Testosterone – more errors from “evidence based medicine” – FDA admits mistake

Email communication from Dr Fred Pescatore 17 July 2015
I’m sticking by testosterone
Dear Reader,

Since I am a big believer in testosterone supplementation–yet STILL get so many questions about its safety–I wanted to discuss this fear-fueled debate a bit more.

Around 80 years ago, medical professionals learned that testosterone can enhance well-being, improve men’s sexual symptoms, boost energy, and more. But by 1941, reports that testosterone “activated” prostate cancer scared off a lot of physicians–and, shockingly, that fear has persisted to this day. Even though that “research” was based on impossible-to-interpret results in just one single patient.

Now, the good ol’ FDA is expressing concern over possible cardiovascular risks of testosterone treatment. In March, they issued a warning about this, advising that testosterone therapy not be used for “age-related” symptoms.

This latest, and needless, fear flare-up came from a study in which investigators analyzed records from 8,709 men in the Veterans Affairs health system who’d had coronary angiography and had low testosterone levels. At 3 years after angiography, they found that the absolute rate of stroke, heart attack, and death was 25.7 percent among men who had received a testosterone prescription compared with 19.9 percent in the untreated group.

These findings received enormous media attention, but there’s one problem–they were completely wrong. The correct absolute rate was actually lower by one half in the testosterone-treated group vs. the untreated group: 10.1 percent vs. 21.2 percent. Someone seriously fell asleep at the calculator here.

So the Journal of the American Medical Association had to start publishing corrections that admitted everything from data errors, to the fact that the “all-male” study was…10 percent women. Oops.

Even the FDA came as close as they ever would to an admission of egg-on-face, saying, “…it is difficult to attribute the increased risk for non-fatal MI seen in the Finkle study to testosterone alone…” To date, 29 medical societies have called for the bogus initial article to be retracted due to incorrect data. But it’s extremely hard to get people to listen to this type of retraction once they’re already scared (and needlessly so). It’s a wildfire effect, and the fear had already spread.

All the while, other studies have routinely shown positive effects from testosterone therapy, including these: low testosterone levels are associated with increased mortality, atherosclerosis, and coronary artery disease; mortality is reduced by one half in testosterone-deficient men treated with testosterone therapy compared with untreated men; and testosterone therapy (vs. placebo) has resulted in uniform improvement in a variety of cardiovascular risk factors (fat mass, waist circumference, insulin resistance).

Sounds like a wonder drug to me.

Sadly, many doctors have stopped prescribing testosterone due to all the controversy. I have not. We are even ostracized by our colleagues for doing so. But when used properly, I’ve seen testosterone therapy work wonders for my patients. Which is why I won’t let the mounting “controversy” scare me into stopping using it for my patients with low-T.

Yes, there are potential risks to testosterone therapy–like acne, gynecomastia, and peripheral edema, but the risks are not as dire as the experts want you to believe (and have no credible evidence for). At this point, there is no evidence that testosterone therapy increases the risk of cardiovascular disease or prostate cancer. In addition, I’ve noted how it can even help diabetics.

The bottom line: Testosterone therapy is an effective option for symptomatic men with low levels of serum testosterone. These symptoms include those of both a sexual (reduced libido) and non-sexual (fatigue, loss of energy, weakness, poor motivation) nature. Testosterone therapy not only can improve these symptoms, but has also been shown to improve general health. And that last part is a given, as we’re talking about a momentum effect. If you feel more energetic and motivated, you’ll be more apt to take that daily walk (which will offer quite a health boost on its own).

To learn in more detail about what normal T levels look like (largely based on age and sex), take a look at the Logical Health Alternatives newsletter I wrote at the beginning of June, titled “Safety of testosterone therapy backed by years of science”. Subscribers can access this issue-and the complete archive-by visiting www.drpescatore.com and logging in to the Subscriber area of the website. (If you’re not already a subscriber, you can sign up here.)

Evidence based medicine or “politically correct bullying”?

Taken from Dr Mark Stengler’s “House Calls”
21 June 2015 Email communication.

Feds approve dangerous and ineffective ‘female Viagra’

If you can’t win with science, try bullying. That may as well be the motto of at least one drug company.

