To fight COVID-19, Indian states turn to ivermectin against WHO advice

BENGALURU - At least two Indian states have said they plan to dose their populations with the anti-parasitic drug ivermectin to protect against severe COVID-19 infections as their hospitals are overrun with patients in critical condition.

The move by the coastal state of Goa and northern state of Uttarakhand come despite warnings from the World Health Organization and others against such measures.

"The current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive," WHO said in a statement in late March. "Until more data is available, WHO recommends that the drug only be used within clinical trials."

Merck, a manufacturer of the drug, has also said available data does not support using the drug as a COVID-19 treatment.

"We do not have enough data to support its use," said Anita Mathew, an infectious diseases expert in Mumbai.

The state of Goa, a major tourist haven, said earlier this week it plans to give ivermectin to all those older than 18, while the Himalayan state of Uttarakhand announced plans on Wednesday to distribute the tablets to any person over the age of two, except for pregnant and lactating women.

"An expert medical panel has recommended this," Uttarakhand's Chief Secretary Om Prakash told Reuters. "We are waiting for supplies to come in. Once they do we will distribute this drug."

Uttarakhand state in March and April played host to the Kumbh Mela, a weeks-long Hindu gathering that attracted millions of devotees from across the country. Images of the gathering showed scant evidence of any mask wearing or social distancing as throngs of people congregated for a holy dip in the river Ganges.

The state, ruled by Indian Prime Minister Narendra Modi's Bharatiya Janata Party, has since early April seen its COVID-19 cases surge from under 300 a day to above 7,000 a day, and the death toll has also risen sharply.

Modi and other political leaders in India have faced sharp criticism for failing to stop big religious and political gatherings in many states, despite evidence from mid-February onward that India's case count was rising.

Despite India's overwhelming surge in cases, Modi has shied away from imposing a nationwide lockdown fearing the economic fallout and has left it to state governments, which experts say have acted too late.

Uttarakhand state currently has coronavirus-related social restrictions, including curbs on interstate travel.

Goa, which is also ruled by Modi's BJP, remains open to tourists and only imposed an extended 15-day lockdown this week, despite data showing more than one in three patients were testing positive for COVID-19 since mid-April. The state is reporting the highest positivity rates in the country.

Goa Health Minister Vishwajit Rane said an expert panel based in Europe had found the drug ivermectin reduced the time to recovery and risk of death, but regulators such as WHO and the U.S. Food and Drug Administration say there is little evidence of this.

The state-run Indian Council of Medical Research recommends doctors could use the drug for mild COVID-19 patients, but warns this is based on "low certainty of evidence."

Rane did not respond to a Reuters request for comment.

-reuters-

Merck plans large outpatient trial of COVID-19 pill

Merck & Co Inc on Thursday said it plans a large study of what could become the first pill to target the coronavirus in people at risk of severe COVID-19, but will no longer pursue use of the experimental antiviral drug in hospitalized patients.

The company said it would study the drug molnupiravir in a Phase 3 trial among COVID-19 patients out of hospitals who have at least one risk factor for poor outcomes, such as advanced age, obesity or diabetes.

Trial participants can have had symptoms for no more than five days, shortened from seven days in a prior study.

"We had some encouraging signals in the outpatient trial. That was not the case in the inpatient trial, but that was not unexpected," Roy Baynes, Merck's chief medical officer, told Reuters. He said COVID-19 patients who need hospital treatment are often in the "inflammatory" phase of the disease, which is too late for an antiviral drug to provide much help.

Molnupiravir, which Merck is developing with Ridgeback Biotherapeutics, is designed to interfere with the ability of the coronavirus to replicate.

Merck also said it discontinued development of an experimental immune modulator, known as MK-7110, for treating COVID-19 after concluding that clinical trial and manufacturing preparations would take too long.

The drugmaker earlier this year stopped development of two COVID-19 vaccines, citing data showing they were less effective than vaccines being developed by rivals.

