The Journals of Gerontology Series A: Biological Sciences and Medical Sciences 59:B674-B681 (2004)
© 2004 The Gerontological Society of America
Anti-Aging Medicine: The Legal Issues
Legal Issues Associated With the Current and Future Practice of Anti-Aging Medicine
Neal R. Reisman
Department of Plastic Surgery, Baylor College of Medicine, Houston, Texas. St. Luke's Episcopal Hospital, Houston, Texas.
Address correspondence to Neal R. Reisman, MD, JD, 6624 Fannin, Suite 1600, Houston, TX 77030. E-mail: drreisman{at}hotmail.com
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Abstract
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This article addresses legal issues and laws that govern physicians, medications, drugs, and the safety of patients in age management and anti-aging medical practices. Age management programs continue to increase and attract more patients despite the lack of scientific proof of their medical benefits. The use of growth hormone, other medications, and supplements is widely reported, although prohibited by the Food and Drug Administration for the treatment of anti-aging. The categories of potential legal liability presented in this article include False Expectations, Fraud, Negligence-Malpractice, Warranty Issues, Product Liability, Human Growth Hormone Usage, and Agency (employee) Issues. This article attempts to identify potential areas of liability for the age management practitioner and the patient seeking such care.
THE era of age management has arrived. Age management medical practices have sprouted based on prescribing various drugs, nutritional supplements, exercise programs, and more to reverse the effects of aging. Baby boomers seeking their fountain of youth will try almost anything, scientifically proven or otherwise, to achieve longevity. Promises of improved health, expanded sexual prowess, and a longer life lure many who have neglected their bodies for years. This manuscript is directed at those medical practitioners who have an existing age management practice, those physicians considering the creation of a new one, and for patients currently using or considering the use of services of age management practices. All those entering this area should be aware of the laws that govern medical practice, medications, drugs, and the safety of patients.
The trend toward age management continues despite the absence of scientific proof that anti-aging medicine increases life span and despite the significant financial cost of such programs (1–10<--?G1-->). The conflict of science versus profit may create added risk for both the patient and age management medical community. The risks to patients in age management programs have been described in a report to the chairman by the Special Committee on Aging entitled "Health Products for Seniors, ‘Anti-Aging’ Products, Pose Potential for Physical and Economic Harm" (11). It is also a dilemma for patients to balance the promises, representations, and true cost of these programs against the risks, which are often either unknown or poorly understood (12). The categories of potential legal liability presented in this article include False Expectations, Fraud, Negligence–Malpractice, Warranty Issues, Product Liability, and Agency (employee) Issues. This article attempts to identify potential areas of liability and does not address the complex issue of creating a standard of medical care. Of particular concern are patients who are indiscriminately treated by age management programs with growth hormone (GH), specially compounded medications that have avoided Food and Drug Administration (FDA) scrutiny, and nutritionally unsound and unnecessarily expensive concoctions that promise unproven results. Some of these treatments are not only unnecessary but also possibly illegal. This article addresses the possible medicolegal risks associated with an age management program. The prospective patient should be aware of these concerns, as should the dedicated and conscientious age management program medical staff.
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FAILED EXPECTATIONS
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A well-known cause of medical malpractice lawsuits is failed expectations (13). When a patient expects to achieve a specific result, is promised that result, and the actual result falls short of what is promised, the patient may become angry and file a lawsuit. Two situations may occur that cause failed expectations to develop into a lawsuit. The first is when the physician or staff "sells" the program to patients, suggesting that they will grow younger and possibly live longer. If a patient develops a complication, either during treatment at an age management clinic or shortly thereafter, it is possible the patient will initiate a lawsuit based on failed expectations and blame the complication on the program's treatments and products. The second situation is when the patient does not seek information based on accepted science with reasonable expectations of improved health, and instead focuses on increased longevity. Improved health is far easier to demonstrate than life extension. Even if the age management practice follows acceptable guidelines and does not raise expectations beyond reality, patients may have their own false expectations. For example, the purchaser of a lottery ticket believes that he or she has a chance of winning, even though the odds may be 1 chance in 30 million. There is always an expectation of a wondrous result, sometimes mixed with unreasonable expectations. A major component of risk is created in age management just by using the old term "anti-aging." Most patients seeking age management do so expecting to achieve some age reversal or at least improved health. The more the practice promotes age reversal and longevity, the more likely false expectations may become a real liability.
