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January 3, 2012

Risks of Anti Aging Medicine: CNN Article

Anti Aging Medicine and ExerciseThis recent article on CNN is extremely misleading, filled with hyperbole, and in some cases factually incorrect, click here to see article. The article attempts to discredit anti aging medicine, or age management medicine by highlighting isolated cases involving bad outcomes, by misrepresenting facts, and confusing the argument.

While there may be some unscrupulous doctors in anti aging medicine as there are in all fields, there is plenty of science and medical evidence to support anti aging treatments. So if there is a problem with anti aging medicine, it is not with the concept of anti-aging, it is with some of the individual physicians who practice it.

The main goal of anti aging medicine is to improve quality of life – to help patients live healthier as long as possible.

The article’s talking points include:

  • Unapproved use of hormones
  • No available treatments to reverse or slow aging
  • Anti-aging medicine as an unrecognized specialty
  • Unproven treatments (“risky hormone therapies”)
  • Growth hormone
  • Fad diagnoses

Let’s address each of these talking points.

Unapproved Use of Hormones

First, every drug approved by the Food and Drug Administration, or FDA is only approved for certain conditions, not just growth hormone or other hormones. The FDA monitors the safety and efficacy of drugs.  It does not regulate the practice of medicine which is left to state medical boards and professional societies.  In the US once a drug is approved a physician in his or her best judgement can prescribe it for other conditions.

In general, the FDA approved conditions does not limit how a physician can prescribe a drug, it limits how a pharmaceutical company can market the drug.  Pharmaceutical companies can only market a drug for the conditions approved by the FDA.  Again, the FDA does not regulate the practice of medicine, which it would be doing if it dictated how a physician can use a drug.

The use of a drug for a non-approved FDA conditions is called off-label use of a drug.  Over 40% of the prescriptions in this country are written off-label, so it’s a common practice.  Human growth hormone is used off-label in scientific and medical studies. Off-label use allows for much faster medical advancements, otherwise most research on new applications of an approved drug would be left to the hands of the pharmaceutical companies, leaving medical universities and research centers without much to do.

Eight out of 10 oncologists (cancer doctors) prescribe chemotherapy treatments off-label and over half of such treatments are being prescribed for cancers not approved.  Chemotherapy agents, which are foreign to the body, are far more toxic than hormones the body naturally makes.

Chemotherapy agents are associated with a higher incidence of side effects and far more devastating consequences such as permanent damage to the heart and nervous system than are hormones. See this article from the American Cancer Society to see it’s rational for off-label use of chemotherapy agents. The same rational applies to all medications, including hormones.

The FDA has interpreted a federal statue regarding human growth hormone as meaning human growth hormone can only be written on-label (for only FDA approved conditions), but that position of the FDA has not held up in our court system.

A word on the FDA. Should we be comforted by “FDA approval”?  Take this into consideration. Unknown to many including physicians is the fact that the FDA is not totally supported by tax dollars, but receives over 65% (2011) of its funding for drug approval from the pharmaceutical companies in the form of user fees. Also click here.

It’s touted by the government as a way to speed up the drug approval process, but is it wise to allow the pharmaceutical industry to fund the agency that regulates it?  In 2011 user fees were expected to add $700 million to the FDA coffers. When you look at the FDA’s expenditures, pharmaceutical companies are in effect paying the salaries of FDA employees.

Also, the scientific advisory committees that review drug applications are replete with scientists/physicians who have financial relationships with pharmaceutical companies. This creates a potential conflict of interest, perhaps leading to approval of drugs that should not have been approved, and rejection of drugs that should have been approved. Read this article published in JAMA (Journal of the American Medical Association).

The point of this discussion is “FDA approval” should be taken with some skepticism rather than simply accepting it as a strong stamp of approval that many consider it to be.

No Treatments to Slow Aging

Dr. Olshansky who said there are no treatments to slow aging is not a physician. He holds a PhD in sociology. The book, The Immortality Edge, which AntiAgingWorld has reviewed on this website discusses the many ways to slow aging by enhancing telomere health.

These include exercise, nutritional supplements (fish oil, vitamin D, acetyl-L-carnitine, carnosine, N-acetylcysteine, plus more), and hormonal optimization. In addition, TA-65 has been shown to increase telomere length, and in human studies has been shown to lower blood pressure, improve glucose control, improve bone density,  and enhance immune function.

Advancements in stem cell therapies are already being employed in heart failure, diabetes, management of strokes and Parkinson’s disease, and aesthetics with encouraging results. This means we will be able to reverse the effects of disease and aging.

