STRANGE BEDFELLOWS IN POLITICS AND PRESCRIPTION DRUGS

..the federal government, not the business.

The business is adapting to the laws.

Jimmy, I want you to know that my "beef," as you call it, is equally divided between the government and the industry. My problem is that the government and the industry are so inextricably entwined.

They are like conjoined twins who should have been separated at the very beginning. Actually, maybe they were separate entities at the very beginning, but they surely aren't now. It has become too profitable.

They have the appearance of being separate entities, but there is still that umbilical cord that seemingly cannot be cut.

The government does not have clean hands in this sordid affair; nor does the drug industry.

In the event anyone is wondering, in this case "the government" refers to U.S. lawmakers, for which my regard diminishes with every day that passes.

The two are "entwined" because the federal government has gotten involved when they have no right to do so. It's not any business' fault, they are simply adjusting as the rules (laws) change in the game.


Also, I don't believe any business can be "too profitable."

Jimmy -- The "right" of government to get involved in the prescription drug arena was back when Kefauver of Tennessee held his commission, with the result being that a drug company would need to prove to the government that a drug was both safe and efficacious.

That's how it started, and it has been snowballing ever since.

And when drug lobbyists have the right (and don't you know they take advantage of it) to use the Congressional parking lot, wander the halls of Congress, hang out in the washrooms, take advantage of the Congressional gym, etc., in my opinion that's just a little too cozy for me.

While I generally agree with you that no [American] business can be too profitable (I love free enterprise), I believe that a bunch of ethics were rolled off the bed along with J.Q. Public when the government and drug firms started getting a little too cozy. There are only so many strange bedfellows that a bed can hold.

Ethics? They don't need no stinkin' ethics.

....and I completely agree with You, BUT I don't blame those running a business for doing what they do because politicians are the ones who created the system in which they play.

Jimmy - I suppose it depends on whose ox is getting gored.

In this case it's mine. My ox doesn't like it. I don't like it for my ox.

My ox is getting gored daily. My complaint, I suppose, should be:

WHERE HAVE ALL THE STINKIN' ETHICS GONE?

I'll tell you where: under the bed with those very strange bedfellows.

No, Doc, it didn't take very long before I was questioning in my own mind just where you fit it with those strange companions. I thought you fit somewhere or other, and that you weren't getting shoved off onto the floor.

I think's it's lovely that drug firms so generously provide free medication to those unfortunates who truly cannot afford it.

I suppose it's something akin to providing all those zillions of samples to the millions of doctors throughout the nation. You give a little, you get a lot.

It's probably something akin to all those seminars provided at posh places by the drug makers to help doctors in their continuing education.

It's probably something akin to keeping track of how much a doctor prescribes prescriptions for samples given to him. That one burns my cork!

You can probably discern that I have spent no little time learning about this industry and how it operates. And it all began when I was dead set against the implementation of the Prescription Drug Plan -- for which I have publicly thanked everybody's grandchildren.

I fought tooth and claw against the PDPs, even though it would benefit me somewhat. It was not good for the country. I believe it was at that point that I became a serious conservative.

Doc, when I referred to the "government" and you referred to the "feds," I believe we were talking about different groups. I believe you were referring to FDA and HHS personnel, while I was referring to our lovely elected legislative "personnel."

Also, I believe that I incorrectly spoke of drug company personnel having the run of Congressional halls, etc. What I did intend was that the drug lobbyists, not the drug firms themselves, have the run of the Congressional washrooms, etc., narrow stance, wide, or whatever.

The FDA is still given the edict to certify that prescription drugs are safe and effective. If they cannot do that, they have the obligation to "reject a compound" in a drug.

I would also suggest that if the drug makers do not believe they are being profitable enough, they should get into some other business. You know, someplace where they can after a hard day at work gather and munch their brie and wafers, sip champagne and laugh at whatever it is that turns them on.

I do not want you to believe that I am ignoring your latest comment.

There's a little matter of life that does take me away from this computer sometimes for hours at a time. Would you believe?

But never fear. You're not being ignored. At least not by me.

I'm really trying to understand your position, here, too, Doc.

As you say, the corporations' boards and executives need to do whatever it is to be profitable; the shareholders will let them know in no uncertain terms if they are not profitable enough to suit them.

For many years I worked for an antitrust lawyer. Talk of the Sherman Act was not a novelty. When the Antitrust Division of the FTC sued a client, we were busy for years.

There was a case where the bottom line was that a client had a better distribution system than its closest competitors. Usually this resulted in better profits; competitors squawked, and then the FTC bared its fangs.

