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New Antibiotics, Stat! - The drug makers are in a bind — and public health is in danger.
NATIONAL REVIEW ONLINE ^ | December 21, 2010 | Josh Bloom & Gilbert Ross

Posted on 12/21/2010 10:46:30 AM PST by neverdem

New Antibiotics, Stat!
The drug makers are in a bind — and public health is in danger.

The development of new antibiotics has slowed to a trickle, just when we need them most. As drug-resistant bacteria are on the rampage worldwide, we find ourselves in a most precarious situation — one not unlike the pre-antibiotic era, before penicillin, when staphylococcal and pneumococcal infections were the dominant pathogens. Now MRSA (methicillin-resistant Staphylococcus aureus) kills more people than AIDS every year, and various multiple-drug-resistant organisms have appeared, leaving doctors with few therapeutic weapons for treating a number of prevalent infections.

How did this happen? Much of the blame can be laid at the feet of the FDA.

In the mid-1990s, the FDA tightened up rules for approval of new antibiotics, requiring companies to provide evidence not only that the new drug candidate was effective and safe, but also that it was more effective than existing antibiotics. Bad move. The drug regulators also began requiring that more patients be enrolled in clinical trials, increasing the cost of drug development. The results were predictable: Drug companies dropped out of antibiotic research en masse.

This trend is clearly demonstrated in the number of new antibiotics. In successive four-year periods beginning in 1983, the number of new antibiotics approved has dropped from 16 (in the period from 1983 to 1987), to 14, 10, 7, and 4 (in the period from 2003 to 2007). And it’s getting worse, not better: only two since 2007. With so many companies having discontinued antibiotic research, the current pipeline is very weak, and so it is unlikely that any magic bullets will soon appear on the horizon.

This repeats a pattern seen two decades ago from which we failed to learn — what happened when the production of vaccines became too onerous and expensive. In 1984, Wyeth Laboratories announced that it would no longer produce its diphtheria-pertussis-tetanus (DPT) vaccine, which the company had been manufacturing for three decades. This was a continuation of an alarming trend, in which most vaccine makers had dropped out of the market, mostly because of the escalating cost of protecting themselves from predatory and frivolous lawsuits. By 1984, the number of companies producing the flu vaccine had fallen by more than half, and the only maker of live polio vaccine left was Lederle Laboratories.

In response to this problem, Congress created the Vaccines for Children Program (VFCP) in 1986. This was designed to provide a mechanism through which a child actually sickened by a vaccine could receive a settlement from a pool funded by fees collected from the vaccine makers. The fees were high –greater than 25 percent of the cost of the DPT vaccine — and the parents of the affected children could still opt out of the program and file civil suits. Despite this program, costs continued to skyrocket, and between 1988 and 2001, ten of 14 global vaccine makers stopped making routine childhood vaccines. Today just four companies are responsible for producing 80 percent of the world’s vaccines. And not surprisingly, between 2000 and 2003, there were unprecedented shortages of eight of the eleven vaccines routinely given to children.

Now, more than 20 years have passed, and Congress has finally awoken to the urgent need to encourage new antibiotic development. Our lawmakers are considering offering drug companies patent extensions and tax breaks, which are intended to regenerate a development pipeline for new antibiotics. Whether this extension will provide a sufficient incentive for drug companies is not clear, since antibiotics are far less profitable than drugs that must be taken for chronic conditions. But even in the best-case scenario, the flow of effective new drugs to combat resistant bacteria won’t start for several years.

Meanwhile, the bugs keep growing and mutating. If the resistance problem jumps ahead of the discovery process, we may again find ourselves with no reliable weapon against infection. Perhaps summing it up best, Dr. Brad Spellberg of the Harbor UCLA Medical Center said: “For these infections we’re back to dancing around a bubbling cauldron while rubbing two chicken bones together.”

— Josh Bloom, Ph.D., is director of public health, and Gilbert Ross, M.D., is medical director, of the American Council on Science and Health.



TOPICS: Culture/Society; Editorial; Government; Politics/Elections
KEYWORDS: antibiotics; fda; microbiology

1 posted on 12/21/2010 10:46:32 AM PST by neverdem
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To: neverdem

Government at its best, regulating us to death, literally.

