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.
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
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.
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.
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.
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.
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?
Not to worry. Bookmark for when you need it. Don’t forget to talk to your MD.
http://www.phage-biotech.com/links.html
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.
> “The flu vaccine industry was killed by hillary’s child protection law”
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Not killed well enough! - Its still around killing people with the vaccine.
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> “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”
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Yep!
That is the purpose of the “food safety” bill just recently passed in the Senate. Real food is now to be regulated out.
Just stock-up on Del-Immune and honey.
No Worries!
Mostly made abroad, however.
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.
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.
You quack like a duck.
Ping... (Thanks, neverdem!)
You quack like a duck.
***********************
That’s brilliant, quack.
True in part. Bacteria are funny little buggies that swap DNA like Paris Hilton. Some strains have been made that way.
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.
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?
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