Can COVID Patients Get Trump’s Treatment?

When Terry Mutter woke up with a headache and sore muscles, the amateur powerlifter attributed it to hard training.

However, that Wednesday night he had a fever of 101 degrees and was clearly ill. “It felt like I had been hit by a truck,” remembers Mutter, who lives near Seattle.

The next day he was diagnosed with COVID-19. On Saturday, the 58-year-old was enrolled in a clinical trial for the same antibody cocktail that President Donald Trump claimed had “cured” him of the coronavirus.

“I had heard it on the news,” said Mutter, who joined the Regeneron lab trial to test whether their combination of two artificial antibodies can neutralize the deadly virus.

Mutter learned about the study from his sister-in-law, who works at the Fred Hutchinson Cancer Research Center in Seattle, one of many trial sites across the country. He is one of hundreds of thousands of Americans, including the president, who took risks with experimental therapies to treat or prevent COVID-19.

But with nearly 8 million people infected and more than 217,000 deaths from COVID-19 in the country, many patients are unaware of these options or cannot access them. Others are wary of unproven treatments.

“I honestly think I would never have gotten a call if I hadn’t met someone who would tell me about the trial,” said Mutter, a retired Boeing executive.

CLINICAL STUDIES

The Clinicaltrials.gov website records more than 3,600 studies involving COVID-19 or SARS-CoV-2, the virus that causes the disease.

More than 430,000 people have volunteered through the COVID-19 Prevention Network. Thousands more have received therapies, such as the antiviral drug remdesivir, which has an emergency federal clearance.

Faced with a serious diagnosis of COVID-19, how do patients or their families know if they can, or should, aggressively seek these treatments? On the contrary, how can they decide whether or not to reject them if they are offered them?

Such medical decisions are never easy, and they are even more difficult during a pandemic, said Annette Totten, associate professor of medical informatics and clinical epidemiology at Oregon Health and Sciences University.

“The challenge is that the evidence is not good because everything with COVID is new,” said Totten, who specializes in medical decision making.

Consumers are understandably affected by conflicting information about possible treatments for LA COVID-19 from political leaders, including Trump, and the scientific community.

QUESTIONABLE TREATMENTS

The drug hydroxychloroquine, touted by the president, received an emergency clearance from the Food and Drug Administration (FDA), only for the decision to be reversed several weeks later for fear that it would cause harm.

Convalescent plasma, which uses blood products from people recovered from COVID-19 to treat those who are still ill, was administered to more than 100,000 patients in an expanded access program and made available to all through another emergency authorization. , although scientists are not sure of its benefits.

Regeneron and the pharmaceutical company Eli Lilly have applied for emergency use authorization for their monoclonal antibody therapies, even as scientists say this could jeopardize enrollment in trials that will test whether or how well they work.

So far, about 2,500 people have signed up for Regeneron’s trials, and of those, about 2,000 are receiving the therapy, a company spokesperson said. Others have received the treatment through so-called compassionate use programs, although the company did not say how many.

The week of October 12, the National Institutes of Health halted Lilly’s antibody test after an independent monitoring board raised safety concerns.

“With all the information circulating in the media, it is difficult for patients to make good decisions, and for doctors to make those decisions,” said Dr. Benjamin Rome, internist and health policy researcher at the Portal de la Escuela de Harvard Medicine.

ASK, ASK

Still, people facing COVID-19 shouldn’t be afraid to ask if they have available treatment options, Rome added. “As a doctor, I don’t care when patients ask,” he said.

Patients and families need to understand what the implications of those treatments might be, Totten advised. The first phase 1 clinical trials focus primarily on safety, while the larger phase 2 and phase 3 trials determine efficacy. Any experimental treatment raises the possibility of serious side effects.

Ideally, health care providers would provide the information on treatments and risks without prior notice. But during a pandemic, and especially in a high-stress environment, they may not, Totten observed.

“It is important to be insistent,” he said. “And ask again. Sometimes you have to be willing to be a little aggressive, ”he suggested.

Patients and families should take notes or record conversations for later review. They should ask about financial compensation for participating. Many patients in COVID-19 trials are paid modest amounts for their time and travel.

