MemberApril 19, 2021 at 12:13 pm
FDA grants ivermectin special permit to another private hospital
posted April 17, 2021 at 01:10 am
by Willie Casas and Maricel V. Cruz
Food and Drugs Administration Director General Eric Domingo said Friday one more private hospital was granted a compassionate special permit (CSP) to use the anti-parasitic drug ivermectin as treatment for COVID-19, as the country grapples with a shortage of supplies of medicines and vaccines.
“Two hospitals have actually applied and granted CSP already,” Domingo told ANC in an interview.A compassionate use permit only allows legal administration of the drug in the country but is not an endorsement of its safety and efficacy from the FDA.The first CSP for the use of ivermectin on COVID-19 patients was granted by the FDA last week.Due to privacy concerns, Domingo said he could not bare the name of the hospitals.“I have to ask permission from the hospitals because of the privacy of their patients,” he said.The Department of Health DOH had repeatedly warned that dispensing of ivermectin for human use as well as its promotion violate Republic Act 9711 or the FDA Act of 2009.Domingo had said that under a CSP, patients must consent to using the drug and doctors take upon themselves “complete responsibility over the product.”Domingo said their requirements for granting CSP are name of the licensed importer and proof of registration of ivermectin from its country of origin.The FDA should also be informed of the “investigational treatment” that the hospital will be following in the use of ivermectin against COVID-19.“Hindi naman puwedeng mag-iimbento ka ng dosage, imbento ng protocol (you can’t just invent dosage and protocols),” Domingo said.In the United States, ivermectin is used in mild to moderate cases of COVID-19, he said.Doctors who will use ivermectin against the coronavirus will be reporting to the FDA on a monthly basis, he said.Amid the push of some sectors, including lawmakers, for the use of ivermectin against COVID-19, the Philippine Association of Pharmacists in the Pharmaceutical Industry (PAPPI) said clinical trials are needed to assess its benefits and risks.The World Health Organization, the US Food and Drug Administration, the European Medicines Agency have all said there is currently a lack of data on ivermectin’s efficacy and benefits as a COVID-19 treatment.The FDA earlier said that despite the approval, ivermectin’s distribution is still prohibited, as the agency said only the hospital that has the permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.Domingo clarified that the Philippine FDA is not against ivermectin.“We recognize that it is a drug under investigation… there is a possibility that it would be proven to be good for COVID-19, there’s a possibility that it would be proven to be useless against COVID-19,” he said.“What the FDA is against is unregulated drugs. What we don’t allow is the prescription of a veterinary drug to humans and the use of unregistered drugs,”he said.Domingo stressed that “there is a legal way” to use ivermectin in the Philippines, which is through a CSP or a certificate of product registration.Meanwhile, a party-list lawmaker chided the Department of Health for preferring two costly investigational COVID-19 therapeutics over what he described as inexpensive “wonder drug” ivermetin that the poor can afford.“The DOH continues to spend hundreds of millions, maybe billions, of pesos to buy Remdesivir and Tocilizumab, not to mention the purchases of private hospitals,” Anakalusugan Rep. Mike Defensor said.He cited the recent statement of treatment czar DOH Undersecretary Leopoldo Vega that new imported stocks of the two therapeutic products were due to arrive in the country to replenish dwindling supply.Defensor said Remdesivir costs P28,000 for 2 shots daily (for about 3-5 days) while the price of Tocilizumab is about $2,000.In contrast, he said ivermectin, which is also an investigational drug like its two more expensive rivals, costs only P35 per tablet.He said for DOH hospitals, it is Philhealth that shoulders the price of Remdesivir and Tocilizumab, while for private hospitals, the cost “is borne by desperate private citizens who try to save their sick loved ones.”He added that the DOH and the FDA were allowing the use of Remdesivir against the advice of the World Health Organization.“We were part of the WHO solidarity trial and yet we do not follow their recommendations and continue to allow Remdesivir to be given to COVID-19 patients. For Remdesivir, we don’t follow and DOH continues to purchase it, but for Ivermectin, where data is still inconclusive and clinical trials are allowed, the DOH and the FDA crack down on supply,” Defensor stressed.He said ivermectin is listed in the WHO, Philippine FDA and US FDA list of essential drugs.“It is considered a wonder drug, along with penicillin and aspiring. It is one of the safest, with a testimony spanning 40 years. It has a 3.7 billion dosage on record,” he said.He admitted that ivermectin “is not a registered drug, but that’s because for many years, it was donated for river blindness and other parasitic illnesses.”“Can the DOH and FDA allow its production? Yes, in the same manner that they have allowed the expensive drugs to be used. An administrative order (AO) allowing drug manufacturers to produce Ivermectin can be issued. The AO would allow them to import legally without facing arrest and confiscation of products given the current policy of the DOH and the FDA,” he said.Defensor said the poor could easily afford the P35 ivermectin.“We can save many lives without draining government and Philhealth coffers or making families, including the poor, pay huge sums for the hospitalization of their loved ones,” he said.
