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The biggest bugaboo in dealing with medication is the national consumer protection agency that is supposed to keep us safe but is, in fact, making our lives more difficult and contributing substantially to painful suffering and even to the death of many of our citizens. From where I sit I have a clear view of the medication debates raging around us. “Take this!” some experts say. “Don’t take that!” say others. “Take 42 of these,” one professional will say. So you take them and then watch the 43rd dose contra-indicate the other 42. And you’re still sick.
I’ve never understood why it takes so long to get a medicine approved. I understand that tests must be done but, good Lord! How many tests do you have to do? Why not just let the drug companies put out whatever drugs they will? We can believe their releases, take the drugs, then if they kill us we’ll simply die. That suggestion sounds unsophisticated and dangerous but sometimes I think I would rather die than have to deal with this agency who seemingly couldn’t find its behind in broad daylight, using both hands and two mirrors. I’m simply ranting about this but Sam Katzman, the General Counsel for the Competitive Enterprise Institute, actually knows about this topic. I asked him if “General Counsel” meant that he was a lawyer and when he admitted that he was, I amused him by telling him that there were 12-step programs designed to help lawyers escape from the practice of law. On a more serious note, Sam admitted that the FDA is an obstacle that stands in the way of faster and less expensive drug development. “ It’s not a matter of our opinion,” he said. “It’s a matter of hard facts.” I told Sam that FDA bureaucrats have been quibble-dicking around for years. He said that nobody knows how many person-hours the FDA actually spends looking at paperwork but under a democratically controlled Congress, the number will always go up. “ Democrats are always willing to push perceived drug safety to the top of their agenda,” he said, “no matter what it means to actual health and certainly without regard to what it will cost American citizens.” The Competitive Enterprise Institute (CEI) is a deregulation-minded and free-market advocacy organization that has been around since 1984. Sam and his CEI share my belief that, in his words, “If you have a problem and the government gets involved it often means that you then end up with two problems.” The CEI tries to raise public awareness of the hidden costs associated with government regulation. “ You almost always hear that this government program or that government program is good for you,” Sam said, “but in our view quite a few government programs are just the opposite and do, in fact, kill people. FDI is one example, but there are others as well. Areas ranging from affordable energy to automotive transportation.” For example, the CEI argues against congressional efforts to mandate minimum MPG standards for the automobile industry, rather than permitting free-market processes to create whatever de facto standards citizens desire. Detroit is bound to increase the average MPG levels by developing lighter and flimsier vehicles, which endanger people by greatly reducing the survivability possibilities of occupants in such vehicles in the event of a crash. The CEI performs an important function because, Sam said, “These are not the things you will be hearing in most political debates. Because there you have a number of interest groups with strong motivation for always pushing for even more government regulations.” I said that these things give people something to do. Sam instantly agreed. “Any new program creates more power, more jurisdiction, and a larger budget,” he said. I said that we know that through its intervention government can screw up almost anything. Concerning the FDA, Sam raised what he thought was nothing less than a life-and-death issue. Sam said that when the FDA approves something that’s medically important they like to tout the fact that they are doing so and take some credit for the role they play in getting these things to the market. “ Whenever you read that the FDA has improved a new medicine or medical device,” he said, “if the new therapy will begin saving lives tomorrow, then how many people died yesterday while waiting for the FDA to act? I wondered how much that actually mattered and Sam replied that, of course, it mattered a huge amount. I pointed out that the people are ill and are going to die from their disease. I wonder what our fascination is with saying that if they had the treatment they would have lived. What would be the quality of life after the cure? Do their kidneys respond and they return to normal? I thought they might not. However, Sam said that the cancer would shrink in a lot of cases providing the sufferer with a return to actual heath. But then he pointed out that nobody would insist that people take the drug; the choice is up to them. However, the FDA was all about preventing people from being able to take the drug — in effect denying to them that choice in the treatment of their disease. He said that many of the people who were denied the treatment would have gladly made the choice of taking the drug even with full knowledge of the risks that they would be running into. There’s simply no point, if I’m going to die anyway, to deny me a treatment that has a good chance of helping me even if there’s a chance that it will cause me harm. “ If you believe that new medical treatments save lives then the quicker you get it to people the more lives you save,” he said. Sam and the CEI have been battling with the FDA for the past two decades over the issue of what they long ago began to characterize as the agency’s “deadly over caution.” Sam summarized the problem
by describing two sorts
of mistakes
that that
the FDA can make
in carrying
out their
mandated
approval processes. The
first mistake is to approve
a medicine
or technology
that later turns out
to have unexpectedly bad side-effects.
