COVID-19 patients respond positively to remdesivir in major US trial

WASHINGTON - Gilead Science's remdesivir, one of the most highly anticipated drugs being tested against the new coronavirus, showed positive results in a large-scale US government trial, the company said Wednesday.

"We understand that the trial has met its primary endpoint and that NIAID (National Institute of Allergy and Infectious Diseases) will provide detailed information at an upcoming briefing," the company said.

Though it is difficult to precisely quantify the finding in the absence of results, it represents the first time any drug has been shown to improve outcomes against the COVID-19 illness, which has claimed more than 200,000 lives globally and brought the world economy to a grinding halt.

There have been mixed results for the intravenous antiviral in recent weeks. A summary of results posted on the website of the World Health Organization showed it failed in a smaller Chinese trial, but days before that, Stat reported it had shown significant efficacy at a Chicago hospital.

However, this trial, begun in late February and overseen by the US government, is the largest and technically most robust. 

According to a data sheet, its estimated enrollment was 800 patients, a portion of whom received the drug while the rest received a placebo. 

Neither the patients nor their physicians were aware of which group they belonged to, in order to eliminate unconscious bias.

It is a Phase 3 trial, the final stage before any medication can receive regulatory approval from the Food and Drug Administration (FDA).

Remdesivir, which previously failed in trials against Ebola, belongs to a class of drugs that act on the virus directly -- as opposed to controlling the abnormal and often lethal autoimmune response it causes.

It mimics 1 of the 4 building blocks of RNA and DNA and gets absorbed into the virus's genome, which in turn stops the pathogen from replicating.

The antimalarial drugs hydroxychloroquine and chloroquine are also being widely used against COVID-19 on a so-called "compassionate basis" pending results from large trials, with early studies decidedly mixed.

Other therapies that are being studied include collecting antibodies from COVID-19 survivors and injecting them in patients, or harvesting antibodies from genetically-engineered mice that were deliberately infected.

Agence France-Presse

Philippines, Japan plan Avigan trials vs coronavirus before end of April

The Philippines and Japan are planning to begin clinical trials of Avigan before the end of the month, in the hope of using the anti-influenza drug as a treatment for the new coronavirus.

Philippine Health Undersecretary Maria Rosario Vergeire told Kyodo News on late Thursday that arrangements are being finalized to begin testing on people afflicted with the disease as soon as possible.

"We are expediting the process, so we hope we could start before the end of the month," she said, noting that discussions for the testing size and duration have yet to be concluded.

The Philippines expressed willingness to participate in the clinical trials for Avigan during a virtual summit held last Tuesday with leaders of Southeast Asian countries, Japan, China and South Korea.

During the teleconference, Japanese Prime Minister Shinzo Abe said there are 50 countries interested in studying the drug further as a potential treatment for COVID-19, the illness caused by the virus.

Avigan is manufactured by a group firm of Japan's Fujifilm Holdings Corp., which has recently started boosting its production of the drug, aiming to have enough supply to treat 300,000 patients a month by September.

Aside from the clinical trials for Avigan, the Philippines, along with 69 other countries, will also participate in the tests organized by the World Health Organization for five other drugs.

Marissa Alejandria, president of the Philippine Society for Microbiology and Infectious Diseases, said the WHO clinical trials will study and evaluate the effectiveness of hydroxychloroquine, chloroquine, lopinavir, ritonavir plus interferon and remdesivir, for their effectiveness against COVID-19.

"We are just waiting for the approval of the (Food and Drug Administration) and our ethical review board to start the clinical trials," she said yesterday, adding that the tests will commence in the coming weeks.

As of Friday, the Philippine government had recorded 5,878 coronavirus cases nationwide and 387 deaths.

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How Purdue's aggressive sales of a painkiller blew up in its face

NEW YORK - In 2002, Andrew Kolodny, a resident in psychiatry, attended a training session on pain treatment in Philadelphia.