MemberApril 19, 2021 at 12:48 pm
According to local Irish press, prominent physicians report at least some hospitals are using ivermectin now as a treatment for COVID-19. This hasn’t been authorized by regulators but rather represents a situation similar to the United States where physicians can and are prescribing the drug off label for COVID-19 at their discretion.
MemberApril 19, 2021 at 12:59 pm
COVID-19: States ignore WHO recommendation on Ivermectin, here’s what doctor who wrote white paper on the drug has to say
Updated: Apr 14, 2021 11:59 AM
“…The World Health Organisation (WHO) recently recommended that antiparasitic drug Ivermectin must be used to treat COVID-19 patients within the clinical trials only. The WHO sighted lack of conclusive data behind this recommendation, which is applicable to “patients with COVID-19 of any disease severity.” Despite this, some states – including Uttar Pradesh and Maharashtra – are using the drug off-label for not only the treatment of coronavirus patients but also as prophylaxis against COVID-19. Ivermectin, also referred to as a ‘wonder drug’ by many, is usually used to treat parasitic infections like onchocerciasis (river blindness), trichuriasis, scabies, strongyloidiasis, and other diseases caused by soil-transmitted helminthiasis. But, Uttar Pradesh has prescribed it as part of a protocol to treat mild and moderate cases of COVID-19.
Moreover, rapid response teams in the state have been ordered to distribute Ivermectin to people under home isolation. The teams of doctors who assess asymptomatic patients are even asking primary and secondary contacts of confirmed cases to take this drug in order to prevent any possible infection. When asked about the decision to continue the usage of the drug for the treatment of COVID-19, Dr Surya Kant Tripathi – Head, Respiratory Medicine Department, King George Medical University, Lucknow – told Financial Express Online that Ivermectin is being used both for the treatment of coronavirus patients and as prophylaxis for COVID-19 for more than nine months without any major side effects being reported.
“The drug is being majorly used for the treatment of COVID-19 when patients are under home isolation and also in all mild cases of the disease. It is true that we have not used the drug in severe cases. But this is also a fact that even healthcare workers shifted from the prophylaxis of hydroxychloroquine to Ivermectin. This is because we observed that 17 per cent of healthcare workers using hydroxychloroquine developed one or another kind of side effects,” Dr Surya Kant – who is also national vice chairman of IMA-AMS – said.
It must be noted that Dr Surya Kant, along with some other health experts of India, wrote a white paper on Ivermectin last year and it was displayed on the website of the World Health Organization. Dr Surya Kant also emphasized that this drug reduces the replication rate of the infection by several thousand times. It was only after this white paper when Uttar Pradesh government started using the drug. UP was the first state to use Ivermectin for treatment of COVID-19 and it has been extensively used since then, the doctor of KGMU said.
“Not only Uttar Pradesh, governments of West Bengal, Maharashtra, and Assam too included Ivermectin in their protocol for the treatment of COVID-19,” he added.
When asked about the lack of clinical trial data on Ivermectin, Dr Surya Kant said that over 40 such trials are underway, and not one has reported any major side effects yet. “More than 40 clinical trials are underway, including eight in India. This includes the most prestigious institute in India i.e. AIIMS Delhi. The trial underway at AIIMS is also on five different types of doses of Ivermectin, which is a very important issue. So, all kinds of trials are underway. My whitepaper was published in the month of July 2020. In the whitepaper, 19 Indian experts have contributed. They collected and compiled all data available on Ivermectin since 1981, when the drug was introduced to the world. Both researchers (William C. Campbell of US and Satoshi Ōmura from Japan) who discovered this drug won the 2015 Nobel Prize in Physiology or Medicine for discovering this drug. It has got more than four properties – anti-viral, anti-parasitic, anti-cancer, and even anti-HIV. This is a wonderful drug, low cost, widely available and used for last 40 years throughout the world.”
