Caster Semenya, Defiant After Race Win, Says She Won’t Take Hormone Reducing Drugs

Caster Semenya was defiant in every way at what very well could be her last 800 meter race.

Her raised fist at the start. Her unstoppable victory. And with her reply Friday to the big question of whether she will now submit to new testosterone regulations in track and field and take hormone-reducing medication.

“Hell no,” the Olympic champion from South Africa said.

Semenya responded to her defeat in a landmark court case against track and field’s governing body two days earlier with a resounding win in a place where she’s done nothing but win the last four years — over two laps of the track.

She won the 800 meters at the opening Diamond League meeting of the season in Doha, Qatar, with a meet record of 1 minute, 54.98 seconds. It was her fourth-fastest time ever. The only person ahead of her at any time during the race was the pacemaker.

Semenya’s nearest challenger, the Olympic silver medalist Francine Niyonsaba, was nearly three seconds and about 20 meters behind her — barely in the picture. Ajee Wilson of the United States was third.

It was Semenya’s first 800 meter race this year and first since losing her case against the IAAF this week.

“Actions speak louder than words,” Semenya told the BBC. “When you are a great champion, you always deliver.”

But Semenya’s four-year dominance over two laps — Friday’s win was her 30th straight in the 800 continuing a run that started in late 2015 — may now be at an end.

Ended not by another competitor, but by new regulations set to come into effect Wednesday. They require the South African star and other female athletes with high levels of natural testosterone to medically lower them to be eligible to compete in events ranging from 400 meters to the mile.

Semenya failed to overturn those rules in her appeal to the Court of Arbitration for Sport.

Now, her career appears to be at a crossroads: Does she take medication to lower her testosterone? The medication will likely inhibit her athletic performance and could blunt her dominance. Or does she switch events and run in long-distance races not affected by the regulations?

She was emphatic when she told reporters after Friday’s race that she wouldn’t take the medication.

“That’s an illegal method,” she said.

But Semenya also didn’t give a clear idea of what she would do next. She said she wouldn’t move up to the 5,000 meters and she definitely wouldn’t retire.

“God has decided my career, God will end my career,” she said in the BBC interview. “No man, or any other human, can stop me from running. How am I going to retire when I’m 28? I still feel young, energetic. I still have 10 years or more in athletics.

“It doesn’t matter how I’m going to do it. What matters is I’ll still be here. I am never going anywhere.”

Semenya’s comments may foreshadow an appeal against the CAS ruling, aimed first at allowing Semenya to defend her 800 title at the world championships, also in Doha, in September and October while not taking the hormone-suppressing drugs.

But, if she keeps her promise not to lower her testosterone, there is a chance that Friday was the last time that Semenya runs in the 800, where she is a double Olympic and a three-time world champion, and arguably the best female athlete to run the distance in 40 years.

Her career, however, seems destined to be overshadowed by the testosterone debate, which has the potential for implications far beyond her own results.

Semenya gave away little on the track to indicate it might be her last race at the distance. She raised her right fist when announcers introduced her before the race.

She was presented with a bunch of flowers and tossed them to the crowd at the end. She then gave a thumbs-up to fans, flashed a brief smile, and walked off the track.

Sports – TIME

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Monthly Shots of HIV Drugs Are as Effective as Daily Pills, 2 Big Studies Show

SEATTLE (AP) — Monthly shots of HIV drugs worked as well as daily pills to control the virus that causes AIDS in two large international tests, researchers reported Thursday.

If approved by regulators in the United States and Europe, the shots would be a new option for people with HIV and could help some stay on treatment. Instead of having to remember to take pills, patients instead could get injections from a doctor or nurse each month.

“Some people will be thrilled” at the convenience, said Mitchell Warren, executive director of AVAC, an AIDS advocacy group.

Condoms remain the most widely available and inexpensive form of HIV prevention. Pills taken daily can keep HIV levels so low the virus is not transmittable to sex partners, but not everyone takes them as prescribed.

The shots could improve how well some people stick to treatment, perhaps helping those who have trouble remembering to take daily medicine to keep infection at bay.

There are other potential benefits. Getting shots at a clinic can lend more privacy to patients worried about the stigma of filling an HIV prescription at a pharmacy, said Dr. Susan Swindells of the University of Nebraska Medical Center in Omaha, who presented results Thursday at an HIV conference in Seattle.

Cost will be an issue “to make sure that everyone has access to this medication,” said Dr. Hyman Scott of the San Francisco Department of Public Health, who was not part of the study. It’s not clear how much the shots would cost. HIV pills can cost a patient up to thousands of dollars monthly , depending on the drug combination, insurance coverage, rebates and discounts.