Seventeen years later, he still shakes his head over the surprising enthusiasm of the lecturer, an authority on the topic, for prescribing opioids.

"The message was that people are suffering because of an overblown fear, and the correct and compassionate way to treat pain is to prescribe aggressively," Kolodny recalled.

The lecturer, Thomas McLellan, had shown the class a short film examining the case of a man seeking relief from chronic back pain.

The patient had been prescribed a strong regimen of OxyContin, the pain medication produced by Purdue Pharma -- but he wanted more, complaining of crippling agony.

After the film, McClellan asked the doctors in the class for their diagnosis.

"For me and for most of the people in the room, the obvious diagnosis was that this patient became addicted to their medicine," said Kolodny, who is now the co-director of opioid policy research at Brandeis University's Heller School in Boston.

"The surprise was that the person teaching the class said it's not true addiction. It's a pseudo-addiction."

McLellan insisted the problem facing the seemingly addicted patient was that he was not getting enough drugs, Kolodny recalled.

At the time, the concept of "pseudo-addiction" was being advanced by Purdue Pharma and other laboratories to promote their opioid products.

OxyContin, an anti-pain medication similar to morphine, was introduced to the American market in 1996 with a campaign that swept aside years of caution on the use of opioids, previously reserved for the gravely ill because of their highly addictive nature.

The campaign featured deceptive marketing, controversial sales practices and endorsements from eminent physicians generously remunerated by Purdue Pharma.

But as a result of the singularly aggressive promotion of the prescription drug, both Purdue and the Sackler family, which owns the firm, now face more than 2,300 lawsuits in the United States.

They stand accused of having provoked the nationwide opioid crisis.

Opioids are blamed for more than 400,000 deaths by overdose since 1999, according to recently published data, and on average for more than 130 deaths a day.

Contacted by AFP, Purdue Pharma declined to comment.

A GREEN LIGHT

The origins of OxyContin, which has generated more than $35 billion in sales for Purdue, date to 1990.

The laboratory, based in the northeastern US state of Connecticut, was looking for a successor to its popular analgesic MS Contin, a morphine-based medication prescribed mainly to cancer patients but which was facing growing competition from generic drugs.

Purdue developed a painkiller based on oxycodone, a semi-synthetic opioid first concocted in Germany in 1916, with effects comparable to those of MS Contin.

Opioids posed well-known risks of dependence, but the laboratory had an answer: the new drug's beneficial effects would last 12 hours, twice as long as similar medications, meaning a patient would take fewer pills and face reduced danger of addiction.

But even before it reached the market, tests showed that OxyContin's effects did not last as long as originally thought, the Los Angeles Times found in a 2016 investigation.

Still, in December 1995, the US Food and Drug Administration (FDA) gave Purdue a green light to market OxyContin for the treatment of moderate to severe pain, authorizing its use for a range of ailments, many less serious than cancer.

"At the time of approval, FDA believed the controlled-release formulation of OxyContin would result in less abuse potential, since the drug would be absorbed slowly and there would not be an immediate 'rush' or high," an agency spokesman told AFP.

The FDA's approval drew growing criticism after Curtis Wright, a doctor who led the agency committee that authorized OxyContin, left to take a senior position with Purdue in 1998.

Another troubling development: once the drug was being marketed and aggressively promoted, OxyContin generated a huge black market that Purdue, critics say, ignored or minimized for far too long.

Quantities of pills were procured -- stolen from pharmacies or obtained from unscrupulous doctors -- and ground into powder to be inhaled, which multiplied their euphoric effects, according to a confidential US Justice Department report cited by The New York Times in 2018.

The 80-milligram pills, the most common dose, sell for $65 to $80 on the black market, compared to $6 in pharmacies, according to several doctors questioned by AFP.

EXPLOSION IN SALES

Despite the warning signals, Purdue continued to present OxyContin as being less addictive than other opioids.

