Dhaka, Aug 9 (UNB) - Drinking three or more cups of coffee daily may be associated with a higher risk of migraine, according to a study published Thursday, reports The Indian Express.
Afflicting more than one billion adults worldwide, migraine is the third most prevalent illness in the world, said researchers at Beth Israel Deaconess Medical Center (BIDMC) in the US.
In addition to severe headache, symptoms of migraine can include nausea, changes in mood, sensitivity to light and sound, as well as visual and auditory hallucinations.
The study, published in the American Journal of Medicine, evaluated the role of caffeinated beverages as a potential trigger of migraine.
Led by Elizabeth Mostofsky, from the Harvard T H Chan School of Public Health (HSPH) in the US, the researchers found that, among patients who experience episodic migraine, one to two servings of caffeinated beverages were not associated with headaches on that day.
However, three or more servings of caffeinated beverages may be associated with higher odds of migraine headache occurrence on that day or the following day.
“While some potential triggers — such as lack of sleep — may only increase migraine risk, the role of caffeine is particularly complex, because it may trigger an attack but also helps control symptoms,” said Mostofsky.
Caffeine’s impact depends both on dose and on frequency, but because there have been few prospective studies on the immediate risk of migraine headaches following caffeinated beverage intake, there is limited evidence to formulate dietary recommendations for people with migraines,” he said.
In the study, 98 adults with frequent episodic migraine completed electronic diaries every morning and every evening for at least six weeks.
Every day, participants reported the total servings of caffeinated coffee, tea, soda and energy drinks they consumed, as well as filled out twice daily headache reports detailing the onset, duration, intensity, and medications used for migraines since the previous diary entry.
Researchers used a self-matched analysis, comparing an individual participant’s incidence of migraines on days with caffeinated beverage intake to thier incidence of migraines on days with no caffeinated beverage intake.
This self-matching eliminated the potential for factors such as sex, age, and other individual demographic, behavioural and environmental factors to confound the data.
The researchers further matched headache incidence by day of the week, eliminating weekend versus week day habits that may also impact migraine occurrence.
Self-matching also allowed for the variations in caffeine dose across different types of beverages and preparations.
“One serving of caffeine is typically defined as eight ounces or one cup of caffeinated coffee, six ounces of tea, a 12-ounce can of soda and a 2-ounce can of an energy drink,” said Mostofsky.
“Those servings contain anywhere from 25 to 150 milligrammes of caffeine, so we cannot quantify the amount of caffeine that is associated with heightened risk of migraine.
The researchers saw no association between one to two servings of caffeinated beverages and the odds of headaches on the same day, but they did see higher odds of same-day headaches on days with three or more servings of caffeinated beverages.
However, among people who rarely consumed caffeinated beverages, even one to two servings increased the odds of having a headache that day, researchers said.
“Despite the high prevalence of migraine and often debilitating symptoms, effective migraine prevention remains elusive for many patients,” said Suzanne M Bertisch from BIDMC.
New York , Aug 7(AP/UNB) — Prescriptions of the overdose-reversing drug naloxone are soaring, and experts say that could be a reason overdose deaths have stopped rising for the first time in nearly three decades.
The number of naloxone prescriptions dispensed by U.S. retail pharmacies doubled from 2017 to last year, rising from 271,000 to 557,000, health officials reported Tuesday.
The United States is in the midst of the deadliest drug overdose epidemic in its history. About 68,000 people died of overdoses last year, according to preliminary government statistics reported last month, a drop from the more than 70,000 in 2017.
"One could only hope that this extraordinary increase in prescribing of naloxone is contributing to that stabilization or even decline of the crisis," said Katherine Keyes, a Columbia University drug abuse expert.
About two-thirds of U.S. overdose deaths involve some kind of opioid, a class of drugs that includes heroin, certain prescription painkillers and illicit fentanyl. Naloxone is a medication that can reverse opioid overdoses, restoring breathing and bringing someone back to consciousness. It first went on sale in 1971 as an injection. An easier-to-use nasal spray version, Narcan, was approved in 2015.
Local, state and federal officials have embraced naloxone as a lifesaving measure. Cities and states have standing orders that allow pharmacies to give it out without a doctor's prescription, and officials have tried to put it into the hands of virtually anyone who might encounter a person overdosing, including drug users, police and even librarians.
CDC researchers noted there were fewer than 1,300 naloxone prescriptions dispensed in 2012, meaning the number grew more than 430-fold in six years.
Health officials said pharmacies should be giving out even more.
"We don't think anybody is at the level we'd like to see them," said Dr. Anne Schuchat of the Centers for Disease Control and Prevention.
The CDC report is based on data from IQVIA, a company that tracks health care information, and looked at prescriptions from more than 50,000 retail pharmacies across the country. It included both prescriptions written by doctors for specific patients and those filled under the broader standing orders.
The report offers only a partial picture, however, since only about 20% of naloxone was sold to retail pharmacies in 2017, according to an earlier government report.
Still, it's the CDC's first close look at where most retail dispensing is happening. The agency provided data for about 2,900 of the nation's 3,100 counties and parishes.
The researchers found it was most common in cities, and in the South.
