Drug Safety - The Eleventh Hour Is Now!

On February 13, 2007 the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations opened hearings lambasting the FDA regarding the safety of drugs. The opening statement by Chairman John Dingell (D-MI) set the tone, “It is clear … that the FDA is badly broken. I expect that before we finish this investigation, which is just getting underway, we will discover whether the problems we have found are due to the work of scoundrels, irrational penny-pinching, or because the doors to the FDA “hen house” have been thrown open to foxes. It may be a combination of all three.”

Testimony given on February 13th and 14th should have curdled the blood of Americans from coast to coast. The mainstream media, which receives several billion dollars a year in advertising income from Big Pharma, failed to report on the bone-chilling testimony that plainly depicts FDA fraud and collusion that is allowing thousands of our citizens to die at the hands of Big Pharma profiteering. Testimony by Charles Grassley (R-IA) paints a picture of a rogue agency with near complete disregard for the law, an agency intentionally exposing Americans to known peril while actively covering the trail and working in partnership with Big Pharma.

Devastating evidence is presented by scientists and researchers showing that the FDA approved a dangerous antibiotic (Ketek), while knowing that the research supporting its safety was fraudulent and that there was no evidence the antibiotic was even effective. In fact, the FDA was well informed that the drug could cause serious liver damage resulting in death, and that they would be exposing millions of adults and children to the drug. The testimony exposes the inner workings of the FDA; as a matter of routine its scientists are threatened and their warnings are ignored. It is crystal clear from the testimony that the Ketek example is one of many FDA flagrant violations of the public trust, a common theme that reveals FDA management and Big Pharma are in fact operating as one team. On February 12, 2007 the FDA issued a press release stating that Ketek was no longer approved for common bacterial sinus and bronchial infections. The only reason the FDA issued this warning is because of the Congressional inquiry into their cover-up of criminal behavior, not because they had any interest at all in protecting the public.

Dr. David Graham, the FDA employee/whistleblower that is a constant thorn in the side of Big Pharma, testified and stated that Eli Lilly's antipsychotic drug Zyprexa needs a thorough Congressional investigation. The drug is known to cause obesity and diabetes, is approved only for adult schizophrenics with serious mental disease, and is being paid for mostly by taxpayer-funded programs. The drug accounts for 28% of Eli Lilly sales, leading numerous people to wonder why the FDA sits by and allows billions of dollars of Zyprexa to be prescribed for children with mild behavioral issues, when it was never approved for use in children and safety for children is completely unknown.

The FDA Sits in Judgment on Life and Death

It comes as a surprise for many Americans that over 100,000 deaths per year and over 3 million serious injuries are caused by drugs – more often than not by the never disclosed or even expected side effects of the drugs. These estimates are conservative, based on official reporting. With reckless abandon, like a drunk driver swerving out-of-control, the FDA has betrayed the public trust and made repeated decisions that expose Americans to unnecessary risk of death and injury.

Naively, most Americans think the FDA is protecting them from harm. A wake-up call occurred last year when the Institute of Medicine released their long awaited federally-funded report on the FDA and drug safety. After extensively interviewing numerous FDA employees, the report stated that the FDA has a dysfunctional organizational culture wherein the FDA and Big Pharma hide relevant safety data from the public. A report earlier in the year found the FDA could not even keep track of which drugs were on the market, let alone make certain any follow up was done to ensure safety of those drugs. To the contrary, the FDA is doing everything in its power to make sure a citizen cannot sue in state court when a drug injures or kills – actively working against citizen's rights.

The FDA responds to its critics by saying it needs more money. Critics respond by saying more money is not the answer; it is the executive decision-making process within the FDA that is hopelessly broken. The reality is that the FDA, if given more money, would do little more than attack competition to drug companies (alternative health), forge ahead with its illegal Trilateral Cooperation Charter with Mexico and Canada, and forward its clearly stated agenda of bringing newer and riskier drugs to the market faster with even less testing.

Under a bizarre law enacted in 1992 known as PDUFA (Prescription Drug User Fee Act) the FDA receives over half the money it needs for new drug approvals from Big Pharma itself – a system more akin to Big Pharma paying the mob for protection than the FDA ensuring drug safety for the public. This law must be renewed later this year and already the FDA is asking for even larger sums of money from Big Pharma. The fox is indeed buying the keys to the henhouse. Life and death hang in the balance.