Sam said that
the Thalidomide Disaster
was the supreme example
of
this. Even though thalidomide hadn’t been approved for sale in this country, in reaction to the tragedy, the United States Congress, as well as other countries, enacted laws requiring that tests be conducted ensuring the safety of any drug during pregnancy before it can be approved for sale. If the FDA makes a mistake like that — which they actually didn’t make with thalidomide — Sam acknowledged that people will suffer and die. However, the other mistake the FDA can make is to delay or deny something that could really help people. In the mid-1990s, for example, the FDA approved Interleukin-2, which was the first drug to be approved for kidney cancer, which has a mortality rate of nearly 100 percent. The FDA spent three-and-a-half years from the time it received the application to final approval. This was after the drug had been approved in seven other countries with medical systems about as advanced as ours. Interleukin-2 provides an obvious example of a drug with life-saving potential that was hung up in the FDA’s approval process. Interleukin-2 has a potentially deadly side-effect and it actually kills about five percent of the people who take it, but it is beneficial to as many 15-20 percent. Through the approval process the FDA focused upon the five percent while simply consigning the 20 percent to death, since the reality is that advanced kidney cancer kills everyone who has it. Sam said that when the FDA delays approval of a life-saving remedy, people suffer and die (the second error) just as much as if the FDA were to approve a dangerous drug before knowing the dangers (the first error). However, if they commit the first error they generate front-page news. The people’s stories of death and dying are dynamite. These peopled sometimes show up before Congressional Investigations with incendiary testimony. But the people in the second group — the ones who suffer and die through the FDA’s delay — don’t agitate about their missing remedies. In most cases they don’t even know about the drug. These dying people are invisible, so the first mistake — allowing a drug that causes problems — is the one the FDA bureaucrats worry about. “ They pay lip service towards the second mistake,” Sam said, “but they always err on the side of the first one.” Allowing people to suffer or die in the absence of drugs and therapies that could have saved them is an awful crime against humanity, however. “ If you’re drowning,” Sam said, “and I’m about to throw you a lifeline when someone says, ‘Wait! First let me see the paperwork on that lifeline to see if it is safe for use,’ you’ll probably drown before the approvals come in.” The FDA kills people by its inaction. Sam said that his function at the CEI with the kidney drug was to do things like compute how many people died who would otherwise have lived. Sam said that they computed this number using information from the FDA’s own press releases. “ We came up with the rough number of 3,500 people.” Sam said they figured that because 10,000 people a year die from the disease, 15-20 percent have significant remission through the use of the drug, five percent die from the drug itself, and it took the FDA over three years for approval. That’s where the figure came from. Sam thinks the offense of the protracted length of approval time went beyond the 3,500, or so, lives that would have been saved. The unnecessary length of time also had the effect of denying a measure of hope to the 35,000, or so, people who contracted the disease during those three-and-a-half years of paper shuffling. The 15 percent chance of life offered by Interleukin-2 is far better than the zero chance people face without it. Even if a drug can save lives, it is illegal to provide it before approval. The FDA claimed that anyone who needed Interleukin-2 could have gotten it through a process of “compassionate use.” The application procedure is cumbersome, however, most people don’t even know about it, doctors rarely use it, and it the procedure almost never results in the requested drug being delivered to the suffering person in time to do any good. “Drug companies can get permission to offer limited availability of a therapy
before approval,” Sam said, “but they aren’t allowed to
charge anything for it. And the more important a therapy is, the more people
will be