The so-called “female Viagra” drug flibanserin has been rejected by the FDA for years, with the agency saying (correctly, for a change) that the med is both unsafe and ineffective.

Yet just this month, flibanserin was rushed through the approvals process and given the OK by an agency committee.

What’s changed?

Not the science. The studies still show exactly what they’ve always shown: A drug that provides a benefit so small you’d need a magnifying glass to see it.

Compared to women on a placebo, women who take the drug have exactly one extra satisfying sexual encounter per month. And on a six-point scale rating desire, the drug provides an “improvement” of 0.3 points.

But while the benefits may not be real, the risks sure are. Women who take the drug report sudden drops in blood pressure, which has led to fainting.

A woman in one study even suffered a concussion as a result.

What’s more, the risk of side effects is even higher when the drug is combined with other meds women commonly take, including birth control pills and the fluconazole given for yeast infections.

If you rely on the science, and science alone, the drug belongs in a trashcan. So the company that makes it stopped using science and resorted to politically correct bullying.

They bankrolled a phony “equality” campaign claiming that the FDA’s failure to approve the drug was sexist — and it looks like their bought-and-paid for charade worked like a charm since it’s passed the committee and is now well on the way to formal approval.

So, ladies, get ready for a wave of marketing like you’ve never seen. Watch out for commercials and magazine ads that will suggest this drug will put the spark back into your love life.

And if you’re battling the frustration of a low libido, it might be tempting to give in and try the drug, just for that tiny boost.

But you deserve better.

This drug company wants women to believe there’s no other way to improve desire and libido — that it’s their lousy drug, or nothing at all.

That’s not even close to true.

There are a number of safe and natural therapies, including the time-tested herbal remedy fenugreek, which is a natural hormone booster. One new study of healthy women between the ages of 20 and 49 finds 600 mg per day for eight weeks can increase both estradiol and free testosterone.

Those are the female and male sex hormones, respectively, but let’s just say the names are a little sexist. We all need both, with women needing more estradiol and men more testosterone.

Estradiol in particular can help, physically increasing the flow of blood to the vagina, which is essential to both arousal and orgasm, and helping with lubrication, which is of course necessary to make sure your moments of pleasure don’t turn into pain

As a result, women who take fenugreek extract have more desire and arousal, leading to more sexual activity when compared to women who take a placebo, according to the study in Phytotherapy Research.

Since the study was on pre-menopausal women it’s unclear whether it would have the same effect on older women. Since it’s safe, you can certainly give it a try.

But if it doesn’t work, don’t give up.

There are other safe ways to improve your sex life, including natural hormone therapies — and you can read all about it in this free report from my House Calls archives — http://www.besthealthnutritionals.com/blog/2014/12/11/testosterone-for-women/

God bless,
Dr. Mark Stengler

Bioidentical Testosterone: The best male anti-aging tool the experts don’t want you to have – Dr Jonathan Wright

This is a useful and interesting article by Dr Jonathan Wright, a Harvard graduate, one of the fathers of bioidentical hormone therapy, in which the author claims:

For over 30 years, I’ve worked with men ages 45 and up whose symptoms and tests indicated a need for bio-identical testosterone. The results have been gratifying for everyone involved. Most notably, bio-identical testosterone therapy helps improve mood, attitude, cognitive ability, and general outlook on life. Many wives and families have observed that “Grandpa is a lot less grumpy,” remembers things better, and laughs and smiles a lot more often.

Plus, bio-identical testosterone improves muscle mass and strength, rebuilds bone, strengthens the heart and blood vessels, lowers total cholesterol and blood sugar, raises HDL (“good”) cholesterol, lowers blood pressure, lessens the chances of blood clots, improves tissue oxygenation, improves the health of a non-cancerous prostate gland-and that’s all before we get to testosterone’s positive effects on libido and your sex life.

Read the whole article and see references at


Thyroid lab tests – Statement by Dr J. C. Lowe

There is no credible scientific evidence that the use of thyroid lab tests improve patients’ symptoms or their health. On the other hand, we have ample scientific evidence that the tests don’t.