The “protections” (food, drugs, air, water, internet, transportation) are to make us not think, or give up because they make it too easy to merely quit.


2 posted on 12/21/2010 10:48:55 AM PST by wac3rd (Somewhere in Hell, Ted Kennedy snickers....)
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To: wac3rd

Yep...good ole FDA....F the Da*n Americans..


3 posted on 12/21/2010 10:51:22 AM PST by goodnesswins (You deciding how to spend your health care $, thatÂ’s freedom. Govt deciding, thats a death panel)
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To: Mother Abigail; EBH; vetvetdoug; Smokin' Joe; Global2010; Battle Axe; null and void; ...
This trend is clearly demonstrated in the number of new antibiotics.

I assume they're not including antiviral drugs, just antibacterial drugs.

4 posted on 12/21/2010 10:51:49 AM PST by neverdem (Xin loi minh oi)
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To: neverdem

The FDA sets one of the four horseman free.


5 posted on 12/21/2010 10:53:00 AM PST by GBA (Not on our watch!)
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To: neverdem

they’d just as soon see a few of the infirm and dependent 6 feet under.


6 posted on 12/21/2010 10:54:12 AM PST by mo
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To: neverdem

“Now MRSA kills more people than AIDS every “

It is my understanding that AIDS actually kills very few people. AIDS (and HIV that precedes it) weaken the immune system so that the person dies of pneumonia or some other disease or infection due to a weak immune system.

So the article seems like a lot of gobbledygook. What we need is naturally strong immune systems and less reliance on drugs. That means changes in lifestyle are more important than changes in the drug development process. I’m not against drug development. But let’s get some perspective here.

Pre-existing conditions is one example. Health Insurance companies, Medicare, etal should be allowed/required to set rates based on lifestyle. Those engaged in promiscuous sex, alcoholism, Drug addiction and similar lifestyle choices should pay a higher rate than those with good lifestyle choices.

The health insurance market would do this naturally if allowed to do it. But government regulations protect and encourage risky lifestyle choices.


7 posted on 12/21/2010 10:59:08 AM PST by spintreebob
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To: neverdem

Unfortunately this propaganda piece leaves out the data about the billions in settlements the drug companies have to pay out for the harm caused by other drugs besides antibiotics. If they want to protect antibiotic research, fine. But this shouldn’t be used to let the drug companies avoid responsibility for drugs like Fen-Phen or the workplace shootings and child suicides occasioned by behavior modifying drugs.


8 posted on 12/21/2010 11:03:18 AM PST by Seruzawa (If you agree with the French raise your hand - If you are French raise both hands.)
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To: neverdem
Might this help? Plasma Therapy, An Alternative To Antibiotics?
9 posted on 12/21/2010 11:04:05 AM PST by decimon
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To: neverdem
In the mid-1990s

This was largely a side effect of Hillarycare. The flu vaccine industry was killed by hillary's child protection law, and the regulators did all sorts of other stupid things.

10 posted on 12/21/2010 11:09:11 AM PST by Cicero (Marcus Tullius)
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To: goodnesswins
How did this happen? Much of the blame can be laid at the feet of the FDA.

The FDA has killed so many Americans it's astounding.

11 posted on 12/21/2010 11:13:25 AM PST by Gondring (Paul Revere would have been flamed as a naysayer troll and told to go back to Boston.)
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To: neverdem

Not a word about the gross over-utilization of antibiotics in viral upper respiratory infections, or the HUGE number of antibiotics pumped into the food chain through livestock and poultry. No wonder bacteria are becoming resistant. They are constantly exposed to conventional antibiotics.


12 posted on 12/21/2010 11:13:58 AM PST by CholeraJoe (Eat moer DUCK! War Eagle!!!!)
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To: neverdem

In the meantime, don’t abuse antibiotics.

Don’t take them unless you know you have an bacterial infection.

Take all the antibiotics prescribed for you, on schedule, and finish them.


13 posted on 12/21/2010 11:15:28 AM PST by justlurking (The only remedy for a bad guy with a gun is a good WOMAN (Sgt. Kimberly Munley) with a gun)
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To: All

Hey, but there’s plenty of erectile dysfunction drugs, anti-depressants and advertisements.

