Monday, July 20, 2020

take drug testing out of the hands of manufacturers.

Corruption and the pharmaceutical industry

In their new book, child psychiatrist Jon Jureidini and philosopher Leemon McHenry dispute the assumption that all approved drugs and medical devices are safe and effective. They warn that when clinical science is hitched to the pharmaceutical industry’s dash for profits, the scientific method is undermined by marketing spin and cherry-picked data. Their proposed solution is inspired by philosopher of science Karl Popper: take drug testing out of the hands of manufacturers.
Nature | 6 min read

Notable quotable

“They literally gained nothing… it’s a self-inflicted wound, and they have no economic gains.”
Economic researcher Jacob Kirkegaard responds to numbers showing that Sweden’s light-touch lockdown approach to the pandemic has cost many lives without protecting its economy. (The New York Times | 9 min read)



Friday, July 3, 2020

Pharmas make billions on people's sufferings


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World

Coronavirus: Wealthy nations compete for remdesivir supplies

The world's wealthiest countries are competing for remdesivir, despite assurances that they would work together to develop drugs that treat COVID-19. Pharmaceuticals giant Gilead Sciences is in an enviable position.
Zolgensma, a gene therapy medicine for treating spinal muscular atrophy in children under the age of two, is now available in Germany. However, a single treatment of the drug, which is produced by Swiss pharmaceuticals company Novartis, comes at the steep price of €1.9 million ($2.1 million).
The manufacturer argues that this is a reasonable price considering that without it, it costs between €2.5 and 4 million to treat the degenerative disease over a lifetime.
Gilead Sciences, which has developed remdesivir, takes a similar line of argument, saying that the drug, which is viewed as a promising tool in the fight against COVID-19, could save costs in the long run.
In an open letter earlier this week, Daniel O'Day, chairman and CEO of Gilead Sciences, wrote: "Taking the example of the United States, earlier hospital discharge would result in hospital savings of approximately $12,000 per patient. Even just considering these immediate savings to the healthcare system alone, we can see the potential value that remdesivir provides."
"We have decided to price remdesivir well below this value," he continued. "To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient."
Read more: Remdesivir is no miracle cure
A box and vials of Zolgensma (picture-alliance/AP Photo/Novartis) A single treatment of Zolgensma, produced by Swiss pharmaceuticals firm Novartis, costs €1.9 million
What is fair drug pricing?
The editor of the German specialist magazine Arznei-Telegramm, Wolfgang Becker-Brüser, is not convinced. He told DW that the costs of treating COVID-19 without remdesivir had been calculated at random.
"There is an attempt to give the impression that the price is fair," he said. "However, if there wasn't a pandemic and so much public attention they might have set the price much higher."
The Association of Research-Based Pharmaceutical Companies (vfa) refused to comment. "The vfa does not comment on the pricing schemes of individual companies," it said in a statement to DW.
But in the past, the vfa has called on the pharmaceuticals sector to show responsibility with regard to consumers and demanded that affordable medicine and vaccines be made available.
An analysis by British researchers cited in the Germany weekly Der Spiegel came to the conclusion that it probably cost about €8 to produce one dose of remdesivir.
However, it is normal for the sale price to be much higher than the production price, considering companies invest huge sums into development.
Read more: How lab animals have fared in the coronavirus crisis
Graphic: Drug life cycle
Gilead Sciences claims that it invested about $1 billion into remdesivir. This is actually at the lower end of the vfa's scale for developing a new drug. The association told DW that companies tended to invest $1 to 1.6 billion in a new product.
For Wolfgang Becker-Brüser, this is "fantasy."
"If the development costs are calculated to be so high then it is easy to demand higher prices," he told DW.
For Alexander Nuyken, a pharmaceuticals expert at the consulting firm EY, there is a reason that development costs are so high: they encompass the risk of failure. "It has to be possible to add a premium for the risks incurred from the development of a drug to its approval," he said.
Watch video 03:16

What is Remdesivir?