The problem with the tests is this: Conventional thyroid specialists arbitrarily decided that the aim of treatment for hypothyroidism should be to get the patient’s lab test results right where the doctors prefer them to be. If the lab test results are where the doctor prefers them, then the doctor pronounces the patient well. The conventional doctor does this with total disregard for whether the patient is still ill or not with hypothyroid symptoms. If the patient complains about continuing illness, which most do, the doctor dismisses the continuing illness as a feature of some other undetermined mysterious disorder. Hence, thanks to the conventional thyroid speciality, we have widespread “new diseases” such as fibromyalgia, chronic fatigue syndrome, and ME.

This conventional medical approach to the “care” of the hypothyroid patient is not scientifically derived. Instead, it is merely an arbitrary convention of doctors. It is based on a combination of erroneous study conclusions and financial incentives from various companies that profit from the widespread use of the mainstream medical protocol. The main companies are ones that produce and market thyroxine and TSH test assays.

The thyroid specialty has imposed this pernicious medical protocol on practicing doctors and their patients. The imposition has resulted in a worldwide public health crisis. Scores of millions of people remain ill because of it, and incalculable numbers of people die prematurely from it, either from cardiovascular disease or suicide.

Some courageous physicians, such as Dr. Barry Peatfield and Dr. David Derry, have become prominent from getting hundreds of patients well by using more rational, nonconventional approaches to thyroid hormone therapy. But the thyroid specialty has deprived thyroid patients of these doctors. It has done so by using regulatory agencies such as the General Medical Council to end these doctors medical practices. This has left the doctors patients without effective care. Many of them have had no choice but to travel from the United Kingdom to the United States for effective treatment through our Center for Metabolic Health—an expensive inconvenience made necessary by the tyrannical power politics of the British thyroid specialty.

It is morally imperative that the false beliefs of the thyroid specialty about the treatment of hypothyroidism be promptly rectified.

Dr John C. Lowe
Board Certified: American Academy of Pain Management
Director of Research: Fibromyalgia Research Foundation
180030th Street, Suite 217-A, Boulder, Colorado 80301 USA
Jlowe55555@… www.drlowe.com

Taken From: https://groups.yahoo.com/neo/groups/hypothyroid/conversations/topics/5104

(See  also Linda’s Long Strugglehttp://www.hormonechoicesingapore.com/2015/08/15/lindas-long-struggle/

Evidence based medicine vs personalised medicine

Some interesting comments on evidence based medicine from this Malaysian doctor. And isn’t the BHRT we get from compounding pharmacies is something like the ‘personalised medicine’ described here?

(Bolding by HCS)

Dr Rizin H Kusop. MBBS, MSc (Anti-Aging, Regenerative and Aesthetic Med), Dip. Family Med

From the website of  Society for Advancement of Hormone & Healthy Aging Medicine Malaysia (SAHAMM)

You may have heard what ‘evidence based medicine’ is all about. This is especially true if you are very inquisitive about your illness and health. Some doctors will also spell this out (including me) in trying to explain certain treatments for your illnesses.

Evidence based medicine is a concept where only practices which has been proven beneficial in majority of patients in the past are chosen to be practiced on you, the patient. It means a treatment is now being given to you because it has been proven to work in the past on majority of patients. If you are behaving like ‘majority of the patients’ then the treatment should work on you too.

Unfortunately there is no single treatment or practice which is considered working effectively on all patients at all time. The key concept of evidence base medicine is, if it works on some ‘statistically significant’ percentage of people then it may work on all people too. Another way looking at it is, if it works on most people, it should works on you too! Now both you and me know that those concepts are at best, oversimplified and at worst, simply not true. We are unique individual.

Then comes the personalised medicine which you may never heard before. Personalised medicine is a concept which treatments or practices are tailored only for you and no one else. This is where your doctor tries to work out the best treatment and management for you which may not be applicable to others. Unfortunately, this concept is still in its infancy. The doctor trained in this field would have to get to know you better than you know about yourself. One of the key concepts in this practice is for the doctor to do a genetic profile on you and work from there to see what medications, diets, exercise regimens and supplements optimise your health.

For example, if you have high blood pressure, the genetic profiling will reveal if one class of drug is effective to lower your blood pressure and the other class may be absolutely useless. Similarly, genetic profiling will tell if weight lifting exercise or aerobic exercise makes you lose weight. Genetic profiling also will tell if you need Statin or only vitamin B12 and folate to lower your cholesterol.

