Quantum Equation Suggests The Big Bang Never Occurred – The Universe Has No Beginning.


bigbang

When it comes to the science regarding the true nature of our reality, you won’t find a shortage of theories, or a shortage of criticisms of each theory. We are like a race with amnesia, trying to discover and search for an answer that most probably exists, but has yet to be discovered. How did the universe begin?

According to new research, there might not have been a big bang. Instead, the universe might have existed forever. The theory was derived from the mathematics of general relativity, and compliment Einstein’s theory of general relativity.

“The Big Bang singularity is the most serious problem of general relativity because the laws of physics appear to break down there.”  – Ahmed Farag Ali, Benha University, Co-Author of the study.

The big bang theory postulates that everything in existence resulted from a single event that launched the creation of the entire universe and that everything in existence today was once part of a single infinitely dense point, also known as the “singularity.”

Here is a good picture representing what the big bang theory is referring to.

bang

So the big bang, again, postulates that the universe started out as an infinitely small point in space called a singularity, then exploded and created space where there was no space before, and that it is continually expanding. One big question regarding that expansion is; how did it happen? As you can see in the picture, “who is that guy?!”

According to Nassim Haramein, the Director of Research for the Resonance Project

“For every action there is an equal opposite reaction.” is one of the most foundational and proven concepts in all of physics. Therefore, if the universe is expanding then “the guy” (or whatever “he” is), who is blowing up that balloon, has to have some huge lungs that are contracting to be able to blow it up. This a concept that Nassim Haramein began exploring when creating an alternative unified field theory to explain the universe.” (source)

This is one out of many criticisms regarding the big bang theory. There are many considerations to be pondered. Can something come from nothing? What about quantum mechanics and the possibility that there is no moment of time at which the universe did not exist?

Again, so many considerations to be pondered.

According to Phys.org:

“The scientists propose that this fluid might be composed of gravitons—hypothetical massless particles that mediate the force of gravity. If they exist, gravitons are thought to play a key role in a theory of quantum gravity.In a related paper, Das and another collaborator, Rajat Bhaduri of McMaster University, Canada, have lent further credence to this model. They show that gravitons can form a Bose-Einstein condensate (named after Einstein and another Indian physicist, Satyendranath Bose) at temperatures that were present in the universe at all epochs.” (source)

The theory also suggests (obviously) that there are no singularities or dark matter, and that the universe is filled with a “quantum fluid.” These scientists are suggesting that this quantum fluid is filled with gravitons.

According to Phys.org:

“In a related paper, Das and another collaborator, Rajat Bhaduri of McMaster University, Canada, have lent further credence to this model. They show that gravitons can form a Bose-Einstein condensate (named after Einstein and another Indian physicist, Satyendranath Bose) at temperatures that were present in the universe at all epochs.”

As you can see, when quantum mechanics is thrown into the equation things appear to be far different. Again, this new theory is suggesting that the universe could have always existed, that it never was what we perceive to be as “the  beginning.” Perhaps it was just an event that did occur that we perceive as the beginning, perhaps the event occurred not from nothing, but something. Again, who is that guy blowing on the balloon in the picture? There is something there that has yet to be discovered.

“As far as we can see, since different points in the universe never actually converged in the past, it did not have a beginning. It lasted forever. It will also not have an end, in other words, there is no singularity. The universe could have lasted forever. It could have gone through cycles of being small and big. or it could have been created much earlier.” –  Saurya Das at the University of Lethbridge in Alberta, Canada, Co-Author of the study. (source)

What We Know Is Often Just Theory

To conclude, it’s clear that we do not yet have a solid explanation regarding what happened during the Big Bang, or if it even happened at all. This new theory is combining general relativity with quantum mechanics, and at the end of the day these are all just theories.

Not to mention the fact that theories regarding multiple dimensions, multiple universes and more have to be considered. When looking for the starting point of creation, our own universe might not even be the place to start. It might be hard given the fact that we cannot yet perceive other factors that have played a part in the make up of what we call reality. What is even harder is the fact that quantum physics is showing that the true nature and make up of the universe is not a physical material thing!