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INCIDENCE OF LAWSUITS
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The malpractice crisis continues (14). There are jurisdictions where health care providers continue to experience a high frequency of lawsuits and a high severity of outcomes. Two variables, frequency and severity, dictate the malpractice arena (15). Some specialties experience a high frequency (how often a lawsuit is filed), but a relatively low severity (the amount of a settlement or judgment). Other specialties, on the other hand, see a low frequency, but high severity or large awards. The trend, absent tort reform, is to be concerned about the incidence of increasing frequency and severity. Malpractice suits and added expenses have caused the costs of many medical practices to increase significantly, calling into question any physician's desire to embark on an age management program without the necessary business skills to manage risks. The malpractice crisis requires an assessment as to the added risk of an age management program, in addition to what may already be a high-risk practice.
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FRAUD
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Any physician who misrepresents the facts about an age management program or anti-aging drugs may be exposed to a legal claim of fraud (16). Fraud has many facets and can severely damage the ability to defend a lawsuit (17,18). In addition, liability insurance will usually not cover fraudulent acts, and so the defendant must personally pay any civil awards for fraud. The allegation that a physician defendant committed fraud and was a bad actor may lead a jury to form the impression that the physician must have been negligent in committing the alleged malpractice act. A definition of fraud is the intentional act of deceiving another into relying on the deceptive information to his or her detriment (19). An age management program has multiple areas where "facts" are presented and misrepresentations could occur. The prospective patient should be aware of areas of possible misrepresentations, which may include laboratory tests and their interpretation and the prescription of nutraceuticals and pharmaceuticals. The initial laboratory test results, interpretations, and discussions may seem suspect, and may be represented as abnormal to pressure the patient into entering the program. The range of reported values for the patient's test results may be manipulated to appear abnormal, thus pressuring the patient into the program. The patient should ask to see not only the summary report that the age management practitioner shows the patient, but also the actual complete laboratory report, including the range of normal values. If the patient's laboratory results are within the testing laboratory's normal values range, there may be no need for treatment. The danger is that the age management practice may misrepresent the results as being abnormal to lure patients into the program. The laboratory results may be higher or lower than desired but still fall within the laboratory's normal ranges. While an increase in certain hormonal values into the high normal range may be a goal in an age management program, it is difficult to defend the use of testosterone, for example, in the absence of scientific studies supporting its use. The intentional misrepresentation of the laboratory results to a patient, who then relies on this information in deciding whether to enter into the program, may constitute fraud. There should be an honest discussion between practitioner and patient on the significance and implication of the laboratory results to avoid a fraudulent misrepresentation and patient harm.
The recommendation and use of pharmaceuticals and nutraceuticals may also reflect fraudulent behavior. A representation that the private label (the practice's own label) is superior to commercially available products, if not truthful, would simply serve to put pressure on the patient to spend more money and bolster the practice's profits. A lawsuit, if filed on any basis, would lead to an investigation, by attorneys, of such claims. If the investigation disclosed that the private label was the same product as the commercial product, merely repackaged and resold as something better, the physician would be viewed as greedy and uncaring by any jury. This is obviously dangerous in defending a lawsuit involving fraud.
Fraud issues can lead to a wider area of liability claims under state deceptive trade practices acts (20) and Federal Trade Commission (FTC) laws. The basic consumer protection statute enforced by the Federal Trade Commission is Section 5(a) of the FTC Act, which provides that "unfair or deceptive acts or practices in or affecting commerce are declared unlawful" (21). A business that deceives the public and commits fraudulent acts exposes itself for added liability.
Lastly, fraud liability could be created by misrepresenting the need for the use of certain prescriptives, such as GH. There are three medically approved uses for GH. They are: 1) children with GH deficiency, 2) patients with treated pituitary tumors or Department of Health and Human Services-approved medical diseases that result in GH deficiency, and 3) wasting syndrome of AIDS. Human GH is statutorily not a dietary supplement, but a drug. Prescribing, administering, marketing, or distributing human GH for anti-aging or age-related problems is illegal (22). Physician "off label" prescribing of human GH for anti-aging or age-related problems maybe illegal.