These variations are due to defects in our genes which can be detected by reading the sequences of DNAs. Often the variation is caused by a single change in the long series of DNA sequences. The variation is named as ‘Single Nucleotide Polymorphism’ or SNP (pronounced as snip). There are just too many SNPs in human body that there are probably no two similar human beings exist at the same time.

Of course, the genetic profiling test comes with its own cost and knowledge to interpret. It will be quite a while before personalised medicines makes it way to main stream medicine. Meanwhile, it make sense for you to take your health personally and understand that some conventional treatments may not work for you.


Evidence Based Medicine?

As we have pointed out before, it’s always good to take a healthy dose of scepticism when you read those scientific studies.

Read how, and why, a journalist tricked news outlets into thinking chocolate makes you thin.

. . .

This spring, the journal “International Archives of Medicine” published a delicious new study: According to researchers at Germany’s Institute of Diet and Health, people who ate dark chocolate while dieting lost more weight.

The media coverage was instantaneous and jubilant:

“Scientists say eating chocolate can help you lose weight” read a headline in the Irish Examiner.

“Excellent News: Chocolate Can Help You Lose Weight!” Huffington Post India boasted.

“Dieting? Don’t forget the chocolate” announced Modern Healthcare.

It was unbelievable news. And reporters shouldn’t have believed it.

It turns out that the Institute of Diet and Health is just a Web site with no institute attached. Johannes Bohannon, health researcher and lead author of the study, is really John Bohannon, a science journalist. And the study, while based on real results of an actual clinical trial, wasn’t aimed at testing the health benefits of chocolate. It was aimed at testing health reporters, to see if they could distinguish a bad science story from a good one.

Linda’s long struggle

Hormone Choice Singapore has been contacted by Linda Thipthorp, a thyroid patient advocate in UK, who has shared her long struggle with thyroid related health issues. (See below and http://www.hormonechoicesingapore.com/…/its-not-new-2001-do…)

She offers help and guidance to those who are struggling with trying to get the right treatment for their thyroid issues.

My Story – Linda Thipthorp

Born in 1955 with lingual thyroid (in the tongue) – not diagnosed.

As a youngster: Always suffered from tonsillitis and had antibiotics frequently. Bouts of exhaustion.

Teenage years: Once menstruation started horrific periods. No energy, heavy periods, fainting through pain. More bouts of tonsillitis. Put on the pill at the age of 11 years by GP to curb the bleeding.

Two successful pregnancies, 2 miscarriages.

1983 aged 28 years: tonsils removed, was told a third tonsil had grown, body very acidic. Tests revealed lingual thyroid. No arteries or thyroid tissue in the neck all in the base of the tongue. Thyroid blood tests proved “within normal range”.

30’s: Periods became heavier and heavier, hysterectomy advised at the age of 39 years due to prolapsed womb. Operation carried out in January 1994. Ovaries were left. Good health for 18 months then suffered chronic chest pains and indigestion. Went to see my GP and was given HRT patch. Admitted to hospital many times with chronic pain; advised to have gall bladder removed, which was carried out.

January 1996: Exactly 2 years on from the hysterectomy chronic symptoms developed: eyesight fading, sweating, severe thrush, extreme fatigue, couldn’t swallow properly due to thyroid gland swelling. Had various thyroid function tests carried out but was told I was “within normal range”. No thyroid hormone offered. Through the pain of the gland growing out of my tongue I was admitted weekly to the hospital and had to have pethadine injections to control the pain. After several months it was decided to kill the thyroid gland and I was administered Radio Active Iodine. This was carried out in the summer of 1996 (still taking HRT in patch form).

Horrendous pain, cortisone was given in very large doses to control the swelling which caused severe oedema. When gland had died after a few months thyroxine (T4) was given controlled by the blood tests.

January 1997: collapsed with severe head pains. Couldn’t see properly. Was rushed to a Professor in Guys Hospital in London. Through damaging the thyroid gland it had developed scar tissue and was thought to be pressing on a nerve. The Professor was appalled that I hadn’t been offered any thyroid hormone. There was no alternative but to have the gland removed and this was carried out within the month.

