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Children with deadly genetic condition HT-1 get fully subsidised treatment

Sunday, July 10th, 2016

Twelve-year-old Charbel Torbey, with his dad David, has the extremely rare genetic condition tyrosinaemia type 1 (HT-1)image www.newcures.info

Twelve-year-old Charbel Torbey, with his dad David, has the extremely rare genetic condition tyrosinaemia type 1 (HT-1). Photo: Wolter Peeters

As Charbel’s parents dressed their four-month-old for his christening they noticed his nappy wouldn’t fit over his engorged tummy.

“He was really bloated, and his body was covered in these different coloured patches and he was squirming in pain,” Charbel’s father David Torbey said.

“We didn’t know that his organs had started shutting down.”

The new parents rushed their baby to hospital. Two days later he was diagnosed with the rare genetic condition Tyrosinaemia​ type 1 (HT-1) and treated with the orphan drug nitisinone (Orfadin).

“The doctors told us another day or two and he would have been dead. We were very lucky,” Mr Torbey said.

Just one in 100,000 babies are born with HT-1, amounting to fewer than 20 cases in Australia.

Without access to nitisinone most babies with the metabolic condition don’t live past their fifth birthday. The only treatment is a liver transplantation.

The oral capsules, distributed in Australia by Menarini, can cost between $2000 and $8000 a month and increases as the patient grows.

Those children are now assured fully subsidised access to the oral pill after the federal government added nitisinone on the Life-Saving Drugs Program (LSDP), committing $12.3 million to cover the cost over the next five years.

HT-1 patients don’t have the enzyme needed to break down tyrosine, an amino acid in protein foods, which builds up in the liver causing serious damage to the organ as well as the kidneys and brain.

The metabolic condition is easily missed at birth and the first few months of life with only ague symptoms including fever and failure to gain weight. Eventually the child develops jaundice – a yellow tinge to the skin and eyes – and a distinctive cabbage-like odour to the skin and urine.

A handful for paediatric services in public hospitals have been footing the bill for the drug since it was approved by the Therapeutic Goods Administration in October 2010.

But families of children with HT-1 had been looking to the future with uncertainty, knowing most hospitals don’t provide the drug, and adding the costly treatment to their drug store was an undesirable prospect for stretched health budgets.

Director of pharmacy at the Children’s Hospital Westmead Peter Barclay said he is worried his patients would struggle to access the drug when they aged into the adult healthcare system before the LSDP listing.

“There’s a lot of uncertainty about what happens to these children when they leave our care,” Mr Barclay said.

“It’s a barrier to finding another doctor and another hospital that will agree to supply the medicine, which would cost them tens of thousands of dollars a year for that single patient.

“The listing is great news for families who now know their children will have access anywhere in Australia. This is truly a life-saving drug.”

Mr Torbey said the concern was the hospitals losing funding for the drugs.

“Our biggest fear was the hospitals would say ‘We’ve had your funding cut, so you’ll have to find somewhere else to get [nitisinone]’,” he said.

“[The LSDP listing] means we don’t have to worry about Charbel later in life. That he won’t be constantly thinking about where he’s going to get [his medication].”

The father from Belfield in Sydney’s south-west knows how dire access to HT-1 can be outside of Australia.

Charbel had become ill during a family holiday in Lebanon when he was six months old and taken to a local hospital where another baby had just been diagnosed with HT-1.

“[The doctors] begged us to donate some of Charbel’s medicine to them,” Mr Torbey said.

“But we just didn’t have enough to give away and get Charbel back home. I’m still torn up about that. I don’t know what happened to that kid.”

Almost 12 years on Charbel has grown into a tall, lean boy.

The talented rugby player will need to take nitisinone for the rest of his life and follow a strict protein-free diet. He will never be able to eat meat, eggs, milk, cheese, nuts or lentils.

“In a way he’s lucky he doesn’t know what he’s missing out on,” Mr Torbey said.

“But he loves the smell of meat on the barbecue.”

tytrcvi yt

Henry Sapiecha

Gonorrhea may soon be un-treatable due to antibiotic resistance, British medical chief warns

Friday, January 1st, 2016

Superbug warning to drug giants

Pharmaceutical companies are being told they must invest more in new antibiotics or risk being blamed for an increase in deaths from drug-resistant superbugs.