Though aging is natural, the accelerated aging that many experience is not natural and therefore accelerated aging can reasonably be argued to be a “disease”. Diabetes is the classic model of accelerated aging. A big goal of anti aging medicine is to prevent this type of accelerated aging.

Anti Aging Medicine is not a Recognized Specialty

This is true.  But every new specialty goes unrecognized by the American Board of Medical Specialties (ABMS) for a period of time.  Sports Medicine has existed since the ancient Olympics and first started to blossom in the US in the 1940’s when orthopedic surgeons started to stand on the sidelines of football fields.

The American Journal of Sports Medicine was launched in 1970.  The ABMS did not recognize Sports Medicine in the primary care specialties until 1993 when the first “accepted” certification test was offered.  I know, I took that first exam.  Sports Medicine became recognized in the field of orthopaedics even later than 1993.  So Sports Medicine existed a very long time before becoming a recognized field in medicine.

There are plenty of opportunities for physicians to become trained in Anti Aging Medicine/Age Management Medicine, either through the American Academy of Anti-Aging Medicine, or Cenegenics Medical Institute.  In addition, several courses on an array of treatments used in the field are offered through other organizations.  Check to see if your physician has received some formal training.

When it comes to hormones endocrinologist are frequently considered the ultimate experts. In reality endocrinology largely involves the management of diabetes and thyroid disorders. Management of sex hormone deficiencies is largely ignored by the field.

Even urologists, many of whom who treat male conditions are poorly trained in male hormone replacement therapy.  There is a definite need to improve training in this area but mainstream medicine has been reluctant to provide it so physicians have had no choice but to look elsewhere.

Unproven Treatments

The CNN anti anti aging medicine article focused on hormone therapies.  Many mainstream physicians are critical of the use of bio-identical hormones even though more and more pharmaceutical companies are receiving FDA approval for their bio-identical formulations. This means that bio-identical hormones have been studied contrary to what many mainstream physicians say. Beyond studies for FDA approval Dr. Ken Holtorf has published a nice review article looking at the evidence to support bio-identical hormones.

The CNN article is critical of compounding pharmacies, even though FDA has gone on record saying compounding fills a necessary role. Compounding is the formulation of a drug for a specific patient in response to a specific prescription.  The drug in essence is being customized for the patient.

There are many reasons for compounding (drug requires dosing based on patient’s body weight, need to avoid toxicity to liver or kidneys, patient unable to take medications orally). It may surprise even doctors that many chemotherapy agents are compounded.  In fact, if the government made compounding illegal the field of medical oncology (cancer) would struggle to survive.

The reality is the oral route that most FDA approved drugs are designed for is probably the worst way to administer a drug. Much of the drug gets destroyed in the GI tract and metabolized by the liver leaving a relatively small amount to take action.  Therefore higher doses of oral drugs must be used to achieve the desired effect leading to more side effects.

Compounding allows for using FDA approved drugs in alternative ways.  While the compounded version is not FDA approved, compounding pharmacies can only compound drugs that are already FDA approved.  Example: a compounding pharmacy could compound the non-steroidal Celebrex (FDA approved) but not Vioxx or Bextra (no longer FDA approved).

There are logistical reasons why compounded formulations are not FDA approved. In part, the FDA cannot verify that the formulation contains the amount of drug specified by the prescription.  The formulation would have to be tested, which then means there is no drug left for the patient since the drug is being formulated or customized for a single person, not mass-produced which allows for sampling and verification of dosing. Keep in mind many chemotherapy agents are compounded and therefore are also not FDA approved just like compounded hormones are not FDA approved.

Contrary to commonly held beliefs by critics, compounding pharmacies are regulated.  They must meet federal OSHA regulations and are regulated by state boards of pharmacy. The FDA has stated that compounded prescriptions are both ethical and legal as long as they are prescribed by a licensed physician for a specific patient and compounded by a licensed pharmacy.

What is really unproven in medicine is the practice of prescribing multiple medications to a patient, or the practice of poly pharmacy.  It is not uncommon these days to see patients on 10 or even 20+ prescribed medications. Do we really think the human body is that poorly designed that it needs all that pharmaceutical help?

Physicians get very little training in pharmacy, yet are conditioned to think that every sign and symptom requires a pharmaceutical solution (the pharmaceutical industry has infiltrated medical education at all levels). If you took the prescription pad away from physicians most would have nothing to offer you.

Drugs are studied in isolation not in commonly prescribed clusters used so commonly today. So we really don’t know what happens to the body from the practice of poly pharmacy. We do know such patients get more side effects, though.

Growth Hormone

The problem with human growth hormone is its name and its associated use in anti aging medicine.  In adults growth hormone is primarily a healing hormone.  It also maintains muscle mass and body composition.  Growth hormone also upregulates receptors for our other hormones, essentially enhancing our other hormones.

