Janet Woodcock, head of FDA’s CDER, strikes me as the type of person you’d want in charge during a crisis.  And that’s exactly where FDA, and CDER, have found themselves this year, so I’m not surprised that Dr. W. was reassigned from her post of Chief Medical Officer and Deputy Commissioner to head up CDER.  Using the triage imagery of the Emergency Room, running the Critical Path initiative is important, but maintaining control of CDER, drug review and inspections, is urgent.

A few years ago the American Cancer Society used vanity to help women stop smoking. Apparently, cancer, stroke, and heart disease weren't convincing them to quit, so the ACS used vanity: it disclosed that nicotine caused capillaries to constrict. Now, that didn't matter when it came to lung disease, but it caused crow's feet, too! In other words derath wasn't as scarey as looking older.

Now, last night, I saw a commercial for ED. Plenty of those around, you would say. However, this one was pushing a cholesterol lowering product. Seems that when your arteries clog (forget heart attacks and stroke), a certain organ doesn't get enough blood. Seems that men care more about sex than health. So, vanity is not the property of women...both genders seem to care more about appearances than their health. (Ask any body-builder about his steroid use and see what I measn.)

 Good thing Proscar grows hair, too, otherwise we'd all have enlarged prostates!

Are health costs too high? Yes! Are the pharmaceutical industry-types to blame? Not so much. The "cost" of health care that includes drugs is only a small fraction of what we spend. The far greatest cost, from knowing a number of doictors, is the "cost of doing business."

The reason we are losing OBY-GYNs in this country is that, no matter how much a pregnant mother smokes, drinks, uses drugs, and makes other unhealthy life choices, whan her child is born with any type of infirmity, there is a lawsuit against the doctor who delivered the baby. Insurance is so high, trauma  to the doctors' families so bad, most either opt out of the practice or forego entering it, in the first place.

In so many cases, when a patient dies during an operation, there are "ambulance-chasers" there to sue the anethesiologist. Insurance for anethesiologists was over $100,000 a year in 2000. Lord knows what it is up to now.

To avoid lawsuits or be given cover in the inevitable ones, doctors order many, many more tests than are warrented for all patients. The appearance that "we did all we could" needs to be maintained...for the inevitable court appearance.

Do doctors, nurses (underpaid and understaffed), and pharmacists make mistakes? Of course. Last time I looked they were still human. Part of the problem is that hospitals are overcrowded because the "Emergency Rooms" are the only place many millions of (uninsured) people can get any type of care. The result? Crowded hospitals, stretched personnel, pressure on facilities and equipment. The end result? And mistakes by harried health care personnel.

We don't seem to care that the massive American embassy in Iraq will cost $2+ billion a year to maintain or that the war has cost (directly) $400 Billion (so far... plus the rehab costs for Vets in the future and replacement of all the equipment left behind), why should we fight so hard not to spend a few hundred million to insure all Americans? If all people had access to yearly exams and preventative medical care, there would be fewer "emergencies." If we get dental check-ups and fillings, there would be fewer emergency extractions with resultant complications.

Remember the old commercial: "Pay me now or pay me later"? 

The "whipping boy" in the title is the pharmaceutical industry. They make a profit, so they are bad! Hey! Could we start with "Big Oil" who is, after all, merely "passing along costs" and scraping by with $40 billion/quarter profits? Whatever the faults of Big Pharma, they are still saving millions of lives. Or, have we forgotten Malaria, Small Pox, Polio, etc. already? 

Since (as I mentioned) the "cure" for drugs in groundwater is not going to happen quickly, there is something we can do right now. There are, approximately, 20 million people without healthcare in the US of A at the moment. That means they might be able to get medical attention at a hospital emergency room or free clinic. However, they may not be able to obtain needed medicines.

Since the first step in groundwater remediation is analyzing what is in the water at the various locations, anyway, we can use this information in the meantime to alleviate one other problem. Whynot publish the information of which drugs are at which location? That way, if someone needed Prozac, they could be sent to City "X" and drink the water. Need a "statin?" Why, just move to City "Y." We will know the levels of each drug, so the emergency room doctor can prescribe how much free water each patient should drink each day from the tap at any given city.

This will modify a common phrase to "drink two gallons and call me in the morning." But, it will be (as Ann Landers used to say) "when life hands you a lemon, make (highly diluted, in this case) lemonade."

Thus, we will be (pun intended) "killing two birds with one stone."

There have been reports lately about prescription drugs being found in our drinking water. The levels are relatively low, so no flares were sent up by the EPA. It is somewhat like the lead in toys from China: probably been there for some time, just not looked for until now.

