I sent this email to Medicare:
Sent: Wednesday, March 31, 2010 10:53 AM
To: Baldwin, JoAnna F. (CMS/OCSQ)
Subject: From the feedback tool - 100331-000018
Regarding:Decision Memo for Dermal injections for the treatment of facial lipodystrophy syndrome (FLS) (CAG-00412N)
I have the following questions:
1- Do patients have to remain depressed to get yearly touch ups ?
2- Are Sculptra and Radiesse (the two FDA approved options) to be included in Medicare part D formularies?
3- How much will doctors get paid for every session?
4- Will there be a maximum number of sessions per year allowed?
Thank you
Nelson Vergel
Founder
FacialWasting.org
******
This the reply from the JoAnna Baldwin from CMS. As you can tell, there is still a lot of work they need to do in establishing rates, etc. I will keep following up for updates.
nelson
(Background for this email for those who have not read Medicare's decision: http://www.hivandhepatitis.com/recent/2010/0326_2010_a.html )
Dear Mr. Vergel,
I hope to be able to help with some of your questions. Please see the below responses and please let me know if you have additional questions.
1- Do patients have to remain depressed to get yearly touch ups ?
I do not know exactly how local Medicare contractors will implement the policy so there is always potential for variation in implementation when the national coverage policy is not explicit. I would venture to say that some documentation would continue to exist in the patient’s medical record that depression is a continued concern and that these conversations be had between the patient and their treating physician. But again, the policy is not explicit in this regard.
2- Are Sculptra and Radiesse (the two FDA approved options) to be included in Medicare part D formularies?
I do not believe these products fall under Part D Medicare coverage. For example, if the injections are delivered in a physician’s office, then the physician would purchase the fillers and then bill Medicare for the fillers and for administering the injections. Part B co-pays and deductibles would apply to this service just as it would be applied to any other Medicare covered service.
3- How much will doctors get paid for every session?
The payment amounts are in the process of being established. Medicare participating providers would accept the payment amount as the full payment but again, co-pays for each office visit would still apply just as any other Medicare Part B service.
4- Will there be a maximum number of sessions per year allowed?
The national coverage policy does not limit the number of sessions per year.
-
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Monday, April 12, 2010
Thursday, April 08, 2010
Table of Contents- Testosterone: A Man's Guide
Table of Contents
About the Author
Chapter 1 Introduction
Chapter 2 Testosterone and Its Replacement Therapy Options
History of Testosterone
What Is Testosterone and Why It Is Important
What Are the Symptoms of Low Testosterone (deficiency)?
Questions to Determine If You May Have Testosterone Deficiency
Causes of Testosterone Deficiency
Diagnosis of Testosterone Deficiency
Top Ten Mistakes in Testosterone Replacement Therapy
Testosterone Replacement Options
Chapter 3 Important Tests Required before Starting Testosterone Replacement Therapy
Ensuring Prostate Health
Ensuring Liver Health
Monitoring Blood Pressure
Avoiding Enlarged Breast (Gynecomastia)
Medications and Products that Can Cause Gynecomastia
Keeping Cholesterol (Lipids) in Check
Hypothalamic-Pituitary-Testicular (or Gonadal) Axis (HPTA or HPGA) Dysfunction
Other Important Hormones
Special Considerations for Women
Supplements That Claim to Have Sexual Function and/or Testosterone Improvement Claims
Resources
Appendix A: Compounding Pharmacies
Frequently Asked Questions about Compounding
Some Compounding Pharmacies I Have Used
Appendix B: Physicians Who Treat Hypogonadism
Appendix C: Interview with Dr. Michael Scally about Testosterone Replacement, Its Side Effects and Management Strategies
Appendix D: Testosterone Physician’s Desk Reference (PDR) Package Insert
Description
Clinical Pharmacology
Pharmacokinetics
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Abuse and Dependence
Overdosage
Dosage and Administration
How Supplied
About the Author
Chapter 1 Introduction
Chapter 2 Testosterone and Its Replacement Therapy Options
History of Testosterone
What Is Testosterone and Why It Is Important
What Are the Symptoms of Low Testosterone (deficiency)?