The lawyers for whom I worked were very good. On most occasions the FTC found itself sans fangs after tangling with them. Most embarrassing for the FTC. Sometimes there was a settlement because the FTC knew better than to appear toothless there in front of God and everybody.

Part II follows.

I am against price-fixing. I am for competition. I am for free enterprise.

Perhaps you didn't read my earlier comments as thoroughly as you could have.

I will not dignify with an answer your statement that my position appears to you to be founded in socialism.

I am not expecting a “free lunch.” Some people do get things “for free.” Correctly speaking, some people do get things free, that is, without charge. That is, they do not pay for it directly. An example would be a sample prescription drug one is given by a doctor.

Another example would be drug research originated by the taxpayer-funded National Institutes of Health (NIH) handed over, gratis, to drug company researchers, who forever have use of that research for their own profit.

That's not a free lunch; it's a free dinner, with cocktails and appetizers.

That NIH research is believed to lead to many, many of what are called “me-too” drugs as well: drugs very much like an original drug, except with different names but with very little else different.

And please remember this: research and development expenses for drug companies are completely tax deductible. After receiving a lot of it, gratis, from taxpayers. That is adding insult to injury.

That's a free lunch with appetizers and cocktails before and dessert after.

Things that make you go 'hmmm':

Companies charged with creating drugs that will heal or remediate symptoms of illness then lobby to make themselves immune from lawsuits if their drugs injure... who will make drugs that 'cure' the injured... who won't have to pay for the injuries their drugs cause... who will make drugs to 'cure' the injured...

Any coincidence that Merck is having to pay damages to Vioxx victims at the same time they're pushing to make Gardisil mandated? They've got a leak they've got to plug, but --uh oh-- it turns out that Gardisil has 8 inconvenient deaths to account for. Hurry up, Merck; you've got to come up with another 'miracle' drug that the American people can't live without.

Thanks! I take that as a compliment.

Your subject is very complex. Often the FDA is as complicit as any drug company at attempting to keep a drug on the market or to prevent the need of a "black box" warning on the information folder. Drug companies would rather do almost anything than add a black box warning about a drug.

Naturally, they'd rather do almost anything to keep from having to take a drug off the market, too.

When it becomes necessary, they do it, but they do it with great reluctance and great embarrassment as well.

Of course, no drug is without side effects. Many times doctors will prescribe off-label just to benefit a patient with the side effects of a drug.

Some drugs, I believe called "orphan drugs," are manufactured at a greater expense than other drugs because they benefit only a small number of patients in the population -- that is, the disease being treated is so rare as to make it unprofitable for a drug company to make it. In those cases, the taxpayer comes along and "helps" the company with its expenses.

Merck probably took the path of least resistance with the Vioxx matter. It would cost less in the long run to settle than to defend every case.

I'm afraid I don't even know what Gardisil is.

This matter has complex legal and regulatory attributes, and it's impossible to exhaust all of the complexities in this venue. Frankly, it's something I wish I knew more about.

Thanks again for your comments. Thanks for reading!

Doc: Re your first line:

Now you're speaking my language!

Don't you know that what's in your comment is what I have been trying in my feeble way to say since beginning this blog entry and continuing with the comments?

Now, don't you know that I advocate free drugs for everybody? (Free everything, what the hay?!)

Now, don't you know I just can't imagine any American company making anything except by way of its stockholders' funds?

Now, don't you know I advocate not just Big Pharma but that every corporation in America lose tax write-offs of ANY kind? Don't you know that?

Now, don't you know that I believe in slave labor, and that drug researchers should be at our beck and call 24/7?

Bankruptcy? Nah, not for a drug firm. Even if they're zillions in the hole. Even if they've been sued to kingdom come.

Now, don't you just know that I believe in price-fixing?

Now, just do one thing for me, if you would, Doc, and that is this:

Just tell me where you see my "opinions" about any or all of the above. They come as a great surprise to me, but if you'll direct me to where you have seen such "opinions," then we'll both know. Not just you, but me, too.

Doc - When, when, when, did I ever say the company whose drug I still buy was wrong? What I did was state a fact: that "I was angry when, for about three months, I was able to purchase a drug at a generic price; however, because of legal patent wrangling, after those nice three months the drug went back to its original brand pricing. I was somewhat miffed at this jerking around. I really don't like being jerked around. I believe the drug came into being in 1987."

Never did I say that the company was wrong; what I said was that because of legal patent wrangling, after three months the drug went back to its original brand pricing. Having worked for lawyers (part of that time for antitrust lawyers, part of that time for intellectual property lawyers), I understand patents.

It appears that this particular drug has been on patent for about 20 years, and I would imagine that soon it will succumb, as all drug patents must succumb, eventually, to generics.