The company's advertising budget surged from $187,500 in 1996 to $4 million in 2001, according to internal documents.

Purdue also built up a so-called "speakers' bureau" -- mainly physicians highly remunerated for attesting to the "miracle" qualities of OxyContin.

Sales exploded -- rocketing from $80 million in 1997 to $2.1 billion only four years later, internal documents showed.

Purdue also enlisted the help of the American Academy of Pain Medicine (AAPM) and the American Pain Society (APS), two respected professional organizations specializing in pain treatment, to support its campaign to destigmatize opioids.

Purdue helped finance both organizations, and several of their members worked as consultants for the laboratory.

Underscoring the close relationship, David Haddox, who headed an APS committee that endorsed the increased use of opiates, was hired by Purdue in 1999, where he remained until earlier this year.

Purdue's sales pitch to physicians was probably helped by the fact that pain treatment has long been a neglected branch of medicine, said Gregory Terman, director of the Acute Pain Service at the University of Washington and the APS president from 2015 to 2017.

"Until the opioid crisis, NIH (the National Institutes of Health) had never spent more than one percent of their budget on pain -- the most common reason people go to doctors -- let alone chronic pain, which troubles more than 100 million Americans," he said.

The APS, facing lawsuits over its promotion of opioids and unable to pay its lawyers, filed for bankruptcy in late June.

Primary care doctors "have little training in addiction or pain, and many of them believed the promises" made by Purdue, Stanford University psychiatry professor Keith Humphreys said.

LEGAL PROBLEMS MOUNT

In 2006, the medical world finally awoke to the dangers of OxyContin, jolted by an article by Leonard Paulozzi of the Centers for Disease Control and Prevention (CDC), who reported that deaths linked to opioids had exploded by 91 percent from 1999 to 2002.

In 2007, for the first time, Purdue Pharma and three of its executives pleaded guilty, in Virginia, to having deceived physicians, patients and regulatory authorities about the risks posed by OxyContin of dependence or abuse. They agreed to pay $635 million in fines.

Yet when Purdue's legal problems grew in the United States and OxyContin sales fell in 2010, the company simply turned to its international subsidiary Mundipharma to promote sales in other parts of the world.

In Europe, where drug ads targeting the general public are banned, Mundipharma aired one in Spain in 2013 drawing attention to the problem of chronic pain and encouraging people to see a doctor and demand treatment.

Asked about that, a Mundipharma spokesperson said only: "We no longer have any such activity today."

The group has also financed seminars for physicians in other countries -- notably Brazil and China -- to promote opioids as effective pain treatment, the Los Angeles Times reported in 2016.

Joseph Pergolizzi, a Florida doctor who the newspaper said had lectured in 2016 at a Mundipharma-sponsored conference in Brazil, rejected any suggestion of deceptive marketing.

"I was invited to a cancer pain conference," he told AFP, adding that he had spoken about "severe cancer pain treatment and what the options are."

Pergolizzi said he had severed all ties to Mundipharma two years ago.

BANKRUPTCY

Purdue has repeatedly stated that OxyContin is only one of several opioid medications on the market, and that it now fights actively against the abuse of such drugs.

It sought bankruptcy protection in mid-September and is now urging the states and cities suing it to agree to its transformation into a trust, with any future profits to be used to alleviate the harm caused by the opioid crisis.

The laboratory has said it is ready to make payments to the plaintiffs totaling $10 billion to $12 billion -- with $3 billion coming from the Sackler family -- if they drop all legal action.

But nearly 25 states, including New York, have rejected the proposal.

The offer from Purdue and the Sacklers falls far short of paying for "the death and destruction they inflicted on the American people," said New York Attorney General Letitia James.

lo/bbk/sst

source: news.abs-cbn.com

UK fears crisis as 11.5 million get potentially addictive drugs

LONDON - More and more Britons are being prescribed potentially addictive medicines like sleeping pills, opioids and other painkillers, raising the risk of a drug crisis like the one in the United States, health officials said on Tuesday.