I was told that I could be dumb if the operation did not go well. The tongue was split down the middle to the base and the thyroid gland removed. I was told it was a perfectly healthy gland. Had to have a tracheotomy as my tongue swelled and blocked the airway. My mouth split due to the swelling.

Left hospital but within weeks my health took a dramatic decline. Was told that it could be my ovaries. Recommended to visit a specialist at the Lister Hospital, London to have an oopherectomy. Paid privately and was admitted within weeks. He said that these were the cause of my illness. Had the ovaries removed and HRT and testosterone implant inserted.

Two weeks later health took dramatic decline once again; this operation had only made matters worse. The HRT was blocking the thyroid medication but I did not know this at the time. Visual disturbances, extreme blurred vision, hardly had the energy to walk properly, horrendous pain in head, panic attacks, anxiety attacks, fluid retention, muscle wastage and weight gain. The pains were so bad that I then lived on sleeping tablets for one year, taking one morning and night. The pain was so unbearable I couldn’t bear to be awake.

Thyroid function tests were showing that I was going toxic. From 200 mcgs T4 I reduced to just 70 mcgs. Could no longer walk and crawled on hands and knees. Continually freezing cold pulse 42. Semi coma state. Drifted in and out of sleep for months. To be asleep was the only way I could cope with the bodily pain. Migraines were constant.

Was told by the Thyroid Support Group to contact Dr B Durrant-Peatfield. Managed to get an urgent appointment with him and attended his surgery. He examined me thoroughly and immediately diagnosed the problem. I was severely hypometabolic. My body was closing down through lack of thyroid hormone. He told me that thyroid blood tests are extremely unreliable. These patients go on to develop diseases such as ME, Fibromyalgia, CFS, heart disease etc. etc. He told me that the T4 hormone that I was being prescribed was not converting in the liver to the active T3 hormone and this is necessary for the body to function. He took me off T4 and I was put on T3 only. After only 3 days the pains in my head started to abate. After a few weeks I had the energy to walk further than the 100 yards that I had been restricted to during the last 18 months. I continued to improve but I was still covered in Fibromyalgia pain.

I discovered that Dr J Lowe & Dr G Honeyman were specialists in Fibromyalgia in the USA. I needed more help to rid my body of pain and so flew to Tulsa, Oklahoma for their advice. Dr J Lowe is a brilliant scientist and doctor who has realised the connection between insufficient thyroid hormone at the cellular level and Fibromyalgia, the crippling arthritic disease, which is missed time and time again through the reliance on these blood tests and T4 only. Although much improved I needed extensive ultra sound treatment on my muscles, I increased my T3 and exercised to tolerance. At last the pain was abating. The muscles had become tight through my thyroid starvation and Dr G Honeyman-Lowe treated me for a period of 2 weeks.

Dr Lowe states:

“There is no credible scientific evidence that the use of thyroid lab tests improve patients’ symptoms or their health. On the other hand, we have ample scientific evidence that the tests don’t.

The problem with the tests is this: Conventional thyroid specialists arbitrarily decided that the aim of treatment for hypothyroidism should be to get the patient’s lab test results right where the doctors prefer them to be. If the lab test results are where the doctor prefers them, then the doctor pronounces the patient well. The conventional doctor does this with total disregard for whether the patient is still ill or not with hypothyroid symptoms. If the patient complains about continuing illness, which most do, the doctor dismisses the continuing illness as a feature of some other undetermined mysterious disorder. Hence, thanks to the conventional thyroid speciality, we have widespread “new diseases” such as fibromyalgia, chronic fatigue syndrome, and ME. . . .

This conventional medical approach to the “care” of the hypothyroid patient is not scientifically derived. . . . The thyroid specialty has imposed this pernicious medical protocol on practicing doctors and their patients. The imposition has resulted in a worldwide public health crisis. Scores of millions of people remain ill because of it, and incalculable numbers of people die prematurely from it, either from cardiovascular disease or suicide.”

Through a large majority of the population being missed with these blood tests “new” diseases have developed. They are nothing more than inadequate thyroid hormone in the muscles and tissues of the body. Spanish scientists have done intensive studies and have proved this but, as yet, the medical profession has ignored them.