And they should think about how any treatment fits into their broader system of values ​​and goals, said Angie Fagerlin, a professor and chair of the department of population health sciences at the University of Utah.

THE ADVANCE OF SCIENCE

“What are the pros and cons?” Fagerlin wondered. One consideration may be the benefit to society at large, not just the patient, he said.

For Mutter, helping advance science was a big reason why he agreed to enroll in Regeneron’s essay.

“I was interested in advancing therapy, they need people,” he said. “At a time when there are so many things that we cannot control, this would be a way to find some kind of solution.”

This is what prompted Fred Hutch, who is participating in two Regeneron trials, one for the prevention of COVID-19 and one for the treatment of the disease.

“It was a six-hour visit,” he said. “It is two hours to receive the infusion. It’s a very slow IV drip. “

Mutter was the second person enrolled in Fred Hutch’s trial, said Dr. Shelly Karuna, co-principal investigator. The study is testing high and low doses of the monoclonal antibody cocktail against a placebo.

“I am struck by the profound altruism of the people we are evaluating,” he said.

Mutter is not sure how he contracted COVID-19. He and his family have been wary of masks and social distancing, and have criticized others for not.

“The irony now is that we were the ones who got sick,” said Mutter, whose wife, Gina Mutter, 54, also has COVID-19.

Mutter knows he has a 1 in 3 chance of receiving a placebo instead of one of two doses of active treatment, but he said he was willing to take that risk. His wife, also infected, did not sign up.

“I said, there are some risks involved. One of us can take the risk, not both of us, ”he said.

So far, Mutter has battled a persistent cough and fatigue. You can’t tell if your infusion has been helpful.

“There is just no way to know if I have the antibodies or not,” he said. “Did I get them and did that keep me out of the mess? Or did I have the placebo and my own immune system did its job?”

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Well-being in body and soul

According to an investigation by the University of the Basque Country (Spain) on the effects of the pandemic, now there is greater uncertainty and concern about suffering from Covid-19 or losing loved ones; a decrease in confidence and optimism, especially in women and in people in poor employment situations; and an increase in irritability, again with a greater impact on women and the unemployed.

If we do not act now, in concert with research with vaccines and treatments, the post-pandemic outlook will be bleak for the mental health of millions of people.

And taking action, obviously, is not prescribing more antidepressants or anxiolytics, or building more psychiatric hospitals. Both actions are necessary to address some consequences; however, the idea is to be proactive and avoid them.

In response to the feeling of anxiety, according to the consulting firm Llorente y Cuenca (LLYC), there has been a rapid and broad change that goes from the “concept of wellness [bienestar], centered on the individual, al by wellbeing [bienestar integral], a more holistic vision that includes different people and sectors of our societies ”.

What does this mean? A call for the participation of the whole society in the benefits of well-being.

Wellbeing is defined as the state of satisfaction and tranquility that a person presents, thanks to their good physical and mental conditions.

“If societies and companies are unable to focus holistically on people’s well-being (including physical, emotional and spiritual health), it will be almost impossible to create safety nets that allow citizens to return to work and be productive ”, They explain from LLYC.

For this reason, I have always opted for wellness programs in all their aspects: emotional, physical, social and financial. This is what happens every November in the event “In Body and Soul”, which this year will be held in an online version, with more universal access, more experts and with the empowering and transforming energy of always.

To keep your balance in difficult times, “you have to grab the bull by the horns” and get going, as a popular saying reflects.

According to the World Health Organization (WHO), the pandemic has disrupted or paralyzed mental health services in 93% of countries. And if, as the WHO itself says, mental health is related to the promotion of well-being, the prevention of mental disorders and treatment, then let’s look for our own tools. Healthy living is much more than curing or protecting yourself from disease.

@cala

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Is it true that many antidepressants have negative effects on sex life?

To combat depression I have been prescribed a drug that reduces serotonin reuptake, but I read that these drugs can negatively affect libido. I’m only 38 years old and have a satisfying love and sex life, I wouldn’t want to give it up. And I really don’t think that if it were to happen my mood would benefit. What can you tell me about it?

Claudio Mencacci, Director of the Department, Mental Health Asst Fatebenefratelli Sacco, Milan, answers.

