusions of our Working Group indicates there are numerous opportunities for development of safer and more effective obesity drugs, and the future of weight-control therapies is potentially bright. The list of molecular targets and mechanistic approaches is long, and grows daily thanks to vigorous basic research in this field. There are good reasons to hope for development of safe and effective drug therapies to assist people in achieving and maintaining healthy weight.

Clinical Trials

I want to take just a moment to talk to you about minority representation in clinical trials for new drug approvals. Some of you, no doubt, are physician scientists busy in laboratories of academia or the industry looking for new molecular entities. Most of you play a different but crucially important role in new product development as either clinical researchers or as practicing physicians who guide patients and their decision-making about whether to take part in a clinical study.

FDA has been alert to the medical importance of minority participation in clinical trials for many years. In 1988, FDA issued guidance to the pharmaceutical industry that highlighted conducting racial and ethnic data analyses of clinical studies on product safety and effectiveness. In 1993, FDA advised the industry that it could refuse to accept drug applications that lacked such information.

In 1998, FDA published the so-called “Demographic Rule”. Sponsors of new drug applications are now required by FDA to provide the total number of subjects planned for inclusion in each study, and the number that actually entered the study, tabulated by gender, age group and race. As a part of this rule, FDA is evaluating demographic subgroups that take part in clinical trials, to determine if labeling information specific to these groups is necessary for new medical products.

In 2000, FDA took another significant step by proposing guidance on relevant racial and ethnicity information in the adverse reactions sections of prescription drug labeling. Last year, following the passage of the Best Pharmaceuticals for Children Act, our agency strengthened its tracking of racial and ethnic participation in testing pediatric drugs by requiring that such clinical trials include minority representation.

We recognize that challenges to increasing minority participation in clinical studies remain. I commend your collective efforts to encourage African Americans to take part in clinical trials.

According to an FDA survey, between 1995 and 1999 African Americans made up 6 to 12 percent of clinical trial subjects, depending on the relevance of the drugs for the black population. This is a fair record. However, clinical studies are increasingly conducted abroad, often in countries with no black population, and this raises the need for greater African American representation in the trials to which they have access.

FDA has worked with prominent African-American physicians in the Washington, DC – Baltimore area (Dr. Ben Carson, Johns Hopkins University and Dr. Elmer Huerta of Washington Hospital Center) to produce brief radio spots about opportunities to join clinical trials.

It is only through participation of all ethnic and minority populations groups that we can ensure the medical products we approve are suitable, safe and effective for all Americans. There are critical differences among ethnic populations’ susceptibility or predisposition to disease, drug metabolism and treatment outcomes. When information about specific groups is available, physicians and other health care professionals can make informed decisions about treatment.

We at FDA do our utmost to assure the educational materials we provide reflect the language and culture of many audiences. To this end, FDA has several initiatives that relate specifically to minority communities. One such program is the “Take Time to Care” campaign for women of color that carries various messages to minority communities about diabetes, and the safe use of medications.

Initiatives and Six-Month Priorities

Finally, I would like to just briefly highlight for you our “Critical Path Initiative” and a few of FDA’s top priorities for the next six months.

The essence of “Critical Path” initiative is that the process of medical product development has become costlier, lengthier, and more uncertain than ever before. There’s a growing chasm between bench and bedside, and it’s threatening the very promise of our biomedical innovations as the research and development community begins to focus on incurable diseases such as Alzheimer’s, MS, lupus and cystic fibrosis.

In response to this grave challenge, FDA is developing a versatile applied science tool kit – containing powerful scientific and technical methods such as animal- and computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques.

The goal of this toolkit is to help predict eventual product failures earlier during clinical trials and to reduce developmental uncertainties in three critical areas: product safety, medical utility, and manufacturing potential. We firmly believe that better applied science will enable us to improve predictability and efficiency along the critical path from laboratory concept to commercial product, and get much-needed treatments in the hands of our nation’s patients faster.

Our Critical Path public docket closed on July 30 th, and we are reviewing all of the valuable input received regarding current hurdles to product development. In late Fall FDA will announce the first National Critical Path Opportunities List, which will pinpoint those areas of product development that could benefit most from innovative approaches and emerging technologies. With this national opportunities list in hand, the Agency can start to rally our partners in government, industry and academia to build the path to innovation in these key areas.

One of our top priorities for the next six months is to increase patient access to important new life-saving technologies. In that regard, I'd like to mention the success of our Generic Drug program in making lower-cost, high-quality medications available to all Americans in need. In fact, we are approving one new generic every day.

We are also moving ahead on a proposed rule regarding the treatment use of investigational drugs. Specifically, this rule proposes expanding access for patients facing terminal conditions to drugs that are still in the investigational (IND) process. This is an important step that will provide greater access to potential treatments for patients who are suffering the most.

In addition, we're expediting global access to treatments for HIV/AIDS. As Secretary Thompson announced a few months back, we have created an expedited review process to ensure that the United States is providing safe, effective drugs for AIDS relief. It is our firm belief that these steps will make a huge difference not only in the lives of millions of people in Africa, Asia, and the Caribbean who are suffering from this terrible illness, but also to our own citizens.

Conclusion

In closing, let me just say that FDA, as the federal agency charged with safeguarding the public health, and the National Medical Association, as the premier African American medical association, can and must find ways to help equalize the chances for all Americans, regardless of their race and ethnic background, to live healthy and productive lives.

Thank you.

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