In case the direction I was coming from was unclear, I was specifically referring to patent protection for pharmaceutical products – drugs. I’m not following how a successful new drug patent could fail to possess serious commercial value.

Obviously I’m aware of the fact that for every new “wonder drug” there are dozens (hundreds?) of failures, millions, tens of millions, even hundreds of millions of dollars “wasted” on research that never pans out, but when the research DOES pan out… I want the innovator – the discoverer – to get the reward, to make back the R&D costs plus substantial LONG TERM profit. I don’t want the generic drug manufacturers getting fat and happy on the intellectual property and risk of the developer.

As I understand it, “the clock” on drug patents starts prior to full FDA approval and mass market consumer sales. (Correct me if I’m wrong.) But in any case, I’d say that those who come up with the “wonder drugs” should be the ones to control sale of THEIR drugs for a bare minimum of 20-25 years – perhaps even 30… even 40 years.

Basically, doc, I want to spur innovation – keep the best and brightest churning out brand new wonder drugs. The effectiveness of the medicine – and of getting lots of effective new medicines out into the market – is what I’m concerned with.

“There are more advantages than disadvantages to handling discovery globally than provincially now that the producers of these patents are multinational entities.”

Hmm. Yes. I see your point. My buddy is a drug rep for Genentech – now wholly owned by Swiss pharmaceutical conglomerate Hoffmann-La Roche.

Still… that’s the finance end of the business – the “business” end of the business. Although we’re not what we once were, it’s my understanding the American is still at the forefront of pharmaceutical research and product development. There must be a reason for this. It must have something to do with America and Americans. (Or do you think I’m wrong?)

The last thing I want is for a “multinational” pharmaceutical industry and world standard that does to drugs and medical research what the UN has done for Peacekeeping. (*SMILE*) (In other words… largely failed.)

Frankly, I’d like American pharmaceutical companies to remain American pharmaceutical companies (or reemerge AS American pharmaceutical companies if they’re presently part of multination’s as Genentech is) and I’d like our government to protect our pharmaceutical companies interests – yes, including profits… profits that all them to keep on doing what they do best.

ANYWAY… (*GRIN*)… we got kind of sidetracked there, huh? (*SMILE*)

“The biggest financial complaint I hear from patients is sticker shock when they go to the pharmacy.”

I hear ya!

“If you look at the shelves of my sample closet there are almost no unique or innovative products developed this decade, only extended release forms of products of the 1980’s repackaged to keep the price higher.”

Yep. I’m aware of this also.

But this is what I’m getting at… HOW do we address these concerns so as to change things for the better – not screw things up for the worse. (*SHRUG*)

“The companies are really not developing, or bringing to market, the products like SSRI’s, statins, ACE inhibitors, H2-blockers that transformed not only the diseases that we treat but the way we look at fundamental disease processes.”

Why not…???

I mean, assuming that the pharmaceutical didn’t just “decide” all of a sudden to “lead with greed,” what’s different nowadays compared to days gone past?

Is it taxes…??? Is it the patent system…??? Is it our litigiousness society…??? Is it the FDA…??? Is it the politicians…??? Is it the doctors… the hospitals… the patients… the insurance companies…???

Do. I want “good drugs at fair prices” and I want as much if not more “innovation” than we’ve ever had in human history. How do we achieve this…???

“Much of the pioneering work is too high risk for stockholders to tolerate…”

Yes. So you say. But WHY…??? What’s different about 2009 vs. say 1999… 1989… 1979… 1969… 1959… and so on and so forth back as far as you wanna go?

Put another way, if you were “King Furrydoc,” unchallenged ruler of America, how would you command “the risks” be lowered to a level where stockholders could and would tolerate them?

“…with the rest of the world not sharing those high prices that American patients are asked to pay…”

Ahh… now we’re again making progress. We’re back to the logic out of which my original patent question came out of! How do we MAKE the world “pay their fair share?”

It seems to me THIS is why we need an AMERICAN pharmaceutical industry whose rights are PROTECTED by the full resources of the United States government. If an American company creates a cure for AIDS (or whatever) that drug should be protected by patent. The Canadians and the Russians and the Chinese and EVERYONE should be paying the same costs for the drug as Americans do. And if foreign companies – backed by foreign governments – violate our patent laws… then we come down on them like a ton of bricks.