Concerns that gonorrhea may become “untreatable” due to growing antibiotic-resistance has led Dame Sally Davies, Britain’s chief medical officer, to reportedly write to doctors and pharmacies across Britain to sound the alarm.

The sexually transmitted infection (STI) is increasingly caused by strains of Neisseria gonorrhoeae that resist antibiotic treatment.

“Gonorrhoea is at risk of becoming an untreatable disease due to the continuing emergence of antimicrobial resistance,” Davies wrote. The Guardian reports that a recent outbreak of a superbug strain of the disease – one that doesn’t respond to the antibiotic azithromycin – has put Britain on high alert.

pills assortment image www.newcures.info

Resistance to some antibiotics to treat gonorrhea is growing.

Davies urged doctors to use proper treatment protocols. A recent study found that many doctors in Britain still prescribe ciprofloxacin, which hasn’t been recommended for a decade now.

Things aren’t much better in the United States: In 2013, the Centres for Disease Control and Prevention gave it the centres’ highest ranking for antibiotic resistance, classifying gonorrhea as an “urgent threat.” At that time, the CDC reported that around a third of cases were resistant to at least one antibiotic.

Gonorrhoea is the second most common STI in Australia, with the rate of diagnosis rising by 67 per cent between 2008 and 2013.

In the United States, there were just over 350,000 cases in 2014; Britain had about 35,000.

Doctors in the United States are now told to use ciprofloxacin in combination with a second antibiotic. For a while, this strategy seemed to be working: A recent study found that resistance to ciprofloxacin had dropped from 1.4 per cent of gonorrhea cases in 2011 to just .4 percent in 2013. But in 2014, the resistance doubled.

Why does this happen? When researchers look for new antibiotics, they obviously look for ones that are incredibly effective against pathogenic bacteria. But as soon as these antibiotics are released for use by the public, they start to lose their effectiveness.

Bacteria are fast-evolving creatures, and individual bacterium are skilled at sharing genes that allow them to survive particular antibiotics. Bacteria can even copy resistance genes from microbes of different strains and species through a process called horizontal gene transfer.

Historically, humans haven’t done much to slow this process. Whenever you take antibiotics you don’t need, you’re introducing bacteria in your body and your environment to the drug, giving those microbes an opportunity to learn resistance to it.

Whenever you don’t finish an entire prescription of antibiotics, you’re leaving behind bacteria that showed some resistance to the first few days of treatment, and allowing them to reproduce.

When farmers treat healthy livestock with antibiotics in order to promote growth, they’re breeding resistance in our meat and in our soil. Now that we know how dangerous this process is, it may be too late to stop it.

It’s possible that scientists will develop new classes of antibiotics that are less likely to fall into this cycle. But for the most part, this is just how bacteria work – so it’s our use of antibiotics that really has to evolve.

Antibiotic resistant gonorrhea has an especially creepy ring to it. Sexually transmitted infections are highly stigmatised, so the idea of one you can’t get rid of with standard treatment is understandably scary.

But as scary as it is, gonorrhea is hardly the biggest of our worries when it comes to antibiotic resistance. This problem isn’t going to go away.

The Washington Post

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Henry Sapiecha

 

This Chemical Compound #29 Could Melt Away Cataracts

Friday, November 27th, 2015
Eye drops made from “compound 29” have been shown to reduce cataracts in mice. Researchers hope the same will hold true for humans.

cataract.eye image www.newcures.info

Eye drops made from “compound 29” have been shown to reduce cataracts in mice. Researchers hope the same will hold true for humans.

Imagine looking through a fogged-up car window. You can see shapes and movement on the other side, but everything is blurry, the colors muted. Now imagine if that’s what the world looked like every time you opened your eyes. That’s what life is like for the millions of people living with cataracts, the leading cause of blindness globally.

While cataracts can be easily removed with surgery, this is an invasive and expensive option. In the developing world, patients may not have access to surgery at all. So a recently announced non-surgical treatment for the condition—a chemical compound that could “melt” cataracts away when applied as an eye drop—has the potential to make a big impact in the medical community.

The compound was discovered by a team of scientists from several U.S. universities. Their findings were published this month in the journal Science.

