Japan has a drug that kills the flu in 24 hours. Why doesn’t the U.S. have it?

❝ This has been an especially deadly flu season here in the U.S., but a new breakthrough medication promises to kill the flu virus in 24 hours. The catch: It’s only available in Japan.

On Friday, officials in Japan approved the single-dose drug, known as Xofluza, for use in the country, according to the Wall Street Journal. In a clinical trial, Japanese and American patients who took the drug when they had the flu saw the virus wiped out, on average, in 24 hours.

❝ Xofluza is manufactured by Japanese drug maker Shionogi and won’t hit shelves until at least May — again, in Japan. According to the Wall Street Journal, the drug won’t be available in the U.S. until at least 2019.

When it does show up in our pharmacies, any bets on how the price here in the GOUSA will compare to what Japanese patients pay?

Clinical trials tend to be positive when Docs get industry dollar$

When study investigators have financial relationships with pharmaceutical companies, clinical trial results are more likely to turn up positive…

In a review of 190 papers on randomized controlled trials, taking money from industry was significantly associated with favorable trial results in a fully adjusted model…Salomeh Keyhani, MD, of the University of California San Francisco, and colleagues reported online…

Their findings suggest bias in the evidence base, Keyhani said. Practicing clinicians “should be concerned enough to employ healthy skepticism while reviewing the results of any one trial,” she told MedPage Today.

❝ The paper makes the distinction between a study being funded by a drug company, and investigators who have financial relationships with those companies.

Researchers with financial relationships can influence the study results in less obvious ways, such as study design and analytic approach, but Keyhani noted that the current research is a “cross-sectional study so any interpretation of the findings should be made with caution.”…

Gasp! Who’da thunk it.

RTFA for methodology – and more.

Marijuana extract a promising treatment for severe childhood epilepsy

An extract of marijuana shows promise as a treatment for children with severe epilepsy who have been unresponsive to other treatments, after an early-phase safety study is presented at the American Academy of Neurology’s annual conference.

The study is an analysis of early clinical trialing, so mainly designed to be the first test of the potential medicine’s safety and tolerability for patients as well as its possible effectiveness. The extract under investigation is cannabidiol (CBD), and was taken in a liquid form once daily…

All the children had severe forms of epilepsy – including Dravet and Lennox-Gastaut syndromes, which can mean lifelong disabling seizures – and their conditions had not responded to other treatments. They received the experimental treatment under the FDA’s expanded access program, which makes investigational drugs available for testing to people with serious or life-limiting conditions.

The results provided so far – and to be presented at the American Academy of Neurology’s annual meeting, which starts at the end of this week in Washington, DC – give only the relative reductions in numbers of seizures suffered by the participants – there was a decrease in these during the study of around half.

Only future phases of clinical trialing could test effectiveness properly – using greater numbers of patients in randomized controlled trials, which will also help to reduce the effects of bias…

Dr. Orrin Devinsky said: “While cannabis has been used to treat epilepsy for centuries, data from double-blind randomized, controlled trials of CBD or THC in epilepsy is lacking. Randomized controlled studies of CBD in targeted epilepsy groups, such as patients with Dravet or Lennox-Gastaut syndromes, are in the planning stages.”

Overdue. Why? Because we are a nation of powerless electors – limited to TweedleDee and TweedleDumb, two wings of the same useless, bought-and-sold, political hacks.

The history of laws and regulations governing cannabis in the United States have absolutely nothing to do with science or reality 101. Religion, myth, superstition, opportunist fumbling under the money-tables of our legal temples have all played a role in codifying stupidity. With the collaboration of cowards as often self-defined as Liberal as Conservative.

For a little more background to the efforts of folks willing to challenge idjit law, wander over to this post from last June.

Study shows HPV vaccine works for boys


“Doc, I have this funny wart on my whatsis”

The vaccine for human papillomavirus (HPV) can prevent 90 percent of genital warts in men when offered before exposure to the four HPV strains covered by the vaccine, according to a new multi-center study led by H. Lee Moffitt Cancer Center and UCSF.

The four-year, international clinical trial, which also found a nearly 66 percent effectiveness in the general population of young men regardless of prior exposure to these strains, provides the first reported results of using the HPV vaccine as a prophylactic in men.

Initial data from this study informed the Food and Drug Administration’s decision to approve the vaccine for boys in 2009 to prevent warts, while results from a substudy led the FDA to expand approval late last year to prevent anal cancer.

