Our FDA Wants More Power to Kill Sick People

Why can't we use whatever medicines we think will help?

There are many reasons to oppose greater government influence over our lives.  We've pointed out over and over that government doesn't do anything efficiently from delivering mail to running railroads.  Government waste has been with us since the dawn of time; it's not news, it's merely inconvenient.

Consider, however, our dependence on foreign countries to supply our energy needs.  Our government can't keep foreign countries from pumping their own oil and selling it to us - nor should it try to - but it's done such a good job of discouraging oil companies from drilling in the US that we're swimming in recoverable fuels which we can't touch because we might harm the odd fish or two.  Meanwhile, we ship trillions of dollars overseas to our enemies who are perfectly happy to pump their own oil, sell it to us, and use some of the money to attack us.

Scragged has pointed out that one of the most important reasons to fight government involvement in anything is that the more power government has, the more opportunities there are for crooked behavior.  We don't often see government bureaucrats ratting each other out because they don't want to remind us how much their interests differ from ours, but in "F.D.A. Reveals It Fell to a Push by Lawmakers," the New York Times reports:

The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency's scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

The FDA reported that "extreme pressure from Democrats on Capitol Hill damaged the integrity of the process."  The New York Times named the politicians involved:

But after receiving what an F.D.A. report described as "extreme," "unusual" and persistent pressure from four Democrats from New Jersey - Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman - agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency's commissioner, said he had acted properly. [emphasis added. Anybody who believes legislators aren't influenced by money must wonder why they bother to keep raising their own salaries - Ed.]

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

The FDA scientists claim that they objected to the device because some patients had to have another operation because the device failed; it was approved after the politicians got involved.

This sounds like the sort of classic New Jersey corruption we've been reading about, doesn't it?  Honest, hard-working, objective, FDA scientists get overruled by corrupt politicians and let a questionable medical device onto the market.

It's not that simple.  The device was approved in Europe long ago and nearly 3,000 Europeans have received it.  The maker has trained surgeons to use it and nearly 30 Americans have received the operation.

The FDA claims that current procedures for approving medical devices are inadequate and that they need to look at medical devices more closely, which would - surprise! - require a larger budget and more staff and result in fewer devices being available at greater cost.  At the very least, though, this will cut pension costs when patients die younger.  The Times reports:

In January, the Government Accountability Office concluded that it was long past time that the agency demanded that manufacturers prove that all complex devices are safe and effective before being approved for sale.

As we've mentioned before, it's impossible to prove that any new medical treatment is either safe or effective without trying it on lots of patients.   Not only does that cost a huge amount of money, but what about the health of all those patients the new device is being tried on?

The FDA uses that approach when approving drugs and they want to apply the same methodology to medical devices.  Let's look at their record and see how the drug approval process has worked out.

Cancer War Stalled

President Nixon declared war on cancer 40 years ago, but, as the New York Times says, "cancer death rates have hardly budged and most new cancer drugs cost a fortune while giving patients few, if any, added weeks of life."

The FDA's cancer drug office has become the target of a great deal of criticism.

Patient advocates have called Dr. Pazdur, director of the Food and Drug Administration's cancer drug office, a murderer, conservative pundits have vilified him as an obstructionist bureaucrat, and guards are now posted at the agency's public cancer advisory meetings to protect him and other committee members. [emphasis added]

Sick people are so frustrated at the slow rate at which cancer drugs are approved that armed guards are needed to protect the bureaucrats who make the decisions?  Does this suggest anything about how people will feel if Obamacare becomes law in its present form and all medical decisions are subject to such bureaucratic scrutiny?

"The industry is not producing that many good drugs, so now they're looking for scapegoats in Rick Pazdur and the F.D.A.," said Ira S. Loss, who follows the drug industry for Washington Analysis, a service for investors.

As the Times explains, part of the reason there are so few drugs is that it costs so much to get a new drug approved.