Questions to Determine If You May Have Testosterone Deficiency
Causes of Testosterone Deficiency
Diagnosis of Testosterone Deficiency
Top Ten Mistakes in Testosterone Replacement Therapy
Testosterone Replacement Options
Chapter 3 Important Tests Required before Starting Testosterone Replacement Therapy
Ensuring Prostate Health
Ensuring Liver Health
Monitoring Blood Pressure
Avoiding Enlarged Breast (Gynecomastia)
Medications and Products that Can Cause Gynecomastia
Keeping Cholesterol (Lipids) in Check
Hypothalamic-Pituitary-Testicular (or Gonadal) Axis (HPTA or HPGA) Dysfunction
Other Important Hormones
Special Considerations for Women
Supplements That Claim to Have Sexual Function and/or Testosterone Improvement Claims
Resources
Appendix A: Compounding Pharmacies
Frequently Asked Questions about Compounding
Some Compounding Pharmacies I Have Used
Appendix B: Physicians Who Treat Hypogonadism
Appendix C: Interview with Dr. Michael Scally about Testosterone Replacement, Its Side Effects and Management Strategies
Appendix D: Testosterone Physician’s Desk Reference (PDR) Package Insert
Description
Clinical Pharmacology
Pharmacokinetics
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Abuse and Dependence
Overdosage
Dosage and Administration
How Supplied
Wednesday, April 07, 2010
From Upcoming Book: Testosterone: A Man's Guide- The top ten mistakes in testosterone replacement therapy
From my upcoming book: Testosterone: A Man's Guide (to be released in May and available on amazon.com)
TOP TEN MISTAKES IN TESTOSTERONE REPLACEMENT THERAPY
In my years of using testosterone and lecturing, I have seen mistakes being made by people who did not know better. Some mistakes really caused serious negative effects on their quality of life. I will attempt to list a few.
1. Using “street sources” of testosterone: I have met men whose doctors do not support the use of TRT, so they buy it in the black market or from someone at their gyms. This is illegal and dangerous since you need physician supervision. Also, no one knows what those street testosterone products may contain. Some may contain just peanut oil. Testosterone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III, so it is a controlled substance regulated by the Drug Enforcement Agency (DEA). It can be legally prescribed by a doctor but it is not legal to use it without a prescription. Buying it, importing it, selling it, or even using it without a proper prescription may have legal consequences. Not having a doctor follow-up your blood work is a sure way to get in trouble! If you have low testosterone, there are hundreds of doctors who will prescribe TRT. If you are using it to increase muscle even though you have normal levels, be a smart patient who knows the legalities and research all you can. The use of testosterone or its cousin molecules (anabolic steroids) is illegal in the United States for those without a medical diagnosis that justifies their use. Be careful not to be set up by “informants” who may inform the DEA of your purchase. Read the information in this book about how stopping testosterone can cause health problems (if you are using black market testosterone, chances are that you will run out of your source eventually). In one word: Don’t do it.
2. Not exploring what TRT option is best for you: Some people are told by their doctors to use injections even if needles were a concern to them or if they had to be inconvenienced to go see their doctors every 2 weeks for an injection. Some did not know that they could learn to self-inject. Others were prescribed daily gels even if their busy lives make it difficult to have perfect compliance to the daily therapy. Others were not told about the potential transfer of testosterone from their skin (after applying gels) if they hug their wives, kids, or sexual partners. Every TRT option has advantages and disadvantages that may be more suitable for one person over another, so read the following section on TRT options.
3. Not using the right dose: People put on TRT need to have their testosterone blood levels rechecked 2 weeks or a month after they start therapy, right before they administer the corresponding dose for that day or week. This gives you information on whether you need to increase or decrease the dose. Total testosterone blood levels under 500 ng/dL that are not improving your sexual desire and energy should be increased to 500–1,000 ng/dL by increasing the frequency of injection or dose, increasing the amount or concentration of the gel, etc. Some doctors fail to retest to adjust and some patients stop using TRT because they do not feel the benefits related to a low dose or had too many side effects related to a higher dose. I have seen people getting 200 mg injections of testosterone cypionate once a month, which actually is worse than not treating them at all. See next sections for more details.
