Donald W. Light

Works

GOOD PHARMA: the Public Health Model of the Mario Negri Institute
Describes how a large institute (51 labs), devoted to developing better medicines for patients, provides a public health model works without patenting any of its discoveries or new uses in an open-science, collaborative, self-critical style at much lower costs with data transparency than commercialized research.

A Trio of Short Critiques of the FDA
1. "The FDA's new clothes (for safer drugs): tattered, missing sleeve, torn pocket...
2. "Why do cancer drugs get such an easy ride? Many trials allowed that lack basic features for clear evidence of benefits or harms.
3. "Serious risks for few new benefits from FDA-approved drugs" That's what the FDA gives us.

Serious Risks and Few Benefits from FDA-Approved Drugs
Health Affairs Blog on how most drugs approved by FDA provide few advantages for patients but expose them to substantial risks.

The Risk Proliferation Syndrome behind Prescription Drugs

Pulls together the syndrome of practices, laws, and rules that are maximizing harmful side effects from new drugs that usually provide few or no off-setting benefits.

Presents evidence of an epidemic of adverse reactions that have made prescription drugs the 4th leading cause of death, tied with stroke. A major cause of hospitalizations, falls, and accidents.

The more drugs are marketed, the more diluted become their benefits but the more widespread become their harmful side effects.

"Why do cancer drugs get such an easy ride?"
Rushed approvals result in a poor deal for both patients and cancer research. While regulators claim they approve major advances, independent evidence documents flawed, biased, and incomplete evidence so that no one can know if most help cancer patients. Accelerated reviews and easy-ride quasi-evidence reward more research for more drugs with little evidence of benefit.

Epidemic of Adverse Side-effects
Although prescription drugs are a major health hazard and leading cause of death, sociologists and epidemiologists fail to mention or study them. Lying at the intersection of medicine and health as an ironic perverse effect makes them particularly interesting

Review of Deadly Medicines And Organised Crime: How Big Pharma Has Corrupted Healthcare By Peter C. Gøtzsche
Describes this readable, deeply researched book by one of Europe's authorities on evidence about the effectiveness and risks of new drugs. Companies are organized and they commit crimes repeatedly; so aren't they like organized crime? Contrasts these practices with a model of ethical, open research, where no patents are pursued.

Institutional Corruption and the Myth of Safe, Effective Drugs
Explains how the FDA has become institutionally corrupt so that 90 percent of new approvals provide few or no advantages, and drugs are the 4th leading cause of death.

"MARKET SPIRAL PRICING OF CANCER DRUGS"
Senior oncologist, Hagop Kantarjian, and I show that very high prices for cancer & specialty drugs are not due to high costs of research, nor to added clinical value. Companies are simply spiraling up prices already 2-3 times what other capitalist countries allow, because we allow them to. High co-pays hurt patients and impede good clinical care.

The Myth of Safe & Effective Drugs (2013)
Review of evidence that only 1 in 10 new drugs has substantial clinical advantages but 1 in every 5 results in serious harms. Due to FDA criteria, budgeting, and practices that put scores of new minor innovations on the market with little evidence of safety.

Health Affairs review of PHARMAGEDDON
Insights in to how drug companies have been transforming illness, diagnosis, the role of doctors, and treatment, away from clinical pathology to risks by numbers.

Wasting money on marginally better new drugs
This web post from the Center for Ethics at Harvard summarizes with links a) the recent article in the BMJ, b) the challenge to the trade associations to verify their high claims for R&D, and c) the costly burden on businesses of high-priced new drugs with few benefits, caused by the businesses themselves.

BMJ "Pharmaceutical R&D: What do we get for all that money?"
High prices and little added value characterize most new drugs. The industry turns out articles on the so-called innovation crisis but we prove there is none. Rather, a hidden business model leads to scores of minor variations.

Data Exclusivity with no benefits
A detailed account of extending data exclusivity without credible evidence it increases innovation. A costly protection from free-market competition

Pharm R&D - Costly Myths
Recent record-high cost estimates of R&D are not only untrue but can impede policy for global health justice

PHARMAMYTHS AND REALITIES



"The Inverse Benefit Law"
The more widely a drug is marketed, the more diluted become its benefits but not its risk of harm. Types and examples given. Forthcoming in the American Journal of Public Health

"Foreign Free Riders drive up US drug Prices" - myth
Drug companies have been campaigning for years to persuade lawmakers and leaders that Europe and Canada are "free riders" that make Americans pay high prices to pay for research costs abroad. This article assembled evidence this is not true and that the free-rider argument itself makes little sense on products sold internationally.

Harvard Professors Violate Ethical Standards
Three Harvard professors violated nearly every standard when we questioned the Tufts-DiMasi high estimate of R&D costs.