He went on to say that anti-viral drug remdesivir has failed drastically. “All trials are saying that this drug is not effective in the treatment of COVID-19, rather it is complicating and resulting in mortality of patients. At so many centers, remdesivir trails were stopped. Also, remdesivir is costing minimum of Rs 5,000 per vial.
Dr Surya Kant said it was only after Australia started including Ivermectin in its protocol for COVID-19 treatment significantly, the WHO started thinking about the drug.
“Australia has triple therapy protocol for COVID-19 which includes Ivermectin, Zinc, and Doxycycline. This is being widely used in Australia and it controlled the spread of COVID-19 very well. Bangladesh too has successfully implemented this protocol of Ivermectin. It was only after Australia successfully controlled the disease, WHO started talking about this ‘wonder drug’,” he said.
When asked whether he would approach the WHO over its recommendation, the national vice chairman of IMA – AMS said he has not read the complete recommendations of the WHO. “But I will go through it and will definitely write back to them,” Dr Surya Kant said.
MemberApril 19, 2021 at 1:36 pm
Australian federal MP Craig Kelly
has been raising the examples of South Africa and Panama on social media and has recently had close to a million views.
“The results are now in, they show that Panama’s Covid Kits have crushed the nation’s death rate, saving thousands of lives in that country,” said Kelly in a social media post. “Panama’s decline in death rates have been one of the most successful in the world. And Panama did this when health bureaucrats in Australia were using their powers to threaten jail to anyone in Australia who did similar.”
Kelly went on to blast Australian Labor politicians and media: “And while Panama was saving lives with these kits, Albanese and Bowen where mocking and ridiculing these treatments – and they were being supported by the ABC and other left wing media. “Nasty little hate groups got their kicks from attacking me for posting the evidence and the peer-reviewed science on FB (Facebook)…”
MemberApril 19, 2021 at 2:04 pm
“…Panama has gone one step further than other Latin American countries that use the unproven drug ivermectin against COVID-19 (see Nature 586, 481–482; 2020).”
So what were the results, let us look at the COVID-19 cases and deaths in Panama
MemberApril 30, 2021 at 5:41 pm
<div>Testimony of a recovering patient
MemberApril 19, 2021 at 2:45 pm
Hope you are able to get Ivermectin that can be used broadly. Effective and few side effects.
WHY is it not being used ASAP at first signs of infection?
MemberApril 19, 2021 at 3:17 pm
<div>United States of America
In the USA, ivermectin is available
One of my friends was prescribed “people” ivermectin for an intestinal use. Then he asked if he could have a prescription for COVID-19 protection and was granted the prescription.
But many people said, “I will see what my doctor says” and are told that ivermectin is not approved. That is that…those kind of doctors don’t budge.
They are afraid to do this.
“Off-label drug use is when drugs are prescribed for a condition or a type of patient or a dosage not officially approved by the U.S. Food and Drug Administration. The FDA does not regulate the medical profession. The agency has no control over how doctors prescribe approved drugs to patients. So once a medication is on the market, it is up to physicians to determine the medically appropriate use of the drug.
Off-label drug use is when doctors legally prescribe drugs for unapproved uses.</div><div>The FDA has no control over how doctors prescribe drugs.
Off-label drug use is not without risks.
– – – – –
Consequently, it’s legal and common for doctors to prescribe drugs for uses other than what is listed on the label, commonly known as off-label. One fifth of all prescriptions are off-label.
20 percent of all prescriptions are written for uses not approved by the FDA.
– – – – –
The fact that a condition or a dosage or a category of patient is not included on a label doesn’t mean that the drug is not appropriate for that use. It means only that the FDA has not approved that particular use of the drug.