In 10 years at the Food and Drug Administration, Dr. Pazdur, 57, has helped to loosen approval standards for cancer medicines and made it easier for dying patients to get experimental drugs.  But he demands that drug makers prove with near certainty that their products are beneficial, a requirement that he repeated at a public advisory hearing on Sept. 1 in the slow, loud tones of someone disciplining a dog. After he spoke, the committee of experts voted to reject both drugs.

Dr. Pazdur's position seems reasonable - who wouldn't want ineffective drugs kept off the market? - but medicine just isn't that simple.  In "Diabetes Case Shows Pitfalls of Treatment Rules," the Times reported that a national guideline-setting group withdrew guidelines for efforts to lower blood sugar in diabetes patients because a new study showed that rapid blood sugar reduction harmed or killed some patients.

Groups who opposed the original guidelines are criticizing the committee all over again, claiming that the committee received $3 million from drug makers who wanted to sell drugs such as insulin that lower blood sugar.  It's our government-sponsored food fight all over again, yet another example of government regulation leading to corruption - or, worse, bureaucrats making decisions on issues when no human being can possibly know what the right answer is for the entire population.

On life-and-death decisions, why should some bureaucrat make the choice for you?  If you and your doctor decide to use an experimental drug and it doesn't work, at least you made up your own mind and were master of your fate.  With some nameless, faceless bureaucrat denying you the right even to try some new drug when you're dying, it should be no surprise that drug regulation has roused passion:

Critics say that Dr. Pazdur's resolve has cost thousands of lives and set back the pace of discoveries.  "Patients are right to be angry and frustrated with Richard Pazdur," said Steven Walker, co-founder of the Abigail Alliance, a patient advocacy group.  "He is a dinosaur."

Experts can't agree on guidelines for treating diabetes, a far simpler disease than cancer.  Cancer patients are so incensed at the FDA cancer office that their meetings have to be protected by armed guards!

The smaller question is whether or not we want the FDA to subject new medical devices to the same sort of scrutiny which has enraged cancer patients.

The larger question is whether we want the government more involved in medical decisions at all.  Available evidence suggests that government is no better at medicine than at running railroads, the post office, or automobile companies.  Why should we let them take over health care?

Will Offensicht is a staff writer for Scragged.com and an internationally published author by a different name.  Read other Scragged.com articles by Will Offensicht or other articles on Bureaucracy.
Reader Comments

The FDA is operated by CEOs from the very companies it is supposed to be overseeing, installed as overseers by their friends in high government offices. It is nothing less than criminal and nothing more than a joke played on the citizens of this wonderful country. The FDA is a terrorist organization. Nothing could be more true. Although, this is nothing new. Look into ANY government regulating body and you will see the same game being played. The FDA is like bullies in the playground, just on a bigger scale. You let someone hit you, intimidate you & demoralise you in the playground, without sticking up for yourself, well, you have a whole lot more of the same to come. I'm not saying it's easy to fight back when they're bigger, stronger people (or institutions), but it's something that has to be done if you value your freedom & your right to exist without being terrorised. This is insane abuse of power verging on government-sanctioned TERRORISM against our own citizens!
Of course the FDA and govenment wants to eliminate natural supplements. How in the world would they be able to control the minds and wallets of the people of this country without all the side effect causing, prescription drugs? The FDA allows many drugs with dangerous side affects plus GMOs and other neurotoxins like aspartame and MSG in our food but wants to abolish natural supplements. What's wrong with this picture? It's all about money from the pharmaceuticals and AMA lobbyists. It's ironic that if one person has a serious side effect from a natural supplement in this country, the supplement is instantly banned from the market place but over 200,000 people each year DIE from side effects of prescription drugs. These drugs are STILL on the market. I'll take my chances with natural supplements. Supplements are usually superior to drugs as they naturally replace whats missing in the body instead of further burdening it with synthetic chemicals. Beware of chemicals, trust nature.
I am so sick of the FDA and it's ludicrous mafia style raids on the Amish for selling whole milk and on natural herb, vitamin and supplement companies. So un-American it makes me want to puke. Every FDA agent should be arrested and locked up for violating basic human rights and the Constitution. As always, shame on the FDA. I don't know how the people who run that place sleep at night. I'm sorry to say this but America sounds nothing like 'the land of the free'.. on pretty much all counts. Our govt is completely out of control, but until the masses wake from their mainstream media induced, hypnotic state things are only going to get worse. WELCOME TO THE USS OF A. Where the true terrorists are those in government.