Merck said its trials of molnupiravir found no drug-related adverse events that led participants to discontinue treatment and there were no drug-related deaths.

Patients in the Phase 3 trial will be given 800 mg of molnupiravir twice a day for five days.

Merck said it plans to present at an upcoming medical meeting details from earlier studies of the drug in both hospitalized and non-hospitalized patients. Results of the Phase 3 trial are expected by September or October, but interim analyses are planned.

Baynes said the company has ramped up production of molnupiravir and aims to have at least 10 million courses of therapy on hand later this year.

Merck also plans to study molnupiravir for preventing coronavirus infection in people exposed to the disease, starting in the second half of the year. 

-reuters-

Merck CEO resigns from Trump council over Charlottesville

Merck & Co Inc Chief Executive Kenneth Frazier resigned from US President Donald Trump's American Manufacturing Council on Monday, saying he was taking a stand against intolerance and extremism.

Trump denounced neo-Nazis and the Ku Klux Klan as criminals and thugs on Monday, bowing to mounting political pressure after initially saying many sides were to blame after a white-nationalist rally turned deadly in Virginia.


Frazier, who is African-American, is the only CEO so far to leave one of Trump's advisory councils because of his reaction to the violence in Virginia, although the AFL-CIO said it was considering pulling its representative on the committee. Prominent Democrats and Republicans criticized Trump's response to the violence over the weekend.

The gathering of hundreds of white nationalists took a deadly turn on Saturday when a car plowed into a group of counter-protesters and killed at least one person.

Trump had said "many sides" were involved, drawing fire from across the political spectrum for not specifically denouncing the far right.

"America's leaders must honor our fundamental views by clearly rejecting expressions of hatred, bigotry and group supremacy, which run counter to the American ideal that all people are created equal," Frazier said in a statement announcing his resignation.

"As CEO of Merck and as a matter of personal conscience, I feel a responsibility to take a stand against intolerance and extremism," he said.

Trump responded shortly after in a tweet, saying that now "Ken Frazier of Merck Pharma has resigned from President's Manufacturing Council, he will have more time to LOWER RIPOFF DRUG PRICES!"

Trump doubled down on his attack later in the day, tweeting that Merck "is a leader in higher & higher drug prices while at the same time taking jobs out of the US Bring jobs back & LOWER PRICES!"

The son of a janitor, Frazier joined Merck as general counsel of one of the drugmaker's subsidiaries in 1992, working his way up to CEO of the company in 2011.

He made his name as the company's top lawyer, steering it through daunting litigation over Vioxx, its widely used painkiller that was withdrawn in 2004 after being linked to heart attacks.

Many observers thought Merck would eventually have to shell out $10 billion or more to thousands of plaintiffs over the drug's withdrawal. But Frazier's legal strategy led to a $4.85 billion settlement in 2007, allowing Merck to refocus on its pipeline of experimental medicines.

Merck shares rose 0.5 percent in afternoon trading on the New York Stock Exchange, roughly in line with the wider market.

Frazier frequently made political contributions during the 2016 election, donating to both Republican and Democratic members of Congress but making no donations to a presidential candidate during the year.

The political PAC maintained by Merck and funded through donations from Merck employees made over $1.1 million in candidate contributions during the 2016 campaign - but did not contribute to Trump or his Democratic rival, Hillary Clinton, according to documents filed with the Federal Elections Commission.

The Pharmaceutical Research and Manufacturers of America, which represents the pharmaceutical industry and lobbies on its behalf in Congress, declined to offer a statement of support for Frazier or to comment on Trump’s reaction.

The industry’s silence comes as Trump is finalizing an executive order on drug prices that would relax industry regulation and contains measures that, some say, would protect existing drug prices or even increase them.

Individually, at least one CEO, John Maraganore of Alnylam Pharmaceuticals, tweeted his support, saying he was “proud to stand with leaders like Ken Frazier.”