Big pharma doesn’t get a pass from me.


14 posted on 12/21/2010 11:16:00 AM PST by Irenic
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To: neverdem

The FDA, protecting us to death.


15 posted on 12/21/2010 11:20:27 AM PST by circlecity
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To: CholeraJoe

You’re right.

This reads like the typical propaganda from the medical industry: No need to use existing drugs wisely, lets just crank out more of them quicker. No doubt the new ones will cost more too.


16 posted on 12/21/2010 11:23:31 AM PST by Pessimist
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To: neverdem

Spineless politicians putting the interests of the Trial Lawyers ahead of the American people


17 posted on 12/21/2010 11:24:02 AM PST by Gopher Broke (Repeal Obamacare !!)
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To: spintreebob

“What we need is naturally strong immune systems and less reliance on drugs.”

True...but that may not save your life if you have an acute infection, particularly MRSA. Young athletes, which one could reasonably assume to have functional immune systems, have been taken down by MRSA. We need both - a strong immune system and the availability of effective antibiotics for worse-case scenarios.


18 posted on 12/21/2010 11:50:08 AM PST by Magic Fingers
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To: neverdem

Much of the blame for resistant bugs falls squarely on the HIV+ and gay community in general.

The HIV+ are immune-suppressed and so are dependant on lots of anti-biotics. They continue with their reckless livestiles, not only spreading HIV, but spreading drug-resitant bugs of other sorts that get out into the community.

All part of the joy that tolerance of irresponsbile people bring.


19 posted on 12/21/2010 12:03:33 PM PST by TheThirdRuffian (Nothing to see here. Move along.)
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To: neverdem

Our Government Masters fr!gging around, again; this time endangering citizen lives, rather than merely wallets.


20 posted on 12/21/2010 12:20:15 PM PST by Jack Hammer
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To: neverdem

That is certainly part of the problem, but I still shake my head at all of the doctors offices, ER’s and clinics who dispense antibiotics like M&M’s, particularly for viral infections


21 posted on 12/21/2010 12:42:54 PM PST by Buckeye McFrog
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To: neverdem

My next door neighbor just nearly died of a scratch (didn’t even bleed) he got when he bumped into a flowerpot on his steps. Two days later he was on IV antibiotics in the emergency room, then spent several days in MICU, and a week later he is out but has an IV needle in his hand for his every-morning visit to the hospital for an IV antibiotic infusion. This will go on for another week.

People underestimate the possibility of things like this in modern times. Once upon a time, a wound infection that became systemic was a very common cause of death, and it will be again unless we take it seriously.


22 posted on 12/21/2010 1:23:15 PM PST by livius
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To: neverdem

No bugs are “mutating”. Resistant populations always existed. They were the remnant hopefully finished off by your natural immunity after the disease was reduced. But they were a minority with no competitive advantage until antibiotics killed their non-resistent brothers and they got back into the environment in large numbers.


23 posted on 12/21/2010 3:03:51 PM PST by UnbelievingScumOnTheOtherSide (REPEAL WASHINGTON! -- Islam Delenda Est! -- I Want Constantinople Back. -- Rumble thee forth.)
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To: Buckeye McFrog

My clinic doesn’t dispense antibiotics like M&M’s. I was just there, but I didn’t necessarily want an antibiotic, what I wanted was something that would successfully depress my cough enough so I could SLEEP. I do not think sleep is overrated, if you can sleep your body can repair itself, and Robitussin plus codeine did the trick.

My biggest gripe is there are other bacteria other then strep. The only bacteria they test for on a regular basis is strep. Sometimes it really does help to have an antibiotic even if the strep test comes out normal.

Or and anyone who crosses over into Mexico can bring back their own Penicillin which they take whenever they think they need it.


24 posted on 12/21/2010 3:27:56 PM PST by tickles
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To: Seruzawa
Unfortunately this propaganda piece leaves out the data about the billions in settlements the drug companies have to pay out for the harm caused by other drugs besides antibiotics.

