How the FDA helped kill my dad

The Federal Food and Drug Administration has a noble purpose—to protect you from dubious drug claims and toxicity. Most government programs are created for high-minded or compassionate reasons.

I know this is an extraordinary claim. And I’ll even grant that the FDA has achieved its goal—some ineffective or dangerous drugs have been kept off the market. But in trying to eliminate all risk, the FDA has also reduced options, and for terminally ill patients, risky options are often the only hope.

My father died of cancer in April 2003. He was only 64 and in apparent good health until his cancer diagnosis. He watched his diet, got regular exercise, had no vices like alcohol, drugs, or tobacco, and lived a conservative lifestyle. He was neither depressed, nor repressed. His father had lived to 79, with a brother who lived to 83, and another who is still alive at 86. I took it for granted that I would have another 15-20 years with my dad.

His cancer started as a renal cell carcinoma (kidney) that spread to a vein and from there to the rest of his body. Carcinomas produce a tiny vascular system of their own that steals blood flow from the organ they inhabit. They also produce dramatically increased amounts of a substance called COX-2. Inhibiting COX-2 retards the creation of the cancer’s vascular system and starves the tumor.

COX-2 also seems to play other key roles in the development of cancer cells, but no successful, cancer-specific COX-2 inhibitors are on the market. Instead, doctors rely on chemotherapy and radiation.

Alas, a COX-2 inhibiting cancer drug does exist. It started its clinical trials for FDA approval in 1999. In Phase I, the FDA concluded that the drug Endostatin (by Entremed, Inc.—NASDAQ: ENMD) has no apparent toxicity. Compare that with chemo or radiation. The drug is currently in Phase II of clinical trials. The research, much of which I studied in my father’s final weeks, shows great promise, but the FDA wouldn’t let my father have it.

This drug might have saved my father’s life, and it almost certainly would not have killed him, but the cancer certainly did.

Endostatin won’t be available for years, and the National Cancer Cooperative Group reports that 350 other new treatments are also awaiting FDA approval. Meanwhile, the American Cancer Society says 552,000 Americans will die of cancer this year alone.

Does it make sense to protect people who are dying of cancer from relatively low risks of toxicity, while approving old treatments that have a very high rate of toxicity, like chemotherapy and radiation?

Yet this kind of thing is the rule with the FDA, not the exception. Depending on which study you trust, it takes seven-to-10 years to get a new drug to market. Those years mean deaths. Sam Kazman of the Competitive Enterprise Institute has studied the FDA approval process and his conclusions are sobering. According to Kazman:

But let’s assume for a moment that these numbers have been overstated by people with political agendas. The FDA process, as we have already demonstrated, moves inexorably slow—slower in fact, than most European countries. This means that there are drugs already at work saving lives in Europe before Americans are able to obtain them. Experts in the field call this phenomenon, “drug lag.” Robert Goldberg of Brandeis University has estimated that FDA delays in approving drugs that were already used safely elsewhere in the world have cost at least 200,000 American lives over the past 30 years.⁷

All of the drugs and treatments described above could have saved lives because they work. But what if they had turned out not to work, or to have harmful side effects? Without the FDA new drugs occasionally can and will kill people. But how many?

The drug that caused the most deaths prior to FDA licensing was Elixir Sulfanilamide. It was poorly researched and ended up killing 107 people.

Now compare this worst-case example from before FDA licensing to just one case caused by “drug lag” under the FDA. Elixir Sulfanilamide killed 107 people while the “drug lag” for Interleukin 2 killed 3,500. This comparison is typical. And that isn’t the end of it.

The FDA charges $250 million to approve a new drug. On top of this, drug manufacturers must spend another $150 million to cover their own expenses for the approval process. Getting just one drug approved costs a whopping $400 million dollars⁸—that’s nearly half a billion dollars. This hurts us in at least five ways:

2. Still other drugs can’t earn enough to cover the $400 million in FDA imposed costs—not because they might not be approved, but because they can’t be prescribed to enough people. Dr. Mary Ruwart explains, “Extra years of drug testing mean that drugs cannot be sold until the patent on them has almost expired. Thus, companies focus on drugs that can be used widely, and do little research on cures for less widespread diseases.” This means that relatively rare diseases (called orphan diseases) that might possibly be treated or cured never will be because of the FDA-imposed costs. Doesn’t this make it fair to say that the FDA harms people who suffer from orphan diseases?