The lens of the human eye is made mostly of water and proteins. While most proteins in the human body are renewed on a regular basis, this is not true of lens proteins.

“Your lens proteins are the same proteins that you’re born with,” says Jason Gestwicki, a professor of pharmaceutical chemistry at University of California, San Francisco. “They’re as old as you are.”

In a healthy lens, the proteins are neatly folded. But age, genetics and environmental factors can cause the proteins to form clumps, called amyloids. These clumps interfere with vision, causing the characteristic clouding associated with cataracts. The amyloids can first appear in a person’s 40s or 50s, but may not cause significant vision impairment until their 60s or later.

Gestwicki and his team members wondered if it would be possible to find a chemical compound that could affect amyloids. The possibilities were many: they started with nearly 2,500 compounds, eventually winnowing the field down to 12 compounds in the chemical class known as sterols. One sterol, called lanosterol, has previously been shown to affect cataracts, but only when injected directly into the eye. The team wanted something that could be used in eye drop form. Another of the 12 sterols stood out. Called “compound 29” by the team, it was shown in petri dish testing to dissolve amyloid clumps with a high degree of efficiency.

The next step was testing compound 29 on mice with cataracts. These mice were treated three times a week for six weeks, using drops of compound 29 in their right eye and an inert control in their left eye. At the end of the six week period, researchers examined the mice using a slit-lamp exam, which is how ophthalmologists measure cataracts in humans. The drops seemed to have dissolved many of the amyloids, making the lenses transparent again.

The next step will be human testing. Gestwicki and fellow researcher Leah Makley have founded a company, ViewPoint Therapeutics, which hopes to develop a safe cataract-fighting eye drop. “If everything goes right,” Gestwicki says, they will begin human testing in the next two years or so.

The implications of compound 29 don’t end with cataracts. Amyloids are the signature of a number of age-related diseases, including Alzheimer’s and Parkinson’s. If it’s possible to melt these clumps of protein in the human eye, then in theory a similar approach could work on the brain as well. Gestwicki hopes to look at this possibility in the near future. Compound 29 itself might not be the breakthrough to treating neurological amyloid diseases, he says. But it’s given scientists a better understanding of how such a process could work.

“Compound 29 really showed us the features of such a molecule that we might want,” Gestwicki says. “I think it was a really important milestone.”

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Henry Sapiecha

Heart attack, stroke: popular painkillers to carry health warnings after 2016

Saturday, November 21st, 2015

spoonfull of pills image www.newcures.infopulsating heart animation image www.newcures.infoAttention sign image www.worldwidediamonds.info

The warnings will state ‘excessive use can be harmful and increase the risk of heart attack, stroke or liver damage’.

Some of Australia’s most popular painkilling medications will carry warnings from next year that they could put people at risk of heart attack and stroke.

The medications, which contain the active ingredients ibuprofen, diclofenac and naproxen, are freely available at the chemist and supermarket under brand names such as Nurofen, Advil and Voltaren.

Health authorities stopped short of the more radical actions of other countries such as the UK, where diclofenac has been made prescription-only.

Earlier this year, US health authorities warned even a few weeks of using the drugs could increase a person’s risk of a fatal heart attack.

Australia’s Therapeutic Goods Administration (TGA) has been reviewing the safety of the drugs against the back of increasing reports of dangerous cardiovascular complications.

In 2010, Fairfax Media reported that the drugs had been linked to stroke and some experts believed they should be banned or sold only on prescription.

The TGA said its review found the medications were “safe when they were used according to the recommended doses for short durations, as instructed on the label”.

“However, inappropriate use or overuse of these medicines could pose a significant risk of cardiovascular events and, in the case of diclofenac, [liver toxicity],” it said.

The drugs are a type of medicine known as a “non-steroidal anti-inflammatory” medications. Another of this class of drugs, the arthritis drug Vioxx, triggered a $4.85 billion lawsuit amid evidence it doubled the risk of heart attack for patients, causing as many as 140,000 in the US alone.

All forms of ibuprofen, diclofenac and naproxen will now carry a warning that using them at high doses can increase your risk of high blood pressure, heart attack, heart failure and stroke.

The warning will state: “Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.”

Most medications will be expected to carry the label by July 2016, although some have been given an extension until January 2017.