We just don’t know yet, and there are still new findings in modern day physics that delve into non-materialistic science that many mainstream materialistic scientists have yet to grasp and acknowledge.

I’ll leave you with a quote that might give you something to think about:

“A fundamental conclusion of the new physics also acknowledges that the observer creates the reality. As observers, we are personally involved with the creation of our own reality. Physicists are being forced to admit that the universe is a “mental” construction. Pioneering physicist Sir James Jeans wrote: “The stream of knowledge is heading toward a non-mechanical reality; the universe begins to look more like a great thought than like a great machine. Mind no longer appears to be an accidental intruder into the realm of matter, we ought rather hail it as the creator and governor of the realm of matter.” (R. C. Henry, “The Mental Universe”; Nature 436:29, 2005)

“Despite the unrivaled empirical success of quantum theory, the very suggestion that it may be literally true as a description of nature is still greeted with cynicism, incomprehension and even anger. (T. Folger, “Quantum Shmantum”; Discover 22:37-43, 2001)

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Stop putting these foods in your fridge


Which of these foods are better kept at room temperature? Photo / Getty

You may think storing the likes of avocados, tomatoes, and bread in the fridge will keep them fresher for longer, but according to experts, you may actually be doing the opposite.

According to the UK’s Good Housekeeping Institute (GHI), storing certain foods in the fridge can not only shorten their lifespan, it can also ruin the taste of others.

GHI’s guide reveals “Nine Things You Shouldn’t Store In The Fridge” and notes their are foods that would taste far better, and last longer, stored at room temperature.

Here’s the list:

1. Bread

Storing bread in the fridge will dry it out and make it go stale much faster than if it were kept in the likes of a bread bin. The guide recommends a bread bag stored in cool, dry place.

2. Onions

When kept in the fridge, an onion’s aroma can taint other foods. The best bet is a dry, ventilated space. Keep them out of the light too to stop them sprouting.

3. Garlic

Like onions, garlic prefers a dry, well-aired space. Storing it in the fridge won’t help it last longer.

Tomatoes, avocados and onions are all best kept out of the fridge. Photo / Getty
Tomatoes, avocados and onions are all best kept out of the fridge.

4. Avocados

When it comes to avocados, it depends where they’re at in the ripening process. If you need to speed things along, store them alongside bananas. Otherwise, a brown paper bag will help slow the process.

 

5. Tomatoes

To get the best taste from tomatoes, keep them at room temperature. When cooled, they lose their natural flavour.

6. Honey

It never goes off, so why would you keep it in the fridge?

7. Melons

If the fruit is still whole, there’s no need for it to take up all that room in the fridge. However, once it’s cut, GHI recommends wrapping and refridgerating it.

8. Cake

This is where plastic containers come in. Unless you’ve got cake made with real cream, an airtight container is your best bet for keeping cake.

9. Coffee

You may have been told coffee should be kept cold, but the trouble with putting it in the fridge is it will absorb the aromas from other foods.

America’s pungent corpse flowers are all mysteriously blooming at once.


Botanists across the US are trying to figure out why so many titan arums – better known as corpse flowers – are blooming simultaneously around the country this year.

This is super weird, because there have only been 157 recorded bloomsever between 1889 and 2008. But this year in the US alone, at least seven flowers have bloomed.

Before we dive headfirst into this foul-smelling mystery, what’s a corpse flower, and why are botanists so into them?

The scientific name for corpse flowers is Amorphophallus titanium, which literally means “giant misshapen penis” in Latin (no, really).

They not only produce one of the biggest flowering structures in the world, sometimes reaching heights of over 1.8 metres (6 feet), their scent happens to mimic the distinct stench of decomposing flesh, with a bit of old fish mixed in.

Native to parts of western Sumatra, these gigantic flowers bloom about once every six years, giving everyone in their vicinity a good whiff of their natural perfume.