Anyway… (*SHRUG*)

BILL

My wife is a patent agent with one of the worlds most prolific patent generating corporations. Very few have serious commercial value. Current patent duration was changed not that long ago from 17 to 20 years but the starting clock was set at a different point to bring American patents into conformity with the rest of the world. We’ve not yet succeeded at lengthening football fields to 100 meters. There are more advantages than disadvantages to handling discovery globally than provincially now that the producers of these patents are multinational entities.

The biggest financial complaint I hear from patients is sticker shock when they go to the pharmacy. I myself allowed one of my own prescriptions to lapse after a month because I didn’t think it was worth what the pharmacy charged. If you look at the shelves of my sample closet there are almost no unique or innovative products developed this decade, only extended release forms of products of the 1980’s repackaged to keep the price higher. I can say the same thing about the anti-obesity drugs that look most promising: repackaged items of combined old products. The companies are really not developing, or bringing to market, the products like SSRI’s, statins, ACE inhibitors, H2-blockers that transformed not only the diseases that we treat but the way we look at fundamental disease processes. There are some useful things out there but they are often niche products misrepresented by company representatives as things all people should be taking.

The development of new compounds has shifted over two decades from exploratory work of corporate labs to university or small start-up projects where discovery can then be sold to larger enterprises for the studies required to confirm safety and efficacy. Much of the pioneering work is too high risk for stockholders to tolerate so it has to be funded from taxpayer grants. The regulatory and development process costs are also too high with the rest of the world not sharing those high prices that American patients are asked to pay to subsidize development of the next stage of marketing. If you look at the history of the pharmaceutical giants over a generation, CIBA and JR Geigy caused quite a stir when they merged in the 1960’s. In the last two decades most of the large players have consolidated in some way with the combined research force numbering much less than would be the case if each company maintained its independence. For the first time, profit margins far in excess of other industrial companies are far less assured.

furrydoc

“…hirsute endocrinologist who treats hirsutism…”

Ahh! (Thanks!)

“At the risk of stigmatizing people, sloth and gluttony need to be made uncool, much the way smoking has been.”

I totally agree!

“Now we have large enough beds, commodes, lounge chairs, machine lifts that a petite nurse can operate and a bed scales that have now replaced the hospital loading dock as the source of accurate weight measurement. At K-Mart et al, one can now be fashionably obese. While these measures reflect kindness to people, which probably should continue, it also reflects a public acceptance of obesity as inevitable and intractable.”

Yep. Where do we place the line between “kindness” and “enabling?” (*SHRUG*)

“If the goal is less disease and more productivity of its citizens, which I think is the purpose of public policy, then some key decisions have to be made. Does fast food and Shabbos morning breakfast cereal advertising need to be regulated? The State of New York in the 1960’s required me to take gym a certain amount of time from grades 1-12. The Talmud obligates a parent to teach his son how to swim. In high school I had to take an annual test of agility, strength and endurance. My kids did not. There is a pervasive medical literature spanning many illnesses correlating health at age 50 with educational attainment at age 20. So maybe a public effort should be made to identify all those underperforming overweight sleep apneic kids, get them C-Pap machines and prod them through high school or bring back the draft so at least the male half of the population gets their physical condition upgraded.”

I too believe that our schools need to SERIOUSLY deal with our childrens’ physical as well as intellectual development. (Now given the piss poor job they do at the later, even as they insist that’s where they’re really trying, only God knows how viable my call is… but, hey… let’s TRY it!)

And, yeah… I’m all for bringing back the draft. (And yeah… before someone posts about how the military itself doesn’t want a draft because they feel an all volunteer force is more professional and therefore will be more proficient and effective… I’LL TAKE MY CHANCES and vote “aye” for a draft anyway.)

“Ultimately though, I regret to say, that drug therapy will need to emerge if weight reversal is to occur to a large enough extent to reverse established weight related disease on a population wide basis.”

Yep. No doubt.

“There has to be publicly generated funds or public policy to encourage private corporations to undertake this research and development.”

I don’t see why; if any effective drug therapy seems like it would be a huge profit center, truly effective weight loss drugs with few side effects sounds like they would fit the bill.

Doc. I’m interested in why you feel that private corporations would have to be “encouraged.” Please expand upon your statement. (Also… question: I’m a big believer in EXPANDING AND EXTENDING Patent protection; would you mind sharing your view?)