The Australian Self Medication Industry supports the changes to the warning labels, however, Alphapharm, which makes non-brand name generic versions of medicines, said while warnings on packets were sufficient for medications sold in pharmacies because of the quality of information provided by pharmacists, product inserts were needed when the drugs were sold at supermarkets to make sure consumers were properly informed.

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Henry Sapiecha

Scientists plants & cancer drugs info, pics & video

Saturday, September 26th, 2015

Scientists Manipulate Common Plants to Produce Cancer Drugs

Stanford researchers have figured out how to transfer a rare plant’s chemical “assembly line” into a cheap, common lab plant

mayapple. drugs plant cure image www.newcures.info

Many commonly used medicines are still derived from plants. Scopolamine, used for motion sickness and to treat post-surgical nausea, is made from plants in the nightshade family. Digoxin, a heart medication, comes from the foxglove plant. Codeine and other opioid painkillers are derived from opium poppies.

But plants used to make medications are sometimes endangered or expensive. A poor growing season or geopolitical instability in the region where a plant is cultivated could cause a decline in medication supply.

Now, a Stanford scientist has figured out how to isolate the molecular “factory” within an endangered plant and assemble it within another, more widely available plant.

“This was a challenge, because plants are pretty complicated,” says Elizabeth Sattely, a professor of chemical engineering. “They’re pretty difficult to work with. Their genomes are very complicated.”

Sattely and her team worked with a Himalayan plant called the mayapple, which produces precursors to a commonly used chemotherapy drug called etoposide. Etoposide is used to treat a variety of cancers, including lymphoma, lung cancer, testicular cancer and some types of leukemia and brain cancer. It’s on the World Health Organization’s list of essential medicines—drugs considered crucial for medical system functioning. But mayapple is slow-growing, and supply has been in decline for years due to high demand.

Sattely realized that mayapple’s chemical assembly line starts up in response to its leaves being injured. Once this injury occurs, the plant starts producing a number of proteins. Some of these proteins eventually produce etoposide’s precursor. But the big question was which proteins? There were more than 30 present, but not all of them were involved in making the precursor.

“What was crucial here was really narrowing down our candidate list,” Sattely says.

She and her team tried out various combinations of proteins until they figured out which 10 constituted the assembly line. Then, they put the genes that made these 10 proteins into a different plant. The plant they chose was Nicotiana benthamiana, a wild relative of tobacco, chosen because it’s widely available and easy to grow in a lab. The Nicotiana plant began producing the etoposide precursor, just like mayapple. Sattely and her graduate student, Warren Lau, published their discovery in the journal Science.

“This is a very nice proof of concept,” says Sattely.

Sattely hopes to ultimately make microbes, such as yeast, produce the same molecules, skipping plants entirely. If she succeeds, she’ll be joining a number of scientists who have figured out how to turn microorganisms into drug-producing factories. Just this week, German scientists announced they’d made genetically modified yeast produce THC, the compound in marijuana that produces the “high” and can help treat side effects from chemotherapy and other illnesses. Last month, Stanford researchers published results showing how they had made yeast produce hydrocodone, an opioid painkiller similar to morphine. The breakthrough has potential to make such drugs cheaper and more accessible. In 2013, chemical engineers at Berkeley coaxed genetically modified yeast into producing anti-malaria drugs.

Making drugs with yeast is even simpler and less expensive than using common lab plants. The supplies are incredibly cheap and easy to produce, take little space or special care, and can be endlessly manipulated.

“The promise of the field of synthetic biology is that you can get cells to make or do anything you want,” Sattely says.

But there’s still much to learn from plants and the chemicals they produce. As plants’ molecular production pathways become better understood, scientists can learn to manipulate them, potentially producing better drugs with fewer side effects.

“Plants are some of the best molecular factories in nature,” Sattely says. “We have a lot to learn about these molecules that are so important for human health and also for plant health.”

www.clublibido.com (8)

Henry Sapiecha

Young people opt for euthanasia drug as overall number of suicide deaths grows in Australia

Tuesday, July 14th, 2015

nebutol suicide substance image www.newcures.info

More Australians are taking their own lives with a drug recommended by euthanasia groups, including people aged in their teens, 20s and 30s.

New data from the national coronial information system shows 120 people died by taking Nembutal – dubbed the “peaceful pill” – between July 2000 and December 2012.