In a government-commissioned report, researchers at Public Health England (PHE) said evidence showed that "since at least 10 years ago more people are being prescribed more of these medicines and often for longer".

In 2017 to 2018 alone, 11.5 million adults in England - more than a quarter of the adult population - was prescribed one or more of the medicines under review, the PHE analysis found.

The medicines included anti-anxiety drugs called benzodiazepines and sleeping pills known as z-drugs, as well as the epilepsy and anxiety medicines gabapentin and pregabalin, antidepressants, and opioid pain medicines.

Many of these can be addictive and could cause problems for people taking them or coming off them, PHE said. The report also found higher rates of prescribing to women and older people.

While prescribing of some drugs, like benzodiazepines and opioids, has dipped a little recently amid fears about the deadly opioid epidemic in the United States, others, such as the gabapentin, pregabalin, and some antidepressants, are being prescribed more often and for longer.

"This means more people are at risk of becoming addicted to them or having problems when they stop using them," PHE said.

"It also costs the NHS (National Health Service) a lot of money, some of which is wasted because the medicines do not work for everyone all the time, especially if they are used for too long."

An opioid epidemic in the United States has killed almost half a million Americans since 1999, and a report by the Organisation for Economic Cooperation and Development (OECD) policy forum earlier this year warned that the United States "is by no means alone in facing this crisis."

The Paris-based OECD said deaths linked to opioid use were rising sharply in Sweden, Norway, Ireland, and England and Wales.

Responding to the PHE report, Britain's Medicines and Healthcare products Regulatory Agency said it is watching the U.S. crisis closely and aiming to take avoiding action.

"We take the experience in the U.S. of dependence and addiction to opioids very seriously and are following ... developments ... to learn from the actions other countries are taking to tackle this issue," it said in a statement. 

source: news.abs-cbn.com

Alcoholism drug may help design HIV cure: study

PARIS - A treatment for alcoholism can reactivate dormant HIV, potentially allowing other drugs to spot and kill the virus hiding out in human immune cells, researchers said Tuesday.

The medication, called Disulfiram, draws out the AIDS-causing virus without any side effects for patients, according to a study published in The Lancet.

In people undergoing treatment for AIDS, the virus can take cover in certain cells and hide away, only to reemerge once therapy is stopped.

This latency has been one of the biggest hurdles in developing a cure.

"Waking up" the virus - and then destroying it -- is a promising strategy for ridding patients of HIV.

But other drugs which are able to rouse HIV from its dormant state are toxic to humans.

In clinical trials led by Sharon Lewin, a professor at the University of Melbourne, 30 people on antiretroviral treatment (ART) were given increasing doses of Disulfiram over a period of three days.

At the highest dose, there was evidence of slumbering HIV being stimulated, with no side effects.

"This trial clearly demonstrates that Disulfiram is not toxic and is safe to use, and could quite possibly be the game changer we need," Lewin said in a statement.

The next step will be to test Disulfiram's rousing effect in combination with a virus-killing drug.

"Waking up the virus is only the first step to eliminating it," said the study's lead author Julian Elliott, head of clinical research in the department of infectious diseases at Alfred Hospital in Melbourne, Australia.

"Now we need to work out how to get rid of the infected cell."

Approximately 34 million people have died of HIV-related causes worldwide. By the end of 2014, there were an estimated 36.9 people living with HIV globally.

source: www.abs-cbnnews.com

Video of US woman planning own death goes viral

LOS ANGELES -- A newlywed US woman with terminal cancer has announced plans online to end her life on November 1 to die with dignity and without debilitating pain.

In January, Brittany Maynard, 29, was given six months to live due to brain cancer, and told her death would be long and painful because of the aggressive nature of the disease.

She was trying for a first child with her husband Dan at the time, but gave up on that hope due to the cancer.