3. FDA-imposed expenses price some drugs out-of-reach for lower-income wage earners. Pharmaceutical companies must recapture their research, development, and legal costs during the patent phase. This means that prescription drugs are frequently too pricey to buy without health insurance that covers prescription drugs. But insurance plans with drug benefits also cost more, and can’t be afforded by many lower income workers either. The FDA causes harm by increasing the cost of both drugs and insurance.

4. This creates pressure for the politicians (like George W. Bush) to provide a prescription drug benefit. But doing so will still impose costs on lower and middle-income wage earners by raising taxes or increasing the national debt, leading to higher taxes later—long after the politicians have left office. (Government funding for prescription drugs will also cause dramatic increases in drug prices for economic reasons that are too complicated to describe here.) Ultimately, the only way to lower the price of drugs is to lower the cost of developing them, by removing the $400 million FDA-imposed burden.

5. Smaller, newer, more daring, and innovative drug companies find it impossible to meet the FDA-imposed costs and have to merge with larger pharmaceutical companies or go out of business. This reduces innovation and experimentation, resulting in fewer cures and treatments.

Ultimately, it’s impossible to determine just how many deaths the FDA has caused. But the toll must be staggering, while the evidence suggests that the number of deaths prevented by the FDA is tiny.

Maybe you’ve watched a loved one die of a disease to which the doctors responded by saying, “We don’t know enough yet,” or “There’s no treatment available.” If the disease your loved one suffered from was rare, the odds are high that no effective treatment is even being developed because the FDA has made it cost-prohibitive. Or you may have lost someone for whom a treatment did exist, pending FDA approval—like I did. Or you may have lost someone because money that could have been invested in finding a treatment was instead spent on the FDA approval process for some other drug.

These examples deal with only part of the problem. It would take an entire book to cover the full scope of this (literally) life-and-death issue, where we’d be able to explain:

We need to understand that the people who run the FDA are appointed by politicians, so it’s commonsense that this agency can be used for political purposes. If someone dies from taking an FDA-approved drug, Congress holds lengthy hearings to see how FDA approval can be made even more difficult.

But if thousands of people die while the FDA strings along the pharmaceutical companies, there are no hearings, no press-conferences, no grim-faced TV anchormen, no outraged editorials, no attention whatsoever—just a lot of prematurely dead people who receive no publicity and whose families have no political pull.

If you were an FDA decision-maker, which way would you lean? Would you want to protect against well-publicized cases of drugs that cause unexpected side effects in some people, or against the unpublicized deaths caused by approval delays that receive no publicity? The answer is obvious, isn’t it?

But does this really mean we’d be better off without the FDA? As I indicated earlier, it’s certainly the case that consumers are protected against dangerous drugs because of the standards the FDA mandates. But published studies also document that FDA-approved drugs kill over 106,000 Americans every year.⁹ This is on top of the deaths that are caused by "drug lag."

Another concern: Wouldn’t closing the FDA allow pharmaceutical companies to market ineffective and even harmful drugs? This would surely occur from time-to-time. But as we’ve already seen the problem was a small one prior to the FDA gaining its broader drug approval powers in 1962, with the worst mistake causing only 107 deaths compared to the thousands and hundreds of thousands of deaths caused by “drug lag.”

Why is this? Why were drugs so safe prior to FDA licensing? To understand the answer put yourself in the “shoes” of the drug companies. What would happen to you if you marketed ineffective or dangerous drugs? You would be sued. Even worse, 60 Minutes, Dateline or some other news service would expose you to damaging publicity. The sure result either way: The value of your firm’s stock would plummet.

Wouldn’t the threat of a big judgment, bad publicity, and tumbling stock prices lead you to be very careful with your products—carefully researching their effects before you released them to the public? But I’m betting you wouldn’t stop there. You would probably also seek insurance to protect yourself against judgments.

Now put yourself in the shoes of the insurance company. You don’t want to insure a company that does sloppy work and markets ineffective or dangerous drugs, do you? So how would you limit your exposure? You’d probably require testing from a lab you trust. Perhaps you’d use a company like Underwriter’s Laboratory to do the testing. All parties to the process, the insurer, the drug manufacturer, and the testing company, would have incentives to make sure the testing was effective but also economical. But they wouldn’t have the political considerations to worry about—the considerations that make a government agency so ineffective and harmful.

The same holds true for doctors. They don’t want to prescribe bad drugs and risk malpractice suits, so they too would take steps to reduce their risk, limit their liability, and protect their patients. This would give patients yet another level of protection, but without adding to the costs of the drug manufacturers.

