Pharmageddon: A dystopian scenario wherein medicine and the pharmaceuticals industry have a net detrimental effect on human health and medical progress does more harm than good.
Prescription drugs were created to heal and prevent health problems, but since the FDA facilitated speedy drug approvals and relaxed drug marketing regulations in the 1990s, U.S. doctors have been prescribing unsafe drugs in alarming numbers.
The pharmaceutical drug culture across America is unparalleled in the world. Every U.S. medicine cabinet is filled with a panoply of drugs for the most varied conditions and symptoms. In fact, a recent report from the Center for Disease Control (CDC) found that death from prescription drug overdoses in America is now more prevalent than death from excessive consumption of illegal drugs.
International Journal of Health Sciences Report: Unsafe Drugs Prescribed
In the light of this information, it is clear that America has enough trouble with safe prescription drugs as it is. However, the prescription of unsafe drugs is also a pressing matter in the U.S. today. According to a report published in The International Journal of Health Services, “Seventeen drugs were approved and later withdrawn during this 18-year period [1993-2010] and were prescribed at 112 million physician office visits in the United States. Nine of these drugs were prescribed more than 1 million times before their market withdrawal.”
But how is this happening? By analyzing large amounts of statistical data, the authors of the paper, who come from Harvard and Hunter College, found that for every 100 new drugs approved by the FDA, 27 are later withdrawn from market with serious safety warnings within the first 16 years. And it takes the FDA an average five years to fully remove an unsafe drug from the market.
During the first years after it has been proven that a drug is unsafe and potentially damaging for human health, Americans may still be taking it in surprising amounts. Moreover, considering some of those drugs might have never been on the market if the FDA still had its stricter pre-1990s regulations, it seems that something must be done by policymakers to protect the health of Americans. The matter becomes even more pressing when one learns that adverse reactions to prescription drugs cause 100,000 deaths per year in America.
Unsafe Pharmaceuticals Kill – FDA Speeds Approvals for Big Pharma
There are no two ways of looking at this. Americans are dying because the FDA is making it easy and fast for pharmaceutical companies to have their drugs approved and sent to market. The current lax regulations are an inheritance of the HIV epidemic era, when the FDA saw fit to speed the process of approval in order to foster the quick development of and access to new drugs.
As the study puts it, “For some drugs, safety concerns are only discovered after they have been on the market, sometimes for several years. The U.S. Food and Drug Administration (FDA) has adopted several policies that could increase the likelihood of approving a potentially unsafe medication.”
The FDA is the gatekeeper that should only be letting safe drugs through into the U.S. market. Besides, this is not only a problem for America, as the FDA’s seal of approval is regarded in a positive light, when foreign countries are considering which drugs to allow into the shelves of pharmacies all over the planet.
Glam Pharma Ads Designed for Consumers to Pressure Physicians
The circumstances that brought about the FDA’s speedy approval practices are no longer the same. The 1997-approved relaxed regulations on direct-to-consumer advertising have done infinitely more damage than good, by allowing pharma companies to conceal reporting on risks in its drug ads. Since then, these companies increased their advertising budgets to 300%. The ads for prescription drugs have never looked so glamorous. As a consequence, patients go into doctor practices and ask for specific drugs, and many physicians may feel pressured to prescribe them.
Meanwhile, many of those unsafe drugs end up being paid for by Medicare and Medicaid. Thus, the FDA’s fast-tracking -and slow withdrawal- of drugs is not only causing damages to Americans’ health, but also making the government pay for medications with potentially adverse effects, medications that can often seriously harm or even take the lives of Americans.
In view of this complex scenario, it seems that something must be done immediately. As Sonali Saluja, Steffie Woolhandler, David U. Himmelstein, David Bor, and Danny McCormick propose in the study’s abstract, “To minimize the negative health consequences of prescribing potentially unsafe medications, we should reconsider some of the FDA policies that encourage the rapid approval and dissemination of new drugs.”
Pharmaceutical Whistleblower Best Hope for Safer Drugs: Big Bounty for Info
Until Congress and the FDA take action, our best hope is the whistleblower, someone from inside the pharmaceutical industry with inside information about manufacturing defects (drugs that are under or over strength), adverse reactions or off label use. In the U.S., whistleblowers can receive large percentage awards for reporting problems with unsafe drugs or drugs being prescribed for uses not approved by the FDA.
Neither the government nor pharmaceutical industry has done a great job at self-policing. Whistleblowers, however, can make the difference. Already some pharma professionals have joined together to create an advocacy group aimed at encouraging whistleblowers and protecting whistleblower confidentiality and jobs within the pharma industry.