Off-Label Drug Use Safety
Off-label drug use is generally not backed by the level of testing and data that allows FDA approvals. Patients don’t have the guides and warnings that come from FDA-approved labels when using a drug off-label. Doctors and patients therefore don’t always have enough information about the effects and dangers of the off-label use of the drug to make informed decisions.
Ivermectin (Stromectol) is not FDA-approved to treat scabies, but many healthcare providers that specialize in skin problems or in treating infections will prescribe ivermectin (Stromectol) for scabies. This is an unapproved or off-label use of this medication.
A doctor who prescribes a medication for an off-label purpose is not necessarily guilty of malpractice. If the use is supported by science, and the prescription falls within a doctor’s applicable standard of care, there will be no malpractice.
– – – – –
There are also safe and effective uses by independent researchers who choose their own ways of preventing viral infections.
I won’t say
MemberApril 27, 2021 at 7:40 pm
Here is a link about India’s use of ivermectin, which, after showing promise, then transitioned to the lessening of use as vaccines were given out.
While seemingly low death rates for COVID-19 in India were probably a result of isolation and non-exposure, rather than WIDESPREAD ivermectin distribution and use, the writer at this link speculates that when the vaccination campaign in India took the spotlight as the treatment of choice and overshadowed ivermectin distribution, then the infection cases rose, implicating the abandonment of ivermectin as a possible reason for the rise in deaths as a result of COVID-19.
Circumstantial? Cases are rising in various places in the world in April 2021. Are India’s rise in cases stoppable with the current vaccination campaign? Is India’s infection rate going to be reduced if there is a return to ivermectin distribution in a more thorough and aggressive way?
People are staying too close to infected people during an infectious disease and then they get infected and spread it to others too.
MemberApril 27, 2021 at 7:44 pm
Here are the Worldometers coronavirus graphs at this webpage:
MemberApril 27, 2021 at 9:28 pm
The MedinCell study affirms that ivermectin is safe in continuous doses.
MemberApril 27, 2021 at 9:34 pm
<b itemprop=”headline”> Clinical Trial Conducted by MedinCell Confirms the Safety of Continuous Administration of Ivermectin
<time datetime=”2021-04-19T10:45:30-05:00″>Apr 19, 2021</time>
<time datetime=”2021-04-19T11:03:36-05:00″>Apr 19, 2021</time>
MONTPELLIER, France–(BUSINESS WIRE)–Apr 19, 2021–
Clinical trial validates the safety of ivermectin taken daily in oral form, to simulate the continuous release of the active substance by a long-acting injection.
No side effects were observed with the three doses of ivermectin tested up to 100 µg / kg.
MedinCell develops several long-acting injectable formulations of ivermectin, the most advanced aims at preventing infection from Covid-19 and its mutants for several months.
Positive results of the safety study
“All our programs are developed in accordance with the highest ethical standards and on the basis of reliable scientific principles with a view to potential massive deployment. Proving the safety of ivermectin in regular daily administration over a long period was an essential step for our ivermectin programs, in particular mdc-TTG in Covid-19,” said Joël Richard, Chief Development Officer at MedinCell.
MemberApril 30, 2021 at 9:22 am
MemberApril 30, 2021 at 5:36 pm
MemberApril 30, 2021 at 6:34 pm
Chiapas is the only state distributing ivermectin
Chiapas is the only state distributing ivermectin
Chiapas vs every other State in Mexico (Chiapas is the only state distributing ivermectin)
Cases and Deaths significantly reduced
MemberApril 30, 2021 at 6:53 pm
MemberApril 30, 2021 at 7:16 pm
Two legislators on Tuesday vowed to push through with a plan to distribute Ivermectin drug through an “Ivermectin Pan-Three” for those who are in dire need of the controversial drug.
To equate both the “sense of urgency and inherent trait of community sharing,” Sagip Rep. Rodante Marcoleta and Anakalusugan Rep. Mike Defensor said each beneficiary would get a minimum of three capsules/tablet free of charge.
The Ivermectin Pan-Three will be formally launched on Thursday at the Matandang Balara Hall Park.
“From the experts’ collective testimony, Ivermectin had been widely used to treat a variety of human parasites since its introduction in 1981 and since then, is being taken along with Vitamins C and D, melatonin, zinc, among others, including steroids for the elderly and asthmatic patients,” the lawmakers said in a joint statement.
Log in to reply.