The number of deaths from the drug reached a high of 24 in 2011, compared with nine in 2001. In 2012, there were 17 deaths. However, there may be more as the data obtained by Fairfax Media does not include cases before the coroner.

Voluntary euthanasia campaigners say the actual number of Nembutal deaths is even higher, as many deaths are not reported to the coroner and people who use the drug to take their lives take steps to make it look like the death is of natural causes.
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The deaths included one person under the age of 20, 11 people in their 20s and 14 people in their 30s.

People aged over 60 made up more than half of the deaths in the same period.

There has also been the biggest increase in Nembutal deaths in this age group.

Euthanasia campaigner Philip Nitschke said the figures reflected that the drug was getting easier to obtain and was displacing some more violent methods.

He said the fact younger people were accessing the drug should be balanced against “the very large number of people who get immense comfort from knowing they have a safety net in place”.

Dr Nitschke said he was facing 12 complaints to the Medical Board of Australia over the involvement of his organisation, Exit International, in several deaths over the past decade.

Last week, the Northern Territory Supreme Court found the board acted unlawfully in using emergency powers to suspend Dr Nitschke’s medical licence.

The full case against him will be heard in November.

Dying with Dignity Victoria vice-president Rodney Syme said some of the deaths in younger age brackets could have involved people with incurable diseases who had obtained the drug.

“Intolerable and unrelievable suffering is not confined by age,” he said.

Dr Syme, who has been obtaining Nembutal for terminally ill patients for more than 20 years, said he once handed the drug to a 30-year-old woman with incurable brain cancer, although the woman never used it and died four years later in palliative care.

In Australia, Nembutal is used by vets to euthanise animals.

The coroner’s figures show that while in most cases the means of obtaining the drug were unknown, 20 people obtained the drug from overseas and 22 from a workplace.

Paul Russell of HOPE, an organisation devoted to preventing euthanasia and assisted suicide, said the data was concerning and something suicide prevention organisations should be heeding.

“We need to find more effective ways of helping people [who] are feeling desperate from going to these clandestine organisations,” he said.

Over the past 10 years, Australian Bureau of Statistics figures show there have been 2300 suicides a year on average, with people under 30 making up 22 per cent of all deaths.

For help or information, contact:

Lifeline 131 114

beyondblue 1300 224 636

SuicideLine 1300 651 251

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Henry Sapiecha

Viagra slows the spread of malaria, report shows

Friday, May 15th, 2015

Viagra does more than treat erectile dysfunction. Researchers have found it can slow the spread of malaria image www.newcures.info

Viagra does more than treat erectile dysfunction. Researchers have found it can slow the spread of malaria.

The little blue pill that gives men more oomph in the bedroom has an unexpected benefit – it can slow the spread of malaria.

Viagra doesn’t just have a stiffening effect on men’s anatomy, it also makes the one-celled parasite that causes malaria more rigid.

A team of European researchers have found that this effect deforms the red blood cells that transport the parasite, encouraging the spleen to clear them from the system.

viagra & malaria image www.newcures.info

With fewer infected red blood cells circulating the body, it becomes harder for one of the most common malaria parasites, Plasmodium falciparum, to be transmitted to an uninfected mosquito when it feeds on an infected person or animal.

Lead researcher Catherine Lavasec, from the Pasteur Institute in France, said there was a desperate need for novel interventions to target the transmission of the malaria parasite from a human host to the mosquito.

“Blocking Plasmodium falciparum transmission to mosquitoes has been designated a strategic objective in the global agenda of malaria elimination,” she said.

Normally, infected blood cells slip by the spleen because they are as squishy as healthy red blood cells.

Using an artificial spleen, the team found that certain drugs such as Viagra, also known as sildenafil, could stiffen these cells by inhibiting an enzyme that would normally make them squishy. The stiff cells are then cleared by the spleen.

As well as treating erectile dysfunction, Viagra has been used to lower blood pressure and relieve altitude sickness.

The research team said their findings are “proof of principle” that certain drugs can target malaria-infected red blood cells and these may be used as a new class of antimalarial drugs.

More than 198 million people were infected with malaria and more than 500,000 people died from the disease in 2013, according to the latest global estimates collected by the World Health Organisation.