Commercial influence on Medical Journal Editors
While medical journal editors work hard to minimize commercial bias in research articles that can threaten their reputation and trustworthiness, editors need to consider commercial influences on themselves, like revenues from reprints of positive results and advertising. These could be significantly reduced.

Global Drug Discovery: Europe is Ahead,” Health Affairs – web exclusive
This article takes industry data used by supported economists to "show" American dominance in R&D and shows that dollar for dollar the opposite is the case.

The quality of the data, however, is terrible; so who knows what the real story is? Yet major policies are decided on this terrible data and bias analysis.


GLOBAL JUSTICE AND VACCINES FOR THE POOR

Estimated Costs of R&D for Rotavirus Vaccines
Based on detailed construction of R&D costs, prices can be much lower than claimed


ADVANCED MARKET COMMITMENTS: CURRENT REALITIES AND ALTERNATE APPROACHES. (click)
The political construction of a mythic tool for getting vaccines to the world's poor. How the G8 leaders were misled, based on grand claims. Ends by calling for designing advanced commitments to suit the situation and needs of key stakeholders, rather than staying wedded to a failed design.



Selected Works

GOOD PHARMA
Describes how a large institute (51 labs) devoted to developing better medicines for patients provides a public health model works without patenting any of its discoveries or new uses in an open-science, collaborative, self-critical style at much lower costs with data transparency than commercialized research.
PHARMAMYTHS AND REALITIES
1. "The FDA's new clothes (for safer drugs): tattered, missing sleeve, torn pocket... 2. "Why do cancer drugs get such an easy ride? Many trials allowed that lack basic features for clear evidence of benefits or harms. 3. "Serious risks for few new benefits from FDA-approved drugs" That's what the FDA gives us.
Pulls together the syndrome of practices, laws, and rules that are maximizing harmful side effects from new drugs that usually provide few or no off-setting benefits. Presents evidence of an epidemic of adverse reactions that have made prescription drugs the 4th leading cause of death, tied with stroke.
Rushed approvals result in a poor deal for both patients and cancer research. While regulators claim they approve major advances, independent evidence documents flawed, biased, and incomplete evidence so that no one can know if most help cancer patients. Accelerated reviews and easy-ride quasi-evidence reward more research for more drugs with little evidence of benefit.
Although prescription drugs are a major health hazard and leading cause of death, sociologists and epidemiologists fail to mention or study them.
Describes this readable, deeply researched book by one of Europe's authorities on evidence about the effectiveness and risks of new drugs.
Explains how the FDA has become institutionally corrupt so that 90 percent of new approvals provide few or no advantages, and drugs are the 4th leading cause of death.
Companies are spiraling up high prices, not because of costs or better value, but because they can get away with it, only the USA.
Review of evidence that only 1 in 10 new drugs has substantial clinical advantages but 1 in every 5 results in serious harms.
Insights in to how drug companies have been transforming illness, diagnosis, the role of doctors, and treatment, away from clinical pathology to risks by numbers.
High prices and little added value characterize most new drugs. The industry turns out articles on the so-called innovation crisis but we prove there is none. Rather, a hidden business model leads to scores of minor variations.
A detailed account of extending data exclusivity without credible evidence it increases innovation. A costly protection from free-market competition
Recent record-high cost estimates of R&D are not only untrue but can impede policy for global health justice
Prescription drugs are less effective and more dangerous than patients or physicians think
Cost of research per new drug is much lower than claimed
How drug marketing undermines patient safety and public health
Provides evidence that research and other costs are recovered at European prices. Higher US drugs prices go largely to more marketing and profits.
Three Harvard professors violated nearly every standard when we questioned the Tufts-DiMasi high estimate of R&D costs.
While medical journal editors work hard to minimize commercial bias in research articles that can threaten their reputation and trustworthiness, editors need to consider commercial influences on themselves, like revenues from reprints of positive results and advertising. These could be significantly reduced.
The Foreign Free Rider claim is a myth. Dollar for dollar, Europeans have discovered more global new drugs than Americans
84% of all funds to discover new drugs comes from public sources
GLOBAL JUSTICE AND VACCINES FOR THE POOR
Costs much lower than claimed and recovered in 18 months; so price can be low & profitable.
The pneumococcal AMC needs changes to avoid sinking GAVI
The only history of this global policy tool and why we need to use open design to do it better.
Two-thirds of $1.5 bn donated by taxpayers will go to extra profits rather than to saving poor children if the pneumococcal AMC is used
Advanced Market Commitments to encourage new vaccines for the poor are impractical, too expensive, and benefit the Big Four more than poor children

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