Trump declares national emergency over opioid abuse

BEDMINSTER, N.J. — U.S. President Donald Trump on Thursday declared the opioid epidemic a national emergency and said his administration was drafting papers to make it official.

“The opioid crisis is an emergency and I’m saying officially right now it is an emergency,” Trump told reporters in New Jersey. “We’re going to draw it up and we’re going to make it a national emergency. It is a serious problem, the likes of which we have never had.”

Trump spoke about a week after a White House commission on the opioid crisis led by New Jersey Governor Chris Christie recommended the president declare it a national emergency.

The declaration could help unlock more support and resources to address the drug overdose epidemic, such as additional funding and expanded access to various forms of treatment, and it gives the government more flexibility in waiving rules and restrictions to expedite action.

National emergencies are typically declared for short-term crises, such as the Zika virus outbreak or a natural disaster. It is unclear what Trump’s declaration will mean for a complex, long-term public health problem.

“We’re going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said. “This is a worldwide problem, not just a United States problem.”

More than 100 Americans die of drug overdoses every day, the commission wrote in a report, noting that “America is enduring a death toll equal to September 11th every three weeks.” Opioids played a role in more than 33,000 deaths in 2015, according to the U.S. Centers for Disease Control and Prevention.

Trump held a “major briefing” on the epidemic on Tuesday, but stopped short of following the commission’s recommendation. Instead, he talked mostly about stopping the flow of drugs into the United States and ensuring young people never start using drugs. He did not discuss access to treatment.

source: interaksyon.com

Nurofen to be pulled in Australia over misleading claims

SYDNEY, Australia - Drug giant Reckitt Benckiser was Monday ordered to pull some of its popular Nurofen painkiller brands off shelves in Australia after a court ruled they made misleading claims.

Australia's consumer watchdog took court action in March, disputing Nurofen packaging that products in its Nurofen Specific Pain range were formulated to treat different types of pain, when the active ingredient was identical.

The Federal Court ruled the British-based multinational engaged in misleading conduct with the main ingredient, 342 milligrams of ibuprofen lysine, the same in all the products with none any better at treating one type of pain than others.

It ordered that Nurofen Back Pain, Nurofen Period Pain, Nurofen Migraine Pain, and Nurofen Tension Headache be removed from retail shelves within three months.

Nurofen in Australia could not immediately be reached but in a statement the Australian Competition and Consumer Commission (ACCC) said Reckitt Benckiser admitted the illegal conduct and consented to the court orders.

"The ACCC took these proceedings because it was concerned that consumers may have purchased these products in the belief that they specifically treated a certain type of pain, based on the representations on the packaging, when this was not the case," chairman Rod Sims said.

"Truth in advertising and consumer issues in the health and medical sectors are priority areas for the ACCC, to ensure that consumers are given accurate information when making their purchasing decisions."

In Australia, Reckitt Benckiser markets and supplies a range of consumer health and household brands, including Nurofen, Mortein, Clearasil, Finish, Airwick, and Gaviscon.

The court also ordered it to pay the ACCC's costs and publish online and newspaper corrections.

A hearing will be held at a later undisclosed date to decide what fine the company faces.

source: interaksyon.com

US FDA approves 'female Viagra' with strong warning

WASHINGTON -- A controversial drug to treat low sexual desire in women won approval from US health regulators on Tuesday, but with a warning about potentially dangerous low blood pressure and fainting when taken with alcohol.

Moreover, the US Food and Drug Administration said the first approved drug for the condition, to be sold under the brand name Addyi, will only be available through certified health care professionals and pharmacies due to its safety issues.

The FDA has twice rejected the drug, flibanserin, made by privately held Sprout Pharmaceuticals. Its latest decision comes after an advisory panel concluded in June it should be approved with strict measures in place to ensure patients are fully aware of the risks.

Shares of rival Palatin Technologies rose 29 percent to $1.21 in extended trade.

The drug has been nicknamed "female Viagra" in media reports, even though it does not work like Pfizer Inc.'s blockbuster Viagra pill for men that in 1998 became the first approved drug for erectile dysfunction.

Flibanserin needs to be taken every day.

Unlike Viagra, which affects blood flow to the genitals, flibanserin works on the brain. It is similar to a class of drugs known as selective serotonin reuptake inhibitors, or SSRI's, that include antidepressants such as Prozac.