The malaria parasite can only be transmitted by the females of certain varieties of mosquitoes from the Anopheles genus. Females need nutrients from a blood meal to develop their eggs.

The study was partly funded by the Bill & Melinda Gates Foundation and the Wellcome Trust and has been published in the scientific journal PLOS Pathogens.

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Henry Sapiecha

 

AUSTRALIA: Over-the-counter sale of codeine pain killers such as Nurofen Plus and Panadeine may end

Monday, April 27th, 2015

woman with headache image www.newcures.info

Proposed changes could see a doctor’s visit required for current over-the-counter painkillers.

Access to Nurofen Plus, Panadeine and other common painkillers sold to millions of Australians each year could soon be curtailed by health authorities amid reports of harmful side effects, addiction and fatal overuse.

Australia’s drug regulator is considering a proposal to make about 150 codeine products prescription-only medicines, meaning they could no longer be freely purchased over the counter at pharmacies and would require a visit to a doctor.

Medicines affected by the change could include Codral Original Cold and Flu Tablets, Aspalgin Soluble tablets and Mersyndol Tablets, which are marketed for short-term pain such as headaches, toothaches and period pain.

pain relief pill box sketch image www.newcures.info

Although many people use the drugs safely in recommended amounts, doctors say an increasing number are suffering severe gastrointestinal damage and internal bleeding from taking excessive doses of ibuprofen, which is often mixed with codeine, a weak but potentially-addictive opioid.
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In 2013, Monash University researchers reported nine deaths over a decade linked to toxicity from codeine-ibuprofen medicines such as Nurofen Plus.

Codeine addicts swallowing up to 100 tablets a day have been known to visit multiple pharmacies to get around rules introduced in 2010 that restrict purchases of more than five days’ supply of the drug at one time.

Recent government agency data shows the number of Australians being treated for codeine addiction more than tripled over the decade to 2012-13, from 318 to more than 1000 a year. But Matthew Frei, addiction medicine specialist and clinical director of Turning Point Alcohol & Drug Centre, said this figure probably vastly underestimated the number of problem users as many patients who abused drugs were not detected.

In response to these concerns, a July meeting of the Therapeutic Goods Administration’s Advisory Committee on Medicines Scheduling will discuss whether codeine drugs should be made “schedule 4” drugs that require a doctor’s prescription. They are currently “schedule 3” medicines.

While Australian Medical Association Victorian branch president Tony Bartone said he personally supported the idea of making codeine a prescription only drug, the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia opposes the proposal. It says governments should instead be investing in real-time prescription monitoring systems to better detect people abusing the drugs.

Pharmacy Guild Victorian president Anthony Tassone​ said pharmacists were qualified to determine who could purchase codeine products over the counter and who should be referred to a doctor for further discussion.

“For pharmacists to supply schedule 3 medication including codeine they need to establish a genuine therapeutic need,” he said.

Australian Self Medication Industry executive director Deon Schoombie​ said forcing people to go to their doctor for codeine tablets ran the risk of them walking away from their GPs with even stronger drugs.

“It just shifts the problem [to doctors]. Does it solve the problem? I doubt it,” he said.

But pain medicine specialist Dr Michael Vagg said codeine purchased over the counter was in such low doses that some people may find themselves taking more and more to produce meaningful pain relief.

Furthermore, he said up to 30 per cent of people do not have the right enzymes in their liver to process codeine, meaning they will not experience pain relief when taking it but will experience other side effects.

“You could certainly make a case that it’s not valuable enough and that it’s too harmful,” said Dr Vagg, a senior lecturer at Deakin University Medical School.

“If you have severe acute pain and the simple analgesics are not cutting it, you are better off going to your doctor to get a diagnosis and prescription. With persistent pain, that advice is even more important. Trying to manage long-term persistent pain with lots of doses of short-acting analgesics is not the best approach.”

U.S. prescription drug spending jumps 13% to a record $374 billion

Friday, April 17th, 2015

PILL IN HAND IMAGE www.newcures.info

The influx of millions of people newly insured under the Affordable Care Act was less of a factor than expected — about $1 billion of the spending growth, it said.

“This was an outstanding year, really a once-in-a-lifetime year,” said Michael Kleinrock, director of research development for IMS Health. “It was the largest dollar growth in a single year we’ve ever measured. This is a huge amount of extra spending.”