Becker-Brüser said that in general drugs were becoming more expensive. "The number of prescriptions for new patented drugs is the same but their price is going up," he said. This was already the case before the COVID-19 pandemic, as indicated by a report by the German health insurance company AOK from last year, according to which insurance companies are paying an increasingly high proportion of their medicine budget on particularly expensive drugs. Drugs as pricey as Zolgensma are only the tip of the iceberg.
Read more: Is the US-China rivalry tangling a coronavirus vaccine with geopolitics?
With regard to remdesivir, however, there had been some expectation that the cost per course of treatment would actually be higher. The Institute for Clinical and Economic Review, a US-based nonprofit organization that analyzes drug prices, had suggested that a reasonable price would be $2,800, while others had recommended $4,000.
But considering that remdesivir is practically a waste product, which Gilead Sciences originally developed to treat Ebola, without major success, Becker-Brüser presumes that the company opted for a compromise in view of the public pressure.
It could turn out to be a win-win situation for the company. Its share price rose when the price of remdesivir was announced earlier this week and orders have gone through the roof.
Gilead Sciences building (picture-alliance/AP Photo/E. Risberg) After being ineffective against Ebola, Gilead Sciences drug remdesivir is getting a second chance against COVID-19
Global competition
According to media reports, the US has already secured the entire stock of projected production for July and 90% for August.
Germany, too, has apparently secured supplies. Health Minister Jens Spahn has been applying pressure. He said that he expected "Germany and Europe to have access to supplies to such a drug." The British government has also said that it has enough reserves.
So far, remdesivir has not been fully approved in any country and there has not been enough research into how effective it really is against the novel coronavirus. But apart from Dexamethason, it is the drug that seems to have the most potential for treating patients with SARS-CoV-2 and limiting the disease's course.
Read more: Is dexamethasone the game changer in COVID-19 treatment?
Alexander Nuyken said that it was not surprising that the world's wealthy nations were all eager to get hold of supplies. "That's why it is particularly important that we find common solutions in international alliances."
There are already several international forums in which this is being attempted and a European vaccine alliance has been formed with the WHO.
However, the problem, as with the global fight against the climate emergency, is that if the US does not play by the same rules, the attempts of other states will be curbed.
Those who benefit, said Becker-Brüser, are the pharmaceuticals giants, "which are in a position to aim higher."
It will soon become clear how high Gilead Sciences is prepared to go. Right now, the European Union is negotiating with the US company and trying to ensure that all 27 states have supplies in the coming months.


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Wednesday, July 1, 2020

Nature Briefing


‘It’s frightening’: Doctors say half of ‘cured’ COVID patients still suffer

Freak pains and half-broken lungs persist months later

‘It’s frightening’: Doctors say half of ‘cured’ COVID patients still suffer

Bnei Brak woman tells The Times of Israel that a month after testing negative she has severe fatigue and anxiety – and her husband is worse than he was when hospitalized

A medical team at the coronavirus unit, in the Ichilov hospital, Tel Aviv, Israel, May 4, 2020. (Yossi Aloni/Flash90)
A medical team at the coronavirus unit, in the Ichilov hospital, Tel Aviv, Israel, May 4, 2020. (Yossi Aloni/Flash90)
Recovered COVID patients are baffling doctors with complaints of freak pains, lungs that just won’t get back to normal, and a range of incapacitating psychological issues.
“What we are seeing is very frightening,” Prof. Gabriel Izbicki of Jerusalem’s Shaare Zedek Medical Center told The Times of Israel. “More than half the patients, weeks after testing negative, are still symptomatic.”
Izbicki is working on a study that involves follow-up with patients who were in hospitals or coronavirus hotels, looking at the aftereffects of the virus and trying to understand why patients continue to suffer long after being confirmed negative. “There is very little research about the mid-term affect of coronavirus,” he said, adding that it is much needed to guide doctors.
In Bnei Brak, at Israel’s first community clinic, doctors have been seeing a spike in recent days in the patients with pains that appear to come from nowhere.
“It can appear in the arms, legs, or other places where the virus doesn’t have a direct impact, and if you ask about the pain level on a 1 to 10 scale, can be 10, with people saying they can’t get to sleep,” said Eran Schenker, director of the month-old clinic in Bnei Brak run by Maccabi Healthcare Services. “It’s something which we’re starting to see much more in the last week.”
Man coughing (iStock)