4. Cycling on and off TRT: TRT is a life time commitment. Once you start, you should assume that you will stay on it unless you have an unmanageable side effect. Some patients think that “giving the body a break” once every few weeks is a good thing. What they do not know is that when you are on TRT, your testicles do not produce testosterone, so when you stop you are left with no testosterone in your system for weeks. Depression, weight loss, lack of motivation, and loss of sex drive can appear rapidly. Some men never have their HPG axis return to normal after stopping testosterone (especially if they were hypogonadal at baseline). Read more details on “resetting the HPGA.”
5. Stopping TRT abruptly due to an unrelated signal: Some of us may be taking medications for other conditions along with TRT. Sometimes new medications can increase cholesterol and triglycerides and/or liver enzymes (I call these “signals”). Some doctors prematurely blame TRT instead of any of the new medications that the patient might have started. I have seen patients suffer because of this poor judgment of their doctors. Weeks later, they learn that stopping TRT did not improve any of these problems and by then they feel tired, depressed, and asexual.
6. Not knowing how to manage potential side effects: Luckily, this will not happen to you after you finish reading this book. I know men who have stopped TRT due to swelling in their nipple area, acne, moodiness, perceived lack of benefit, hair loss, or a prostatic specific antigen (PSA) increase that was due to a prostatic infection. Knowing how to manage these is key to long-term success so that you do not prematurely stop when you could have just readjust the dose, the delivery method, or taken a medication to counteract the potential problem. Only the best doctors who do not overreact know how to do this.
7. Having a life style that is not “testosterone friendly”: If you smoke, drink more than two drinks a day, smoke too much pot, are overweight, do not exercise, do not keep your blood sugar or lipids in control, and do not show up to doctor’s appointments, you do not have a testosterone-friendly lifestyle. Studies have shown that these factors may influence your sexual function and long-term health. Excessive alcohol can decrease testosterone. Exercise can increase it (to a certain degree if done properly). You can read more about this later in this book.
8. Not reading or being “networked” with other patients: Being in isolation when it comes to information and experiences make you a less effective patient. There are online groups of men who discuss testosterone and other issues (see the Resource section). Sharing your experiences and learning from others are keys to being an empowered and proactive patient who maximizes benefits of any therapy you are using. Many of the practical “tricks” that I have learned have been obtained via this method. The collective wisdom is more powerful than just relying on everything your doctor tells, or does not tell you.
9. Not divorcing your doctor when you have to: Divorcing your incompetent doctor can be difficult, especially if you are not a networked patient who reads a lot about your condition. Many people do not have options and have to see a certain doctor in an health management organization (HMO) setting. But most of us can search for educated doctors who do not speak down to you and who treat you as equal. Your doctor should be your partner in your health and not just an unquestionable authority. Although they are saving lives and have spent hundreds of hours in school and practice to do so, they are human beings who are exposed to myths and misconceptions similar to all of us. I have heard the most incredible things from doctors about TRT that make me question how unfortunate their patients may be. So, do your home work and find a doctor who supports you in your search for optimum health. See the Resource section.
10. Poor compliance: Forgetting when to inject or apply gels is a common complaint. Good time management and reminders are key. I use Google calendar which can be set up to send me text messages to my phone as reminders. Avoid the yo-yo effect that poor compliance causes! TRT is a lifetime and life style commitment that should be explored with care.
TOP TEN MISTAKES IN TESTOSTERONE REPLACEMENT THERAPY
In my years of using testosterone and lecturing, I have seen mistakes being made by people who did not know better. Some mistakes really caused serious negative effects on their quality of life. I will attempt to list a few.