The FDA is Now Headed by a Biotech Sales Rep

Dr. Andrew von Eschenbach is now the permanent head of the FDA, voted in by the Senate during the lame duck session. His extensive financial connections to biotech companies and the cancer industry were never investigated. Senators, mostly under the spell of Big Pharma's wallet, simply rubber stamped his approval. One Senator, Charles Grassley (R-IA), had the courage to speak up. His Senate confirmation testimony regarding Andrew von Eschenbach on December 7, 2006 was accurate, frank, and to the point:

“People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the position he is currently occupying [acting head of the FDA].…That is an insult….In my interactions with the Department of Health and Human Services and the FDA these last 8 months, I have seen a complete and utter disrespect for congressional authority and hence the law.…This body [the Senate] should not walk hand in hand with the executive branch and sit idly by as instances of abuse and fraud continue to endanger the health and safety of American people…Under Dr. Von Eschenbach, the FDA has not only avoided transparency, it also has threatened those who are trying to desperately expose the truth….”

Andrew von Eschenbach wants to make sure that no American can ever sue a drug company in state court. He wants these laws in place because he plans to turn a whole new array of dangerous biotech drugs loose on the American public, while at the same time turning the FDA into a drug development company – providing software that guides the development of all new biotech drugs. If Americans could sue when they are injured, they'd be suing the FDA. It is time for Americans to wake up.

Politics – Not as Usual

A major battle is brewing in the House and Senate over the future of the FDA. The battle lines do not split down traditional Republican and Democratic lines. The Congressional leaders on the good side are those who realize the insanity of Americans being needlessly killed by drugs and have the guts to stand up to the Big Pharma money lobby and take action in the face of extreme vested interests and the personal threat to re-election security.

Leaders on the other side are beholden to the Big Pharma golden idol and have track records so entrenched with Big Pharma profiteering that they should be considered enablers and in some cases co-conspirators in the FDA/Big Pharma crimes. Topping this list are Edward Kennedy (D-MA) and Orrin Hatch (R-UT), followed by numerous Congressional sheeple who will do anything to maintain their positions of power – based in no small part on the flow of money coming to their campaign coffers from Big Pharma.

It is true that the Republican leadership of the last six years has stalled all meaningful attempts at FDA reform. However, it should be pointed out that a Republican (Charles Grassley of Iowa), standing on true conservative values, is spearheading the campaign for meaningful FDA reform.

What Can Americans Do

Americans must demand an independent office within the FDA to monitor drug safety. Such a bill has been introduced by Senator Grassley and deserves the support of all Americans. S.468 (also HR 788), the Food and Drug Administration Safety Act of 2007, would create an independent office within the FDA to monitor the ongoing safety of drugs. No other solution will work. This is the type of legislation that Big Pharma and the current FDA management deplore.

Without major public support it is highly unlikely that the Grassley bill will even get a hearing. This is because the Senate committee in charge of health legislation, known as the HELP committee (Health, Education, Labor, and Pensions) is controlled by Edward Kennedy (D-MA) and Mike Enzi (R-WY). Kennedy and Enzi have been negotiating with Big Pharma and the FDA for over a year. Last year they used the issue of drug safety as a political ploy to present a Trojan Horse bill (S 3807: Enhancing Drug Safety and Innovation Act of 2006.) Never has a name been more misleading. It should have been called “Exposure of Americans to Risky Medications and Creation of a New FDA Drug Company Act of 2006.” This bill would not have stopped any of the drug scandals of the past five years and would actually act to create a drug company within the FDA! Kennedy and Enzi are planning to reintroduce an updated version of their fake drug safety bill, which they can readily bring to the floor of the Senate for a vote.

Only an independent office within the FDA can effectively monitor drug safety. Hundreds of thousands of American lives are at stake and the health of millions hangs in the balance. Rome is burning. Can the voice of the people be heard over the wallet of Big Pharma – a bank roll that is ironically funded by U.S. taxpayer and U.S. corporate dollars? Shall we fund our own demise or shall we stand and be heard?