"The thoughts that go through your mind when you find out you have so little time is everything that you need to say to everyone that you love," she said in the video which has been seen over 5.5 million times on YouTube.

Maynard and her husband Dan, who had just married when she first began having severe headaches, moved from their home in California to Oregon, one of a handful of states with a right-to-die law in force.

A doctor could therefore prescribe her the medication she needs to end her own life, surrounded by her family in the bedroom she shares with her husband.

Maynard is currently on medication to limit the swelling of her brain, but which has the side effect of making her gain weight.

She agreed to make the six-and-a-half minute video publicizing her case "in spite of some profound shyness regarding her new prescription drug-induced appearance," her fundraising website said.

"I didn't launch this campaign because I wanted attention... I did this because I want to see a world where everyone has access to death with dignity, as I have had," it said.

source: www.abs-cbnnews.com

Texas Ebola patient gets experimental drug

WASHINGTON - A Liberian man diagnosed with Ebola in Texas was given an experimental drug for the first time, officials said Monday as the White House mulled tougher airport screening at home and abroad.

Thomas Eric Duncan was given the investigational medication, brincidofovir, on Saturday, the day his condition worsened from serious to critical, said Texas Health Presbyterian Hospital Dallas.

The medication is made by the North Carolina-based pharmaceutical company Chimerix, and until now had never been tried in humans with Ebola, the company said.

However, it has been tested in about 1,000 people against adenovirus and cytomegalovirus.

The drug "works by keeping viruses from creating additional copies of themselves," Chimerix said.

Duncan is the first person to be diagnosed with Ebola in the United States, and he is believed to have become infected while in Liberia.

West Africa is currently battling the largest outbreak of Ebola in history, with more than 3,400 dead from the hemorrhagic virus since the start of the year.

Meanwhile, President Barack Obama was briefed by senior health and security advisors about the situation in Texas and US preparedness against Ebola.

Obama said the chances of a US Ebola outbreak were "extraordinarily low" but vowed to press world leaders to step up the global fight against the deadly epidemic in West Africa.

"We have not seen other countries step up as aggressively as they need to," Obama said.

"I'm going to be putting a lot of pressure on my fellow heads of state and government around the world to make sure that they are doing everything that they can to join us in this effort."

He said the United States is considering tougher airport screening to ward against the spread of cases by airline travelers.

"We're also going to be working on protocols to do additional passenger screening both at the source and here in the United States," Obama told reporters.

In Nebraska, a US photojournalist who tested positive for Ebola in Liberia arrived at a hospital and was able to walk off the airplane that carried him.

"We are really happy that his symptoms are not extreme yet," Ashoka Mukpo's mother, Diana, told reporters, adding that he was feverish and nauseous.

He is being treated at the Nebraska Medical Center, the same facility that treated American missionary doctor Rick Sacra last month.

Sacra also came down with Ebola in Liberia and was treated with the Canadian firm Tekmira's Ebola drug, TKM-Ebola, as well as serum from another doctor, Kent Brantly, who had Ebola and recovered.

Brantly was treated with a drug called ZMapp, which is hard to make, and there are no doses left.

There is no market-approved drug for treating Ebola yet, and no vaccine to prevent it.

source: www.abs-cbnnews.com

How pain relievers can harm the liver

MANILA -- The health of a person's liver can be determined through the level of certain enzymes in the body, a gastroenterologist explained on Tuesday.

On radio DZMM's "Magandang Gabi Dok," Dr. Edward Lim, a gastroenterologist from the Chinese General Hospital, said a person can determine if his or her liver is healthy by undergoing a routine blood test.

He said this can be done by determining the level of serum glutamic-pyruvic transaminase (SGPT) or serum glutamic-oxaloacetic transaminase (SGOT) in the blood.

Both SGOT and SGPT are enzymes that can be found in a person's liver.