Propaganda piece? Maybe you need to read it again. The article is a grim assessment of the state of the pipeline for new antibiotics to deal with the many bugs that are resistant to existing drugs, and the role government played in creating the mess.

Most people have no idea what's involved in creating sophisticated compounds to combat complex diseases. Instead, they look at the drug companies as the bad guys and as a lottery ticket to be cashed whenever something goes wrong. As such, you get what you get: an industry taking fewer risks and making profits from lifestyle drugs rather than life saving drugs. Unfortunately, we'll get what we deserve.

25 posted on 12/21/2010 4:10:50 PM PST by Mase (Save me from the people who would save me from myself!)
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To: Irenic
Hey, but there’s plenty of erectile dysfunction drugs, anti-depressants and advertisements.

Damn those companies for making products people want. They should be making products they're told to make instead. Damn them for advertising their products. If only someone, like government, would force them to spend that money on things you think are more important.

Big pharma doesn’t get a pass from me.

How about Little Pharma?

26 posted on 12/21/2010 4:16:31 PM PST by Mase (Save me from the people who would save me from myself!)
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To: neverdem

Not to worry. Bookmark for when you need it. Don’t forget to talk to your MD.

http://www.phage-biotech.com/links.html


27 posted on 12/21/2010 5:26:15 PM PST by meatloaf
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To: neverdem

This is about the fact they want many of us to just die.

If they don’t kill us one way, they will create the situation where you will die in another way.


28 posted on 12/21/2010 5:29:01 PM PST by dforest
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To: Cicero

> “The flu vaccine industry was killed by hillary’s child protection law”

.
Not killed well enough! - Its still around killing people with the vaccine.
.


29 posted on 12/21/2010 5:37:03 PM PST by editor-surveyor (Obamacare is America's kristallnacht !!)
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To: indylindy

> “This is about the fact they want many of us to just die.

“If they don’t kill us one way, they will create the situation where you will die in another way”

.
Yep!

That is the purpose of the “food safety” bill just recently passed in the Senate. Real food is now to be regulated out.


30 posted on 12/21/2010 5:39:50 PM PST by editor-surveyor (Obamacare is America's kristallnacht !!)
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To: meatloaf

Just stock-up on Del-Immune and honey.

No Worries!


31 posted on 12/21/2010 5:43:40 PM PST by editor-surveyor (Obamacare is America's kristallnacht !!)
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To: editor-surveyor

Mostly made abroad, however.


32 posted on 12/21/2010 5:44:35 PM PST by Cicero (Marcus Tullius)
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To: editor-surveyor

The democrats have been meddling in the fields of healthcare and medicine for more years than I can count. I remember going to a doctor, paying for the visit out of pocket and getting a prescription all without any help from insurance or the government.

All of this neddling on purpose to bring us to this horrible point. One election has resulted in the implementation of all their diabolically planned schemes, all in the name of “helping the people”.

This last week has left me cold.


33 posted on 12/21/2010 5:49:53 PM PST by dforest
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To: Mase
Damn those companies for making products people want.

They convince/lobby physicians to prescribe and consumers to demand (building a better consumer--not a better product...also, I wonder if those doc's hold stock in this stuff, the politicians?)

They should be making products they're told to make instead.

Nice drama there.

Damn them for advertising their products.

Actually, somewhat, yes. They suck at the public teat for research and development and more is spent on advertisement than on their R&D. I'm not pro-corporate welfare, are you?

If only someone, like government, would force them to spend that money on things you think are more important.

Uh, that's part of the problem-- government has put their fingers in the pie to 'fix' things and gov't has mostly created this monster. I don't blame Big Pharma for taking advantage, it's business. I also don't intend to smile about it, either. This costs tax dollars-- my children and grandchildren will carry the cost-burden for this folly.

Bayh–Dole Act...Hatch-Waxman Act are just a couple and they have lead to many unintended consequences

How about Little Pharma?

Yes, I tend to give small bio-tech a pass. They are usually the ones who come up with most of our new and innovative drugs/breakthroughs. Big Pharma is like Big Government and I don't like it. Thank you.

I haven't formed my opinions off-the-cuff and I will support my opinions with the research I have found, if you want. The server seems to be laggin' hard this eve, so if more is needed, I will post tomorrow.

