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Trump and Navarro press again for hydroxychloroquine. Can the FDA stay independent?

Trump and Navarro press again for hydroxychloroquine. Can the FDA stay independent?

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Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

Taking to Twitter, the President was more explicit. “Act Now,” he wrote, tagging the FDA’s official handle.

The administration’s renewed push for the unproven and potentially dangerous drug sets up a pivotal test for the agency: Just how independent is it? The FDA’s reputation as an apolitical scientific and medical regulator had long been stalwart, but its conduct during the pandemic – most notably authorizing hydroxychloroquine in March despite scant evidence, but also in failing to regulate the first wave of antibody tests – has led prominent researchers to wonder how much it is subject to the whims of the Trump administration.

Luciana Borio

“In this context, the recent issuance of the chloroquine/hydroxychloroquine EUA, in the midst of political pressure and with scant and conflicting supporting evidence, should be of serious concern,” former FDA chief scientists Luciana Borio and Jesse Goodman wrote in JAMA in April. “When EUA status is sought or granted seemingly under pressure, it may also open a floodgate of efforts to promote unfounded use of other unproven treatments, risking a perception that special interests can influence FDA decisions.”

Two months later, when the FDA retracted that authorization in the face of new evidence that showed the drug in effective, including the first randomized controlled studies testing hydroxychloroquine in Covid-19, Harvard public health researcher Ashish Jha reflected on the agency’s pandemic conduct with the Washington Post: “Until six months ago, I never worried that the FDA decision-making was being driven primarily by political considerations, even when I disagreed with some of that.”

More recently the concerns have shifted over to vaccines. Those authorizations and the White House’s lobbying have led public health and vaccine researchers to wonder whether Trump might pressure the agency into approving a vaccine before it’s been fully tested, to boost his chances of re-election.

“Given how this president has behaved, this incredibly dangerous scenario is not far-fetched,” rotavirus vaccine inventor Paul Offit and University of Pennsylvania professor of medical ethics Ezekiel Emmanuel wrote in a New York Times op-ed in June. “In a desperate search for a political boost, he could release a coronavirus vaccine before it had been thoroughly tested and shown to be safe and effective.”

Paul Offit

FDA commissioner Stephen Hahn, for his part, has tried to dispel the concerns, repeatedly insisting that politics have not and will not be involved in any decision. Last week, in advance of a congressional hearing on Operation Warp Speed and amid concerns that politics could sway a decision on whether to sanction a vaccine candidate, the FDA announced that any candidate would need to be at least 50% better than placebo to be cleared.

The new comments from Trump and Navarro represent the first major White House attempt to promote hydroxychloroquine since the FDA rolled back its authorization. That kind of meddling can thwart any public health effort, said former FDA associate commissioner Peter Pitts.

”When politics get enmeshed in public health, whether it’s Democrats or Republicans, it’s a plague on both their houses,” Pitts told Endpoints News. 

Peter Pitts

He added that there was no legitimate reason for doctors to even want an emergency use authorization, as the drug is already approved for malaria and they can prescribe it off-label (as many do for lupus or rheumatoid arthritis). “The only reason I would see that any doctor or health system would want an EUA, is to cover its behind on medical liability,” he said. “And I don’t think that’s a proper use of FDA authority.”

At issue is a new study from Henry Ford Health Systems, published in the International Journal of Infectious Disease, that looked at 2,500 patients with Covid-19 and found that those who received hydroxychloroquine had a 50% lower mortality rate than those who didn’t. Navarro, who does not have medical experience, called the results “astonishing.” But researchers say that the picture is more complicated and that the study leaves a lot of questions unanswered.

When the FDA issued the emergency use authorization, only anecdotal reports and small retrospective studies were available evaluating the effects of hydroxychloroquine in Covid-19 patients. But since then, two randomized controlled trials – the gold standard for medical research – have come out, one showing the drug is ineffective in preventing people recently exposed to the virus from getting infected and the other one showing it’s ineffective in hospitalized patients. An NIH trial in hospitalized patients was also halted after a review board found the drug wasn’t harmful but had no benefit.

By contrast, the new study was retrospective and non-randomized. It was unclear why patients were selected for different treatments, outside scientists said; the group given hydroxychloroquine were twice as likely to receive dexamethasone, a steroid that has already been shown to improve survival on its own; the control group had an unusually high mortality compared to the control groups from other major studies; and, though the doctors said they treated patients “early” in the course of disease, they didn’t present data proving that fact.

Borio, the former FDA chief scientist, called it “in short, a really bad study,” one that couldn’t be the basis for an FDA OK.

”Given how it was designed and conducted, it’s obviously not an interpretable or reliable study,” she said in an email to Endpoints.  “Scientific review staff at the FDA has expertise in these matters and would not recommend the issuance of another EUA on the basis of what was presented in the publication.”

