Posts Tagged ‘Pfizer’

FDA panel recommends approval of Pfizer vaccine, 17 to 4. But why did 4 oppose?

December 11, 2020

As expected, the FDA’s independent vaccine advisory committee recommended approval of the Pfizer vaccine yesterday, “17 to 4 in favor of recommending the drug for emergency use for people aged 16 years and older, with one of the members withholding”.

CBS News

A federal advisory panel on Thursday recommended the emergency use of Pfizer’s COVID-19 vaccine. The Food and Drug Administration is expected to approve the drug, kicking off a massive nationwide operation to get nearly 3 million doses of the vaccine to hospitals and drug stores across the country. The experts voted 17 to 4 in favor of recommending the drug for emergency use for people aged 16 years and older, with one of the members withholding. Health care workers and nursing home residents will be among the first to get the vaccine.  …….. Clinical trials showed the Pfizer vaccine was nearly 95% effective for adults 18 to 64 and was just as effective for people of all ethnicities. However, some groups — people with weak immune systems, individuals with severe allergic reactions, and pregnant women — could be restricted from getting the shot. However, British health officials on Wednesday warned that people with a history of “significant” allergic reactions to vaccines, medicine, or food should not be given Pfizer’s vaccine. Hahn said the FDA is working closely with its partners in the U.K. to understand what happened with the allergic reactions. “We study the data very carefully to say who should not receive the vaccine and these are the things the FDA does to ensure the safety and effectiveness” of the drug, Hahn said Thursday.

The advisory committee’s recommendation will probably lead to FDA approval by the weekend. The consensus is that the vaccine is safe and 95% effective. The Covid-19 pandemic is clearly out of control and there is a fear – quite justified – that without widespread acceptance of the vaccines the pandemic may continue unchecked. The Spanish flu pandemic (1918 – 21) lasted almost 3 years without any vaccine. Even with widespread and effective vaccination against Covid-19, this pandemic is set to last for at least two years until Spring 2022. Currently there is a widespread, global “information campaign” in favour of vaccination. Sometimes the simplistic and unnuanced messages are, I think, counter-productive. The WHO and UN information programs, in particular, talk down to the “great unwashed” and come close to being brainwashing attempts.

It can be expected that all members of an expert panel on vaccines will generally be in favour of vaccines. A key question then is why 4 of the expert panel did not recommend approval. In the current climate the dissenting expert views are of special importance. Unfortunately there is not much reporting of their views (with some exceptions).

The WSJ has some details:

Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine, said she dissented from the recommendation vote because there isn’t enough data justifying including 16 and 17 year olds in an emergency authorization. …. Oveta Fuller, a virologist at the University of Michigan Medical School, also dissented, saying in an interview that she would like to see at least two more months of data on trial participants that could help determine whether the vaccine reduces transmission.

The issue of using placebos in double-blinded trials for some patients and denying such patients vaccines came up (of effectively using humans as guinea-pigs). This is not really an ethical question at all, though the medical profession assuages its conscience by presenting it as such.

……. Doran Fink, deputy clinical director of the FDA’s division of vaccines, said further evaluation of the vaccine after its release will be necessary to see if its benefits continue to outweigh its risk, and whether any labeling changes will be required. Dr. Fink also addressed one major topic that has been in question—whether patients in the Pfizer trial who were randomly assigned to placebo should automatically be switched over and get the vaccine. FDA staffers told the committee they shouldn’t.

Steven Goodman, a Stanford University School of Medicine dean and epidemiologist, described that choice in testimony before the panel as an “ethical dilemma” in which both answers—getting vaccines to placebo patients and developing long-term safety and effectiveness—are right, and neither is unethical. ….. Marion Gruber, director of the FDA’s office of vaccines (and no relation to Bill Gruber), said she is concerned that if there is an unblinding of patients, that might limit the ability of the study to gather enough data about the vaccine’s safety.

Of course, there is no ethical dilemma. It is a simple case of the one being over-ruled by the many. Those patients involved in trials who get placebos instead of the vaccines are effectively human guinea-pigs whose health (and lives) are being adventured, without their knowledge, “for the common good”. Guinea-pigs (human or not) are not required to be told, or to understand, their fate. Their role is only to be counted in the appropriate column.