I should never have been prescribed HRT. Little did I know that HRT and the Pill are anti-thyroid drugs, they block the thyroid from working properly. Natural hormone replacement can be given but only when the thyroid is balanced and strong.

I have regained my life through the dedication of Dr B Durrant-Peatfield, Dr J Lowe & Dr G Honeyman-Lowe.

I now run my own helpline to give people information I have learnt through my own suffering.

Lyn Mynott runs Thyroid UK which is a support/campaign group in the UK. They support people with both diagnosed and undiagnosed thyroid disease. Many of these people have become well again after being treated by private doctors like Dr Peatfield.

Dr Peatfield tries to get the body back into balance once again. Surgery destroys the delicate balance of the body and hysterectomies cause a massive endocrine shock. If a woman’s body is low in thyroid hormone for many years then the imbalance makes periods heavier as the oestrogen/progesterone balance is disrupted through low thyroid hormone and the body becomes acidic, the end result normally being a prolapsed womb and hysterectomy. Endometriosis is also a problem through this imbalance and I have recently undergone a 6 hour operation to remove this.

Through my horrendous experience I have been able to help my two daughters and mother who suffered from thyroid disease; sadly I lost her. Her Armour thyroid medication was changed to T4 only and she didn’t last long after this. I believe she had a conversion problem like me. My youngest daughter aged 21 was beginning to go down the same road as me but with the help of Dr Peatfield she was diagnosed and treated. She has regained her health and can get on with her life.

I urge doctors to look at the patient’s symptoms and not to rely solely on the blood tests. If this form of practice is changed we will then turn the corner and eliminate these “new” chronic diseases that are plaguing our hospitals.

I will carry on my work in helping thyroid suffers in the hope that my suffering has not been in vain. I pray for the day the medical profession understand the enormity of the problem that these tests are causing.

Linda Thipthorp

Bio-identical hormones

Dr. Karla Dionne, writing about Bioidentical hormones, says:

“I am optimistic that as patients become more informed and continue to ask for bio-identical hormones, the medical community will respond by recognizing and acknowledging the benefits of a natural hormone over a synthetic one.”

. . .

HCS: If only . . .

What about compounded hormones?

This excerpt comes from an article entitled What are bioidentical hormones? first printed in the August 2006 issue of the Harvard Women’s Health Watch

Much of the confusion about bioidentical hormones comes from the mistaken notion that they must be custom-mixed at a compounding pharmacy. But custom compounding is necessary only when a clinician wants to prescribe hormones in combinations, doses, or preparations (such as lozenges or suppositories) not routinely available — or to order hormones not approved for women, such as testosterone and DHEA. Compounding pharmacies use some of the same ingredients that are made into FDA-approved products, but their products are not FDA-approved or regulated.

One size doesn’t fit all in women’s health. Compounded hormones can certainly help to individualize treatment, but if you’re considering them, be aware of the following:

•Compounded drugs are mixed to order, so there are no tests of their safety, effectiveness, or dosing consistency.

•There is no proof that compounded hormones have fewer side effects or are more effective than FDA-approved hormone preparations.

•Some clinicians who prescribe compounded hormones order saliva tests to monitor hormone levels. Most experts say these tests are of little use because there’s no evidence that hormone levels in saliva correlate with response to treatment in postmenopausal women.

•There is no scientific evidence that the compounded preparations Biest and Triest, which are largely estriol, are safer or more effective than other bioidentical and FDA-approved formulations. Some proponents claim that estriol decreases breast cancer risk and doesn’t increase endometrial cancer risk. Both claims are unproven.

•Heath insurers don’t always cover compounded drugs.

This doesn’t mean that you shouldn’t consider compounded hormones. Just realize that, in a real sense, you’re going to be an experiment of one. Unless your clinician has considerable experience with bioidentical hormones and a particular compounding pharmacy, you’re better off with a prescription for commercially available hormones, many of which are bioidentical.

See the whole article at http://www.health.harvard.edu/womens-health/what-are-bioidentical-hormones

HCS: We do have doctors in Singapore who have “considerable experience with bioidentical hormones” but their ability to help us is being curtailed.