The physician that fraudulently suggests a patient has growth hormone deficiency to justify prescribing GH is at huge risk. The physician that assumes a low GH level, without appropriate testing, is also at risk for violating federal statutes prohibiting such use. The problem is that clinicians test GH levels in their patients and compare them to GH levels present among a younger population. It is then mistakenly assumed that reacquiring the GH levels present at younger ages will make the patient grow younger. There are several problems with this assumption. First, because there is no baseline measure taken at younger ages for new patients in an age management practice, the physician does not really know whether the patient has experienced a decline in GH levels. Second, it is not known whether comparing GH levels of an older person to the levels present in a population of younger people is appropriate. Perhaps the decline in GH with age actually performs a useful function. The physician and staff must accurately represent findings and allow the patient a clear choice as to which path to follow. A low-normal laboratory test should not deter the patient from seeking what may be a significant improvement from an age management program, which could include additional medications and nutritional supplements. The pressure to bring laboratory values into a higher range should be represented as potentially desirable, but not required or medically necessary.
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NEGLIGENCE
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Negligence in a medical malpractice lawsuit can arise from many sources. The physician is at risk when expectations are difficult to assess and there are multiple health factors to resolve. The elements of a successful negligence malpractice claim include a duty to provide some level of care to the patient, and a breach of that duty that directly results in damages to the patient (23,24). There are many areas in which an age management practice may fail to provide a standard of care to the patient. These include the initial and ongoing medical assessment, ensuring stable health to proceed with dieting and exercise, following the patient after treatments begin for development of disease or tumors, evaluations of test results, and the potential for abandonment should the patient's financial resources end. The practice of medicine is difficult today in its own right, and the age management scenario adds another layer to that difficulty. The initial patient assessment should be adequate to permit a safe recommendation of treatment. Often the age management physician will rely on the patient's own family physician's testing and examinations. This may be unwise. The patient is seeking a goal, and possibly may not provide an honest report of his or her health status. There should be some ongoing assessment and evaluation to ensure safety in following diet and exercise programs, as well as laboratory results and prescriptive and neutraceutical usage. A routine physical to detect the presence of disease or changes in health status is needed. The patient should expect a complete evaluation, including his or her medical history and treatment plan. There is some evidence that certain components of an age management program, such as human GH or other prescriptives, may actually influence the presence of diabetes or cancer (11,25,26).
The patient should review the treatment plan so that each component is understood as necessary to achieve the patient's goals. Lastly, the patient should seek a clear understanding of what will occur if the patient can no longer pay for services or products. The physician may still be liable after the relationship ends unless some clear steps are taken and agreed upon with the patient in advance.
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WARRANTY ISSUES
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A warranty is a guarantee that the patient will reach a certain goal. For example, the age management practice makes statements in one form or another that guarantees weight loss, increased stamina, or rejuvenation within a certain time frame. A warranty for professionals is usually difficult to establish in a medical malpractice claim, but more courts are allowing such allegations (27). It is certainly easier to prove such a claim of breach of warranty if a product is sold or distributed, such as age management supplies and nutritional supplements (28,29). The danger to the physician of a warranty claim is that there is usually no malpractice liability coverage and no "battle of the experts" to establish negligence. If a breach of warranty is proved, the physician may be to pay the injured party damages. This allegation is also used to pressure the physician defendant into settling the case because of the knowledge that there is no insurance coverage for these acts. Many malpractice suits include a claim of breach of warranty to pressure the defendant into settling the claim. There are two types of warranty breaches. First, an express warranty may be established when written, photographical, or other demonstrative evidence is placed in the record depicting a promised result. It should be easy for a physician to avoid this. The physician should be careful to separate the selling of a program and the guaranteeing of results from that program's documentation and distributed materials. The second type of warranty is an implied warranty and this is more insidious. The patient often makes statements and demands about outcomes. An implied warranty may be established if the unrealistic demands are not negated (30). The age management team must dispel such a demand and negate such promises (31). For example, a patient states a desire to lose weight by a certain date in order to keep a specific job. While this result may be a possibility, it cannot be guaranteed. An implied warranty may be created if the practice accepts the patient's request and does not document and disclose the possibility of failure within the time frame. Advertising, office brochures, and the presentation of the program may help create such a warranty. Patients should understand that there are no guarantees in health care, and this includes age management.