And there will be concerns about patients missing a monthly shot, which could lead to drug-resistant strains of the virus. It will be “a good option for some people,” Scott said.

Whether monthly shots will also work to protect users’ sex partners hasn’t been studied yet, but there is reason to think they will, said experts at the conference.

The shots are a long-acting combo of two HIV drugs — rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen, and ViiV Healthcare’s experimental drug known as cabotegravir.

ViiV Healthcare paid for the research. The drugmakers are seeking approval later this year in the United States and Europe.

One study included 616 people who were taking pills to treat their HIV infection. The other study enrolled 566 people who hadn’t yet started treatment, so they first got pills to get the virus under control.

In each of the studies, half the participants switched to the shots while the rest stayed on pills. After nearly a year, 1 to 2 percent of people in both groups had traces of virus in their blood, whether they got shots or pills. That shows the shots worked as well as the standard pill therapy. A few people withdrew from the studies because of pain after the injections.

The studies were done in Europe and North America and in nations including Argentina, Australia, Russia, South Africa, South Korea, Sweden, Japan and Mexico.

“We don’t have experience rolling out an injection in the real world,” said Warren, the AIDS advocate. He said the next challenges will be how to deliver the shots and whether patients will remember to come back monthly. “These are big questions.”

Sports – TIME

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Expired drugs may remain effective, safe to use in a pinch

(Reuters Health) – Even medicines that are years past their expiration date and haven’t always been kept in strict climate-controlled conditions may still retain their original potency, a small study suggests.


Reuters: Arts

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NASH Drugs At A Crossroads…

Non-alcoholic steatohepatitis, or NASH, which refers to liver inflammation due to fat buildup in the liver, is said to affect an estimated 16 million Americans. NASH is a more severe form of nonalcoholic fatty liver disease, or NAFLD. The incidence of NASH is on the rise, and even worrying is the fact that there are no approved treatments for the disease, yet.
RTT – Top Story

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SAP Unveils Blockchain Project To Help Eliminate Counterfeit Drugs

erman software giant SAP SE announced the launch of its blockchain-based supply chain tracking system that helps eliminate counterfeit drugs along the pharmaceutical supply chain. In a statement, the company noted that its blockchain-based solution helps customers comply with the U.S. Drug Supply Chain Security Act or DSCSA.
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Health Care Industry Spends $30B A Year Pushing Its Wares, From Drugs To Stem Cell Treatment

Hoping to earn its share of the $ 3.5 trillion health care market, the medical industry is pouring more money than ever into advertising its products — from high-priced prescriptions to do-it-yourself genetic tests and unapproved stem cell treatments.

Spending on health care marketing doubled from 1997 to 2016, soaring to at least $ 30 billion a year, according to a study published Tuesday in JAMA.

“Marketing drives more testing. It drives more treatments. It’s a big part of why health care is so expensive, because it’s the fancy, high-tech stuff things that get marketed,” said Steven Woloshin, co-director of the Center for Medicine and Media at The Dartmouth Institute for Health Policy and Clinical Practice. His study captured only a portion of the many ways that drug companies, hospitals and labs promote themselves.

Advertising doesn’t just persuade people to pick one brand over another, said Woloshin. Sophisticated campaigns make people worry about diseases they don’t have and ask for drugs or exams they don’t need.

Consumer advocates say that taxpayers pay the real price, as seductive ads persuade doctors and patients alike to order pricey tests and brand-name pills.

“Whenever pharma or a hospital spends money on advertising, we the patients pay for it — through higher prices for drugs and hospital services,” said Shannon Brownlee, senior vice president of the Lown Institute, a Brookline, Mass., nonprofit that advocates for affordable care. “Marketing is built into the cost of care.”

High costs ultimately affect everyone, because they prompt insurance plans to raise premiums, said Diana Zuckerman, president of the National Center for Health Research, a nonprofit that provides medical information to consumers. And taxpayers foot the bill for publicly funded insurance programs, such as Medicare.

“These ads can be amazingly persuasive, and they can exploit desperate patients and family members,” said Zuckerman, who was not involved in the new study.

Drug companies spend the bulk of their money trying to influence doctors, showering them with free food, drinks and speaking fees, as well as paying for them to travel to conferences, according to the study.

Dr. Lisa Schwartz and Dr. Steven Woloshin(Courtesy of the Dartmouth Institute for Health Policy & Clinical Practice)

Yet marketers also increasingly target consumers, said Woloshin, who wrote the study with his wife and longtime research partner, Dartmouth’s Dr. Lisa Schwartz, who died of cancer in November.