Originally developed by Germany's Boehringer Ingelheim, flibanserin was first rejected by the FDA in 2010 after an advisory panel said the benefits did not outweigh the risks. Sprout acquired the drug, conducted additional studies and resubmitted the application. In 2013, the FDA rejected it again.

The rejection sparked a lobbying campaign by Sprout, aided by some women's groups who accused the FDA of gender bias because it had approved Viagra for men - a charge the FDA vigorously rejected.

Flibanserin is designed for premenopausal women whose lack of sexual desire causes distress. Women who took the drug in a clinical study had an increase of about 1.0 sexually satisfying event per month compared with those taking a placebo.

Advocates claim that increase is meaningful. Critics say the small benefit is outweighed by the drug’s risks.

source: interaksyon.com

Drug safely cuts prostate cancer risk, study finds

Long-term results from a major federal study ease worries about the safety of a hormone-blocking drug that can lower a man's chances of developing prostate cancer.

The drug cut prostate cancer risk by 30 percent without raising the risk of dying of an aggressive form of the disease as earlier results hinted it might.

The new work could prompt a fresh look at using the drug for cancer prevention. Experts say it could prevent tens of thousands of cases each year, saving many men from treatments with seriously unpleasant side effects.

The drug is sold as Proscar by Merck & Co. and in generic form as finasteride to treat urinary problems from enlarged prostates. It's also sold in a lower dose as Propecia to treat hair loss.

A decade ago, the drug was found to cut the risk of prostate cancer. But there was a small rise in aggressive tumors among its users. Some researchers said that by shrinking the prostate, the drug was just making these tumors easier to find in a biopsy sample — not causing them.

But the concern led the Food and Drug Administration to turn down the drug for cancer prevention and warnings were added to its label.








Now, with 18 years of follow-up from that earlier study, researchers report that men on the drug were no more likely to die than those not taking it.

That's reassuring because if the drug were truly spurring lethal tumors, there would have been more deaths among its users as time went on, said Dr. Michael LeFevre, a family physician at the University of Missouri.

LeFevre wrote an editorial that appears with the study in Thursday's New England Journal of Medicine. He is one of the leaders of the U.S. Preventive Services Task Force, an independent panel of doctors who advise the federal government. The group has not taken a stance on finasteride for prevention but has advised against screening with PSA blood tests.

Screening does more harm than good, the panel has said, because although 240,000 new prostate cancers are diagnosed each year in the United States, only about 30,000 prove fatal. That means many men are treated for cancers that grow too slowly to be life-threatening, and often suffer sexual and urinary problems as a result.

The study, led by Dr. Ian Thompson at the Cancer Therapy and Research Center in San Antonio, was done to see whether finasteride could lower the risk of prostate cancer in men who were getting screened with annual PSA blood tests, as many still choose to do.

Researchers assigned 18,882 men 55 or older with no sign of prostate cancer on blood tests or a physical exam to take finasteride or dummy pills for seven years. When the study ended, those who had not been diagnosed with prostate cancer were offered biopsies to check for hidden signs of the disease.

For the new analysis, researchers tracked the study participants for a longer time — 18 years in all since enrollment began. Only about 10 percent of men on finasteride developed prostate cancer versus 15 percent of those on dummy pills. Aggressive tumors were found in 3.5 percent of men on the drug versus 3 percent of the others. Yet 78 percent of both groups were alive after 15 years.

That means the drug cannot be recommended to prolong life, just to ease suffering by preventing disease, LeFevre said.

"You may be preventing cancers that don't need to be prevented" because so few are life-threatening, but screening is finding these tumors anyway and leading to unnecessary treatments, he said. Reducing that number is a valid reason to use a prevention drug, he said.

Finasteride's other impact is financial. Proscar and a similar drug, GlaxoSmithKline PLC's Avodart, cost about $4 a pill. Generic finasteride is available for less. Insurers cover it when prescribed to treat urinary problems but may not pay if it's used solely for cancer prevention.

The drug also can cause hot flashes, fatigue, weakness, low sex drive and trouble having sex.