Other top business leaders also spoke out in response to the violence in Charlottesville.

"I support Ken Frazier’s decision. I’m thankful we have business leaders such as Ken to remind America of its better angels," said Hewlett Packard Enterprises CEO Meg Whitman, who ran for governor of California as a Republican in 2010.

Goldman Sachs CEO Lloyd Blankfein tweeted: "Lincoln: 'A house divided against itself cannot stand.' Isolate those who try to separate us. No equivalence w/ those who bring us together."

Richard Trumka, president of the largest federation of U.S. labor unions, the AFL-CIO, questioned the council's effectiveness and said the group was mulling leaving.

"The AFL-CIO has unequivocally denounced the actions of bigoted domestic terrorists in Charlottesville and called on the president to do the same," Trumka said in a statement.

Several executives from top US companies have previously stepped down from a number of presidential advisory councils in protest to Trump policies.

Tesla Inc CEO Elon Musk and Walt Disney Co CEO Robert Iger left the President’s Strategic and Policy Forum, a business advisory group, in June, after Trump said he would withdraw from the Paris climate accord. Musk also left the manufacturing council.

Former Uber Technologies Inc CEO Travis Kalanick quit the business advisory council in February amid pressure from activists and employees who opposed the administration's immigration policies.

The White House said Sunday that Trump's remarks condemning violence at a white nationalist rally were meant to include the Ku Klux Klan and neo-Nazi groups.

Democrats and Republicans criticized Trump for waiting too long to address the violence - his first major domestic crisis as president - and for failing when he did speak out to explicitly condemn white-supremacist marchers who ignited the melee.

Trump on Saturday initially denounced what he called "this egregious display of hatred, bigotry and violence on many sides."

On Sunday, however, the White House added: "The president said very strongly in his statement yesterday that he condemns all forms of violence, bigotry, and hatred, and of course that includes white supremacists, KKK, neo-Nazi, and all extremist groups. He called for national unity and bringing all Americans together."

source: news.abs-cbn.com

Dengue fever spreads around the world

PARIS - Dengue fever, the world's fastest growing mosquito-borne disease, has spread its wings from being a tropical disease, endemic in just nine countries, to a worldwide threat.

Globalization, urbanization, climate change and jet travel have enabled it to move into more temperate zones.

Following are some basic facts:

- What is dengue fever ? -Dengue fever is a flu-like infection, caused by the flavivirus in the same family as yellow fever.

Dengue fever has four separate strains -- DEN-1, DEN-2, DEN-3 and DEN-4. Once cured, the patient is protected for life but only against the strain he was stricken by.

- How is the virus transmitted ? -Dengue is transmitted by several species of mosquito within the Aedes aegypti, which originate in Africa but which are now present in all tropical and subtropical areas.

- The symptoms - Dengue can trigger a crippling fever along with headache, nausea, vomiting, muscle and joint pain, and skin rashes similar to measles.

- The most severe form -The most severe form of the disease, dengue haemorrhagic fever, accounts for one percent of cases, killing 22,000 people a year, the World Health Organisation (WHO) says. It results in bleeding and blood plasma leakage. It can be fatal, in particular among children.

- How many cases ? -The number of cases in the world has risen 30-fold over the last 50 years, according to the WHO, making it the world's fastest growing mosquito-borne disease and leaving more than half of the world's population potentially at risk.

The WHO says that half a million people are hospitalised by the illness every year, many of them children of which around 2.5 percent die.

- Treatment and vaccination -There is currently no specific treatment for dengue fever.

The world's first-ever dengue vaccine, Dengvaxia, manufactured by French pharmaceutical giant Sanofi, secured its first regulatory approval in Mexico on December 9.

The Philippines became the first Asian country on Tuesday to approve the sale of the vaccine.

Other pharmaceutical companies are developing dengue vaccines, including US firm Merck, Japan's Takeda and Britain's GlaxoSmithKline.

source: www.abs-cbnnews.com