1. Using “street sources” of testosterone: I have met men whose doctors do not support the use of TRT, so they buy it in the black market or from someone at their gyms. This is illegal and dangerous since you need physician supervision. Also, no one knows what those street testosterone products may contain. Some may contain just peanut oil. Testosterone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III, so it is a controlled substance regulated by the Drug Enforcement Agency (DEA). It can be legally prescribed by a doctor but it is not legal to use it without a prescription. Buying it, importing it, selling it, or even using it without a proper prescription may have legal consequences. Not having a doctor follow-up your blood work is a sure way to get in trouble! If you have low testosterone, there are hundreds of doctors who will prescribe TRT. If you are using it to increase muscle even though you have normal levels, be a smart patient who knows the legalities and research all you can. The use of testosterone or its cousin molecules (anabolic steroids) is illegal in the United States for those without a medical diagnosis that justifies their use. Be careful not to be set up by “informants” who may inform the DEA of your purchase. Read the information in this book about how stopping testosterone can cause health problems (if you are using black market testosterone, chances are that you will run out of your source eventually). In one word: Don’t do it.
2. Not exploring what TRT option is best for you: Some people are told by their doctors to use injections even if needles were a concern to them or if they had to be inconvenienced to go see their doctors every 2 weeks for an injection. Some did not know that they could learn to self-inject. Others were prescribed daily gels even if their busy lives make it difficult to have perfect compliance to the daily therapy. Others were not told about the potential transfer of testosterone from their skin (after applying gels) if they hug their wives, kids, or sexual partners. Every TRT option has advantages and disadvantages that may be more suitable for one person over another, so read the following section on TRT options.
3. Not using the right dose: People put on TRT need to have their testosterone blood levels rechecked 2 weeks or a month after they start therapy, right before they administer the corresponding dose for that day or week. This gives you information on whether you need to increase or decrease the dose. Total testosterone blood levels under 500 ng/dL that are not improving your sexual desire and energy should be increased to 500–1,000 ng/dL by increasing the frequency of injection or dose, increasing the amount or concentration of the gel, etc. Some doctors fail to retest to adjust and some patients stop using TRT because they do not feel the benefits related to a low dose or had too many side effects related to a higher dose. I have seen people getting 200 mg injections of testosterone cypionate once a month, which actually is worse than not treating them at all. See next sections for more details.
4. Cycling on and off TRT: TRT is a life time commitment. Once you start, you should assume that you will stay on it unless you have an unmanageable side effect. Some patients think that “giving the body a break” once every few weeks is a good thing. What they do not know is that when you are on TRT, your testicles do not produce testosterone, so when you stop you are left with no testosterone in your system for weeks. Depression, weight loss, lack of motivation, and loss of sex drive can appear rapidly. Some men never have their HPG axis return to normal after stopping testosterone (especially if they were hypogonadal at baseline). Read more details on “resetting the HPGA.”
5. Stopping TRT abruptly due to an unrelated signal: Some of us may be taking medications for other conditions along with TRT. Sometimes new medications can increase cholesterol and triglycerides and/or liver enzymes (I call these “signals”). Some doctors prematurely blame TRT instead of any of the new medications that the patient might have started. I have seen patients suffer because of this poor judgment of their doctors. Weeks later, they learn that stopping TRT did not improve any of these problems and by then they feel tired, depressed, and asexual.
6. Not knowing how to manage potential side effects: Luckily, this will not happen to you after you finish reading this book. I know men who have stopped TRT due to swelling in their nipple area, acne, moodiness, perceived lack of benefit, hair loss, or a prostatic specific antigen (PSA) increase that was due to a prostatic infection. Knowing how to manage these is key to long-term success so that you do not prematurely stop when you could have just readjust the dose, the delivery method, or taken a medication to counteract the potential problem. Only the best doctors who do not overreact know how to do this.
7. Having a life style that is not “testosterone friendly”: If you smoke, drink more than two drinks a day, smoke too much pot, are overweight, do not exercise, do not keep your blood sugar or lipids in control, and do not show up to doctor’s appointments, you do not have a testosterone-friendly lifestyle. Studies have shown that these factors may influence your sexual function and long-term health. Excessive alcohol can decrease testosterone. Exercise can increase it (to a certain degree if done properly). You can read more about this later in this book.
8. Not reading or being “networked” with other patients: Being in isolation when it comes to information and experiences make you a less effective patient. There are online groups of men who discuss testosterone and other issues (see the Resource section). Sharing your experiences and learning from others are keys to being an empowered and proactive patient who maximizes benefits of any therapy you are using. Many of the practical “tricks” that I have learned have been obtained via this method. The collective wisdom is more powerful than just relying on everything your doctor tells, or does not tell you.