Botanists have suggested that this noxious smell helps to attract flies and other insects that typically eat decaying material, so they can pollenate the flower. So you can think of the corpse flower as a kind of ‘anti-flower’, because instead of attracting pollinators with its sweet smelling nectar, it attracts them with carrion-like smells.

Since the flowers are so large and produce such powerful smells, it takes a lot of time and energy for the plant to reach bloom, making it a pretty rare sight.

The first corpse flower ever to bloom through cultivation took place in London in 1889. Since then, there have only been 157 other blooms through cultivation around the world, as Jessie Guy-Ryan reports for Atlas Obscura.

This year, though, is different. So far, seven corpse flowers have bloomed around the US within months of each other, which – given that it takes so long for a corpse flower to develop – is an anomaly that botanists would love to get to the bottom of.

The problem is that the blooms are so rare, the research behind them is still in its infancy. One of most popular hypotheses right now is that the rampant blooming is due to US greenhouses and botanical gardens sharing seeds with one another, meaning most of the corpse flowers that are currently blooming are likely related (think: cousins).

But, as Guy-Ryan points out, many greenhouses say they’re not sure of the exact origin of their corpse flower seeds, which makes this hypothesis very difficult to prove.

Another hypothesis is that corpse flowers are more popular now than ever among botanical gardens in the US, so more are blooming because, well, there are simply more of them.

Just last week, a corpse flower at the New York Botanical Garden began blooming, and another at the US Botanic Garden in Washington, DC – named Charlotte – showed signs of blooming this week, making this extraordinarily rare event seem not so rare after all.

If you happen to be near a botanical garden that has a corpse flower, you should definitely check it out (if you can stand the smell), because no one knows when this opportunity will come around again.

Ditch sausages for a longer life, say Harvard scientists


Stay away from sausages, scientists say. Photo / iStock

Swapping a sausage for whole grain toast, a few tomatoes or a handful of nuts could lead to a much longer life, research has shown.

It might seem like a simple substitution, but exchanging just a small amount of processed red meat for plant protein reduces the risk of early death by 34 per cent. Ditching bacon and eggs could also extend life, the study suggests.

Researchers at Harvard Medical School and Massachusetts General Hospital followed more than 130,000 people for 36 years, monitoring their diet, lifestyle, illness and mortality.

For a man, they found that switching 19g of animal protein – the equivalent of a sausage or a few slices of bacon – for nuts, vegetables, or wholegrains significantly cut the risk of early death. A woman needs to exchange just 15g for the same effect.

Substituting eggs for plant protein also led to a 19 per cent reduction in death risk.

In contrast, raising the animal protein share of calories by 10 per cent led to a 2 per cent higher risk of all-cause death and an 8 per cent greater chance of dying from a heart problem.

“Overall, our findings support the importance of the sources of dietary protein for long-term health outcomes,” said Dr Mingyang Song, the lead scientist, from Massachusetts General Hospital.

“While previous studies have primarily focused on the overall amount of protein intake – which is important – from a broad dietary perspective, the particular foods that people consume to get protein are equally important.

“Our findings suggest that people should consider eating more plant proteins than animal proteins, and when they do choose among sources of animal protein, fish and chicken are probably better choices.”

Animal protein foods include all types of meat, fish, eggs and dairy products such as milk and cheese. Plant sources of protein include cereals, beans, nuts, legumes, soya and bread.

The greater risk of dying linked to eating animal protein was more pronounced among people who were obese, had a history of smoking, drank heavily, and who did little exercise.

Among the healthiest participants, the association disappeared – possibly because health-conscious people tended to eat more fish and poultry rather than red and processed meat, said the researchers.

Prof Tim Key, director of Oxford University’s Cancer Epidemiology Unit, said the findings showed that cutting out processed meat was crucial to good health.

“Few previous studies have specifically addressed the relationships of mortality with animal versus plant protein, but previous long-term studies on major animal and plant foods are broadly consistent with these findings, and there are several mechanisms which could explain the findings,” he said.

“Overall, the study adds to the view that healthy diets should emphasise plant foods, including plant sources of protein, and that intakes of animal source foods – especially processed meat – should be low.”