The source of industrial pollution is somewhat easy to discover: air monitoring at an indistrial site, checking the effluent from a plant, looking for seepage from underground tanks are all standard procedues for state and the federal EPA/DoEP. But, where do these drugs come from?

Well, as I once pointed out to a friend, individual humans are a terrible source of pollution. [Imagine the formaldehyde from cemetaries, not to mention the plutonium in buried pacemakers because we didn't want to desecrate poor aunt Myrtle.] We excrete both unused drug entities and metabolies continuously. Multiply what we excrete by millions and you see where we are.

The problem is made more difficult by the huge number of chemicals, all physiologically active, we need to screen for in drinking water. Literally thousands of chemicals, not to mention industrial chemicals, need to be discovered and removed from or water supply. This will not be fast or inexpensive. New and better ways are going to be needed to bring our water back to where it is, once more, the elixer of life....and we can once again recommend drinking at least 6 glasses a day.

Bottled water is suggested as an answer to the pollution by drugs (by bottled water sellers, obviously). One minor problem with that idea: most commercial bottled water comes from the same municipal sources we all use right now. Obvioulsy, merely passing it through charcoal doesn't work, since that what many municipalities already do! (Forget for a minute the benzene found in Perrier a few years ago: that was an industrial accident.)

So the water bottlers want you to believe that paying $20/gallon for their water, pumped from the same sources you are already drinking makes them any safer? To answer Agnes' blog (On Pharma) question: Evian spelled backwards is Naive...what the bottled water people hope you are! Me? I'll stay with single malt whiskey for now. (After all, "whiskey" is an Irish word for water of life, anyway ;-D)

I'm in New Orleans for PittCon 2008. I was teasing a saleslady who was yawning at midday, when I learned something. She was tired from going out after work, buying as much bread and "fillins" as she could afford, making sandwiches and taking them to the 400+ homeless under the nearby underpass. She felt bad that she could only make 100 or so sandwiches, but was doing the best she could.

Now, I may be going out on a limb here, but I suspect that, since they have no homes, food, or clothing, they probably have no access to medicine, either.  

While PhRMA only sounds a little like FEMA, I fear they are doing about the same level of good works down here. My guess is that, in its (PhRMAs) rush to profit, there is little thought of the many homeless here. In fact, the "fabulous" mobile homes brought in by FEMA will be taken back by summer [while occupants are advised to open trailor doors and windows to allow the formaldehyde to vent, FEMA employees are warned not to even enter them!], leaving many, many more homeless. Apparently, insurance companies are shorting the people on refunds, demanding they repair their homes themselves, THEN they will reimburse them!

There are a bunch of St. John's University (NY) students down here volunteering along with Harry Connick, jr. and Wynton Marsalis...but I saw no government-funded work proceeding. [The new levees I did see looked weaker than some handball courts in NY.] One of the peple on the tour commented that maybe the NO residents shouldn't rebuild under sea level. I pointed out that most of the Netherlands was farther below the (North) Sea than NO, we build on earthquake faults in California (even, I understand, a nuclear reactor on the San Andreas Fault), rebuild Florida and the Carolina barrier islands after every hurricane, and, don't forget the mudslides and fires in California.

But, the poor African Americans in New Orleans shouldn't rebuild? Need I mention how most of the other cases I mentioned voted in 2004 versus how Louisiana voted? Hmmmm...coincidence? Of course, it might be easier if the Lousiana  National Guard weren't "busy" elsewhere, but that's another story...

Anyway, how about medicine for the people under the bridges? No? Shame, shame, rich companies! ("Heck of a job, Brownie," to quote another "big help" down here.)

As my wife and I were returning by train from "The City" last night (if you need to ask "which city?" you don't live on the east coast), we were listening to a group of teenagers. It was satisfying to actually hear them discussing the presidential election. Some of their comments on positions were simplified to the "bumper sticker" (a.k.a., "Karl Rove" slogans) level. One lad stated thet the biggest difference between Democrats and Republicans was that the GOP wanted less regulations a' la smaller government. (He backed his claim by saying "liberals" wanted more because they are on the left and, if you move all the way to the left, you get communists...who want total control. Wonderful sophistry...]

I wanted to comment on that idea, but they got off the train before I could speak with them. The "fine tuning" would have been that the GOP wants less laws affecting business. Hence "RR" gutting the FDA staff and firing all the air traffic controllers... and "W" cutting staff such that there is one person in one lab checking all the imported toys (now, are you still surprised by the lead in toys?). The idea is free enterprise should be allowed to lead to monopolies (check out AT&T now as compared with before it was broken up...see any differences?), not to mention thiose pesky USDA inspectors that just slow down the meat to our tables. And, who cares that Exxon-Mobile makes obscene profits while the economy goes in the can?