While the HPV vaccine was approved in 2006 for girls to prevent cervical cancer, the vaccine’s benefit for young men was not initially addressed. Yet infection and diseases caused by HPV are common in men, the researchers said, including genital warts, which are one of the leading sexually transmitted diseases (STD) for which treatment is sought nationwide. The Centers for Disease Control and Prevention estimate that half of all sexually active Americans will get HPV at some point in their lives…

The authors noted that while they find it likely that the prevention of HPV infection and disease in men will have additional benefits, such as preventing anal, genital and throat cancers, these benefits need to be directly demonstrated through further clinical trials.

More good reasons for expanded trials. If we could get Congress and the FDA to discuss the question without special permission from someone in the Old Testament.

Clinical trials on the way for spinal cord injuries

StemCells Inc has filed for Swiss regulatory approval for the first clinical trial of its nerve stem cells in patients with spinal cord injuries as much as a year old, the company said…

“To date, the focus has been on the acute spinal cord injury phase,” StemCells CEO Martin McGlynn said in a telephone interview. “That’s an important area to address, but the largest unmet need is those who have passed that immediate acute phase of injury…”

StemCells Inc, based in Palo Alto, California, said the relevant ethics committees have approved the trial, which it plans to conduct in Switzerland due to the expertise of the investigator and the institution it selected as well as the strong network in Europe for spinal cord patients and referrals.

A study published earlier this year showed that mice treated with StemCells’ nerve stem cells — which are extracted from aborted fetuses — were able to walk better than those treated with ordinary human skin cells or a placebo, even when the treatment came weeks after their injury.

The cells are a form of stem cell, the master cells of the body. These are technically adult stem cells, taken from the partly developed brains of fetuses and tested for qualities showing they are destined to form particular types of nerve cells…

Patients in the StemCells trial will receive a single infusion of cells into the spinal cord. Results are expected within months of the treatment.

Politicians and the religious nutballs they fear the most will waste a certain amount of time standing in the way. The pols will step aside – because they know the average American wants this research to continue. The nutballs will be swept aside by history.

What Do You Lack? Probably Vitamin D

Vitamin D promises to be the most talked-about and written-about supplement of the decade. While studies continue to refine optimal blood levels and recommended dietary amounts, the fact remains that a huge part of the population — from robust newborns to the frail elderly, and many others in between — are deficient in this essential nutrient.

If the findings of existing clinical trials hold up in future research, the potential consequences of this deficiency are likely to go far beyond inadequate bone development and excessive bone loss that can result in falls and fractures. Every tissue in the body, including the brain, heart, muscles and immune system, has receptors for vitamin D, meaning that this nutrient is needed at proper levels for these tissues to function well.

Studies indicate that the effects of a vitamin D deficiency include an elevated risk of developing (and dying from) cancers of the colon, breast and prostate; high blood pressure and cardiovascular disease; osteoarthritis; and immune-system abnormalities that can result in infections and autoimmune disorders like multiple sclerosis, Type 1 diabetes and rheumatoid arthritis.

Most people in the modern world have lifestyles that prevent them from acquiring the levels of vitamin D that evolution intended us to have. The sun’s ultraviolet-B rays absorbed through the skin are the body’s main source of this nutrient. Early humans evolved near the equator, where sun exposure is intense year round, and minimally clothed people spent most of the day outdoors…

Although more foods today are supplemented with vitamin D, experts say it is rarely possible to consume adequate amounts through foods. The main dietary sources are wild-caught oily fish (salmon, mackerel, bluefish, and canned tuna) and fortified milk and baby formula, cereal and orange juice.

People in colder regions form their year’s supply of natural vitamin D in summer, when ultraviolet-B rays are most direct. But the less sun exposure, the darker a person’s skin and the more sunscreen used, the less previtamin D is formed and the lower the serum levels of the vitamin. People who are sun-phobic, babies who are exclusively breast-fed, the elderly and those living in nursing homes are particularly at risk of a serious vitamin D deficiency.

An article well worth reading. Lots of detail. Lots of sound, sensible science-based recommendations.

If you’re lazy, experts recommend that adults take a daily supplement of 1,000 to 2,000 units. You need to know that much.

Yes, I do.

Missing: the clinical trials that did not make the news

This week the media ignored a study looking at that exact question. It was also one of the most important papers to be published this year: only one in five trials on cancer treatment actually gets published; the rest are missing in action. And it gets worse: only 5.9% of industry-sponsored trials on cancer treatment get published. Later, it will get worse again.

For decades people have known that negative results tend not to get printed in academic journals, and it can happen for all kinds of reasons: they’re not newsworthy, they’re not much fun to write up, they don’t look good on your CV, and they might not flatter your idea or product.

One suggestion which I bang on about incessantly is that all clinical trials should be registered before they begin: then people stand a chance of noticing if and when a trial goes missing in action. This took about 20 years to be put into practice. But there is a problem: who will chase up the missing studies?
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