- Front Page
by RS Bailey
In 2009, just as President Obama was taking office, nine scientists and physicians working at the Food and Drug Administration (FDA) sent him a letter, openly stating and giving examples of FDA corruption that was being perpetrated at its highest levels. The nine signers had their names blacked out for fear of reprisals. The FDA recently authenticated the letter, which is about as close to an admission of corruption as the government is likely to get.
The FDA “is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed.” This statement was made by FDA associate director of the Office of Drug Safety, Dr. David Graham almost two years ago.
In 2009, I remember reading an article quoting An FDA official who was trying to make the sales of some nutritional supplemental illegal because a drug company was developing a product from it. The article quoted him as saying the sale of the supplement was unfair competition. Since that time numerous incidents have taken place blatantly showing that the FDA no longer is a watchdog for the people but rather an organization increasingly designed to facilitate getting products to market.
The letter reveals more, stating in no uncertain terms that “the Director of the Office of Device Evaluation (ODE) has: Ordered physicians and scientists to ignore FDA Guidance document, knowingly allowed subordinates to issue written disciplinary actions for failure to change scientific opinions, issued illegal documents that are not publicly available and would circumvent scientific and legal requirements, failed to properly document significant decisions, made and allowed false statements in FDA documents, allowed manufacturers to market unapproved devices, removed Black Box warnings FDA experts recommended, bypassed FDA experts and failed to properly label devices ,and excluded FDA experts from meetings when manufacturers didn’t want them there.” And this is only the tip of the iceberg.
FDA Administrators routinely become employed by companies representing Pharmaceutical or Agribusiness companies or come from those companies to “facilitate” their interests. FDA Commissioner, Lester Crawford, approved Merck Pharmaceuticals’ Vioxx. By this time most everyone has seen the TV commercials for law firms trolling for clients in class action lawsuits because Vioxx is linked to 140,000 heart attacks and 60,000 deaths. After resigning Crawford became senior council for Policy Directions Inc, Merck’s PR firm.
It should be noted the FDA doesn’t actually conduct any scientific clinical trials of any drug it approves; it relies entirely on a drug company’s self-funded tests to determine whether the drug is safe or not. “If the drug company doesn’t present evidence that there’s a safety problem, the FDA presumes that the drug is not unsafe.” And FDA scientists are kept out of the meetings if they disagree or their input ignored.
As the letter in question stated, “The culture of wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior.” The Wall St. Journal reported “managers have ordered intimidated and coerced scientists to manipulate data in violation of the law.” The letter also names names and speaks of, “extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA.”
These days the FDA is also involved in much more that the drug market, they are approving the genetic modification of agricultural crops despite the clear scientific evidence showing the very real danger of continuing to do so.
In the beginning of the letter it clearly states, “…those FDA employees who have engaged in wrongdoing, who have violated laws, rules, and regulations, who have abused their power and authority, and/or who have engaged in retaliation, should be dealt with swiftly. Immediate and decisive disciplinary action will send a strong message FDA-wide that wrongdoing will no longer be tolerated and those who engage in wrongdoing will be held accountable. Some wrongdoing may be beyond the scope of FDA’s jurisdiction and may need referral to the U.S. Attorney General.”
It has not happened yet. It should be noted that the Pharmaceutical and Agricultural companies in question are among the largest contributors to political campaigns and involved in spending the most money lobbying members of both political parties.