It's a little like saying "My God, for a long time I had to pay $4.00 for a loaf of bread; then for three months I was able to buy it for 50 cents; now it's back up to $4.00!" I was dismayed, but I was not pitching a hissy fit; I was NOT indignant.

Wanting to buy things for less is the American way. That is why I believe we are in this noxious mess with China's poisoned products.

I'm sure I was not the only drug customer to be somewhat surprised about this unusual circumstance. Never before that time was I able to purchase a generic drug for three months or so, then be told the generic cannot be sold anymore: the original patent holder was able legally to hang on to the patent, so the brand price must also be put in effect.

I understand legal wranglings. And I still pay whatever price is being charged. I don't have to like it, any more than we like the surge in gas prices. Most of us pay it anyway, grousing all the way down the road.

If I really wanted to stiff someone, I would have ordered the drug from Canada. However, I did not order it from Canada. I kept purchasing it either through my U.S. mail order source or from my local pharmacy.

There is something else I NEVER SAID; RATHER, YOU SAID IT: That is as follows:

"And you can write about your gored ox until the oxen come home, and besmirch me as a lackey of the drug industry....."

I NEVER SAID YOU WERE A LACKEY OF THE DRUG INDUSTRY. YOU SAID IT, NOT ME. AND I RESENT HAVING IT ATTRIBUTED TO ME.

You also mentioned something about my thinking as the Socialists think. I RESENT THAT INTIMATION WITH EVERY FIBER OF MY BEING. (See the first line of "For the record, Part II.)

I believe that if you go over every word I have written, being careful to put your not-so-shabby comprehension skills into effect, you will realize that I am the farthest thing from a Socialist as you can imagine.

And by the way, you didn't address my requests to be shown all the reasons for your beliefs in the incorrect ideas that you attribute to me. Don't bother. You can't.

I'm done.

I'm glad I'm not as tangled up in this defense as you are.

It is hard for me to believe you haven't heard of Gardisil... the highly publicized, highly advertised, highly controversial 'vaccine' for the human papilloma virus (HPV) which is known to cause some cases of cervical cancer.

The makers of Gardisil would have us believe that injecting preteen and teenage girls with 3 doses of this stuff will prevent as much as 70% of cervical cancer cases.

Reality check:
HPV cannot be contracted unless one is sexually active, but of course you can't buy any leverage with people by teaching abstinence. Clean living never made drug companies rich.

The majority of HPV cases go unnoticed and untreated, but will actually resolve themselves. No intervention necessary.

The remaining minority of HPV infections will incubate for years, usually never being noticed until a woman is into her late 40s or 50s. These are the ones at risk for HPV induced cervical cancer.

No studies have been done to prove Gardisil is effective beyond a few years (at best). Furthermore, no studies have been done to prove its safety in the age range now recommended for Gardisil (probably b/c you can't force as many adults into vaccines since they aren't all channeled through a school or other easily regulated organization).

What 'they' also don't say is that there are a ridiculous number of adverse reactions to the vaccine, including at least 8 deaths. Could it be due to the insane amount of aluminum in each shot, or one of the other toxic ingredients?

But you're archaic and out of touch if you actually tell teens not to have sex until they're married (to someone else who also has remained a virgin). Instead, the culture says, "Go ahead and have your 'fun'". Nevermind that your health and life are at risk when you do.

Check out http://www.vaccineinfo.org

I'm sorry about temporarily forgetting what Gardisil is. I knew, but it did not register with me when you wrote your earlier comment. The subject had died down for a couple of days.

My opinion is that there should be no government or school interference in the health care or sex education of peoples' offspring unless explicit permission has been given.

And any drug, where the long-term effects are unknown, should be shelved for the young until a whole lot more clinical trials have been held.

My husband was raised in a family that did not believe in vaccinations of any kind; the very first smallpox vaccination he got was when he joined the Navy!

Those were the days, I suppose, when government kept its big nose and big fist and little brain out of the business of Americans. Naturally, I was horrified to learn that my husband had not had any vaccinations when growing up, and I was glad he'd made it through without having had the need of them.

I believe that administering Gardisil is rather on a par with dispensing birth control pills to fourteen-year-olds. I do not believe that even now the FDA or the medical community has made any decisive pronouncements about the long-term safety of birth control pills. There always seems to be some divergent opinion in the drug community.

In my opinion, unless the "government" is ready, willing and able to catch the fall-out resulting from the administration of Gardisil or the dispensing of birth control pills to young girls, it needs to keep its nose out of parents' affairs.

I wish you success in your position with respect to Gardisil. You will naturally need to do a lot of letter-writing to those people we send to Washington to do our bidding. Our bidding, not theirs.