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PRODUCT LIABILITY
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Product liability claims, often included as part of a medical legal claim, are also excluded from medical liability insurance coverage. Whenever a medical practice sells or gives a product to a patient, there is potential liability (32,33). This may include vitamins, prescriptives, or other nutritional products (nutraceuticals). The added profit to the medical practice from these sales may be disclosed in a lawsuit, and this may help the patient's lawyer attach a greedy and uncaring label to the practice. A reasonable profit margin is acceptable, but, as I have observed, a 400% or higher mark-up from cost to sales price may hurt the practice in a lawsuit. Distributing a product, by sales or otherwise, exposes the medical practice to negligence in prescribing or using the product, negligence in warning about risks and reactions of product use, and risks to foreseeable users of the product. The patient should obtain careful and detailed instructions as to the use and possible interactions with other medications. Medical practices often utilize a private label, using their own name on the medication or product. The private label in and of itself is not an added risk, but when the label masks ingredients or instructions, there is a problem. A common practice involves compounded nutritional supplements and vitamins. The pharmacy mixes and compounds specific ingredients that may be recommended. This use appears to be a loophole in the Federal Food, Drug, and Cosmetic Act of 1938, and the FDA Modernization Act of 1997 specifically exempts compounded drugs from the "new drug" FDA scrutiny (34). This pharmacy compounding law offers some protections against unsafe and ineffective compounded products, including the following main provisions:
- The compounded product must be individually prescribed for an identified patient.
- A bulk drug substance (basically, the chemical that becomes the drug's active ingredient) can qualify for use in compounding in any of three ways:
- It is found in an FDA-approved drug;
- It is listed in a book of widely used drug substances published by the United States Pharmacopeial Convention, an independent standard-setting organization;
- It is listed in an FDA rule as acceptable for pharmacy compounding (based on the agency's evaluation of the medical literature).
- Previously marketed drugs found to be unsafe or ineffective and removed from the market may not be compounded.
- Drug products listed in FDA regulations as difficult to compound may not be compounded. The FDA is making a list of difficult-to-compound drugs for discussion at a future advisory committee meeting.
Although each drug component must be approved for the intended therapeutic use, the combination as a compounded medication may not require specific FDA approval. The patient should be careful about these compounded drugs, as they may not be proven as safe as the FDA-approved drugs. In addition, the FDA does not generally regulate nutritional supplements. This fact permits the age management program to distribute, sell, and recommend many vitamins and supplements, often without FDA scrutiny. The program may recommend compounded items over less expensive, readily available supplements and drugs, usually at a significantly higher cost. The patient should compare the ingredients with those proven and available, and discuss this with the physician. It is also foreseeable that others, including family members and neighbors, may use the products. The physician should warn the patient of such use by others without a physician's input would be dangerous. Careful instructions must be given with each product, as well as the suggested purpose of the product. Drug interactions should also be evaluated, as many patients take over-the-counter medications that they may not disclose to the physician. Products are an essential component of an age management program and should be distributed or sold with care and full disclosure. The medical practice can usually avoid product liability by a documented information packet disclosing why products are given or prescribed, their intended use, dosage, allergic and other reactions, and tips for their effective use. The patient should ask for such information and add these items to his or her list of current medications.
