September 20th, 2014

FDA Panel Backs Limiting Use of Low-T Drugs (PLEASE READ)

FDA Panel Backs Limiting Use of Low-T Drugs
Wednesday, 17 Sep 2014
Testosterone replacement therapies should be reserved for men with specific medical conditions that impair function of the testicles, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday.

The FDA is not obliged to follow the advice of its advisory panels but typically does so.  The panel also recommended that companies be required to conduct additional studies to assess the cardiovascular risk of their products for patients with age-related low testosterone.

Prescriptions for "Low T," as low testosterone has been described in television commercials, have soared over the past decade, driven by an increase in use by middle-aged men with lowered testosterone levels related to advancing age.

Alert:

5 Warning Signs of Prostate Cancer. How Many Do You Have?

Symptoms of low testosterone include loss of libido, decreased muscle mass, fatigue and depression.

The panel voted 20-1 in favor of restricting the drugs' authorization to people with medically related low testosterone, such as a genetic disorder or a tumor.

If implemented, the restriction would mean companies could not market or promote their products for age-related low testosterone, although physicians would allowed to prescribe products "off label" in any way they choose.  REMEMBER:  to evaluate your testosterone level accurately the blood sample HAS TO BE DRAWN between 4AM and 5PM to get an accurate account and blood samples drawn any other time of the day in any 24 hour period is not acceptable.

Fourteen members of the panel voted in favor of additional safety studies to assess potential cardiovascular risks associated with the drugs in patients with age-related low testosterone.

Four panelists recommended that cardiovascular studies be conducted regardless of the population in which they are used. One member voted against the need for a study. Most panelists said any safety study should be large and randomly controlled, the gold standard for assessing safety and efficacy.

The market for testosterone treatments currently includes skin patches, short-acting injections and topical gels.  AbbVie Inc's AndroGel, the market leader, generated about $1.04 billion in sales in 2013.  Other products include Auxilium Pharmaceuticals Inc's Testim and Eli Lilly & Co's Axiron.

On Thursday, an FDA advisory panel will consider Rextoro, a product being developed by privately held Clarus Therapeutics Inc. which, if approved, would be the first oral treatment to meaningfully challenge existing treatments.

In a preliminary review of the data published on Tuesday, FDA reviewers said that although the Rextoro drug met the main goal of a clinical trial, a separate analysis by the FDA that accounted for missing data found it was not as effective as it might appear.

RISE IN PRESCRIPTIONS

In 2013, 2.3 million men received a prescription for testosterone, up from 1.3 million in 2010, according to the FDA.  About 70 percent of men prescribed testosterone drugs were between the ages of 40 and 64.

According to an FDA analysis, 21 percent of patients prescribed testosterone drugs did not appear to have had their testosterone concentrations tested before or during treatment, something the agency described as "concerning."

In February, the consumer watchdog Public Citizen petitioned the FDA to immediately add a black box warning, the most serious available, about heart risks associated with the drugs.

The FDA denied the petition, saying it was still assessing the potential cardiovascular risks of the products.  Most panelists said a black box warning would not be appropriate at this time because there was not enough data to assess the level of risk.

Some recommended adding more moderate language to the label noting that the FDA is exploring whether there is a heart risk but that the evidence to date is inconclusive.

Officials for AbbVie argued that there was no evidence of a causal relationship between testosterone replacement therapies and cardiovascular problems, but said more information would be useful and that companies would be willing to discuss changes to the drug labels.

Alert:

5 Warning Signs of Prostate Cancer.  How Many Do You Have?
Prostate Cancer

Previous Topic What are the key statistics about prostate cancer? Next TopicDo we know what causes prostate cancer?. What are the risk factors for prostate cancer?
A risk factor is anything that affects your chance of getting a disease such as cancer.  Different cancers have different risk factors.  Some risk factors, like smoking, can be changed.  Others, like a person's age or family history, can't be changed.

But risk factors don't tell us everything.  Many people with one or more risk factors never get cancer, while others who get cancer may have had few or no known risk factors.

We don't yet completely understand the causes of prostate cancer, but researchers have found several factors that might change the risk of getting it.  For some of these factors, the link to prostate cancer risk is not yet clear.

Age
Prostate cancer is very rare in men younger than 40, but the chance of having prostate cancer rises rapidly after age 50.  About 6 in 10 cases of prostate cancer are found in men over the age of 65.

Race/ethnicity
Prostate cancer occurs more often in African-American men and Caribbean men of African ancestry than in men of other races.  African-American men are also more likely to be diagnosed at an advanced stage, and are more than twice as likely to die of prostate cancer as white men.  Prostate cancer occurs less often in Asian-American and Hispanic/Latino men than in non-Hispanic whites.  The reasons for these racial and ethnic differences are not clear.