Throughout human history “the few” have always been sacrificed for “the many”. That, after all, is the essence of democracy. The reality is that the health of those receiving placebos in a vaccine trial is always subordinated to the results of the trial.


Vaccine races

December 4, 2020

Long-term effects can only show up in the long-term. The UK has won the Pfizer race but Russia and China already won their own races. The EU and the US are just slow (but claim credit for a prudence that is not possible). They are both so heavily invested that they cannot not approve. In fact, the world needs the vaccination initiatives to proceed with all speed, no matter the immunization conferred. Deployment of their own vaccines has started in Russia and China and the Pfizer vaccine will start being deployed in the UK next week. Other countries will follow – have no choice but to follow. The low cost vaccine is the Astrazeneca / Oxford vaccine which is probably 2 months away. Some few countries will deploy the Chinese and Russian vaccines. 2021 is vaccination year. It remains to be seen if this succeeds in preventing another Covid-19 spike in spring 2021.

Long-term effects are unknown but unlikely. The period of conferred immunization is unknown and will come out in the wash.


AstraZeneca prepared to talk to Pfizer if bid is increased another 10%

May 19, 2014

According to the Svenska Dagbaldet

After AstraZeneca today rejected Pfizer’s latest bid of nearly 770 billion kronor, it looks like no deal for this year But in its written response to the bid Astra Zeneca’s board writes that it is prepared to negotiate with Pfizer if the bid is raised by ten percent.

So I suspect that it may be better for shareholders in AstraZeneca to sit tight and wait for the next bid – but it may take a few months. In the worst case, holding on to an independent AstraZeneca is not such a bad deal in the long run.

I have been a little amused with the conservative politicians in Sweden and the UK abandoning their “free market” principles and  invoking the “public interest”  to oppose the deal. But unless they can convert their concern for the “public interest” into something tangible for AstraZeneca shareholders, they are doing them a disservice. In fact I would argue that without acknowledging that the AstraZeneca shareholder interests are also a public interest to be protected, both Cameron’s government and Reinfeldt’s government are engaging in an extra-legal, repressive and discriminatory behaviour.

Needless to say the Left and the Communists are opposed to the deal on religious grounds because rationalisation  – if it leads to the loss of any jobs and even redundant jobs –  is always a great SIN.

Pfizer writes off $725 million – were they a victim of scientific fraud?

January 20, 2014

Whether it is just error or bad judgement or fraud we will never know. Perhaps all three.

NewsObserver: In 2008, Pfizer paid $725 million for the rights to a Russian cold medicine called Dimebon. The pharmaceutical giant thought the drug could help ameliorate the symptoms of Alzheimer’s. Several clinical trials showed the medicine had no more impact than a placebo. Pfizer has largely abandoned the project.

Earlier this week came the news that Pfizer have now written off the entire $725 million.

The last flickering hope that Medivation’s Dimebon could help Alzheimer’s disease patients has just been extinguished. The biotech announced this morning that a 12-month study of the drug failed to register significant improvements for patients, mirroring two shorter Phase III studies in which Dimebon failed to outperform a sugar pill. Pfizer took the opportunity to bow out of its partnership, writing off its $225 million upfront and $500 million milestone program for what proved to be another embarrassing pipeline failure.

In 2008, Dimebon looked like an odds-on success, with positive data from a Russian study and 10 years of sales experience to underscore its safety. But Medivation was shaken to the core when its first late-stage study ended in failure, with an additional pratfall for Huntington’s disease to cap the disaster.

In the end, Dimebon’s failure helped tarnish the reputation of Russian drug studies while raising severe doubts about Medivation.

It is not only Pfizer which has been forced to make costly write-offs. Not long ago  GlaxoSmithKline was forced to shut down Sirtris Pharmaceuticals which it had acquired in 2008 for $720 million:

Xconomy:

Glaxo paid $720 million to acquire Sirtris in April 2008, to get ahold of technology that generated lots of breathless media coverage as a modern-day fountain of youth. The company sought to make drugs that act on sirtuins, a class of proteins that scientists believe play a role in aging, programmed cell death, and other key cell processes.