Experts said the findings likely reflect a number of factors. More naloxone is likely prescribed in places where more people are using opioids and where policies increase access.
Of the 30 counties with the highest rate of naloxone dispensing in 2018, 13 were in Virginia and five were in Kentucky. But the highest naloxone dispensing rate was in Marshall County, Indiana, according to the CDC data.
The CDC recommends that naloxone be prescribed to patients who are getting high-dose opioids and are at risk for an overdose. It noted that only one naloxone prescription is written for every 69 high-dose opioid prescriptions.
Another finding: The number of high-dose opioid prescription painkillers dispensed fell to about 38 million last year, from nearly 49 million the year before.
That likely also contributed to the decline in overdose deaths last year, Schuchat said.
Kampala, Aug 3 (AP/UNB) — Researchers in Uganda have launched the largest-ever trial of the experimental Ebola vaccine that is expected to be deployed in neighboring Congo, where a deadly outbreak has killed over 1,800 people.
The trial of the Janssen Pharmaceuticals vaccine involves up to 800 people in the western district of Mbarara and is supported by Doctors without Borders and the London School of Hygiene and Tropical Medicine.
Pontiano Kaleebu, a Ugandan researcher who leads the trial, said Friday that he regrets that the Janssen vaccine has not yet been deployed in Congo. The health minister there who stepped down last month had argued against its deployment, saying a second vaccine could create confusion on the ground.
Already more than 180,000 people in Congo's yearlong outbreak have received an experimental but effective Merck vaccine, but health experts worry about the availability of doses as the virus now spreads in a major city, Goma, along the Rwanda border. The wife and 1-year-old daughter of the man who died this week of Ebola in Goma now have the disease.
Both the wife and child were doing well in treatment, Congo's new Ebola response coordinator, Jean-Jacques Muyembe, told reporters on Friday.
But he warned that about half of the cases in this outbreak are going undetected and at that rate "this epidemic could last two or three years." The current goal is to strengthen surveillance and bring the detection rate to 80%, he said.
Health experts have watched with dismay as the promise of the Merck vaccine in this outbreak has been largely overshadowed by severe challenges to virus containment efforts including rebel attacks and community resistance in a part of Congo that had never experienced Ebola before.
The Janssen vaccine has already been tested in about 6,000 people, most of them Africans, Kaleebu said. "We are excited about this (trial) ... because this is one of the promising vaccines," he said. "It's one of those vaccines that have shown a lot of promise in animal studies but also in other trials that have been conducted."
Ugandan researchers said the new trial is expected to last two years and will test how long any protection from Ebola would last. Juliet Mwanga, a co-investigator on the trial, said there is the need "to study many vaccines" in light of Congo's epidemic.
Uganda has had multiple Ebola outbreaks in the past. While it is currently free of the virus, three people died in June after crossing into the country's Kasese district on an unguarded footpath. Their family members were taken back to Congo for treatment.
The Ebola virus can spread quickly and be fatal in up to 90% of cases. Symptoms include fever, vomiting, diarrhea, muscle pain and at times internal and external bleeding. The virus is most often spread by close contact with bodily fluids of people exhibiting symptoms and with contaminated objects such as sheets. Health care workers are often at risk.
Washington, Aug 1 (AP/UNB) — The Trump administration said Wednesday it will create a way for Americans to legally and safely import lower-cost prescription drugs from Canada for the first time, reversing years of refusals by health authorities amid a public outcry over high prices for life-sustaining medications.
The move is a step toward fulfilling a 2016 campaign promise by President Donald Trump. It weakens an import ban that has stood as a symbol of the political clout of the pharmaceutical industry.
But it's unclear how soon consumers will see benefits, as the plan has to go through time-consuming regulatory approval and later could face court challenges from drugmakers. And there's no telling how Canada will react to becoming the drugstore for its much bigger neighbor, with potential consequences for policymakers and consumers there.
The U.S. drug industry is facing a crescendo of consumer complaints over prices, as well as legislation from both parties in Congress to rein in costs, not to mention proposals from the Democratic presidential contenders. Ahead of the 2020 election, Trump is feeling pressure to deliver on years of harsh rhetoric about pharmaceutical industry prices.
Making the announcement, Health and Human Services Secretary Alex Azar said the administration recognizes that prescription drug manufacturing and distribution is now international.
"The landscape and the opportunities for safe linkage between drug supply chains has changed," Azar said. "That is part of why, for the first time in HHS's history, we are open to importation. We want to see proposals from states, distributors, and pharmacies that can help accomplish our shared goal of safe prescription drugs at lower prices."
Stephen Ubl, president of the industry group Pharmaceutical Research and Manufacturers of America called the plan "far too dangerous" for American patients. "There is no way to guarantee the safety of drugs that come into the country from outside the United States' gold-standard supply chain," Ubl said in a statement. "Drugs coming through Canada could have originated from anywhere in the world."
Most patients take affordable generic drugs to manage conditions such as high blood pressure or elevated cholesterol. But polls show concern about the prices of breakthrough medications for intractable illnesses like cancer or hepatitis C infection, whose annual costs can run to $100,000 or much more. And long-available drugs like insulin have seen serial price increases that forced some people with diabetes to ration their own doses.