"Marami kasi sa mga pasyente, kapag nagpa-routine blood examination, lumalabas na mataas ang katas sa atay. Ibig sabihin, may problema sila (sa atay)," Lim said.

If the SGPT is higher than the SGOT, then it means that there is something wrong with the liver.

However, if the SGOT is higher than the SGPT, then it means that there is something wrong with the tubes of one's liver.

Lim said people who often consume alcoholic drinks usually have higher levels of SGOT in their blood, which means they might have problems with the tubes on their liver.

"Sa tubo ng atay dumadaan ang mga katas o enzymes papunta sa small intestines. 'Yung bile, tumutulong sa digestion. Kapag may bumabara sa tubo ng atay, hindi makakalabas yung enzymes, mamamaga siya," he added.

On the other hand, a person with higher levels of SGPT in his blood may have liver problems such as hepatitis, fatty liver, or a damaged liver caused by medication.

Lim explained that all medicines are metabolized either in the kidney and liver, and may have bad effects on the organs if taken beyond the recommended dose.

"Medicines hit the liver or the kidney. Kailangan silang ilabas, otherwise, nagiging toxic. Kapag sobra ang dosage, nakakasira ng kidney o atay."

Some medicines that affect the liver are pain relievers like acetaminophen and paracetamol, and medication used to cure tuberculosis.

Lim clarified that these medicines can only affect the liver if the person takes more than the required dosage.

He said this is a common problem in the US and Europe, but is uncommon in the Philippines.

"Sa Pilipinas hindi masyadong problema kasi marami, hindi compliant sa gamot. Minsan kahit 1 linggo dapat, iinumin lang ang gamot, 2 araw," Lim said.

Some people, especially those who are overweight, or have a diet high in fat, may suffer from fatty liver.

"Nagkakaroon ng fatty liver kapag hindi na alam ng liver kung anong gagawin sa excess fat. Namamaga ang atay, nababalutan ng taba. 'Yung mga pagitan ng cells ng atay, may taba," Lim added.

He also explained that men should have an SGPT below 30, while women should have SGPT below 20.

Those who want to know if they have problems with their liver should undergo a blood test, and have their liver enzymes checked.

source: www.abs-cbnnews.com

Prenatal smoking tied to worse asthma in kids

NEW YORK- Children whose mothers smoked during pregnancy may have a tougher time controlling their asthma than other kids do, a new study suggests.

The findings, from a study of nearly 2,500 U.S. kids, add to evidence that prenatal smoking may affect children's future lung health.

There are already plenty of reasons for women to quit smoking during, and ideally before, pregnancy, said lead researcher Sam Oh, of the University of California San Francisco.

This study offers more motivation for women, and for doctors to ask moms and expectant moms about smoking, Oh said in an interview.

"Pregnancy is a great opportunity for smoking cessation," he said.

Smoking during pregnancy is linked to increased risks of miscarriage, low birth weight, certain birth defects and other pregnancy complications.

As for asthma, many studies have found that secondhand smoke may worsen children's asthma symptoms, or possibly raise their risk of developing the lung disease in the first place. The same risks have been linked to moms' prenatal smoking.

But, Oh's team says, it has not been clear how much of an impact prenatal smoking might have on kids' asthma symptoms later in life, independent of any current exposure to secondhand smoke.

HIGHER RISK AMONG POOR MINORITIES

For their study, the researchers focused on 2,481 black and Hispanic kids between the ages of 8 and 17 who all had asthma and were mostly from low-income families.

In the U.S., poor, minority children are at particular risk of asthma. About 16 percent of low-income black children have asthma, versus the national prevalence of 9 percent, according to the U.S. Centers for Disease Control and Prevention.

In this study, almost 19 percent of African-American moms smoked at some point during pregnancy, as did 5.5 percent of Hispanic moms.

Overall, their kids were at greater risk of poor asthma control later in life, even when childhood secondhand-smoke exposure was taken into account -- as well as other factors like a child's age and asthma medication use.