David Boulware

David Boulware, the University of Minnesota infectious disease researcher who led the trial testing hydroxychloroquine in newly exposed people, said the new study was “interesting” but outlined a long series of questions and idiosyncrasies he noted about how it was done.

“It raises more questions than answers,” he told Endpoints in an email.

Navarro did call for a randomized controlled study to confirm the findings, but several have already been conducted and many have been launched since the game. A recent analysis from STAT and AppliedXL found that 1 in every 6 Covid-19 treatment studies were for hydroxychloroquine – a proportion that may have sapped patients and resources that could have gone toward testing other antiviral drugs, such as favipiravir. It’s “excessive,” Susan Desmond-Hellmann, former CEO of the Bill and Melinda Gates Foundation and longtime Genentech executive, told the news site.

Navarro, though, argued that the drug had not been given a fair shake by journalists and some doctors who “made this a battle between President Trump and them” and created “fear and hysteria.”

”All I’m saying is give hydroxychloroquine a chance,” he said. “And please don’t contribute to hydroxy hysteria.”

For a look at all Endpoints News coronavirus stories, check out our special news channel.

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Economics

Five things you can do to help you have a more positive birth experience

Becoming a parent can be nerve-wracking – but there are many things you can do to feel more in control.

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Don't be afraid to make your preferences clear to your care provider. Syda Productions/ Shutterstock

Whether you’re a first time parent or have had children before, you’re probably willing to try anything to ensure you have the most positive birth experience you can. After all, the kind of birth experience you have can not only affect your own mental health, but can have an affect on parent-child bonding, as well as partner-to-partner relationships for years after giving birth.

It can be confusing to know what to expect or where to turn to for advice, especially as maternity services have changed due to falling staff numbers and the continued impact of COVID-19. But here are a few things you can do yourself as you navigate your maternity care, which may help you have a more positive birth experience:

1. Get educated

Studies have shown that signing up for antenatal classes can help reduce fear, depression and anxiety – both during pregnancy and after birth.

Typically, antenatal classes will help you understand what’s happening to your body during pregnancy and explain the birth process. They may also teach you coping strategies to help relax during labour, alongside guidance on caring for your new baby. Antenatal classes can also be a great way of meeting other parents going through the same thing as you.

Another option is creating a personalised care and support plan, which is offered by most NHS trusts in the UK. This is a tool you can use with your care providers to explore what’s important to you – and discuss what your range of options are, such as your preferred place of birth, or whether you prefer skin-to-skin contact with your baby immediately after birth.

Understanding what your body’s going through, and making a personalised plan for your birth, may help you feel more prepared and less anxious about what to expect.

2. Know your carers

Being cared for by one nominated midwife, or being assigned to a team of familiar midwives, is shown to be associated with better outcomes for you and your baby – including decreased chance of having a premature labour and lower likelihood of needing interventions (such as birth with the help of forceps). You’re also more likely to be satisfied with your overall experience.

When an allocated midwife is not an option this makes choosing the right birth partners crucial. They can not only offer you reassurance, encouragement and support but can be your advocate, help you try different positions in labour and help provide you with snacks and drinks. Most typically these would be trusted loved ones. But be aware that research shows birth partners may also feel anxious or overwhelmed at taking on this role, and may struggle with seeing a loved one in pain – so it’s important to be realistic about your expectations, and choose the right person. It may be the best birth partner for you is a close friend or relative.

3. Challenge care recommendations if you aren’t happy

There are likely to be many other options available to you – such as where you might give birth, or how you want to be cared for during labour.

During antenatal appointments be sure to pause, think and ask about benefits, risks and alternatives to the care being proposed. Research shows how important choice and personalised care are for expectant parents who want their voices and preferences to be acknowledged, and to receive consistent advice.

Expectant couple speak with female doctor in doctor's office.
Bringing a loved one or partner with you can make it easier to voice any concerns you may have. wavebreakmedia/ Shutterstock

If you have concerns over a suggestion your care providers have made or have questions, don’t be afraid to ask. Take your birth partner with you if you prefer, who can empower you to ensure your voice is heard. After all, care providers are duty bound to ensure you make fully informed choices.

4. Don’t always listen to your friends and family

Once people hear you have a baby on the way it seems everyone feels the need, without asking, to tell you the full (and often graphic) details of their own children’s birth.

But it’s perfectly acceptable to politely change the subject if you don’t want to listen, or if hearing these stories makes you nervous or worry. It’s also worth remembering that each person has a different labour and birth, even with their own children – so what was true for someone else is likely not to be the same for you. While it can be helpful for some people to debrief after the birth, it’s okay to avoid hearing this yourself if it makes your nervous, and maybe suggest they speak with a professional about their experience instead of telling you.

5. Visit your preferred place of birth

Many maternity units are now opening up their doors again to tours and informal visits – and those that aren’t are doing this virtually.