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AGENCY ISSUES
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Agency law makes the employer legally responsible for the acts of employees while they perform tasks that further the employer's business and are within the scope of the employment (35). In other words, an employee's negligent acts become the negligence of the employer, the physician (36). Many age management programs utilize experts from a range of disciplines, such as exercise physiologists, nutritionists, internists, and other medical specialties. Practice consultants may suggest that office time be maximized and made efficient by utilizing nonmedical personnel, who perform quasimedical acts while the physician is out of the office. The practice should be fully aware of the employee's job description and allowable acts. For example, it is good practice not to refill medicine or give medical advice without a physician's written approval. An employee manual, which outlines job descriptions, allowed and disallowed acts, staff descriptions, and guidelines and rules, is recommended to create a safe, regulatory-approved office environment. Significant liability can be created by staff actions without the knowledge or consent of the physicians who own the practice (37). A well-planned program should eliminate or diminish this risk. A variant of agency law is the independent contractor. These members of the work force are not employees of the medical practice, but are hired on a contract status for a specific role (38). Liability is limited if the practice does not supervise or have control over the contracted staff, but there is often a problem in proving that the independent worker is actually independent. The presence of independent contract staff requires additional verification of intact state licenses and active liability insurance. There may be a credible legal argument against making the physician responsible for the acts of an independent contractor, but the burden of proof is often on the physician (39). The more that documentation demonstrates the independence of the contractor, the easier it may be to dismiss a lawsuit based on allegations of independent contractor negligence. The patients will meet and consult with many professionals during their age management assessment, but there should be a unified message and treatment plan with the director of the treatment group.
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FINANCIAL ISSUES–ABANDONMENT ISSUES
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The financial component of an age management program must be disclosed to the patient. This includes full disclosure of all costs, including professional fees, laboratory fees, supplements, and medications. Because hidden fees and costs may be the first thing to trigger patient annoyance, a financial disclosure form that the patient acknowledges and agrees to before proceeding with the program is essential. Insurance coverage should also be discussed with the patient, as many insurance companies and insurance products do not cover this type of program. The patient should be aware of the possibility of denial of coverage by the insurance company and his or her personal responsibility for expenses and fees. A major issue arises when the patient becomes financially unable to remain current in an age management program, and a clear understanding of how this scenario will be handled should be reached before the practice accepts the patient (40). This understanding should be in writing and agreed upon by the patient and family. The negative perception created when a practice can no longer care for a patient due to his or her inability to pay for services may add to existing liability (41). The practice may be responsible for the patient's care until a suitable alternative can be arranged (42). A documented explanation of the risks of ending or interrupting a program should be included in the patient's information booklet. The practice may appear greedy and uncaring if the only reason for dismissal is financial. A variation of these facts may also develop if the patient can afford professional services, but refuses to pay for additional or more expensive private label supplements and compounded medications, opting instead for less expensive and more available sources. Will the practice continue to provide care, and will the practice be able to provide the same level of excellence they represented to the patient before the program began?
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LABORATORY AND TESTING ISSUES
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Maintaining quality of laboratory services and the accurate reporting to the patient of both abnormal and normal results is very important. If a clinician at an age management practice misrepresents low-normal results as abnormal, this would falsely encourage patients to do further testing and use the anti-aging products being sold at the practice. If such behavior occurs, it may support a lawsuit for fraud and deceptive trade practices. The practice should not misrepresent low-normal results as abnormal, but rather explain to the patient, and document with scientific evidence, any potential benefit of a higher performance level. An appropriate treatment plan to reach that goal could then be customized between practitioner and patient.
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FEDERAL, CIVIL, AND CRIMINAL ISSUES
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The use of GH is restricted by Federal liability (22) and is permitted only for the treatment of a disease or a recognized medical condition. The law states in 21 U.S.C. 
481.071:
Medical Purpose Required Before Prescribing, Dispensing, Delivering, or Administering Controlled Substance
- (a) A practitioner defined by Section 481.002(39)(A) may not prescribe, dispense, deliver, or administer a controlled substance or cause a controlled substance to be administered under the practitioner's direction and supervision except for a valid medical purpose and in the course of medical practice.
- (b) An anabolic steroid or human growth hormone listed in Schedule III may only be: 1) dispensed, prescribed, delivered, or administered by a practitioner, as defined by Section 481.002(39)(A), for a valid medical purpose and in the course of professional practice; or 2) dispensed or delivered by a pharmacist according to a prescription issued by a practitioner, as defined by Section 481.002(39)(A) or (C), for a valid medical purpose and in the course of professional practice.
- (c) For the purposes of Subsection (b), bodybuilding, muscle enhancement, or increasing muscle bulk or strength through the use of an anabolic steroid or human growth hormone listed in Schedule III by a person who is in good health is not a valid medical purpose.