‘Broken’ by the virus

A patient from the clinic spoke to The Times of Israel on condition that her name is not published. She was diagnosed in March and tested negative a month ago. But the woman, a Bnei Brak resident in her 40s, still has severe fatigue and anxiety, and can only walk for a few minutes at a time.
Her husband, who also caught coronavirus in March and tested negative last month, now “feels like he’s broken,” she said. “He’s actually worse than he was when he was hospitalized.”
Her husband, 55, had some health problems before contracting coronavirus in March, but was active “from morning until night,” with plenty of energy. He is now extremely lethargic, can hardly walk, and has heart problems, she said.
This came as a particular shock to the family, as during his initial hospitalization in March and early April he did not require oxygen and X-rays showed no damage to his lungs. He was hospitalized again during April with pneumonia-like symptoms, and declared negative in May. But the man then developed pains and significant breathing problems, and has seen cardiologists, neurology experts, rehabilitation teams, and other professionals at the clinic.
This man was “one of the hard cases, but he’s not the worst and we have patients who suffer more,” according to Schenker.
He said that with all illnesses patients can be left reeling from long hospitalizations, and ventilators use can slow full recuperation — but COVID-19 is causing patterns that are not usually seen.
“We’re amazed that people aren’t just suffering from the things we expected, but things we just weren’t aware would have relevance,” he told The Times of Israel. “It’s not textbook.”
He stressed that his patients are not all newly recovered. “Some of them had coronavirus in March, so they may have been recovered for months,” he said.
Gabriel Izbicki, head of the Pulmonary Institute at Jerusalem’s Shaare Zedek Medical Center (Shaare Zedek Medical Center)
Izbicki, director of Shaare Zedek’s Pulmonary Institute, also emphasized that many of his patients have long been declared coronavirus-free. One of the biggest surprises, he said, is that there is no predicting which patients will find the disease hard to shake, and which will not.
“There is no correlation between seriousness of disease during hospitalization and extent of symptoms afterwards,” he said, discussing preliminary results from his study on recovered patients who were treated in hospitals and coronavirus hotels.
“Within the symptoms that we checked for, we revealed general weakness among the majority of patients alongside shortness of breath, sustained cough, and other complex breathing and pulmonary issues,” he said, adding that he is also familiar with the freak pains that Schenker discussed.
These pains — seen in young patients and old alike — have doctors scratching their heads. Schenker said: “Painkillers block the pain but don’t relieve the source, but we don’t know how to address the source and you can’t be on painkillers the rest of your life.”
While the pains are excruciating for some, others describe the pains more as a major discomfort: burning sensations, tingling, or just a hard-to-place sense that a limb does not feel normal.
The patients with these pains do not normally raise red flags during the main medical examinations. Schenker said: “We check their lung and hearts and they have no disease, and they have no neurological issues. We do scans and can’t see anything, but they have this pain — we’re told about it again and again.”
Dan Oyero, deputy director of medicine in central Israel for Maccabi Healthcare Services (courtesy of Maccabi Healthcare Services)
Dan Oyero, Maccabi’s deputy director of medicine in central Israel, said that the overarching issue doctors are dealing with is the far-reaching change in people’s lives, for which doctors cannot predict an end point.
“The most distressing thing is that people compare how they feel now compared to how they were a few weeks ago before they were infected,” he said. “And they say they just can’t do the things they used to do.”
The sense of taste and smell, lost during the illness, sometimes does not return. When patients ask if it will come back, given that doctors have such limited experience of the disease, they cannot give a clear answer. “We just don’t know,” said Oyero.
When doctors can invoke a precedent from other illnesses, it can be bad news.
Elderly patients who were badly stricken by the coronavirus, even if they had no previous respiratory issues, can find their lungs working at half capacity, long after testing negative, said Schenker.
Eran Schenker, director of the clinic for recovered COVID patients in Bnei Brak run by Maccabi Healthcare Services (courtesy of Maccabi Healthcare Services)
“They have two lungs, but they are the equivalent of one, because each lung is working at 50% — and it could be like this for the rest of their lives,” he said. He draws this conclusion from the pattern of lung damage that is seen from some other diseases — but normally only affecting patients who had previous lung complications.
“The damage was not done by the virus, but by an inflammation process which, we know from other diseases, will not leave lungs with the capacity to exchange oxygen as before,” Schenker commented.
Izbicki said that in his experience, COVID-related lung damage can affect patients of all ages, and said he shares the concern that people will not regain full lung performance. “We don’t know if the lung function tests will become normal,” he said.
Some patients require physical therapy. Schenker said: “We’ve seen cases of weight loss that have been so extreme that people find it hard to walk.” Meanwhile, some who are physically able to move around just don’t have the energy or motivation to do so.
A recovered coronavirus patient sees a cardiologist at the special clinic in Bnei Brak run by Maccabi Healthcare Services (courtesy of Maccabi Healthcare Services)
Some of these patients are young and normally energetic, Schenker said.
“It’s amazing how many people went back to work — they can be educators, lawyers and in other professions — but when they sit for an hour they feel anxiety, feel insecure, and sometimes the people suffer from depression beyond what we expected.”
Oyero said:“The main complaints are actually fatigue, compacts [intense periods] of low energy — nothing we can give a name to. Many people say that they don’t have the energy they had before. They are more tired. Some say they don’t have the drive to do things. We can’t give the complaints a name or tell them they have a particular syndrome, but we’re trying to help them.”