About 30 percent of Hispanic kids and 38 percent of black kids had poorly controlled asthma symptoms -- and the risk was 50 percent for those exposed to smoking in the womb, versus unexposed kids.

"There are measurable effects even years down the road," Oh said.

The findings do not, however, prove that prenatal smoking, itself, causes more-severe asthma symptoms later in life. They can only point to a correlation.

But there is lab research, in animals and human cells, suggesting there could be a direct effect, Oh pointed out.

Fetal exposure to tobacco smoke may, for example, impair early lung development, or have lasting effects on the activity of certain genes.

The bottom line, according to Oh, is that there is already a host of reasons for pregnant women to quit smoking for good, and this may be one more.

"This study provides more impetus for healthcare providers to ask about smoking at each visit," he said.

Some pregnant women may be able to quit with behavioral counseling. In some cases, a doctor may prescribe nicotine replacement therapy or other medication.

source: interaksyon.com

Botox ingredient has limited effect on headaches: study

NEW YORK - The main ingredient in Botox may be modestly helpful for people with chronic migraines, a new report suggests, but the wrinkle treatment doesn't seem to offer much relief for those whose headaches are less frequent.

Patients who started out having headaches almost daily reported two fewer headaches per month when they were given injections of botulinum toxin A. They also had more side effects, including weak muscles and a stiff neck.

The medication is marketed under multiple brands, but NEW YORK - The main ingredient in Botox may be modestly helpful for people with chronic migraines, a new report suggests, but the wrinkle treatment doesn't seem to offer much relief for those whose headaches are less frequent.

Patients who started out having headaches almost daily reported two fewer headaches per month when they were given injections of botulinum toxin A. They also had more side effects, including weak muscles and a stiff neck.

The medication is marketed under multiple brands, but Allergan's Botox is the best known. Botox is used to treat a range of conditions, including migraines and excessive sweating.

"The effect these appear to be having on migraine headaches is small -- it only reduces headaches by a couple of days a month," said Dr. Jeffrey Jackson, the study's lead researcher, from the Medical College of Wisconsin in Milwaukee.

That's "really, really modest," he told Reuters Health.

Still, it's possible that some chronic migraine patients will benefit from injections much more than others, he said.

For their new analysis, he and his colleagues looked back at 27 studies in which more than 5,000 headache patients were randomly assigned to get botulinum toxin A injections in the head and neck or an injection of a drug-free placebo. The study was published on Tuesday in the Journal of the American Medical Association.

The initial trials varied widely in their use of the drug, with researchers injecting the medication into any of four to 58 spots, either at a single time or at three different times a few months apart.

Most trials allowed patients to use other headache medication in addition to the injections.

Study participants with chronic headaches or chronic migraines initially reported having 17 to 20 headaches per month, on average. Twelve weeks or more after getting botulinum toxin A injections, that had dropped by an average of two monthly headaches, compared to patients getting the placebo.

In people with fewer migraines to begin with -- six per month, on average -- the drug injections didn't seem to provide any change in headache frequency. The findings were consistent regardless of patients' age as well as the botulinum toxin A dose and injection strategy used.

Impact still significant

About half of study participants experienced side effects during the trials. People randomly assigned to receive the active drug injections were 25 percent more likely to report any type of side effect. Muscle weakness was nine times more common in those patients, and neck pain or stiffness was reported three to five times more often than in the placebo groups.

Botox is approved by the US Food and Drug Administration to treat chronic migraines -- but not for less-frequent "episodic" headaches, a spokesperson for Allergan noted.

Headache researcher Dr. Vincent Martin, from the University of Cincinnati, said doctors have known for years that Botox doesn't help people with less-frequent headaches -- and the new review "gives a more definitive conclusion" on that.

But given that Botox is the only FDA-approved treatment for chronic migraines -- the most disabling type of headache -- its effect in those patients is not insignificant, said Martin, who wasn't involved in the new study.