The labeling and marketing of the system is subject to the Federal Food, Drug and Cosmetic Act (43), and more particularly, the Medical Device Amendments. There are age management programs that advertise prescribing human GH, and attempt to justify its use by presenting a low-level laboratory test result. There may or may not be an actual GH deficiency, but the concern is that there is a misrepresentation of results or a clear violation of this law. There are civil and criminal penalties for violating this law. The civil and criminal penalties for violating this law include fines ranging from $1000 to $1,000,000 and imprisonment ranging from 1 to 10 years. Repeat offenders are subject to increased civil and criminal fines. Criminal prosecution of a drug company for violating the FDA's rules against illegally promoting a GH drug for unapproved uses, in 1999, resulted in a $50 million penalty (44).
This law prevents usage for the "average" patient seeking an aid to rejuvenation. A physician may seek and obtain an institutional research board study with strict controls and informed consents that would permit GH usage in a medically controlled scientific environment. There is also a move at the federal level to tighten the restrictions on such usage of other potentially anabolic steroid and enhancement drugs and supplements. The practice should monitor these changes carefully. A realistic assessment of the anti-aging program should remain within compliance with local, state, and federal laws.
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THE FDA AND CUSTOMS ENFORCEMENT
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The FDA controls and approves specific usage for most products and medications. There are three FDA classifications that age management practitioners and patients should understand. These classifications are 1) approved, 2) off label, and 3) unapproved. There is, however, some confusion about "off label" and non-FDA approved, and what affect such usage may have on the practitioner and practice (45).
Off-label use involves utilizing a drug or device in a method other than what is currently approved by the FDA. There are many examples of drugs that are approved for one purpose, but physicians prescribe for another. Legally, case law and current statutes permit such use, without assumed negligence, as long as the off-label use is not deemed "experimental," and full disclosure of the off-label use is provided to the patient (46). There may still be negligence and malpractice issues, but the fact that the treatment is off label, in and of itself, does not equate to negligence (47). Physicians are permitted to prescribe off-label medications, or, in other words, prescribe drugs for indications other than FDA approved. This is a difficult area for the physician. The age management practitioner may believe it necessary to prescribe a drug not approved for the specific intended use. The physician may even explain this to the patient. However, it remains an issue if the use is scientifically accepted by other physicians in the specialty, and therefore not experimental. Growth hormone use is a good example of the problem. Code 21 U.S.C. 333(f)(1) allows physicians to distribute human GH in connection with either 1) "treatment of a disease" or 2) "other recognized medical condition" that has been authorized by the Secretary of Human Services. This law clearly states what GH can and cannot be used for. The Secretary of Health and Human Services has not approved GH for age management or age-related problems, and therefore the off-label use of GH falls outside of these authorizations. Physician off-label use of GH may be illegal. It is not scientifically proven that GH is an acceptable treatment modality for aging. I believe the issue is not whether GH is scientifically proven as an anti-aging treatment, because the law cited above requires that GH use must be approved by the Secretary to be used. Even if a scientific paper proves GH to be a treatment for aging, the physician prescribing GH may be classified as a drug dealer and eligible for prosecution under this Act.
The "unapproved" FDA classification poses a greater risk for the medical practice. A non-FDA-approved label is somewhat different. Although mainstream magazines and articles freely discuss European wonder drugs, their efficacy and availability are in question. The non-FDA approved drug or device has no approval for any use. The FDA's oversight and control is with the manufacturers' labeling, promotion, and uses. The same legal requirements for nonexperimental use, as defined by peer evaluation, and full disclosure to the patient, are necessary. The main concern here is the transport into the practice. Non-FDA approved drugs are considered contraband, and there may be difficulty for the physician on two fronts (48).
First, the customs declaration form requires disclosure of all material imported as well any commercial product imported (49). The importation of non-FDA approved drugs or devices, whether for commercial or for personal use, falls under a new amendment to the Controlled Substances Act (22). This amendment allows a United States resident to import up to 50 dosage units of a controlled medication without a valid prescription at an international land border. These medications must be declared upon arrival, be for one's own personal use, and be in their original containers. However, travelers should be aware that drug products that are not approved by the United States FDA might not be acceptable for such importation.
