FDA Overhaul Needed to Quell Drug Threat

Food and Drug Administration The director of the international Drug-Free Alliance says objective, independent safety net needed to reign in the corruption of Big Pharma


The Food and Drug Administration (FDA) was created to promote the public health by promptly and efficiently reviewing clinical research, taking appropriate action on the marketing of regulated products in a timely manner and to protect the public health by ensuring that drugs are safe and effective.


However, new drugs that are found unsafe are continually reaching the market and pharmaceutical profits are hitting record highs.


The Vioxx fiasco is not an isolated incident. The fallout from that drug produced over 27,000 lawsuits, 265 class-action suits and there were an additional 14,000 settlements. Some financial experts have estimated the cost to Merck to be around $5 billion when it is all said and done, yet nothing can compare the lives lost or altered due to the heart attacks and strokes caused by the drug.


A federal grand jury indicted one physician and six TAP Pharmaceuticals managers with conspiracy to pay kickbacks to doctors and other customers and conspiracy to defraud the state Medicaid programs. The result was that the company had to pay out more than $1.2 billion in settlements with the United States in 2003.


In 2004, Warner-Lambert, a subsidiary of Pfizer, Inc. - the world's largest pharmaceutical company - entered into a settlement worth $430 million with federal and state agencies due to Medicaid fraud over Neurontin. The settlement is over allegations that the company illegally promoted the drug to doctors for many unapproved uses.


More recently, Lilly has paid out at least $1.2 billion to over 28,000 people who were injured by the drug Zyprexa, which was found to have caused diabetes. More than 1,000 lawsuits against the company are still pending.


Despite the corruption and enormous settlements, prescription drug profits continue to rise – and so has the number of Americans abusing prescription drugs.


Perhaps Pulitzer prize-nominated author Stephen Pizzo put it best last year when he compared Big Pharma to Big Tobacco. He wrote that they both produce and sell products that often cause injury or death when used as directed; that they knew that some of their most profitable products were injuring and killing people, and either hid such evidence, lied about it or both; that they hired their own experts to produce often phony, always misleading non-peer-reviewed, research designed solely to cast doubt on any genuine research by outside experts that came to conclusions that could hurt sales.


Big Tobacco has had to pay big, and the numbers of smokers continue to decrease. At least those who still smoke know they’re causing their own ill health and possibly death. After all, there is a Surgeon General’s Warning on cigarette packages, one of which reads: “Smoking Causes Lung Cancer, Heart Disease, Emphysema, And May Complicate Pregnancy.”


Black box warnings aren’t enough. Perhaps we could have a similar Surgeon General’s Warning on most prescription drugs – something like “This drug might make you feel better temporarily, but over time you have a high risk of developing dependency, serious mental and/or physical side effects and possibly death.”


Mike Adams of Newstarget.com wrote “It's the greatest con in American history. It's the racket of the millennium. The drug companies are running the show, cutting off drugs from Canada, monopolizing the U.S. market, running the FDA, bribing doctors and killing patients all the while. Even based on statistics from conventional medicine, prescription drugs are right now killing 100,000 Americans each year and injuring another two million.”


Earlier this month the Public Citizen, a national non-profit public interest organization, wrote a letter to the British medical journal the Lancet regarding a study conducted on the FDA’s use of advisory committees. The study found that the FDA follows committee recommendations only 72 percent of the time, and in 18 percent of the time didn’t even present its own oral reviews. The Public Citizen also reported that an advisory committee meeting was held on only 24 percent of new molecular entities (NMEs) approved between 2000 and midway through 2006.


An interview conducted by Manette Loudon, the lead investigator for Dr. Gary Null, Dr. David Graham (senior drug safety researcher at the FDA) said, “As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that is the way the FDA is currently structured. Within the Center for Drug Evaluation and Research about 80 percent of the resources are geared towards the approval of new drugs and 20 percent is for everything else. Drug safety is about five percent. The “gorilla in the living room” is new drugs and approval. Congress has not only created that structure, they have also worsened that structure through the PDUFA, the Prescription Drug User Fee Act, by which drug companies pay money to the FDA so they will review and approve its drug. So you have that conflict as well.”


A study released in April of 2006 also revealed that the majority of psychiatrists who worked on the most recent edition of the American Psychiatric Association’s widely influential diagnostic manual had financial ties to the pharmaceutical industry before, during or after the latest edition of the growing manual was published.


Today there are numerous law suits being filed against makers of antidepressant drugs since the release of new evidence showing that many actually increase the risk of suicide, and one can bet that some of these drugs will be removed from the market in the future as well, but not before the drug companies make many more billions of dollars. By then, a few hundred million dollars spent on settlements is nothing to them.


In case you haven’t guessed, my point is this – the relationship between the pharmaceutical industry, the FDA, and our healthcare system is seriously flawed and costly in many ways. It threatens American lives every single day, and it will take average citizens like you and me to do something about it, because those who have been trusted to look out for our health and safety have clearly failed.


© 2009 Drug-Free Alliance