Modern Medicine

[Haggis@wk]

IMAGINING A WORLD WITHOUT THE FDA:

Since 2005 the FDA has approved 18 new cancer drugs, many of them breakthrough products. But the pipeline contains hundreds more that will never get to market because corporate developers aren't able, or willing, to come up with the money, time, and patients necessary to establish acceptable data.
...
The clinical trial process now is a three-part, years-long effort that effectively kills off all but a handful of once-promising drugs.
...
It would have been the first new drug for prostate cancer in 20 years


Twenty years! Just stop a moment and think about how far and fast biotechnology and medical science has moved in the past twenty years. Think about what the far less regulated computing industry has achieved in the same timeframe. We live in the early years of the biotechnology revolution, with something amazing and new demonstrated in laboratories every week. Yet the dominant regulatory body for one of the most advanced regions of the world has managed to stop the clock at 1988 for a major disease, the subject of research in a hundred laboratories worldwide.

This situation exists in every field of medicine, and all participants labor under the crushing burdens imposed by regulators incentivized to stop progress from happening. The same will be true of the future of longevity medicine, unless we do something about it.

The insanity of this all is quite staggering - that people largely accept and defend the need for regulation that achieves this sort of result, that is. I have heard it said that the failure of libertarianism, of the urge to freedom and personal responsibility, is a failure of imagination on the part of those who have been brought up knowing nothing other than government and regulation on a massive scale. The majority cannot make the leap to see an unregulated marketplace for medical development that works in the same way as the unregulated marketplace for computers - enormous choice, low barriers to innovation, efficiency and low cost, competing review organizations, accountable sellers, rapid progress and responsiveness to customers driven by fierce competition, and so forth.

What is, is, and to propose another way is already an uphill battle regardless of merits. That is also hardwired into the human condition. But the present dismal state of affairs must be changed if we are to see the defeat of degenerative aging in our lifetime - nothing short of a revolution is called for, given just how far in the hole we find ourselves. The technologies needed to repair aging will take only a few decades to develop, and indeed some already exist in prototype, but the present regulatory burden placed upon medical technology will ensure we are all dead and buried, that wondrous potential squandered.

[Shapley]

Ah! To live long enough to see longetivity become a reality!

[Selma in Sandy Eggo]

I'll agree that the regulatory burden on pharmaceutical companies is huge. There's also another hazard out there - lawyers.

While I've been convalescing I've watched more than usual amounts of TV. At unusual times. There are a whole lot of commercials run by lawyers who are filing, or seeking to file, class-action lawsuits against drug manufacturers and who are actively seeking clients who may fit into a case. It's obscene.

Nothing is risk-free. The only guarantee in life is that life itself is temporary. Any drug capable of changing your normal body metabolism to produce a desired effect is also capable of producing side-effects. This should not be news to anybody and unless a known side-effect was concealed by a drug company, accidental harm done should not be actionable.

[dai bread]

One word here- Thalidomide.

[Selma in Sandy Eggo]

One word here- Thalidomide.

Yup. Not suggesting that we eliminate regulation or liability: it's just that in the US the liability angle is being worked to death by hungry lawyers.

[jamiebk]

It's amazing too that so many flawed drugs still seem to get through "the system"...Vioxx comes to mind.

[Haggis@wk]

One word here- Thalidomide.

Thalidomide: Research advances in cancer and other conditions

Thalidomide is part of the problem we're facing now. After the effects of thalidomide were known our Congress (those well known scientists and pharmaceutical researchers) determined that our process to approve new drugs needed to be lengthened even though the drug was never approved for use in the U.S.

As jamiebk points out there are, and probably will be, drugs that have reactions that need to be fully examine. But what is not discussed is the fact that Thalidomide, Vioxx and other drugs were never the bogyman killer drug they were portrayed to be and they still have uses, albeit with greater caution that might have been indicated before.

Hollywood and lawyers have done the American public grievous harm; the former to hype (Erin Brokovich comes to mind) the latter - as Selma points out – to courtroom extortion.

The bottom line is there are proven treatments and effective drugs that might never see the light of day because of perceived or possible side effects raise a specter of lawsuits that drug companies don’t want to bother with.

[Shapley]

A big part of the problem is over-prescription of new drugs.

Drug companies advertise on television, with the disclaimer at the end that says: "Ask your doctor of ______ is right for you." People rush to their doctors to get prescriptions for these new wonder drugs, and the doctors seem willing to write them. I have to wonder how many of these doctors are actually determining whether or not _______ is right for their patients.