The researchers analysed more than 3.5 million person-years of data in the study.

Dr Ian Johnson, from the Institute of Food Research in Norwich, said: “This interesting and robust work seems to support the growing consensus that diets based largely on plant foods are better for long-term health than diets containing large quantities of meat and dairy products, but it tells us little about mechanism.

“It is far from clear whether plant proteins are protective or animal proteins are detrimental to health, or whether these protein levels are simply markers for something else.”

US Government Wants To Microchip All Kids “Sooner Rather Than Later”


New born baby infant (10 days old), sleeping in an adult's hand.

Credit: Mirror Spectrum

US Government Wants To Microchip All Kids “Sooner Rather Than Later”

Need any more proof that homeopathy is useless? We’ve just got it, so let’s finally end this farce


A new study has found that homeopathy is effective for 0 out of 68 illnesses.

The National Health and Medical Research Council of Australia recently published what might be the most thorough evaluation of homeopathy ever since it began 200 years ago.

They assessed 176 individual clinical trials focused on 68 different conditions, and had two conclusions. Firstly, that there is no evidence that homeopathy works better than placebo and, secondly, that patients may harm themselves if they use homeopathy instead of effective therapies.

warned against homeopathy in 2002, and a range medical experts have been vocal about the dangers of homeopathy for many years now. Yet homeopaths around the world seemed shocked by the news of this study, and are now on the warpath to suppress it.

Their reaction is ridiculous. As Oliver Wendell Holmes wrote in 1842, “[homeopathy is] a mingled mass of perverse ingenuity, of tinsel erudition, of imbecile credulity, and of artful misinterpretation, too often mingled in practice… with heartless and shameless imposition.” And yet, 174 years later, people still continue to believe.

Homeopaths have claimed for the last 200 years that science was not yet able to explain how it works. In other words, they believe they’re ahead of their time. However, scientists have always been perfectly able to affirm that there cannot be an explanation for homeopathy that does not fly in the face of science.

“The proof is in the pudding”, homeopaths countered, “if patients benefit from homeopathy, it works regardless what the science tells us!” This argument too has long been shown to be based on little more than the delusion of homeopaths. Patients benefit from the therapeutic encounter, from the placebo-effect and from other phenomena that are unrelated to the sugar pills dished out by homeopaths. To convey such benefits to their patients, clinicians do not need placebos. Administering truly effective treatments with compassion will make them benefit from both the specific and the non-specific effects of the therapy in question. This means that just using placebos like homeopathics is unethical and amounts to cheating the patient.

Given the overwhelming evidence against homeopathy it now seems like the time to act. There is no reason any longer for anyone to believe in homeopathy. Pretending there is room for a legitimate debate is merely misleading the public. There is no reason to have homeopathy on the NHS, to pay for homeopathic hospitals, or to invest into further research. After researching the subject for more than two decades, I am convinced that the only legitimate place for homeopathy is in the history books.

 

How a shrinking belly can help a growing family


A 38-year-old white man came to see me because he and his wife were thinking of having another child.

The patient had a history of hypogonadism and the couple had their first child four years ago with in vitro fertilization/intracytoplasmic sperm injection. The patient had had a normal puberty. He was not complaining of erectile dysfunction or premature ejaculation. He shaved daily. There were no changes to his voice and he had not had any fractures or loss of height. The patient stated that he had been heavy as a child, but was slim in his 20’s. He had gained 45 kg over the past eight years and was diagnosed with type 2 diabetes half a year before the visit.

After brief treatment with insulin, he was switched to his current regimen of metformin 1,000 mg by mouth twice a day and pioglitazone 15 mg by mouth daily. The patient experienced weight gain with pioglitazone. He initiated lifestyle changes by keeping a diet log and attempting to increase his exercise; however, the weight gain continued over three months. The patient stated that his last HbA1c was 5.5%. He was concerned about his continued weight gain and his low testosterone levels.

His other medical history consisted of type 2 diabetes as mentioned above, nonalcoholic fatty liver disease, which improved with treatment on the TZD, and hypertension.