Less government is a noble idea...except, in a complex modern society, citizens can't test for tainted meat, lead in toys, counterfiet drugs, and drug safety, in general. Just as we can't build our own roads and install sewage lines; some government is a necessity! The choice of which laws are passed and enforced is the crux of what we should be watching... we could just need more FDA inspectors...

Of course, when it comes to personal liberties, "father knows best" is the theme of the "small government crowd. Can't have laisse faire in our lives, can we? We need to be told what forms of sex to have and with whom, who we can and can't marry, and whether a woman can control her own body. Oh, by the bye, if you check the government website, it will tell you the proper way to dispose of an American flag is to burn it. Screws that amendment, no?

And, to think I believed water-boarding was a summer sport...

Now it appears that the Heperin distributed by Baxter (that caused illness and deaths) came from a plant in China (What? No lead this time?) that had been "inadvertently overlooked" by the USFDA for pre-production inspection. Oops, I did it again (even more appropriate considering what's happening to Brittany)! We are asking the FDA to do more and more on no more people or facilities. Guess we reap what we sow...

My wife has compared taking drugs to Russian Roulette: first you have to worry about counterfeits in the system, then you have to worry that you actually did get the correct drug. It is getting to be like playing with more than one shell in the chamber, no?

It's not as if heperin is a new drug or anything, is it? Seems like we have to re-visit ancient Greece. Remember, "First, do no harm?" Maybe, in our rush to find a quick fix to everything, we should consider lifestyle changes first. High blood pressure? Take a pill, don't lose weight. High cholesterol? Another pill, keep eating the Whoppers. Legs hurt? Can't be lack of exercise, let's give it a name: Restless Leg Syndrome...and make a new medicine for it. Overweight? Well, now it's a recognized condition...you can call in "fat" to work and stay home (presumably to have a few more Whoppers). And the beat goes on...never take the blame for what we can name a syndrome for.

QbD and PAT can give us more consistant products. Maybe we should look hard at ourselves and ask why we need so many products. Any chemical, any drug affects the body...and not always in a good way. [Even aspirin, around for over a century, makes the stomach lining bleed.] Even water has an LD50, so what does that say about drugs? Since so many are taken merely to alleviate symptoms, we may want to work on the cause of the symptoms and stop taking so many chemicals to save ourselves the trouble of taking responsibility for our own lives.

Sorry for the run-on sentence...must be a syndrome of some kind.

There are so many 800 pounders that I don't know where to start.  I merely look at what the candidates aren't talking about and I see a bunch.

What about Medicare drug pricing? Our "mission accomplished" crew, so recently departed and departing, forbade the Medicare folks from negotiating for a lowest pricing (a la' Canada), ensuring drug company profits remained up there.  Ever hear that mentioned by all the "Change" candifates? Hmmm...

What about the multi-trillion national debt? El Presidente cites a "mere" $400 billion deficit for 2006/7. That is calculated by leaving out Medicaid, Medicare, and Social Security benefits paid. When looked at carefully, the number closes in on $1.3 trillion! My understanding is that the debt run up by the current administration is greater than all the past presidents, combined! That includes the Civil War, Spanish American War, WWI, WWII, Viet Nam, Korea, etc. and all of Roosevelt's programs during the Depression. If debt is the answer, Mission Accomplished! Not one spending bill was vetoed in the last seven years! (Over 1100 "signing staements," though...)

Oh, yes...global warming? I don't even have time for that one...Al Gore, save us please!

What experiences do pimps, Tony Soprono, and pharmaceutical executives have in common? (No, not that.) When they are levied court fines that don't come close to the monies they got through "less than honorable" ways. A fine that one of the "girls of the evening" pays is considered "the price of doing business" by the pimp. The bribes Mr. Soprono pays? The same thing, no? When a company sells billions of dollars worth of (contolled) drugs, partially based on fraudulent lab data and clinical results, what happens? Well, recently, some fines and no prison time.

I would humbly suggest that the "time should fit the crime." Would companies think twice about policing its execs if, for instance, they were given a "poison pill?" Using the NCAA for an example, perhaps the company would have to pay all the monies from fraud and be given a two or three ban on any NDA submissions. Too harsh? I have often thought that embezzling $5-10 million and getting 5 years and not being required to return the money would be a pretty sweet deal. Imagine, 5 years in a white-collar prison and then never having to work again. Many people will take that deal.

Until companies are made to pay (big-time), they will "wink-wink, nod-nod" continue to keep a sharp eye on the behavior of their executives. Yeah! Sure! Gotta go now, I'm expecting the Tooth Fairy.