Even though the company is closing the Sirtris site, Stubbee says Glaxo remains confident in the drug candidates it got from that acquisition. ….

…. Sirtuins are known to be active when the body is in a calorie-restricted state, which scientists have shown contributes to longer lifespan. The idea at Sirtris was to make small-molecule chemical compounds that activated sirtuins as a way of fighting diseases that develop as people age—including Type 2 diabetes and cancer. ….. The research into the biological role of sirtuins, from Sirtris co-founder David Sinclair, has attracted its share of skeptics. Just last week, Sinclair, a researcher at Harvard Medical School, sought to buttress his early work with a new article in Science that says resveratrol and related compounds can activate sirtuins. One critic, quoted by the Boston Globe last week, said the role of one sirtuin called SIRT1 in aging, “is still as clear as mud.”

GSK is putting a brave face on all of this.

But for many medical and biotech researchers, the path to fame and fortune is by starting a start-up with some new compound or technique and by “leveraging the promise”. For pharma and biotechnology start-ups the objective is to be bought up by one of the majors for as exorbitant an amount as can be managed. And it seems that one way to inflate the value is by making preliminary data and trials show very optimistic results. Negative results never see the light of day and the positive aspects are exaggerated and at worst manipulated.

The ten-fold growth of retractions in medicine related fields since 1975 is mainly due to misconduct according to this report in Nature where “fraud or suspected fraud was responsible for 43% of the retractions”.

For Big Pharma this is simply a consequence of having “outsourced” part of their research. They can afford a few failures it could be thought. Of course the final cost is eventually borne by the consumers but some start-ups make a killing along the way.

Noted in Passing 9th February 2013

February 9, 2013

A weekly post on things that were interesting or which I would have liked to have blogged about …….

Science and Behaviour

The Fonseca Bust

Hair-dos and archaeology come together in an intriguing article in the Wall Street Journal which shows that there is a logic to hair styling.

MIT research suggests that India joined with Asia 10 million years later than previously thought while Caltech research indicates that that iron melts at higher temperatures than has been reported in the past and that the earth’s core more be a trifle warmer than has been assumed before.

257,885,1611, which is also the 48th  Mersenne prime, was discovered on the computer of Dr. Curtis Cooper, a professor at the University of Central Missouri.

Global warming hard-liners are having to accept that the world isn’t warming as quickly as their catastrophe theories suggest. But they are not yet giving up on their religious beliefs about the anthropogenic causes of warming. But some more of the alarmism around global warming has to be recanted or at least toned down as new studies show that the Amazon rain forest is far more resilient to climate change than the doomsayers would have us believe.  Back in 1975 when the catastrophe theory of the day was the imminent cooling of the world, there were suggestions that the Arctic should be melted to try to get the world to warm up!!

Apparently certain certain volatile organic gases can promote cloud formation in a way  never considered before by atmospheric scientists. So much for “settled” climate science.

Pain and itching are both sensations which have a protective purpose and are linked to survival. Itching warns of the presence of irritants and it may be that there are a specific set of nerve cells that signal itch but not pain.

Flocking starlings strike an optimal balance between the work of responding to social cues from their neighbors and the need to conserve energy. They do this by coordinating with their seven nearest neighbors and form their characteristic flocks with the least effort.

Sweden is not immune to discrimination against job-seekers who have “foreign” names.

Amherst College seems to be taking sexual violence on campus seriously……

Engineering and Technology

The oil shale boom is having unexpected benefits even for rural banking in addition to changing the face of energy supplies.

The origin of the battery fire that occurred on a Japan Airlines (JAL) 787 at Boston Logan Airport in January has been identified as a single cell in a lithium-ion battery cell. Now the causes of the initiating short-circuit have to be found.

Meanwhile, Boeing has started telling its customers to expect serious delivery delays for the Boeing 787 as far out as this summer.

Bad Science

A mediocre academic, Brett Mills, seeks publicity by claiming that David Attenborough is minimising the prevalence of gay animals!

Earthworms are long revered for their beneficial role in soil fertility, but with the good comes the bad: they also increase greenhouse gas emissions from soils.

The Japanese Education Ministry is eyeing stricter penalties for researchers who misuse public research funds or commit fraud.