“Limiting pediatric medical care to slim doctors or requiring surgeon generals to camouflage their girth by purchasing a uniform one size above what their tailor recomments doesn’t really reduce the scourge of obesity related illness, now or into the future.”

Perhaps not… but it’s a step in the right direction – it send a message. “Dress for success” isn’t just about clothing – or at least it shouldn’t be. The Surgeon General of the United States should look fit. Very few fat people truly look fit. No offense, but Dr. Benjamin doesn’t look fit.

HOWEVER… as previously noted… neither I nor as far as I know is saying she shouldn’t be appointed period; what I’m saying and what others have signed on to is that if she’s going to take the job, she should publicly pledge and publicly act in such a way as to lose weight and get fit. In other words, she should serve as a role model, of a “I practice what I preach” role model.

Anyway… I hope you can make time to pop in occasionally and post.

BILL

My perspective differs from that of the doctors noted in the article largely because the people I see already have weight related disorders. Nothing gets a person’s ear like having a trusted primary doctor creating added seriousness by referring to a specialist. The approach I take, which I hope a Surgeon General of any dress size will endorse, is to first correct the immediate medical problem, meaning insulin or other drugs to correct the diabetes even if the weight control has to be sacrificed. Smoking cessation even if weight control has to be sacrificed. Then we talk about weight control which takes four stages: Step 1, self-directed diet of their choosing–whichever they think they are most likely to actually follow with a second self directed diet if the first one fails, which is most of the time. But at least they got to convince themselves that it’s time to bring in another person. Step 2, the assistance of another person, usually a diet program. Any commercial program or church group will suffice, though for people with really serious medical problems I send to my top dietician and her superb program. The medical literature supports the advantage of supervised dieting over self-directed dieting, at least while the supervision is in force. Step 3, medication. This one is filled with misadventures: amphetamines of the 1960’s,fen-Phen, redux of blessed memory, Accomplia in Europe. At the moment we have orlistat which is not really patient friendly stuff but reasonably safe, sibutramine which is n0t really all that much better than prozac that you can now get for $4 a month and stuff they sell without a prescription but occasionally gets pulled from the shelves to protect public safety. There are clinical trials of several others that give consistent weight reduction though with 50% failure rates if you call 5% weight reduction a success. Step 4, surgery. This really does correct medical problems at reasonable risk relative to the diabetes, sleep apnea or immobility.

As people go through these steps there is an element of determination and an element of frustration and often self-blame. For the children it is particularly difficult since underperformance in school from sleep apnea driven sleep deprivation is not always obvious and the trump card of surgery really isn’t there until one reaches the late teens. And when you take histories of obese diabetics who you would recommend gastric bypass, you frequently find that they were the fat boys in school, decades before the epidemic of obesity and diabetes arrived in our current medical consciousness.

Public policy, which is what David suggested I comment upon? At the risk of stigmatizing people, sloth and gluttony need to be made uncool, much the way smoking has been. A certain amount of empathy has to go with those patients and people have found a way to make a buck on the prevalence of obesity as well. As a resident in the 1970’s a 500 pound patient would send the medical student on an errand to the hospital maintenance unit to get a couple of C-clamps to construct a bed from two standard beds. Now we have large enough beds, commodes, lounge chairs, machine lifts that a petite nurse can operate and a bed scales that have now replaced the hospital loading dock as the source of accurate weight measurement. At K-Mart et al, one can now be fashionably obese. While these measures reflect kindness to people, which probably should continue, it also reflects a public acceptance of obesity as inevitable and intractable.

If the goal is less disease and more productivity of its citizens, which I think is the purpose of public policy, then some key decisions have to be made. Does fast food and Shabbos morning breakfast cereal advertising need to be regulated? The State of New York in the 1960’s required me to take gym a certain amount of time from grades 1-12. The Talmud obligates a parent to teach his son how to swim. In high school I had to take an annual test of agility, strength and endurance. My kids did not. There is a pervasive medical literature spanning many illnesses correlating health at age 50 with educational attainment at age 20. So maybe a public effort should be made to identify all those underperforming overweight sleep apneic kids, get them C-Pap machines and prod them through high school or bring back the draft so at least the male half of the population gets their physical condition upgraded. Ultimately though, I regret to say, that drug therapy will need to emerge if weight reversal is to occur to a large enough extent to reverse established weight related disease on a population wide basis. There has to be publicly generated funds or public policy to encourage private corporations to undertake this research and development.

