Happy about my membership in the DHHS HIV Adult and Adolescent Guidelines Panel

Gang

I am very happy about having been selected to be a community member to this respected panel. This is my second try in the past 4 years and I finally made it through. This is one of the most important (if not the most important) medical guidelines panel in HIV treatment. I will be lucky to be working with great researchers and clinicians, and will make sure that the concerns from the patients in the field are brought to their attention. Jules Levin has already reminded not to forget bone density issues, aging related issues, some women-specific issues and toxicities as areas to bring up as data and signals in the field become available. I am glad I have good mentors like Jules, Bob Munk. Marty Delaney and Lynda Dee that have been there before me !

Wish me luck!

Nelson

Issue No. 52 | December 12, 2008

AIDSinfo.nih.gov is pleased to provide you with a weekly update of highlights about what has happened in the world of HIV/AIDS treatment, prevention, and research. We hope you find this encapsulated view of HIV/AIDS news useful.

Adult and Adolescent Guidelines Panel Announces New Members

The Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (a working group of the Office of AIDS Research Council) is pleased to welcome the following new members to the Panel. The new members will begin a 4-year term beginning February 2009.

New Scientific Members:
Robert Dodge, Ph.D., R.N., A.N.P. (University of North Carolina)
Christopher Gordon, Ph.D. (National Institute of Mental Health, NIH)
Michael Hughes, Ph.D. (Harvard University)
William Kapogiannis, M.D. (National Institute of Child Health & Human Development, NIH)
Daniel Kuritzkes, M.D. (Harvard University)
Mark Sulkowski, M.D. (Johns Hopkins University)

New Community Member:
Nelson Vergel (Houston, Texas)

The following members will be concluding their services to the Panel in February 2009. The Panel thanks them for their contributions over the years.
A. Cornelius Baker (National Black Gay Men’s Advocacy Coalition)
Charles Carpenter, M.D. (Brown Medical School)
Suzanne Willard, Ph.D., C.R.N.P. (Elizabeth Glaser Pediatric AIDS Foundation)

Should I take Vitamin D if I am taking Viread or Truvada?

Vitamin D and Viread. Should I be concerned?
Dec 1, 2008

Dear Nelson:

Thanks for what you do for us

I just read an email that said that a study showed that people on Viread had low vitamin D and may have problems with bone. Should I take Vitamin D with Viread?

I do not want to have broken bones as I age

Tony

Response from Mr. Vergel

Dear Tony

Researchers at Mount Sinai School of Medicine recently presented a very interesting paper at the ICAAC 2008 conference on this issue. As you well know, Tenofovir (Viread) is probably the best nucleoside analog out there with the least problems with lipoatrophy and other side effects. However, it has been associated with kidney issues in some treatment experienced patients and also with loss of bone density in some studies. It seems that the bone effects are greater in those taking tenofovir with boosted protease inhibitors. Unfortunately, most of us do not know we have low bone density until we get a fracture.

Vitamin D is needed by our bodies to metabolize calcium to build up bone. Most of it is made when our skin in exposed to sunlight. Many people do not get enough sun in winter months.

In this study, most patients on tenofovir had low Vitamin D levels in their blood (measured as 25(OH)D). 39% of those with low Vitamin D levels also had high parathyroid hormone levels (PTH)

PTH is produced in the parathyroid glands which are four pea-sized glands located on the thyroid gland in the neck. Though their names are similar, the thyroid and parathyroid glands are entirely different glands, each producing distinct hormones with specific functions. The parathyroid glands secrete PTH, a substance that helps maintain the correct balance of calcium and phosphorus in the body. PTH regulates the level of calcium in the blood, release of calcium from bone, absorption of calcium in the intestine, and excretion of calcium in the urine.

When the level of calcium in the blood falls too low, the parathyroid glands secrete just enough PTH to restore the blood calcium level. High PTH usually means that there may be some bone loss problems. Low Vitamin D is known to cause hyperparathyrodism (high PTH).

The study investigators hypothesize that Viread’s effect on bone may be related to this low Vit D/high PTH effect. More studies are needed with a larger number of patients

You may want to ask your doctor to measure 25 (OH) D levels. I am also an activist who is trying to get DEXA bone scans to be part of standard of care for people with HIV. It would be great to get a DEXA bone scan before someone starts HAART and then repeated it every two to three years to see how your bones are doing on therapy.

By the way, HIV infection by itself has also been associated with loss of bone density. But some medications may also add to this problem.

Bone density research in HIV is progressing. I tell people to work out with weights and machines, to get at least 30 minutes of sun a day, and to make sure their thyroid hormones and testosterone are in normal range to prevent bone loss. Some people would also benefit from taking Calcium/Vitamin D supplements and/or precription drugs approved to increase bone density.

Talk to your doctor since this is very new data.