lining up at the back door to get it.” The bureaucrats are willing to deny hope to people that I’m sure they would never deny to themselves or to a loved one. They are disallowing for others the remedies that they themselves — or anybody — would take advantage of, if they had the chance. One thing that CEI has done over the past decade is to run a series of polls and surveys with medical professionals and specialists, beginning with oncologists and cardiac professionals back in 1995 and 1996 up to 2007 with orthopedic surgeons determining whether the professionals considered the FDA to be too fast or too slow in releasing new therapies. Sam said that the results have been remarkably consistent from year to year and from specialty to specialty. Between two thirds and three quarters of the doctors agreed that the FDA was too slow in approving new drugs. I said it didn’t surprise me a bit because the government is too slow about everything. Sam said the surveys run counter to claims by some activist groups headed by Ralph Nader type people that, as evidenced by Vioxx and other drugs that following release have been shown to have unexpected side effects, indicating that the process was, in fact, too hurred. He further added that 80 of the orthopedic surgeons polled would like to have access to Vioxx if it were readmitted as a prescription drug. When a treatment is released to the general public and is being taken by hundreds of thousands of people inevitably things will show up that didn’t appear on clinical trials that had been limited to hundreds of test cases. “New things will inevitably be found out,” Sam said. “ If we set as a national goal not having any unexpected side effects, the only way of reaching that goal would be to introduce zero new drugs. Period.” In that case, I said, everyone would drink plain water with some kind of saline solution in it. Just like I’m doing now with the water alkaline system in my own house. Sam said that not having access new drugs would, from a public health standpoint, be the biggest disaster of all. I wondered why people didn’t go to Europe or Canada to take the liver cancer drug. Sam said that sufferers probably didn’t even know the existence of the drug, for one thing, and the other problem came from the fact that it is a difficult decision for people who are gravely ill to pack themselves up and take off for an extended stay in another country. I remain troubled by a conviction that if you were really searching for a cure and it was available anywhere, you would certainly go there. In fact, there are an amazing number of people in other countries — literally around the globe searching for cures. I
wondered about
Ted Kennedy’s effort to get tobacco regulated as
a drug. Sam said that was crazy because, for example, if tobacco is a drug
than what
is the disease? For me, it is a moral issue. Just like prostitution and social drugs. You can get anything you want in the alleys of Philadelphia, Chicago, Biloxy, Minneapolis — your town — to kill yourself or damage yourself, but the FDA won’t get something that might save your life because of bureaucrats who are busy protecting themselves and their jobs. In my opinion the particular disease involved here is a year ‘round federal legislature who feels that it must legislate. They can’t figure out what else to do so they think up laws to pass and keep mixing around in our lives until they own us. I thought that Sam’s organization should push for a legal closet approach. No new law can be passed by Congress without throwing out two old laws. Enough already with the laws. Nobody reads them. They don’t come up until they are adjudicated. We have legislated ourselves and bureaucrated ourselves (to create a term) to our toenails. I can’t get a pedicure without the process being regulated. The comment about the toenails hit home with Sam because he said that for several years in the 1990s he had a toenail fungus condition that wouldn’t respond to any treatments available in the United States. His research uncovered two drugs, Lamisil and Sporanox, which were not available in this country for a long time. I checked these online and discovered that they, in fact, provide effective treatment for the kind of fungus Sam described in over 70 percent of the cases. These had been sold in Canada for a long time. I wondered why he didn’t get on a plane, fly to Canada, and buy the drugs. Sam replied that toenail fungus can, in some cases, be a major irritation but that in his case it was minor and not worth the trip. “It’s not a life-threatening thing.” He didn’t see why he should have been forced to wait. “There was a federal agency,” he said, “standing between me and what my dermatologist knew would have been the best drug around.” Sam explained about why is it so expensive to get a drug approved. No new drug or device can be approved until the manufacturer presents documentation of the drug or device’s safety. But Sam said that enormous expense was incurred because many of the tests mandated by the FDA were not tests that many companies would undertake on their own. “
Any company in its right mind will do basic safety, toxicology, and efficacy
testing,” he said. “They
will
do
a lot
of
the
tests
required
by
the
FDA.
But
there
comes
a point
many
companies
are
required
to
go
beyond
what
good
science
and
medicine
require
and
to
carry
out
tests
merely
to
satisfy
people
at
the
agency.” I raised a specter with Sam that really does bother me about prolonging |
The
Drug Circus