117.THE IMMORALITY AND INSANITY OF THE DRUG MANUFACTURERS AND THE FDA

It is beyond the scope of this article to argue in depth about the role of the FDA (Food and Drug Administration of the USA) and the behavior of the pharmaceutical laboratories (the “industry”).

But it is crystal clear that none of the people that have been surveyed for the writing of this report would have seen their lives destroyed, had their doctors known the real toxic profile of these antibiotics. Almost all the other hundreds of people that we know that have suffered proven toxic reactions to quinolones could have been treated with less toxic antibiotic for their sinusitis, sore throats or prostatitis. Probably millions of people are suffering from "fibromyalgias", all sorts of pains, insomnia and neuropathies thanks to the low constant dose of quinolones (enrofloxacin, mainly) ingested through food. So much of this antibiotic is currently ingested that now many people would not get any medical benefit of a treatment with ciprofloxacin.

We do not propose to wipe out the quinolones from the pharmaceutical arsenal, but rather disclose their true properties, so that:

they are only used when other less toxic alternatives are not available

they are used with the minimum dosage that works and for the minimum length of time

they are used the least number of times throughout a person's lifetime

they are completely forbidden for treatment of animals that enter the human food chain

That should be the role of the Food and Drug Administration, but they fail appallingly. Instead, like the general that sends some thousand soldiers to be slaughtered on remote hills just to erode the fighting capacity of the enemy-- for the Food and Drug Administration it doesn't matter how many people are killed or disabled as far as some lives are saved in critical medical situations and how much disproportionate profit is earned.

The point is that both issues are compatible. Hospitals can have the quinolones for critical cases and doctors should also know their real toxicity, a thing that will only happen if the FDA discloses it.

In consequence, the FDA bears the highest responsibility in all the suffering and destroyed lives of so many tens of thousands of people. There is enough evidence that the FDA knows so much about the quinolone toxicity epidemic that is happening, but their "client" is the industry, and the top officers work very much towards protecting the interests of the manufacturers.

Look to a passage of the interview of Food and Drug Administration (FDA) employee and Vioxx whistleblower Dr. David Graham (the whistleblower of Vioxx), conducted by Manette Loudon:

Dr. Graham: The FDA has a very peculiar culture. It runs like the army so it's very hierarchal. You have to go through the chain of command and if somebody up above you says that they want things done in a particular way well, they want it done in a particular way. The culture also views industry as the client.

They're serving industry rather than the public. In fact, when a former office director for the Office of Drug Safety criticized me and tried to get me to change a report I'd written on another drug -- Arava -- he said to me and to a colleague who was a co-author on this report that "industry is our client."

I begged to differ with him. I said, "No, industry is not the client, it's the American people, the people who pay our taxes. That's who we're here to serve." He said, "No! Industry is our client." I ended the conversation by saying, "Well, industry may be your client, but it will never be my client."

Dr. Graham: ........... But I've been a target of retaliation in the past. You take 10 drugs off the market well, no good deed goes unpunished at the FDA. I've experienced retaliation with many of those other episodes but not as severe as what I've experienced with Vioxx.

This is the first time that my job was actually in jeopardy and where the FDA actually intended to fire me. That was stopped only because Sen. Grassley intervened. He put the heat on the FDA and told them, "Lay off. This guy has told the truth. He's helped America. Whose side are you on?"

There are also some books and investigative reports on the subject. We recommend “BITTER PILLS, INSIDE THE HAZARDOUS WORLD OF LEGAL DRUGS”, (Bantam Publications, and author’s webpage www.stephenfried.com) by Stephen Fried, whose wife suffered a mild, but debilitating, long-lasting and life altering reaction to a quinolone antibiotic (Floxin).

The book will help you to learn how the “industry” is the only provider of information on medications to the FDA, how they have hidden toxic drug profiles for years, how they fail in keeping a safe program of post marketing reporting, how the laboratories spend much more on advertising and gifts than in research and safety development and how the FDA is unarmed and understaffed before all the challenges related to consumer safety.

In summary, after knowing some of the facts going on in behind the scenes and observing the experience of many friends and relatives, and our own ordeal, it is not difficult to conclude that we are subjected to corporate terrorism of low intensity and vast range, that every year ends up with many thousands of avoidable deaths and an enormous social and economic cost.

The root of the problem is in the national policies that uniformly have been opted by the ostrich model. The main guidelines of this model are:

Deliberately trying to keep the adverse events of drugs largely unknown and unrecognized to avoid uneasiness and distress among the population, and to make the system easier to manage with low conflict.

Fictional creation of a common notion that the system cares for us and has a drug arsenal of perfect medications.

This model causes 250.000 deaths every year due to medical errors--mostly drug related--in the United States alone. Instead of this model, one that has not been tested so far and that could save many thousands of lives would be one of clearness, truth, and simplicity. There is no reason to hide the toxic profiles of medications from citizens and doctors. It should be widely known that all drugs have undesirable adverse effects-that there are no wonder drugs; and that any given drug is intended to cure a disease but at the cost of some adverse effects on the body. It should be very clearly stated in all the drugs inserts and/or prescription notes the dosage adjustments for weight, age, body type, renal and liver function and the real figures of toxicity, classified by dosing and length of treatment, that in many cases are on average 20 to 50 times higher than currently stated. People would think twice before self-medicating and doctors would be much more responsible in their practice, carefully choosing the best alternatives and making a complete follow up of patients, with a dramatic increase in testing.