What about pharmaceutical companies that don’t take precautions like those described above? They wouldn’t get insurance coverage and investors probably wouldn’t risk their money. Companies like this will probably go out of business very quickly, if they ever get off the ground at all.

Compare this with the FDA. What happens when it makes a mistake? Does it go out of business? Never. Is its funding reduced? No.

The politicians assume it needs more money so it can fix its mistakes. But the mistakes may have been caused because government agencies have no incentive to spend the money they receive wisely. After all, it’s not their money!

Worse still, government agencies like the FDA almost always respond to their mistakes by making their regulations tougher. The cost of the drug-approval process has doubled since the 1960s and the number of clinical trials required has soared from 30 in the early 1980s to nearly 70 during the mid-1990s. And the time required for the approval process has increased from just over seven years to just under eight years (85 months to 92 months) during the last decade.

The FDA is not an isolated example of government inefficiency and harm. It’s the rule. And obviously, I take it personally. After all, when it’s your life at stake, why shouldn’t you be free to make your own decisions about the risks you’re willing to take? Why didn’t my dying father have that option? What’s the worst thing that could’ve happened to him from taking a bad drug?

Even while in the hospital my father intuitively (and humorously) understood this point. When the doctors wouldn’t let him have a Pepsi because it was bad for him he responded with irony, “The worst thing that could happen is it could kill me.” But if he had been talking to his doctor about Endostatin instead of Pepsi, it wouldn’t have been funny anymore.

I believe it’s quite fair to say the evidence in the case of the FDA supports a general conclusion about federal programs: they are ineffective and all-too-often cause considerable harm. We need to downsize DC, restore the federal government to its constitutional limits, and end the income tax completely. Then government couldn’t harm you or your family the way it did my dad.

Jim Babka is a RazorMouth contributor and president of the American Liberty Foundation and Real Campaign Reform. This article was written as a feature on the American Liberty Foundation’s new website, www.DownsizeDC.org.

1. Bovard, James, “Shakedown: How the Government Screws You From A to Z,” p. 47: Penguin Books, 1995.
2. Bovard, James, “Shakedown: How the Government Screws You From A to Z,” p. 46-47: Penguin Books, 1995.
3. Ruwart, Dr. Mary J., “Healing Our World: The Other Piece of the Puzzle,” p. 78: SunStar Press, 1992.
4. Ruwart, Dr. Mary J., “Healing Our World: The Other Piece of the Puzzle,” p. 78: SunStar Press, 1992.
5. Bovard, James, “Shakedown: How the Government Screws You From A to Z,” p. 47: Penguin Books, 1995.
6. Bovard, James, “Shakedown: How the Government Screws You From A to Z,” p. 47: Penguin Books, 1995.
7. Fortune, November 11, 1996
8. The $400 million figure to approve a drug comes from an excellent article which references a study by Dr. Henry I. Miller at the Hoover Institute and Competitive Enterprise Institute. The link to this study no longer exists, but other scholars report even higher estimates. Famed life extension researchers Durk Pearson and Sandy Shaw arrive at an even higher estimate of $500 million for each drug tested (scroll down to the article in the blue box). The Tufts Center for the Study of Drug Development says the cost is $802 million.
9. Bates DW. Drugs and adverse drug reactions: how worried should we be? JAMA 1998 Apr 15;279(15):1216-7. Cimons M. “FDA Moves to Reduce Accidental Drug Deaths.” LA Times May 10, 1999. Home Edition Section: PART A Page: A-1. Both cited from an article at Life Extension.
Lazarou J, et al. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. Journal of the American Medical Association 1998 Apr 15;279(15):1200-5. This last study places the number at 125,000 deaths caused each year by FDA approved drugs.

The article is right, and I hate to defend anything the FDA has done.

However, they have some new management and seem to be trying to reform themselves. They just approved Velcade only four months after the application for approval was submitted (a new record).

'Course, it took years and many millions before the application for approval could even be submitted. Still, this was a couple of years faster than it would have taken under the Clintonistas.

The underlying assumption of this article is that taking the drug would have cured the guy's dad of cancer.

While it's possible, the likelihood is that his dad would still be dead of cancer.

All I have to do is look at those clinical results for injecting stem cells into the brains of Parkinson's sufferers (disastrous) to acknowledge that some level of approval is required. And if we acknowledge the claims/potential benefits of new drugs, we must also acknowledge the potential damage they can cause.

As drugs get more and more complex in terms of how they work, the mechanisms for bad results also become more complex. As potential results become more spectacular, so do the potential failures.