September 12, 2011 6:50 PM

I concur wholeheartedly with the above statement! The FDA is a JOKE at best and totally CORRUPT. Our food supply is polluted, tainted, manufactur­ed and engineered for profit and political control. And how about the sponsors for the other ADA- the American Diabetes Associatio­n? Major sponsors for them include diabetes drug manufactur­ers and diabetes equipment makers. Like cancer, just another rampant disease that was extremely rare prior to 1977. Businesses such as the diabetes and cancer industries are in business to make money and they have their little bought and paid for helpers in the FDA making sure Americans continue to eat GARBAGE like High Fructose Corn Syrup, gmo soy and canola oil which is rancid toxic CRAP. They aren't there out of the goodness of their hearts and they have no intention of ever finding a "cure" while they take your money in pretense of such. Luckily for the diet industry, the even more powerful food industry (estimated value: astronomical -- U.S. food-based retailing alone >$1,200 billion) make their main profits from cheap processed foods. Foods which make people fat. The medical industry is similarly grateful -- the unhealthy obese are as vital for their profit margins as oil is to the oil business. And we've seen what happens when the oil industry has their supply stream compromised.
Before 1977 the obesity level was low and remained relatively steady. In 1977 America was given the government's "food pyramid" and since 1977 the obesity epidemic has greatly increased and continues to do so. In a nutshell (or, more likely, an ADA approved Mars bar): Eat more starchy foods, eat more carbohydrates, saturated fats are bad. If that sounds like pretty good advice to you, then you don't know enough about what you are putting into your mouth. Your grandparents were raised in a generation aware that God's supermarket was better than man's. Saturated fat such as lard was a vital part of their diet. For them, obesity was not a common health problem. They were not suffering malnutrition in the fat soluble vitamins (A, D, E and K). It is definitely to the benefit of corporatio­ns to keep us fat and unhealthy -- but just healthy enough not to die -- to keep us alive, fat, and living long. To get all of us on statins, blood pressure pills, diabetic drugs -- you need us to be overweight­, and afraid of dying from heart disease or cancer. It's amazing that the so called "food pyramid" is created by the politicize­d USDA -- the organizati­on that needs to create foods that are stable and exportable -- definitely not health-cre­ating (so we are poisoning the rest of the world also). I don't know if this is all an evil plot, or it has just worked out this way through greed and exploitati­on. But it is a great conspiracy­, nonetheles­s. Its perfect because a great structure has been created to keep us fat and sick, yet we all turn around and blame each other. Perfect.
I'd like to hear from someone of the "medical establishment" gloss over all the facts mentioned here with some of their standard BS studies about how eating low fat and partially starving oneself is the solution to Americas obesity epedimic. Science is very much on my side in terms of the 'high carb, low fat' message being the cause - rather than the acclaimed solution - to the obesity epidemic. People who battle with their weight are the victims. Big corporations, big pharma and the largely (not totally) complicit medical establishment are the benefactors. High carb foods are addictive. The more you feed candida, the more it screams to be fed. If eating low fat worked, why are we all fatter now? Oh, I know, it's because we eat too many calories and don't exercise..­. Riiiiight, that's the problem. How many gyms/fitne­ss centers did we have before 1977? What did people eat in the 1950's, when obesity was rare, and the idea of "Jogging" was rare or didn't exist?

February 17, 2012 2:56 PM
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