If my research is wrong-- then perhaps you can show me yours and change my opinion?

I am not anti-business or a big gov't dupe. I am also not an apologist, water-girl, sheeple for every single business out there.

Ethanol...that's a business plan that needs the BIG gov't kicked out from under it-- I feel the same about Big Pharma. Do you think we'll get the better research/product that the market is begging, while BIG gov't (tax payer) is lining their pockets-- just to stay the course? I'm not that hopeful.

We're broke and they're a burden and they're not meeting our needs. It's time to cut the umbilical cord.

34 posted on 12/21/2010 10:36:48 PM PST by Irenic
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To: Irenic
Big Pharma is like Big Government and I don't like it. Thank you.

You quack like a duck.

35 posted on 12/21/2010 11:05:13 PM PST by Chunga (Go, Sarah, GO!! - Jim Robinson)
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To: 2ndreconmarine; Fitzcarraldo; Covenantor; Mother Abigail; EBH; Dog Gone; ...

Ping... (Thanks, neverdem!)


36 posted on 12/21/2010 11:07:06 PM PST by Smokin' Joe (How often God must weep at humans' folly. Stand fast. God knows what He is doing.)
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To: Chunga

You quack like a duck.
***********************
That’s brilliant, quack.


37 posted on 12/22/2010 12:13:41 AM PST by Irenic
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To: UnbelievingScumOnTheOtherSide

True in part. Bacteria are funny little buggies that swap DNA like Paris Hilton. Some strains have been made that way.


38 posted on 12/22/2010 6:54:33 AM PST by redgolum ("God is dead" -- Nietzsche. "Nietzsche is dead" -- God.)
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To: neverdem

With antibiotics, less is more. Here’s the logic.

1) Resistant strains of bacteria are generally caused by overuse and improper use of antibiotics.

2) Oddly enough, most resistant strains of bacteria are not harmful when in balance with our other intestinal flora. Most of us have some resistant strains in us right now, with no ill effects. There are typically 300-1000 different types of bacteria in our gut right now, dominated by just 30-40 different types, that occupy almost all the space.

3) What makes resistant bacteria harmful is when you take antibiotics that wipe out the *other* intestinal flora. This results in a population explosion of the resistant strains. And while a little of this resistant bacteria is usually not harmful, a *lot* of it is very, very harmful.

4) When a hospital is hit with an outbreak of a resistant strain, their typical response is to *assume* that there is something in the hospital that is physically contaminated, which is spreading the disease. So they clean everything. But it doesn’t work, because the bacteria causing the problem is not “out there”, but already inside their patients.

5) A few hospitals plagued with outbreaks of resistant strains, have stopped the epidemic in its tracks, by simply enforcing stringent antibiotics discipline. That is, only giving targeted antibiotics to patients with *proven* bacterial infections of a known type.

6) One of the latest techniques is called “fecal transplant”, which basically means the transfer of a sample of a healthy person’s intestinal flora to the intestines of a sick person with a “bad” or “weak” intestinal flora. Often doing so reverses both acute and chronic health problems.


39 posted on 12/22/2010 9:00:52 AM PST by yefragetuwrabrumuy
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To: Irenic
They convince/lobby physicians to prescribe and consumers to demand (building a better consumer--not a better product...also, I wonder if those doc's hold stock in this stuff, the politicians?)

Damn them! Doctors and individuals freely determining what the best course of treatment is for any particular ailment. This must be stopped. The government must do something. Only government can determine what's in our best interest. The American public is far too stupid to make these decisions on their own. It's just like the food companies manipulating us into eating junk food with their advertising. We're too stupid to discern good from bad. Government: please do something, and do it now!!

Nice drama there.

If you don't like the products they make, what's your solution for change? If the market doesn't determine what products get developed, and how they are marketed, who does? The government? You?

Actually, somewhat, yes. They suck at the public teat for research and development and more is spent on advertisement than on their R&D.

The real Irenic surfaces. Primary research is mostly conducted at universities and mostly survives on taxpayer funding. This amount, however, is minuscule compared to the burgeoining social welfare programs that make slaves out of tens off millions. This method may be repugnant to you but it is one reason why 90% of all new drugs are discovered in the USA.