My stepson was placed on a particular medication at one time, two pills/day. Quite expensive, too, if I recall correctly. We later took him to another doctor, who asked why he was receiving so much. We told him that was what the doctor prescribed. He became quite agitated and told us that the body could only absorb so much of the medicine and, given the stepson's small size, he probably couldn't absorb one pill, let alone two. Most of the medicine was merely being flushed down the toilet, as it just passed through his body.

There was an article a while back about the alarming amount of medicines found in our drinking water. The article indicated that most of it was there because it is not absorbed through the body and is passed through urine, which finds it way back into the drinking water supply through the water cycle.

I've always wondered at the 'one size fits all' dosages on many medicines. "Adults and children over 12, two pills every four hours". The same dose for a 95 lb. grandmother as for a 250 lb. man? It hardly seems proper. I think our pharmacists and pharmaceutical companies are doing a poor job of regulating the product they sell. I wonder who determines those dosages?

V/R
Shapley

[piqaboo]

Having spent time wandering thru the FDA's website, reading warning letters etc, I'm all in favor of an FDA-type agency. Remember the Lilly drug NIAU for HBV, that worked like a charm , then ~ 3 months in, caused catastrophic kidney failure? http://www.healthforyou.org/m/medical/fialuridine.htm Me, I'm all for an FDA.

All a new drug candidate has to do is show its: more efficacious than the existing standard of care, or otherwise beneficial to the patient.
"Otherwise beneficial" includes:
Works no better but fewer daily doses needed
works no better but better tolerated
works no better but less risk of serious side effects
works no better but less expensive

Cancer drugs can get approved if they can show an average increase in life-expectancy of days vs the existing standard of care.

Cancer drugs havent taken nearly the hit that contraceptives etc have. The Dalkon Shield lawsuits much shut down that industry. I cant remember the name of the drug, but it turned out to cause cancer in the female children of women who had taken it - not a happy outcome. Still - do you conduct a 2 generation study?

Clinical trials are incredibly expensive & many many drugs dont get thru the three trial process. Still, whining about the money is silly. If you dont think your drug is good enough, you wont put it on trial. There is even an 'orphan drug' status, for drugs to treat diseases that are sufficiently rare that there is no profit potential.

Safety trials start with 10-25 people, typically. That's a Phase I clinical trial.
It tests whether the drug will kill people outright, essentially.
Phase II are dosage etc determining trials. Different doses and regimens are used, and the company determines which is the best for the final test.
Phase III trials are big. This is where the drug has to prove itself better than the competition in sort of real-world conditions. Often, this is the first time a large number of people get the drug. Interesting things happen here.

One thing I hope is changing - often studies in the past have used 'surrogate markers' in place of endpoint markers, with the accepted assumption that the surrogate correlated with the true endpoint (ex: reduction in serum cholesterol equates to reduction in death from heart disease). Turns out quite a few surrogates are not as predictive as expected. I think trials are going to become more expensive as they turn to the actual markers.

Over prescription - amen to that! I'm seeing a lot of people (finally) told to do sinus flushes for infections, in place of the automatic antibiotics they took with each cold, 'just in case'.

[piqaboo]

OTC dosing - I'm with ya there Shap. However:
dose is a compromise, between efficacy and safety. The kidneys/liver/whathave you of the larger person are probably not commensurately more effective. Still, for pain meds to work, the larger person needs more.

I went to a class with a bunch of animal med-tech type people. We were given 'homework', to calculate anaesthetic doses, based on drug strength and animal weight. I used the quotes because I did mine in my head while the assignment was being explained. However, most of the class reported it took more than an hour that night, and they didnt finish because it was too hard. So, manufacturers put tables on the backs of bottles. You see it mostly in pediatric OTCs where there is a table with dosage by weight range.

FWIW, the current dose of tylenol is 7 mg/lb for infants. Not that I ever calculate from memory. I have the dose written down, and I refer to it before making the calculation.

[piqaboo]

Think of the potential, both for good and for amazing error, in this!

Pentagon, medical facilities pursue regenerative medicine
[url=http://r.smartbrief.com/resp/ljiMkCrDkIzvAICibvasyTcT?format=standard]CNN article
[/url]
The Pentagon and other medical facilities are pursuing a major regenerative medicine study with almost $250 million in dedicated funds. A focus of the study is a powder made from pig tissue, which tricks the body's stem cells into regrowing body parts. "If it is next to the skin, it will start making skin. If it's next to a tendon, it will start making a tendon," said a Brooke Army Medical Center doctor

[jamiebk]

Think of the potential, both for good and for amazing error, in this!

