Dr. Thomas A. Sharon, R.N., M.P.H., DNP

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FDA Approved: Medicinal Mayhem

July 31st, 2015 · Comments Off on FDA Approved: Medicinal Mayhem

FDA approved2The United States has the largest pharmaceutical industry in the world to the tune of about 325 billion dollars per year. This industry has evolved to the point that the media is now calling it the pharmaceutical biotechnology industry. The development of new drugs has evolved from isolating specific ingredients in plants to molecular engineering in creating chemical reactions within the human body that alter biological functions. There are two types of responses to these chemical reactions: the therapeutic effect and the side effect.

The first alleviates one or more symptoms or enhances a body function like increasing urine output, raising or lowering blood pressure, and the like. The side effect is an unintended response, which is usually harmful or fatal. Thus, the goal of research and development is to elicit the therapeutic effect and learn what harmful side effects are likely to occur and estimate what percentage of consumers would be at risk. Side effects, to name a few, can be anything like damage to vital organs, vomiting and diarrhea, constipation, confusion, disorientation, homicidal behavior, suicidal behavior, mood swings, itching, seizures, migraine headaches, twitching, dystonia, hair loss, loss of appetite, and sudden death. In the earlier years of drug development new innovations like Alexander Fleming’s discovery of Penicillin in 1928 were so dramatic in saving millions of lives over such a short time, that it spawned a powerful industry that can sell its product at any price and virtually own its government regulators through political influence or outright bribery.

Subsequently, the people who pioneered the drug industry became highly motivated to repeatedly reproduce the same dramatic effect on society and they have done so countless times despite that many of their products ended up killing thousands of people with little therapeutic benefits. Obviously, the human drive for survival at any cost provides a powerful demand for pharmaceutical solutions that encourages price gouging under the guise of incorporating research and development costs into the price. Certainly, there have been more than a few great discoveries that have provided fast cures for debilitating and painful diseases like antiviral drugs to eradicate shingles. On the other hand, this type of dramatic innovation, resulting in a legal monopoly yielding windfall profits of billions of dollars, gave rise to rampant industry fraud and government corruption.

The Food and Drug Administration got its start in 1906 to protect the public from unscrupulous activity such as the proliferation of cocaine solutions being sold as cure-all elixirs and became known as “snake oil”. The new law of the land was simple; before you claim that a medicine will have a certain effect or provide a cure, you have to prove it scientifically. The other part of the FDA mission was to force manufacturers to identify all ingredients in ingestible products and cosmetics on the label for the consumer to have full disclosure of any potentially harmful ingredients.

Over the last century the FDA became known as a stellar organization and had become a universal worldwide model. Anyone who could claim that their product was FDA-approved would inspire confidence in the user that the item underwent rigorous testing and scrutiny. Simultaneously, however, scandal after scandal erupted, charging fraud and bribery, resulting in multiple deaths and disability. The inexplicable phenomenon is that the FDA reputation would always bounce back after a political charade of pretending to shake the management tree to make the bad apples fall out. Every once in a while, some low echelon lackeys would have to fall on their swords to take the heat off the bosses who gave the orders to approve various drugs despite obviously bogus test results. Perhaps the idea that FDA approval depends mostly on who pays the most money in bribes and political campaign contributions is so horrifying that people are more willing to live in denial and believe that the new president has eradicated the FDA corruption, when in reality it continues unabated.

However, after the latest rude awakenings of 2007, 2008, and 2009, and after tens of millions of unnecessary deaths over the last 50 years, we have to face the problem and deal with it, because the United States food supply being at risk and proliferation of harmful drugs and devices to millions of people that offer little or no benefit threatens to destroy our society. The root cause of the problem is absolute power and greed. The FDA Commissioner and underlings have complete control over 25% of our economy. They decide what products can be legally marketed in the United States and have the power to remove any product immediately from the market with armed enforcers and they don’t even need to have probable cause or a warrant to take action.

Such powers, when used with integrity are necessary to protect us from unknowingly ingesting toxic substances. However, the FDA officials have the power to create instant financial success with billions of dollars in profits and help certain companies eliminate the competition and create monopolies. Therefore, with each decision, the stakes are very high and the name-your-price temptation to use the absolute power of selective enforcement is irresistible. Time after time, we have seen FDA-approved drugs proliferate on the market with claims of miraculous cures with negligible risk of side effects; only to find out that tens of thousands of people suffered permanent damage, or died after distribution of the new drug with little or no benefit to those who escaped harm. Such catastrophes occurred because the manufacturers presented false reports from bogus clinical trials and bribed FDA officials or used political connections to coerce managers into granting approvals. A few of the notable disasters were the Diethylstilbestrol scandal of 1971, the generic drug disgrace of 1989, the Fen-Phen and Redux scams of the 1990’s, the Troglitazone travesty that Parke-Davis perpetrated between 1996 and 2000, the Ketek drug scandal of 2006 revealing patterns of scientific fraud at the FDA, the attempted Crestor flimflam of 2008, and the revelation of radiation poisoning from CT scans in hospitals across the United States.

 

Comments Off on FDA Approved: Medicinal MayhemTags: Food and Drug Administration · Medical Error Alert · Medical Ethics · Medical Malpractice · Medical Mistakes · Medication Errors