Does it bother you so much that 10 million more people now have access to healthcare? Is it a bad thing that thousands of people are receiving treatment for the previously incurable Hep C and will no longer be spreading it amongst the population?
I mean, I’m sure you don’t have much human contact at all – to say nothing of intimate – so you don’t worry about communicable diseases. But some of us do.

-ooo

Henry Sapiecha

Experimental cholesterol drugs could halve heart attack and stroke rates

Wednesday, March 18th, 2015

A new class of experimental cholesterol drugs might sharply reduce the risk of heart attacks and strokes, preliminary research has found.

A new class of experimental cholesterol drugs may sharply reduce the risk of heart attacks and strokes, initial research has discovered.

by Andrew PollackA new class of experimental cholesterol drugs might sharply reduce the risk of heart attacks and strokes, researchers reported on Sunday, citing what they described as preliminary evidence.

The drugs, one being developed by Amgen and the other by Sanofi and Regeneron Pharmaceuticals, are already known to sharply reduce so-called bad cholesterol, sometimes to levels lower than those achieved by statins like Lipitor, the mainstay lipid-lowering medicines.

What has not been known, however, is whether the drugs do what patients and doctors really care about: protect against heart attacks, strokes and other cardiovascular problems or “events.”

Big benefits may be possible

The early results suggest that there might be such a benefit, maybe even a big one. In small studies sponsored by the manufacturers, both drugs reduced the rate of such cardiovascular problems by about half.

“To see a reduction in cardiovascular events already is very encouraging that we’re on the right track,” says Jennifer G. Robinson, the lead investigator in the trial of the Sanofi drug.

The studies were published in The New England Journal of Medicine and were presented at the annual meeting of the American College of Cardiology on  Monday in San Diego.

More research required

Researchers caution, however, that the studies were small and intended to assess whether the drugs lower the bad cholesterol and were safe, not whether they stave off heart attacks. That could make the conclusions about heart attack and stroke risk less trustworthy. Judging those effects will require larger trials involving tens of thousands of people; such studies are underway and are expected to be completed by 2017.

“I do not think that either study answers the question definitively of cardiovascular benefit,” says Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, referring to the drug makers’ research. He was not involved in either study.

Risk of memory problems

Researchers say long-term safety still must be assessed, especially since these drugs are reducing LDL cholesterol to levels never achieved by medicines before. While the drugs appear to be generally safe, there is evidence that they could cause memory problems.

Still, the findings could help smooth the way for regulatory approval, wider use of the drugs by doctors and possibly reimbursement by insurers.

The drugs, evolocumab from Amgen and alirocumab from Sanofi and Regeneron, inhibit a protein in the body called PCSK9 that helps regulate cholesterol. In the studies detailed on Sunday, both drugs reduced the bad cholesterol by about 60 percent, to about 50 milligrams per deciliter from about 120 at the start of the studies. In many cases such big reductions were achieved even though the patients were already taking statins.

Both drugs could win approval from the US Food and Drug Administration by the Northern summer. Analysts say the drugs will have billions of dollars in annual sales and will be taken by millions of people who cannot lower their cholesterol enough using statins alone or cannot tolerate statins. (However, the PCSK9 drugs are taken by injection every two weeks or four weeks, which could deter some users.)

Statins reduce cardiovascular risk and scientists believe it is because they decrease low-density lipoprotein, or LDL, the so-called bad cholesterol. But merely looking at cholesterol levels can be misleading. The drug niacin did not protect against heart attacks and strokes even though it raised so-called good cholesterol and modestly lowered bad cholesterol.

Insurers in particular might demand proof that the PCSK9 drugs stave off heart attacks, strokes, deaths from coronary disease and procedures to open arteries before agreeing to pay for them for many patients. Executives at CVS Health, a leading pharmacy benefits manager, recently said that PCSK9 inhibitors might cost $US7,000 to $US12,000 a year and would strain health care budgets because so many people might use them.

“Managed care pharmacy, indeed the health care system, has never seen a challenge like this to our resilience in absorbing costs,” they wrote in the Health Affairs blog.

Whether the results from these two small studies will be persuasive enough remains to be seen.

The New York Times

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Henry Sapiecha