The biggest increase in medical marketing over the past 20 years was in “direct-to-consumer” advertising, including the TV commercials that exhort viewers to “ask your doctor” about a particular drug. Spending on such ads jumped from $ 2.1 billion in 1997 to nearly $ 10 billion in 2016, according to the study.

A spokeswoman for the pharmaceutical industry group, PhRMA, said that its ads provide “scientifically accurate information to patients.” These ads “increase awareness of the benefits and risks of new medicines and encourage appropriate use of medicines,” said Holly Campbell, of PhRMA.

The makers of genetic tests — including those that allow people to learn their ancestry or disease risk —also bombard the public with advertising. The number of ads for genetic testing grew from 14,100 in 1997 to 255,300 in 2016, at a cost that year of $ 82.6 million, according to the study. AncestryDNA spends more than any other company of its kind, devoting $ 38 million to marketing in 2016 alone.

Some companies are touting stem cell treatments that haven’t been approved by federal regulators. The Food and Drug Administration has approved stem cell therapy for only a few specific uses — such as bone marrow transplants for people with leukemia. But hundreds of clinics claim to use these cells taken from umbilical cord blood to treat disease. Many patients have no idea that these stem cell therapies are unapproved, said Angie Botto-van Bemden, director of osteoarthritis programs at the Arthritis Foundation.

Stem cell clinics have boosted their marketing from $ 900,000 in 2012 to $ 11.3 million in 2016, according to the study.

In recent months, the FDA has issued warnings to clinics marketing unapproved stem cell therapies. Twelve patients have been hospitalized for serious infections after receiving stem cell injections, according to the Centers for Disease Control and Prevention.

Medical advertising today goes beyond TV and radio commercials. Some online campaigns encourage patients to diagnose themselves, Woloshin said.

The website for Restasis, which treats dry eyes, prompts patients to take a quiz to learn if they need the prescription eye drops, said Woloshin, who co-wrote a February study with Schwartz on the drug’s marketing strategy. The Restasis website also allows patients to “find an eye doctor near you.”

Many of the doctors included in the Restasis directory have taken gifts from its manufacturer, Allergan, Woloshin said. The doctor directory includes seven of the top 10 physicians paid by the company, his study says.

In a statement, Allergan spokeswoman Amy Rose said the company uses direct-to-consumer advertising “to support responsible disease awareness efforts.” The ads “do not displace the patient-physician relationship, but enhance them, helping to create well-informed and empowered consumer and patient communities.”

Drug sites don’t just lead patients to doctors. They also provide scripts for suggested conversations. For example, the website for Viagra, which treats erectile dysfunction, provides specific questions for patients to ask.

The website for Addyi, often called the “female Viagra,” goes even further. Patients who answer a number of medical questions online are offered a 10- to 15-minute phone consultation about the drug for $ 49. Patients who don’t immediately book an appointment receive an email reminder a few minutes later.

“This is more evidence,” Brownlee said, “that drug companies are not run by dummies.”

Kaiser Health News

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Tainted drugs: When medicine makes patients sicker

Since the start of 2013, pharmaceutical companies based in the U.S. or abroad have recalled about 8,000 medicines, a Kaiser Health News investigation shows.
ABC News: Health

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As obesity rates in America soar, new weight loss drugs are in the offing that offer hope

There are several promising drug candidates to combat obesity, one of America's biggest diseases and contributors to mortality. Still, doctors have been slow to call obesity a disease, and insurance coverage remains skimpy.
Health and Science

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Mel B spills on bisexuality, attempted suicide and drugs in tell-all memoir

Back in the ’90s, when the Spice Girls were hot, Melanie Brown, aka Mel B, was known around the world as Scary Spice. But Brown’s life became truly scary a couple of decades later, when, as a mother of three daughters trapped in an allegedly abusive marriage to second husband Stephen Belafonte, she attempted suicide….
Living | New York Post

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Hidden Drugs And Danger Lurk In Over-The-Counter Supplements, Study Finds

Everyone has seen the ads or the products on the shelves.

A dietary supplement that promises to make consumers skinny, without dieting or exercise. Or the one that will bulk them up and turn them into the envy of other weightlifters at the gym. Not to mention the one to make them perform better in the bedroom.

Their labels say they are safe and all-natural. But are they?

Many of these products contain unapproved and unregulated pharmaceutically active ingredients, according to a study published Friday in JAMA Network Open. The authors wrote that the substances represent “a serious public health concern.”

Researchers from the California Department of Public Health found that, from 2007 to 2016, 776 products marketed as dietary supplements contained hidden active ingredients that are unsafe or unstudied. Among them, dapoxetine, an antidepressant that is not approved in the United States; and sibutramine, which was included in some weight-loss supplements but was banned from the U.S. market in 2010 because of cardiovascular risks.