I'm sure you have no idea how to read a financial statement, otherwise you wouldn't have bought into the lie that "Big (bad) Pharma" spends more on advertising than on R&D. Liberals use that talking point (lie) to promote their war on the drug industry and to show the need for more government control of what they do. You've become useful to them. Beyond all that though, what business is it of yours how they spend or invest their money? Are you a shareholder? If so, there are avenues for you to make your opinion known. You can always sell your shares and invest in more socially conscious companies. Otherwise, it's absolutely no business of yours.

Uh, that's part of the problem-- government has put their fingers in the pie to 'fix' things and gov't has mostly created this monster.

Big Pharma is a monster? The same monster that provides us with the drugs that save lives and make life more enjoyable? First you argue that we need government (if not government, then who?) to set these companies straight on their priorities, but now you want to argue that government meddling is the problem. I think you're confused.

I don't blame Big Pharma for taking advantage, it's business.

Taking advantage of what, commercializing new and innovative drugs to provide you with a more comfortable life that is longer today than at any other time in history?

This costs tax dollars-- my children and grandchildren will carry the cost-burden for this folly.

Your children and grandchildren are going to carry the cost of the folly of new and innovative therapies being created to treat an ever growing list of maladies we suffer from? Maybe you need to look at what's causing the budget deficit to grow.

Bayh–Dole Act...Hatch-Waxman Act are just a couple and they have lead to many unintended consequences

Sounds like government is the problem. Why in the world then, would you want to empower them even more?

Yes, I tend to give small bio-tech a pass.

Even though most of them are partnering with some university using your tax dollars on these follies and, in most cases, are partnered with "Big (bad) Pharma?"

They are usually the ones who come up with most of our new and innovative drugs/breakthroughs.

Even though those discoveries come from primary research funded by your tax dollars and a close association with "Big (bad) Pharma?"

Big Pharma is like Big Government and I don't like it. Thank you.\

Big Pharma is nothing like big government. You have no understanding of the industry you're railing against. Your ignorance causes you to say such things and your opinions are what I'd expect to hear from a hard core leftist, not from a conservative on a conservative forum.

I am not anti-business or a big gov't dupe.

You just sound like an anti-business big gov't dupe. Got it.

I feel the same about Big Pharma. Do you think we'll get the better research/product that the market is begging, while BIG gov't (tax payer) is lining their pockets-- just to stay the course?

So, Big Pharma is making obscene profits thanks to government lining their pockets? Again, I don't think you ever learned how to read a financial statement. If what you claim is true though, maybe you should purchase some stock in these companies. As evidence to the contrary, I submit the fact that to bring a NME to market it can cost "Big Pharma" almost a billion dollars and can take up to 13 years. Then, of course, the patent can expire in just four years. Yeah, four years to recoup your investment and turn a profit before your property is turned over to the generic packers. Great. In the meantime, "Big Pharma" has to resist government attempts to install price controls on their products, thereby determining their profits, while battling the economic illiterates who want to re-import drugs from countries that force "Big Pharma" to sell to them at the price they're willing to pay. Yup, big government is lining the pockets of those evil drug companies. Uh, huh. Fur shure.

We're broke and they're a burden and they're not meeting our needs. It's time to cut the umbilical cord.

Yup, let's cut the umbilical cord that's a drop in the bucket in the annual budget, while ignoring the massive growth in entitlement spending, to cut the drug pipeline at it's earliest stage. Nothing but good can come from something like that. I'm sure your "new way" will promptly fill the pipeline with the drugs that will "meet our needs." Good luck with that.

Did you learn this nonsense from hard core leftist professors while you weren't studying science and economics?

40 posted on 12/22/2010 2:00:59 PM PST by Mase (Save me from the people who would save me from myself!)
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To: Mase
There is much info available about the efficacy of intraveous Vit C combating these super bugs.

I know of no one who has done it but it needs to be explored more because we're certainly working our way into a box and if there is a better way available, we need to be open to it.

41 posted on 12/23/2010 8:43:41 AM PST by Conservativegreatgrandma
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