Last year, the conclusion of a thorough review of the scientific literature was released that officially recognized the existence of a new condition produced by treatment with SSRi (selective serotonin reuptake inhibitors) and SNRI (serotonin reuptake inhibitors) antidepressants. of norepinephrine) called Post SSRi / SNRI Sexual Dysfunction.

Notice on leaflets

In recent months, an alert has been included in the information leaflets of antidepressant drugs with the signaling of the possible appearance of a long-lasting sexual dysfunction, which persists even after the suspension of therapy. It was already known that the most common long-term side effect deriving from the use of these drugs concerned the sexual sphere as the inhibition of the reuptake (reuptake) of serotonin at the hypothalamic level first of all determines the difficulty in achieving pleasure, but also the reduction of desire.

Men and women: different difficulties

It is important to underline the diversity between men and women: in men there is mainly a reduction in desire and delay in ejaculation, in women a reduction in arousal state. The problem is more severe in women, but tends to be slightly more frequent in men. The syndrome typically manifests with hypoanesthesia in the genital area, erectile dysfunction, anhedonia (inability to feel pleasure), anorgasmia and loss of libido, debilitating and still underdiagnosed conditions.

Not only transitory effects

The undesirable effects of antidepressants have been known for some time and are usually transient, that is, they occur only during treatment and are dose sensitive. In the past he thought that very frequently they ceased at the end of the path, but today they are clearer cases of persistence even after discontinuation of therapy. As a consequence of all this, emotional relationships can be compromised and relationships and marriages can break up.

The alternative

Nnot all antidepressants have for these effects on the sexual sphere, in particular vortioxetine, but also bupropion, trazodone, agomelatine have minor effects on both male and female sexuality. There is also evidence of a consolidated efficacy of phosphodiesterase inhibitors (sildenafil) on various aspects of antidepressant-induced sexual dysfunction, except on decreased desire. After the use of drugs to limit the side effects on the sexual sphere, we can think of saffron, the natural remedy with greater evidence of efficacy together with treatments with nutraceuticals based on L-citrulline.

Confounding factors

IThe problem has remained hidden until today because depression itself is a confounding factor with regards to health and sex life. Patients who for some time complained of this type of disorders and decided to stop treatment early have probably not been listened to sufficiently. Stopping your depression treatment means you risk a relapse.

September 27, 2020 (change September 28, 2020 | 14:22)

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There is still no consensus on its effectiveness against COVID-19

(Cnn in Spanish) – Members of the US National Institutes of Health COVID-19 Treatment Guidelines Panel say that there is currently not enough information on convalescent plasma to recommend for or against the treatment.

“Taking everything into account, the Panel has determined that currently the data are insufficient to recommend for or against convalescent plasma for the treatment of COVID-19 “said an article published Friday in the Annals of Internal Medicine.

Some background information on convalescent plasma

The US Food and Drug Administration. (FDA) authorized the emergency use of convalescent plasma for the treatment of COVID-19 in August. The FDA cited an analysis of an expanded access convalescent plasma program run by the Mayo Clinic to support the decision.

But the panel noted that the data from the expanded access program show that treatment can be effective, but are not sufficient to establish safety or efficacy, citing the lack of an untreated control group.

Read also: The powerful story of a Chilean nurse hospitalized for COVID-19 in Argentina: “I was drowning in life”

While randomized control trials for convalescent plasma began in the US this year, the panel said enrollment has been slow. They point out that the only time the treatment has been shown to be effective against an infectious disease, Argentine hemorrhagic fever, fIt was more than 40 years ago.

The panel requests further analysis of the expanded access program and the completion of the current randomized control trials.

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The first step towards personalized medicine

What does systemic medicine mean? Systemic medicine is the first step on the path to personalized medicine. Systems medicine is based on computer models, in which large amounts of clinical data are used to analyze the health of individual patients. Systemic medicine allows to deepen our understanding of disease mechanisms, to increase the effectiveness of treatments and to reduce the costs of health care.

There is no average patient

Ultimately, these trends towards a more personalized approach can radically change the interaction between patients, doctors and other healthcare professionals. There is no average patient, today people are living longer and there are more patients with three or more chronic diseases. In patients with more than one disease, treatment guidelines can even be contradictoryIndeed, the guidelines are often based on clinical trials of patients who are likely to be very different from the patients in the doctor’s office. No single patient ever exactly the same as the average patient for which guidelines have been written and that is why, drugs administered in the context of current treatment regimens rarely have 100% of the expected result. How do you do systemic medicine? With a multidisciplinary, data-driven approach. And the medicine becomes personalized.