"A man certainly needs to know what he's getting into if he decides to take this," LeFevre said.

source: philstar.com

The stem cell miracle

The room was crowded. Christian Drapeau was going to speak on stem cells. He told us that the discovery of humans coming from a single cell called the stem cell happened decades ago but not much attention was paid until around 10 years ago when the focus slowly shifted to the stem cell. Stem cells are in our bodies manufactured by our bone marrow then released into our blood stream. There they begin to circulate. All our organs lose living cells day to day. As the stem cell circulates, other cells that are part of our organs release some kind of sticky liquid that catches the stem cells and converts them into cells needed for that organ. For example, if you had a heart attack, there is damage to the cells in your heart. They need replacing. When your bone marrow releases stem cells into your blood, the heart will reach for them and slowly repair the damage.

One of the reasons why it took them so long to discover this is because the stem cells immediately begin to look like heart cells so one cannot say – oh those are new cells made from stem cells. But they discovered a blue-green substance that helped the bone marrow manufacture and release more stem cells. This gave the new cells a blue-green color. Now they were able to track the movement of stem cells and claim that the new cells were created by the equally new stem cells. Stem cells are the body’s natural healing system.

It is difficult to say what organs stem cells repair because they repair anything that needs repair. But StemEnhance is not a miracle drug. It is made from algae from a lake in Oregon, which has been tested over the years and proven to make the body’s bone marrow release more stem cells. Then it is up to your body to heal itself wherever it needs healing.

When I started to take StemEnhance I felt increased energy maybe after ten days. Instead of dragging myself around in my pajamas I began to wake up cheerful, shower, get dressed and organize my day. This is the very least of the capsules’ effects. Many of my friends claim this same effect on them and add that their friends comment on how young they look. So they keep coming back for more.

But I also know someone who came because her neighbor had to be carried to the hospital once a month for a check up. They read my article written last November 24. Now the old man walks and opens the gate himself. A young man regularly gets for his father who is 84, in tremendous perpetual pain when he first came to see me. Now his father feels no more pain and goes to the mall to walk. However, everything takes time. You have to commit to taking at least three capsules a day.

My only son, who is 41, is extremely diabetic. At 41 he has had cataract operations. He takes a double dose of the pills daily. I asked him how he was. He said, “My sugar is still high but these days I can arrange three songs, compose two and write a jingle all in one day. I never could have done that before. Your pills give me energy.” Over time I am certain even his diabetes will go.




But there are obstacles. So many people asked Christian Drapeau why the medicine was so expensive. He said, “Why don’t you look at the other side? How much does it take us to harvest, manufacture and get here?” And he is right.

What is more expensive? Stem Cell Therapy that involves taking your bone marrow then doing something to it then injecting it back into you for a couple of million pesos or to buy a bottle that increases your stem cells? It depends on how much money you have. If you are very rich, of course, go all the way to Switzerland for your stem cell therapy. But if you are average then just take StemEnhance. It is not cheap enough for everybody but it is good enough for most people.

But I must share this story. One of our recent recruits is an integrative doctor, Dr. Chris Tengco, M.D. He has a medical degree, also studied alternative medicine, anthroposophy and something else. Mostly his patients are people with level 4 cancer and so far he has managed to heal most of them. That afternoon he presented us with two of his patients who were healed. What is his secret? He has a special formula, which he gives them intravenously and he asks them to drink StemEnhance.

Don’t you think that’s remarkable? I think that is truly excellent.

article source: philstar.com

Epilepsy drug has long-term effect on child IQ - study

PARIS - A drug found to affect the cognitive ability of toddlers born to women who took the medication for epilepsy has a longer-term impact on their IQ, a study said on Wednesday.

Researchers in the United States carried out follow-up tests among the same group of children whose investigation in 2009 led to warning by the US health watchdog about the potential risks of the drug valproate in pregnancy.

The children -- examined at the age of three -- had below-par cognitive skills, which prompted the US Food and Drug Administration (FDA) to issue a warning about its use in pregnancy.

The new research, published in the journal The Lancet Neurology, examined the same children at the age of six.

Children born to mothers who had used valproate in pregnancy had an IQ that was seven to 10 points lower than children whose mothers had used one of three other epilepsy drugs, it found.

The higher the dose of valproate the mother took in pregnancy, the greater the IQ discrepancy. Verbal skills and memory were also affected.