Pentagon, medical facilities pursue regenerative medicine
[url=http://r.smartbrief.com/resp/ljiMkCrDkIzvAICibvasyTcT?format=standard]CNN article
[/url]
The Pentagon and other medical facilities are pursuing a major regenerative medicine study with almost $250 million in dedicated funds. A focus of the study is a powder made from pig tissue, which tricks the body's stem cells into regrowing body parts. "If it is next to the skin, it will start making skin. If it's next to a tendon, it will start making a tendon," said a Brooke Army Medical Center doctor

The sex shops could make a killing on this stuff

[Serenity]

What if you grow it on a culture of one body part and embed it in another?

[Serenity]

Yesterday I had old medicine done............i had an ingrown toenail that cut into my skin and got infected .......I went through 10 days of antibiotics to kill the biotic battlefield!

yesterday.................the podiatrist injected my toe with Novacain (it felt like someone was stabbing my inmobilized toe with an ice pick).....as he squeezed the novacain into my toe (once on each side of my toe..so that's twice), it felt as though someone had lit a bonfire under my toe and was fanning the flames as he slowly squeezed the stuff in....I hugged the top of the chair behind me with my arms as hard as i could so as not to make any jerky-foot movements that would piss-him-off or kick him in the jaw or chest as a knee-jerk reaction.................

Those 10 minutes of Novacaine numbing were welcome............there was a flimsy flap covering sight of the butchering happening on the other side and, although i was dying of curiosity and wanted to ask many questions, my other half wanted me to keep my mouth shut and not know any details.

i went home with a gigantic-mummy-bandage wrapped around my big toe that made my foot fit tightly into my shoe and, as I limped forward, felt as though the seam of my shoe kept "pulling" my toenail upward (and OFF!) with every step....

and now I sit here, half-drunk, staring at the complicated mummy-wrap the doctor performed, wanting to snip it away and discover an awful, RAW-looking eyesore, visibly pulsating in PAIN! as I anxiously await WWF Friday-night Wrestling to help me tough it out!

[Shapley]

I hope that, when you wake up sober, your toe will feel better than your head!

[Selma in Sandy Eggo]

[quote="Serenity"and now I sit here, half-drunk, staring at the complicated mummy-wrap the doctor performed, wanting to snip it away ...[/quote]
Snip away. Soak your poor foot in some nice warm salt water and it'll all feel better. Bare feet and sandals for you for a couple of days, though!

[Haggis@wk]

Depressing when you consider the treatment for ingrown toenail has not advanced since Hippocrates.

[jamiebk]

Thank the stars for Lidocaine/novocaine though. That first needle jab is nothing compared to the pain of some of these procedures. Everytime I watch a civil war film (or Master and Commander) I just about get sick thinking about how they lopped off arms and legs etc.

[Serenity]

......and so I passed out......no headache though (must be quality liquor)...........

it took me half an hour to pull off the adhesive tape in reverse order (that really sticky adhesive that you can see still clinging to the opposite surface even though there's a 2 mm separation). When I got to the gauze pad, it was soaked in dried blood. I removed several layers carefully 'til I got to the last couple. I looked at the waste can and thought, "Yuk, I better throw that out before someone else sees it and pukes" . i took 2 deep breaths and peeled off the last 2 layers of gauze while semi-holding my breath. It looked like I was looking at someone else's toe . The whole toe was swollen, especially around the joint and the skin around the entire nail, with a couple of bloody spots at the tip and base of the nail. There was also a clear ooze building at the edges of the nail . I got in the shower, being careful of not letting too much water pounce on my foot. Still, it felt like the shower drops were bouncing off my toe like those bouncy, hard rubber balls that kids play with . I watched the water and soap (the soap didn't sting like I feared) flush away the blood and ooze. I kept looking down at my toe to see if it had changed appearance a few second later . When dry, I took a 2x2 inch gauze pad, folded it in half and placed it softly on top of my nail after I had applied a string of Neosporin around the entire nail-skin interface like a bead of caulk over a crack. Two overlapping bandages went around the circumference of the toe and two more covered the top of the nail while folding the corners of the gauze. The checkup is in two weeks.

Thank you for sympathy. I wanted to share the aftermath of the procedure with you. And since that alcohol I applied worked so well, I'll have to reapply some more later today!

Time to limp into the sunset!

[jamiebk]

I'll spare you the gory details about my prostate biopsy yesterday....It's amazing what a vicodin and 2 glasses of wine will do for pain. I highly recommend.