Last week, a California woman filed a lawsuit against Pfizer, the maker of Zoloft, alleging that Zoloft works no better than placebo, that Pfizer knew it, and that the company has run a systematic campaign to deceive doctors and the public in order to continue selling the drug.

 

McGill University reprimands Professor for medical ghostwriting

August 11, 2011

Something stinks when academics are “helped” to write their papers by professional ghostwriters who are paid for by pharmaceutical companies. It is even worse when the papers are written by the pharmaceutical companies  and academics in the field are flattered or otherwise persuaded by their agents to put their names to the papers. McGill University has “reprimanded” a senior professor, Barbara Sherwin, for the practice but are at pains to point out that she has not been “sanctioned”.

What exactly does a reprimand – which is no sanction – accomplish?

The ghostwriting for what was ostensibly a peer-reviewed scientific article was essentially just promotional literature for Wyeth Pharmaceuticals’ and hormone replacement therapy (HRT). Wyeth paid a New Jersey professional-writing firm, DesignWrite, to help Sherwin produce a paper on treatment options for age associated memory loss that was eventually published in the Journal of the American Geriatrics Society. The paper was published in 2000. Sherwin was listed as the sole author of that paper, even though Karen Mittleman, an employee of DesignWrite, was involved in the process. The paper was published just when critics started raising doubts about hormone-replacement therapy.

Wyeth – through DesignWrite – had commissioned at least 40 scientific papers endorsing the therapy. During 2001, Wyeth sold hormones for HRT worth $2.1 billion.

Apparently Dr. Sherwin is no longer a member of the Quebec Order of Psychologists, which means she can no longer practice under the title of psychologist.

The Montreal Gazette has the full story.

Even more worrying is the Macleans story that Karen Mittleman of DesignWrite – on behalf of Wyeth – actually solicited this paper. There is also a hint of a rather cozy relationship between the Journal of the American Geriatrics Society and DesignWrite.

The stink is more of a stench!

Her alleged transgression came to light in a class-action suit involving 8,400 women against the drug company Wyeth (now part of Pfizer). Lawyers representing the women, who claim they were harmed by their hormone replacement therapy (HRT) drugs, discovered that scientific research papers extolling the virtues of the treatment while downplaying potential harm appeared to have been written, not by the academics who signed their name to the papers, but by writers hired by the pharmaceutical company.
According to court documents filed by the plaintiffs, Wyeth paid the Princeton, New Jersey-based medical communications company DesignWrite to produce articles on HRT for publication in academic journals between 1997 and 2003. DesignWrite would write the papers, then approach leading academics to claim authorship for them.

Sherwin’s relationship with the pharmaceutical company started innocently enough. In the early 1990s, she was invited to give a presentation about her work on androgens and psychological functioning in women. There, she met a woman named Karen Mittleman during the lunch break. Mittleman introduced herself as a PhD and a former academic who worked in medical communications. The pair hit it off, and kept in touch. “I liked her, and considered her a casual friend,” Sherwin told Maclean’s over the phone from her office at McGill.
Several years later, in 1998, Mittleman called Sherwin to ask if she wanted to write a paper for the Journal of the American Geriatrics Society at the invitation of the journal’s editor. The subject was pharmacological treatment options for age-associated memory loss. Sherwin, an expert on hormones and how they influence memory and mood in people, had just completed a grant proposal on the subject, and said she’d be happy to write the article. 
“[Mittleman] told me she would provide support by typing the manuscript and formatting it in the style of that particular journal,” explains Sherwin. The work itself would be based on Sherwin’s notes. In return, Mittleman, a senior writer at DesignWrite, promised to send Sherwin typed drafts for editing, and hard copies of references the professor requested. “I was completely under the impression that [Mittleman] was working for the journal, that it was the journal who hired her.” 

What Mittleman never revealed was that her employer, DesignWrite, had a business relationship with Wyeth and other pharmaceutical companies.

Karen Mittleman, as Antidote has noted, has the perfect Dickensian name for her job as the go-between finding researchers willing to sign their names to papers written by drug companies.

The reprimand by McGill seems little more than a very mild slap on the wrist.

Related: McGill sets bad example on integrity


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