The FDA could no doubt stand a thorough house-cleaning. But this article doesn't make a very good case for it.

Ever since the thalidomide problem that caused thousands of babies to be born deformed in Europe, the FDA has equated bureauracratic foot dragging with prudence and caution.

And all that "caution" STILL does not shield the manufacturer from lawsiuts!

Opposing the FDA is as futile as opposing the War on Some Drugs.

You're right. And in my opinion, its for the same reason. The government and Dr. aliance wants to make sure they keep tight control of any substance that might have any affect on the body. Not for anyone's physical protection. But in order to maintain the monopoly they now hold.

Nothing is so dangerous as threatening a bureaucrats job. And passing laws that let people decide what substances they put into their bodies will put lots of people out of work (and reduce the cost of medicinal drugs too).

How many people did the stem cell failure harm? Thousands? Like the FDA kills every year? Or a few dozen?

The purpose of the FDA (and any other such organization) is to provide easy, good paying jobs for government functionaries. If it approves an occassional drug, that is ok, but not its reason for being.

How many people did the stem cell failure harm? Thousands? Like the FDA kills every year? Or a few dozen?

It was a clinical study, so of course it was only a few dozen. A required clinical study, of course -- which is the whole point. Best to catch those failures before they can hurt thousands, right?

Managed health problems and terminal health probs are two different animals.

The FDA should be more lax on approving treatments for people who are suffering from a fatal disease.

If you have 2 months to live, you really don't want to hear that a promising drug that is doing excellent in lab tests, is on year 6 of it's 8 year trial program.

By not allowing the patient to use this drug, it does not protect the patient. If it's high blood pressure medicine, or asthma meds, or something chronic, fine... run the red tape loop, cancer, AIDS, etc... should be treated differently.

No drug or medical company is going to be very careless with its tests as the legal profession would skin them out and salt them down. Is the FDA even more careful? Probably, but that has costs of its own...like several thousand people dead each year from delays. The current system makes rational trade offs impossible. Let the people who are most interested, patients and doctors, make the choices. If the FDA has to exist, make it advisory without power to enforce.

So their statement that it takes AT LEAST $400 Million and the SEVEN to TEN YEARS it takes to market a drug that has already been approved by other countries does nothing to sway the argument?

Even with all the "caution" (footdragging) by the FDA, there is no guarantee that what they approve of will not cause problems, witness the Phen-fen(sp?) debacle.

The FDA is a government agency whose primary purpose is to guarantee their future budget and number of bureauracrats will be larger than previous years'.

The FDA is a government agency whose primary purpose is to guarantee their future budget and number of bureauracrats will be larger than previous years'.

Sigh. We can agree on the presence of problems in the FDA. But it is stupid to go from there to saying the FDA serves no purpose.

The problem with folks like you is that you see no middle ground. It marginalizes you, and makes even your good ideas sound bad.

I too have watched someone I love die from renal cell carcinoma. It is a horrible death. But, due to our sue happy society, we have forced the FDA to go overboard on the tests and approvals that they require. How many times has our society crucified drug companies and physicians for drugs that do more harm than good? The lawyers dance in glee. If we truly want some of these drugs pushed through faster, we need to change our expectations for outcomes of medications we take. Anytime we introduce a chemical into our systems, we need to expect a chemical reaction. Some people have different reactions. Until we accept that physicans are not infallible, drug companies cannot be perfect, the process to legalize life saving drugs is going to be a slow, frustrating process. We need to evaluate what risks we are willing to take to save our loved ones. I would have paid any amount of money and taken huge risks to save my sister if a drug had been available to make her well again. But then again, I truly can't say what acceptable side effects I would have wanted her to have (i.e. paralysis, personality change, etc.) Its almost a no win situation.

"The problem with folks like you is that you see no middle ground. It marginalizes you, and makes even your good ideas sound bad.
"

There's another problem. There are many, many drugs under investigation. Most of them just don't work out, or end up being dangerous.

Suppose the company doing this initial testing went along with this unfortunate man's requests and gave him the drug, then died as a result of that.

I imagine the survivors would sue immediately. There's no way a drug company is going to distribute an experimental drug that way. They just can't.

It's terribly sad that this man died. Would this new drug have saved him? We don't know. Would giving him this drug put the drug company into a serious ethical and legal dilemma? You bet.

While the FDA needs to streamline its policies with regard to terminal patients, especially in the case of promising drugs nearing their release, it would be wrong of them to simply let anyone use just anything on just anyone at just any time.

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