Ronald Tamler, MD, PhD, MBA
Ronald Tamler

Medications included lisinopril 10 mg by mouth daily, aspirin 81 mg by mouth daily, metformin and pioglitazone as mentioned above. The patient was a physician. Review of systems was relevant for shortness of breath after climbing two flights of stairs.

Physical examination: obese white male in no acute distress. Height six foot one inch and weight 277 lbs; BMI of 36. Blood pressure 130/80 mmHg and heart rate 90. Notable skin tags and acanthosis. Heart: regular rate and rhythm with no murmurs, rubs or gallops. Lungs were clear to auscultation bilaterally. Genitourinary exam revealed normal-sized testicles of about 20 cc bilaterally. There was a small varicocele present. Waist circumference was 48 in. Labs: normal chem 12 and fasting lipids at goal for a patient with diabetes.

Total testosterone low at 193 ng/dL, on repeat blood draw total T 235, sex hormone-binding globulin 13, free T low-normal at 8 ng/dL, bioavailable T low-normal at 153 ng/dL. Luteinizing hormone 4, follicle-stimulating hormone 2.7 mIU/mL, estradiol 34 pg/mL. Semen analysis was remarkable for a low count of 0.5 mill/mL (normal: 20 mill/mL) and decreased sperm motility.

Which of the following is inappropriate for this patient?

  1. Referral to see a bariatric surgery team to discuss weight loss surgery.
  2. Prescribe sibutramine 10 mg daily, increase lisinopril to 20 mg daily and have the patient monitor his blood pressure for worsening hypertension.
  3. Start transdermal testosterone 1%, 5 g daily.
  4. Prescribe orlistat 60 mg with meals and a multiple vitamin injection and warn the patient of loose stools.
  5. Discontinue pioglitazone and start exenatide 5 mcg twice a day with meals.

CASE DISCUSSION

This patient is fairly typical of what we see in the Mount Sinai Men’s Wellness Program. The patient is obese, has low testosterone and a low sperm count.

Obesity and metabolic syndrome are strongly related to male hypogonadism. Hypogonadism has high positive predictive value of future metabolic syndrome and type 2 diabetes. Conversely, metabolic syndrome, in this case type 2 diabetes, obesity and hypertension, are predictive of hypogonadism.

The pathophysiology in obese men is thought to be related to aromatization of testosterone to estradiol in the adipose tissue. This not only means that less testosterone is available due to the conversion, but it also implies increased suppression of luteinizing hormone by estradiol with subsequently decreased testosterone production. This state is therefore aptly named hyperestrogenic hypogonadotropic hypogonadism. Sex hormone-binding globulin is often suppressed due to increased insulin production in these insulin-resistant patients, thus yielding low-normal free and bioavailable testosterone levels.

Weight loss has not only been shown to decrease aromatization and increase testosterone levels but is also associated with improved fertility (see figure 1). Therefore, any method to decrease weight in this patient will also improve testosterone levels and fertility. It should be noted that a systematic attempt to induce lifestyle changes has failed in this patient.

Figure 1. Abdominal CT scan of bilateral macronodular adrenal hyperplasia
Figure 1. Abdominal CT scan of bilateral macronodular adrenal hyperplasia. (A) Axial image. (B) Coronal Image. The red arrow indicates the bilateral macronodular adrenal hyperplasia with multiple large hypodense nodules. Green arrow: Kidney. L: Liver.

I therefore initially started him on exenatide. This GLP-1 analogue can be used effectively for glycemic control in patients with diabetes and can lead to significant weight loss in some. However, the patient discontinued the medication after two months, because he was still gaining weight.

There are currently two pharmaceutical agents that are FDA approved for long-term (up to two years) treatment of obesity: orlistat and sibutramine.

I first initiated orlistat, which inhibits pancreatic lipase; this decreases breakdown into absorbable fatty acids in the intestine. Adverse effects include “anal leakage,” and one has to make sure that the patient is getting enough fat-soluble vitamins. The patient was very concerned about the gastrointestinal adverse effects and in fact (this is a real case, you can’t make this thing up) got so excited after taking the first dose that he had constipation for three days. He then returned to my office and felt he would not do well on this medication.