9. Not divorcing your doctor when you have to: Divorcing your incompetent doctor can be difficult, especially if you are not a networked patient who reads a lot about your condition. Many people do not have options and have to see a certain doctor in an health management organization (HMO) setting. But most of us can search for educated doctors who do not speak down to you and who treat you as equal. Your doctor should be your partner in your health and not just an unquestionable authority. Although they are saving lives and have spent hundreds of hours in school and practice to do so, they are human beings who are exposed to myths and misconceptions similar to all of us. I have heard the most incredible things from doctors about TRT that make me question how unfortunate their patients may be. So, do your home work and find a doctor who supports you in your search for optimum health. See the Resource section.
10. Poor compliance: Forgetting when to inject or apply gels is a common complaint. Good time management and reminders are key. I use Google calendar which can be set up to send me text messages to my phone as reminders. Avoid the yo-yo effect that poor compliance causes! TRT is a lifetime and life style commitment that should be explored with care.
Tuesday, March 23, 2010
MEDICARE EXPANDS COVERAGE FOR TREATING FACIAL LIPODYSTROPHY SYNDROME IN PEOPLE LIVING WITH HIV
MEDICARE NEWS
For Immediate release Contact: CMS Office of Media Relations
March 23, 2010 (202) 690-6145
MEDICARE EXPANDS COVERAGE FOR TREATING FACIAL LIPODYSTROPHY SYNDROME IN PEOPLE LIVING WITH HIV
The injections included in today’s coverage decision are “fillers” that have been approved by the U.S. Food & Drug Administration (FDA) to be injected under the skin in the face to help fill out its appearance specifically for treatment of facial LDS. Data show that these injections can improve patient self-image, relieve symptoms of depression, and may lead to improved compliance with anti-HIV treatment.
The final decision is posted on the CMS Web site athttp://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=234.
Monday, February 15, 2010
Strive To Thrive While Growing Older With HIV
| By Dennis McMillan Published: February 11, 2010 | ||
However, a plethora of recent research has clearly demonstrated that people living with HIV are suffering from accelerated aging; sometimes their minds and bodies manifest problems decades earlier than their HIV-negative counterparts. Consequentially, researchers, medical providers, treatment advocates, and HIV-positive people alike are trying to figure out how to conquer this new phase of living with HIV. Many community forums on HIV and aging involve doctors and other socio-medical professionals speaking clinically, and providing the same information, from the same point of view, time and time again. Positive Force decided to move in a different direction. They invited Vergel, a man who has lived with HIV for more than two decades and who is an internationally renowned treatment advocate, to discuss HIV and aging concerns from a peer perspective. Vergel has traveled the world talking about living and thriving with HIV; has written books on the topic; and has been featured in numerous publications for his expertise and perspective.Participants who attend the forum will benefit from Vergel’s unique perspective, presentation style, and lots of information. He will present the latest treatment information, both clinical and practical, for a range of subjects, including but not limited to lipodystrophy/ lipoatrophy, accelerated aging of both mind and body, and sexual health. Forum attendees will walk away with a better handle on how to deal with problems they may already be facing and how to prevent new problems associated with HIV and aging. Vergel is a 27-year HIV survivor, Venezuelan, retired chemical engineer, lecturer and author of Built to Survive, founder of the Body Positive Wellness Clinic in Houston, and treatment activist involved in research advocacy. Bay Times interviewed him recently. “I am the founder of pozhealth at yahoogroups.com, the largest online health discussion group, and serve as an expert at thebody.com, the HIV web site with the largest reach in HIV related health issues,” he said. “I have provided over 600 lectures since 1994 in English and Spanish. I am a member of the DHHS HIV Treatment Guidelines Panel. I have presented in many conferences about issues related to living with HIV.” What is different about what he does is his being able to lecture in layman terms by blending the latest research data with a patient perspective.He spoke of the hot topics in HIV in the next five years. “The search for a cure using stem cell and immune based therapy research will become more important as well as how to deal with long term effects of HIV medications on aging, frailty, cognitive function, bone density, frailty, body changes, and others,” said Vergel. “Combating stigma and dealing with challenges in funding will be essential to controlling the spread of this epidemic.” Vergel provides a unique angle to patients. He speaks in their language about the latest research findings on facial lipoatrophy options, cardiovascular health, sexual dysfunction, hormonal balance, exercise and nutrition, latest HIV medications for those with limited treatment options, side effect management, and many other issues that are important to patients. | ||
Monday, February 01, 2010
Survivor Health Wisdom: Lecture in Orange County on March 9, 2010
Time: March 9, 2010 from 5pm to 8pm
Location: Dave and Busters, Irvine Spectrum
Street: 71 Fortune Dr.
