Regulatory Failure at the FDA: Withholding Data Harms Patients

Two researchers in Denmark, Professor Peter Gøtzsche and Dr Anders Jørgensen, were recently published in the British Medical Journal asserting that withholding unpublished trial data from drug trials is preventing doctors from determining the best treatment for their patients...The authors believe authorities who function as Drug Regulators are protecting drug profits while failing to protect people who take drugs by allowing drug companies to suppress negative data.  The authors write an accurate analysis of a crisis occurring globally, propelled by greed; and causing disability and death to patients.   


In the US, drug studies are conducted to expand the market for a particular drug--unethical, and not a valid scientific or medical purpose for a drug trial; yet widely done.  Drug trials designed to garner the desired results: to gain initial FDA approval or to validate marketing schemes are unethical and outright fraud.  Drugs are approved by the FDA based on deceptive and corrupt research and business practices used by the drug makers.  Drugs are approved based on carefully constructed marketing strategies; not ethically conducted and reported research.   The results of these pseudo-studies are published in professional journals.   Professional medical journals originally served the purpose of disseminating valid information and treatment recommendations to medical professionals.

Professionals have traditionally relied on journals to better inform them, so they may treat their patients based on the best information available.  Today, journals are sometimes little more than marketing tools used by the drug industry to influence doctors.  Suppressing information about drugs ultimately undermines a professional's ability to provide sound advice or provide quality care to patients.


Drugs that gain the approval of the FDA based on deceptive research and dishonestly reported trial data, (outright FRAUD) remain on the market, and are not reviewed when deception is discovered.  This further protects drug industry profits and increases regulatory failure.  Why would the FDA approve drugs on less than complete information?  It is plain that a careful review all of the data from drug trials is required to accurately assess the safety and efficacy of a particular drug ethically and honestly.  Why is this not being done?   Why are doctors and other medical professionals not required to report adverse events, even death, when a drug that has FDA approval is the known or suspected cause?  Not requiring professionals to report adverse events puts Americans at risk, and prevents discovery of previously unknown, undocumented or undisclosed risks of the drugs; it also prevents the discovery and correction of any regulatory failures.   Not collecting adverse event data, makes it impossible to quantify the risks, or accurately assess the safety and efficacy of any drug once approved by the FDA.  By not collecting data which would refute or support a drug company's claims of a particular drug's  safety and efficacy, the FDA further puts the American people at risk.  The FDA is failing it's mission to protect the American people.   This failure is disabling and killing some of us. 

"There is something fundamentally wrong with our priorities in healthcare if commercial success depends on withholding data that are important for rational decision making by doctors and patients," say Gøtzsche and Jørgensen.  Read the article here.


more on the prevalence and effect of concealing information:


"In an article published in the journal Trials, researchers at the German Institute for Quality and Efficiency in Health Care (IQWiG) compiled over 60 examples illustrating how the dissemination of medical knowledge has been impeded...

Concealment is common

In science the phenomenon is called "publication bias", i.e. bias through selective publication. This occurs on two levels: On the first level complete studies remain unpublished. For example, an analysis of 90 drugs that had been newly approved in the US showed that they had been tested in a total of 900 trials. However, even 5 years after approval, 60% of these studies were unpublished. On the second level only selected outcomes from studies are published. Nowadays researchers have to specify in a study protocol which outcomes they want to measure and how they are going to analyse them. Comparisons of protocols and journal articles of studies showed that in 40% to 60% of studies, results had either been completely omitted or analyses changed. "In this way study results are often presented in a more positive way than is actually the case," says Beate Wieseler, Deputy Head of IQWiG's Drug Assessment Department."  

read Medicine's Secret Archives 

Any time there is a decision to conceal information, it does not benefit patients.  Decisions to suppress information are invariably made to mislead, to hide harm, and to enrich drug makers.  Ultimately, concealing and suppressing information undermines patient care and destroys trust.