Human growth hormone is unique in that it’s the only drug I can think of in which the pediatric dose is higher than the adult dose. In fact, the pediatric dose is 4 to 6 times higher than the approved adult dose.

Many early studies on growth hormone in adults that critics like to cite involved pediatric doses, doses too high for adults. Growth hormone has been used in the pediatric population for more than 40 years, longer than it has been used in adults, and after decades of use in pediatrics at doses far higher than used in adults, growth hormone as been found to be safe.

The side effects of growth hormone in adults are dose related and are primarily the result of swelling which responds by simply lowering the dose. The following quote comes from an article published in the Journal of Clinical Endocrinology and Metabolism in 1998,    “As recombinant GH has exact sequence homology with natural human GH, side-effects result from excess replacement alone.”  It can be found on page 391 under “Reported Adverse Effects of GH Replacement”.

This means that human growth hormone is exactly identical to what the body makes.  This explains why adverse effects related to its use occur only because of excessive dosing – a manageable problem.

Side effects from other drugs occur because of excessive dosing, but also due to their metabolites.  The body struggles sometimes in metabolizing the many drugs that are foreign to the body. The body makes growth hormone, it does make the many drugs prescribed by physicians. In physiologic doses and when prescribed to adults with a growth hormone deficiency, human growth hormone is safe.

Fad Diagnoses

The article calls the diagnosis of adrenal fatigue bogus.  Hormonal deficiencies conventionally are defined by an archaic method that relies solely on laboratory testing which arbitrarily establishes the cut-off for diagnosing a hormone deficiency as a level 2 standard deviations below the mean.

This means that only 2.5% of the population can ever be “diagnosed” as having a hormone deficiency. (Some physicians think that as many as 40% of the US population is low in thyroid hormone). In reality patients can have many symptoms of a hormonal deficiency while having hormone levels within the reference range, because the reference range has little to do with what a normal level is in a given individual.

In discussing testosterone deficiency, Abraham Morgantaler, MD, a Harvard urologist who has debunked the many myths surrounding testosterone and prostate cancer, says the testosterone deficiency is a clinical diagnosis, not a biochemical diagnosis.  A clinical diagnosis takes into account signs and symptoms, not just blood hormone levels. The same holds true for other hormone deficiencies/insufficiencies. The body runs on a continuum, not on conveniently and arbitrarily set cut-off points used to make a diagnosis.

Also, hormone deficiencies cause many symptoms. The reason for this is that there are receptors for all our hormones on all our cells. So hormone deficiencies cause symptoms related to all organ-systems. It’s a common maxim in medicine to explain the occurrence of many symptoms with as few diagnoses as possible.

When a patient presents with many symptoms at once it is more likely to be explained by one or two diagnoses rather than multiple diagnoses. Example: low thyroid commonly causes fatigue, muscle aches, depression, elevated cholesterol, and constipation. Simply replacing thyroid has a good chance of resolving all those issues.

But, instead many physicians will make 5 diagnoses and prescribe an anti-depressant, an anti-inflammatory, a statin drug, a laxative, and tell the patient that they probably have chronic fatigue syndrome.  They will make 5 diagnoses simply because thyroid tests will the show the patient to have results in the reference range, even though the patient has the classic symptoms of low thyroid. The same can be said for adrenal insufficiency/fatigue.

In other words if it looks like a duck, walks like a duck, and quacks likes a duck, it’s probably a duck. So treat it like a duck.

The CNN article correctly mentions the overall health benefits obtained through exercise and nutrition.  Anti-aging treatments are no substitute to healthy living, and in my practice every patient receives a 2 hour consultation with an exercise/nutrition specialist with monthly follow-ups.

Many primary care physicians, however are unable to provide such education to their patients as it is time consuming and generally not covered by insurance. In addition, most primary care physicians are poorly trained in the areas of exercise and nutrition. Thus, Anti Aging Medicine or Age Management Physicians can fill a void created by the current sick-care model of health care that places emphasis on surgery and pharmaceutical drugs.

See related articles.

“Get Ready to Celebrate Another Day of Living”

“Anti-Aging, the Four Secrets: Part 1”

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Dr. Joe Jacko

Dr. Joe is board certified in internal medicine and sports medicine with additional training in hormone replacement therapy and regenerative medicine. He has trained or practiced at leading institutions including the Hughston Clinic, Cooper Clinic, Steadman-Hawkins Clinic of the Carolinas, and Cenegenics. He currently practices in Columbus, Ohio at Grandview Primary Care. Read more about Dr. Joe Jacko

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