Bariatric surgery is a valid option in obese patients with a BMI >40 or a BMI >35 with obesity-related comorbidities, such as type 2 diabetes. Only 10% to 20% of patients undergoing bariatric surgery are male, and the research on hypogonadism and fertility in these patients is therefore limited. However, the data so far show that testosterone levels and semen analyses improve significantly with weight loss after surgery.

In this particular case, however, I started sibutramine 10 mg daily. Sibutramine is a centrally acting agent that decreases appetite. It should not be used in conjunction with antidepressants. The most notable adverse effect is hypertension. Since the patient’s blood pressure was borderline on lisinopril, I increased the dose of his antihypertensive to 20 mg and asked him to monitor his blood pressure at home. Over the next four months, the patient lost 15 lbs, and when I last saw him, he weighed 243 lbs, which yielded a BMI of 32. Total testosterone was up to 732 (bioavailable T at 545), along with a normal semen analysis. The couple had delayed the second child for personal reasons, but the patient has done so well with his weight loss that he was able to discontinue pioglitazone and keep his HbA1c at 5.5% just with metformin 500 mg by mouth twice a day.

Testosterone supplementation (option C) can indeed lead to increased lean body mass and possibly decreased fat mass, but it would decrease semen production even further. It is therefore the wrong choice in this particular patient.

Thyroid cancer risk increases with hysterectomy


Among postmenopausal women, the risk for thyroid cancer is increased with hysterectomy regardless of oophorectomy status, according to recently published data.

Use of exogenous estrogen was associated with lower risk for thyroid cancer in women who had undergone hysterectomy without oophorectomy, particularly for those with long duration use of hormone therapy, researchers wrote.

Juhua Luo, PhD, associate professor in the department of epidemiology and biostatistics at the School of Public Health, Indiana University Bloomington, and colleagues evaluated data from the Women’s Health Initiative on 127,566 women aged 50 to 79 years who were enrolled between 1993 and 1998 to determine the relationships between hysterectomy, bilateral salpingo-oophorectomy and thyroid cancer incidence. Follow-up was a mean 14.4 years.

At baseline, 36.7% of women had undergone hysterectomy, and 55% of them had bilateral salpingo-oophorectomy. Through follow-up, 344 participants developed thyroid cancer.

An increased risk for thyroid cancer was related to hysterectomy, regardless of ovarian status (HR = 1.46; 95% CI, 1.16-1.85). A similar increased risk for thyroid cancer was found in participants with hysterectomy alone and participants with hysterectomy plus bilateral salpingo-oophorectomy compared with participants without hysterectomy.

The risk for thyroid cancer was not associated with HT use in participants without hysterectomy and participants with hysterectomy plus bilateral salpingo-oophorectomy, but HT use in participants with hysterectomy alone was associated with a significantly lower risk for thyroid cancer (HR = 0.47; 95% CI, 0.28-0.78). This was especially pronounced in participants using HT for 10 or more years (HR = 0.24; 95% CI, 0.11-0.52).

Compared with participants without hysterectomy, participants with hysterectomy had an increased risk for thyroid cancer (HR = 1.78; 95% CI, 1.33-2.37).

“Our large prospective study observed that hysterectomy regardless of oophorectomy status was associated with increased risk of thyroid cancer among postmenopausal women,” the researchers wrote. “[HT] use was associated with lower or no risk of thyroid cancer. These findings did not support that exogenous estrogen is a risk factor and estrogen deprivation is a protective factor for thyroid cancer. Our study suggests that when deciding to remove the uterus for benign conditions, possible increased risk of thyroid cancer should be considered.” – by Amber Cox

FDA announces preliminary safety review of pioglitazone


The FDA is evaluating preliminary results from a long-term, observational study suggesting patients assigned pioglitazone may be at increased risk for bladder cancer. As of press time, the FDA’s review is ongoing and they have not confirmed an association between pioglitazone and bladder cancer risk.