* Member of Digital Health Working Group, European Public Health Alliance (WG-DH EPHA); CIRM medical director

21 September 2020 (modified on 21 September 2020 | 19:30)

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Putin shows his chest for his Covid vaccine and offers it free to the UN

The President of Russia, Vladimir Putin, He put his chest out before the UN on Tuesday for the rapid development in his country of a coronavirus vaccine and offered it free of charge to the organization to protect all its employees.

In his video message to the General Assembly, Putin He pointed out that his Government is ready to offer the United Nations all the necessary assistance, which includes free vaccination for all staff who want it.

He also said thatYour country is open to supply other nations with the so-called “Spútnik V”, which, as he highlighted, has been proven “safe” and “effective.”

Putin insisted that citizens around the world should have free access to a Covid-19 vaccine and He also underlined the Kremlin’s willingness to work with other governments to share diagnostic methods. and treatment of the disease.

In addition, in contrast to the United States, he defended that the World Health Organization (WHO) should have a central role in coordinating the response and said that Russia is working to strengthen the capacity of the Geneva-based entity.

On the other hand, Putin warned of the long-term economic effects that the current crisis will have and defended the need for the entire international community to work board to drive growth.

In this context, he stressed the importance of eliminating barriers, restrictions and, above all, “illegitimate sanctions” in international trade.

In the geopolitical and military sphere, the Russian leader He assured that he wants to cooperate with the United States to extend the strategic arms reduction treaty and hoped that there will be “restraint” when it comes to deploying new missile systems.

Too reiterated interest in a binding treaty to ban weapons in outer space and opted for more cooperation in cybersecurity.

Coinciding with the 75th anniversary of the United Nations, Putin defended the work of the organization and, although he recognized that it is necessary to adapt it to the reality of the 21st century, he made it clear that his country opposes major changes in the Security Council, where it is one of the five permanent members and has veto power.

According to him, for the Council to continue being the “pillar of global governance” it is essential that these five countries, nuclear powers and victors of World War II, retain the privilege of the veto.

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AIDS: The “cure” of an HIV-positive girl, inspires a curative treatment

DR.

AIDS: The “cure” of an HIV-positive girl, inspires a curative treatment

A 9-year-old child born with HIV was able to live without treatment for 8.5 years. This news raises a lot of hope in South Africa, this Monday, July 24, relayed the news site bbc.com

Our source explains that the doctors found this exceptional case because very often, “most of the people in the same situation as her, are obliged to undergo treatment every day to prevent the HIV from destroying their immune system and causing AIDS.”

Could the only shock treatment followed by the child after its birth have produced this result? For the time being, if “the doctors succeed in understanding the mechanism by which the girl is protected, they could come to develop a curative treatment or a vaccine against the HIV”, we also learned.

Isabelle Somian

isabelle.somian@fratmat.info

Source: bbc.com

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Peanut allergy. Treatment would reduce effects, study says

Pleasure of the aperitif for some or on the morning toast for others, peanuts represent a danger for those who are allergic to peanuts.

Hope is emerging for them thanks to a new study published by The Lancet Child & Adolescent Health. Scientists say they have found a way to reduce the effects of peanut allergy, reports the HuffPost.

The results come from a phase 3 clinical trial carried out in eighteen European hospitals. Scientists were looking to evaluate a desensitization strategy by exposure to increasing doses of allergens.

In conclusion, the allergic reaction was considerably reduced in those who received oral immunotherapy treatment.

58% of people desensitized

The nine-month-long study involved the participation of 175 minors, aged 4 to 17, who were allergic to peanuts.

Three-quarters of them (132 exactly) took a new treatment based on AR101, a molecule derived from peanuts. The doses were increasing during the first six months to reach a plateau of 300 mg thereafter. Placebo was given to the remaining quarter of the participants.

The results of the study highlighted the good assimilation of the treatment. 58% of the young people who benefited from it had no allergic reaction when consuming peanuts, which was also the case for 2% of those subjected to the placebo.