Second, the Federal Food, Drug, and Cosmetic Act (43) [21 U.S.C. sections 331(d), and 355(a<--?G2-->)], which is administered by the FDA, prohibits the interstate shipment (which includes importation) of unapproved new drugs. Unapproved new drugs are any drugs, including foreign-made versions of U.S.-approved drugs that have not received FDA approval by demonstrating that they meet the federal requirements for safety and effectiveness. It is the importer's obligation to demonstrate that the FDA has approved any drugs offered for importation. Chapter 9 of the FDA's Regulatory Procedures Manual, "Coverage of Personal Importations," identifies circumstances in which the FDA may consider exercising enforcement discretion and refrain from taking legal action against illegally imported drugs. Those circumstances are as follows:
- The intended use (of the drug) is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means;
- There is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue;
- The product is considered not to represent an unreasonable risk;
- The individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than a 3-month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.
It is against our customs laws not to properly declare imported medications to customs agents. If full disclosure is made, the "contraband" may not be permitted entry into the United States. If the drug is imported for personal use, and therefore not commercial, it should not be distributed to other patients. This may become an issue should a negligence case arise from the drug's usage. Liability may also arise for false statements that may have intended to deceive importation laws. The FDA and its labeling should be carefully reviewed when developing programs for patients.
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MEDICAL PRACTICE ASSIMILATION AND RISKS
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Physicians' medical practices developing age management programs do so for a variety of reasons. There may be patient demand, or the physician may want to compensate for lost revenues as managed care reimbursements continue to fall. The physician may continue to see patients for his or her primary practice specialty and try to develop an age management program "on the side." The danger is that both areas of the practice may suffer. There should be a clear focus on age management, while utilizing required specialties for a complete program. It is possible to integrate an age management program into a medical practice, but separate goals and team development are important. A suitable business plan and practice incorporation are critical to success (50). The practice may be under financial pressures to produce revenues, and the balance between risk and profit may become skewed. A successful incorporation of clinically accepted age management doctrines should be an integral part of patient care. The level and enthusiasm of such a program can be appropriate and promising to the patient base and practice. It is important, however, for the patient to investigate the age management program, its experience, reputation, and dedication to this field.
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CONCLUSION
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There are many potential risks for physicians to consider when entering an age management practice, and numerous risks for patients considering treatment from such programs. Physicians entering this field may be subject to legal liability on a variety of grounds and legal claims. However, obstacles to creating an age management practice that is based on scientific evidence are not insurmountable. Careful planning and documentation are necessary to limit risk. A facilitated staff, using an ongoing and open communication process, must be established to address not only the issues noted above, but also future issues. Patient care can be positively affected with a complete and carefully planned program. I have heard for years, and continue to believe, that if patients receive great compassionate care, the physician's practice will be successful. On the other hand, quick fixes and end runs usually are noticed by the patient, are not successful in the final assessment, and are very risky. The patient seeking health improvement should balance the his or her own desire for longevity and a healthier existence with the above risks and recommendations.
There are three areas of greatest concern. The first involves the illegality of programs advocating GH usage without scientific documentation of a real GH deficiency, and without disclosing long-term health risks. In my opinion, many physicians' justification for "off-label" GH usage does not meet federal law requirements for GH use, or fall under a nonexperimental guideline for off-label use. The abuse of this hormone may be rampant, with widespread advertisements by many qualified and unqualified practitioners. The second concern is with compounded medications, sold to unsuspecting patients, represented as being better and worth the added cost, despite avoiding FDA evaluations as to their safety and efficacy. The third greatest concern is the nutritional supplement business (nutraceuticals), apparently avoiding FDA review, appears to be a major component of age management programs, without proven scientific basis or rationale. The 2001 Report to the Chairman, U.S. Senate Special Committee on Aging, "Health Products For Seniors—‘Anti-Aging’ Products Pose Potential for Physical and Economic Harm," exposes the many risks from these products. A careful incorporation of real science, diet, exercise, nutritional counseling, and legal compliance, all personalized to the patient, may be the best formula for success.
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Acknowledgments
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The author wishes to thank Virginia D. Reisman, EdD, Tracey M. Reisman, JD, and Dan McClure, JD, for their assistance with the manuscript.
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Footnotes
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Decision Editor: James R. Smith, PhD
Received January 19, 2004
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Abstract
Failed Expectations