Azar, a former drug company executive, said U.S. patients will be able to import medications safely and effectively, with oversight from the Food and Drug Administration. Azar used to be a skeptic of importation, and was once quoted dismissing it as a gimmick.
One prong of the administration's proposal would allow states, wholesalers and pharmacists to get FDA approval to import certain medications that are also available here. Trump had recently endorsed a new Florida law to allow importation.
Another part of the plan would allow drugmakers to seek approval for re-importation of their own drugs. This second provision would cover cutting-edge biologic drugs as well mainstays like insulin, and it could apply to drugs from other countries besides Canada.
Azar said complex regulations setting up the system could take "weeks and months." He called on Congress to pass legislation that would lend its muscle to the effort, making it harder to overturn the policy in court.
"The FDA has the resources to do this," said acting FDA Commissioner Ned Sharpless. "The agency is interested in considering any reasonable proposal that maintains the bedrock of safety and efficacy for the American consumer."
Importation has backers across the political spectrum.
Sen. Chuck Grassley, R-Iowa, chairman of the panel that oversees Medicare, is a longtime supporter. He and Democratic presidential candidate Sen. Amy Klobuchar of Minnesota have a bill to facilitate importation. Sen. Lamar Alexander, R-Tenn., who chairs the health committee, welcomed the plan but said the key is whether importation can be done safely.
During Tuesday night's Democratic presidential debate , multiple candidates talked about the need to lower drug costs. Sen. Bernie Sanders, Vermont Independent, noted the disparity in U.S. and Canadian prices. "I took 15 people with diabetes from Detroit a few miles into Canada and we bought insulin for one-tenth the price being charged by the crooks who run the pharmaceutical industry in America today," he said.
The leading drug industry trade group, known as PhRMA, is a powerhouse that generally gets its way with lawmakers. It spent $128 million on lobbying in 2017, according to its most recent tax filings. But pressure on the industry is rising across many fronts.
In the Senate, Trump is supporting Grassley's bipartisan bill to cap medication costs for Medicare recipients and require drugmakers to pay rebates to the program if price hikes exceed inflation. Democrats in the House are pressing for a vote on a bill allowing Medicare to directly negotiate prices on behalf of millions of seniors. Separately, the Trump administration is pursuing a regulation that would tie what Medicare pays for drugs administered in doctors' offices to lower international prices.
Drug costs are lower in other economically advanced countries because governments take a leading role in setting prices. But in the U.S., Medicare is not permitted to negotiate.
Some experts have been skeptical of allowing imports from Canada, partly from concerns about whether Canadian suppliers have the capacity to meet the demands of the much larger U.S. market.
Backers argue that the prospect of competition will pressure U.S. drugmakers to reduce prices.
Sacramento, Jul 30 (AP/UNB) — Three pharmaceutical companies collectively are agreeing to pay California nearly $70 million to settle allegations that they delayed drugs to keep prices high, California Attorney General Xavier Becerra said Monday.
The bulk of the money will come from Teva Pharmaceutical Industries Ltd. and its affiliates for paying to delay a generic narcolepsy drug, Provigil, from entering the market for nearly six years.
Teva is paying $69 million, which Becerra says is the largest pay-for-delay settlement received by any state.
Such agreements let the developer of brand name drugs keep their monopolies over the drugs after their patents expire, thereby letting them continue to charge consumers higher prices. The drug developer pays the generic manufacturer to keep the cheaper version of the drug from entering the marketplace for an agreed period of time.
Teva said the money will come from a pre-existing fund that was created in 2015 as part of the company's settlement with the U.S. Federal Trade Commission over similar claims, and it will not make any additional payments.
Becerra said such agreements can force consumers and the health care market to pay as much as 90% more than if there were generic alternatives. More than $25 million of the settlement will go to a consumer fund for California residents who purchased Provigil, Nuvigil or Modafinil between 2006 and 2012.
"No one in America should be forced to skip or ration doses of medicine that they need ... and certainly not because a drug company is colluding to keep the price of your drug artificially high even when cheaper options could be available. But that's what's happening," Becerra said.
The second, $760,000 settlement is with Teva, Endo Pharmaceuticals and Teikoku Pharma USA over keeping a genetic alternative to the pain patch Lidoderm from entering the market for nearly two years.
Teva said it is paying $200,000 to cover the state's legal costs after settling similar federal claims earlier this year. Neither Endo nor Teikoku responded to requests for comment.
Both settlements bar the companies from pay-for-delay agreements for several years. Teva is agreeing to not to enter any such agreements for 10 years, while Endo Pharmaceuticals has an eight-year agreement and Teikoku a 20-year injunction.
Teva said the restriction is identical to its federal consent decree.
Becerra also backed pending legislation, AB824 by Democratic Assemblyman Jim Wood of Santa Rosa, that would ban such agreements.
The measure would require pharmaceutical companies to prove that their agreements are not anticompetitive. It passed the Assembly 56-0 in May and is awaiting a vote in the Senate.
Pharmaceutical companies oppose the bill, arguing the Federal Trade Commission already does this monitoring.