11

tl:dr Yee-es?!? The pharmaceuticals in the US are subsidising something. But what that is is certainly not anything that benefits the rest of the world. The sentences in the claim in question are blatant lies. US prices end up as profits for a large part and are not reinvested, certainly not into research and development of new drugs, as the industry likes ...


8

According to the US Federal Trade Commission June 2009 report Emerging Health Care Issues: Follow-on Biologic Drug Competition at page 14 small-molecule generic drugs product development costs range from approximately $1 to $5 million It also states that small molecule generic drugs "typically take three to five years to develop" (page iii) A wider ...


7

There has not been any statin vs statin comparisons, but there was a comparison of different dosages of the same statin. 10,001 patients were either assigned to treatment with either 10 mg of atorvastatin or 80 mg of atorvastatin. The primary end point was the occurrence of a first major cardiovascular event, defined as death from CHD, nonfatal non-procedure-...


6

According to the FDA the question they want to answer at a new drug approval is: "Does this drug work for the proposed use?" To answer that question the FDA requires the drug company to submit studies that prove the drug to be safe and effective for the proposed use. There are a host of criteria's such as preregistration that the FDA takes into account but ...


5

Yes, it's known that some drugs work, but how they work is unknown. For example, acetaminophen (a.k.a. paracetemol). MedScape explains: The exact mechanism by which acetaminophen produces its analgesic and antipyretic effects remains undefined. Wikipedia explains the general case as "unknown mechanism of action". These drugs are FDA approved because it'...


3

Summary: This is a partial answer: I found FDA programmes that are possibly meant by the claim, but I don't have access to the claim paper and cannot check: I may be barking up the wrong tree. FDA can grant a "preliminary" (my term) type of approval after only one clinical trial (and using surrogate endpoints), yes. FDA decides this on the basis of the ...


2

Arguably the modern drug era started with the discovery of penicillin in Alexander Fleming, Professor of Bacteriology at St. Mary's Hospital in London in 1928 with purification developed in Oxford It was Howard Florey, Ernst Chain and their colleagues at the Sir William Dunn School of Pathology at Oxford University who turned penicillin from a laboratory ...


1

You don't have to look far to find examples of major classes of drug where we don't have a good knowledge of how they work. One of the earliest "modern" medical advances was anaesthetics, first used in 1842 to transform surgery. Despite using them for a century and a half, medicine is still debating exactly how they work. There is an excellent summary on ...


1

Partly yes referring to independent expert review in the points listed below. Eight percent of 946 new products in the review period 2002 to 2011 were clinically superior, down from 11 to 15 percent in previous decades referring to Donald W. Light in 2014. In a recent decade, between 2002 and 2011, independent reviews by clinical expert teams in France, ...


1

Some experts clearly believe that too many new drugs don't bring significantly advances to therapy In an article in the BMJ in 2012, two experts reviewed the evidence about a perceived crisis in innovation in the pharmaceutical industry. They concluded that there was no crisis and the long term rate of new drug discoveries and introductions had been stable ...


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