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More than half of the FDA budget provided by pharma companies applying for approval


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2021 Sep 21, 9:37am   582 views  16 comments

by Patrick   ➕follow (61)   💰tip   ignore  

https://www.medpagetoday.com/publichealthpolicy/fdageneral/94596?xid=patrick.net&utm_source=patrick.net&utm_medium=patrick.net&utm_campaign=patrick.net&utm_term=patrick.net

Study: FDA Has 'No Tradition or Structure to Ensure Consistency' in Decisions
— Has regulatory "flexibility" gone too far? Former employees, advisor say yes
by John Gever, Contributing Writer, MedPage Today September 20, 2021

... "A perception of inconsistency with prior decisions breeds distrust in FDA decisions and belief that they are not being driven primarily by evidence, threatening the FDA's scientific, public, and political standing," Janiaud's group argued.

Piling on was one of those advisory committee members who quit in protest. In an accompanying editorial, Joel Perlmutter, MD, of Washington University in St. Louis, suggested that industry influence was too strong at the FDA, "with more than half of the FDA budget provided by applicant companies."

Not only should the "financial tether between the FDA and industry" be severed, but the agency needs "prospective rules for transparency," as well as more funding from Congress, Perlmutter wrote.


Gosh, might there be a conflict of interest between the FDA and the pharma companies who are funding it?

Comments 1 - 16 of 16        Search these comments

1   AmericanKulak   2021 Sep 21, 9:37am  

LeT InDuStRy SeLf-ReGuLaTe
2   Patrick   2023 Dec 6, 9:04pm  

https://sharylattkisson.com/2023/12/pharma-exec-say-most-drugs-dont-work-on-most-people/


A top executive with Great Britain's biggest drug company at the time, GlaxoSmithKline, stated that most prescription drugs don't work on most people.

The admission was made by Dr. Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline, at a scientific conference in 2003 and not intended for a consumer audience. But the frank statement made its way into popular news and grabbed headlines.

According to one news article, "It is an open secret within the drugs industry that most of its products are ineffective in most patients but this is the first time that such a senior drugs boss has gone public."

Considering the trillions upon trillions that governments and individuals spend on prescription medicine, it's a remarkable fact. It means most of the money we spend on drugs is utterly wasted while patients are needlessly exposed to side effects. In other words, most aren't helped by the medicine they take, but stand to be hurt by it.

At the scientific conference in 2003, Roses cited data on the effectiveness of classes of drugs in real patients. The data showed "drugs for migraines, for osteoporosis, and arthritis work in about half the patients." The numbers were even worse for cancer drugs. They worked in only one in four patients.

Most drugs work in fewer than half of patients "mainly because the recipients carry genes that interfere in some way with the medicine," said Roses, an academic geneticist at Duke University.

According to an article at the time in The Independent:

"Roses is a smart guy and what he is saying will surprise the public but not his colleagues," said one industry scientist. "He is a pioneer of a new culture within the drugs business based on using genes to test for who can benefit from a particular drug."

Dr Roses has a formidable reputation in the field of "pharmacogenomics" - the application of human genetics to drug development - and his comments can be seen as an attempt to make the industry realise that its future rests on being able to target drugs to a smaller number of patients with specific genes.

The idea is to identify "responders" - people who benefit from the drug - with a simple and cheap genetic test that can be used to eliminate those non-responders who might benefit from another drug.

It's hard to imagine a more impactful line of research. Yet if any of that has made it into applied medicine in the 20 years since, it's been kept a secret from us. As far as I know, doctors don't consider our genetics when prescribing medicine, and don't disclose to us that there is every likelihood the medicine they're prescribing won't work, and aren't even bothering to gather data from patients to query as to which drugs seem to work best for an individual.
4   Ceffer   2024 Feb 5, 10:49pm  

Patrick says





It is weird. Watching daytime TV at the gym, the drug ads have the voice over (sort of motor mouthing the side effects) while showing people supposedly on the drugs in some kind of cocaine hypomanic high living blissful twenty million dollar lifestyles in wonderful weather with wonderful activities and hobbies. Of course, the subliminal is that these drugs are not only just great, they are mood altering in a positive way, hang the side effects.
I guess it is the advertising version of the brilliant poison frog colors on the processed food packaging in the stores.
5   Patrick   2024 Feb 6, 11:18am  

https://tobyrogers.substack.com/p/covid-is-the-enclosure-of-the-human


In the early 1990s Pharma used the AIDS epidemic and the activism of ACT UP to pass the Prescription Drug User Fees Act. Now about half of the FDA budget comes from Pharma, not the taxpayers, and new drug applications are reviewed in less than a year. They also passed laws to set up side foundations at the FDA, CDC, and NIH so Pharma can buy regulators directly and embed their employees in these government agencies. So by the mid 1990s Pharma knew that they can get any drugs they want through the FDA regulatory process. ...