However, the researchers specify that this desensitization treatment is not curative. It only helps to reduce the effects of allergy.

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Even without standard treatment, the Covid-19 scares caregivers less and less

The destitution and uncertainty that were palpable a few months ago are no longer relevant. In hospitals that continue to receive severe cases of Covid-19 infection, caregivers seem to have put in place reflexes. ” “Much progress has been made,” assures Prof. Éric Maury, president of the French-language intensive care company (SRLF). “Survival has improved considerably in the United States, in all age groups,” said Daniel Griffin, head of infectious diseases at ProHEALTH, a group of a thousand doctors in 22 hospitals in the New York area. »Reports The voice of the North .

The local daily provides an overview of the treatments and drugs used by doctors. The combination of corticosteroids and anticoagulants is thus highlighted by several teams on the front lines. The first used to fight against inflammations which develop in severe cases when the second make it possible to fight against blood clots which are one of the serious complications observed.

As for hydroxychloroquine on which the debate is still not closed, the professionals interviewed by The voice of the North did not use it. But observe on the other hand that the recourse to intubations is less automatic than before: ” Beyond drugs, great progress has been made in the respiratory care of the most affected patients, who are in intensive care. “At the beginning, we intubated patients very quickly. Now we are doing everything to avoid intubation, ”summarizes Kiersten Henry, nurse at MedStar Hospital in Olney (Maryland). “We quickly realized that the patients who were placed on artificial respirators had very little chance of survival,” recalls Professor Griffin.. »

Read the full article of La Voix du Nord cited

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corticosteroids, “a treatment that will save lives”, according to a specialist


Health

Corticosteroids have effects on severe forms of Covid-19. The WHO states thatCorticosteroids save lives when used in patients on oxygen and on a ventilator. But they are not effective in patients with mild or moderate disease and can be harmful. Therefore, the WHO recommends the use of corticosteroids only in patients in severe or critical condition.

For Pr Djillali Annane, the proven effect of corticosteroids on severe forms of Covid-19 is “A spectacular turning point”, and this treatment “Will save lives” in poor countries as well as in rich countries.

Head of the intensive medicine-intensive care unit at Raymond Poincaré hospital in Garches (AP-HP), Prof. Annane is co-author of one of the 7 studies confirming the effectiveness of these drugs, published on September 2 in the American magazine Jama. It goes around the question in three points.

1.

Why is the proven effectiveness of corticosteroids for some patients important for the future?

“It is a spectacular turning point, in several ways. First,
it is the first treatment for which a very favorable effect on survival has been demonstrated, with very high certainty and several clinical trials conducted on five continents.

Secondly,
this treatment is not only beneficial in severe forms in intensive care, but also for patients who are on oxygen without being in a sufficiently serious condition to go to a sheave. Treatment can prevent their condition from getting worse and keep them from going.

Third, in published clinical trials, there is no reason to worry about complications.

The fourth element, and perhaps the best of the good news,
is that this treatment is not expensive.
It costs 10 to 40 euros to treat a patient and it is available all over the world, in the poorest countries as well as the richest. It is a treatment that will be able to save lives in Africa, Latin America as well as in New York, Paris or Tokyo. “

2.

How do these drugs work?

“Cortisone has been used by millions of people for 70 years. It is a drug that works to decrease inflammation from whatever source. There are millions of people with asthma and rheumatic fever around the world who take corticosteroids every day.

Corticosteroids do not act directly on the coronavirus: they will prevent the inflammation produced by the virus
, or if this inflammation has already occurred, will decrease its intensity and shorten its duration. But it is absolutely not a preventive treatment, we should not take it if we have no symptoms. “

3.

Dexamethasone has been mentioned a lot, but is it the only beneficial corticosteroid?

“No, it’s the class of corticosteroids that is interesting. Cortisone is a natural hormone that we all produce. Dexamethasone is a molecule made from this natural hormone. But there are other molecules: hydrocortisone, which is natural, methylprednisolone, betamethasone, etc.

This is important because the fact that there are several molecules will reduce the risk of a global shortage. If the effect only came from dexamethasone and not from the other corticosteroids, one might have feared that everyone would rush on it and that it would eventually run out. “

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