At least as far back as 2013, Big Media, in cahoots with Big Pharma, misinformed the American public about the dangerous relationship between the FDA and pharmaceutical companies.

That was the year that the prestigious Journal of Law, Medicine and Ethics (JLME), presented evidence that about 90 percent of all new drugs approved by the FDA over the previous 30 years were little or no more effective for patients than existing drugs.

Today, some of them may be better than indirect measures or placebos, but most are no better for patients than previous drugs approved as better against these measures. The few superior drugs make important contributions to the growing medicine chest of effective drugs.

The bar for “safe” is equally low, and over the past 40 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed.

Every week, about 56,000 excess hospitalizations and about 2,700 excess deaths occur in the United States among people taking properly prescribed drugs to be healthier.

• One in every five drugs approved ends up causing serious harm, while one in ten provide substantial benefit compared to existing, established drugs. This is the opposite of what people want or expect from the FDA.

• Prescription drugs are the 4th leading cause of death.

•Deaths and hospitalizations from over-dosing, errors, or recreational drug use would increase this total.

• American patients also suffer from about 80 million mild side effects a year, such as aches and pains, digestive discomforts, sleepiness or mild dizziness.

The JLME 2013 report presented systematic, quantitative evidence that:

• since the industry started making large contributions to the FDA for reviewing its drugs,

• as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation,

The FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths.

The report’s forecast was right on as new FDA policies systematically increase the epidemic of harms and, as warned, increased costs for insurers but increase revenues for providers.

In an examination of 2008 through 2018 compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic, arthritis, and cardiac or renal drugs, a Science study found widespread after-the-fact payments or research. The research showed:

• Out of 107 physician advisers who voted on the FDA committees, 40 received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and six more than $1 million.
• Of the more than $24 million in personal payments or research support from industry to the 16 top-earning advisers—who received more than $300,000 each—93% came from the makers of drugs those advisers previously reviewed or from competitors.
• Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA.
• A majority later received money for travel or consulting, or received research subsidies from the makers of the drugs on which they voted or from competing firms.

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IN GOD WE TRUST

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CINDY LEAL MASSEY, TEXAS AUTHOR

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