City/Town: Irvine, CA
Website or Map: http://www.nelsonvergel.com/
Phone: 949.452.0888
Event Type: educational, forum
Organized By: Shanti Orange County
Location: Dave and Busters, Irvine Spectrum
Street: 71 Fortune Dr.
City/Town: Irvine, CA
Website or Map: http://www.nelsonvergel.com/
Phone: 949.452.0888
Event Type: educational, forum
Organized By: Shanti Orange County
More information :http://shantioc.ning.com/events/big-7-series-nelson-vergel
Lecture: Survivor Health Wisdom: Strive To Thrive While Growing Older With HIV
STOP AIDS Project's Positive Force Presents "Survivor Health Wisdom: Strive To Thrive While Growing Older With HIV" on Wed, February 17 6:30-9:30 pm at the LGBT Community Center in San Francisco.
Join Nelson Vergel, author of Built to Survive, for the latest information on: Lipoatrophy, Combating Premature Aging, and MUCH MORE!!! A light dinner will be provided.
This evening's event is part of Positive Force's ongoing series "Healthy Minds Healthy Bodies" occurring on the third Wed of every month. For more information about Positive Force, this series or to RSVP to this month's event, contact Justin Jones at 575-0150, x 250 or jjones@stopaids.org.
Join Nelson Vergel, author of Built to Survive, for the latest information on: Lipoatrophy, Combating Premature Aging, and MUCH MORE!!! A light dinner will be provided.
This evening's event is part of Positive Force's ongoing series "Healthy Minds Healthy Bodies" occurring on the third Wed of every month. For more information about Positive Force, this series or to RSVP to this month's event, contact Justin Jones at 575-0150, x 250 or jjones@stopaids.org.
Background:
The face of HIV changes with each passing day. For example, thanks to treatment advances, many people living with HIV today are living longer lives. Along with longer lives comes the usual health concerns: increased risks for heart disease, non-HIV related cancers, bone loss, decreased mental function, etc. However, a plethora of recent research has clearly demonstrated that people living with HIV are suffering from accelerated aging; sometimes their minds and bodies manifest problems decades earlier than their HIV-negative counterparts. Consequentially, researchers, medical providers, treatment advocates, and HIV-positive people alike are trying to figure out how to conquer this new phase of living with HIV.
Many community forums on HIV & Aging involve doctors and other socio-medical professionals speaking clinically, and providing the same information, from the same point of view, time and time again. Positive Force decided to move in a different direction. We invited Nelson Vergel, a man who has lived with HIV for more than two decades and who is an internationally renowned treatment advocate, to discuss HIV & Aging concerns from a peer perspective. Nelson has traveled the world talking about living and thriving with HIV, has written books on the topic, and has been featured in numerous publications for his expertise and perspective.
Participants who attend will benefit from Nelson's unique perspective, presentation style, and gobs of information. Nelson will present the latest treatment information, both clinical and practical, for a range of subjects, including but not limited to lipodystrophy/lipoatrophy, accelerated aging of both mind and body, and sexual health. Forum attendees will walk away with a better handle on how to deal with problems they may already be facing and how to prevent new problems associated with HIV & Aging.