“It’s mind-boggling to imagine what’s happening here,” said Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Massachusetts. Cohen wasn’t involved in the study but wrote a commentary published alongside the research.

The California researchers based their findings on an analysis of a Food and Drug Administration database that identifies “tainted” supplements. “The study lays a foundation for ongoing enforcement work in this area, by the FDA and other partner agencies, to curb the illegal manufacture, importation, distribution, and sales of adulterated dietary supplements,” CDPH spokesman Corey Egel said in an email.

Being tainted or adulterated means the product contains active ingredients not listed on the label that fly under the FDA’s radar.

Dietary supplements aren’t classified by the FDA as drugs. They are instead considered foods. They include vitamins, minerals and botanicals, among other things. They are not intended to treat or prevent disease and are not subject to premarket safety and efficacy testing that drugs undergo.

The FDA database tracked problems that emerged during “post-market surveillance” — for instance, adverse events reports and consumer complaints — when bottles were already in consumers’ medicine cabinets. These issues generally draw FDA warning letters and agency requests for voluntary recalls by the manufacturer.

With an estimated 50 percent of Americans consuming some type of supplement, researchers note that the $ 35 billion industry is a big business.

But Duffy MacKay, senior vice president for scientific and regulatory affairs at the supplement industry’s Council for Responsible Nutrition, noted that with between 50,000 and 80,000 supplement labels on the market, 776 tainted products is serious but not widespread.

Of the adulterated products, nearly 46 percent were for sexual performance, 41 percent were for weight loss and 12 percent were for building muscle. Ingredients like sildenafil, the active drug in Viagra, and ephedrine, a stimulant banned from diet pills since 2004, were found in supplements. Anabolic steroids, or ingredients like them, were in 73 of the muscle-building supplements.

Nearly a fifth of these supplements contained more than one unapproved ingredient.

“Adulterated dietary supplements have the potential to cause adverse health effects both on their own and also in combination with other medications an individual may be taking,” the authors wrote.

Cohen agreed, noting that a patient with heart disease might be told to steer clear of prescription erectile dysfunction meds because they could interact with other prescription medications and dangerously lower the consumer’s blood pressure.

Instead, that patient turns to over-the-counter supplements that are marketed as all-natural, thinking this product will not pose the risks he was warned about. “And that’s very worrisome,” said Cohen.

The study authors wrote that these adulterated dietary supplements “are consumed under the presumption of safety and have the potential to cause dangerous consequences in cases of misuse or overdose.”

Cohen suggested looking for supplements with a single ingredient, because they probably will have a lower likelihood of containing secret, harmful ingredients. And never trust a supplement that definitively says it can improve your health.

That advice was echoed by MacKay, from the supplement industry’s trade group, who said outrageous claims about weight loss or body building are red flags.

These products are sold online or by shady retailers and have ridiculous names like “Ball Refill” or “Weekend Prince,” he said.

“There is such a difference between legitimate products and these products,” he added, noting that these “very extreme products” are marketed to “a consumer base that may be OK with this kind of illegal stuff.” That could include, he said, consumers who are “gym rats” and people who want Viagra without a prescription.

But earlier research conducted by Cohen and cited in this study offered a different lens through which to consider the numbers. It pointed to shortcomings in the post-marketing surveillance system, especially the inability of physicians and consumers to identify an adulterated product as the cause of a health problem or to know that such things should be reported to the FDA.

“In fact,” the researchers wrote, “poison control centers received over 1,000 more reports of adverse events associated with dietary supplements use than the FDA did over a 3-year-period.”

There’s little the FDA can or will do once a bad actor is identified. Supplement recalls aren’t like food recalls, Cohen said. With supplements, the FDA can only notify a company that their products have unapproved ingredients. It’s up to the company to conduct a voluntary recall.

“The recall process itself has completely broken down as far as I can tell,” Cohen said.

Kaiser Health News

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Trump signs bills to help patients stop overpaying for drugs

President Donald Trump has signed into law two bills that would allow pharmacists to tell consumers when paying cash would be cheaper than using insurance
ABC News: Health

SPECIAL NEWS BULLETIN:

http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Trio wins chemistry Nobel for work on antibody drugs, smart enzymes

Two Americans and a Briton won the 2018 Nobel Prize for Chemistry on Wednesday for harnessing the power of evolution to generate novel proteins used in everything from environmentally friendly detergents to cancer drugs.


Reuters: Science News

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Trio wins chemistry Nobel for work on antibody drugs and detergents

Two Americans and a Briton won the 2018 Nobel Prize for Chemistry on Wednesday for harnessing the power of evolution to produce novel proteins used in everything from environmentally friendly detergents and biofuels to cancer drugs.


Reuters: Science News

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