At some point, drugs for healthy people and the medicalization of the human condition were not enough to keep the profits rolling at Pharma. A number of blockbuster drugs were coming off of patents in the early 2000s with no new drugs in the pipeline (actual R&D is expensive and scientific breakthroughs are rare). So Pharma needed new sources of disease to create the market for new patentable drugs. Enter gain-of-function research. ...

So it was only a matter of time before the temptation to create and release a gain-of-function virus became too great for the corrupted souls of the Pharmaceutical Industrial Complex to bear. In the early 2000s Ralph Baric at the University of North Carolina and others began experimenting with splicing pieces of HIV into bat coronaviruses. And in 2019, SARS-CoV-2 was released into the population together with a worldwide program to block access to effective treatments and censor anyone who asked any questions. ...

mRNA shots turn millions of your own cells into factories, the machines inside these factories are your own RNA, and what they produce are spike proteins. One of the reasons that so many vaccinated people are getting so sick is because these spike protein factories have no off switch — in some people they just keep producing spike proteins until the person dies. This hacked biological system works to produce profits for Pharma. Vaccine mandates are the state seizing your body by eminent domain and transferring it to the ruling class for their further enrichment.

There’s a reason why the World Economic Forum, the World Health Organization, Pharma, and the Bill and Melinda Gates Foundation absolutely love mRNA shots in spite of the fact that they are the deadliest vaccines in history and cannot be made safe. To them, this new form of enclosure represents, potentially, the most profitable enterprise in human history — more profitable than the Atlantic slave trade, gold mines, or oil. This is especially attractive to the ruling class given that other forms of capital accumulation have stalled out.

I previously explained the mechanism by which this happens — vaccines cause chronic illness that leads families to transfer all of their wealth to hospitals, doctors, and pharmacies in order to pay for treatments until the person is bankrupt and then allowed to expire at which point the cycle starts all over again with the next person.
8   Al_Sharpton_for_President   2024 Jul 28, 7:32am  

Most U.S. pharmas don't pay any U.S. income tax

Although they receive the bulk of revenue from sales in the U.S. and report large overall profits, most large U.S.-based pharmaceutical companies don't pay any taxes in the country.

A new analysis of corporate taxes paid by the largest U.S. pharma companies by the Council on Foreign Relations found that in 2023, the top seven based on revenue had a combined U.S. tax obligation of (-)$250M.

CFR noted that Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), and Merck (NYSE:MRK) had no U.S. tax liability in 2023 and even had tax losses to carry forward.

AbbVie (NYSE:ABBV) did pay a little in U.S. taxes, but CFR authors Brad Setser and Michael Weilandt added that the company books the profits from its blockbuster drug Humira (adalimumab) in Bermuda because that country has no corporate income tax.

The duo also noted that, based on 10-K filings, many pharmas reported losses in the U.S. in 2023. Among them: Pfizer, $4.4B; AbbVie, $3.5B; Merck, $15.6B; and Johnson & Johnson $2B.

However, Setser and Weilandt estimated that Eli Lilly (LLY) reported a $0.9B U.S. profit.

Gilead Sciences (GILD) is an outlier among large biopharmas. It is the eighth largest U.S. biopharma by revenue, yet reported paying $3B in U.S. taxes in 2023.

Setser and Weilandt explain how pharmas can book U.S. profits overseas to save on paying U.S. taxes. The first reason is the Tax Cuts and Jobs Act of 2017, which the pair say provided for lower taxes on foreign profits than U.S. profits, providing an incentive for companies to book more profits overseas.

Second, since many drugs sold in the U.S. market are actually made abroad, pharma companies decide to book those profits in the country of manufacture.

Finally, many pharmas have moved their intellectual property to wholly owned subsidiaries in locations with more favorable tax rates than the U.S.

https://seekingalpha.com/news/4129257-most-us-pharmas-dont-pay-any-us-income-tax
13   stereotomy   2024 Oct 21, 12:30pm  

Patrick says

https://babylonbee.com/cleanArticle/healthiest-man-alive-just-does-the-opposite-of-whatever-the-government-recommends




I might not be the healthiest man alive, but I definitely do the opposite of what the gub'ment recommends. The standard American diet (SAD) is your gateway to Type II diabetes, heart disease, dementia, colorectal and prostate cancer for men, breast and ovarian cancer for women.

Cancers and chronic diseases are the result of chronic inflammation. Eliminate the cause of the inflammation, and the chronic diseases and cancers go away.

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