Many community forums on HIV & Aging involve doctors and other socio-medical professionals speaking clinically, and providing the same information, from the same point of view, time and time again. Positive Force decided to move in a different direction. We invited Nelson Vergel, a man who has lived with HIV for more than two decades and who is an internationally renowned treatment advocate, to discuss HIV & Aging concerns from a peer perspective. Nelson has traveled the world talking about living and thriving with HIV, has written books on the topic, and has been featured in numerous publications for his expertise and perspective.
Participants who attend will benefit from Nelson's unique perspective, presentation style, and gobs of information. Nelson will present the latest treatment information, both clinical and practical, for a range of subjects, including but not limited to lipodystrophy/lipoatrophy, accelerated aging of both mind and body, and sexual health. Forum attendees will walk away with a better handle on how to deal with problems they may already be facing and how to prevent new problems associated with HIV & Aging.
Thursday, December 03, 2009
FDA denies approval to long acting testosterone injections
Endo's drug is Nebido, a long acting injectable (testosterone undecanoate) , that has been available in Europe, Mexico, and many countries for years. It requires injections every three to four mouths instead of every week or two. Too bad the FDA made this decision.
This shows how difficult it is getting drugs approved now at the FDA with review panels that do not know much about the science (review panel members cannot have any conflict of interests and be part of any data review panels for any companies,which excludes a lot of the experts in the field). Anaphylactic reactions are common side effects with all approved testosterone injectables due to bad injection technique, so it is amazing that they stopped this approval based on a side effect that is well known with currently available testosterone products in the United States. Common symptoms of anaphylactic reactions with testosterone injections are cough and dizziness that subside after a few minutes. It is believed that this happens when testosterone enters the blood stream and ends up in the lungs (injections are meant to form a "pocket" for slow release in the muscle. Some people may inject in a blood vessel and have anaphylactic reactions). I have had this reaction and found a quick solution to it: breathe into a paper bag until the cough stops.
Nelson
http://www.reuters.com/article/americasMergersNews/idUSN038783120091203
NEW YORK, Dec 3 (Reuters) - U.S. health regulators declined to approve Endo Pharmaceuticals Holdings Inc's (ENDP.O) drug for low testosterone, requesting more information about rare but serious side effects, the specialty drugmaker said on Thursday, sending its shares down nearly 4 percent.
The U.S. Food and Drug Administration wants information about anaphylactic reactions following injection of the drug, and about events when a poor injection technique leads to oil leaking into the lung, causing coughing.
In its so-called complete response letter, the agency also said Endo's proposed strategy to mitigate risks for the drug, Aveed, was not sufficient.
Endo said it was evaluating the FDA letter. The drug is sold outside the United States by Germany's Bayer AG (BAYGn.DE) and is available in more than 50 countries under the brand name Nebido. Endo licenses Aveed from Bayer.
Jefferies & Co analyst Corey Davis said Endo may choose to end its development of the drug if it cannot resolve the FDA's concerns.
"It's hard for us to imagine what the company could do to satisfy FDA concerns over exceedingly rare events that we would guess are not even product-specific in the first place," Davis said in a research note.
However, Davis said consensus estimates for Aveed sales had been "relatively modest" at $94 million by 2012.
An Endo spokesman said it was not yet clear what the next steps for the product would be. "Our goal is to work closely with the agency," the spokesman, Kevin Wiggins, said.
Aveed was one of the main products Endo acquired earlier this year in its $370 million purchase of Indevus Pharmaceuticals, a deal designed to expand its product line beyond pain treatments.
"It clearly casts a cloud on their ability to make acquisitions," said Jim Molloy, an analyst with Caris & Co. "They made it very clear they are looking to acquire more things. This one didn't go so well, so there's going to be some scrutiny on what the next one will be."
Low testosterone, also known as hypogonadism, is linked to symptoms such as fatigue, loss of muscle mass and decreased libido, and there is increasing evidence of an association with conditions such as diabetes and cardiovascular disease, according to Endo.
The Aveed action marks the second regulatory setback for Endo in as many months related to a testosterone product. In October the FDA delayed approval of Endo's Fortesta, a gel for men with low testosterone.
In September the FDA extended its review of Aveed by three months.
Endo shares fell 86 cents, or 3.8 percent, to $21.56 in afternoon trading on Nasdaq.
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