Limiting pediatric medical care to slim doctors or requiring surgeon generals to camouflage their girth by purchasing a uniform one size above what their tailor recomments doesn’t really reduce the scourge of obesity related illness, now or into the future. My guess is that given the recent track record of the public’s perception of republicanism, this type of political capital may reinforce that perception of a party that chooses the trivial symbol of the reality of tackling a difficult problem.

I hope the perspective of a lot of time in the exam room has been of benefit.

furrydoc

(Just curious… or you a vet… a very hairy doctor… or is it just a weird handle?)

OK. The article –

First. We’re talking schmucks. The doc… the mom… schmucks. Lazy. Stupid. Irresponsible. Weak.

“When she gets home from a long day at work, she told me, she knows she really ought to tell her three children to turn off the television and ride their bikes, while she is cooking broccoli and salmon for dinner.”

Then frigg’n DO IT! Jeezus frigg’n Christ… laying aside the meal choice for the moment, what the above sentence tells me (the inference being…) is that the ADULT can’t take it upon herself to PARENT her three children properly. Period.

Next…

“But I was as conscious of my own body as I was of hers. How on earth, I was thinking, am I supposed to give sound nutritional advice when all they have to do is look at me to see that I don’t follow it very well myself?”

Whine… whine… whine; me… me… me…

Jeez! Suck it up, doc! “Do what I say, not what I do.” There’s a REASON we’re all familiar with that line.

Here… pro bono advice to that doc: Tell your patient, “Just because I’m a schmuck doesn’t mean you have to be a schmuck.” Simple. To the point.

“The advice we’re supposed to give in pediatric clinic, it boils down to ‘Eat less, exercise more,’ ” said Dr. Julie C. Lumeng, an assistant professor of pediatrics at the University of Michigan Medical School and an expert in childhood obesity. “This is such blasphemy, but when I deliver this advice to families, my heart’s not in it, because I just feel like so often the families are just glazing over, and when that advice is delivered to me, I glaze over, too.”

Perhaps Dr. Lumeng should seek a new and different career. Hey… I’m absolutely serious. If I were her boss reading this… let’s just say it wouldn’t be good for Dr. Lumeng’s career.

We tolerate NONSENSE. That’s the bottom line. We have doctors who won’t do their jobs, parents who won’t do their jobs… what the hell is the matter with people…?!?!

“Back in the exam room, with that 8-year-old, I took some early and unsure steps toward discussing the topic. I showed her her growth chart, on the pink (for girls) graph paper. See, I said, you’re growing — you’re getting taller, and you’re adding muscle to your body as you grow. But we need to give you time to get taller before you add more weight. And we talked nutrition (cut back on sweet drinks, fast food, eating in front of the TV), and we talked exercise (how about tap dancing, soccer, swimming lessons?). And finally I looked the mother in the eye and said, without planning to say it, “If this were easy, I would be thin and fit.””

Schmuck. (*SHRUG*)

Schmuck. (*SHRUG*)

Hmm… with my ZERO years of pre-med coupled with my ZERO years of med school and my NON-EXISTENT medical license allow me to “prescribe” a mother-daughter (whole family preferably) appointment with the nutritionist… dietitian… personal trainer – whatever.

Furrydoc – Thanks for bringing the article to our attention.

BILL

http://www.nytimes.com/2009/07/21/health/21klas.html?_r=1&ref=health

Do you know what the heck these “white box” comments (example: Comment #34) are all about or where they’re coming from?

Anyone…???

BILL

While food may be where smoking was in the 1960’s, there is a lot of public support for agricultural policies that keep food plentiful, purchases of inexpensive food reasonable accessible to Americans irrespective of income, legal tolerance of advertising that encourages people to eat more, and gutting of school requirements for a certain amount of physical activity mandated by the school system. And there is a body of medical study that consumption of that available food may be regulated in a manner that maintains weight in adults and promotes size in children.

So while eating generously and beyond one’s caloric needs is currently encouraged by public policies, gluttony has been discouraged from the time of Pope Gregory, something uncool. A good public illustration of this took place on the Aunt Jemima Pancake box over the last generation. This morbidly obese icon of my childhood slimmed down in one or two stages, though more to eliminate stereotype than to promote dietary restraint.

FYI: My Body Mass Index is 23.2