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.
There are a lot of choices when
it comes to medicating ourselves, but in fact, there aren’t as many
choices as we actually deserve because at any given point a number of new
— and often groundbreaking — medicines and medical technologies are
tied up by the FDA’s bureaucracy-run-amok and labyrinthine qualification
processes.
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.”
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. All of us
in my generation and older have vivid memories of this, when about 10,000
seriously malformed children were born as a result of their mothers taking the
drug during pregnancy.
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.” Particularly galling is the fact that even though the
bureaucrats at the FDA are so slow to permit the sale of potentially
life-saving remedies, we can readily imagine that if, for example, the spouse
or a child of one of the top people in the FDA had contracted liver cancer
during the three-plus years of the drug’s test, we know that he/she would
get the necessary doses of Interleukin-2 to afford their loved one a chance for
survival.
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.
“ Medical Tourism” is
a reality, in part — as shown by medical professionals that I have had on
my program: American doctors who have walked out of their American practices
because it is so tough to practice medicine under the burdens imposed by
insurance companies, attorneys, and the FDA.
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? He
said that regulating tobacco was foolish because everyone knows that tobacco is
dangerous. It is like downhill skiing. If you are willing to assume the risks,
any adult should be permitted to do so.
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
wondered why I never had heard of the CEI before. Sam said he should talk to
his press people. He really should because this is a huge undertaking. He needs
better marketing.
I raised a specter with Sam that
really does bother me about prolonging life. All these extraordinary new drugs
and medical technologies sometimes serve to keep people alive against their
will and often against what is obviously their best interest. My friend’s
mom contracted pneumonia when she was 89 years old, took some penicillin, and
recovered in four days. She told my friend, “People used to call pneumonia
‘the old person’s friend’ because it would just carry elderly
people away.”
And then she added in a somewhat
plaintive voice, “Pneumonia isn’t ‘the old person’s
friend’ any more. We just take some pills and get better.”
I noted that too often
we’re pumping people full of miracle drugs that maintain their existence
in a vegetative state. And we do that whether because of the inability of the
next-of-kin to make a courageous decision or because of a greedy physician who
knows that the patient, or at least the patient’s insurance company, has
deep pockets.
“ Dealing with death is a
very tough thing,” Sam admitted, “and it should come as no surprise
that many people don’t do a very good job at it.”
I’m confident that our
problem lies in the fact that grief is not about the person who died; it is
about us. I know what I’m talking about because I’ve personally lost
family members who were themselves ready to go before I was prepared to let
them go. My grief was about me, not them. I had something more to say, whether
or not they were able to listen, or even cared to do so.
But I would never permit my
feelings to get in the way of their right to death. I would never consider
pumping them full of drugs or hooking them up to some expensive machinery as my
way of fighting against their right to get on with their quest in whatever
after-life they were preparing to go into.
Many foolish people never come
to sufficient spiritual light to see that the too-often painful realities of
mere survival are nothing like the dream of eternal life that such prolonged
existence might foolishly be mistaken for.
Mark Twain famously said,
“If you can’t get to 70 by an easy road, don’t go.” If he
were alive today I’m sure that Twain would increase the goal to 90, or
even 100, but the principle remains that not everyone should be forced to live
as long as they can possibly be kept alive by tubes, gadgetry and warning
alarms. What that lacks in quality in life an arrogant profession makes up for
in squeezing the last dollar out of insurance companies or out of the suffering
person’s family.
We’ve lost the wisdom that
Mary Oliver urged upon us when she wrote:
To live in this
world you must be able to do three things: to love what is mortal; to hold it
against your bones knowing your own life depends on it; and, when the time
comes to let it go, to let it go.
“ Just one more day,”
isn’t very often an admirable goal, but it is one that the FDA and drug
culture has set before us as an ideal.
Personal responsibility
hasn’t gone away. Let’s practice it.
In the meantime, I say kudos to
Sam Katzman and to the Competitive Enterprise Institute. I wish them great
success. However, they probably often feel as though they are in a Quixotic
battle against the huge windmills of governmental waste and bureaucratic
insensitivity using only their puny little swords of intelligence, logic, and
common sense. But it’s a battle worth fighting!
I actually have come up with a
perfect plan to solve the entire FDA nightmare in a single stroke, saving the
U.S. taxpayers hundreds of millions of dollars that we are currently investing
in the bloated and bungling FDA bureaucracy, and ensuring the flow of medicines
and remedies that will relieve our illnesses and, on some occasions, save our
lives.
The solution came to me in one
of those brilliant epiphanies that sometimes occur to people, since it came in
a flash while I was ruminating on how much time and money Americans spend
traveling back and forth between the U.S. and Canada on trips with the sole
— or at least main — purpose of purchasing medicines denied to them
in their own country by the FDA’s ponderous processes.
The entire problem would
disappear if we would simply enact an amendment to the constitution. It would
have to be an amendment since politicians, enslaved as they are to special
interests, would never enact the legislation on their own. We the people should
rise up, take the matter into our own hands, and pass an amendment to the
constitution that would mandate the legalization of medicine and medical
processes as a carbon copy of Canada’s own practices.
Whatever drugs are legal in
Canada become quid-pro-quo legal in America; those that are illegal in Canada
become illegal here.
It is obvious from the
trafficking of Americans back-and-forth with our neighbors to the north that
Canada has figured out how to implement safeguards for their citizens in a
manner that actually works. So lets just copycat them? Why not?
This is a modest proposal with
extraordinary potential so let’s just do it! We’ll send those FDA
bureaucrats off to engage in some more productive and honest work. If nothing
else they could wait on tables, for example. And feel, thereby, that they were
actually offering a service to humanity instead of working to the detriment of
us all.
Let’s get started!
We’ve wasted enough on these people already! This should be a great
challenge for Sam Katzman and his Competitive Enterprise Institute.
Sam Katzman General Counsel
Competitive Enterprise Institute www.cei.org
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