The study, conducted between October 1999 and February 2004, by Kimford Meador at Emory University in Atlanta, Georgia, covered 305 pregnant women who had been using either valproate, carbamazepine, lamotrigine, or phenytoin.

The first analysis looked at 311 children in the United States and Britain; in the followup at the age of six, it covered 224 of them.

Counteracting measures

However, the study also suggested that IQ may improve with age for infants exposed to any of these drugs.

And by taking folic acid supplements, expectant mothers may improve IQ scores. This is the first time a boost has been shown in a study of pregnant women with epilepsy.

Valproate is, for some people, the only drug that can control their epilepsy, so the findings on dosage and the beneficial effects of folic acid could be useful.

"Valproate usage during pregnancy has a significant negative effect on children's IQ, which lasts beyond their earliest years. IQ at age six is strongly predictive of adult IQ and school performance, so our research suggests that valproate use during pregnancy is likely to have long-term negative effects on a child's IQ and other cognitive abilities," Meador said.

"For many antiepileptic drugs, there is simply no research available on their effects on women and their children during pregnancy, and given that many women do not have the option of stopping medication during pregnancy, more research in this area is urgently needed."

source: interaksyon.com

7 dead in spreading US meningitis outbreak

WASHINGTON DC - At least seven people have died and 91 have fallen ill in the United States in a worsening meningitis outbreak tied to a contaminated drug, updated figures showed Sunday.

Cases have been identified in nine states, with the hardest-hit being Tennessee, where 32 people have been diagnosed with the fungal infection and three have died, the Centers for Disease Control and Prevention said.

Michigan is the second-most infected state, with 20 cases and two deaths, so far. Cases have also been noted in a vast region spanning Florida, Maryland and Minnesota.

In its latest bulletin, the CDC urged doctors to "actively contact" any patients who received doses of the potentially contaminated steroid injection -- typically used to treat back pain -- as far back as May 21.

The public health agency said symptoms of fungal meningitis, which has a very long incubation period, include fever, new or worsening headaches, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site.

The rare infection -- which inflames the protective membranes covering the brain and spinal cord -- often goes undetected until it is too late because its flu-like symptoms can be mild at first. But meningitis is not contagious in this form.

Early detection and treatment -- requiring a hospital stay to administer intravenous anti-fungal medications -- can prevent permanent damage.

An initial investigation found that Tennessee clinicians who administered the contaminated drug "had no way of knowing" there was anything wrong with it and found "no lapses" in their standards, according to the state's health commissioner John Dreyzehner.

"The evidence indicates this is a product issue," he told reporters on Friday.

A multi-state investigation is underway to determine the cause of the outbreak, but the Food and Drug Administration said it had detected a fungal contaminant in a sealed vial of the drug produced by the New England Compounding Center in Massachusetts.

While further testing is required to confirm it was the source of the outbreak, the company has issued a voluntary recall of all of its products and shut down all operations.

Officials posted a list of the 75 health care facilities that received lots of the contaminated drug at: www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html.

source: interaksyon.com

Etsy blocks sales of drugs and human remains

NEW YORK (CNNMoney) -- Etsy has become the go-to spot for homemade jewelry, knickknacks and household goods. Apparently, some have also been using the online marketplace to sell everything from drugs to human remains.

Now Etsy is cracking down.

The online marketplace recently revised its policies, excluding from its list of sellable items such products as tobacco, hazardous materials and body parts. (Hair and teeth are still OK).

"Odd as it may sound, we've spent long hours over the past several months extensively researching some offbeat and fascinating topics, from issues surrounding the sale of human bones to the corrosive and toxic properties of mercury," the company wrote on its official blog on Wednesday.

Etsy says the changes are made in order to comply with legal rules and restrictions.

"But beyond that, when it comes right down to it, some things just aren't in the spirit of Etsy," the online company wrote. "While we understand that it is possible for certain items to be carefully and legally bought and sold, Etsy is just not the right venue for them."

The new policy prohibits the sale of human body parts, including but not limited to "things such as skulls, bones, articulated skeletons, bodily fluids, preserved tissues or organs, and other similar products."

Etsy banned most drug paraphernalia, though the company said it is not explicitly banning the sale of medical drugs. Instead, it's asking that sellers remove any claims of "cure or relief of a health condition or illness."