And to refresh a little for the depraved drug marketing representatives and their respective companies---all advertising should be banned as well as any visit of any doctor or rep. to another doctor with the intention of selling a medication or buying the doctor’s will by any means. All non- over the counter drugs (prescription drugs) would be exhaustively listed in, and only in, the apothecary books and their electronic compilations for consultation.

Some of the profits of the laboratories would go down but surely they would still be the most profitable activities in the world. And there would be much more money available for research. The market for testing would also soar up.

Unfortunately the legal drug policies seem to be forever ruled by the industry because of the corruption of the western political systems--with powerful lobbies influencing governments to act against general public interest to maximize private earnings of a few companies.

118.THEY CONTINUE TO LET THE DAMAGE OCCUR

According to the Journal of the American Medical Association (JAMA), "Adverse drug reactions are the fourth leading cause of death in America. Reactions to prescription and over-the-counter medications kill far more people annually than all illegal drug use combined."

Annually, drug companies spend billions on TV commercials and print media. They spend over $12 billion a year handing out drug samples and employing sales forces to influence doctors to promote specifically branded drugs. The drug industry employs over 1,200 lobbyists, including 40 former members of Congress. Drug companies have spent close to a billion dollars since 1998 on lobbying. In 2004, drug companies and their officials contributed at least $17 million to federal election campaigns.

Find reproduced another passage of the interview of Food and Drug Administration (FDA) employee and Vioxx whistleblower Dr. David Graham (the whistleblower of Vioxx), conducted by Manette Loudon (leading investigator of the team of health guru Gary Null):

Loudon: On November 23, 2004 (during the) PBS Online News Hour Program, you were quoted as making the following statement: "I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx. Simply put, FDA and the Center for Drug Evaluation Research (CDER) are broken." Since you've made that statement, has anything changed within the FDA to fix what's broken and, if not, how serious is the problem that we're dealing with here?

Dr. Graham: Since November, when I appeared before the Senate Finance Committee and announced to the world that the FDA was incapable of protecting America from unsafe drugs or from another Vioxx, very little has changed on the surface and substantively nothing has changed.

The structural problems that exist within the FDA, where the people who approve the drugs are also the ones who oversee the post marketing regulation of the drug, remain unchanged. The people who approve a drug when they see that there is a safety problem with it are very reluctant to do anything about it because it will reflect badly on them. They continue to let the damage occur. America is just as at risk now as it was in November, as it was two years ago, and as it was five years ago.

Loudon: In that same PBS program, you were also quoted saying, "The organizational structure within the CDER is currently geared towards the review and approval of new drugs. When a serious safety issue arises at post marketing, the immediate reaction is almost always one of denial, rejection and heat. They approved the drugs, so there can't possibly be anything wrong with it. This is an inherent conflict of interest."

Based on what you're saying it appears that the FDA is responsible for protecting the interests of pharmaceutical companies and not the American people. Do you believe the FDA can protect the public from dangerous drugs?

Dr. Graham: 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 5 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.

Loudon: Are you at liberty to discuss some of the problems your colleagues are finding with other drugs and if so, how widespread is the problem?

Dr. Graham: I'm really not at liberty to talk about things that pertain to my official duties at the FDA. I can talk in my private capacity, but I can't talk about material that would be confidential.

What I can say is that there are a number of other scientists within the FDA who have also worked with drugs that they know are not safe, even though the FDA has approved or allowed them to remain on the market. They face some of the same difficulties that I do. The difference is that either the problem isn't as serious in terms of the numbers of people that were injured or that it's a fatal reaction -- they're not willing to expose themselves to retaliation by the FDA -- and retaliation would surely follow.

extracted from www. healthliesexposed.com

119. THE CORRUPT POST MARKETING SURVEILLANCE OF DRUGS

In an annual report by the US Food and Drug Administration (FDA), the agency admitted that about two-thirds of the post-marketing drug studies it had mandated have never been finished.

US Representative Maurice D. Hinchey said "while the agency insisted that it demanded that drug makers prove their medication safe, those demands 'continue to be blatantly ignored by the pharmaceutical industry.'"

In reply, Dr John Jenkins, director of the FDA Office of New Drugs, emphasized that "only 5 percent of promised drug trials were officially considered 'delayed.' In many cases, trials have been pending for more than a decade but are not considered delayed because the agency never insisted on a specific timeline for them."

Harvard Professor Jerry Avorn reminded, "This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has 'mandated' drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven't even been started yet"

Demanding post-marketing studies to assess drug safety appears to be a compromise that the agency offered in the face of demands from patient advocacy groups and political conservatives that the agency approve potentially beneficial drugs more quickly, based on relatively limited data from small randomized controlled trials.

It is not clear why the FDA has been mandating these studies, but not mandating any deadlines for their completion. Patients and physicians are harmed by these delays in accomplishing honest post marketing studies.

The existing systems of post-marketing drug surveillance are inadequate as well. In approving a new drug, the FDA may demand that a company conduct additional safety trials after release to the public, but the agency can't enforce these post-approval studies, and more than half of those agreed to by the manufacturers never occur, according to a Department of Health and Human Services report.

From the most visited health site (www.mercola.com) run by Dr. Mercola, you can read:

...Once the drugs are on the market, the FDA virtually stops paying any attention whatsoever to whether or not they might cause harm.