According to the FDA, the preliminary data are based on 5-year results from an ongoing, 10-year study conducted by Takeda Pharmaceuticals. Although preliminary findings indicated no association between exposure to pioglitazone (Actos, Takeda) and risk for bladder cancer, there was an increased risk among patients with the longest duration of exposure to the drug as well as in those assigned the highest cumulative dosage.

Pioglitazone is prescribed to control blood glucose in patients with type 2 diabetes. The only other drug in this class is rosiglitazone (Avandia, GSK). FDA officials have no clinical data suggesting an association between rosiglitazone and bladder cancer. However, following an FDA advisory committee meeting back in July, officials recommended restrictions be placed on the use of rosiglitazone in addition to revised labeling that includes additional warnings about cardiovascular safety.

The FDA recommends for patients to discuss any concerns with their health care professional. Patients should not stop taking pioglitazone unless told to do so by their health care professional.

Bladder cancer risk not increased with pioglitazone therapy


Through an analysis of nearly 200,000 patients, no statistically significant increased risk for bladder cancer was found with the use of Actos, according to recent study findings published in JAMA.

Assiamira Ferrara, MD, PhD, of Kaiser Permanente Northern California, and colleagues conducted a bladder cancer cohort analysis of 193,099 people aged 40 years or older in 1997 to 2002 until December 2012; evaluated 464 case patients and 464 matched controls for additional confounders; and performed a cohort analysis for 10 additional cancers on 236,507 people aged 40 years or older in 1997 to 2005 until June 2012. All participants were members of Kaiser Permanente Northern California.

Assiamira Ferrera

Assiamira Ferrara

The additional cancers included prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin’s lymphoma, pancreas, kidney/renal pelvis, rectum and melanoma.

Among the bladder cancer cohort, 34,181 participants received Actos (pioglitazone, Takeda) during follow-up. Overall, 0.65% of participants were diagnosed with bladder cancer. No significant association was found between ever use of pioglitazone and bladder cancer (HR = 1.06; 95% CI, 0.89-1.26).

Through the case-control analysis, researchers found similar rates of bladder cancer between ever use (19.6%) and nonusers (17.5%).

In the study analyzing additional cancers, 16% of participants had received pioglitazone by the end of follow-up. The researchers found no association between most of the cancers and pioglitazone use; however, there was an increased risk for prostate cancer (HR = 1.13; 95% CI, 1.02-1.26) and pancreatic cancer (HR = 1.41; 95% CI, 1.16-1.71).

“There was no statistically significant increased risk of bladder cancer associated with pioglitazone use,” the researchers wrote. “However, a small increased risk, as previously observed, could not be excluded. The increased prostate and pancreatic cancer risks associated with ever use of pioglitazone merit further investigation to assess whether the observed associations are causal or due to change, residual confounding, or reverse causality.”

In an accompanying editorial, Joshua M. Sharfstein, MD, of Johns Hopkins Bloomberg School of Public Health, andAaron S. Kesselheim, MD, JD, MPH, of Brigham and Women’s Hospital, wrote that the results “shed new light on the safety of pioglitazone reflecting the dynamic nature of many drug safety questions.

“As in this case, caution and further review are the appropriate responses to many safety signals,” they wrote. “But when emerging available data — clinical, laboratory, observational and even population-based studies — create a compelling picture of risk in excess of potential benefit to patients, the FDA should act to protect the public.”

In another editorial, Phil B. Fontanarosa, MD, MBA, executive deputy editor of JAMA, and colleagues wrote that medical journals have a responsibility to review studies evaluating the potential relationship between drugs, devices or vaccines and adverse outcomes.

“Even though no observational study examining the relationship between an exposure and an outcome can definitively establish ‘positive’ cause-and-effect results, and no observational study can definitively prove ‘negative’ results, each study adds to the totality of evidence regarding the safety of drugs, devices and vaccines,” they wrote. “By publishing the results of these studies, JAMA will continue to provide information physicians can use in discussions with patients and regulatory bodies can use in policy decisions about the benefits and risks of various therapies.”