That set off a slew of angry posts from Etsy sellers in the company's public forums.

"Now I need to change near[ly] a quarter of my listings or remove them," wrote Etsy user Chrissy-jo, who operates an online store called KindredImages. "How am I going explain the use of a salve or even an aromatherapy eye pillow without making the claim that it aids in healing wounds or it helps relieve migraines?"

Another Etsy user named Irina, who runs PheonixBotanicals, wrote: "As an herbal crafter, I find the idea of being banned from listing traditional uses and folklore of plants quite disheartening."

Sellers on Etsy operate their own shops, where they vend goods that are usually homemade. The online store plans to reach out to individual sellers to ask them to either remove a problematic listing or make changes to align with the company's policy.

source: CNN

US approves first obesity drug in 13 years

WASHINGTON DC - US regulators on Wednesday approved the first drug to treat obesity in 13 years, a drug called lorcaserin, marketed as Belviq and made by Arena Pharmaceuticals.

The drug works to control the appetite through receptors in the brain and was approved as additional therapy for certain overweight and obese patients, combined with diet and exercise.

Trials showed the drug helped people lose an average of three to 3.7 percent of their body weight after a year when compared to a placebo, the US Food and Drug Administration said.

It is approved for use in obese adults with a body mass index of 30 or greater, or overweight adults with a BMI of 27 or greater who have at least one other condition such as high blood pressure, type 2 diabetes, or high cholesterol.

Arena's stock opened the day at $9 per share and jumped as high as 47 percent on news of the US approval. The company said it is also seeking approval on the European market, but has no timeline yet for a decision.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, described obesity as "a major public health concern," and said the new drug offers a treatment option when used "responsibly in combination with a healthy diet and lifestyle."

However, the FDA warned that Belviq is not for women who are pregnant or nursing, and called for further long-term postmarketing studies on the drug's potential risks.

The label will also recommend that Belviq be discontinued in patients who fail to lose five percent of their body weight after 12 weeks of treatment.

"These patients are unlikely to achieve clinically meaningful weight loss with continued treatment," said the FDA statement.

Belviq activates the serotonin 2C receptor in the brain, and may cause serious side effects if taken in combination with certain medications for depression and migraine that increase serotonin levels or activate serotonin receptors.

"Belviq may also cause disturbances in attention or memory," said the FDA.

Common side-effects in patients without diabetes include headache, dizziness, fatigue, nausea, dry mouth, and constipation.

In diabetic patients, side effects may include low blood sugar, headache, back pain, cough, and fatigue.

Lorcaserin was rejected in 2010 by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the FDA, over concerns that it formed breast tumors in rats.

But those effects did not appear in trials on overweight and obese humans.

An independent advisory committee to the FDA recommended the drug be approved in May after three randomized, placebo-controlled trials of nearly 8,000 patients spanning one to two years.

"All participants received lifestyle modification that consisted of a reduced calorie diet and exercise counseling," the FDA said.

"Compared with placebo, treatment with Belviq for up to one year was associated with average weight loss ranging from three percent to 3.7 percent."

Some patients with type 2 diabetes experienced higher levels of weight loss, with 38 percent of these patients achieving at least five percent loss of their body weight compared to 16 percent who did the same on a placebo.

The pills will be manufactured at Arena's facility in Zofingen, Switzerland, and will be distributed in the US by Eisai Pharmaceuticals.

Arena is headquartered in San Diego, California.

According to Michael Aziz, internist at Lenox Hill Hospital in New York City, the biggest apparent drawback to the drug is the tiny amount of weight loss that patients experience while taking it.

"The only problem with this drug is the weight loss is so, so very low," Aziz told AFP, remarking that a 200 pound (91 kilogram) person might lose just six pounds (2.7 kg) in a year, based on the study data.

"That is so insignificant," he said. "I think people should also implement lifestyle changes because the fact is, people can lose one pound a week and that is perfectly healthy."

The last anti-obesity drug approved in the United States was Xenical (Orlistat) by Roche in 1999.

Sold over the counter as Alli by GlaxoSmithKline, it works by preventing the body from absorbing fat, though its tendency to cause gastrointestinal side effects such as oily, loose stools have curbed its popularity among patients.

article source: interaksyon.com