Becoming familiar with where you might give birth – even down to where you might park on the day – can help you feel more confident about giving birth. It may also remove some of the unknown, helping you regain a sense of control – which in itself is linked to a more positive birth experience.

For those planning a homebirth, speak to your midwife about how you can improve your space to facilitate the most safe and positive experience. For one of the most important days of your life, visualising where this will take place ahead of time can help you feel more confident and in control.

Ultimately, it’s important to remember that no one can predict exactly how your labour and birth journey will go. Even after heeding the above steps – there’s always a chance you may need to consider a plan B, C or even D. But no matter what, remember you’ve done your very best, and you’re not likely to repeat this exact experience the next time.

Claire Parker does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Economics

Is it safe to buy WTI crude oil after bouncing from horizontal support?

A lot has happened in the energy markets in 2022, especially in the oil markets. WTI crude oil price surged to $130 in the second quarter of the year,…

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A lot has happened in the energy markets in 2022, especially in the oil markets. WTI crude oil price surged to $130 in the second quarter of the year, after only in 2020 it had traded in negative territory.

Futures contracts settle daily, and back in 2020, during the COVID-19 pandemic, when demand for oil declined sharply, clearinghouses let the futures contracts settle below zero for the first time ever.

Since then, however, the market has bounced dramatically. Few traders have bet on energy prices, especially because in the last years, the rise of the ESG meant many investments fleeing the energy field.

But supply chain issues, monetary and fiscal stimulus during the pandemic, and the Russian invasion of Ukraine are major drivers in the energy space. After reaching $130/barrel, the WTI crude oil price has corrected but found strong support at the $100/barrel area.

The recent bounce in the last few days came from Macron’s comments during the G7 meeting. He said that the United Arab Emirates does not have spare capacity to produce more oil, something confirmed yesterday by the UAE authorities.

UAE is producing at maximum capacity based on its OPEC+ agreements. Therefore, the price of oil should remain bid on every dip.

A triangular pattern forms on the daily chart

The technical picture looks bullish while the price remains above horizontal support seen at the $100/barrel. Moreover, a confluence area given by both horizontal and dynamic support made it difficult for the market to extend its decline.

As such, a triangular pattern suggests more upside in the price of oil. A triangle may act as both a continuation and a reversal pattern, and traders focus on a breakout above or below the upper or the lower trendline.

Furthermore, every attempt to the downside since last March was met with more buying. Therefore, it is hard to argue with the bullish case, especially since the series or higher lows remains intact.

All in all, the WTI crude oil price remains bullish, and the triangular pattern may break either way. However, as long as the $100 level holds, the bias is to the upside.

The post Is it safe to buy WTI crude oil after bouncing from horizontal support? appeared first on Invezz.

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Spread & Containment

FTSE 100 gains as commodity-linked stocks bounce back

The commodity-heavy FTSE 100 gained 0.4%, while mid-cap FTSE 250 index inched up 0.3% UK’s FTSE 100 gained on Monday, as an easing of COVID-19 restrictions…

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The commodity-heavy FTSE 100 gained 0.4%, while mid-cap FTSE 250 index inched up 0.3%

UK’s FTSE 100 gained on Monday, as an easing of COVID-19 restrictions in China brought relief to commodity prices, lifting shares of major oil and mining companies.

As of 0704 GMT, the commodity-heavy FTSE 100 gained 0.4%, while mid-cap FTSE 250 index inched up 0.3%.

The risk sentiment improved after a Wall Street rally late last week and a rebound in copper and iron ore prices on Monday, boosted by an easing COVID-19 restrictions in Shanghai and relaxed testing mandates in several Chinese cities.

The burst of global enthusiasm for equities has put a spring in the step of the FTSE 100 at the start of the week, Hargreaves Lansdown analyst Susannah Streeter said.

Mining stocks led gains on the FTSE 100 index, with Anglo American, Rio Tinto and Glencore rising more than 3%, after Group of Seven leaders pledged to raise $600 billion private and public funds in five years to finance needed infrastructure in developing countries.

It is hoped this scheme, seen as a counter to China’s Belt and Road Initiative, will set off a spurt of spending and demand for commodities around the world, Streeter added.

Among individual stocks, CareTech surged 20.8% after the UK-based provider of care and residential services agreed to be acquired by a consortium led by Sheikh Hoidings in an 870.3 million pounds ($1.07 billion) deal.

Carnival Corp jumped 5.6%, extending its Friday gains after the leisure travel company forecast a positive core profit for the current quarter despite surging costs.

London-listed shares of Rio Tinto added 2% after a U.S appeals court ruled that the federal government may give the UK copper miner a right to lands in Arizona.

BAE Systems inched up 0.4% after the defence company received a $12 billion contract from the U.S Department of Defence.

The post FTSE 100 gains as commodity-linked stocks bounce back first appeared on Trading and Investment News.

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