Nationality
Prostate cancer is most common in North America, northwestern Europe, Australia, and on Caribbean islands.  It is less common in Asia, Africa, Central America, and South America.

The reasons for this are not clear.  More intensive screening in some developed countries probably accounts for at least part of this difference, but other factors such as lifestyle differences (diet, etc.) are likely to be important as well. For example, men of Asian descent living in the United States have a lower risk of prostate cancer than white Americans, but their risk is higher than that of men of similar backgrounds living in Asia.

Family history
Prostate cancer seems to run in some families, which suggests that in some cases there may be an inherited or genetic factor.  Having a father or brother with prostate cancer more than doubles a man's risk of developing this disease.  (The risk is higher for men who have a brother with the disease than for those with an affected father.)  The risk is much higher for men with several affected relatives, particularly if their relatives were young at the time the cancer was found.

Genes
Scientists have found several inherited gene changes that seem to raise prostate cancer risk, but they probably account for only a small number of cases overall.  Genetic testing for most of these gene changes is not yet available.

Some inherited gene changes raise the risk for more than one type of cancer.  For example, inherited mutations of the BRCA1 or BRCA2 genes are the reason that breast and ovarian cancers are much more common in some families.  Mutations in these genes may also increase prostate cancer risk in some men, but they account for a very small percentage of prostate cancer cases.

Recently, some common gene variations have been linked to a higher risk of prostate cancer. Studies to confirm this are needed to see if testing for the gene variants will be useful in predicting prostate cancer risk.

For more on some of the gene changes linked to prostate cancer, see  “Do we know what causes prostate cancer?”

Diet
The exact role of diet in prostate cancer is not clear, but several factors have been studied.

Men who eat a lot of red meat or high-fat dairy products appear to have a slightly higher chance of getting prostate cancer.  These men also tend to eat fewer fruits and vegetables. Doctors are not sure which of these factors is responsible for raising the risk.

Some studies have suggested that men who consume a lot of calcium (through food or supplements) may have a higher risk of developing prostate cancer. Dairy foods (which are often high in calcium) might also increase risk. Most studies have not found such a link with the levels of calcium found in the average diet, and it's important to note that calcium is known to have other important health benefits.

Obesity
Most studies have not found that being obese (very overweight) is linked with a higher risk of getting prostate cancer overall.

Some studies have found that obese men have a lower risk of getting a low-grade (less dangerous) form of the disease, but a higher risk of getting more aggressive prostate cancer. The reasons for this are not clear.

Some studies have also found that obese men may be at greater risk for having more advanced prostate cancer and of dying from prostate cancer, but not all studies have found this.

Smoking
Most studies have not found a link between smoking and the risk of developing prostate cancer.  Some recent research has linked smoking to a possible small increase in the risk of death from prostate cancer, but this is a new finding that will need to be confirmed by other studies.

Workplace exposures
There is some evidence that firefighters are exposed to substances (toxic combustion products) that may increase risk.

Inflammation of the prostate
Some studies have suggested that prostatitis (inflammation of the prostate gland) may be linked to an increased risk of prostate cancer, but other studies have not found such a link. Inflammation is often seen in samples of prostate tissue that also contain cancer.  The link between the two is not yet clear, but this is an active area of research.

Sexually transmitted infections
Researchers have looked to see if sexually transmitted infections (like gonorrhea or chlamydia) might increase the risk of prostate cancer, possibly because they may lead to inflammation of the prostate.  So far, studies have not agreed, and no firm conclusions have been reached.

Vasectomy
Some earlier studies had suggested that men who have had a vasectomy (minor surgery to make men infertile) – especially those younger than 35 at the time of the procedure – may have a slightly increased risk for prostate cancer.  But most recent studies have not found any increased risk among men who have had this operation.  Fear of an increased risk of prostate cancer should not be a reason to avoid a vasectomy.

AS I SEE IT:

In my practice in the patient's preparation of required data, all drugs taken and specific laboratory test the request for a PSA (Prostate Specific Antigen) test.  It is disappointing to see so many old men that their physician hasn't ordered a PSA in several years.  The score in the PSA test if from 1 to 4 and the closer to 4 the higher the risk.  To my dismay I have had to refer 18 old men to the Urologist to discover that they all had last stage Prostatic cancer.  This is totally unnecessay and indicates a degree of incompetency in their attending physician.  Please be sure you ask your Doctor to include this test always with your annual physicial and I believe as often as every 6 months.