Nelson

World AIDS Day: Adverse Impact of Steroid Law and Steroid Hearings on Anabolic Therapies

World AIDS Day: Adverse Impact of Steroid Law and Steroid Hearings on Anabolic Therapies
Posted on 15:42 December 1st, 2008 by Millard Baker

http://www.mesomorphosis.com/blog/2008/12/01/world-aids-day-adverse-impact-of-steroid-law-for-hiv/

In recognition of World AIDS Day, we urge Congressional leaders in the United States to carefully consider the significant harm that morally-guided U.S. steroid policy has had for the life-saving therapeutic applications offered by anabolic-androgenic steroids. The criminalization of anabolic steroids and steroid hysteria perpetuated by Congressional steroid hearings has had an adverse impact on medical research and medical therapies involving anabolic steroids, particularly in the prevention and treatment of HIV+ associated wasting disease.

Anabolic steroids are one of the safest and most effective treatments for HIV associated wasting and have been invaluable in helping HIV+ patients retain, preserve and restore lean body weight and stay alive. Given that wasting is one of the most common symptoms of HIV and that HIV+ patients with wasting symptoms have significantly higher mortality rates, anabolic steroids have been an invaluable medical treatment.

Michael Mooney, of Medibolics, and Nelson Vergel, of the Program for Wellness Restoration, have spearheaded educational efforts and have extensively documented the benefits of anabolic steroid therapy for AID/HIV wasting in “Built to Survive“. Mooney and Vergel have discussed the negative consequences arising from the demonization of steroids by the Anabolic Steroid Control Act of 1990 (”Anabolic Steroid Legality and the Physician,” January 28).

The Anabolic Steroid Act of 1990 created grave misunderstandings about the legal status of “steroids as medicines” to the public and to the physicians trying to help their patients. This law states only that anabolic steroids can not be prescribed for cosmetic or athletic purposes, but the impression it created was that steroids were off limits to everyone, and that they are basically illegal for any use. This is not the case. To compound this climate of fear, it seems that when this law was passed in 1990 several of the more conservative regional governing medical organizations made doctors uneasy, giving them impression that they would become the object of scrutiny if they prescribed steroids at all.

The scheduling of anabolic steroids as controlled substances was a medical catastrophe that pandered to anti-doping crusaders in sports while ignoring the medicinal value of androgens and the life-saving therapeutic potential this category of pharmaceutical drugs offered for HIV+ patients. The regulatory agencies in charge of scheduling of drugs strongly protested the inclusion of anabolic steroids in the Controlled Substances List. Legislators ignored the scientific advisors and experts from the American Medical Association (AMA), the Food and Drug Administration (FDA), the Department of Health and Human Services (DHHS) and the Drug Enforcement Enforcement (DEA) to pass the Anti-Drug Abuse Act of 1988 and the Anabolic Steroid Control Act of 1990.

The legislators were guided by the moral condemnation of athletes that use anabolic steroids and performance enhancing drugs rather than a rational empirical analysis of steroid use and abuse and the effects of such legislation on leigitmate medical research and anabolic therapy.

Unfortunately, the steroid hysteria has continued with the Congressional steroids and baseball hearings initiated by Henry Waxman (and former chief of staff Phil Schiliro) and the passage of more draconian steroid laws in recent years. California resident Mark A. Meier outlined the impact the steroid hearings in a letter to the Nancy Pelosi, Speaker of the House (”Representative Henry Waxman’s Hearings on Steroids in Sports and the Impact on Treatments for HIV and other Medical Conditions,” March 12).

The result, then, of Representative Waxman’s hearings has been an attack on an important, powerful, beneficial and legal therapy solely because professional athletes use it improperly. Patients with legitimate medical needs should not be made to suffer because of the improper actions of a few.

Nelson Vergel of the HIV Blog explains how political pressure and steroid hysteria have restricted the availability of anabolic steroids for HIV+ patients. The moral and political pressure resulted in the discontinuation of Deca Durabolin by Watson Pharmaceutical and the discontinuation of nandrolone decanoate by compounding pharmacies like Applied Pharmacy (”Important information about nandrolone in the U.S.” March 17).

Watson stopped making [nandrolone decanoate] because… Congress and the DEA are treating anabolics like the treat crack-cocaine and are closely watching every prescriber’s and manufacturer’s move. No HIV doc has ever got in trouble since many studies have shown nandrolone’s benefit and can justify its medical use. However, inexperienced HIV doctors who have not been around long enough to know its history shy away from prescribing due to the bad publicity and misconceptions around these medicines. […]

Applied Pharmacy stopped all production due to DEA pressure. Some compounders are making doctors sign a waiver to say they will not prescribe nandrolone for non medical uses. Some doctors feel this represents extra liability.

The effects of anabolic steroids in treating HIV+ associated wasting syndrome by preserving and increasing lean body weight has been well documented by multiple studies. Unfortunately, Congressional leaders in the United States have based steroid policy on emotional testimony and moral objections to cheating in sports rather than scientifically-guided legislative policy; this has been to the detriment of individuals with AIDS/HIV+ associated wasting syndrome. The morally-guided steroid policy has effectively limited the availability of anabolic steroids for those individuals who use steroids as a matter of medical necessity. We urge Congress to reconsider and re-evaluate the Anabolic Steroid Control Act to address the address the adverse effects of current steroid policy on the advancement of anabolic therapies in medicine.