"It's a very important treatment for many people with chronic migraine -- not for everyone," he told Reuters Health.

The drug costs nearly $1,000 for the dose used in chronic migraine patients, and injections aren't typically covered by insurance, according to Jackson.

He said the study had no outside funding source and wasn't linked to any companies that make botulinum toxin A products.

Dr. Mitchell Brin, Allergan's Chief Scientific Officer for Botox, pointed out that previous studies have suggested people with chronic migraines who are prescribed the drug also tend to have shorter-lasting migraines on the days when they still have headaches.

The difference equaled about 40 fewer hours per month of pain, compared to patients given placebo injections, he said.

That's "quite meaningful," Brin told Reuters Health. "The impact on their lives is quite significant."

Martin agreed that doctors often take into account more than just headache frequency when they prescribe the injections.

"Just looking at headache days per month may not tell the whole story," he said.is the best known. Botox is used to treat a range of conditions, including migraines and excessive sweating.

"The effect these appear to be having on migraine headaches is small -- it only reduces headaches by a couple of days a month," said Dr. Jeffrey Jackson, the study's lead researcher, from the Medical College of Wisconsin in Milwaukee.

That's "really, really modest," he told Reuters Health.

Still, it's possible that some chronic migraine patients will benefit from injections much more than others, he said.

For their new analysis, he and his colleagues looked back at 27 studies in which more than 5,000 headache patients were randomly assigned to get botulinum toxin A injections in the head and neck or an injection of a drug-free placebo. The study was published on Tuesday in the Journal of the American Medical Association.

The initial trials varied widely in their use of the drug, with researchers injecting the medication into any of four to 58 spots, either at a single time or at three different times a few months apart.

Most trials allowed patients to use other headache medication in addition to the injections.

Study participants with chronic headaches or chronic migraines initially reported having 17 to 20 headaches per month, on average. Twelve weeks or more after getting botulinum toxin A injections, that had dropped by an average of two monthly headaches, compared to patients getting the placebo.

In people with fewer migraines to begin with -- six per month, on average -- the drug injections didn't seem to provide any change in headache frequency. The findings were consistent regardless of patients' age as well as the botulinum toxin A dose and injection strategy used.

Impact still significant

About half of study participants experienced side effects during the trials. People randomly assigned to receive the active drug injections were 25 percent more likely to report any type of side effect. Muscle weakness was nine times more common in those patients, and neck pain or stiffness was reported three to five times more often than in the placebo groups.

Botox is approved by the US Food and Drug Administration to treat chronic migraines -- but not for less-frequent "episodic" headaches, a spokesperson for Allergan noted.

Headache researcher Dr. Vincent Martin, from the University of Cincinnati, said doctors have known for years that Botox doesn't help people with less-frequent headaches -- and the new review "gives a more definitive conclusion" on that.

But given that Botox is the only FDA-approved treatment for chronic migraines -- the most disabling type of headache -- its effect in those patients is not insignificant, said Martin, who wasn't involved in the new study.

"It's a very important treatment for many people with chronic migraine -- not for everyone," he told Reuters Health.

The drug costs nearly $1,000 for the dose used in chronic migraine patients, and injections aren't typically covered by insurance, according to Jackson.

He said the study had no outside funding source and wasn't linked to any companies that make botulinum toxin A products.

Dr. Mitchell Brin, Allergan's Chief Scientific Officer for Botox, pointed out that previous studies have suggested people with chronic migraines who are prescribed the drug also tend to have shorter-lasting migraines on the days when they still have headaches.

The difference equaled about 40 fewer hours per month of pain, compared to patients given placebo injections, he said.

That's "quite meaningful," Brin told Reuters Health. "The impact on their lives is quite significant."

Martin agreed that doctors often take into account more than just headache frequency when they prescribe the injections.

"Just looking at headache days per month may not tell the whole story," he said.

source: interaksyon.com